Health
Coronavirus: It is at this time that the Pfizer vaccine can be fully approved by the FDA.
Staten Island, NY — As more and more Americans are vaccinated to protect against the coronavirus (COVID-19) Pfizer and BioNTech announced on Friday Their vaccine will be fully approved by the US Food and Drug Administration (FDA) by January.
The two companies said the FDA has granted priority review designation for the Pfizer-BioNTech mRNA Vaccine Biopharmacy Approval Application (BLA) for individuals over the age of 16. The target date for the FDA’s approval decision, also known as the Prescription Drug Administration (PDUFA), is January 2022.
However, FDA Commissioner Dr. Janet Woodcock said approval could come sooner.
“On the contrary, this BLA review is underway and is one of the top priorities of the agency, which will complete the review long before the PDUFA target date,” Woodcock wrote. .. twitter.
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The Pfizer vaccine was first approved by the FDA in December 2020 as an Emergency Use Authorization (EUA). Emergency Use Authorization facilitates the availability and use of medical measures, including vaccines, in public health emergencies such as the COVID-19 pandemic. This means that the vaccine has not been officially approved for use by the FDA.
In May, the FDA expanded its emergency use authorization for the Pfizer vaccine as follows: Including individuals aged 12 to 15 years.. Pfizer and BioNTech will submit a supplementary BLA for full FDA approval for this age group.
The other two vaccines available (Moderna and Johnson & Johnson) have also been approved for emergency use by people over the age of 18 and have not yet been fully approved by the FDA.
Vaccines for children under 12 are coming soon
Only people over the age of 12 can get the coronavirus vaccine, FDA officials said Thursday that vaccines for children under the age of 12 could soon be available.
Vaccines may receive an emergency permit from early winter to midwinter, shortly after which full approval of the vaccine is expected. According to the published report.
Two US-approved vaccine companies, Moderna and Pfizer, began testing vaccines in children under the age of 12 in March and are expected to see results this fall.
In a statement NBC NewsPfizer said the outcome for children aged 5 to 11 is expected to be sometime in September, at which point the company can apply for an emergency permit.
Dr. Buddy Kleech, a researcher at the Modana trial, said: NBC News The company expects to follow a similar timeline, with data expected to arrive in late fall.
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