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Inovio at 23rd HCW on 9/13. Dr. Kim’s presentation should be available at 7am on Monday via their website.
https://journey.ct.events/view/207eb2d6-26cb-4553-ab0a-5e43f4b94542
H.C. Wainwright 23rd Annual Global Investment Conference - September 13-15, 2021
Eastern Daylight Time
INOVIO Pharmaceuticals, Inc.
Live on Monday, 9/13 at 7:00 AM (Eastern Standard Time)
Please register to view.
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4800 China Booster study Link: A randomized, double-blinded, placebo-controlled phase II clinical study to evaluate the intradermal injection of different doses of COVID-19 DNA vaccine and the booster vaccination of inactivated vaccines in healthy adult and elderly subjects
https://www.chictr.org.cn/hvshowproject.aspx?ID=96769
Registration number:
ChiCTR2000040146
Date of Last Refreshed on:
2021/8/4 23:41:55
second segment: Primary objectives: 1.To evaluate the humoral immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the safety of the healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. Secondary objective: To evaluate the cellular immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine.
Exploratory objective: 1.To evaluate the immunogenicity persistence in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the neutralizing response against COVID-19 variants in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine.
Outcome:
GMT of specific antibody against S protein of SARS-CoV-2
GMT of neutralizing antibody against S protein of SARS-CoV-2
Measure time point of outcome:
30 days after the second dose of vaccine
Group:
The second segment: A1 group
Sample size:
????:
??????????(Vero??)0.5mL
??????:
Intervention:
COVID-19 Inactivated Vaccine (CoronaVac) 0.5mL
Intervention code:
??:
????:A2?
???:
50
Group:
The second segment: A2 group
Sample size:
????:
??????????(Vero??)0.5mL
??????:
Intervention:
COVID-19 Inactivated Vaccine (CoronaVac) 0.5mL
Intervention code:
??:
????:A3?
???:
25
Group:
The second segment: A3 group
Sample size:
????:
???? pGX9501 1.0 mg
??????:
Intervention:
pGX9501 1.0 mg
Intervention code:
??:
????:A4?
???:
25
Group:
The second segment: A4 group
Sample size:
????:
???? pGX9501 2.0 mg
??????
Pfizer has been accused of “bullying” Latin American governments in COVID-19 vaccine negotiations and has asked some countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases.
https://science.thewire.in/health/pfizer-demands-governments-gamble-with-state-assets-to-secure-vaccine-deal/
Inovio welcome you.
Mexico’s COFEPRIS, Argentina’s ANMAT, Peru’s DIGEMID (Lambda variant, world highest CV death/1M pop), Columbia’s INVIMA (MU variant), Thailand‘s FDA, Czech’s SUKL, Poland’s BIP, South Africa’s MCCZA (Beta variant).
This is a global study with a forecast of 7,116 participants distributed among Brazil, Argentina, Colombia, Philippines, Mexico, Peru, Poland, Czech Republic and Thailand. Africa was added per 8/9/21 2Q21 ER CC.
Brazi’s ANVISA (Gamma variant), Philippines’ FDA already authorized 4800 P3 start.
Two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine and Sinovac.
Is Inovio Stock A Buy After Brazil OKs Phase 3 Test For Covid Vaccine?
Brazil's national health agency gave Inovio the go-ahead to run a Phase 2 and Phase 3 study of its shot-plus-device Covid vaccine. The company is also planning to conduct the final-phase test in multiple countries with its partner, Advaccine Biopharmaceuticals Suzhou.
Also last month, INO stock popped after the company dosed the first participant in a study to vaccinate against Middle East Respiratory Syndrome, or MERS. The illness is caused by a coronavirus. It's more fatal than Covid, though far less common.
It has big biopharma partners like AZN, REGN.
The revenue picture could change quickly if Inovio succeeds in making an effective coronavirus vaccine. The biotech also has a drug in Phase 3 testing to treat a precancerous condition of the cervix. It's partnered with privately held ApolloBio on that drug.
As of June, 232 funds owned 25% of Inovio stock.
Analysts say it's possible Inovio could still launch its vaccine and device internationally. And, now, Advaccine is partnering on the Phase 3 test. That news, on June 9, sent INO stock flying higher.
Last month, Inovio and Advaccine received regulatory clearance to test a boosting strategy using the experimental Covid vaccine and one from Sinovac Biotechnology. The study will take place in China and test sequential immunizations using the two vaccines.
The firm is also working on a vaccine to target Covid variants. In May, the company said preclinical tests showed the vaccine induced immune responses against the variants first found in the U.K., South Africa and Brazil, as well as the original strain.
In Feb, INO stock soared after a Reddit user called for a short squeeze of the stock. Also helping the biotech company: BlackRock, an investment management firm, upped its stake to more than 14.2 M shares. It now owns 8.4%.
What is important, for now, is watching INO stock as the biotech company works to get back on track in developing coronavirus vaccine. Its DNA approach differs from traditional vaccines and from the newer messenger RNA approach.
Moderna’s stock price is ‘ridiculous,’ says BofA analyst
Last Updated: Aug. 11, 2021 at 8:25 a.m. ET
Valuation is no longer just ‘unreasonable,’ as bearish analyst Geoff Meacham’s price target implies a decline of more than 75%
Shares of Moderna Inc. have soared so much that the biotechnology company’s valuation is “unjustifiable on a fundamental basis,” said analyst Geoff Meacham on Tuesday, as his analysis suggests the stock should be priced roughly 75% below current levels.
On Monday, the stock shot up 17.1%, the biggest one-day gain in nearly nine months, to a record close of $484.47, after the company’s COVID-19 vaccine was granted provisional authorization in Australia. At that price, the stock had rocketed 364% year to date, and valued the company at $195.56 billion.
“Valuation: From unreasonable to ridiculous.”
— Analyst Geoff Meacham at BofA Securities wrote in a note to clients.
At that valuation, Meacham, an analyst at Bank of America, noted that the 11-year-old company was worth more than the 40-year-old Amgen Inc. AMGN , which is currently at about $129.3 billion, and the 130-year-old Merck & Co. Inc. MRK , at roughly $189.7 billion, both of which are Dow Jones Industrial Average DJIA components.
Meacham reiterated his underperform rating on the stock and kept his price target at $115, which is 75.2% below current levels.
He said that while Moderna’s COVID-19 vaccine has been a major contributor to the global recovery, to justify $200 billion in value, one would have to assume two things:
Moderna would deliver 1 billion to 1.5 billion doses of its COVID-19 vaccine each year through 2038.
100% probability of success for the company’s entire pipeline, which includes four programs in Phase 2 trials, 10 Phase 1 programs and eight preclinical programs not yet in human testing, for total peak sales of $30 billion. In comparison, Moderna has recorded total revenue of about $7 billion over the past four quarters.
“These assumptions are, in our view, impossible to justify,” Meacham wrote.
The stock dropped 4.2% in afternoon trading on Tuesday, bringing Moderna’s market capitalization down to $187.3 billion, which would put it just below Merck’s current market cap.
The analyst acknowledged that he was bullish on the mRNA technology that Moderna’s vaccine is based on, it’s just how the market has valued the company that has made him bearish on the stock.
“While we acknowledge the momentum could continue, we reiterate our underperform rating especially given broad C-19 expert feedback that goes against overly bullish market sentiment,” Meacham wrote.
Moderna’s stock has skyrocketed 544.6% over the past 12 months. In comparison, shares of Pfizer Inc. PFE have rallied 32..5% and BioNTech SE BNTX have soared 473.9% over the past year, while the S&P 500 index SPX has advanced 32.0%.
Oppenheimer reiterated a "buy" rating and set a $35.00 target price on shares of Inovio Pharmaceuticals in a research note on Friday, July 2nd. Jefferies Financial Group initiated coverage on Inovio Pharmaceuticals in a research note on Thursday, June 24th. They set a "hold" rating and a $9.00 price objective on the stock. Zacks Investment Research cut Inovio Pharmaceuticals from a "hold" rating to a "sell" rating in a research note on Friday, August 13th.
Ino was downgraded by investment analysts at Bank of America from a "neutral" rating to an "underperform" rating in a research note issued to investors on Sept 10th. They presently have a $8.00 target price, down from their prior target price of $9.00.
Inovio downgraded to Underperform from Neutral at BofA BofA analyst Geoff Meacham downgraded Inovio to Underperform from Neutral with a price target of $8, down from $9. Meacham continues to see limited opportunity from the COVID-19 asset, for which he believes there is still meaningful value being reflected in the share price, the analyst tells investors in a research note.
