FDA approves Novavax coronavirus vaccine and adds it to the pandemic arsenal

Still, the delay in adding the Novavax vaccine to the medical arsenal is not expected to have a significant impact on the orbit of the coronavirus. Two-thirds of Americans receive at least the first series of injections, and doses of other companies’ vaccines are abundantly available.

The approval is intended for the use of the vaccine as an initial set of two shots for adults. The company will seek approval for boosters and young people.

Novavax’s 2 Regimen Shot utilizes the technology used to make vaccines against influenza and shingles. Vaccines from Moderna and Pfizer and its German partner BioNTech use messenger RNA technology to direct the body’s cells to build proteins. Johnson & Johnson’s vaccine uses a harmless cold virus.

An advisory board for the Centers for Disease Control and Prevention will meet on Tuesday to vote on whether to recommend a vaccine.

The federal government has secured the Novavax vaccine 3.2 million times. It will be available “within a few weeks” after the company completes quality testing. statement From the Ministry of Health and Social Welfare on Monday.

Novavax CEO Stanley C. Erck said in a statement that Wednesday’s FDA decision “emphasized the significant need to provide Americans with another vaccine option for the duration of the pandemic. I have. “

In the long run, Novavax executives believe that vaccines could prove to be crucial in managing the virus as a seasonal booster. The FDA has already instructed companies to: Renew their shots For Autumn boosterAnd Novavax scientists are working on improved shots for the circulating BA.4 and BA.5 subvariants.

Initial data is expected for Novavax’s new variant boosters targeting BA.4 and BA.5 subvariants in late summer or fall, and the company expects to be able to provide booster shots updated last quarter. increase.

Novavax executives recently presented intriguing data to some FDA advisors, suggesting that the original formulation of the vaccine may well tolerate difficult mutations in distribution.

” Novavax data Wayne A. Marasco, FDA advisor and professor of cancer immunology and virology at the Dana-Farber Cancer Institute, appears to provide excellent protection against challenging Omicron BA.5 mutants. Said. “Are we not witnessing some of the restrictions that may exist? [of] mRNA vaccine. Yes, they were out of the gate first. But they don’t seem to have such widespread protection. “

The Novavax vaccine is manufactured by the Serum Institute in India, and a Novavax spokeswoman confirmed that the dose arriving on July 6 was shipped to the United States.

Novavax is slow to roll out with the technology at the core of the vaccine (which takes time to manufacture) and the small company that is working hard to launch the first vaccine on a large scale and meet the strict regulatory standards of the United States. It reflects a stumbling block.

The messenger RNA vaccine, approved in late 2020, directs cells in the body to create spikes of coronavirus scattered outside the virus. Novavax needs to produce and purify these peplomer proteins in the laboratory. This process will take longer.

However, Novavax also faced significant delays due to manufacturing issues throughout the development of the vaccine. Formal approval took more than a month, in contrast to other vaccines that were approved within hours or days after the FDA advisor voted. In a briefing document in early June, FDA officials said, “Manufacturing and product information testing and submission … is still underway at the time of this review.”

The government’s 3.2 million purchases leverage existing agreements between businesses and the government. $ 1.6 billion contract To support the development and manufacture of Novavax vaccines and the purchase of 100 million doses.