FDA Authorizes Novavax Coronavirus Vaccine, Adding To Pandemic Arsenal

U.S. regulators Wednesday authorized the nation’s fourth coronavirus vaccine, a shot developed by Novavax, a Maryland biotechnology company that has been a straggler in the vaccine race.

For a relatively small niche of people who want to be vaccinated, but can’t or won’t take existing vaccines, Wednesday’s decision by the Food and Drug Administration has been impatiently awaited. Some people are allergic to an ingredient in messenger RNA vaccines or simply prefer the more traditional technology at the core of Novavax’s shot, which is the United States’ first protein-based vaccine.

Still, the late addition of Novavax’s vaccine to the medical arsenal is not expected to have a major impact on the trajectory of the coronavirus. Two-thirds of Americans have received at least their initial series of shots, and doses of other companies’ vaccines are abundantly available.

The authorization covers the use of the vaccine as an initial set of two shots in adults. The company plans to seek authorization for a booster and for younger people.

Novavax’s two-regimen shot utilizes a technology used to make vaccines against influenza and shingles. Vaccines from Moderna and from Pfizer and its German partner, BioNTech, use messenger RNA technology to instruct the body’s cells to build a protein. A vaccine from Johnson & Johnson uses a harmless cold virus.

An advisory committee to the Centers for Disease Control and Prevention that votes on whether to recommend vaccines is scheduled to meet Tuesday.

The federal government secured 3.2 million doses of Novavax’s vaccine, which will be available “in the next few weeks,” after the company completes quality testing, according to a statement Monday from the Department of Health and Human Services.

Wednesday’s FDA decision “underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” Stanley C. Erck, Novavax’s chief executive, said in a statement.

In the long run, Novavax’s executives believe their vaccine may prove pivotal in managing the virus as a seasonal booster. The FDA has already instructed companies to revamp their shots for fall boosters, and Novavax scientists are working on a revamped shot targeting the BA.4 and BA.5 subvariants that are circulating.

Initial data is expected on Novavax’s new variant booster that targets the BA.4 and BA.5 subvariants in the late summer or fall, and the company projects being able to supply an updated booster shot in the last quarter.

Novavax executives recently presented data that intrigued some FDA advisers, suggesting that the original formulation of the vaccine may hold up well to challenging variants in circulation.

“The Novavax data was pretty significant,” said Wayne A. Marasco, an FDA adviser and professor of cancer immunology and virology at Dana-Farber Cancer Institute, noting that it appeared to give good protection even against the challenging omicron BA.5 variant. “I wonder if we’re not witnessing some of the limitation that there may be [of] the mRNA vaccines. Yes, they were first out of the gate. But they don’t appear to have that breadth of protection.”

The Novavax vaccine is being manufactured by the Serum Institute of India, and a Novavax spokeswoman confirmed that doses had been shipped to the United States, arriving July 6.

Novavax’s slower rollout reflects the technology at the core of its vaccine — which is more time-consuming to produce — and the stumbles of a small company working furiously to launch its first vaccine at a massive scale and meet rigorous U.S. regulatory standards.

Messenger RNA vaccines, which were authorized in late 2020, instruct the body’s cells to make the coronavirus spikes that dot the outside of the virus. Novavax must manufacture those spike proteins in a laboratory and purify them, a process that takes more time.

But Novavax also faced significant delays because of manufacturing issues throughout the development of the vaccine. In contrast to other vaccines that were authorized within hours or days of FDA advisers voting on them, it has taken more than a month for the official sign off. In briefing documents in early June, FDA officials noted that “testing and submission of manufacturing and product information … were still in process at the time of this review.”

The government’s purchase of 3.2 million doses leverages existing agreements between the company and the government, including a $1.6 billion contract to support Novavax’s vaccine development and manufacturing and the purchase of 100 million doses.


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