FDA to review Novavax’s COVID vaccine EUA application

After many delays, the Food and Drug Administration’s Advisory Committee on vaccines and related biological products will discuss on June 7 the request for emergency use authorization (EUA) of Novavax’s COVID-19 vaccine for individuals 18 years of age and older.

The committee will meet in an open session and will make materials for the meeting available on the meeting’s main page.

As CNBC pointed out in mid-May, “an endorsement from the committee, which is made up of independent experts, would mean the drug regulator is almost certain to quickly authorize the two-dose vaccine for use in the U.S.”

“We continue to hear from physicians, healthcare organizations, and consumers who are anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax, back in April.

Although the Novavax’s protein-based shot NVX-CoV2373 has been authorized or approved in several other countries, including the U.K. and Singapore, has not yet been authorized for use in the U.S.

Alternative for people refusing mRNA vaccines

The company describes NVX-CoV2373 as “a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.”

The vaccine “is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies” and contains “purified protein antigen and can neither replicate nor can it cause COVID-19.”

Called Nuvaxovid, “Novavax’s vaccine is similar in design to a flu shot that’s been available in the U.S. since 2013. And some experts believe it could serve as an alternative for people hesitant to get an mRNA vaccine,” as per Market Watch.

“I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, and a researcher for one of the Novavax vaccine trials.

NVX‑CoV2373 was approved in Europe last December against the original strain of Sars-Cov-2 and has proven efficient in 82% of the cases with the Delta variant, and according to Novavax, a BIO member, on Jan. 28, 2021, it became the first protein-based vaccine candidate to demonstrate clinical efficacy against the original strain of the virus and both of the rapidly emerging variants in the U.K. and South Africa.

The latest data by the European Centre for Disease Prevention and Control shows that “a two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant,” as the study abstract says.

Meanwhile, Novavax, as its press release says, initiated “its Phase 3 strain change trial to determine if its Omicron variant-specific vaccine, NVX-CoV2515, induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine.”

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