Pfizer the First COVID-19 Vaccine to Get Full FDA Approval
The first coronavirus vaccine has been approved by the FDA. Previously known as the Pfizer-BioNTech COVID-19 vaccine, it will now be distributed under the name Comirnaty and will be used to prevent SARS-CoV-2 virus in people aged 16 and up.
The vaccine will still be available under (EUA) emergency use authorization for those aged 12–15 and as the third dose for specific immunocompromised people.
The Pfizer-BioNTech and other vaccines have satisfied the FDA’s strict requirements for emergency use approval. Nevertheless, people may be confident that it fulfills the FDA’s high criteria for effectiveness, safety, and manufacturing quality as the first FDA-approved COVID-19 vaccine.
Vaccines that have been FDA-approved have gone through the agency’s regular process for evaluating medical products’ quality, safety, and efficacy.
The first EUA for the Pfizer-BioNTech COVID-19 Vaccine for people 16 and above was issued on Dec. 11 and was based on safety and effectiveness data from a randomized, controlled, blinded continuing clinical trial involving thousands of people.
To support the FDA’s approval decision, the FDA reviewed revised data from the clinical study that supported the EUA and included a longer duration of follow-up in a wider clinical trial population.
As part of its approval evaluation, the FDA examined effectiveness data from about 20,000 vaccination and placebo recipients ages 16 and older who did not have evidence of COVID-19 virus infection within a week of getting the second dose.
Comirnaty’s safety was tested in about 22,000 patients aged 16 and up who received the vaccination and another 22,000 who received a placebo.
According to the clinical trial results, the vaccination was 91% effective in preventing COVID-19 sickness.
The FDA has monitoring systems to ensure that any safety concerns are discovered and investigated as soon as possible.
In addition, the FDA has ordered the manufacturer to do postmarketing studies to better understand the risks of myocarditis and pericarditis after receiving Comirnaty immunization.
The long-term consequences of people who develop myocarditis after receiving Comirnaty immunization will be evaluated in these investigations.
In addition, the company has undertaken additional postmarketing safety studies, including a pregnancy registry study to examine pregnancy and newborn outcomes after receiving Comirnaty throughout pregnancy, even though the FDA did not require this.
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