HHS and DOD order 3 million doses of Novavax COVID-19 vaccine

Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC.

The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.

There are currently two FDA-approved mRNA vaccines and an authorized adenovirus vector vaccine.

The protein-based Novavax vaccine is built using a more traditional technique than rivals and is adjuvanted to enhance the immune response. Hepatitis B and shingles vaccines are also protein-based and adjuvanted.

The vaccine includes a small amount of the SARS-CoV-2 spike protein.

In June, an FDA advisory committee recommended authorization of the Novavax vaccine.

Typically, FDA grants authorization soon after hearing from its advisors but has not yet authorized the Novavax vaccine.

Novavax note…

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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…

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HHS offers guidance for HIPAA-compliant audio telehealth

The HIPAA Security Rule does not apply to audio-only telehealth services provided via landline, but does apply to calls over cellular and internet connections. (Imagy by Frederik Lipfert on Unsplash)

The Office for Civil Rights at the U.S. Department of Health and Human Services today issued guidance on providing audio-only telehealth services in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

“Audio telehealth is an important tool to reach patients in rural communities, individuals with disabilities, and others seeking the convenience of remote options,” Office for Civil Rights Director Lisa Pino said in a news release. “This guidance explains how the HIPAA rules permit health care providers and plans to offer audio telehealth while protecting the privacy and security of individuals’ health information.”

HHS said the guidance is meant to ens…

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U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health.

HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy director, effective next month.

Russell currently serves as chief scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS). He previously spent more than 10 years as a program manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA).

At Darpa, Russell focused on new experimental platforms and tools to facilitate discovery, quantification and “big validation” of fundamental measures in social science, behavioral science and human performance, accordin…

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HHS to support more healthcare products manufacturing

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.

Get th…

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HHS to support more manufacturing of APIs, other healthcare products

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

The White House briefing statement said: “The United States remains critically dependent on imports for a range of key pharmaceutical products and active pharmaceutical ingredients—the primary ingredients of generic drugs.”

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

“This program will ensure timely availability of essential domestic industrial resources; establish the necessary authorities and mechanis…

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HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. 

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

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HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. 

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

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Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

President Joe Biden [Image courtesy of the White House]President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the  Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

Get the full story on our sister site Drug Discovery & Development. 

 

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Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the  Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …

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HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states

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]

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. 

The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above. 

HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…

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Xavier Becerra confirmed as HHS secretary

Image from Gage Skidmore on Flickr

The U.S. Senate narrowly voted to confirm Xavier Becerra as the secretary of the U.S. Dept. of Health & Human Services (HHS) today.

Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as the attorney general of California. He will succeed Alex Azar, who held the position during the Trump administration until his resignation just days before Biden’s inauguration.

Get the full story at our sister site, Medical Design & Outsourcing.

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