Moderna has just made a major announcement on its vaccine
The company takes the next step of its vaccine process.
If you gotvaccinated in the United StatesYou have received one of the three vaccines-Pfizer, Moderna or Johnson & Johnson - because it is the only three COVID vaccines that have been authorized by the Food and Drug Administration (FDA) for emergency use. However, none of these vaccines have been fully approved by the FDA, with Pfizer the first tosubmit For complete approval almost a month ago. Now another vaccine company takes this key step: Moderna has just announced that it has begun its request to obtain a complete approval of the FDA.
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June 1, Moderna stated that he had started "the process of rolling" toRequest full approval FDA for its Covid vaccine with 18 years and over. The Company also requested a priority revision, which requires the review of the FDA and take action on its application.Within six months Rather than the 10 months that are allocated to the standard examination, by CNN.
"We are pleased to announce this important step in the United States regulatory process for a biology license application (BLA) of our CVIVID-19", "CEO of Moderna CEOStéphane Bantel said in a statement. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complement the bearing submission."
Moderna data published on April 13 which has shown thatHis vaccine maintained Efficiency of at least 90% six months after initial vaccination. The vaccine proved to be greater than 90% against all cases of COVID and more than 95% in effect against serious covidation cases in this chronology.
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It's good news for moderna, because there is no indication that society would refuse a bla. The FDA states that it has the right to revoke emergency authorization (EUA) for any vaccine if safety or efficiency concerns occur, but it is indicated that most vaccines under the UEA should meet the criteria of a BLA as long as it does not happen.
"It is expected that data supporting the UEA, as well as those that will be collected when using vaccination under the UEA, and additional data collected in ongoing tests are sufficient to support the license ( Approval) of an authorized vaccine under the UEA ", the FDA says.
And while disease control and prevention centers (CDC) indicate that more than 54 million people in the United States have already been fully vaccinatedwith the moderna vaccine, receive a blat will help the company long term. According toThe New York TimesComplete approvalwould allow a company Marketing its vaccine directly to customers, as well as facilitate businesses, government agencies and schools to impose vaccinations.
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It also means that the Moderna vaccine could be long for a long time. According toNytThe euas areintended to be temporary And can be revoked once an emergency of public health is over. However, any vaccine that received full FDA approval can remain on the market after the end of the pandemic and is no longer considered an emergency.
Moderna also releases preliminary process data showing how its vaccine works in adolescents. According to a report of May 25, Moderna saysNo COVID cases Have been observed during a phase test 2/3 of more than 3,700 children aged 12 to 18 - demonstrating 100% efficiency in adolescents two weeks after the second dose. Moderna says it plans to submit data in early June to achieve an emergency use of its vaccine for people in this age range.
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