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PR. Valneva Advances Booster Phase of Cov-Compare Trial of Its Inactivated COVID-19 Vaccine Candidate
Saint-Herblain (France), January 25, 2022 – Valneva SE, a specialty vaccine company, today announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare. This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results. The data are not intended for the initial regulatory approval process which the Company expects to finalize in the coming weeks.
The trial extension will evaluate a booster dose of VLA2001 in adults, aged 18 and above, who received primary vaccination with two doses of VLA2001, as well as participants, aged 30 and above, who received two doses of AstraZeneca’s (AZD1222). The VLA2001 booster vaccination will be given at least seven months after completion of the primary vaccination series. The trial is currently ongoing in the UK and is supported by the National Institute for Health Research (NIHR). It is expected to provide topline data during the second quarter of 2022.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “While we are focused on completing our rolling submissions for initial regulatory approval of VLA2001 in a primary vaccination context, we are working extremely hard in parallel to generate further data for VLA2001 in order to assess the role it could play in a booster context as well. We continue to believe that VLA2001 may play an important role to fight the current pandemic phase and beyond. We would like to thank all those who are demonstrating continued interest in our vaccine, and we remain fully committed to bring our inactivated solution to the market as soon as we can.”
Valneva announced first positive homologous booster results at the end of December 2021[1]. The data showed an excellent immune response after a booster dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. In addition, Valneva plans to initiate a further dedicated heterologous booster only trial of VLA2001 in the coming weeks. Valneva also recently reported laboratory results demonstrating that serum antibodies induced by three doses of VLA2001 neutralize the initial SARS-CoV-2 virus as well as the Omicron and Delta variants[2].
Valneva is continuing to provide data to the European Medicines Agency (EMA) as well as the UK and Bahraini agencies (MHRA and NHRA respectively), and expects to complete these rolling submissions in time to receive potential regulatory approvals in the first quarter of 2022.[3]
About the Booster extension of Phase 3 Cov-Compare Study VLA2001-301
Cov-Compare is a randomized, observer-blind, controlled, comparative immunogenicity study for which Valneva reported positive topline data in October 2021. As part of the study’s booster extension, all participants are offered a third vaccination, except those who already received a licensed COVID-19 vaccine outside of the study. Participants will receive a VLA2001 shot at least seven months after completion of the primary vaccination series with VLA2001 or AZD1222; follow-up visits will be performed 14 days and six months after the booster vaccination. Participants who will not receive a VLA2001 booster vaccination will continue with their scheduled Month 12 follow up visit. In addition to evaluating tolerability of a VLA2001 booster dose, blood samples will be taken for immunogenicity analysis from a subset of adults who received primary vaccination with two doses of VLA2001, as well as from a subset of participants who received two doses of AZD1222 for primary immunization.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
BG&Co target 25 EUR & VAL.PA closing at 14 € today - Valneva SE (VLA.PA) (EUR value): https://finance.yahoo.com/quote/VLA.PA?p=VLA.PA&.tsrc=fin-srch
VALNEVA: Kepler Cheuvreux reiterates its Buy rating > 24 EUR
https://valneva.com/investors/analysts/
Side note > IDT Biologika/DE
"IDT Biologika"/Germany > The contracts with the Austrian/French manufacturer Valneva had been signed at the weekend. At the Dessau site, production capacities are being significantly expanded for this reason, among others.
Around 350 jobs are to be created in the course of the 100 million euro investment, the company announced on Thursday. IDT Managing Director Jürgen Betzing told: "We have now created 150 new jobs. In 2022/23, another 200 employees will be added." He said he expects this to double production output.
According to Haseloff, 2,500 employees work at Pharmapark Dessau, 1,800 of them at IDT alone. Haseloff said during his visit to Dessau-Roßlau, "We have backed the right horse. The region can be proud."
https://goo.gl/maps/mZLws6UGouBo9S8e9
Next mRNA boosters not effective (Israel)
mRNA: Israel Finds Fourth COVID Booster is Ineffective
https://healthpolicy-watch.news/israel-fourth-covid-booster-ineffective/
According to Regev-Yochay, the third dose resulted in "much higher antibodies, neutralization and the antibodies were not just higher in quantity but also in quality" than the second dose – but the fourth vaccine did not show significant antibody increase.
"Maybe there are a few more antibodies but not much more compared to the third dose," said Regev-Yochay.
...
"the amount of antibodies returns to the level it was after the third vaccine, not more. It’s nice, but it’s not what we expect from a booster."
Something strange at valn... positive pr on companies COVID-19 vaccine..yet share price is driven down 20% as of this morning...
Can someone share some Intel on this...are the HFs shorting valn in control for now???
(!) Effective against Omicron. (JAN-20).
Valneva says early studies show COVID-19 vaccine effective against Omicron
January 20, 20226:50 AM UTC
Last Updated an hour ago
French biotech firm Valneva (VLS.PA) said on Wednesday that preliminary studies showed that three doses of its inactivated COVID-19 vaccine candidate neutralised the Omicron variant of the disease.
