The 0.1 ml dose has been approved in US and Europe. I'm sure that will be accepted worldwide. A million doses will now treat 5 million patients. The investment facts have changed and I went to the sidelines.
Earnings and CC Aug 24.
So far, the U.S. federal agencies have demonstrated once again their lack of urgency and agency by insisting on the dosing schedule specified on the label. In an unexpected development, instead of stretching the time interval between two 0.5-milliliter doses, the Biden administration asked the FDA to authorize so-called intradermal injection, which would involve injecting a 0.1-milliliter dose into the skin instead of a full 0.5-milliliter dose into the underlying fat. The FDA did so on Aug. 9. But some experts have expressed concerns because the efficacy of this intradermal method with only one-fifth of the full dose is unknown. This method is also complicated for vaccinators, who need to guide a needle into a skin-deep space. It requires additional training, posing challenges to an already overstretched healthcare workforce.
The Biden administration’s proposed solution quickly backfired, drawing strong opposition from Bavarian Nordic, the manufacturer of Jynneos, as the Washington Post reported. Its CEO has apparently threatened to revoke upcoming orders from the U.S., jeopardizing the fight against monkeypox. The “first dose first” approach, in contrast, is supported by solid data and has the support of the manufacturer as well as state and local public health organizations.
We urge the CDC, FDA, and the recently elevated Administration for Strategic Preparedness and Response to seriously factor in the ongoing severe shortage when developing a national monkeypox vaccine distribution strategy. Pretending that there are no supply shortages will not make the problem go away.
Bavarian Nordic Near Deal With US Firm to Make Monkeypox Shots
Bavarian Nordic vaccine to be finished in Michigan facility
US company to be ready to start work within four months
Monkeypox vaccine maker Bavarian no longer certain it can meet demand
The company is exploring the possibility of outsourcing production, including technology transfer to the US, to meet demand. PHOTO: AFP
PUBLISHED AUG 17, 2022, 7:19 PM SGT
COPENHAGEN (BLOOMBERG) - Bavarian Nordic, the only company with an approved vaccine for monkeypox, said it is no longer certain it can meet demand as cases continue to rise across the world.
The Danish company is now exploring the possibility of outsourcing some of the production, including technology transfer to a United States contract manufacturer, to meet accelerating demand.
"It's a very dynamic market situation," Mr Rolf Sass Sorensen, a vice-president at the firm, said by phone on Wednesday (Aug 17).
"Demand keeps rising and it's no longer certain that we can continue to meet the demand we're facing even with the upgrade of our existing manufacturing site in Denmark."
A move to outsourcing production would mark a shift for Bavarian which, until now, has said it could deliver on all orders from its Danish facility.
It also previously said a technology transfer to a third-party producer - which would allow bulk production of the vaccine rather than just "fill-finish" where the doses are put into vials and packaging - would be too cumbersome, expensive and take too long.
The flare-up of the virus, which has spread to thousands of people in more than 70 countries in just a few months, was declared a public health emergency of international concern by the head of the World Health Organisation last month.
Britain said earlier this week it is facing a temporary shortage of the vaccine as it awaits further production of doses by the manufacturer.
"We're looking at ways to get help from partners in all the various production steps of the vaccine," Mr Sorensen said.
"We are also investigating a tech transfer to a contract manufacturer in the US to increase capacity. We don't have any concrete negotiations in the works with bulk producers, but we're investigating and looking at what options there are."
The Danish company has raised its financial outlook several times this year as governments across the globe have spent hundreds of millions of dollars ordering its Jynneos vaccine, which originally was developed for smallpox.
Bavarian can currently produce 30 million doses per year at its bulk facility based north of Copenhagen.
Bavarian's chief executive, Mr Paul Chaplin, told Danish newspaper Borsen on Wednesday that a possible tech transfer for Jynneos to a US producer could take about three months if the process is sped up, compared with about nine months under normal circumstances.
