On 23rd August 2021, Food and Drug Administration has recognised and approved Pfizer as the first vaccine. The official name Pfizer-BioNTech COVID 19 Vaccine has change it’s name to Comirnaty (koe-mir’-na-tee). The vaccine is ready for use under EUA, emergency use authorisation. The eligibility for the vaccine ranges from 16 years to above.
Acting FDA “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” Janet Woodcock, M.D ‘
All types of vaccines undergoes a careful examination, where the FDA takes a look at the manufacturer’s submission of a biologics license application (BLA). BLA is a document that contains important and accurate requirements, which is sent to the agency.
For Comirnaty, the BLA has already submitted the research that supported the EUA, such as
-preclinical and clinical information
-manufacturing process details
-testing results to confirm vaccine quality
-thorough site inspection of the vaccine creation
The agency further analyses the BLA to prove vaccine’s safety, effectiveness, and whether they demonstrate the FDA’s standards for approval.
Comirnaty contains RNA (mRNA), a molecule similar to your DNA. The mRNA in the body helps copy of one of the proteins in the virus that causes COVID-19. When an individual gets this vaccine, their immune system will react defensively to the virus with COVID-19’s property. The mRNA in Comirnaty remains in the body for a short time and is not mixed or combined, nor does it alter – an individual’s genetic material. Comirnaty and EUA vaccine is formed in the same way, and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
On December 11, EUA provided Pfizer Vaccine to be used by 16 years old or older population. All this was based on the data collected from randomised, controlled, blinded, and clinical trial that was in progress. The data proved that the vaccine was safe and effective.
The FDA properly examined the updated data from the clinical trial, that supported the EUA. All this also required a longer time to follow up in a larger clinic.
To pass the FDA approval process, the agency gathered the data from 20,000 vaccine and 20,000 placebo recipients ages 16 and above who were COVID-19 negative within a week of receiving the second dose. The safety of Comirnaty was proved in 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and above.
From the clinical trial, it was evident that the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who took Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
Safety Monitoring
Additionally, the FDA conducted a evaluation of the post-authorization safety surveillance data related to myocarditis and pericarditis with Pfizer Vaccine and has showed data of increased risks, within the seven days following the second dose. The risk was common in ages under 40 years compared to females and older males. The risk is highest in males 12 through 17 years of age. Other data from short-term follow-up suggest that most individuals have had resolution of symptoms. Other individuals required intensive care support. Information is not yet fully certain about potential long-term health issues. The Comirnaty Prescribing Information includes a warning about these risks.
The FDA and Centers for Disease Control and Prevention will be monitoring continuously about any safety concerns that arises, in a responsive manner. FDA is requiring the company to have postmarketing studies to look more into myocarditis and pericarditis. This consists of long term outcomes with those who develop myocarditis after the Comirnaty vaccine.
In addition, which is not FDA requirements, the company has committed to additional post-marketing safety studies, that gathers data about pregnancy and infant outcomes with Comirnaty vaccinated females during pregnancy.
