According to a statement released by Moderna on Tuesday, the FDA has received an application for emergency use permission of the company’s revised COVID-19 booster shot.
Ages 18 and older should receive the vaccination, which targets the BA.4 and BA.5 Omicron variants. In September, dosages of Moderna will be available for shipping.
“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated, bivalent booster, which, if approved, may offer higher, broader, and longer-lasting protection against COVID-19 than the currently authorised booster,” said Stephane Bancel, CEO of Moderna, in a statement.
The FDA asked vaccine producers including Moderna and Pfizer to adapt their doses to target BA.4 and BA.5 earlier this year. The variations, which have taken over in the United States since early July, are more adept at evading antibodies from earlier vaccinations and infections.
On Monday, Pfizer submitted an application to the FDA asking for permission to use an upgraded booster. The business added that September delivery of dosages was possible.
The brand-new bivalent vaccinations work by targeting both the coronavirus’s original spike protein and the spike mutations carried by BA.4 and BA.5. According to the most recent CDC data, BA.5 was responsible for 89% of new infections in the United States as of last week. BA.4.6 was second with 6.3% and BA.4 was third with 4.3%.
According to The Wall Street Journal, public health experts have been looking for an improved vaccination for a fall booster campaign to boost protection before a potential surge this winter.
According to the publication, the Biden administration said on Monday that revised booster doses would be accessible in September. According to a fall vaccination planning guidance created by CDC authorities, states, pharmacies, and immunisation locations can start preordering the doses from now through the end of August.
Moderna started a clinical trial for its brand-new booster shot earlier this month. This month, Pfizer will also begin a clinical trial for its booster.
A significant antibody response was seen following vaccination against the Omicron BA.1 subvariant, as well as a limited reaction against BA.4 and BA.5.
The Journal reported that vaccination clinics will provide two different vaccine types. Unvaccinated individuals will be given the original vaccine, and those who have had the entire course of vaccinations will be given boosters that protect against the Omicron subvariants.
According to the most recent CDC data, 77% of people in the U.S. are regarded as completely vaccinated, while almost 90% of persons in the country have had at least one vaccination shot. A booster dosage has reportedly been administered to an estimated 51.5% of people, and 33% of people 50 and older have had two booster shots.