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HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

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. 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…

Paratek Pharmaceuticals wins more funding from BARDA

Antibiotic specialist Paratek Pharmaceuticals (NSDQ: PRTK) has secured additional funding from the Biomedical Advanced Research and Development Authority (BARDA) to develop the antibiotic Nuzyra (omadacycline) for anthrax.

Specifically, the latest funding will support Paratek’s program to develop the tetracycline-class antibiotic Nuzyra as a post-exposure prophylaxis and pulmonary anthrax treatment.

The latest BARDA funding will support studies valued at approximately $19 million. Overall, the BARDA contract now has a total value of $340 million.

Last week, Paratek released data related to Nuzyra for treating pneumonia and skin infections.

“Paratek has been studying Nuzyra against select biothreat pathogens for over a decade, and we are excited to build on the promising in vitro and in vivo animal data and advance the pulmonary anthrax development program for treatment and PEP,” said Randy Brenner, chief development and regulatory officer of Parat…

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]

U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Get the full story at our sister site, MassDevice.

What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

BARDA awards $12.9M to Ortho Clinical for coronavirus antigen test

Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test.

Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts, according to a news release.

BARDA awarded Ortho $12.85 million in support of its SARS-CoV-2 antigen test for the rapid detection of the virus causing COVID-19. That funding will also go toward the pursuit of regulatory clearance for Ortho’s total and IgG antibody tests that were granted FDA emergency use authorization (EUA) in April.

Ortho’s total antibody test is designed to detect all COVID-19-related antibodies, while the IgG test detects the IgG antibody which appears in the later stages of infection and remains elevated even after recover…

Fujifilm Diosynth lands $265m to produce COVID-19 vaccine

Fujifilm Diosynth Biotechnologies announced that its College Station, Texas, site will manufacture a COVID-19 vaccine candidate under a $265 million federal contract.

The contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies said it received the federal task order through the Texas A&M System Center for Innovation in Advanced Development & Manufacturing (CIADM), a public-private partnership between the government’s Biomedical Advanced Research and Development Authority (BARDA) and the university. CIADM subcontracts manufacturing to the Fujifilm Diosynth Biotechnologies’ owned-and-operated flexible biomanufacturing facility in College Station. The task order reserves manufacturing at the plant capacity in through the end of 2021.

The money will help accelerate Fujifilm Diosynth’s planned facility expansion by several months, now with an anticipated completion by fall 2020. The Texas…

Smiths Medical lands major vaccine-related contract

Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them.

The Plymouth, Minn.-based company said it received an order for 78.6 million syringe-and-needle units and that BARDA and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will foot $20 million of the Smiths’ $38 million capital expansion project in Keene. The partnership will increase needle production capacity by 125 million units per year, according to the company. The federal government will have priority access to this expanded capacity for vaccination efforts dedicated to COVID-19, flu vaccines and future pandemics.

Get the full story on our sister site, Drug Delivery Business News.

Smiths Medical lands major vaccine-related contract

Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them.

The Plymouth, Minn.-based company said it received an order for 78.6 million syringe-and-needle units and that BARDA and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will foot $20 million of the Smiths’ $38 million capital expansion project in Keene. The partnership will increase needle production capacity by 125 million units per year, according to the company. The federal government will have priority access to this expanded capacity for vaccination efforts dedicated to COVID-19, flu vaccines and future pandemics.

“Over the last 6 months, Smiths Medical has delivered the healthcare industry significant increased production of ventilators, infusion pumps, extended dwell catheters and other respirator…