Blessing a fourth COVID-19 vaccine could prod Americans who are leery of messenger-RNA shots from Pfizer and Moderna to come forward and get immunized, a top U.S. regulator said Tuesday.
Outside advisers to the Food and Drug Administration are debating whether a protein-based vaccine from Maryland drugmaker Novavax should be authorized for emergency use in the U.S.
The authorization would expand the menu of coronavirus vaccines beyond the trinity 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 director of the 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 share.
Novavax, of Gaithersburg, 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 dominant options that use messenger RNA, which uses genetic instructions to teach the body to identify and attack the virus. Until 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.”
Novavax is seeking authorization as a primary vaccine that is given in two doses, 21 days apart, for persons 18 and older.
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 is also 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.
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.
The Novavax vaccine has been authorized for use in dozens of other countries.
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.
