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.
[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 …
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…
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.
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.
Democrats unanimously backed his nomination in the Senate, while Republican senators were nearly united in opposing his confirmation, claiming Becerra’s past, which included Democratic legal challenges to policies from the Donald Trump administration, made him unfit for the position.
Becerra, a 12-term veteran of U.S. Congress, had previously advocated for healthc…
[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.
Pfizer-BioNTech vaccine image courtesy of Wikipedia
Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile.
On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice.
But federal officials had already drained vaccine reserves before the HHS vowed to open up a vaccine stockpile, according to state officials who had been expecting more doses.
Local government officials expecting vaccine supplies to roughly double starting next week are now forced to contend with the status quo.
Critics of Operation Warp Speed, a public-private partnership established by the Trump administration to support COVID-19 vaccine distribution, have been frustrated with the speed …
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety.
U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.
Earlier this month, AstraZeneca voluntarily paused its trial after a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains paused.
“Look at the AstraZeneca program, Phase 3 clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical …
Philips Trilogy EVO portable ventilator (Image courtesy of Philips)
The U.S. Dept. of Health and Human Services (HHS) is reportedly terminating more ventilator contracts as the national stockpile is full.
The Hill reported today that HHS is throwing out some of the contracts that totaled $3 billion as the U.S. government sought to supply as many ventilators as possible during the first surge of the COVID-19 pandemic.
This news follows a recent announcement from Royal Philips (NYSE:PHG) that it would not be supplying the remaining 30,700 ventilators it was slated to manufacture by December to the Strategic National Stockpile, with HHS canceling the contract after the Amsterdam-based company delivered 12,300 total bundled ventilator configurations supplied to the stockpile through August, falling in line with the stipulations of the contract.
HHS has not divulged details on any terms of their can…
(Image courtesy of Ventec)
Ventec Life Systems and General Motors announced today that they completed their government contract to produce 30,000 ventilators.
The two companies kicked off mass production of Ventec’s V+Pro critical care ventilator at GM’s Kokomo, Ind., plant in April, having received a $489.4 million contract from the U.S. Dept. of Health and Human Services to deliver 30,000 ventilators by the end of August amid the COVID-19 pandemic.
Following yesterday’s shipment to complete the delivery, GM has formally turned over operational control of the Kokomo manufacturing operation to Ventec, which will produce its VOCSN multi-function critical care ventilators there and in Bothell, Washington, to continue to meet demand for ventilators as the COVID-19 pandemic roars on.
Ventec’s monthly ventilator production increased by 80 times during the pandemic, the compan…
[Photo by Fusion Medical Animation on Unsplash]
FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website.Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision posted Aug. 19.
The decision stated: “The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts.”
Get the full story on our sister site Medical Design & Outsourcing.
[Photo by Fusion Medical Animation on Unsplash]
FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website.Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision posted Aug. 19.
The decision stated: “The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts.”
The move appears to have surprised FDA insiders and comes after disagreements between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, according to The Washington Post,…