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Novavax Covid vaccine clears key steps on the road to FDA approval after the committee approves the shot

Novavax’s two-dose Covid-19 vaccine for adults aged 18 and older took an important step towards food and drug administration approval on Tuesday.

The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend approval of the shot for use in the United States after a full-day public meeting where they weighed data on safety and efficacy. The FDA usually follows the committee’s recommendations, although it is not obligated to do so. The agency may clear Novavax’s vaccine for distribution in the United States as soon as this week.

The Centers for Disease Control Prevention will still have to sign off on the shots before pharmacies and other healthcare professionals can begin administering them to people.

Novavax̵[ads1]7;s shot will be the fourth Covid vaccine approved for use in the United States. The Maryland Biotechnology Company’s shots are based on protein technology that has been used for decades in hepatitis B and HPV vaccines. The technology differs from Pfizer and Modern’s images, which were the first to use messenger RNA technology to receive FDA approval.

Dr. Peter Marks, head of the FDA’s office responsible for reviewing the vaccine’s safety and efficacy, said Novavax’s vaccine would potentially appeal to people who have not been vaccinated yet because they would rather receive a shot that is not based on mRNA. the technology used by Pfizer and Moderna. Although the Johnson & Johnson syringe is also available, the CDC has restricted its use due to the risk of blood clots, mainly in women.

About 76% of adults aged 18 and older have already received two doses in the United States, primarily with Pfizer and Moderna vaccines, according to CDC data. However, around 27 million adults in the United States have not yet received their first dose, according to Heather Scobie, an official in the CDC’s Covid emergency team. Novavax executives believe their vaccine will appeal to some people in this group who are not opposed to vaccination, but want an alternative that uses technology with a longer track record than mRNA.

Novavax’s vaccine was 90% effective in preventing Covid’s disease across the board and 100% effective in preventing serious illness, according to the company’s clinical trials from the United States and Mexico. However, the trial was conducted from December 2020 to September 2021, months before the highly contagious omicron variant and its various sublines became dominant in the United States.

In briefing documents released ahead of Tuesday’s meeting, FDA officials said that no data is available on the effectiveness of the Novavax vaccine against omicron, although the shots are likely to continue to protect against serious disease from the variant. Novavax, like any Covid vaccine, was designed to target the original strain of the virus that first appeared in Wuhan, China in 2019. However, the virus has mutated dramatically over the past two years. The effectiveness of all Covid’s mild vaccines has dropped significantly as the virus has evolved.

“The study was conducted a while ago and said that the cases that occurred were not during the time the omicron was circulating,” said Dr. Lucia Lee, an official at the FDA’s Department of Vaccine Research, during her presentation to the committee.

Novavax’s Chief Medical Officer Dr. Filip Dubovsky said data from the company’s youth study showed that two doses induced an immune response to omicron, even though it was lower than that of the Wuhan strain. A third dose increased the immune response to omicron to levels comparable to the first two doses against the Wuhan strain, Dubovsky said. Novavax plans to ask the FDA to approve a third dose if the agency clears the primary series for use in the United States, he said.

“It is in fact that we do not have effect data against omicron, what we have is a technology that we believe generates a broad immune response, demonstrated against a wide range of variants,” Dubosvky said.

The most common side effects of Novavax shots were injection site pain, fatigue, headaches and muscle aches, according to FDA briefing documents. However, FDA officials also raised a red flag that Novavax’s vaccine may be associated with a risk of heart inflammation, as is the case with Pfizer and Modern’s shots.

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 receiving a shot, even though one of them had a viral illness that could have caused the symptoms. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the hearing.

Lee said these cases were worrying because patients reported their symptoms within days of receiving a Novavax shot, and there is already an established link between mRNA vaccination and heart inflammation in younger men. Regarding the mRNA shoots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination.

Novavax’s safety director, Dr. Denny Kim, said that the rates of myocarditis were essentially the same between people who received and did not receive the vaccine in the clinical study, although it was slightly higher among people who received the injections.

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

Novava’x vaccine technology differs in a number of ways from Pfizer and Modern’s shots. The latter rely on messenger RNA to turn human cells into factories that produce copies of Covid’s nail protein to induce an immune response that fights the virus. The spike is the part of the virus that attaches to and invades human cells.

Novavax produces copies of virus spike outside the human body. The genetic code of the spike is inserted into a baculovirus that infects moth cells, which then produces copies of the spike which are then purified and extracted. The spike copy, which cannot replicate or cause Covid, is injected into humans which induces an immune response against the virus.

The vaccine also uses another ingredient called adjuvant, which is an extract cleansed from the bark of a tree in South America, to induce a broader immune response against the virus. The syringes consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Novavax’s vaccine can also be stored at refrigerator temperature, while Pfizer and Moderna’s shots require deep cold below zero.

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

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