FDA Advisory Panel Recommends Novavax COVID-19 Vaccine for Emergency Use

An illustration picture shows vials with COVID-19 Vaccine stickers attached and syringes with the logo of U.S. biotech company Novavax, on Nov. 17, 2020. Justin Tallis/AFP via Getty Images

A U.S. Food and Drug Administration (FDA) vaccine advisory panel voted on Tuesday to recommend the emergency use of Novavax’s COVID-19 vaccine.

The advisory voted 21–0 with one abstention, after seven hours of discussion, agreeing that the benefits of a two-dose Novavax vaccine outweighed its risk for use in adults aged 18 and older.

Dr. Michael Nelson, professor of medicine at the Division of Asthma, Allergy, and Clinical Immunology at the University of Virginia School of Medicine, said that the Novavax vaccine is another tool for people who are not able to get the mRNA shots.

“I do feel that it does offer something for fulfilling unmet needs including those populations who have hesitancy with regards to the messenger RNA vaccines,” Nelson said. “As an allergist, that offers me an additional tool for individuals who have hypersensitivity responses to initial doses of the messenger RNA vaccine.”

About 22 percent of Americans have not received a single dose of the COVID-19 shot, with 78 percent who have gotten at least one dose, as of June 7, according to the Centers for Disease Control and Prevention (CDC).

While the Johnson & Johnson COVID-19 shot is available, the FDA restricted its use in May 2022 due to the risk of developing potentially life-threatening blood clots with low levels of platelets.

Dr. Cody Meissner, chief of Pediatric Infectious Diseases at Tufts Children’s Hospital, said that more vaccine options are needed as it’s not clear whether the mRNA COVID-19 injections “will turn out being optimal vaccines for these viruses.”

“I think we still need new vaccines,” Meissner said. “I don’t think we want to rest on just what we have at this point because there’s always an opportunity to improve on a vaccine ... such as sterilizing immunity and the duration of the immune response and the breadth of the immune response.”

Studies have shown that the effectiveness of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines administered in the United States wanes significantly after three months. In addition, the harmful effects of these vaccines are being observed by physicians like Dr. Ryan Cole and Dr. Richard Urso, among other doctors and medical scientists.

A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of the displayed Novavax logo in this illustration taken on Oct. 30, 2020. Dado Ruvic/Reuters

The Novavax vaccine, if authorized by the FDA, as is expected, will become the fourth COVID-19 vaccine available in the United States and the only traditional vaccine offered.

Called NVX-CoV2373, the Novavax shot is a protein-based vaccine given in two doses three weeks apart.

Protein-based vaccine technology has been used for decades—to protect people from certain diseases like the flu and hepatitis—by delivering proteins, coupled with an immune-stimulating adjuvant, directly to a person’s cells to induce a protective immune response.

The vaccine was found to be 90.4 percent effective in preventing mild, moderate, and severe COVID-19, based on a phase 3 trial that involved nearly 30,000 participants, conducted between December 2020 and September 2021.

Most adverse reactions to the Novavax injection were mild to moderate that resolved in 1 to 2 days, according to Dr. Denny Kim, senior vice president and chief safety officer at Novavax.

Kim also addressed the heart inflammation, or myocarditis, detected within 20 days post-vaccination, which was flagged by the FDA last week.

He said the “rates of myocarditis were balanced” between the two cases in the vaccine group (0.007 percent) and the one case in the placebo (0.005 percent), adding that “no pericarditis was reported.”

“We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with a vaccine,” Kim said.

The FDA, in briefing documents released earlier on June 3, had said that the myocarditis “events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines.”

About 744,000 doses of the Novavax vaccine have been administered worldwide as of April 30, according to Kim.