All of the serum samples tested presented neutralizing antibodies against the ancestral virus and Delta variant, it said, while 87% of samples did so against the Omicron variant.
"We are extremely pleased with these results," said Chief Medical Officer Juan Carlos Jaramillo in a statement, noting that these added to an earlier Phase III trial that showed improved immune response with two doses of the VLA2001 candidate.
Valneva expects to receive potential approvals for its vaccine within the first three months of 2022, and is providing data to the European Medicines Agency (EMA) as well as regulators in the UK and Bahrain.
Should the shot be approved in Europe, it expects to start delivering doses there in April.
current jobs at valneva/vienna
Senior Program Manager (f/m/d) 2022-JAN-10
Act as relationship owner for key stakeholders in the European Commission and Member States (e.g. reporting, supply). Work with VLA's Program Director and ...
Quality Control Manager*in 2022-JAN-07
Management der QC Analytics
As constant booster strategy makes less sense,
an annual booster would fit,
otherwise one would have to vaccinate MRNA every quarter, means
complex logistics/cost-intensive/a burden for ppl. with current temporary vaccines
As the neutralizing antibodies become less important,
annual use of "Valneva" would probably be ideal. Let's see ...
EMA press briefing on COVID-19 starts now (CET 16:00- 11/JAN/2022)
https://www.ema.europa.eu/en/events/ema-regular-press-briefing-covid-19-11#event-summary-section
hard to say, could be some are skeptical about the performance w/ omicron (as CoronaVac reported) + prob. too many stop loss-orders were triggered
What's causing the 16% drop at 10am Tuesday morning?
Upcoming Events 6. JAN 2022 + 7. JAN 2022 LifeSci Corporate Access Event + Oddo BHF Forum
LiefeSci - https://www.lifesciadvisors.com/
Oddo BHF - https://www.oddo-bhf.com/en
https://valneva.com/investors/calendar/
thetimes.co.uk: Valneva & NHS staff
https://en.wikipedia.org/wiki/National_Health_Service
https://www.thetimes.co.uk/article/drugmaker-valneva-woos-nhs-staff-with-scottish-covid-vaccine-r6dln35jn
David Lawrence, finance director of French vaccine producer Valneva, said that the firm would make its jab available to frontline workers ahead of an April deadline for all NHS employees to be vaccinated. “We believe, because we get messages every day, that there are people who would take a Covid vaccine when one like ours is available,” Lawrence said.
UK. Multi-million pound grant (Livingston, Scotland)
Valneva and Scottish Enterprise in Advanced Discussions for Major Grant to Complete Livingston Site
https://valneva.com/press-release/valneva-and-scottish-enterprise-in-advanced-discussions-for-major-grant-to-complete-livingston-site/
December 23, 2021
Saint Herblain (France), December 23, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is in advanced discussions, with Scottish Enterprise, for a multi-million pound grant which will enable it to fully complete its strategic manufacturing site in Livingston, Scotland.
Following the termination of the supply agreement with the UK Government (HMG) for Valneva’s inactivated COVID-19 vaccine candidate, VLA2001, Valneva paused its site plans. Valneva and Scottish Enterprise have since engaged in a highly constructive dialogue, and under the proposed grant, the Livingston site will be fully developed as a key vaccine production site for the long term.
Both Valneva and Scottish Enterprise would invest in the plant. Scottish Enterprise’s contribution is expected to be through a series of grants totalling £10-20 million to enable Valneva to commence production at the plant. Discussions between the Company and the Scottish Government also include potential supply of VLA2001 for Scotland in the future, subject to regulatory approval. Valneva has also offered to make up to 25,000 doses of VLA2001 available for primary immunisation, free of charge, to National Health Service and frontline workers in Scotland, subject to regulatory approval. The grant is subject to contract and final due diligence and is expected to include commitments to jobs for the future in Livingston.
Commenting, David Lawrence, Acting Chief Financial Officer, said “We’re pleased that we’ve been able to advance discussions with Scottish Enterprise quickly, following the UK Government’s unexpected decision to terminate our supply agreement with them. We’ve reported excellent Phase 3 data and homologous booster data in the past couple of months, underlining the potential importance of VLA2001 – our inactivated, adjuvanted whole virus vaccine. Subject to regulatory approval we want to make VLA2001 available to people who need it, as soon as we can. We already have some vaccine stock available for distribution, upon approval. The grant will be very welcome and, subject to contract, will ensure that Livingston becomes a strategic vaccine manufacturing site for the future, successfully completing the work we began with HMG”.
Ivan McKee, Scottish Government Minister for Business, Trade, Tourism and Enterprise, said “Valneva is a valued contributor to our life sciences sector and the Livingston facility is an important asset, developing vaccines for the treatment of several important infectious diseases and supporting high quality jobs. Ministers and Scottish Enterprise are in advanced discussions with the company to agree a package of support which would underpin the company’s operations in Scotland.”
