Medical syringes and Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021.
Jakub Porzycki | NurPhoto | Getty Images
The Food and Drug Administration’s independent advisors will meet in June to discuss Novavax’s Covid vaccine for adults as well as Pfizer and Moderna’s shots for younger kids, a sign that the vaccines are moving a step closer to authorization.
The FDA committee will review Novavax’s vaccine for adults ages 18 and over on June 7. The FDA has selected three possible dates – June 8, 21 and 22 – to discuss Moderna and Pfizer’s shots for children under age 5 who are not yet eligible for vaccination. The drug regulator, in a press release 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 whether the current Covid vaccines need to be redesigned to target mutations of the virus. FDA officials have said the U.S. needs to rapidly make a decision about whether the shots should be changed to have them ready ahead of a possible fall wave of infection. Pfizer and Moderna are both studying shots that target the omicron variant as well as the original strain that emerged in Wuhan, China in 2019.
The FDA panel, the Vaccines and Related Biological Products Advisory Committee, holds meetings open to the public where independent physicians and scientists discuss the data supporting a company’s vaccine. The panel then makes recommendations to the FDA about whether the vaccine should receive authorization. The FDA is not bound to follow the committee’s recommendations, though 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 clear a vaccine for this age group.
The FDA had sought to fast track the first two doses of Pfizer’s three-shot vaccine for kids under age 5 in February, but the company decided to postpone its application because the data wasn’t good enough. Pfizer CEO Albert Bourla has said a third shot 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 U.S. have been infected by the virus at some point during the pandemic, according to data from national blood sample survey from the CDC.
Some Americans have also been waiting for the authorization of Novavax’s vaccine. If authorized by the FDA, Novavax’s shot will be the first new Covid vaccine to hit the market in more than a year.
Novavax was an early participant in Operation Warp Speed, the U.S. government’s race to develop a vaccine against Covid in 2020. However, Moderna and Pfizer ultimately beat Novavax to the punch because the company struggled with manufacturing issues.
Novavax’s vaccine uses different technology than Pfizer’s and Moderna’s shots, 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 spike outside the human body. The genetic code for the spike is put 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, an extract purified from the bark of a tree in South America, to induce a broader immune response.
While mRNA vaccines were first authorized during the pandemic, the protein technology that underlies Novavax’s shots has been used in past vaccines. Novavax’s adjuvant has been used in licensed vaccines against malaria and shingles.
Novavax has said some people who are hesitant to take mRNA vaccines might be more willing to use its shots.
(With inputs from CNBC)