FDA approves emergency use of Novavax Covid-19 vaccine for ages 12 to 17

A box of the Novavax Covid-19 vaccine is arranged at a pharmacy in Schwenksville, Pennsylvania, U.S., on Monday, August 1, 2022.

Bloomberg | Bloomberg | beautiful pictures

Biotech company Novavax announced Friday that its Covid-19 vaccine has been approved for emergency use by the US Food and Drug Administration for adolescents aged 12 to 17 years.

In July, Novavax’s two-dose Covid-19 vaccine for adults 18 years of age and older received emergency approval from the FDA.

Having more vaccine options for adults and children will “hopefully help increase vaccination rates, especially as we prepare for a continued surge in Covid-19 as the fall and back to school season,” Stanley C. Erck, president and CEO of Novavax, said in a statement.

Novavax is one of the original participants in the US government’s Covid vaccine race in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company has struggled to get production in place quickly, and its clinical trial data read much later than rivals. Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine will likely appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used. by Pfizer and Moderna.

How is Novavax different?

Novavax vaccination is based on the more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines using mRNA.

Pfizer and Moderna’s vaccine uses mRNA, a molecule encoded with genetic instructions, to command human cells to make copies of a virus particle called a mutant protein. The immune system reacts to copies of this spike, to prepare the human body to attack the actual virus.

Novavax makes copies of the spike virus outside of human cells. The stem’s genetic code is inserted into an insect virus that infects moth cells, which make copies that are then purified and extracted during production. The completed mutant copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of trees in South America, to induce a broader immune response. The injections include 5 micrograms of the spike clone and 50 micrograms of excipients.

Effective and safe

Two doses of the Novavax vaccine are 90% effective at preventing widespread illness from Covid and 100% effective at preventing severe illness, according to clinical trial data from the United States and Mexico. However, testing was conducted from December 2020 to September 2021, several months before the omicron variant became dominant.

Novavax did not present any data on the effectiveness of the shot for the variant at the FDA committee meeting in June. However, the vaccine is likely to be less effective against omicrons, as is the case with Pfizer and Moderna vaccinations. Omicron is so different from the original Covid strain that the antibodies produced by the vaccine have difficulty recognizing and attacking the variant.

Novavax released data in December showing that the third injection boosted the immune response to the same extent as the first two doses were 90% effective against disease. The company plans to ask the FDA to authorize a third dose of its vaccine.

The FDA approval for Novavax’s vaccine comes as the United States prepares to update its Covid shots to target omicron variants BA.4 and BA.5 to increase protection against the virus. -withdraw. Novavax’s vaccine, like all injections, is based on the original version of the virus that first appeared in Wuhan, China. The effectiveness of Covid vaccines against mild illness has decreased significantly as the virus has evolved, although they still protect against severe illness.

Novavax presented the data at a FDA committee meeting at the end of June demonstrated that the third dose of the vaccine produced a strong immune response against omicron and its sub-variants. Committee members were impressed by the company’s data on omicron.

The Novavax vaccine also carries a similar risk of heart inflammation in younger men, known as myocarditis and pericarditis, similar to the Pfizer and Moderna shots. Myocarditis is an inflammation of the heart muscle and pericarditis is an inflammation of the pericardium.

FDA officials flagged four cases of myocarditis and pericarditis from Novavax’s clinical trial in young men ages 16 to 28. People who develop heart inflammation as a side effect of the Covid vaccine often hospitalized for a few days as a precaution but then recovers.

The FDA has issued a fact sheet for healthcare providers warning that clinical trial data suggest an increased risk of myocarditis with the Novavax vaccine. According to the FDA, people who experience chest pain, shortness of breath, and a feeling of a pounding or pounding heart should seek medical attention immediately.

inside case of the mRNA photo, the CDC has found that the risk of myocarditis from a Covid infection is higher than with vaccination. Myocarditis is usually caused by a viral infection.

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