Hannah Bardell, MP for Livingston, added “I am delighted that the Scottish Government and Scottish Enterprise have listened to my constituency colleagues and I by agreeing to invest in Valneva’s vaccine manufacturing site in Livingston. This funding will enable Valneva to complete its expansion, boosting vital production capacity and protecting skilled jobs. It has been a pleasure to work with all involved in securing this agreement and I can only hope the UK Government will see the faith that we in Scotland have in Valneva.”
Valneva is continuing to try to reach an amicable resolution with HMG regarding its termination of the supply agreement and performance of the ongoing clinical trial agreement. The Company continues to reserve all rights in the event that an amicable outcome is not achieved.
Germany ordered 11 Mill. of Valneva/COV
https://www.reuters.com/article/idUSS8N2RT080
(PH developing lab-on-a-chip device to detect Chikungunya, Dengue, Zika)
https://mb.com.ph/2021/12/13/ph-developing-lab-on-a-chip-device-to-detect-chikungunya-dengue-zika/
Published December 13, 2021, 4:44 PM
by Charissa Luci-Atienza
The Philippines is seeking to develop a “cost-effective lab-on-a-chip device” that will be used to detect chikungunya, dengue, Zika, and Japanese encephalitis, the Department of Science and Technology (DOST) said.
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said the agency is supporting the development of such device to strengthen the country’s healthcare system.
“DOST supports a project that aims to develop a cost-effective lab-on-a-chip device that will be able to diagnose chikungunya, dengue, Zika, and Japanese encephalitis,” she said in an interview with the Manila Bulletin.
She said the device will be deployable to areas in the country with limited access to medical equipment.
Guevara said the DOST-funded project is “expected to end by the first quarter of 2022 and will then proceed with clinical evaluation afterwards.”
Meanwhile, she also bared that the DOST also supported a study that will look into aptamers for multiple antigens of Leptospira species.
The project is implemented by the team of Dr. Windell Rivera of the University of the Philippines (UP)- Diliman.
“Selected aptamers will be applied as biorecognition molecules in a diagnostic platform,” Guevara said.
“This tool for the direct and early detection of Leptospira can help in the surveillance and control of cases of leptospirosis in the country.”
Guevara had disclosed that two local studies on the development of diagnostic kits for the detection of human immunodeficiency virus or HIV are “ongoing” and are expected to be completed by next year.
READ MORE: https://mb.com.ph/2021/12/12/2-studies-on-devt-of-diagnostic-kits-for-hiv-detection-ongoing-to-be-completed-by-2022-dost/
Background Info: WHO/Chikungunya virus (CHIKV).
Key facts
Chikungunya is a viral disease transmitted to humans by infected mosquitoes. It is caused by the chikungunya virus (CHIKV).
A CHIKV infection causes fever and severe joint pain. Other symptoms include muscle pain, joint swelling, headache, nausea, fatigue and rash.
Joint pain associated with chikungunya is often debilitating, and can vary in duration.
There is currently no vaccine or specific drug against the virus. The treatment is focused on relieving the disease symptoms.
The disease mostly occurs in Africa, Asia and the Indian subcontinent. However a major outbreak in 2015 affected several countries of the Region of the Americas, and sporadic outbreaks are seen elsewhere.
The disease shares some clinical signs with dengue and Zika, and can be misdiagnosed in areas where they are common.
Severe cases and deaths from chikungunya are very rare and are almost always related to other existing health problems.
Due to the challenges in accurate diagnosis for chikungunya, the is no real estimate for the number of people affected by the disease globally on an annual basis.
The proximity of mosquito breeding sites to human habitation is a significant risk factor for chikungunya.
As in previous years, Asia and the Americas were the regions most affected by chikungunya. Pakistan faced a persistent outbreak that started the previous year and reported 8 387 cases, while India suffered with 62 000 cases. In the Americas and the Caribbean were reported 185 000 cases; the cases in Brazil accounted for >90% in the region of the Americas. Chikungunya outbreaks were also reported in Sudan (2018), Yemen (2019) and more recently in Cambodia and Chad (2020)
Full TXT
https://www.who.int/news-room/fact-sheets/detail/chikungunya
____
from https://outbreaknewstoday.com/chikungunya-in-brazil-cases-up-32-in-2021/:
According to the latest data published by the Pan American Health Organization ,
cases of chikungunya increased by 32% in Brazil in comparison between 2020 and 2021.
Through November 27 of this year, 127,487 total cases of the disease, caused by a
virus and transmitted by the bite of the Aedes aegypti mosquito, had been registered.
This compares with 96,044 reported during the same period in 2020.
The Northeast region continues to be the most affected, with an incidence of 111.7
cases per 100,000 inhabitants. But the increase of affected people in other parts
of the country is also noteworthy, such as the Southeast, which reported 29.1
cases per 100,000 individuals.
In São Paulo alone, the number of people affected by chikungunya jumped from
281 in 2020 to 18.2 thousand in 2021, which represents an increase of more than 6,000%.
VLA1553/Phase III: Positive Lot-to-Lot Consistency Results for Chikungunya
https://valneva.com/press-release/valneva-announces-positive-lot-to-lot-consistency-trial-results-for-its-single-shot-chikungunya-vaccine-candidate/
December 21, 2021
Saint Herblain (France), December 21, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.
