Medical syringes and the Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland, December 2, 2021.
Jakub Porzycki | NurPhoto | Getty Images
The Food and Drug Administration’s independent advisers will meet in June to discuss Novavax’s Covid vaccine for adults as well as Pfizer’s and Moderna’s vaccines for young children, a sign that the vaccines are getting closer to approval.
The FDA committee will review Novavax’s vaccine for adults 18 and older on June 7. The FDA has selected three possible dates — June 8, 21, and 22 — to discuss vaccines from Moderna and Pfizer for children under age 5 who are not yet eligible for vaccination. . The drugs regulator, in a news release on Friday, said the dates are tentative because none of the companies have completed their submissions.
The FDA committee will also meet on June 28 to discuss the need to redesign current Covid vaccines to target mutations in the virus. FDA officials said the United States must quickly make a decision about whether vaccines should be modified to prepare them before a possible surge of infection in the fall. Both Pfizer and Moderna are studying vaccines that target the omicron variant as well as the original strain that emerged in Wuhan, China in 2019.
The FDA’s panel, the Vaccines and Related Biologicals Advisory Committee, hosts open-to-the-public meetings where doctors and independent scientists discuss the data supporting a company’s vaccine. The panel then makes recommendations to the FDA on whether the vaccine should receive approval. The FDA is not required to follow the committee’s recommendations, although it usually does.
The FDA committee’s busy June schedule comes a day after Moderna asked the drug regulator to authorize its two-dose Covid vaccine for children six months to 5 years old. Parents have been waiting months for the FDA to authorize a vaccine for this age group.
The FDA had sought to fast-track the first two doses of Pfizer’s three-shot vaccine for children under age 5 in February, but the company decided to postpone its application because the data was not good enough. Pfizer CEO Albert Bourla said a third vaccine should provide much higher protection against omicron.
During the winter omicron wave, children under age 5 were hospitalized with Covid at five times the rate of the peak when the delta variant was predominant, according to the Centers for Disease Control and Prevention. About 75% of children in the United States have been infected with the virus at some point during the pandemic, according to data from a nationwide survey of CDC blood samples.
Some Americans are also awaiting approval of the Novavax vaccine. If cleared by the FDA, Novavax’s vaccine will be the first new Covid vaccine to hit the market in over a year.
Novavax was an early participant in Operation Warp Speed, the US government’s race to develop a vaccine for Covid in 2020. However, Moderna and Pfizer ultimately beat Novavax to the fist because the company was grappling with manufacturing issues.
Novavax’s vaccine uses different technology than injections from Pfizer and Moderna, which rely on messenger RNA to turn human cells into factories that produce copies of the virus’ spike protein, inducing an immune response that fights Covid. The spike is the part of the virus that latches onto and invades human cells.
Novavax produces the virus peak outside the human body. The spike’s genetic code is placed into a baculovirus that infects insect cells, which then produce copies of the spike that are purified and extracted for the shots. The vaccine also uses an adjuvant, a purified extract from the bark of a South American tree, to induce a broader immune response.
While mRNA vaccines were first licensed during the pandemic, the protein technology that underpins Novavax injections has been used in earlier vaccines. Novavax’s adjuvant has been used in licensed malaria and shingles vaccines.
Novavax said some people who are reluctant to take mRNA vaccines may be more willing to use its vaccines.