If your doubting the size of HHS orders and rest of world:
$2 Billion Dollar HHS Contract Awarded for Smallpox Vaccine
Emergent BioSolutions ACAM2000 is a live vaccinia virus smallpox vaccine
PublishedSeptember 3, 2019
ACAM2000 is the smallpox vaccine BARDA has in storage and not being used in this outbreak because of side effects. Bavarian Nordic's US orders are to replace the small[px vaccine kept for bioterrorism. The MPX order will include civilian use in use n the US and rest of world. Much bigger numbers coming over time.
Spain revealed that 32 of the 181 patients had previously received a childhood vaccination against smallpox.
6/25 - HHS released news that one billion dollar order added to the $875 million order already in effect. Order is intended for BARDA for the bioterrorism stock.
Genomic update today shows 5 new Monkeypox clades
Each clade has distinct characteristics and has been given nomenclature-based names (depending on the system used).
The B.1 clade appeared this year. History has shown new clades being rare in this DNA virus with none seen the first 40 years of watching this virus. And this branch beginning in 2018 and nothing until this latest outbreak
Over 30,000 cases, a week ago we were looking at 23,000
This is happening while the world is now on high alert. I think the ease of transmission is far higher than health agencies realize. Watching the cases it most reminds me of Herpes.
Herpes is easily spread from skin-to-skin contact with someone who has the virus. You can get it when your genitals and/or mouth touch their genitals and/or mouth — usually during oral, anal, and vaginal sex.
About 50% of the population is positive for oral herpes.
Should be noted that herpes can also “shed” and get passed to others when there are no sores and your skin looks totally normal.
Most people get herpes from someone who doesn’t have any sores.
tomorrow morning work for you?...
Yeah, read that. So where is our jump this week?
Monkeypox lacks same 'urgency' as COVID-19 for Moderna: CEO
Monkeypox doesn't carry the same urgency for Moderna (MRNA) as COVID, says CEO Stéphane Bancel.
Though the company is working on a vaccine for the disease, it remains focused of the novel coronavirus, the flu, and ongoing expansion.
"We don't have the urgency we had when COVID happened, because as you know, there is already a vaccine on the market," Bancel said.
Monkeypox has been endemic in Africa for five years, and already has a viable vaccine and treatment on the market. Denmark-based Bavarian Nordic, maker of JYNNEOS, is currently the only player on the market. But it has struggled to meet even the current demand over manufacturing woe
Anjalee Khemlani·Senior Reporter, Yahoo
yeah, I would have expected this week to be a big up week.
If cases continue higher there will be plenty of upside
Tuesday, July 26th, 2022
The world's only company with an authorized monkeypox vaccine, Bavarian Nordic, may soon be running 24/7 after the World Health Organization defined the current outbreak as a global health emergency, according to Bloomberg.
WSJ July 30th
A Copenhagen company worked for nearly two decades to develop a vaccine and only six governments bought it. Within the last few weeks, orders have come in from dozens of countries around the globe and it is looking at whether it can operate 24-hours a day, seven days a week, to meet demand.
Death toll now at 5
Indian death was in a patient that had been cleared of symptomatic and previously tested negative after infection.
Female in Ghambia was first death out of 34 cases diagnosed. No vaccine available as an embarrassment for WHO. Folks wondering what this disease would look like without vaccine and treatment available now know data would be much worse.
Recent positive cases now showing up in patients with no history of coming into contact with infected patients. Asymptomatic transmission? Children now testing positive and there has been zero chance it was sexually transmitted.
Folks hesitant to report or seek treatment because of stigma attached to monkeypox.
If this week shows exponential growth again, I think the world has another pandemic that is also lethal without vaccine or treatment. Extremely painful is norm for cases diagnosed as mild.
Two MPOX deaths reported today. One is Spain and one in Brazil.
Public awareness will increase 10X and demand for vaccine access/storage will lead to policy response, US declaring Emergency status coming this weekend?
Bavarian recently agreed to an outsourcing agreement with a US company. Emergency status will lead to grants and quick approval to get production up and running as soon as possible.
Biden Administration estimating the immediate response will lead to a request for $7 billion for vaccines, testing and treatment.
