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

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A box of the Novavax Covid-19 vaccine arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

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Biotechnology company Novavax announced on Friday that its Covid-19 vaccine has been authorized for emergency use by the united statesFood and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.

Having more vaccine options for adults and kids will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the beginning of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, said in an announcement.

Novavax was certainly one of the unique participants within the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. Nevertheless, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated individuals who would like a shot that isn’t based on the messenger RNA technology utilized by Pfizer and Moderna.

How Novavax is different

The Novavax shot relies on more conventional protein technology used for a long time in hepatitis B and HPV vaccines, while Pfizer and Moderna are the primary FDA-approved vaccines to make use of mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic instructions, to inform human cells to provide copies of a virus particle called the spike protein. The immune system responds to those copies of the spike, which prepares the human body to attack the actual virus.

Novavax makes copies of the virus spike outside human cells. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies which can be then purified and extracted in the course of the manufacturing process. The finished spike copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an extra ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Effectiveness and safety

Two doses of the Novavax vaccine were 90% effective at stopping illness from Covid across the board and 100% effective at stopping severe illness, in line with clinical trial data from the U.S. and Mexico. Nevertheless, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant.

Novavax didn’t present any data on the shot’s effectiveness against the variant on the FDA committee meeting in June. Nevertheless, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna’s shots. Omicron is so distinct from the unique strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant.

Novavax published data in December showing that a 3rd shot boosted the immune response to levels comparable to the primary two doses which had 90% effectiveness against illness. The corporate plans to ask the FDA to authorize a 3rd dose of its vaccine.

FDA authorization of Novavax’s vaccines comes because the U.S. is preparing to update Covid shots to focus on the omicron BA.4 and BA.5 variants to extend protection against the virus. Novavax’s vaccine, like all the opposite shots, relies on the unique version of the virus that first emerged in Wuhan, China. The effectiveness of Covid vaccines against mild illness has slipped substantially because the virus has evolved, though they still generally protect against severe disease.

Novavax presented data at an FDA committee meeting in late June demonstrating that a 3rd dose of its vaccine produced a robust immune response against omicron and its subvariants. Committee members were impressed by the corporate’s data on omicron.

The Novavax vaccine also appears to hold a risk of heart inflammation for younger men, often called myocarditis and pericarditis, just like Pfizer and Moderna’s shots. Myocarditis is an inflammation of the guts muscle and pericarditis is inflammation of the outer lining of the guts.

FDA officials flagged 4 cases of myocarditis and pericarditis from Novavax’s clinical trial in young men ages 16 to twenty-eight. Individuals who develop heart inflammation as a side effect of Covid vaccines are frequently hospitalized for several days as a precaution but then get well.

The FDA has issued a fact sheet for health-care providers warning that clinical trial data indicates there may be an increased risk of myocarditis with the Novavax vaccine. Individuals who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, in line with the FDA.

Within the case of the mRNA shots, the CDC has found that the chance of myocarditis is higher from Covid infection than vaccination. Myocarditis is often attributable to viral infections.

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