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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ບໍລິສັດເຕັກໂນໂລຊີຊີວະພາບ NOVAVAX announced on Friday that its Covid-19 vaccine has been authorized for emergency use by the U.S Food 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 children will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, said in a statement.
Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, 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 ທັນສະ ໄໝ.
Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.
How Novavax is different
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Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. Committee members were impressed by the company’s data on omicron.
The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna’s shots. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.
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 Covid vaccines are usually hospitalized for several days as a precaution but then recover.
The FDA has issued a fact sheet for health-care providers warning that clinical trial data indicates there is an increased risk of myocarditis with the Novavax vaccine. People who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, according to the FDA.
ໃນ ກໍລະນີຂອງການສັກຢາ mRNA, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.
Source: https://www.cnbc.com/2022/08/20/fda-authorizes-emergency-use-for-novavax-covid-19-vaccine-for-ages-12-and-17-.html