Read more at:
https://thefly.com/n.php?id=3370280
Three equities research analysts have rated the stock with a sell rating, four have assigned a hold rating and three have given a buy rating to the company's stock. Inovio Pharmaceuticals currently has a consensus rating of "Hold" and an average target price of $14.13.
4800 P3 Next Up are Mexico’s COFEPRIS, Argentina’s ANMAT, Peru’s DIGEMID (Lambda variant, world highest CV death/1M pop), Columbia’s INVIMA (MU variant), Thailand‘s FDA, Czech’s SUKL, Poland’s BIP, South Africa’s MCCZA
This is a global study with a forecast of 7,116 participants distributed among Brazil, Argentina, Colombia, Philippines, Mexico, Peru, Poland, Czech Republic and Thailand. Africa was added per 8/9/21 2Q21 ER CC.
Brazi’s ANVISA, Philippines’ FDA already authorized 4800 P3 start.
two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") together with Sinovac Biotechnology ("Sinovac").
https://www.who.int/medicines/areas/quality_safety/regulation_legislation/list_mra_websites_nov2012.pdf
9/9/21 The @FDAPhilippines has authorized the start of our global Phase 3 trial in the Philippines for INO-4800. With many countries experiencing low vaccination rates and an increase in infections, INOVIO is committed to supporting the worldwide #COVID19 response.
The @FDAPhilippines has authorized the start of our global Phase 3 trial in the Philippines for INO-4800. With many countries experiencing low vaccination rates and an increase in infections, INOVIO is committed to supporting the worldwide #COVID19 response. pic.twitter.com/4x688PGTiM
— INOVIO Pharmaceuticals (@InovioPharma) September 9, 2021
September 2021: Initiate Phase 3 segment of global INNOVATE efficacy trial
2H21: Report complete REVEAL 1 data
INO-5401
4Q21: Present 24-month survival and immunology data at SNO 2021
26th Annual Meeting and Education Day of the Society for Neuro-Oncology
November 18 - 21, 2021
The General Abstract acceptance emails were sent on 8/6/21
Embargo Details:
The embargo for abstracts published in the 2021 abstract supplement to SNO official journal Neuro-Oncology will lift at 7:00 AM (EDT) on Thursday, November 11, 2021.
These abstracts will be made available at: https://academic.oup.com/neuro-oncology
General Abstract Deadline was Monday, May 24, 2021, 11:59pm EDT
Late Breaking Abstract Deadline: Friday, September 3, 2021, 11:59pm EST.
Chinese and foreign pharmaceutical companies All in: The world's first new crown DNA vaccine is approved, and the third vaccine revolution is accelerating?
"A few days ago, Ai Di Weixin announced that the company plans to submit a biological preparation license application or emergency use authorization application for DNA vaccines to the National Medical Products Administration in the second half of 2021. It is expected that as many as 100 million doses of vaccines will be produced in China in 2021."
"In addition, Inovio uses its patented drug delivery device Cellectra to deliver the drug. This instrument can send short electrical pulses to reversibly open small holes in the cell membrane so that the drug can enter the cell membrane. Difficulty in transmembrane is a major limitation of nucleic acid drugs, and Cellectra provides an effective solution."
https://wap-eastmoney-com.translate.goog/a/202109082088166884.html?_x_tr_sl=zh-CN&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=ajax,nv,elem
9/8/21 Joint COVAX statement on Supply Forecast for 2021 and early 2022
This is a joint statement from the COVAX co-leads CEPI, Gavi, WHO, and UNICEF.
Geneva/New York/Oslo, 8 September 2021
Twelve months ago, the world came together to support COVAX, a multilateral initiative aimed at guaranteeing global access to life-saving COVID-19 vaccines.
With the support of the international community, COVAX immediately began securing financing, entering into negotiations with vaccine developers and manufacturers and addressing the host of technical and operational challenges associated with rolling out the largest and most complex vaccination programme in history.
COVAX has already achieved significant progress: more than US$10 billion has been raised; legally-binding commitments for up to 4.5 billion doses of vaccine; 240 million doses have been delivered to 139 countries in just six months.
Yet the global picture of access to COVID-19 vaccines is unacceptable. Only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries.
In the critical months during which COVAX was created, signed on participants, pooled demand, and raised enough money to make advance purchases of vaccines, much of the early global supply had already been bought by wealthy nations. Today, COVAX’s ability to protect the most vulnerable people in the world continues to be hampered by export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval.
According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021, in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX. Of these doses, approximately 1.2 billion will be available for the lower income economies participating in the COVAX Advance Market Commitment (AMC). This is enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India. Over 200 million doses will be allocated to self-financing participants. The key COVAX milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.
In addition to working closely with participating governments to ensure the conditions are in place on the ground to facilitate successful rollout of vaccines, COVAX and its partners call on donors and manufacturers to recommit their support, and prevent further delays to equitable access by ensuring the following:
– Manufacturers deliver to COVAX in accordance with firm commitments and provide transparency on timelines for availability to COVAX to allow countries to plan in advance.
– Where countries are ahead of COVAX in manufacturer queues, and already have achieved high coverage, to give up their place in the queue to COVAX so that its participants can access the doses already secured via supply contracts and deliver vaccines to where they are needed most.
– Expand, accelerate, and systematize dose donations from countries that are already well advanced in their vaccination programmes. This includes ensuring doses are available in larger and more predictable volumes, with longer shelf lives – reducing the burden on countries trying to prepare for deliveries.
As the COVID-19 pandemic continues to claim lives, destroy livelihoods and stunt economic recovery, we continue to emphasise that no one is safe until everyone is safe. There is only one way to end the pandemic and prevent the emergence of new and stubborn variants and that is by working together.
Inovio has applied for Rare and Orphan Designations for both VIN (Vulvar) and AIN (Anal) before starting P3’s.
Vulvar dysplasia is a rare disease that affects women in immunocompetent and immunocompromised populations. HPV-16/18-associated precancerous vulvar lesions (vulvar HSIL) are challenging to treat and typically require repeat ablation and excision procedures to achieve disease and risk reduction.
Without adequate treatment, vulvar HSIL can progress to vulvar cancer.
1/6/21
- DNA immunotherapy candidate VGX-3100 demonstrated clinically significant reduction of HPV-16/18-associated precancerous vulvar lesions in 63% of treated participants six months after treatment
- P2 results indicate that VGX-3100 can be a safe, tolerable and efficacious adjunct to current standard of care for women with vulvar dysplasia
- Phase 3 trial planned in 2021
A 25% or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based upon these results INOVIO is planning to pursue Phase 3 development.
Welcome to Mexico’s COFEPRIS, Argentina’s ANMAT, Philippines’ FDA, Peru’s Digemid, Columbia’s INVIMA.
https://www.who.int/medicines/areas/quality_safety/regulation_legislation/list_mra_websites_nov2012.pdf
INDONESIA INO-4800 DEVELOPMENT AND LICENSING GUIDANCE PROPOSAL
BEM KMFA UGM INDONESIA
Country Background Indonesia [276,943,775 ppl] is one of the most populated countries in the world with up to 2 million COVID-19 cases per June 2021 [4,140,634 cases 9/7/21]. Despite the high number of cases, Indonesia vaccination rate is still considered low compared to other countries, which is 4, 8%. There are only 3 licensed vaccines that are being used by the Indonesian government, therefore the number of doses available is still limited. By licensing INO-4800 in Indonesia, it is expected that INOVIO will contribute in increasing Indonesia’s vaccination rate by supplying more doses for the society. Considering the urgent need for a COVID-19 vaccine, we will apply for INO-4800 as an Emergency Use Authorization (EUA) and targeting a 22 months process from vaccine production until first legal dose in Indonesia.
https://scholar.google.com/scholar?hl=en&as_sdt=0,1&q=inovio&scisbd=1#d=gs_qabs&u=%23p%3DhPpsfsqOIlMJ
9/1/21 VIN P2 Completed, Ready for P3 w/ Partnership
Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
Record Verification: July 2021 => September 2021
Overall Status: Active, not recruiting => Completed
Study Completion: July 2021 [Anticipated ] => December 18, 2020 [Actual ]
Last Update Submitted that
Met QC Criteria: July 20, 2021 => September 1, 2021
Last Update Posted: July 27, 2021 [Actual ] => September 5, 2021 [Actual ]
Experimental: VGX-3100 + EP + Imiquimod
IM injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24. In addition, participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
https://clinicaltrials.gov/ct2/history/NCT03180684?A=37&B=38&C=Side-by-Side#StudyPageTop
Inovio has plans to conduct initial trials of DNA vaccines in Asia, South America and Africa. The company said last week that it has been authorized by the Brazilian regulatory agency and is expected to begin large-scale clinical trials of the DNA vaccine INO-4800 in Brazil in September. The company is expected to obtain regulatory authorization in more countries and regions in the next two weeks.
