In this illustration, the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vial.
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Novavax’s two-dose Covid-19 vaccine for adults 18 years of age and older represents an important step on the road to achieving Food and Drug Administration approval on Tuesday.
The FDA’s committee of independent vaccine experts voted 21-0 with an abstention at the end of an all-day meeting to recommend authorizing the shot in the US after an all-day public meeting in which they weigh the data for safety and effectiveness. The FDA generally follows the committee’s recommendations, although it is not required to do so. Authority can be clear Novavax’s vaccine for distribution in the US as soon as this week.
The Centers for Disease Control and Prevention still need to sign the shots before pharmacies and other health care providers can start giving them to people.
Novavax’s vaccine will be the fourth Covid vaccine approved for use in the United States and the first new vaccine since Johnson & Johnson’s shots were cleared in February 2021.
Novavax is one of the early entrants in the US government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the company struggled for more than a year to get it to production, and its clinical trial data was released much later than expected. Pfizer and Moderna.
Known technology
The Maryland biotech company’s shots are based on protein technology that has been used for decades in vaccines against hepatitis B and HPV. This technology differs from that of Pfizer and Moderna, which were the first technologies using messenger RNA technology to receive FDA approval.
Peter Marks, the head of the FDA office responsible for reviewing the safety and effectiveness of the vaccine, said Novavax’s vaccine will likely appeal to people who haven’t been vaccinated because they want it. a shot that is not based on the mRNA technology that Pfizer uses. and Moderna. However Johnson & Johnson’s also available, CDC has restricted its use due to the risk of blood clots mainly in women.
According to data from the CDC, about 76% of adults 18 years of age and older have received two doses of the vaccine, primarily with the Pfizer and Moderna vaccines. However, about 27 million adults in the US have yet to receive their first dose, according to Heather Scobie, an official on the CDC’s Covid emergency response team. Novavax executives believe their vaccine will appeal to some in this group, who aren’t against vaccinations, but want an option to use the technology with a longer track record than mRNA. .
According to the company’s clinical trial results from the US and Mexico, Novavax’s vaccine is 90% effective in preventing widespread illness from Covid and 100% in preventing severe illness, according to trial results. corporate clinical trials from the US and Mexico. However, testing was conducted from December 2020 to September 2021, several months before the highly contagious omicron variant and its various subtypes became dominant in the US.
Omicron
In summary documents released ahead of Tuesday’s meeting, FDA officials said there are no data available on the effectiveness of Novavax’s vaccine against omicrons, although the shots may still provide protection against omicrons. severe disease from variant. Novavax, like all Covid vaccines, is designed to target the original strain of the virus that first appeared in Wuhan, China in 2019. However, the virus has mutated significantly in past two years. The effectiveness of all vaccines against mild illness from Covid has been significantly reduced as the virus has evolved.
“The study was done quite a while ago and shows cumulative cases not during the time omicrons were circulating,” said Dr. Lucia Lee, an official in charge of the FDA’s vaccine research division. .
Committee member Dr. Eric Rubin, an infectious disease expert at Harvard, said he was disappointed that the company did not present data on Novavax’s effectiveness on omicrons. However, Rubin said the data the company submitted met the same standards used to license Pfizer and Moderna’s vaccines in December 2020.
Novavax Chief Medical Officer Dr Filip Dubovsky told the panel that data from the company’s trials showed that two doses caused an immune response against omicrons, although it was lower than that of the Wuhan strain. The third dose boosted the immune response against omicrons to a level comparable to the first two doses being 90% effective against disease, Dubovsky said.. Novavax plans to ask the FDA to authorize a third dose if the agency clears the main series of drugs for use in the US, he said.
“The fact that we don’t have efficacy data against omicrons, what we do have is a technology that we think induces a broad, proven immune response against a wide range of variables. possible,” said Dubosvky.
Side Effects
The most common side effects of Novavax injections were injection site pain, fatigue, headache, and muscle pain, according to the FDA summary document. However, FDA officials also raised red flags that Novavax’s vaccine may be associated with an increased risk of heart inflammation, as was the case with injections by Pfizer and Moderna.
In a safety database of 40,000 Novavax vaccine recipients, four young men aged 16 to 28 years reported myocarditis or pericarditis within 20 days of vaccination, even though one of them Having a viral illness can cause symptoms. Myocarditis is an inflammation of the heart muscle and pericarditis is an inflammation of the outer membrane of the hearing.
These cases are concerning because patients have reported their symptoms within days of receiving the Novavax shot, and there has been an established link between these cases, Lee said. mRNA vaccination and heart inflammation among young men. inside case of the mRNA photoThe CDC has found that the risk of myocarditis from a Covid infection is higher than with vaccination.
Novavax chief safety officer Dr Denny Kim said rates of myocarditis were essentially the same between vaccinated and unvaccinated people in the clinical study, although the rates were slightly higher. in those who have been vaccinated.
Myocarditis
“We believe that the entire clinical evidence here is insufficient to establish an overall causal relationship with the vaccine,” Kim told the committee. He said Novavax is tracking cases of heart inflammation using accumulated data from clinical trials and using the actual wording of the injections they have been authorized.
Panel member Dr. Arthur Reingold, an epidemiologist at UC Berkeley, said he suspects a large number of vaccines are hesitant to vaccinate Novavax, given the evidence of a vaccine by Novavax. may be associated with a similar risk of heart inflammation to Pfizer and Moderna’s. Photograph.
Dr Cody Meissner, a pediatrician at Tufts University who was also on the committee, said there is clearly a link between the Covid vaccine and myocarditis, although there isn’t enough data to say whether a corporate injection carries a higher risk or not.
Novavax’s vaccine technology differs from Pfizer and Moderna’s injections in several ways. The latter relies on messenger RNA to turn human cells into factories that produce copies of Covid’s mutated protein to induce an immune response against the virus. The mutant protein is part of a virus that attaches to and enters human cells.
Novavax makes copies of the virus’s mutant protein outside the human body. The spike’s genetic code is inserted into a baculovirus that infects the cells of the moth, then produces copies of the buds that are then purified and extracted. The mutant copy, which cannot replicate or cause Covid, is injected into the person to induce an immune response against the virus.
The vaccine also uses another ingredient called an adjuvant, which is a purified extract from the bark of a tree in South America, to induce a broader immune response against the virus. The injections include 5 micrograms of the spike clone and 50 micrograms of excipients.
Novavax’s vaccine can also be stored at refrigerator temperature, while Pfizer and Moderna’s injections require deep refrigeration.
