U.S. to boost supplies of Tpoxx to fight monkeypox outbreak

[Monkeypox images from CDC]

The Administration for Strategic Preparedness and Response (ASPR) will make 50,000 courses of the small-molecule drug Tpoxx (tecovirimat) from SIGA Technologies (Nasdaq: SIGA) available to help fight the monkeypox outbreak.

There have been 13,517 confirmed monkeypox/orthopoxvirus cases in the U.S. to date, according to the CDC.

In 2018, Tpoxx became the first drug to win an FDA indication for smallpox.

The agency approved the drug under its Animal Rule for treating smallpox using animal efficacy data and human safety data.

The FDA has authorized the use of Tpoxx to treat monkeypox patients through expanded access protocols.

The U.S. maintains a substantial inventory of the drug as part of the Strategic National Stockpile (SNS).

An announcement from the White House noted that it would allocate courses of Tpoxx with a formula based 75% on the number of…

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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…

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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 …

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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…

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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…

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U.S. gears up monkeypox vaccination campaign 

Photo by Thirdman from Pexels

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…

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BD and CerTest Biotec team up on molecular monkeypox diagnostic test

A lab worker prepares samples for the BD Max system. [Photo courtesy of BD]

Becton, Dickinson and Co and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the monkeypox virus.

The CDC is tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus, which causes a rash and lesions. Monkeypox has been shown to be fatal in up to 10% of cases in Africa.

A “testing bottleneck” may be jeopardizing the ability to contain the virus, experts warned this week.

The automated BD Max platform’s open system reagent suite will validate the CerTest Viasure Monkeypox CE/IVD molecular test, BD said in a news release.

The Monkeypox PCR Detection Kit for the BD MAX system will be offered in a lyophilized format. The test will come in a tube that snaps into the test-specific position on the…

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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…

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