According to the agreement signed at the beginning of this year, Ai Diweixin will produce and sell Inovio's new crown vaccine candidate in China, and will obtain the exclusive rights of the vaccine in China. It is expected that up to 100 million doses of vaccine will be produced in China in 2021.
According to the prospectus, Ai Di Weixin plans to submit to the State Drug Administration in the second half of 2021 an application for a DNA vaccine biologics license or emergency use authorization application.
The India-approved DNA vaccine ZyCoV-D is administered via a needle-free device. This device generates a small flow of high-pressure fluid that can pierce the surface of the skin without the need for injections, eliminating the pain of injections. However, the vaccine requires at least three doses to be effective.
The researchers said that although the effectiveness of Zydus vaccine is not particularly high compared with the new coronavirus mRNA vaccine that has begun to be commonly vaccinated, the effectiveness of the vaccine is also against the Delta variant, so the success of the vaccine is still of great significance.
India Sony Pat Ashoka University virologist Shahid Jameel said: "If the DNA vaccine proved to be successful, then this represents the future of vaccinology as they are easy to produce."
researchers told the CBN reporter that DNA vaccines also have many advantages, such as easier production, and the finished product is more stable and easier to store than mRNA vaccines.
"MRNA vaccines usually need to be stored at a temperature of minus 80 degrees Celsius, but DNA vaccines can be stored at room temperature." A researcher at the Chinese Academy of Sciences who is developing DNA-related vaccines told China Business News. It is understood that DNA vaccines can be stable for more than 1 year at room temperature, and can be stored for 5 years at standard refrigeration temperatures (2°C-8°C). The requirements for storage conditions of mRNA vaccines are very stringent, and mRNA vaccines can only be stored for 5 days under standard refrigeration conditions.
some researchers believe that India’s approval process for the vaccine lacks transparency because it has not officially announced the results of late-stage clinical trials. In this regard, Zydus Cadila said that the clinical trial is still in progress and a complete analysis will be submitted for publication soon.
https://finance-sina-cn.translate.goog/2021-09-04/detail-iktzscyx2248937.d.html?from=wap&_x_tr_sl=zh-CN&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=ajax,nv,elem
$65B for • Conduct small human clinical trials for many vaccine candidates to assess safety, likely efficacy based on correlates/surrogates of protection, and the impact of dose and schedule on immungenicity. Small human research studies (“Phase 0”) can show whether a vaccine candidate can elicit immune responses expected to mediate protection, although they won’t directly test immune protection. (In the case of a highly transmissible and lethal threat from a pandemic or biological weapon, it is possible that biomarkers might need to serve as a substitute for direct protection.)
• Test the effectiveness of vaccines developed against multiple targets and multiple genetic variants. It will be important to assess the effectiveness of vaccines that target multiple viral proteins and/or genetic variants simultaneously. Such approaches might improve vaccine design in general, and might provide new ways to combat resilient and highly mutable viruses, like HIV and influenza, by encoding multiple targets in a single vaccine to generate broadly neutralizing antibodies and T-cell responses capable of broad-based protection.
• Test the ability to develop ‘universal vaccines’ against all viruses in a family or subfamily. A holy grail of vaccine research is creating vaccines that can protect against entire virus families, such as all coronaviruses or all influenza viruses, that mutate frequently and/or circulate seasonally. Programmable vaccine platforms will enable testing of multiple approaches to assess whether universal vaccines may be possible, with the potential to address entire families of viruses.
(2.2) Producing neutralizing antibodies against a virus. Develop, to deploy when a pandemic threat emerges, the ability to rapidly identify neutralizing antibodies in recovered patients and manufacture monoclonal antibodies for administration to infected individuals. While this approach is known to yield effective therapies for protecting infected individuals, we have lacked to ability to produce such antibodies at rapid-enough speed and large-enough scale for wide spread use.
• Ensure large-scale programmable manufacturing capacity for monoclonal antibodies. Continued efforts are needed to optimize the process for identifying and selecting neutralizing antibodies, and to design manufacturing processes for large-scale antibody production.
(1.3) Vaccine distribution. Enable delivery of vaccines rapidly and easily to anywhere in the world, by eliminating challenging requirements for transportation and storage.
• Simplify vaccine distribution and delivery, including by eliminating the need for cold chain. Vaccine formulations that do not require specialized conditions, such as ultra-cold temperatures, and are long-lived will simplify transportation to both resource-rich and resource- constrained settings around the world.
(1.5) Vaccine adaptation. Develop ways to quickly and easily update vaccines to keep pace with changes in the virus.
• Develop strategies to address viral variants that evade vaccine-induced immunity. As virus spreads, they will likely evolve the ability to increase their transmissibility — including in vaccinated individuals. Efforts should be undertaken now to understand the relative effectiveness of various strategies for dealing with vaccine evasion, including using boosters to increase antibody titer and administering ‘next-generation’ of vaccines matched to variant strains.
https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
This document that just dropped from the White House outlining it’s Plan to fund & be prepared for future pandemics is very interesting! Although they didn’t mention DNA or INO specifically… many of the goals they mentioned for improving vaccine effectiveness like t-cell response, vaccines that don’t need to be injected or stored at sub freezing temps had INO written all over them.
“Vaccine formulations that do not require specialized conditions, such as ultra-cold temperatures, and are long-lived will simplify transportation to both resource-rich and resource constrained settings around the world.
2.2) Producing neutralizing antibodies against a virus. Develop, to deploy when a pandemic threat emerges, the ability to rapidly identify neutralizing antibodies in recovered patients and manufacture monoclonal antibodies for administration to infected individuals. While this approach is known to yield effective therapies for protecting infected individuals, we have lacked to ability to produce such antibodies at rapid-enough speed and large-enough scale for wide spread use.“
https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
9/3 The White House wants $65 billion for an ‘Apollo’-style pandemic preparedness program
WASHINGTON — The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19.
The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s.
The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.
“For the first time in the nation’s history, due to these types of advancements in scientific technology, we have the opportunity not just to refill stockpiles but to transform our capabilities,” Lander said. “But we really need to start preparing now.”
Indeed, the White House funding request comes with a near-term deadline. While the spending would be spread over the coming seven to 10 years, it also includes an ask for at least $15 billion to be included within a forthcoming, $3.5 trillion budget plan still pending on Capitol Hill. The White House is still in discussions with Congress, Lander said, but he was “very optimistic” that lawmakers would agree to the request.
The new spending would target a wide array of new pandemic preparedness capabilities. It would include over $24 billion for vaccine infrastructure, with a goal of beginning to manufacture vaccine doses meant to protect against any virus family within 100 days of a pandemic threat first emerging.
The plan would include nearly $12 billion to develop — and have on hand — a range of treatments available for any known virus family even before a particular pathogen emerged as a pandemic threat.
It would also provide $5 billion for diagnostics that the government would aim to make available within weeks of identifying a new biosecurity threat.
“What this plan is about is ensuring the United States has the capabilities it needs to operationalize [its response] when we see the first signs of an emerging outbreak that could have epidemic or pandemic potential,” Beth Cameron, the top biosecurity expert on the National Security Council, said during the briefing.
It’s not yet clear how Congress will respond to the Biden administration’s sweeping proposal, which expands on a previous request to spend $30 billion over four years on improving future pandemic prevention and preparedness. In a subsequent version of Democrats’ budget bill, however, lawmakers included just $5 billion, drawing criticism from many public health experts who said the government was repeating the same mistakes that led to the country’s chaotic response to Covid-19.
The $65 billion proposal doesn’t stop at treatments, tests, and vaccines.
It would include $3.1 billion aimed at establishing an early-warning system for new disease outbreaks, including systems to sequence pathogens found in wastewater and a “reliable clinical surveillance system.” Biden also calls for spending to help reduce health inequity, fund lab capacity, and improve public health communication. He also wants to put money toward developing better protective equipment for health workers and creating better systems for “pathogen protection,” like better ventilation systems and surface cleaners.