Lot-to-lot trials demonstrate manufacturing consistency, one of the standard requirements for vaccine licensure. The trial, which included 408 participants aged 18 to 45 years, confirmed the excellent immunogenicity profile demonstrated in the pivotal Phase 3 trial, VLA1553-301. All three lots were equally well tolerated and the safety profile was consistent with results in the pivotal Phase 3 trial. Study VLA1553-302 therefore confirmed clinical equivalence as well as manufacturing consistency of the three lots.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “We are extremely pleased with these lot-to-lot Phase 3 data, which come in addition to the compelling pivotal Phase 3 results we reported in August. The lot-to-lot data will be part of our submission with the US Food and Drug Administration (FDA), which we plan to start in 2022. Chikungunya is a major, growing and unmet public health threat, yet no vaccine or specific treatment is currently available to prevent this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
The lot-to-lot trial will continue towards final six-month analysis with final trial results expected in the second quarter of 2022.
Valneva’s chikugunya program was awarded Breakthrough Therapy Designation by the US FDA in July 2021. This new milestone followed the US FDA’s Fast Track designation and the European Medicines Agency (EMA)’s PRIME designation which the Company received in December 2018 and in October 2020, respectively. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV) [1].
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there were more than 3 million reported cases in the Americas[2] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to more than 100 countries. It has been designed by deleting a part of the chikungunya virus genome.
In August 2021, Valneva reported positive topline results for pivotal Phase 3 clinical trial, VLA1553-301. In this double-blind, multi-center, randomized Phase 3 clinical trial, 4,115 participants aged 18 years and above were randomized 3:1 into two groups to receive either 0.5mL of VLA1553 or a placebo. The trial met its primary endpoint, inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.2-99.6). The seroprotective titer was agreed with the FDA to serve as a surrogate of protection that can be utilized in a submission for approval of VLA1553 under the accelerated approval pathway. VLA1553 was highly immunogenic, with a GMT of approximately 3,270.
VLA1553 was generally well tolerated among the 3,082 subjects evaluated for safety. An independent Data Safety Monitoring Board, or DSMB, continuously monitored the study and identified no safety concerns. The majority of solicited adverse events were mild or moderate and resolved within 3 days.
Additionally, VLA1553 was highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as an equally good safety profile.
VLA1553-301 will continue towards final analysis including the 6-month safety data. The Company expects to report final trial results in early 2022.
VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for chikungunya vaccines is estimated to exceed $500 million annually by 2032[3].
To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[4]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[5], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.
About Phase 3 study VLA1553-302
VLA1553-302 clinical lot-to-lot consistency Phase 3 study is a prospective, multicenter, randomized, pivotal Phase 3 study including 408 participants aged 18 to 45 years. Lyophilized VLA1553 are administered as a single intramuscular immunization. Equivalence of immune responses will be determined based on neutralizing antibody titers. The primary objective of the study is to evaluate a pair-wise comparison of the 95% Confidence Interval (CI) on the ratio of GMTs on Day 29 after vaccination in the three vaccine lots. The two-sided 95% CI on the GMT ratio should be within 0.67 and 1.5 in order to demonstrate consistency.
Study volunteers will be followed for six months after vaccination. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04786444).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. Valneva has leveraged its expertise and capabilities to successfully commercialize two wholly owned vaccines and rapidly advance multiple vaccine candidates into late-stage clinical development, including candidates against Lyme disease (partnered with Pfizer), the chikungunya virus and COVID-19.
Media & Investors Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, PhD
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
[1] https://priorityreviewvoucher.org/
[2] PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 13 Oct 2020.
[3] VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020
[4] Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries
[5] CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine
Valneva says its booster works https://www.reuters.com/markets/stocks/valneva-says-its-booster-works-follow-up-its-own-covid-19-shot-2021-12-16/
Valneva in talks with more countries interested in its COVID vaccine
https://www.reuters.com/business/healthcare-pharmaceuticals/valneva-talks-with-several-countries-over-further-vaccine-supply-contracts-2021-12-16/
UK Government 'short sighted' to scrap Scottish vaccine contract with Valneva
https://www.heraldscotland.com/politics/19784114.uk-government-short-sighted-scrap-scottish-vaccine-contract-valneva/
PR: VALN/+1 million doses for Kingdom of Bahrain (VLA2001)
https://valneva.com/press-release/valneva-signs-advance-purchase-agreement-with-bahrain-for-inactivated-covid-19-vaccine-vla2001/
Saint-Herblain (France), December 8, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Company’s inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.
Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority (NHRA).
Franck Grimaud, Chief Business Officer of Valneva, commented, “We are grateful to the Bahraini government for their trust and confidence in our vaccine and are eager to work with them to start helping to address the pandemic evolution in the Middle-East. Subject to regulatory review and approval, we plan to start deliveries in the first quarter of 2022.”
