Topline
The Biden administration introduced Monday it has secured 3.2 million doses of the two-dose Novavax Covid-19 vaccine, which it plans to launch free of charge pending emergency authorization from the Meals and Drug Administration even after manufacturing points, a transfer that seeks to broaden vaccine availability because the fast-spreading BA.5 omicron subvariant is now dominant in the U.S.
The Biden administration introduced Monday it secured 3.2 million doses of the Novavax Covid-19 … [+]
Key Info
The Division of Well being and Human Companies secured the doses in collaboration with the Division of Protection, in keeping with a White House statement launched Monday, with plans to offer them for gratis to states, native jurisdictions, federal pharmacy companions and federally-qualified well being facilities.
Not like the Pfizer and Moderna vaccines – which had been the primary within the nation to be made with a messenger RNA construction – Novavax comprises a small Covid-19 “spike protein,” an analogous construction to commonly-used vaccines for hepatitis B and shingles, which the corporate hopes will persuade the third of People who haven’t been vaccinated over objections to receiving an mRNA-derived shot that comprises a fetal cell.
If approved, Novavax would be part of Pfizer, Moderna and Johnson & Johnson as the one out there Covid-19 vaccines.
The FDA’s Vaccines and Associated Organic Merchandise Advisory Committee voted final month to grant emergency use authorization for the Novavax vaccine for individuals 18 and older – nonetheless the vaccine nonetheless wants a optimistic advice from the Facilities for Illness Management and Prevention, along with emergency authorization from the FDA, earlier than it may be administered.
Novavax is predicted to finish “all mandatory high quality testing” within the subsequent few weeks.
The federal authorities didn’t say how a lot it will pay for the doses.
Key Background
In February, Novavax reported an 82.7% efficacy price for its vaccine in opposition to Covid-19 an infection over a six-month interval when used as a booster. A follow-up scientific research within the U.S. discovered an 82% efficacy price in opposition to the delta variant, and confirmed indicators it may stop the omicron variant. Final month, nonetheless, the FDA raised issues over the chance of coronary heart irritation for individuals given the shot – prompting the U.S. to pause funding for manufacturing of the vaccine, and inflicting shares of the corporate to fall as a lot as 20%. By June, the FDA had concluded that any threat of coronary heart irritation was outweighed by the vaccine’s efficacy price.
Essential Quote
“Whereas greater than two-thirds of the American public are already absolutely vaccinated, we should preserve a way of urgency to make sure all eligible people get vaccinated, notably heading into the autumn,” stated Jason Roos, the COO of the U.S. Division of Well being and Human Companies’ Coordination Operations and Response Aspect.
Tangent
A contagious subvariant of omicron – referred to as BA.5 – is now the dominant variant within the U.S., and its resistance to antibodies has fueled the biggest Covid unfold in months. The BA.5 variant now represents 53.6% of all U.S. instances, in keeping with CDC data, whereas the variety of new instances hit a five-month peak of 240,705 final week.
Large Quantity
The U.S. authorities invested $1.6 billion in Novavax in December, 2020 – greater than any vaccine producer on the time. The Maryland-based vaccine producer has fared nicely in scientific trials, however has handled manufacturing hurdles because it started growing its vaccine.
Additional Studying
Novavax Inventory Halted Pending FDA Panel Assembly—Right here’s What To Know About The Firm’s Covid Vaccine (Forbes)
Novavax Studies Enduring Covid Immune Response Six Months After Vaccination (Forbes)
Down 18% Over The Final Month, What’s Subsequent For Novavax Inventory? (Forbes)
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