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Novavax Covid-19 Vaccine Receives FDA Authorization

“Today’s authorization offers adults in the United States who have not yet received a Covid-19 vaccine another option that meets FDA’s stringent standards for safety, efficacy and manufacturing quality required to support emergency use authorization,” said FDA Commissioner Robert Califf said in a statement. .

Background: The Novavax vaccine contains a synthetic coronavirus spike protein made from clay cells and compounds that promote an immune response. This formulation is similar to older vaccines.

In a trial of more than 26,000 adults in the US and Mexico, two doses of the Novavax Covid vaccine were more than 90 percent effective in preventing symptomatic disease. For adults over 65, the effectiveness was more than 78 percent. There were no serious side effects or safety concerns, including about 21,000 adults who were followed for more than two months after the second injection.

In a press release, the FDA noted that it conducted a thorough analysis of Novavax’s manufacturing capabilities as part of its decision to authorize the shot.

received a shot Strong support from Trump-era Operation Warp Speed effort, but face Difficulties with production During the long process of vaccine development.

What is the following: The Centers for Disease Control and Prevention will then decide whether to approve the vaccine for adults. Agency Immunization Practices Advisory Committee The meeting is scheduled for July 19However, the agenda of the meeting has not been published yet.

The Biden administration announced earlier this week that it had purchased 3.2 million doses of the Novavax vaccine. The Department of Health and Human Services said Monday that Novavax “expects to complete all necessary quality testing in the next few weeks, which will facilitate the final release of the product.”

If the vaccine receives a favorable recommendation from the CDC, HHS said the protein-based vaccine will be available to states, jurisdictions, federal pharmacy partners and federally qualified health centers.

The FDA said it expects Novavax to continue clinical trials to generate data that support full approval of the vaccine.

Adam Kankrin contributed to this report.

Novavax Covid-19 Vaccine Receives FDA Authorization

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