AUSTIN, Texas — The first COVID-19 vaccine is approved by the FDA. The Pfizer-BioNTech vaccine is now approved. It will be branded and marketed as "Comirnaty."
Until now, the company had the drug listed as authorized under an Emergency Use Authorization.
The Kaiser Family Foundation studied 1,888 people. The foundation found 31% of those who are not vaccinated said they would get the vaccine once federally approved.
“We hope those who have waited until now to make the choice to protect themselves, also help protect their communities by reducing the spread of COVID-19 will go and get vaccinated,” Peter Marks, M.D., Ph.D., director of FDA Center for Biologics Evaluation and Research (CBER), said in a national press call.
Pfizer submitted required material to the FDA as it went along in the process. The company’s website shows its phase 3 study was “pivotal.”
The study was published in the New England Journal of Medicine. Pfizer gave injections to 43,448 people. Half of the group received the vaccine, the other half had a placebo.
The company studied the participants from July 27 through Nov. 14, 2020. Results showed 95% effectiveness in preventing COVID-19.
However, this study was performed before the delta variant. Now, a CDC nursing home study shows the effectiveness at 53.1%.
“Data coming out of Israel seems to suggest that with time, immunity from the vaccine does tend to wane, and so that's something we'll be following closely,” Marks said.
Comirnaty is for those 16 and older.
The FDA Website shows adolescents 12 through 15 years old are still able to get vaccinated under the Pfizer-BioNTech Emergency Use Authorization.
The FDA shows risks associated with Comirnaty.
“The FDA conducted a rigorous evaluation of the of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks,” the FDA website shows.
It also pointed readers to the Vaccine Information Fact Sheet for Recipients and Caregivers.
The Texas Department of State Health Services said the current vaccination sites will continue using all authorized vaccines.
Full FDA response:
“On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and then issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
“Based on this declaration and determination, the FDA may issue an EUA after the agency determines that the following statutory requirements are met (section 564 of the Food, Drug & Cosmetic Act [21 U.S.C. 360bbb-3]):
The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition (COVID-19).
Based on the totality of scientific evidence available to FDA, including data from adequate and well controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat COVID-19.
The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.
“If a COVID-19 vaccine is licensed (approved) by the FDA, that would not automatically preclude issuance or continuation of an EUA for another COVID-19 vaccine. For example, if the approved COVID-19 vaccine is only available in limited quantities, that vaccine may not be considered available to address the public health emergency. Additionally, if the vaccine is approved for use only in a limited population, then FDA could issue or continue an EUA for that vaccine, or another vaccine, to cover the populations not covered by the approval.
“It is not possible to predict how long it may take the agency to review an application for any future COVID-19 vaccine. We recognize that we are in a critical moment during this public health emergency, warranting expedited - while at the same time, thorough - review of the data and information submitted in any application for a COVID-19 vaccine. We will continue to carefully consider other applications we receive and take timely actions given the public health emergency. With regard to review of vaccine Biologics License Applications (BLAs) outside of the public health emergency, the FDA always strives to meet or exceed our PDUFA goals. While each vaccine BLA review is unique, the FDA aims to complete priority reviews for vaccines within eight months of receiving a complete BLA, and standard reviews within 12 months.”
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