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Novavax’s two-dose COVID-19 vaccine for adults 18 years of age and older on Tuesday took a significant step towards a Food and Drug Administration authority.

The FDA’s committee of independent vaccine experts voted 21 to 0 to recommend authorization of the shot for use in the US after a full-day public meeting in which they weighed safety and effectiveness data. The FDA generally follows the recommendations of the committee, although it is not obliged to do so. The agency may approve Novavax’s vaccine for distribution in the US as soon as this week.

The Centers for Disease Control and Prevention will still require pharmacies and other health care providers to sign off on the shots before people can start administering them.

Novavax’s shot will be the fourth COVID vaccine authorized for use in the US. The Maryland biotech company’s shots are based on protein technology that has been in use for decades in vaccines against hepatitis B and HPV. The technology differs from shots from Pfizer and Moderna, which were the first to use messenger RNA technology to gain FDA approval.

Dr. Peter Marks, who leads the FDA’s office responsible for reviewing vaccine safety and effectiveness, said Novavax’s vaccine will potentially appeal to people who have not yet been vaccinated because they will receive a shot similar to that used by Pfizer. Not based on known mRNA technology. and Modern. Although the Johnson & Johnson shot is also available, the CDC has restricted its use primarily in women because of the risk of blood clots.

According to CDC data, about 76% of adults age 18 and older have already received two doses in the US, primarily the vaccines from Pfizer and Moderna. However, according to Heather Scobie, an official on the CDC’s COVID emergency response team, about 27 million adults in the US have not yet received their first dose. Novavax officials believe their vaccine will appeal to some in this group who are not against vaccination but want an alternative that uses a technology with a longer track record than mRNA.

According to the results of the company’s clinical trials from the US and Mexico, the Novavax vaccine was 90% effective in preventing disease from COVID and 100% effective in preventing severe disease across the board. However, the trial was conducted from December 2020 to September of 2021, months before the highly infectious Omicron variant and its various subspecies became effective in the US.

In briefing documents published ahead of Tuesday’s meeting, FDA officials said there is no data available on the effectiveness of the Novavax vaccine against Omicron, although the shots will still protect against severe disease from the variant. Novavax, like every COVID vaccine, was designed to target the original strain of the virus that first emerged in 2019 in Wuhan, China. However, the virus has mutated dramatically over the past two years. The effectiveness of all vaccines against mild illness from COVID has declined significantly as the virus has evolved.

Dr. Lucia Lee, an official in the FDA’s Department of Vaccine Research, said during her presentation to the committee, “The study was conducted a long time ago and it was said that the cases that were reported were not from the time when the Omicron spread. Had been.”

Dr. Eric Rubin, a member of the Committee on Infectious Diseases Experts at Harvard, said he was disappointed that data on Novavax’s effectiveness against Omicron had not been presented. However, Rubin said the data the company submitted met the same standard that was used to authorize Pfizer and Moderna’s vaccines in December 2020.

Novavax’s chief medical officer, Dr. Philip Dubowski, told the panel that data from the company’s trials showed that the two doses induced an immune response against Omicron, although it was less than the Wuhan strain. Dubowski said the third dose boosted the immune response against Omicron to a level comparable to the first two doses, with 90% effectiveness against the disease., Novavax plans to ask the FDA to authorize a third dose if the agency approves the primary series for use in the US, he said.

“It’s a fact that we don’t have efficacy data against Omicron, we have a technology that we think produces a broad immune response, demonstrated against a wide variety of forms,” ​​Dubowsky said.

According to FDA briefing documents, the most common side effects of shots of Novavax were injection site pain, fatigue, headache and muscle aches. However, FDA officials also raised a red flag that the Novavax vaccine may be associated with an increased risk of heart inflammation as is the case with shots from Pfizer and Moderna.

In a safety database of 40,000 Novavax vaccine recipients, four young men aged 16 to 28 reported myocarditis or pericarditis within 20 days of receiving a shot, although one of them had a viral illness that may have caused symptoms. Was. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer layer of the eardrum.

Lee said these cases were related because patients reported their symptoms within days of receiving the Novavax shot, and there is already an established link between the two. mRNA vaccination and heart inflammation among younger men. In The case of mRNA shotsThe CDC has found that the risk of myocarditis is greater with COVID infection than by vaccination.

Novavax Chief Security Officer Dr. Denny Kim said the rate of myocarditis was essentially the same between people who received and did not receive the vaccine in clinical studies, although it was slightly higher among people who received the shots.

“We believe that the totality of clinical evidence here is not sufficient to establish an overall causal relationship with the vaccine,” Kim told the committee. He said Novavax is monitoring cases of heart inflammation in accumulated data from its clinical trials and real-word use of shots where they are already authorized.

Panel member Dr. Arthur Reingold, an epidemiologist at UC Berkeley, said he doubts that a large number of vaccine hesitants will get the Novavax shot, noting that the company’s vaccine is at comparable levels to Pfizer and Moderna. May be associated with an increased risk of heart inflammation. shot.

Tufts University pediatrician Dr. Cody Meisner, who is also on the committee, said there is clearly a link between the COVID vaccine and myocarditis, although there is not enough data to say whether a company’s shot carries more risk.

Novavax’s vaccine technology differs from Pfizer’s and Moderna’s shots in several ways. The latter rely on messenger RNA to turn human cells into factories that produce copies of COVID’s spike protein to induce an immune response that fights the virus. The spike is the part of the virus that attacks and invades human cells.

Novavax makes copies of the virus’s spike protein outside the human body. Spike’s genetic code is put into a baculovirus that infects moth cells, which then produce copies of the spike which are then purified and extracted. The spike copy, which cannot replicate or cause COVID, is injected into people producing an immune response against the virus.

The vaccine also uses another ingredient called adjuvant, which is a purified extract from the bark of a tree native to South America, to induce a widespread immune response against the virus. Shots contain 5 micrograms of spike copy and 50 micrograms of adjuvant.

The Novavax vaccine can also be stored at refrigerator temperature, while shots from Pfizer and Modern require a deep subzero cold.

This is a developing story. Please check back for updates.



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