United States health authorities Monday gave full approval to the COVID-19 vaccine developed by Pfizer-BioNTech, which will now be marketed under the Comirnaty brand. Moderna's drug is expected to be approved shortly.
The Food and Drug Administration's (FDA) decision emergency use authorization was granted in December. The ruling came way earlier than expected.
According to health officials, the full approval is expected to make it easier for employers, the military and universities to make vaccination compùlsory as well as reassure those who are still hesitant about the medication.
After the FDA's clearance, US President Joseph Biden warned: Let me say this loudly and clearly: If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened, he said. The moment you've been waiting for is here. It's time for you to go get your vaccination. Get it today. Biden also encouraged businesses to step up their vaccine requirements.
Meanwhile, acting FDA Commissioner Janet Woodcock said in a statement that while this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.
The FDA's full approval applies to people 16 and older. Those ages 12 through 15 can still receive the vaccine under the existing emergency use authorization. For that age group, “there are still trials ongoing here,” Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters.
As of Sunday, 73% of adults in the U.S. have had at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccines. Pfizer's vaccine is most commonly administered, accounting for about 56% of the doses administered overall.
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of the third dose in certain immunocompromised individuals,” said the FDA in a statement.
“FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results ensure vaccine quality and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval,” the statement added.
“Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart,” the FDA document went on.
“Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease,” the FDA pointed out.
“The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death,” the agency underlined.
Regarding myocarditis and pericarditis, the FDA report stated that “the data demonstrate increased risks, particularly within the seven days following the second dose” and that “tobserved risk is higher among males under 40 years of age compared to females and older males,” while “the observed risk is highest in males 12 through 17 years of age,” but the Comirnaty Prescribing Information includes a warning about these risks.