The two-dose Covid-19 vaccine for Novavax for adults over the age of 18 took an important step towards approval by the Food and Drug Administration on Tuesday.
An independent vaccine expert FDA committee abstained to recommend approval of shots for use in the United States after a full-day public meeting comparing safety and efficacy data 21-0 I voted in. The FDA usually follows the Commission’s recommendations, but is not obliged to do so. The agency can clear the Novavax vaccine for distribution in the United States soon this week.
The Centers for Disease Control and Prevention needs to approve shots before pharmacies and other healthcare providers start administering them to people.
The Novavax shot will be the fourth Covid vaccine approved for use in the United States. Shot, a Maryland biotechnology company, is based on protein technology that has been used in vaccines against hepatitis B and HPV for decades. This technique differs from Pfizer and Modana shots using the first FDA-approved messenger RNA technology.
Dr. Peter Marks, who heads the FDA office for vaccine safety and efficacy reviews, appeals to people who haven’t been immunized yet because Novavax vaccines want to receive shots that aren’t based on the mRNA technology used by Pfizer. Said there is a possibility. And Moderna. Johnson & Johnson shots are also available, but the CDC limits their use primarily due to the risk of blood clots in women.
According to CDC data, about 76% of adults over the age of 18 have already received two doses in the United States, primarily using the Pfizer and Modana vaccines. However, according to Heather Scobie, an employee of the CDC’s Covid emergency response team, approximately 27 million adults in the United States have not yet received the first dose. Novavax executives believe the vaccine will appeal to some people in this group who are not opposed to vaccination, but want the option to use technology that has a longer track record than mRNA.
According to the company’s clinical trial results in the United States and Mexico, the Novavax vaccine was 90% effective in preventing Covid’s disease and 100% effective in preventing severe illness. However, the study was conducted from December 2020 to September 2021 months before the highly contagious Omicron variant and its various substrains became predominant in the United States.
In a briefing document released prior to Tuesday’s meeting, FDA officials said shots are likely to protect against serious illness from mutants, but no data are available on the efficacy of the Novavax vaccine against Omicron. Said. Novavax, like all Covid vaccines, 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 last two years. The effectiveness of all vaccines against Covid’s mild illness declined significantly as the virus evolved.
“This study was done long ago, and the cases that occurred were not during the circulation of Omicron,” Dr. Lucia Lee, an official at the FDA’s Vaccine Research Division, said in a presentation to the Commission. “.
Dr. Eric Rubin, a committee member who is an infectious disease expert at Harvard University, said he was disappointed that no data was presented on the effectiveness of Novabax on Omicron. However, Rubin said the data submitted by the company meet the same criteria used to authorize the Pfizer and Modana vaccines in December 2020.
Dr. Filip Dubovsky, chief medical officer at Novavax, told the panel that the data from the company’s study showed that two doses elicited an immune response against Omicron, albeit lower than the Wuhan strain. According to Dubovsky, the third dose increased the immune response to Omicron to levels comparable to the first two doses, with a 90% effect on the disease... Novavax will ask the FDA to approve a third dose if the FDA clears the primary series for use in the United States, he said.
“It’s true that we don’t have efficacy data for Omicron. We have a technique that we believe will produce a wide range of immune responses that have been demonstrated against a variety of mutants,” Dubosvky said. I am saying.
According to the FDA’s briefing document, the most common side effects of Novavax shots were injection site pain, malaise, headache, and muscle aches. However, FDA officials have also given a warning signal that the Novaxovid vaccine may be associated with a risk of heart inflammation, as in the case of Pfizer and Modana shots.
In the safety database of 40,000 Novavax vaccinated, four young men between the ages of 16 and 28 reported myocarditis or pericarditis within 20 days of having a seizure. Myocarditis is an inflammation of the muscles of the heart, and pericarditis is an inflammation of the outer layer of the ear.
Lee said these cases were of concern as the patient reported symptoms within days of receiving the Novavax shot. mRNA vaccination and heart inflammation Among young men.In For mRNA shotsCDC found that the risk of myocarditis was higher with Covid infection than with vaccination.
Dr. Denny Kim, Chief Safety Officer at Novavax, said that the incidence of myocarditis was basically the same in clinical trials with and without vaccination, but slightly higher in those who received the injection. Said that.
“We believe that the whole clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” Kim told the Commission. He said Novavax is monitoring cases of cardiac inflammation in the accumulated data from its clinical trials and in the actual use of shots already permitted.
Dr. Arthur Raingold, an epidemiologist at the University of California, Berkeley, said there is evidence that the company’s vaccine may be associated with the risk of heart inflammation at the same level as Pfizer and Moderna. A shot saying that many people who are hesitant to get the vaccine are skeptical about getting an injection of Novabax.
Dr. Cody Meissner, a pediatrician and committee member at Tufts University, does not have enough data to determine if a company’s injections pose a higher risk, but between the Covid vaccine and myocarditis. Was clearly related to.
Novavax’s vaccine technology differs in many ways from Pfizer and Modana shots. The latter relies on messenger RNA to turn human cells into factories, producing copies of Covid’s peplomer protein and eliciting an immune response that fights the virus. Spikes are part of the virus that latch and invade human cells.
Novavax produces a copy of the viral peaplomer outside the human body. The genetic code of the spike is put into the baculovirus that infects the moth cells, where the moth cells make a copy of the spike, which is purified and extracted. Spike copies that cannot replicate or trigger Covid are injected into people who elicit an immune response against the virus.
The vaccine also uses another ingredient called an adjuvant, which is an extract purified from the bark of South American trees, to induce a broader immune response to the virus. The shot consists of a spike copy of 5 micrograms and an adjuvant of 50 micrograms.
Novavax vaccines can also be stored at refrigerator temperatures, but Pfizer and Moderna shots require deep freezing cold.
This is a developing story. Please check for updates.