A Bahraini government spokesperson stated, “Bahrain is once again at the forefront on adopting new measures to protect the health of citizens and residents against the threat of COVID-19. Subject to approval, Bahraini citizens and residents will have the ability to choose from a variety of vaccines in Bahrain that will have a positive impact on driving up vaccinations rates with 93% of the eligible population now fully vaccinated in the Kingdom.”
Last month, Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA2001[1]. Valneva reported positive Phase 3 results for VLA2001 in October 2021[2].
2021-DEC-13. Scots covid vaccine that could beat Omicron axed by Boris Johnson
https://www.dailyrecord.co.uk/news/scottish-news/scots-covid-vaccine-could-beat-25618953
PR 2021-DEC-03. don't put lipstick on the pig ,) what if no booster is needed at all (oT: peppa pig https://www.theguardian.com/commentisfree/2021/nov/23/boris-johnson-peppa-pig-world-ant-dec)
last time it was -50 %, now only -15 % thx
December 3, 2021
Saint Herblain (France), December 3, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today responded to data published from the COV-Boost COVID-19 vaccine trial, which investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines at different dose levels when administered as a third dose, or booster, to people primed with either Pfizer’s Comirnaty or AstraZeneca’s Vaxzevria.
The COV-Boost trial, which launched in May 2021 and was led by University Hospital Southampton NHS Foundation Trust (UK), included Valneva’s inactivated, adjuvanted, whole virus COVID-19 vaccine candidate VLA2001. The aim of the COV-Boost trial was to quickly generate data to inform advice from the UK’s Joint Committee on Vaccination and Immunization on the autumn booster campaign. Participants were given a booster dose relatively early, only two to three months after completion of the second dose of the primary vaccination series, when they did not need a booster from either an immunological standpoint or under the currently recommended interval for licensed COVID-19 vaccines. Valneva believes it is likely that the short interval between the second shot and booster shot could have adversely impacted the results for VLA2001, given that a longer interval is generally required for inactivated vaccines.
The Company has already begun generating data to inform any regulatory discussions regarding a potential booster indication for VLA2001. The first data from a continuation of existing clinical trials (homologous) are expected in the first quarter of 2022. Additionally, Valneva is in the process of setting up a dedicated heterologous booster trial. All of Valneva’s trials will evaluate a booster shot provided at least six months after primary vaccination, as per the currently recommended interval for licensed COVID-19 vaccines. The results of the COV-Boost trial were never intended to be, nor will they be, part of the Company’s regulatory submissions to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA), which seek approvals for VLA2001 in the primary vaccination context solely based on the positive data from the pivotal Phase 3 Cov-Compare trial.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, said, “The setting in the study leads us to believe that COV-Boost does not allow any conclusions to be reached regarding the use of VLA2001 as a booster in a real-life setting. The protective antibody threshold has not yet been established therefore relative increases in antibody levels should not be seen as indicative of efficacy. I concur with Professor Faust’s statements that the data describe the immune response at 28 days, not vaccine effectiveness, and that the relationship between that response and long-term protection is still poorly understood, especially since several studies have shown that longer periods between doses improve immune response. Our submissions for authorization of VLA2001 in a primary vaccination context remain on track, with the EMA announcing yesterday that it has started its rolling review of VLA2001, and our teams are working diligently so that we can quickly deploy our vaccine and ensure it reaches the people who need it.”
On October 18, 2021, Valneva announced positive topline results from Cov-Compare, the pivotal Phase 3 comparative immunogenicity trial of VLA2001. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile. The Company commenced rolling submission for initial approval of VLA2001 with the MHRA on August 23, 2021 and rolling review with the EMA on December 2 and will continue to work very closely with those authorities to complete their review process.
Valneva announced on November 23, 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years – including 24.3 million doses in 2022. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the EMA.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Shorts stats/insignificant (dec.)...
large image
Novavax starts production JAN 2022.
Novavax tailoring Covid-19 vaccine to Omicron variant while advancing campus expansion plans
By Sara Gilgore
– Staff Reporter, Washington Business Journal
Dec 2, 2021
Updated 3 hours ago
As Novavax Inc. (NASDAQ: NVAX) works to get its Covid-19 vaccine to the world and develops a Gaithersburg campus to manufacture its product long term, the biotech is putting another priority at the top of its list: adapting its vaccine to the Omicron variant.
The company said Thursday it’s implementing “a two-pronged variant strategy” that includes assessing how its existing vaccine — not yet to market in the U.S. — protects against the new variant of concern. It also involves developing a vaccine tailored specifically to the Omicron variant.
As part of the first prong of that response, Novavax plans to evaluate in its ongoing studies whether its vaccine induces an immune response, and to what extent. The biotech also plans to test whether antibodies in people who received the vaccine previously protect them from the Omicron variant “with lab-based data expected in the coming weeks,” it said in its statement.
A rendering of Novavax's future headquarters and manufacturing building, alongside its larger holdings in Montgomery County.
KGD Architecture
Then there’s Part 2.
“The initial steps required to manufacture an Omicron-specific spike are underway,” Novavax said Thursday. Its team will start assessing the vaccine, matched to the new strain, within a few weeks, and will shoot to start manufacturing that vaccine in January, according to Novavax.
