Moderna Inc completed Her file to request permission from the United States to obtain a booster dose targeting the latest Omicron COVID variantsa step to provide more protection against Continuous corona virus.
In a statement, the company said it has concluded an emergency authorization application for the company’s bivalent COVID-boosted vaccine that targets the BA.4 and BA.5 strains along with the original version of COVID. The registry includes pre-clinical data of the booster against the latest strains, along with clinical data from the company’s other bivalent booster targeting the original Omicron strain.
Moderna said it would be ready to ship doses of the bivalent booster shot in September, if authorized in that time frame. The Moderna Booster app is intended for adults of 18 years and over.
Centers for Disease Control and Prevention advisors will hold a two-day meeting next week to discuss booster shots for COVID-19 vaccines, an agency spokesperson confirmed in an email. The Immunization Practices Advisory Committee published a notice of the meeting, which will take place on September 1 and 2, at website Tuesday. A panel of external experts advises the Centers for Disease Control and Prevention on how best to administer new vaccines. No agenda for the meeting has been published.
Vaccine makers are working to design shots that match circulating strains of the coronavirus more closely in an effort to better protect against a pathogen that is still spreading around the world more than two and a half years after it was first discovered in China. New cases in the United States averaged about 95,000 in the seven days ending August 17, according to the US Centers for Disease Control and Prevention, but hospital admissions and deaths have fallen as more people gain immunity through vaccination and early exposure to the virus.
The two rival vaccine partners, Pfizer Inc. And BioNTech SE, on Monday, they sent data to the Food and Drug Administration for permission to Their bivalent booster Against BA.4 and BA.5 for people 12 and over. Pfizer said Tuesday that the three-dose regimen of its current COVID vaccine was 73.2% effective against the disease in a trial for children aged 6 months to 4 years, adding to data that led to the injection being allowed for young children in June. The companies are working with the U.S. Food and Drug Administration (FDA) to prepare an application for children ages 6 months to 11 years of age for a bivalent booster targeting BA.4 and BA.5.
Moderna shares rose less than 1% in late trading.
– With assistance from Fiona Rutherford.
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