December 9, 2022

Moderna seeks the authorization of the booster vaccine against covid-19

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(CNN) — Moderna has submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization of its updated COVID-19 vaccine booster for use in people 18 and older. years, the company said in a press release on Tuesday.

This updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets the BA.4 and BA.5 subvariants of omicron and would be administered in a 50-microgram dose.

The company says that a phase 2/3 clinical trial with these boosters is already underway. The data they have submitted to the FDA comes from experiments in mice, as well as data from humans using a different booster that was updated to protect against the BA.1 variant of omicron.

“We have worked closely with the FDA to ensure that Americans have access to Moderna’s updated bivalent booster, which, if approved, may offer higher, broader, and longer-lasting protection against COVID-19 compared to the booster.” currently licensed,” said Stephane Bancel, CEO of Moderna.

The announcement comes a day after Pfizer and BioNTech said they submitted their application to the FDA for emergency use authorization of their bivalent COVID-19 vaccine booster for use in people 12 years and older.

Epidemiologist advises covid-19 vaccine booster 2:36

When might vaccines be available?

Dr. Ashish Jha, White House COVID-19 response coordinator, recently said the updated boosters should be available to the public in early to mid-September, but it’s ultimately up to the FDA when green light for the vaccine.

“The FDA will use the totality of available evidence to authorize the fall bivalent boosters,” FDA spokeswoman Abigail Capobianco said in a statement emailed to CNN last week. “There are data on many millions of individuals who have received the prototype component as a booster. For the BA.4/5 component, a combination of non-clinical data from mice, data from earlier variant vaccines ( including beta, delta and omicron BA.1), along with our extensive knowledge of the safety and efficacy of mRNA platforms.”

The booster dose “elicited strong neutralizing antibody responses against the BA.4 and BA.5 subvariants of omicron in all participants, regardless of prior infection,” according to data previously published by Moderna in June.

The FDA will now evaluate Moderna’s data, but has not said whether it will convene its vaccine advisers before making a decision on authorization. Such a step could push back when injections can be administered.

Production of the updated vaccines is already underway. The US government bought 105 million booster doses of the bivalent covid-19 vaccine from Pfizer and another 66 million updated vaccines from Moderna.



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