Novavax uses what’s called recombinant nanoparticle technology in its vaccine, making it different from messenger RNA and viral-vector vaccines. It’s the same platform Novavax uses for its experimental seasonal flu and other vaccines, but it swaps in the genetic sequence for the coronavirus in place of the other antigens to fight Covid.
https://finance.yahoo.com/m/69a70e7a-5a47-36de-9550-4ff1930f1033/novavax-tailoring-covid-19.html
----------------
Valneva has been producing in the UK for a long time and recently started in DE. I don't know anything about the swedish production facilities, anyone?
also IDT Bilogika production is already underway > "Major order for IDT Biologika"*
"Dessau-based company fills new Corona pot vaccine"
...
Production of the preparation is already underway in Rodleben, Betzing announced. In recent months, the company has been working with Valneva to set up production. However, the IDT managing director did not disclose how many doses have already been produced. No details were given about the financial dimension of the order.
*source: https://www.mz.de/lokal/dessau-rosslau/grossauftrag-fur-idt-biologika-dessauer-unternehmen-fullt-neuen-corona-totimpfstoff-ab-3284298
PR 2021-DEZ-02 / Omicron
Valneva is also providing an update on VLA2001 in the context of the emergence of the Omicron variant. Valneva believes that VLA2001 can make an important contribution to the global fight against the COVID-19 pandemic and potentially play a role in protecting against the new Omicron variant.
In contrast to other vaccines that target only the spike protein of the SARS-COV-2 virus, VLA2001 is developed using the entire SARS-CoV-2 virus envelope. Preserving the whole virus envelope is expected to elicit a broad immune response and together with the CpG1018 adjuvant may provide an improved immunological profile by boosting T-cell responses against additional SARS-CoV-2 proteins. Valneva will test for cross-neutralization of VLA2001 against the Omicron variant.
Valneva also confirms that its technology platform is adaptable for new variants, if required. The Company has undertaken laboratory development and testing of variants, at its sites in France and Austria, including the production of viral seedstock for three earlier variants of concern, including Delta. Valneva produced a full scale pilot lot derived from the Alpha variant, validating the suitability of its well-established manufacturing process for variant-based vaccines.
Valneva has commenced manufacturing for the European Commission supply contract and has some inventory ready for labelling and deployment upon regulatory approval. Valneva expects to have capacity to produce over a hundred million doses of vaccine per annum through a combination of in house production and CMO capacity.
full txt: https://valneva.com/press-release/valneva-initiates-rolling-review-with-ema-and-provides-updates-on-its-covid-19-vaccine-program-vla2001/
Through these rolling reviews, EMA can start evaluating data while the development is still ongoing, and before the vaccine developer has submitted a request for marketing authorisation. The rolling review assesses data on the vaccine's quality as well as results from laboratory studies. EMA also looks at results on the vaccine's efficacy and initial safety data emerging from large-scale clinical trial as they become available. This significantly shortens the normal assessment times while maintaining the principles of quality, safety and efficacy.
In the context of the rolling reviews, a dedicated group of experts, the COVID-19 EMA pandemic Task Force, has been established on the development, authorisation and safety monitoring of COVID-19 vaccines and is responsible for thoroughly assessing the scientific data. Hence, when a marketing authorisation is requested, the formal assessment can proceed much more quickly, as the data have already been scrutinised during the rolling review.
Moreover, EMA assesses the data with a view to issue a Conditional Marketing Authorisation (CMA). Such an authorisation ensures that the safety, efficacy and quality of the vaccine is demonstrated and that the benefits of the vaccine outweigh its risks, whilst at the same time allowing the vaccine developers to submit additional data also after the marketing authorisation (contrary to a normal marketing authorisation where all data are submitted before the authorisation is granted).
The European Commission is also ensuring that the process leading to the marketing authorisation can take place as quickly as possible by shortening administrative steps, such as the period for consulting Member States and by allowing for the translation of the product information in all official languages to take place in the first instance in electronic form to save time.
Whilst the average standard process for the authorisation of medicinal products takes 67 days, including 22 for the consultation of Member States, by making use of the provisions specifically provided for under EU legislation for emergency situations, the Commission will be able to proceed with a marketing authorisation within 3 days following a positive recommendation from EMA.
EMA starts accelerated review of Valneva vaccine approval/
Marketing authorisation application
The European Medicines Agency (EMA) has announced an accelerated review for Valneva's Corona vaccine. The review of the VLA2001 vaccine has already begun, the Amsterdam-based EU agency announced Thursday. When a decision on the inactivated vaccine from the Austrian-French biotechnology company will be made is still open, it said.
Valneva's inactivated vaccine contains killed components of the coronavirus for immunization. As such, it uses similar technology to traditional flu vaccines and is said to be able to be stored in normal refrigerators. In October, Valneva had announced "positive" initial results from its Phase 3 clinical trial of the vaccine. The drug was more effective than the AstraZeneca vaccine, it said, and "generally well tolerated."