Now that the world is aware of Monkeypox evolving into a real threat no country will want to be caught without reserves of vaccine for a future outbreaks, so billions $ around the world to stock the vaccine.
Should take out the 52 week high this week, $19
The WHO declaring emergency has opened funding and grants for expansion of production. Expect the see a big emphasis on Africa where the disease had killed 22 so far this year. With testing I suspect confirmed deaths would be 10X that as the Congo Clade is much more severe and commonly seen in children. It is a disgrace that the disease has been endemic in that part of the world for decades and not been treated. African nations have been very critical of WHO ignoring the problem until it was seen in the West.
The news for Malaria is what WHO will be doing for Monkeypox in the Congo region
Historic funding to expand roll-out of first-ever malaria vaccine in Africa
21 July 2022
Brazzaville – The World Health Organization (WHO) welcomes the launch by Gavi, the Vaccine Alliance, of the landmark opportunity for countries to apply for funding to introduce, or further roll-out, the RTS,S/AS01 (RTS,S) malaria vaccine.
* Over 20 deaths from Moneypox reported in the region earlier this year. If widespread testing were available the total would be much higher.
News for July 19th, another large order
COPENHAGEN, Denmark, July 19, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that a non-disclosed country has ordered an additional 1.5 million doses of IMVANEX®, a non-replicating smallpox vaccine. While deliveries under this contract will start in 2022, the majority of the doses will be delivered during 2023
* Supply is limited, needs another licensing agreement for production and I'm guessing talks are ongoing. WHO and CDC could also grant funds for expansion of facilities.
* Nobody doubts the Monkeypox threat could be halted with wide availability of the vaccine.
nice day here....+9% so far...
Bavarian Nordic agreed to outsource production of monkeypox vaccines to a plant in the U.S. in a deal with the federal government aimed at increasing supply of the scarce shots.
* "agreed", meaning FDA is requesting ramping production. Rest of World is likely requesting production agreements. Huge need in Africa's endemic regions if this rapidly mutating virus is to be halted.
8169 cases as of 7-8
When do they make vaccinations available to anyone that wants one. Bavarian is offering a safer more effective vaccine than the one used to vaccinate trillions of people to completely eliminate small pox.
Funding to ramp up vaccine production and immediately make it available to the African nations with endemic and more severe versions of Monkeypox. Millions more in the West will also likely be interested in getting vaccinated if it were widely available.
The bigger news has been totally ignored:
COPENHAGEN, Denmark, June 28, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the European Medicines Agency (EMA) has granted access to its priority medicines (PRIME) scheme for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults ≥60 years of age
$ Bilions in US dollars in sales, maybe after the US announces access is granted the big move comes for this vaccine
WHO to reconvene as soon as possible as situation has evolved.
The committee "advised that I should reconvene them quickly based on the evolving situation, which I will do," Adhanom Ghebreyesus said at a press availability, adding that the virus is potentially poised to "move into high-risk groups including children, the immunocompromised, and pregnant women."
"We are starting to see this with several children already infected," he said.
Assuming a MPX case count of 6,500 worldwide for today. Then a growth rate of 7% for the next 20 days, then 6.5% for 20 days etc. Then in 4 months the # of MPX cases might be 5,306,000.
Today I used a longer averaging period to estimate growth rates. Z
4940 confirmed cases as of today. Exponential growth continues and ease of spread is the most glaring stat not being discussed WHO and CDC. Serious actions need to be taken yesterday as patients and those exposed should be on lockdown for up to 14 days. Nobody wants this spread to continue.
Worse is the millions of vaccinations that should already be in transit to Africa where there have already been 62 deaths (reporterd) this year. WHO should be requesting funding now and placing order with Bavarian.
I just double down on Bavarian
COPENHAGEN, Denmark, June 28, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the European Medicines Agency (EMA) has granted access to its priority medicines (PRIME) scheme for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults ≥60 years of age. There are no approved vaccines for RSV, and access to PRIME has been granted upon an assessment that the available clinical data overall show the potential of MVA-BN-RSV to address the unmet medical need in the proposed target population.
