The two-dose vaccine for adults ages 18 and older cleared a key hurdle on Tuesday.
The FDA's committee of independent vaccine experts voted 21 to 0 with one abstaining to recommend authorization of the shot for use in the U.S. The FDA doesn't have to follow the committee's recommendations. Novavax's vaccine could be cleared by the agency this week.
The shots have to be approved by the CDC before they can be given to people.
Novavax would be the fourth Covid vaccine to be approved for use in the US. The technology is different from Pfizer and Moderna's shots which received FDA approval.
According to Dr. Peter Marks, who leads the FDA office responsible for reviewing vaccine safety and effectiveness, Novavax's vaccine could appeal to people who have not gotten immunized yet because they would rather receive a shot that is not based on the technology used by Pfizer and Moderna. The shot is restricted by the CDC due to a risk of blood clot in women.
According to data from the CDC, about 75% of adults in the U.S. have already received two doses of Pfizer and Moderna's vaccine. Heather Scobie is an official on the CDC's Covid emergency response team. Novavax executives believe their vaccine will appeal to some people in this group who are not against vaccinations, but want an option with a longer track record.
According to the company's clinical trial results from the U.S. and Mexico, Novavax's vaccine was effective at preventing illness and preventing severe illness. The trial took place from December 2020 to September of 2021.
According to documents published ahead of Tuesday's meeting, FDA officials said there is no data available on the effectiveness of the Novavax vaccine against omicron. Like every Covid vaccine, Novavax was designed to target the original strain of the virus. The virus has changed a lot over the past two years. As the Covid virus has evolved, the effectiveness of all the vaccines has declined.
During her presentation to the committee, Lucia Lee, an official with the FDA's division of vaccine research, said that the cases that accrued were not during the time that omicron was circulating.
The data from the company's adolescent study showed that two doses caused an immune response against omicron, but it was less than against the Wuhan strain. The immune response against omicron was boosted by a third dose. If the FDA clears the primary series for use in the US, Novavax will request a third dose.
Dubosvky said that they don't have efficacy data against omicron, but that they have a technology that can generate an immune response.
Injection site pain was the most common side effect of Novavax. The FDA raised a red flag that Novavax's vaccine may be associated with a risk of heart inflammation as was the case with Pfizer and Moderna's shots.
In a database of 40,000 Novavax vaccine recipients, four young men who ranged in age from 16 to 28 reported myocarditis or pericarditis within 20 days of receiving a shot, one of them had a virus that could have caused the symptoms. pericarditis and myocarditis are inflammation of the heart muscle.
Lee said these cases were concerning because the patients reported their symptoms within days of receiving a Novavax shot. The risk of myocarditis is higher when the vaccine is used than when the shot is taken.
The rate of myocarditis was the same for people who received the vaccine and those who didn't, according to Novavax's chief safety officer.
Kim told the committee that there wasn't enough evidence to establish a causality with the vaccine. He said Novavax is watching for cases of heart inflammation in the accumulating data from its clinical trials and real-word use of the shots where they are already authorized.
Pfizer and Moderna have different vaccine technology. The latter rely on messenger RNA to turn human cells into factories that produce copies of Covid's spikeProtein to fight the virus. The spike is the part of the virus that attacks humans.
The human body has copies of the Novavaxviruses. The spike's genetic code is put into a baculoviruses, which is then used to make copies of the spike, and then to extract it. The spike copy is injected into people in order to induce an immune response.
An extract from the bark of a tree in South America is used in the vaccine to induce an immune response. The shots contain 5 and 50 micrograms of the same substance.
Novavax's vaccine can be stored at a lower temperature than Pfizer and Moderna's.
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