Even before an approval, the EU Commission had signed a supply agreement with Valneva. The Commission said less than a month ago that the agreement provides for the supply of up to 60 million Corona vaccine doses over the next two years, if the EMA actually approves the drug. Announcing the agreement, EU Commission President Ursula von der Leyen stressed that the vaccine could be adapted to new Corona variants. This could be important, not least in view of the new coronavirus variant Omikron.
(diepresse.at)
more @
News 02/12/2021
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-valnevas-covid-19-vaccine-vla2001
(While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.)
Vaccination obligation in the EU, von der Leyen: “Let’s discuss it”
It is time for the European Union to start “discussing” the advisability of introducing compulsory vaccination against covid-19. Thus the president of the European Commission Ursula von der Leyen, responding, at a press conference in Brussels, to a question about the sanctions envisaged by Greece for those over 60 who refuse to be vaccinated. And recalling that there are still about “150 million” of individuals who have not received the vaccination, even though many of them could protect themselves from the disease caused by Sars-CoV-2, he premised that whether or not to impose the obligation to be vaccinated “is absolute competence of the Member States. On this it is not up to me to give any recommendations “. Then he added: “If you ask me what my personal position is, two or three years ago I never thought I would see what we are seeing now. We have a horrible pandemic, we have vaccines that save lives, but they are not being used properly. everywhere. Therefore, this is a huge health cost. If we look at the numbers, we now have 77% of the adults vaccinated in the EU, and if we take the total population it is 66%, which means that one third of the European population is not vaccinated. There are 150 million people: there are many “. Read also Of course, he continues, “not everyone can be vaccinated: very young children, for example, or people in special health conditions, but the vast majority could be. Therefore, I think it is understandable and appropriate to conduct this discussion now, on how we can encourage and potentially think about compulsory vaccination within the EU. For this we need to discuss. We need a common approach, but I think – he concludes – that it is a discussion that must be held “.
Review VAL<->UK + Bingham expects Omicron vaccine impact to be known in a week
Under Bingham's leadership, the UK taskforce ordered vaccines as they were still being trialled, securing supplies from Pfizer (PFE.N), AstraZeneca (AZN.L), Moderna (MRNA.O) and others to give Britain a head start in the rollout.
She said on Wednesday that she had backed the vaccine from French company Valneva (VLS.PA), which differs from others by relying on an inactivated virus similar to flu vaccines, because having a varied portfolio would be useful when variants emerged.
"The idea of having that as a potential vaccine in our portfolio, knowing it was going to come on stream later than the earlier ones, was precisely that you could deal with variants," she said.
She added that "unfortunately" the Valneva contract had been cancelled. "I wasn't part of the decision so I don't know the basis of it," she said. "But I would have thought that was a useful vaccine to have in our panoply of tools to actually address variants and future pandemic strains."
https://www.reuters.com/world/uk/uks-bingham-expects-omicron-vaccine-impact-be-known-week-2021-12-01/
UK: Valneva order ‘may be reinstated’ to fight Omicron
https://dailybusinessgroup.co.uk/2021/11/valneva-order-may-be-reinstated-to-fight-omicron/
confirmed production sites currently: UK, DE, SWE
Livingston (Scotland)
Dessau-Roßlau (Germany)
Solna (Sweden)
Interesting co. p0. Yeah, the two board thing is odd.
And then there's the otc INRLF - odd there with no bid
No board here for that one.
Covid vax getting all the attention but Lyme Disease jab would be sumthin'
https://www.biopharma-reporter.com/Article/2021/03/08/Valneva-and-Pfizer-start-new-Phase-2-study-for-Lyme-disease-vaccine-candidate
https://www.nih.gov/news-events/nih-research-matters/targeted-antibiotic-treating-lyme-disease
Cheers and congrats - nice chart.
Valneva + IDT Biologika (= higher production rate + production also in the "EU" / outside UK)
Saint-Herblain (France) and Dessau-Roßlau (Germany), November 29, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced their collaboration for the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years.
Under the collaboration, IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “IDT is a well-established partner within Valneva’s manufacturing network. As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”
Dr. Jürgen Betzing, Chief Executive Officer of IDT Biologika, added, “This is great news for our company. This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees. The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.”
Valneva has continued to review its manufacturing strategy following discussions with the UK Government (“HMG”) in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand. The Company’s sites in Livingston, Scotland and Solna, Sweden will continue to form part of the Company’s core manufacturing strategy.
Valneva reported positive Phase 3 results for VLA2001 in October 2021[1]. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency (EMA), which is expected to start a rolling review of VLA2001 shortly.
CEO Lingelbach interview (2021-NOV-23) Part II
profil: How well does VLA2001 work compared to the already approved vaccines?
Lingelbach: We compared our vaccine candidate VLA2001 with AstraZeneca's vaccine in the phase 3 trial. VLA2001 proved superior in terms of neutralizing antibody titers, had a significantly better tolerability profile, and was non-inferior in terms of seroconversion rates (i.e., the percentage of individuals who form specific immunity after vaccination).
