USAoderna Inc. completed the application to request US clearance for the latest targeted booster shot Omicron COVID variantsa move intended to provide more protection against persistent coronavirus.
In a statement, the company said it has completed an emergency authorization submission for its bivalent COVID booster vaccine targeting strains BA.4 and BA.5 along with the original version. of COVID. The filing includes preclinical data on the enhancer against the latest strains, along with clinical data from the company’s other divalent enhancer targeting the original Omicron strain.
Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were allowed in that timeframe. Moderna’s booster app is intended for adults 18 years of age and older.
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Centers for Disease Control and Prevention advisers will hold a two-day meeting next week to discuss booster shots for the COVID-19 vaccine, an agency spokesman confirmed. received in an email. The Advisory Committee on Immunization Practices posted notice of the meeting, to be held on September 1 and 2, on website on Tuesday. The panel is composed of outside experts who advise the CDC on how best to administer the new vaccines. No agendas have been posted.
Vaccine manufacturers are working to design shots better suited to circulating strains of the coronavirus in an attempt to better protect against the pathogen still spreading around the world more than two and a half years later. when it was first discovered in China. According to the US Centers for Disease Control and Prevention, there were an average of 95,000 new cases in the US in the seven days ending on August 17, but hospitalizations and deaths have been declining as more people get sick. immunity through vaccination and earlier exposure to the virus.
Rival vaccine partners Pfizer Inc. and BioNTech SE said Monday that they have submitted the data to the Food and Drug Administration for permission. their own divalent booster against BA.4 and BA.5 for persons 12 years of age and older. Pfizer said Tuesday that its existing three-dose COVID vaccine regimen was 73.2% effective against the disease in a trial in children 6 months to 4 years old, adding to data led to the granting of injections for young children in June. The companies are working with the FDA to prepare applications for children 6 months to 11 years of age for bivalent boosters targeting BA.4 and BA.5.
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Shares of Moderna were up less than 1% in late trading.
Moderna speak on August 11 that it has begun clinical trials of the anti- BA.4 and BA.5. UK regulators have cleared another Moderna enhancer that focuses on the original strain of Omicron.
–With support from Fiona Rutherford.
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