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Real-world data begin to emerge for the Jynneos vaccine in monkeypox outbreak

[Photo by Artem Podrez from Pexels]

Until recently, CDC had warned that it remained uncertain how effective the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) and the ACAM2000 vaccine from Emergent BioSolutions (NYSE:EBS) were at guarding against the current monkeypox outbreak.

The CDC, however, has begun to release data related to the former vaccine. The agency found unvaccinated patients were approximately 14 times more likely to become infected with the virus based on early real-world effectiveness data.

In the week of August 28, monkeypox incidence was 230 per 100,000 for unvaccinated individuals. Among those who received at least one dose of the Jynneos vaccine in the same period, 15 per 100,000 became infected.

Although the U.S. government has made the ACAM2000 vaccine available for use against monkeypox, it remains unclear how protective it is in the current outbreak.

Because…

Bavarian Nordic launches Phase 3 clinical study of COVID-19 booster candidate

Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2.

The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will assess how the vaccine stacks up against other variants of concern.

In May, Bavarian Nordic announced that a Phase 2 study found that ABNCoV2 induced a solid boost in neutralizing antibodies against the original omicron strain.

The non-adjuvanted ABNCoV2 vaccine candidate uses a virus-like particles (VLP) platform.

Copenhagen, Denmark–based Bavarian Nordic has become best known recently for its monkeypox and smallpox vaccine. Known as Jynneos in the U.S., the monkeypox vaccine is named Imvanex in Europe and Imvamune in Canada.

Bavarian Nordic’s product portfolio includes…

EMA emergency task force backs intradermal use of Imvanex/Jynneos monkeypox vaccine

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EMA’s Emergency Task Force (ETF) has given national authorities in the EU permission to use the Imvanex vaccine as an intradermal injection while supplies of the vaccine remain limited. In a statement, the ETF described the decision as a “temporary measure.”

The FDA recently reached a similar decision but authorized the intradermal use of the Imvanex vaccine from Bavarian Nordic A/S (OMX:BAVA, OTC:BVNRY) in adults with an elevated risk of contracting monkeypox.

The Imvanex vaccine is known as Jynneos in the U.S.

While the EMA has only authorized subcutaneous injection of the vaccine, the ETF acknowledged that the intradermal use of the vaccine supports dose sparing, allowing a fraction of the vaccine to be administered than conventionally.

Supplies of the vaccine remain limited throughout the world.

Increased risk of side effects for intradermal Imvanex? <…

U.S. government makes an additional 442,000 monkeypox vaccine doses available

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Officials from the U.S. Department of Health and Human Services (HHS) have announced plans to provide up to 442,000 doses of the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) available across the country.

In May, Biomedical Advanced Research and Development Authority (BARDA) said it had a contract with Bavarian Nordic worth up to $119 million to convert bulk vaccine into freeze-dried vaccine doses.

The FDA recently signed off on an emergency use authorization to allow the vaccine to be delivered intradermally to support dose sparing.

The agency made the decision based on data from a 2015 clinical study published in Vaccine. That study found that a lower intradermal dose of smallpox vaccine was “immunologically non-inferior to the standard subcutaneous dose.”

The dose-sparing strategy will enable a fraction of the vaccine to be used per patient 18 a…

3 critical monkeypox vaccine questions

Scanning electron micrograph of monkeypox virus (orange) on the surface of infected VERO E6 cells (green).[Image courtesy of NIAID]

In the U.S., federal authorities have allowed two vaccines to be used to reduce the risk of monkeypox virus infection. The preferred option is the Jynneos vaccine from Bavarian Nordic (OMX:BAVA), followed by Emergent BioSolutions’ (NYSE:EBS) ACAM2000.

While vaccination efforts are ramping up, California, New York and Illinois have declared states of emergency as the monkeypox virus spreads.

As the monkeypox outbreak continues to gain momentum, here are three questions to keep in mind.

1. How effective are monkeypox vaccines?

CDC notes that the effectiveness of the vaccines is unknown in the current outbreak.

While some media outlets have reported that the smallpox vaccines are 85% effective in protecting against monkeypox, that figure is based on a small stu…

FDA greenlights 786,000 additional monkeypox vaccine doses

[Photo by Artem Podrez from Pexels]

FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S.

The extra doses are available following an FDA expedited inspection and approval of Bavarian Nordic’s fill-and-finish capabilities.

HHS is moving to ship the doses to states and jurisdictions as soon as it can, according to the U.S. Department of Health and Human Services Secretary Xavier Becerra.

Becerra indicated that the federal government would continue to ramp up the distribution of further monkeypox vaccine doses in the near future.

The U.S. has been working to procure 5.5 million monkeypox vaccine doses for 2023.

The country had distributed more than 300,000 vaccine doses in July.

“We …

U.S. purchases more monkeypox vaccine doses from Bavarian Nordic

Bavarian Nordic A/S (OMX:BAVA) has announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has ordered an additional 2.5 million doses of liquid-frozen Jynneos vaccine.

FDA first approved Jynneos, a non-replicating smallpox and monkeypox vaccine, in 2019.

It continues to be the only FDA-approved vaccine indicated for monkeypox.

The company will begin deliveries in the recent contract in the fourth quarter of 2022 and continue into early 2023.

In May, Bavarian Nordic announced that it had secured a separate BARDA contract worth $119 million to convert bulk vaccine into freeze-dried doses of Jynneos vaccine.

In all, the company will supply a total of 4.4 million doses to the U.S. in 2022 and 2023.

The company’s share price increased 3.89% to 243.00 Danish Krone.

Earlier this week, the U.S. Department of Health and Human Services (HHS) announced an updated nationwide monkeypox vaccination strategy t…

U.S. gears up monkeypox vaccination campaign

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Federal officials have announced that the clinics across the company would vaccinate individuals with presumed exposure to the monkeypox virus.

Earlier, the U.S. had reserved the vaccine for individuals who had confirmed exposure to the virus.

The U.S. has confirmed a preference for the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA).

In May, Bavarian Nordic entered into a contract with the U.S. worth up to $119 million to convert bulk vaccine into freeze-dried doses of Jynneos vaccine.

The U.S. will provide doses of the Jynneos vaccine from the federal stockpile after reviewing recent data on the spread of the monkeypox virus.

At present, U.S. officials have allotted 56,000 doses of the Jynneos vaccine, with 240,000 more doses following in the coming weeks.

The U.S. government expects to receive an additional 750,000 doses over the su…

U.S. secures option to purchase millions of monkeypox vaccine doses from Bavarian Nordic

As monkeypox cases are investigated in North America and Europe, Bavarian Nordic A/S (OMX:BAVA) has secured a contract worth potentially $119 million with Biomedical Advanced Research and Development Authority (BARDA) to convert bulk vaccine into freeze-dried doses of Jynneos vaccine.

Jynneos was FDA approved for both smallpox and monkeypox in 2019.

Smallpox and monkeypox are broadly similar with the latter causing lymph nodes swelling while the former does not. Smallpox and monkeypox are broadly similar with the latter causing lymph nodes swelling while the former does not. Monkeypox also tends to be milder.

BARDA has additional options to convert up to roughly 13 million freeze-dried doses of the Jynneos vaccine that would likely be manufactured in 2024 and 2025.

BAVA shares have surged in recent days. Today, it rose 18.4% to 216.60 DKK. In the past five days, the stock has increased 63.6%.

Monkeypox remains extremely rare in the U.S., CD…