* (((A $6 billion dollar market))) and no competition. The over 60 was the targeted patient for the drug.
In 4 months (Election day) there may be 125,000,000 cases worldwide at current growth rate. Prez Joe B said, “There’s going to be a second pandemic”. Just a coincidence, right ?
Could be at 6,000 cases tomorrow. 9-10% per day. In 60 days there will be 1,000,000 cases worldwide if growth continues at this rate. (Should slow a little over that time frame.)
Remember : The Wuhan Institute of Virology was working on monkeypox and published a paper on it in February in a journal called … Virologia Sinica ? Or something like that.
US Health Officials Announce New Monkeypox Vaccination Plan
Vaccines will be prioritized for states with most the cases
HHS is bolstering vaccine supplies of Bavarian’s Jynneos
*News also broke today of cases have now been seen in children where sexual abuse was ruled out. There is a new story about transmission that needs to be told.
2587 total cases today as the numbers of cases has now gone exponential as todays one day total exceeds 500 cases. More cases in one day than seen in a week's total last week.
Mutating more like a common virus than a DNA virus and ease of spread looks at least 10X what was though capable.
Cases crossed 2000 today and the growth is going exponential
WHO and CDC has a narrow window to prevent a new virus gaining endemic status. Ease of transmission has been greatly underestimated.
A couple of cases of mutated Congo variants reported in the US. This was the worst case scenario. Everyone hopes Congo subtype outbreak is focused on and halted. WHO needs to get funding and start offering vaccinations in the 20 African nations already in endemic status. 9 deaths have been reported in the Congo this year.
What's the monkeypox vaccine and who should get it
Nicole Ireland · CBC News · Posted: Jun 15, 2022 4:00 AM ET | Last Updated: 4 hours ago
A health-care worker prepares a syringe at a monkeypox vaccination clinic run by public health authorities in Montreal. (Christinne Muschi/Reuters)
As the number of confirmed monkeypox cases continues to rise in Canada, infectious disease and public health experts are providing vaccinations to those at risk of infection.
Since monkeypox and smallpox are both part of the orthopox family of viruses, experts say some vaccines will work against both.
But the vaccines being recommended for use against monkeypox today are different from those used in the last century's global effort to eradicate smallpox, the World Health Organization (WHO) says.
"Some countries have maintained strategic supplies of older smallpox vaccines from the Smallpox Eradication Programme (SEP) which concluded in 1980," said the WHO's interim monkeypox vaccination guidance issued on Tuesday.
"These first-generation vaccines held in national reserves are not recommended for monkeypox at this time, as they do not meet current safety and manufacturing standards."
Monkeypox causes flu-like symptoms and skin lesions, and spreads through close contact.
Both WHO and Canada's National Advisory Committee on Immunization (NACI) have now released guidelines on what vaccine to use against monkeypox, and who might benefit from it.
What monkeypox vaccine is available in Canada?
The vaccine approved for immunization against monkeypox in Canada is MVA-BN, or Modified Vaccinia Ankara - Bavarian Nordic. Bavarian Nordic, headquartered in Denmark, is the company that manufactures it.
In Canada, the vaccine has the trade name Imvamune. (It's called Imvanex in the European Union and Jynneos in the U.S.)
Imvamune was originally authorized in Canada for "extraordinary use" against smallpox in November 2013, as part of the federal government's emergency plan to immunize people if the deadly disease were ever to resurface. In 2020, Canada expanded the vaccine's authorization to include immunization against monkeypox, NACI documents say.
An employee of the vaccine company Bavarian Nordic works in one of its laboratories near Munich, Germany, on May 24. The company's Imvamune vaccine is approved in Canada for immunization against monkeypox. (Lukas Barth/Reuters)
Routine smallpox vaccinations stopped in Canada in the early 1970s. But because the viruses are related, those smallpox vaccinations may have provided some degree of immunity against monkeypox as well, experts say.
"It's likely that this, you know, mass immunization campaign for smallpox really kept monkeypox in check for many years," said Dr. Isaac Bogoch,