Medical syringes and the Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland, on December 2, 2021.
Jakub Porzycki | NurPhoto | fake images
Independent advisers from the Food and Drug Administration will meet in June to discuss by Novavax Covid vaccine for adults as well as Pfizer Y modern’s vaccines for younger children, a sign that vaccines are getting one step closer to authorization.
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 Moderna and Pfizer vaccines for children under 5 years of age who are not yet eligible for vaccination. . The drug regulator, in a press release on Friday, said the dates are tentative because neither company has completed its filings.
The FDA committee will also meet on June 28 to discuss whether current Covid vaccines need to be redesigned to target mutations in the virus. FDA officials have said the US must quickly make a decision on whether the injections should be changed to have them ready before a possible fall wave of infection. Pfizer and Moderna are studying injections targeting the omicron variant, as well as the original strain that emerged in Wuhan, China, in 2019.
The FDA’s panel, the Advisory Committee on Vaccines and Related Biologics, holds meetings open to the public in which independent doctors and scientists review the data supporting a company’s vaccine. The panel then makes recommendations to the FDA about whether the vaccine should be licensed. The FDA is not required to follow the committee’s recommendations, although it normally 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. Parents have been waiting months for the FDA to approve a vaccine for this age group.
The FDA had tried to speed up the first two doses of Pfizer’s three-shot vaccine for children under 5 in February, but the company decided to postpone its rollout because the data wasn’t good enough. Pfizer CEO Albert Bourla has said that a third injection should provide much greater protection against omicron.
During the winter omicron wave, children under the age of 5 were hospitalized with Covid at a rate five times higher than the peak when the delta variant predominated, according to the Centers for Disease Control and Prevention. About 75% of children in the US have been infected by the virus at some point during the pandemic, according to data from the CDC’s national survey of blood samples.
Some Americans have also been waiting for approval of the Novavax vaccine. If cleared by the FDA, the Novavax shot 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 US government’s race to develop a covid vaccine in 2020. However, Moderna and Pfizer ultimately beat Novavax because the company ran into problems with manufacturing .
Novavax’s vaccine uses a 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 the virus. covid. The spike is the part of the virus that attaches to and invades human cells.
Novavax produces the virus spike 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 injection. 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 underlying Novavax injections has been used in previous vaccines. Novavax adjuvant has been used in licensed malaria and shingles vaccines.
Novavax has said that some people who are hesitant to take mRNA vaccines might be more willing to use their injections.