We believe that VLA2001 may offer advantages over currently licensed vaccines in terms of safety, cost, ease of manufacture, and distribution.
Inactivated vaccines meet standard cold chain requirements (two to eight degrees Celsius), making them easier to store and distribute than mRNA vaccines.
profil: And in terms of safety?
Lingelbach: In the AstraZeneca comparative study, participants who were 30 years and older reported significantly fewer adverse events up to seven days after vaccination.
Valneva #COVID19 vaccine contract signed today
✅Valneva #COVID19 vaccine contract signed today.
— Stella Kyriakides (@SKyriakidesEU) November 23, 2021
▶️As we aim to increase our vaccination efforts, it will add another option to our broad portfolio of safe and effective vaccines, for Europeans and citizens around 🌍. pic.twitter.com/hOYjCB2Bsp
CEO Lingelbach interview (2021-NOV-23)
(excert from https://www.profil.at/oesterreich/totimpfstoff-valneva-menschen-aus-aller-welt-warten-auf-unseren-impfstoff/401815750)
profil: The U.S. company Novavax could launch its inactivated vaccine on the market in just a few weeks. Was the competitor's head start in terms of time foreseeable?
Thomas Lingelbach: Since Novavax has already started the approval process with the European Medicines Agency EMA in February 2021, the timing of the approval did not come as a surprise to us.
profil: How do the Novavax and Valneva inactivated vaccines differ?
Lingelbach: Our vaccine comes closest to a natural infection. Unlike Novavax's vaccine, which contains only the spike protein of COVID-19, Valneva's vaccine candidate VLA2001 contains the whole virus in killed form. The basis of the Valneva vaccine is the virus in its natural form, which is chemically inactivated and cannot replicate in the body of the vaccinated. However, upon contact, the body reacts with the same immune response as with the active coronavirus and forms antibodies.
profil: Many unvaccinated people with whom we are in contact are waiting for an inactivated vaccine for themselves or their children. Some specifically mention the name of their group. How do you deal with this high expectation?
Lingelbach: We receive many messages from people around the world who are waiting for an inactivated vaccine. We are determined to bring an alternative vaccine solution to market as quickly as possible. Our Phase 3 results have confirmed the benefits often associated with inactivated vaccines, and we believe we could still make an important contribution to the global fight against the COVID-19 pandemic. We are now also moving quickly to investigate potential use in children and adolescents. Valneva has already started recruiting adolescents and studies in children are underway.
Around 65% of the EU population has already had
two vaccine doses,3 while just 4% of those in low
income countries have received at least one dose.4
This has raised questions over why Valneva focus
for approval and rollout is on the EU.
Penny Ward, visiting professor in pharmaceutical
medicine at King’s College London, said that the UK’s
order cancellation could allow Valneva “to provide
an immediate supply of the vaccine for other
countries struggling with the freezer shipping
requirements of other, more expensive, vaccines.
Good news for Covax [the international covid vaccine
alliance] and countries still awaiting supplies.”
Announcing the deal, the EC hinted that its interest
in the vaccine could relate to new variants. EC
president Ursula von der Leyen said, “The contract
allows for the vaccine to be adapted to new variants.
Our broad portfolio will help us to fight covid-19 and
its variants in Europe and beyond. The pandemic is
not over. Everyone who can, should get vaccinated.”
Differences VALNEVA / NOVAVAX
VALNEVA
With this vaccine, actually the whole killed viruses are vaccinated.
This means that the body produces an immune response against a wide variety of
parts of the virus, not just against the surface molecule, the spike protein,
as with the other vaccines. A virus consists of many molecules against which
the immune system can theoretically mount an immune responsw.
NOVAVAX
Here, the spike protein - i.e. the surface molecule of the virus -
is used and mixed with an active ingredient booster, which is
intended to guarantee that the vaccination then also triggers a
correspondingly strong immune response.
This works in a similar way
to previously known vaccines against influenza or hepatitis.
Novavax does not consist of whole viruses,
but of components of the virus.
Stock Price Paris/INT https://valneva.com/investors/stock-price/
Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses (2022-2023)
Valneva (VALN) Begins Submission for COVID-19 Vaccine in UK
https://finance.yahoo.com/news/valneva-valn-begins-submission-covid-143402351.html
Valneva and Pfizer Complete Recruitment for Phase 2 Trial of Lyme Disease Vaccine Candidate
https://www.globenewswire.com/news-release/2021/07/19/2264541/0/en/Valneva-and-Pfizer-Complete-Recruitment-for-Phase-2-Trial-of-Lyme-Disease-Vaccine-Candidate.html
Valneva's Chikungunya Vaccine Candidate Gets FDA Breakthrough Tag
https://finance.yahoo.com/news/valnevas-chikungunya-vaccine-candidate-gets-182044974.html
Valneva Completes Recruitment for Phase 3 Lot-to-Lot Consistency Trial of its Chikungunya Vaccine Candidate
https://finance.yahoo.com/news/valneva-completes-recruitment-phase-3-050000210.html
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