FDA advisers endorse Maryland company’s COVID-19 vaccine

A federal advisory panel endorsed a COVID-19 vaccine from Novavax, putting the U.S. on track for a fourth option and sparking hopes that the company’s traditional vaccine technology will entice unvaccinated holdouts leery of the messenger-RNA shots.

The Food and Drug Administration’s advisory committee said in a 21-0 vote that the benefits from the protein-based vaccine from Novavax, a Gaithersburg, Maryland-based company, would outweigh any risks for persons 18 and older. One adviser abstained.

The committee’s opinion carries weight and emergency use authorization, which could arrive from the FDA within days, would expand the menu of coronavirus vaccines beyond the trio that’s been used since early 2021.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccine,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told advisers. “We do have a problem with vaccine uptake that is very serious in the United States. Anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something we feel we are compelled to do.”

Two-thirds of Americans are fully vaccinated against COVID-19, but there’s been little progress in increasing that percentage.

Novavax is playing catch-up in the vaccine race after it was dogged by manufacturing problems.

But the company is betting its protein-based vaccine will be attractive to those who chafed at options from Pfizer and Moderna that deploy messenger RNA, which uses genetic instructions to teach the body to identify and attack the virus.

Before this pandemic, mRNA vaccines had never been deployed on a wide scale.

Dr. Marks said a third option, from Johnson & Johnson, uses an adenovirus platform but regulators restricted its use due to concerns about a rare but severe blood clotting issue. Therefore, Novavax would likely fulfill “some unmet need.”

A number of public commenters said Americans deserve options beyond the mRNA vaccines.

“When one is at war, many different approaches are used,” said Martha Dawson, president of the National Black Nurses Association.

Yet Dr. Arthur Reingold, an adviser and professor of epidemiology at the University of California, Berkeley, said he doubts the authorization will result in a big increase in vaccinations.

“I’m hoping to be proven wrong and that there are large numbers of people who sign up for this vaccine who wouldn’t take the mRNA vaccines, but count me as skeptical about that,” Dr. Reingold said.

Novavax is seeking authorization as a primary vaccine that is given in two doses, 21 days apart, for persons 18 and older.

The company told The Washington Times on Tuesday that it will have “millions of doses ready to ship to the U.S.” upon authorization.

It is gathering data on booster doses, either as a follow-up to its vaccine or to mix-and-match with mRNA shots. The virus isn’t going away, and experts believe the public is destined for annual shots.

Novavax also is testing its vaccine in adolescents and younger children, hoping to tap into those markets.

Its shots showed 90% efficacy against symptomatic infection in studies against the original strain and early variants, putting it roughly on par with the mRNA vaccines’ initial results.

However, the Novavax vaccine was not tested in trials against the omicron variant. The company said immune-response tests found a third shot could spur protection against omicron and, like other companies, it is working on an omicron-specific shot ahead of a likely fall booster campaign.

Advisers said they were disappointed there was no omicron-related data because it is the dominant variant, but said the data that was presented was quite similar to data offered by prior drugmakers who won authorization.

They also raised concerns about six cases of myocarditis detected in trials involving 40,000 people, though Novavax chief medical officer, Filip Dubovsky, argued there wasn’t much evidence of a “causal” relationship between the shots and inflammation of the heart muscle.

FDA officials said the shots could at some point be used as mix-and-match booster doses for persons who received mRNA shots earlier and might want to switch to Novavax.

But that discussion will have to wait until after the initial authorization.

“We would evaluate study data to inform the safety and effectiveness of a booster dose as it comes to us,” said Doran Fink, a deputy FDA director for the clinical division of vaccines and related products.

Experts say Novavax might be able to carve out a slice of the COVID-19 market if its shots prove to be more durable than mRNA shots, which induce antibodies that wane after several months.

Novavax was among six companies in the Trump administration’s Operation Warp Speed effort to create a vaccine in record time.

It received $1.8 billion in taxpayer funding for the development of its vaccine, which takes genes to create an antigen (the spike protein for the coronavirus) and puts them into an insect virus that infects moth cells and replicates, creating plenty of spike proteins.

It uses an adjuvant, which enhances the body’s immune response to an antigen that’s derived from a kind of tree bark that grows in South America. The spike proteins are purified and delivered by needle right into the body instead of forcing the body to create and recognize the spikes.

Similar technology is used against hepatitis B, shingles and other conditions.

The Novavax vaccine has been authorized for use in dozens of other countries. The company said it has delivered 42 million doses globally.

“While we’re pleased with the initial utilization of our vaccine, we expect to see additional pull-through within these markets in the coming months as demand continues with recent surges in COVID around the world,” Novavax said in a written statement.

The company said it is confident in its manufacturing abilities, and its vaccine can be stored at normal refrigeration temperatures, making it attractive to global markets that struggle with the ultra-cold requirements needed to preserve mRNA shots.

Tuesday’s advisory meeting kicked off a series of FDA debates and actions on COVID-19 vaccines this month.

The panel will discuss vaccines for children under 5 in mid-June and discuss on June 28 whether the vaccines should be reformulated to target the omicron variant before a potential booster campaign this fall.

For more information, visit The Washington Times COVID-19 resource page.