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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

Photo by Frank Meriño from Pexels

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…

The most common monkeypox vaccine side effects

Photo by Artem Podrez from Pexels

Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA), the most widely used vaccine to protect against monkeypox, tends to have generally mild side effects according to clinical trial data.

It is also clear that the Jynneos vaccine can help reduce the severity of monkeypox infections. Researchers are uncertain, however, about how the vaccine’s potential to reduce transmission, how strong its protective effect is, or how long it lasts.

A small study in Africa from 1988 found that an older smallpox vaccine was 85% effective in protecting against monkeypox.

CDC notes that there are no data about the effectiveness of the Jynneos or the ACAM2000 vaccine from Emergent Biosolutions (NYSE: EBS) in the current outbreak. The latter vaccine has not found widespread use in the monkeypox outbreak and generally is not as well tolerated as the Jynneos vaccine.

The …

Jynneos vaccine: The best weapon against monkeypox?

[Image courtesy of HHS]

Over the past few months, healthcare leaders have been working on identifying vaccines to prevent the spread of monkeypox. One such development is the use of Bavarian Nordic’s (OMX:BAVA) Jynneos vaccine for the prevention and treatment of the fast-spreading disease.

The Jynneos vaccine won approval in the U.S. in 2019 for the prevention of monkeypox and smallpox. The vaccine is made with weakened vaccinia virus. The vaccine is indicated to help protect people against monkeypox. Specifically, it is intended to be given before exposure to the virus or reduce the risk of infection if given within four days after exposure. In addition, FDA has authorized its use to cut the risk of serious illness if given within 14 days after exposure.

The FDA approved the two-dose Jynneos vaccine in 2019 for people ages 18 and older with a high monkeypox or smallpox exposure risk.

Jynneos is no…

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 …

HHS makes 144,000 more doses of Jynneos monkeypox vaccine available

The U.S. Department of Health and Human Services (HHS) has said it would make available an additional 144,000 doses of the Jynneos vaccine doses available to states and jurisdictions.

Bavarian Nordic A/S (OMX:BAVA) is the manufacturer of the vaccine.

Jynneos won FDA approval for both smallpox and monkeypox in 2019.

There have been approximately 700 confirmed monkeypox cases in the U.S., according to the CDC.

HHS said it would begin shipping the most recent doses from the Strategic National Stockpile (SNS) on July 11.

“We are using every tool we have to increase and accelerate Jynneos vaccine availability in jurisdictions that need them the most,” said Steve Adams, Director of the Strategic National Stockpile, in a statement. “In less than ten days, we’ve made available 200,000 Jynneos vaccine doses in communities where transmission has been the highest and with high-risk populations, and significantly scaled testing availability and conveni…

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…