Medical syringes and the Novavax logo in the background are visible in this illustration taken in Krakow, Poland on December 2, 2021.
Jakub Pozhitsky | NurPhoto | Getty Images
FDA independent consultants will meet in June to discuss the Novavax Covid vaccine for adults, as well as the Pfizer and Moderna vaccines for young children, a sign that the vaccines are a step closer to resolution.
The FDA committee will review the Novavax vaccine for adults 18 years of age and older on June 7th. The FDA has chosen three possible dates – June 8, 21 and 22 – to discuss Moderna and Pfizer vaccinations for children under 5 who are not yet eligible for vaccination. . The drug regulator said in a Friday press release that the dates are tentative as neither company has completed its submissions.
The FDA committee will also meet on June 28 to discuss whether current Covid vaccines need to be redesigned to target virus mutations. FDA officials said the U.S. needs to make a quick decision on whether to change vaccinations so they are ready for a possible fall wave of infection. Pfizer and Moderna are studying vaccines that target the omicron variant as well as the parent strain that emerged in Wuhan, China in 2019.
The FDA Panel, the Advisory Committee on Vaccines and Biological Complementary Products, holds meetings open to the public where independent physicians and scientists discuss evidence supporting the company’s vaccine. The panel then makes recommendations to the FDA about whether the vaccine should be approved. 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 regulator to approve its two-dose Covid vaccine for children aged six months to 5 years. Parents waited months for the FDA to approve a vaccine for this age group.
The Food and Drug Administration sought to expedite the first two doses of Pfizer’s triple vaccine for children under 5 in February, but the company decided to delay filing because the data was not accurate enough. Pfizer CEO Albert Burla said the third shot should provide much better protection against omicrons.
Children under 5 years of age were five times more likely to be hospitalized with Covid during the winter omicron wave than at its peak, when the delta variant predominated, according to the Centers for Disease Control and Prevention. About 75% of U.S. children were infected with the virus at some point during the pandemic, according to a national study of blood samples by the CDC.
Some Americans were also waiting for approval for the Novavax vaccine. If the FDA approves, the Novavax vaccine will be the first new Covid vaccine to hit the market in more than a year.
Novavax was an early entrant in Operation Warp Speed, the 2020 US government race to develop a Covid vaccine. However, Moderna and Pfizer ended up getting ahead of Novavax because the company struggled with manufacturing issues.
The Novavax vaccine uses a different technology than the Pfizer and Moderna vaccines, which rely on messenger RNA to turn human cells into factories that produce copies of the virus’ spike protein, triggering an immune response that fights Covid. The spike is the part of the virus that attaches to and invades human cells.
Novavax produces a virus spike outside the human body. The genetic code for the spike is inserted into a baculovirus, which infects insect cells, which then produce copies of the spike, which are purified and extracted for inoculation. 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 behind Novavax vaccines has been used in past vaccines. Novavax adjuvant has been used in licensed malaria and herpes zoster vaccines.
Novavax said some people who are hesitant to take mRNA vaccines may be more willing to use its shots.