The plan also includes measures to ensure that research and development “involving potentially dangerous biological agents is conducted safely and securely, by fostering a global research environment that adopts and enforces high standards.” The lab-safety provisions are a potential nod to the unproven theory that Covid-19 originated from “gain-of-function” research performed in a Chinese laboratory, a long-running controversy in U.S. and global politics.
https://www.statnews.com/2021/09/03/biden-wants-65-billion-for-apollo-style-pandemic-preparedness-program/
https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
Top 21 Covid Deaths/1M Pop: 1)Peru 6)Czech 9)Brazil 11)Argentina 12)Columbia 19) Mexico 20)Poland 21)USA 9/3/21
118) Philippines 131) Thailand
4800 P3 is a global study with a forecast of 7,116 participants distributed among Brazil, Argentina, Colombia, United States of America, Philippines, Mexico, Peru, Poland, Czech Republic and Thailand. Initial studies (Phase 1 and 2) were carried out in the United States, South Korea and China)
4802 P1/2 will be most likely externally funded or partnered, and conducted in S Africa, India, and more countries.
# Country,
Other Total
Cases New
Cases Total
Deaths New
Deaths Total
Recovered New
Recovered Active
Cases Serious,
Critical Tot Cases/
1M pop Deaths/
1M pop Total
Tests Tests/
1M pop Population
1 Peru 2,152,118 198,364 N/A N/A N/A 1,237 64,226 5,920 16,840,906 502,588 33,508,377
2 Hungary 813,040 +247 30,061 +1 777,988 +79 4,991 19 84,414 3,121 6,606,051 685,871 9,631,624
3 Bosnia and Herzegovina 216,124 +811 9,862 +15 192,218 14,044 66,359 3,028 1,148,516 352,640 3,256,910
4 North Macedonia 178,879 +720 6,013 +26 157,868 +574 14,998 85,864 2,886 1,175,766 564,384 2,083,274
5 Gibraltar 5,376 +5 97 5,191 +7 88 1 159,625 2,880 339,904 10,092,461 33,679
6 Czechia 1,680,046 +306 30,405 +1 1,647,382 +7 2,259 10 156,542 2,833 36,219,289 3,374,814 10,732,234
7 Montenegro 117,080 +547 1,748 +15 107,041 +624 8,291 11 186,386 2,783 631,401 1,005,161 628,159
8 Bulgaria 459,051 19,001 407,029 33,021 333 66,653 2,759 4,276,501 620,939 6,887,152
9 Brazil 20,830,712 582,004 19,801,725 446,983 8,318 97,191 2,716 56,897,224 265,470 214,326,515
10 San Marino 5,321 90 5,150 81 1 156,436 2,646 75,461 2,218,528 34,014
11 Argentina 5,195,601 112,195 4,884,418 198,988 2,497 113,737 2,456 22,307,283 488,331 45,680,639
12 Colombia 4,913,031 125,097 4,742,640 45,294 542 95,368 2,428 24,268,743 471,084 51,516,791
13 Slovakia 395,532 +232 12,549 +1 381,335 +84 1,648 27 72,405 2,297 3,336,980 610,862 5,462,738
14 Paraguay 458,716 15,821 437,843 5,052 90 63,403 2,187 1,781,035 246,172 7,234,912
15 Belgium 1,189,710 +2,204 25,392 +10 1,103,638 60,680 192 102,133 2,180 18,779,255 1,612,142 11,648,637
16 Italy 4,559,970 +6,735 129,410 +58 4,293,535 +6,544 137,025 556 75,549 2,144 84,928,897 1,407,092 60,357,722
17 Slovenia 269,248 +610 4,453 258,465 +334 6,330 18 129,491 2,142 1,457,824 701,122 2,079,273
18 Croatia 376,417 +816 8,355 +6 363,906 +597 4,156 57 92,359 2,050 2,573,737 631,498 4,075,606
19 Mexico 3,387,885 +18,138 261,496 +993 2,727,659 +12,616 398,730 4,798 25,958 2,004 9,852,284 75,487 130,516,103
20 Poland 2,889,773 +349 75,372 +5 2,657,274 +97 157,127 58 76,453 1,994 19,819,235 524,345 37,798,076
21 USA 40,607,091 +92,097 663,695 +720 31,226,722 +26,887 8,716,674 25,743 121,843 1,991 589,857,715 1,769,893 333,273,117
https://www.worldometers.info/coronavirus/#countries
China Considering Foreign Booster Shot to Improve Efficacy of Its Vaccines
By Adam Xu, Adrianna Zhang
Updated July 21, 2021 09:43 PM
China is reportedly considering using a foreign vaccine as a booster shot for people who have been fully inoculated with Chinese vaccines such as Sinovac and Sinopharm.
According to Caixin, a respected Chinese financial magazine, drug regulators in China have completed an expert panel review of the booster vaccine jointly developed by China's Shanghai Fosun Pharmaceutical (Fosun Pharma) and German company BioNTech. The booster shot, Fosun-BioNTech COVID-19, is now in the administrative review stage.
The report came days after Thailand and Indonesia announced they would switch from doses made in China to Western vaccines.
For Beijing, which has been touting the effectiveness of its vaccines for months and donating and selling doses to low- and middle-income countries eager for protection in an effort often referred to as "vaccine diplomacy," the possibility of a booster shot may be seen as a blow.
"It is implicitly an admission that they are not doing well with their own vaccines," Steve Morrison told VOA Mandarin. Morrison is the senior vice president and director of the Global Health Policy Center at the Center for Strategic and International Studies (CSIS), a Washington think tank.
VOA Mandarin contacted the Chinese Embassy in Washington, D.C., and the Foreign Ministry in Beijing for further comment on the possibility of a booster for Chinese-made vaccines. Embassy staff referred VOA to the two companies as well as "competent authorities in China." VOA did as suggested but received no responses.
Dr. Amesh Adalja, an infectious disease physician at Johns Hopkins Bloomberg School of Public Health, told VOA Mandarin in a virtual online interview that although the data on the Chinese vaccines are not widely available and China has yet to publish its phase 3 data in a peer-reviewed journal, "We've anecdotally seen lower efficacy with Chinese-made vaccines, and that may be prompting the need for a booster."
Shih Shin-ru, director of the Research Center for Emerging Viral Infections and professor at the department of medical biotechnology and laboratory science at Chang Gung University in Taiwan, said a "good" vaccine should be safe and immunogenic (able to produce enough neutralizing antibody) and protect against real infection. At the start of developing any vaccine, scientists cannot know "how good" the vaccine in development might be, she said. But recently, as more studies have been conducted, scientists can correlate immunogenicity to?protection rate, Shih added.
"Therefore, I think scientists in China also realized the fact of low antibody [levels] in the serum of Sinovac or Sinopharm vaccines. Therefore, they may suggest the Chinese government has another shot as a booster," Shih told VOA Mandarin in an email.
According to a World Health Organization study published early last month, in a large phase 3 trial in Brazil, two doses of?the vaccine developed by Sinovac/China National Pharmaceutical Group,?administered 14 days apart, had an efficacy rate of 51% against symptomatic SARS-CoV-2 infection, 100% against severe COVID-19 and 100% against hospitalization, with protection starting 14 days after the second dose.
Earlier this month, the American news outlet CNBC reported that of the six countries worldwide with the highest rates of inoculation, adjusted for population, five countries that relied on vaccines from China showed elevated weekly numbers of COVID-19 cases.
In contrast, real-world data gathered by Israel's Ministry of Health show that the Pfizer-BioNTech vaccine's effectiveness was at least 97% in preventing symptomatic disease,?severe-to-critical disease and death, according to an article on Pfizer's website in March.
The Moderna COVID-19 vaccine had an efficacy rate of 94.1% after two doses, according to U.S. ?Centers for Disease Control and Prevention research published on January 1.
Earlier this month, however, as the delta variant caused an increase in Israel's number of COVID-19 cases, the Ministry of Health announced that the effectiveness of the Pfizer-BioNTech vaccine dropped to 64% against all coronavirus infections from about 95% in May. Israel has more than 852,940 confirmed cases, according to the Johns Hopkins University of Medicine Coronavirus Resource Center, and 6,450 deaths as of Tuesday.
Jin Dong-Yan, a professor at Hong Kong University's School of Biomedical Sciences, said in a phone interview with VOA Mandarin that the plummeting effectiveness of the Pfizer-BioNTech vaccine in the face of variants meant that Chinese vaccine efficacy could drop to well under 50% in preventing infections by new variants. This, he said, would make booster shots "imperative."
