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Moderna has submitted an application to the FDA for emergency use authorization of its updated COVID-19 booster vaccine, the company announced Tuesday.
The vaccine targets the BA.4 and BA.5 Omicron variants and is meant for ages 18 and older. Moderna will be ready to ship doses in September.
"We have worked closely with the FDA to ensure that Americans will have access to Moderna's updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster," Stephane Bancel, Moderna's CEO, said in the statement.
Earlier this year, the FDA asked vaccine manufacturers such as Moderna and Pfizer to update their shots to target BA.4 and BA.5. The variants, which have been dominant in the U.S. since early July, are better at escaping antibodies from earlier vaccines and prior infections.
Pfizer submitted its FDA application on Monday to seek approval for an updated booster. The company also said it could ship doses in September.
The new bivalent vaccines target both the original spike protein on the coronavirus and the spike mutations carried by BA.4 and BA.5. As of last week, BA.5 is causing 89% of new infections in the U.S., followed by BA.4.6 with 6.3% and BA.4 with 4.3%, according to the latest CDC data.
Public health officials have been seeking an updated vaccine for a fall booster campaign to increase immunity before a potential surge this winter, according to The Wall Street Journal.
The Biden administration said Monday that updated booster doses would be available in September, the newspaper reported. States, pharmacies, and vaccination sites can begin preordering the doses from now through the end of August, according to a fall vaccination planning guide prepared by CDC officials.
Earlier this month, Moderna began a clinical trial of its new booster shot. Pfizer will start a clinical trial of its booster this month as well.
The Moderna and Pfizer applications to the FDA are based on early studies of the newest vaccines, as well as clinical data from previous updates to their vaccines, to speed along the approval process. Vaccines targeting the Omicron BA.1 subvariant showed a strong antibody response against BA.1, as well as some response against BA.4 and BA.5.
Vaccination sites will offer two types of vaccines, the Journal reported. Those who aren't fully vaccinated will be offered an original vaccine, and fully vaccinated people will be offered boosters that work against the Omicron subvariants.
About 90% of adults in the U.S. have received at least one vaccine dose, and 77% are considered fully vaccinated, according to the latest CDC data. An estimated 51.5% have received a booster dose, and 33% of ages 50 and older have received a second booster shot.
Moderna: "Moderna Completes Application to U.S. Food and Drug Administration for Emergency Use Authorization of Omicron-Targeting Bivalent COVID-19 Booster Vaccine, MRNA-1273.222."
CDC: "COVID Data Tracker: Variant Proportions."
The Wall Street Journal: "Moderna Asks FDA to OK Updated Covid-19 Shot."
CDC: "CDC Fall Vaccination Operational Planning Guide."
CDC: "COVID Data Tracker: COVID-19 Vaccinations in the United States."
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Cite this: Moderna Seeks Approval for Updated COVID Booster - Medscape - Aug 24, 2022.