U.S. Secures 3.2 Million Novavax Covid Vaccines — Offering Alternative To MRNA Shots As New Variant Spreads

Topline

The Biden administration announced Monday it has secured 3.2 million doses of the two-dose Novavax Covid-19 vaccine, which it plans to release for free pending emergency authorization from the Food and Drug Administration even after manufacturing issues, a move that seeks to expand vaccine availability as the fast-spreading BA.5 omicron subvariant is now dominant in the U.S.

Key Facts

The Department of Health and Human Services secured the doses in collaboration with the Department of Defense, according to a White House statement released Monday, with plans to provide them at no cost to states, local jurisdictions, federal pharmacy partners and federally-qualified health centers.

Unlike the Pfizer and Moderna vaccines – which were the first in the country to be made with a messenger RNA structure – Novavax contains a small Covid-19 “spike protein,” a similar structure to commonly-used vaccines for hepatitis B and shingles, which the company hopes will convince the third of Americans who have not been vaccinated over objections to receiving an mRNA-derived shot that contains a fetal cell.

If authorized, Novavax would join Pfizer, Moderna and Johnson & Johnson as the only available Covid-19 vaccines.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted last month to grant emergency use authorization for the Novavax vaccine for people 18 and older – however the vaccine still needs a positive recommendation from the Centers for Disease Control and Prevention, in addition to emergency authorization from the FDA, before it can be administered.

Novavax is expected to complete “all necessary quality testing” in the next few weeks.

The federal government did not say how much it would pay for the doses.

Key Background

In February, Novavax reported an 82.7% efficacy rate for its vaccine against Covid-19 infection over a six-month period when used as a booster. A follow-up clinical study in the U.S. found an 82% efficacy rate against the delta variant, and showed signs it could prevent the omicron variant. Last month, however, the FDA raised concerns over the risk of heart inflammation for people given the shot – prompting the U.S. to pause funding for production of the vaccine, and causing shares of the company to fall as much as 20%. By June, the FDA had concluded that any risk of heart inflammation was outweighed by the vaccine’s efficacy rate.

Crucial Quote

“While more than two-thirds of the American public are already fully vaccinated, we must maintain a sense of urgency to ensure all eligible individuals get vaccinated, particularly heading into the fall,” said Jason Roos, the COO of the U.S. Department of Health and Human Services’ Coordination Operations and Response Element.

Tangent

A contagious subvariant of omicron – called BA.5 – is now the dominant variant in the U.S., and its resistance to antibodies has fueled the largest Covid spread in months. The BA.5 variant now represents 53.6% of all U.S. cases, according to CDC data, while the number of new cases hit a five-month peak of 240,705 last week.

Big Number

The U.S. government invested $1.6 billion in Novavax in December, 2020 – more than any vaccine producer at the time. The Maryland-based vaccine manufacturer has fared well in clinical trials, but has dealt with manufacturing hurdles since it began developing its vaccine.

Further Reading

Novavax Stock Halted Pending FDA Panel Meeting—Here’s What To Know About The Company’s Covid Vaccine (Forbes)

Novavax Reports Enduring Covid Immune Response Six Months After Vaccination (Forbes)

Down 18% Over The Last Month, What’s Next For Novavax Stock? (Forbes)

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