Jason Li, a research associate with the East Asia program at the Stimson Center in Washington, told VOA Mandarin in an email that "China's move [to consider a Pfizer booster] could be a positive sign against the worst fears of unproductive 'vaccine diplomacy' competition — at least from the Chinese side" and could indicate that "the Chinese authorities may be putting public health above politics, for now."
On June 2, Wang Wenbin, a spokesperson for China's Ministry of Foreign Affairs,?said during a news conference that China had provided "more than 350 million doses of vaccines to the international community, including vaccine assistance to over 80 countries and vaccine exports to more than 40 countries."
China provided vaccines either by donation or sale to 102 countries in Africa, the Asia-Pacific region, Europe and Latin America, according to a vaccine tracker published by BridgeBeijing.com, a global health advocacy group affiliated with the New York-based Global Health Strategies group. In the Asia-Pacific region, 38 countries have received Chinese vaccines, and in Latin America, 19 countries. In Africa, 35 countries received vaccines from China, but the number of doses was the lowest.
China expert Ian Chong of the National University of Singapore told the BBC that Beijing's push to sell or donate vaccines worldwide had been "an effort to change the narrative away from the fact that infections were first detected in Wuhan, and to show that [China is] a scientific powerhouse."
Health experts expect those countries will need booster shots if China's plan moves forward.
Thailand, which has used Sinovac vaccines, is now experiencing new highs in cases and fatalities. In Indonesia,?where cases are surging, less than 7% of the population of 271 million has been vaccinated, according to Johns Hopkins. Indonesia had placed one of the world's biggest orders for Sinovac vaccines, purchasing 125 million doses.
Both Asian nations will stop using Sinovac vaccines once supplies are depleted, a step Malaysia will also take, according to The Diplomat. The Philippines and Chile are researching the possibility of using the Fosun-BioNTech booster and vaccines that are not Chinese.
In Thailand, public anger over the government's handling of the pandemic and its use of Chinese vaccines prompted street protests in Bangkok on July 18, with people demanding that the government import Western vaccines.?
Chong told the BBC that nations stopping the use of Chinese vaccines "in effect calls into question the technical prowess of China."
However, analysts don't see the gains from China's vaccine diplomacy being eliminated.
"At a time of scarcity and slow distribution of vaccines to the Global South,?diplomatic relations between vaccine recipients and China will mostly remain appreciative," said Li, of the Stimson Center. "Front and center in China's initial vaccine diplomacy efforts was an emphasis on South-to-South 'brotherhood.' "
Morrison of CSIS said: "It certainly begins to erase the gains that were made diplomatically. I don't know that it hurts the gains entirely because, you know, the Chinese have been very generous with these vaccines."
Columbia’s Mu, Peru’s Lambda will usher in 4800 P3. Based on latest reports, the countries with the most new deaths were United States with 1,549 new deaths, followed by Mexico with 993 and Russia with 799.
The United States is the worst-affected country with 643,669 deaths from 39,549,299 cases. After the US, the hardest-hit countries are Brazil with 581,914 deaths from 20,830,495 cases, India with 439,895 deaths from 32,903,289 cases, Mexico with 261,496 deaths from 3,387,885 cases, and Peru with 198,364 deaths from 2,152,118 cases.
The country with the highest number of deaths compared to its population is Peru with 602 fatalities per 100,000 inhabitants, followed by Hungary with 311, Bosnia-Herzegovina with 300, Republic of North Macedonia with 287, Czech Republic with 284 and Montenegro with 276.
Latin America and the Caribbean overall has 1,444,902 deaths from 43,415,848 cases, Europe 1,255,063 deaths from 63,555,958 infections, and Asia 785,922 deaths from 50,585,531 cases.
The United States and Canada has reported 670,648 deaths from 41,053,945 cases, Africa 197,742 deaths from 7,851,924 cases, Middle East 183,378 deaths from 12,377,934 cases, and Oceania 1,742 deaths from 125,019 cases.
The World Health Organization estimates that the pandemic's overall toll could be two to three times higher than official records, due to the excess mortality that is directly and indirectly linked to Covid-19.
A large number of the less severe or asymptomatic cases also remain undetected, despite intensified testing in many countries.
On Thursday 9/2/21, 10,625 new deaths and 653,399 new cases were recorded worldwide.
Based on latest reports, the countries with the most new deaths were United States with 1,549 new deaths, followed by Mexico with 993 and Russia with 799.
https://www.gmanetwork.com/news/news/world/802015/global-covid-19-cases-close-to-219-million-as-death-toll-nears-4-54-million-afp/story/
7,116 ppl 4800 P3 is distributed among Brazil, Argentina, Colombia, United States of America, Philippines, Mexico, Peru, Poland, Czech Republic and Thailand.
ZyCov-D was developed on a DNA platform using a non-replicating and non-integrating plasmid carrying the novel coronavirus gene, making it very safe. In addition, ZyCoV-D is a three-dose, intradermal vaccine, which is applied using The PharmaJet® needle-free system, Tropis®, which can also lead to a significant reduction in any side effects. Also, being a plasmid DNA vaccine, ZyCoV-D doesn’t have any problem associated with vector-based immunity, says the company.
The DNA platform is known to have better vaccine stability and lower cold chain requirements, which would make it easier to store and transport to remote parts of the country. ZyCoV-D is stored at 2-8 C but has shown good stability at temperatures of 25C for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.
given the recent progress of India-based company Zydus, which reported 67% efficacy using its DNA vaccine on 30,000 patients, Inovio's executives are confident that they can "top" that performance using the CELLECTRA in vivo electroporation system for inoculating patients with INO-4800. This, according to them is a better delivery mechanisms for DNA plasmids than the jet injector used by Zydus.
Moreover, the Zydus vaccine, in some way validates the DNA rationale, but being realistic, even with a better vaccine, the time factor is playing against Inovio and a "Made in India" vaccine may be cheaper than INO-4800. Still, the fact that the biotech is focusing efforts in other geographies is a positive.
Second, there is VGX-3100, an investigational DNA-based immunotherapy being developed as an alternative to surgery and ablation for cervical High-Grade Squamous Intraepithelial Lesion (HSIL), with the aim of preserving reproductive health while treating precancerous disease. In this case, dataset for the REVEAL 1 study should be provided by the end of the year.
Third, there is INO-4800 used in a combined therapy with Sinovac's vaccine.
Finally, with a rich pipeline in different areas of unmet medical needs, Inovio simply cannot be ignored,
NIH further adds that heterologous prime-boost (in this case using INO-4800 and CoronaVac together) represents a new way of immunization.
Pursuing further, there is also INO-4802, Inovio's second generation, pan-COVID vaccine candidate, which is designed to protect against current and future variants of concern. A lot of praises were voiced about the cure during the earnings call.
Inovio dosed the first subject in its Phase 2 clinical trial for INO-4700, its DNA vaccine candidate for the Middle East Respiratory Syndrome (MERS), a viral respiratory illness for which there is currently no approved vaccine. It is caused by a coronavirus that is about 100 times deadlier than COVID-19 and fatal to approximately 34% of those infected. The Phase 2 trial is being conducted at sites in Jordan and Lebanon, where MERS cases have been reported.
Inovio's pursuit of a MERS vaccine is funded by a previously announced $56 million grant from Coalition for Epidemic Preparedness Innovations (CEPI), also including INO-4500 for Lassa fever. An additional funding of $10.3 million to partners for Lassa fever has been announced.
Exploring further, the biotech remains diversified in immuno-oncology through its INO-5401 compound in a partnership with Regeneron (NASDAQ: REGN). Survival data will be shared during an oncology conference in the fourth quarter of this year.
Separately, the University of Pennsylvania enrolled its first patient in a Phase 1b investigator-sponsored study of INO-5401 (alone or in combination with INO-9012) for adult cancer and non-cancer patients with BRCA1 or BRCA2 mutations.
As a consequence of these clinical studies, R&D expenses for the second quarter were $70.8 million compared to $22.4 million for the same period in 2020. Going deeper, the increase was primarily attributable to scale-up activities for INO-4800, including acquisition of manufacturing equipment, drug production, and clinical study expenses. These increases were offset by an increase in funding through grant agreements, amounting to $8.1 million.
