OGINVU
2 years ago
https://www.barrons.com/articles/monkeypox-covid-supply-chain-vaccines-51660928179
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.
OGINVU
2 years ago
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
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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.
https://www.straitstimes.com/world/europe/monkeypox-vaccine-maker-bavarian-no-longer-certain-it-can-meet-demand
roadkilll
2 years ago
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
roadkilll
2 years ago
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.
roadkilll
2 years ago
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.
roadkilll
2 years ago
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.
OGINVU
2 years ago
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, an infectious diseases specialist at Toronto General Hospital.
But most people under 50 in Canada didn't get that protection — and that might be one of the reasons we're seeing monkeypox now, he said.
How is Imvamune different from the old-school smallpox vaccine?
Imvamune contains a weakened strain of the vaccinia virus, which provokes the immune response to fight off smallpox and monkeypox.
Unlike the original smallpox vaccine, this weakened virus is non-replicating, meaning it can't make copies of itself.
Early-generation vaccines based on replicating vaccinia strains led to unpleasant side effects for some and could be problematic for people who were immunocompromised, said Dr. Zain Chagla, an infectious disease specialist at McMaster University in Hamilton.
In addition, older generations of smallpox vaccine are administered differently. Instead of a regular syringe, the health-care provider uses a "bifurcated needle" with two prongs and pricks the skin repeatedly to get the dose in.
Who should consider vaccination against monkeypox?
Infectious disease specialists say, right now, monkeypox is not affecting the majority of the general Canadian population, although anyone can get the virus if they're in close physical contact with someone who is infected.
The LGBTQ community, particularly men who have sex with men, are at disproportionate risk of infection in this outbreak, they say. Health-care workers or lab workers who work directly with orthopoxviruses could also be at risk.
Quebec expands monkeypox vaccination efforts as virus continues to spread
World Health Organization holding emergency session next week on monkeypox
As a result, experts say monkeypox vaccinations should be offered to those at-risk populations as a preventative measure. The vaccine can also be offered to those who have already been exposed to someone with monkeypox — known as post-exposure prophylaxis.
In both cases, monkeypox immunization outreach needs to be targeted, they say.
"This is not a widespread vaccine for everyone; it is risk-based vaccination," Chagla said.
Bogoch agreed.
"I don't think we're anywhere near starting, you know, vaccine campaigns for the general public," he said.
"At this point in time, this should be a very focused and targeted vaccine campaign for people who have been exposed and for people who are at the highest risk of getting this infection."
How many doses?
Both the WHO and NACI recommend two doses of Imvamune, given 28 days apart.
A possible exception, according to NACI's guidance, is someone who has had a smallpox vaccination in the past. In that case, they could be given just one dose to act as a booster.
Are there any potential allergens in the vaccine?
Yes. NACI says Imvamune includes the following ingredients:
Traces of residual host (egg) cell DNA and protein.
Tromethamine (Trometamol, Tris).
Benzonase.
Gentamicin and ciprofloxacin.
https://www.cbc.ca/news/health/monkeypox-smallpox-vaccine-imvamune-1.6488917
OGINVU
2 years ago
WHO convenes experts to decide if monkeypox is an emergency
The World Health Organization will convene its emergency committee to determine if the monkeypox outbreak that has mysteriously spread beyond Africa warrants being declared a global health emergency
ByJamey Keaten Associated Press
June 14, 2022, 12:25 PM
The extremely rare disease is slowly making its way around the world; here’s what to look out for.
GENEVA -- The World Health Organization will convene an emergency committee of experts to determine if the expanding monkeypox outbreak that has mysteriously spread outside Africa should be considered a global health emergency.
WHO Director-General Tedros Adhanom Ghebreyesus said Tuesday he decided to convene the emergency committee on June 23 because the virus has shown “unusual” recent behavior by spreading in countries well beyond parts of Africa where it is endemic.
“We believe that it needs also some coordinated response because of the geographic spread,” he told reporters.
Declaring monkeypox to be an international health emergency would give it the same designation as the COVID-19 pandemic and mean that WHO considers the normally rare disease a continuing threat to countries globally.
The U.K. said Monday it had 470 cases of monkeypox across the country, with the vast majority in gay or bisexual men. British scientists said last week they could not tell if the spread of the disease in the U.K. had peaked.
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The meeting of outside experts could also help improve understanding and knowledge about the virus, Tedros said, as WHO released new guidelines about vaccinating against monkeypox.
Dr. Ibrahima Soce Fall, WHO’s emergencies director for Africa, said case counts were growing every day and health officials face “many gaps in terms of knowledge of the dynamics of the transmission” — both in Africa and beyond.
“With the advice from the emergency committee, we can be in a better position to control the situation. But it doesn’t mean that we are going straight to a public health emergency of international concern,” he said, referring to WHO's highest level of alert for viral outbreaks. “We don’t want to wait until the situation is out of control to start calling the emergency committee.”
The U.N. health agency does not recommend mass vaccination, but advises the “judicious” use of vaccines. It said controlling the disease relies primarily on measures like surveillance, tracking cases and isolating patients.
Last month, a leading adviser to WHO said the outbreak in Europe and beyond was likely spread by sex at two recent rave parties in Spain and Belgium.
Scientists warn that anyone, regardless of sexual orientation, is susceptible to catching monkeypox if they are in close, physical contact with an infected person or their clothing or bed sheets.
WHO has been working with partner countries to create a mechanism by which some vaccines for smallpox — a related disease — might be made available to countries that are affected, as research continues into their effectiveness against the new outbreak.
Tedros said more than 1,600 cases and nearly 1,500 suspected cases have been reported this year in 39 countries, including seven where monkeypox has been reported for years. A total of 72 deaths have been reported but none in the newly affected countries, which include Britain, Canada, Italy, Poland, Spain and the United States.
The ongoing outbreak of monkeypox in Europe and elsewhere marks the first time the disease has been known to spread among people who have no travel links to Africa.
https://abcnews.go.com/Health/wireStory/convenes-experts-decide-monkeypox-emergency-85384577
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fung_derf
2 years ago
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