No wonder Sinovac wanted INO-4800 so badly. Sinovac COVID-19 Vaccine Has ‘0 To 40’ Antibody Levels Versus Pfizer’s 1,300:
https://www.ibtimes.com/sinovac-covid-19-vaccine-has-0-40-antibody-levels-compared-pfizers-1300-expert-3285248
AND:
[Global Times (The Chinese Government's propaganda media, for internal use only): "In the group of participants who received the 3µg vaccine (of Sinovac's Coronavac), which is approved for emergency use, the geometric mean titer (GMT) of serum neutralizing antibodies increased to 305 on day seven after the third dose, an approximately seven-fold increase compared to the levels at day 28 after the second dose."
? (!) Compared with INO-4800 Phase 2 preprint data: INO-4800 second dose GMT = 2,210.
So INO-4800 second dose produces 7 times more neutralizing antibodies than Sinovac third dose.] By CAD
A study in China found that SinoVac and SinoPharm were 70% effective in preventing COVID-19 infection
A preprint study in Brazil found that SinoVac was only 54% effective in preventing coronavirus infection
Singapore had previously refused to count SinoVac jabs in the country's tally of vaccinations
The China-made COVID-19 vaccine, SinoVac, has been found to produce significantly lower levels of antibodies compared to the vaccine developed by Pfizer-BioNTech, prompting residents in Singapore to get booster shots.
Antibody levels in people who have received two doses of the Pfizer vaccine were normally between 1,300 and 2,000 international units per milliliter. However, the numbers are much lower in individuals who received two shots of the SinoVac vaccine.
“For Sinovac, it is zero to 40. We have a few with 200 to 300,” Dr. Leong Hoe Nam, an infectious diseases specialist at Rophi Clinic in Singapore, told South China Morning Post.
Dr. Leong noted that the lower antibody levels in SinoVac recipients have prompted an increasing number of individuals to get Pfizer as a booster shot.
“They took the Sinovac shots, did the blood test and saw low antibody levels, then opted for Pfizer as the third dose,” he added.
A study conducted by researchers in China found that the SinoVac and SinoPharm vaccines had a combined efficacy of 70% in preventing an infection caused by the more contagious Delta variant in the city of Guangzhou. The study, which has yet to be peer reviewed, also noted that the shots were 100% effective in preventing severe infections and deaths.
However, a Brazilian preprint study comparing SinoVac to the AstraZeneca COVID-19 vaccine found that recipients of the Chinese-made vaccine had lower protection levels against the virus.
SinoVac recipients were 54% less likely to contract COVID-19 and 74% less likely to die of the virus compared to the unvaccinated. The efficacy waned in the older population, reducing the risk of death by only 35% in people over the age of 80. In comparison, AstraZeneca reduced the risk of infection by 70% and the risk of death by 90%.
The Singaporean government had previously excluded people who received the SinoVac shots from the country’s total count of vaccinations. Health Minister Ong Ye Kung cited inadequate efficacy data as the reason for the move.
"We don't really have a medical or scientific basis or have the data now to establish how effective SinoVac is in terms of infection and severe illnesses on Delta," Ong said during a July media briefing, according to Reuters.
Singapore’s Ministry of Health later announced it will consider people who received vaccine shots included in the World Health Organization’s emergency use list, such as SinoVac, Sinopharm and AstraZeneca, as fully vaccinated, in an effort to be more “inclusive.”
“What is important now is the difference between those who are vaccinated and not vaccinated and less so between different vaccines,” Ong said at a press conference in early August.
Despite this, the Singaporean government is still offering third doses of vaccines to residents who had taken the SinoVac jab as part of a “heterologous vaccination strategy.”
"We have not stopped them although data is still lacking considering what the effectiveness is of this strategy using two different vaccines – we call this a heterologous vaccination strategy," Director of Medical Services Kenneth Mak said during a virtual doorstop interview.
8/30/21 Update P2: 52ppl INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
Actual Study Start Date :
May 31, 2018
Estimated Study Completion Date :
December 30, 2021
21 US study locations
OS30 is Nov 2021. OS24 was May 2021.
https://clinicaltrials.gov/ct2/history/NCT03491683?A=28&B=29&C=merged#StudyPageTop
8/30/21 Update: 35ppl P2 INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Actual Study Start Date :
May 24, 2018
Estimated Study Completion Date :
December 30, 2021
28 study locations In US, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Catalan Institute of Oncology (ICO)
Barcelona, Spain, 08908
Clinica Universidad de Navarra - Madrid location
Madrid, Spain, 28027
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain, 28050
Clinica Universidad de Navarra - Pamplona location
Pamplona, Spain, 31008
https://clinicaltrials.gov/ct2/history/NCT03502785?A=24&B=25&C=merged#StudyPageTop
9/1 Tweet: There is an urgent need for an effective, tolerable and non-invasive treatment for Recurrent Respiratory Papillomatosis to eliminate the need for recurrent surgeries. INOVIO’s #DNAMedicine candidate, INO-3107, is a potential non-surgical option
https://www.inovio.com/our-focus-serving-patients/hpv-associated-diseases/
9/8/21 Next Gen Cancer Vaccine Development Summit. Laurent Humeau
Chief Scientific Officer Inovio 11:15A PST. Leveraging Optimized DNA Plasmid Design and Delivery to Treat Glioblastoma Multiforme and Prostate Cancer
• Presentation of clinical trial data to show a DNA based cancer vaccine in combination with FLT3 ligand and PD-1 targeting metastatic castration resistant prostate cancer
• Updates on clinical status of a GBM vaccine in combination with cemiplimab (PD-1 inhibitor)
9/7/21 Conference Day One
Niranjan Sardesai 1:45P PST
CEO Geneos
Targeting Unique Neoantigens From Individual Patient Tumors
To Develop Novel Treatment For Cancer
• Optimized DNA plasmid containing encoded neoantigens, used in combination with IL-2 to boost T cell response
• Electroporation-based delivery system for enhanced and efficient plasmid uptake to allow optimal antigen production
• Combination therapy shows robust functional antigen specific CD4+ and CD8+ killer T cells
https://cancer-vaccine-development.com/whats-on/full-event-guide/
Dr. J. Joseph Kim, President and CEO, will present at the following investor conferences in September:
H.C. Wainwright 23rd Annual Global Investment Conference
Date: September 13-15, 2021
Time: Recorded presentation will be available on-demand
Presentation Format: Fireside Chat
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Date: Tuesday, September 21, 2021
Time: 9:55 AM ET
Presentation Format: Fireside Chat
Cantor Fitzgerald Healthcare Conference
Date: Monday, September 27, 2021
Time: 10:00 AM ET
Presentation Format: Fireside Chat
https://www.marketwatch.com/press-release/inovio-to-present-at-upcoming-investor-conferences-in-september-2021-09-01
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-to-Present-at-Upcoming-Investor-Conferences-in-September/default.aspx
8/28/21 Mexico: Cofepris promotes P3 authorization of 3 new vaccines against Covid: INO-4800, Walvax, Sanofi in coming days. Following the approval of Sinopharm this week, Cofepris will evaluate another 3 biologics,
In the last year, one of the priorities of Foreign Minister Marcelo Ebrard has been the negotiation with the different pharmaceutical companies and governments of the world to achieve the arrival to the country of vaccines against Covid-19, a management that has even been praised by critics and most staunch opponents of Q4 and of the strategy headed by the Undersecretary of Health Hugo López-Gatell.
Now, and while the Delta variant causes a worsening of the pandemic in much of the world, Mexico included, Ebrard announced during his appearance before the Morena senators that the health authorities could authorize in a short time another 3 biologicals to join the campaign of vaccination.
"We are going to have, in the coming days, other types of authorizations for phase III in Mexico, such as Walvax, which is a Chinese messenger RNA vaccine; Inovio, which is a vaccine based on North American DNA; or Sanofi, which it is a vaccine of French origin, "said the head of Mexican diplomacy.
This announcement comes some after Cofepris approved the Sinopharm vaccine for emergency use, which will be the third Chinese vaccine that will begin to be applied in the country, as is already being done in 40 countries, including much of the Asian continent and Latin America. .
It will also be the ninth vaccine that residents of Mexico will be inoculated with, after the regulatory agency gave the go-ahead in the past to Pfizer, AstraZeneca, Cansino, Sputnik V, Sinovac, Covaxin, Janssen and Moderna vaccines.
In making the announcement, Ebrard said that this was part of the strategy to "have timely access to vaccines and accelerate vaccination in Mexico to try to contain and reduce the impact of the pandemic."
In addition, he said that negotiations with the Biden government will continue to open the land borders with the United States as soon as possible, something that the Chancellor himself recognized in recent days that will not be in the short term due to the increase in cases due to the Delta variant. although he said he was confident that it will be before the end of the year.
According to the latest official data, almost 84 million vaccines have been applied in Mexico since the start of the vaccination program in late December, and 3.4 million vaccines arrived this week alone, in shipments from Pifizer, Cansino and Moderna.
Around 33 million have already been immunized in Mexico against Covid-19, with Mexico City, Baja California and Baja California Sur being the states with the largest population vaccinated with the two doses.
https://www-lapoliticaonline-com-mx.translate.goog/nota/137951-la-4t-impulsa-la-autorizacion-de-3-nuevas-vacunas-contra-el-covid/?_x_tr_sl=es&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=ajax,nv,elem
P2 56 ppl Completed 5/17/21: Safety, Immunogenicty and Anti-Reservoir Activity of an Electroporation-Administered HIV DNA Vaccine Encoding GAG, POL and ENV Proteins With IL-12 Plasmid in HIV-Infected Adults on Antriretroviral Therapy.
3/31/17 received a multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP with the goal of attaining long-term HIV remission in the absence of antiviral drugs.
Although current antiretroviral therapy can reduce the amount of circulating HIV in the blood to an undetectable level, latent cellular reservoirs of HIV continue to exist in the body such that when therapy is discontinued, these cells begin to produce HIV again. This proof-of-concept clinical program will test whether enhancing anti-HIV specific CD8 killer T cell immune responses alone or in combination with other products can influence the size of the viral reservoir pool, potentially resulting in reducing or eradicating the virus.
Inovio And Collaborators Receive NIH Grant To Evaluate HIV Immunotherapy PENNVAX®-GP's Ability To Induce Remission Of HIV Infection And End Lifetime Of Drug Therapy
Grant will fund therapeutic clinical studies testing PENNVAX-GP with INO-9012 (an IL-12 immune activator) alone and with the addition of a PD-1 checkpoint inhibitor
Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract awarded to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded a five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID.
Brief Summary:
The central premise of our program is that durable control of HIV in the absence of antiretroviral therapy ("remission") will require the generation of de novo potent and sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our program is inspired by the recent success of VGX-3100 (Inovio), a DNA therapeutic vaccine for HPV that leads to histopathologic regression of pre-malignant lesions in people and is associated with a potent, sustained boost to HPV-specific CD8+ T cell populations. A closely related multi-clade gag/pol/env DNA vaccine administered with an IL-12 DNA plasmid (PENNVAX, Inovio) has been studied for HIV prevention and is known to be both safe and highly immunogenic. In a randomized placebo-controlled study we will compare the immunogenicity and anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with IL-12). We will determine for the first time in established HIV disease whether presence of env in a DNA vaccine blunts T cell responses to more conserved Gag-specific and Pol-specific epitopes. We will also determine if Env-specific responses (which will presumably be mediated by antibodies and ADCC) have a measurable effect on reservoir.
Biological: PENNVAX-GP
PENNVAX®-GP is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag, Pol and Env proteins.
Biological: INO-6145
INO-6145 is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag and Pol proteins.
Other Name: HIV DNA vaccine
Biological: INO-9012
The IL-12 DNA adjuvant (INO-9012) consists of a single plasmid containing a dual promoter system for expression of both the IL-12 p35 and p40 genes necessary for production of the active heterodimeric (p70) IL-12 protein.
Device: CELLECTRA® 2000
Locations
University of California, Los Angeles
Los Angeles, California, United States, 90025
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, United States, 94110
Sponsors and Collaborators
Steven Deeks
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Los Angeles
Inovio Pharmaceuticals
Investigators
Principal Investigator: Steven Deeks, MD, UCSF
https://clinicaltrials.gov/ct2/show/NCT03606213
8/31 J&J HIV shot fails, adding another blow to decades-long effort to curb epidemic
J&J’s HIV vaccine failed its first major trial Tuesday, handing another setback to the nearly 40-year effort to build a vaccine against one of the deadliest epidemics in history.
The candidate, which uses the same technology as J&J’s Covid-19 and Ebola shots, was among the last major HIV vaccine constructs in late-stage trials — a holdover from a wave of Big Pharma efforts that have so far gone bust.
J&J’s attempts aren’t ending, though. The latest study, a Phase II known as Imbokodo, was one of two late-stage trials testing slightly different vaccine regimens on different populations. Although Imbokodo is ending, the second study, a Phase III known as Mosaico, will continue.
“The development of a safe and effective vaccine to prevent HIV infection has proven to be a formidable scientific challenge,” NIAID director Anthony Fauci said in a statement. “Although this is certainly not the study outcome for which we had hoped, we must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV.”
With the J&J shot, researchers had been hoping to build off one of the only successes in the history of HIV vaccines. In 2009, researchers reported on a trial known as RV144 that mixed multiple different vaccine constructs together. Although the study failed, it appeared to reduce the risk of infection by 30%. It was the first sign of vaccine efficacy in the then 30-year-old epidemic.
Efforts to replicate those results, however, have so far come up flat. Last year, a Phase III trial for a vaccine developed by Sanofi and GSK showed virtually no difference between placebo and vaccine arms.
In the Imbokodo trial, volunteers received either placebo or four injections of a common cold virus (technically known as adenovirus 26) engineered to carry a “mosaic” of HIV proteins. They were also directly given a couple doses of an HIV protein called gp140 and an adjuvant meant to set the immune response in motion.
After two years, 63 of the 1,109 participants on placebo were infected with HIV, compared to the 51 of the 1,079 participants on the vaccine. Although that technically computed to 25.2% efficacy, the results were not statistically significant.
And the confidence interval for the vaccine — the range of possible efficacies that would be consistent with the trial’s results — were wide: -10.5% to 49.3%.
Although the company is ending and unblinding the Imbokodo trial, J&J said that a data safety and monitoring board decided the Mosaico trial should go on. Because the vaccine uses a slightly different regimen and studies a different patient population, it could lead to different results.
And despite the setbacks, a new generation of HIV vaccines is now entering early-stage studies. Moderna is initiating trials on an mRNA vaccine that’s meant to induce a particular type of neutralizing antibody the NIH isolated from HIV patients who show profound and unusual control over their virus. And Vir Biotechnology has started a Phase I trial on a vaccine that uses the virus CMV to teach T cells to recognize HIV proteins.
Just published @ScienceMagazine
The importance of rapid, cross-reactive immunity for prior Covid and vaccine effect
"Our results highlight the functional contribution of pre-existing spike-cross-reactive T cells in SARS-CoV-2 infection and vaccination"
Abstract
The functional relevance of pre-existing cross-immunity to SARS-CoV-2 is a subject of intense debate. Here, we show that human endemic coronavirus (HCoV)-reactive and SARS-CoV-2-cross-reactive CD4+ T cells are ubiquitous but decrease with age. We identified a universal immunodominant coronavirus-specific spike peptide (S816-830) and demonstrate that pre-existing spike- and S816-830-reactive T cells were recruited into immune responses to SARS-CoV-2 infection and their frequency correlated with anti-SARS-CoV-2-S1-IgG antibodies. Spike-cross-reactive T cells were also activated after primary BNT162b2 COVID-19 mRNA vaccination displaying kinetics similar to secondary immune responses. Our results highlight the functional contribution of pre-existing spike-cross-reactive T cells in SARS-CoV-2 infection and vaccination. Cross-reactive immunity may account for the unexpectedly rapid induction of immunity following primary SARS-CoV-2 immunization and the high rate of asymptomatic/mild COVID-19 disease courses.
https://www.science.org/doi/10.1126/science.abh1823
8/31 BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down
Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.
The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.
A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.
FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
In a letter from Marks to staff, he explained:
https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/
AZN seeks regulatory approval to commercialize AZD7442 being cloned by INOVIO’s DNA-encoded monoclonal antibodies (dMAb®s)
A monoclonal antibody cocktail against the COVID-19 virus discovered at Vanderbilt University Medical Center and developed by AstraZeneca reduced the risk of symptoms in a study of immunocompromised and chronically ill adults later exposed to the virus by 77%, the company announced today.
Based on the positive results from the PROVENT Phase III trial, the company will seek regulatory approval for AZD7442, a combination of two long-acting antibodies, as a one-dose pre-exposure prophylaxis that for chronically ill people may be more effective than a vaccine.
AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial, company officials said. The trial included more than 5,000 participants. More than 75% had conditions that can cause a reduced immune response to vaccination.
Delivered by intramuscular injection, the antibody treatment was well tolerated with only minor side effects and could afford up to 12 months of protection from COVID-19, company officials said. Preliminary laboratory findings also suggest that AZD7442 can neutralize recent emergent variants of the virus, including the delta variant, they said.
“It’s deeply gratifying to see the antibodies we isolated under challenging circumstances, in the middle of the international lockdown last spring, protecting the most vulnerable amongst us,” said James Crowe Jr., MD, director of the Vanderbilt Vaccine Center who led the VUMC research effort. “This single-shot prevention is likely to be a game changer for at-risk patients.”
“The near-term availability of AZD7442 comes at an opportune time,” added Robert Carnahan, PhD, associate director of the Vanderbilt Vaccine Center. “It is clear that we need additional solutions beyond vaccines to protect those most vulnerable members of our society, such as the immunocompromised.
“These studies specifically targeted patients with comorbidities where interventions beyond a vaccine are warranted,” Carnahan said.
The original antibodies that were the basis for the engineered long-acting antibodies that make up the AZD7442 two-antibody cocktail were isolated last year at VUMC. Crowe and his colleagues have developed ultra-fast methods for discovering highly potent antiviral human monoclonal antibodies and validating their ability to protect small animals and non-human primates.
Six of the antibodies were licensed to AstraZeneca in June for advancement into clinical development. In October the company announced it was advancing into phase 3 clinical trials an investigational therapy consisting of two long-acting antibodies discovered at VUMC and optimized by AstraZeneca.
https://www.tullahomanews.com/news/coronavirus_news/vandy-discovers-covid-antibody-cocktail/article_7eb41a16-06ad-11ec-9314-dfea4d51b1ba.html
South Africa INO-4802, “Yes. We are definitely considering doing our trial in the heart of the storm - South Africa, India, etc … We will keep you informed. Thanks as always.” 7/2/21
”our primary focus is getting this [4800] to trial initiated next month to enroll healthy men and non-pregnant women 18 years and older across several countries, concentrating on Latin America, Asia, in addition to expanding the trial to Africa. We will engage the FDA on a formal lifting of the partial clinical hold as a part of our long-term plans to pursue a BLA approval in the US once INO-4800 efficacy is demonstrated in the global INNOVATE Phase 3 trial.” JK 8/9/21
AZD7442 Twin: Monoclonal antibodies based on INOVIO’s DNA-encoded monoclonal antibodies (dMAb®s) technology.
Status: INOVIO said December 15 that scientists from the company, The Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana University received a $37.6 million grant from the U.S. Defense Advanced Research Projects Agency (DARPA), to use INOVIO’s dMAb® technology to develop anti-SARS-CoV-2-specific dMAbs that could function as both a therapeutic and preventive treatment for COVID-19.
Under DARPA’s two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates designed to mirror AstraZeneca’s traditional recombinant monoclonal antibody candidates now being tested in clinical trials to treat COVID-19, such as AZD7442. Through dMAb technology, INOVIO said, it can encode the DNA sequence for a specific monoclonal antibody in a DNA plasmid and deliver the plasmid directly into cells of the body using the company’s proprietary CELLECTRA® smart device. The resulting DNA medicine is designed to serve as a genetic blueprint that instruct the patient’s body to build its own highly specific antibodies in vivo.
According to INOVIO, dMAb candidates can be quickly developed and produced in vivo, offering a cost-effective and scalable therapeutic and preventive option for treatment of SARS-CoV-2 virus infection. INOVIO plans to advance the dMAb candidates into preclinical studies and then into rigorous, first-in-human clinical trials within one year of funding.
https://www.genengnews.com/covid-19-candidates/inovio-pharmaceuticals-and-astrazeneca-dmabs/
https://www.genengnews.com/covid-19-candidates/astrazeneca-azd7442/
Type: Long-acting antibody (LAAB) combination therapy for preventing and treating COVID-19, consisting of two monoclonal antibodies derived from convalescent patients with SARS-CoV-2 infection, AZD8895 and AZD1061. Both were discovered at Vanderbilt University Medical Center (VUMC)’s Vanderbilt Vaccine Center. The coronavirus-neutralizing antibodies were developed through the company’s program to use the Defense Advances Research Project Agency’s Pandemic Prevention Platform (P3).
2021 Status: Mixed Phase III Results—AstraZeneca acknowledged June 15 that its Phase III STORM CHASER trial (NCT04625972) did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo. While AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% compared to placebo, the difference was not deemed statistically significant.
However, in a pre-planned analysis of SARS-CoV-2 PCR positive (detectable virus) and PCR negative (no detectable virus) participants, AZD7442 was shown to reduce the risk of developing symptomatic COVID-19 by 73% compared with placebo in participants who were PCR negative at time of dosing. A post-hoc analysis showed that in participants who were PCR negative at baseline, AZD7442 reduced the risk of developing symptomatic COVID-19 by 92% versus placebo more than seven days following dosing, and by 51% up to seven days following dosing.
“We are encouraged by the protection seen in the PCR negative participants following treatment with AZD7442,” stated Mene Pangalos, AstraZeneca Executive Vice President, BioPharmaceuticals R&D. He said the company will await results from its Phase III PROVENT pre-exposure prevention trial (NCT04625725) and Phase III TACKLE treatment trial (NCT04723394) to understand the potential role of AZD7442 in protecting against COVID-19.
STORM CHASER included 1,121 participants randomized 2:1 AZD7442 to placebo, with 23 cases of symptomatic COVID-19 accrued in the AZD7442 arm (23/749) and 17 cases accrued in the placebo arm (17/372), AstraZeneca said.
The U.S. Army Contracting Command on March 30 reserved a minimum of 100,000 doses of AZD7442 through a contract modification valuled at $204.88 million, to be funded through its fiscal 2021 research, development, test and evaluation funds. The doses will be produced in Wilmington, DE, with an estimated completion date of December 31.
AstraZeneca said March 16 that it modified an existing agreement with the U.S. government to supply up to 500,000 additional doses of AZD7442. The agreement with the departments of Health and Human Services and Defense builds on an October 2020 agreement to support late-stage development of AZD7442 and the supply of an initial 100,000 doses of AZD7442, including the option to acquire additional doses in 2021. The company also has a separate agreement to supply the Defense Department with 100,000 doses, bringing potential U.S. supplies of AZD7442 to 700,000 this year.
The NIH and its National Institute of Allergy and Infectious Diseases (NIAID) said February 8 that it was evaluating AZD7442 in the international randomized, controlled Phase III ACTIV-3 trial (NCT04501978), designed to assess the safety and efficacy of AZD7442.
ACTIV-3 is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, designed to develop a coordinated research strategy for prioritizing and accelerating development of the most promising treatments and vaccines. ACTIV-3 is a master trial through which NIAID is conducting multiple different trials of experimental therapeutics simultaneously. In addition to AZD7442, ACTIV-3 includes sub-studies of VIR-7831, a Vir Biotechnology/GlaxoSmithKline partnered monoclonal antibody; and of the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences.
If outcomes assessed at five days, after approximately 150 volunteers have received AZD7442, indicate that AZD7442 is likely to be both safe and effective, enrollment in the trial will be expanded, NIAID said, to an additional 700 participants, some of whom may have more severe cases of COVID-19. ACTIV-3’s primary endpoint is sustained recovery as defined by patients being discharged from the hospital and living at home for 14 consecutive days.
2020 Status: AstraZeneca on October 9 was awarded $486 million toward two Phase III trials and related development activities related to AZD7442, including a large-scale manufacturing demonstration project and supply of doses in the U.S. The company estimated that 100,000 doses of AZD 7442 could be available from the project for high-risk patients unable to benefit from a vaccine by December 2020.
One Phase III trial will assess the safety and efficacy of the antibody combination to prevent infection for up to 12 months in approximately 5,000 volunteers. An additional Phase III study will evaluate if AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting. That study will enroll approximately 1,100 volunteers.
AstraZeneca’s Warp Speed funding comes from the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command.
Ino, Advaccine’s heterologous 4800 China trial partner - Sinovac‘s CoronaVac is approved in 39 countries, per WHO: https://covid19.trackvaccines.org/vaccines/7/
An official from Inovio said, "Since the Chinese Sinovac vaccine is being vaccinated all over the world, if the clinical trials go well, it is expected to be widely used."
8/26/21 P1 4800 120 ppl booster data update to FDA. KB said working on Manuscript since May 2021 During 1Q21 ER CC. Expect Bioxriv or Medrxiv paper.
https://clinicaltrials.gov/ct2/history/NCT04336410?A=11&B=12&C=merged#StudyPageTop