FDA Grants the First Covid-19 Vaccine Approval: BioNTech

One of the Most Important Public Health Steps in History…

On August 28, 2021, the FDA (US Food and Drug Administration) granted the first Covid-19 vaccine approval. Previously, the FDA had supported the use of these vaccines under “emergency use authorization”; now the first “regular approval” has been granted. The vaccine known as Pfizer-BioNTech, developed by Uğur Şahin, Özlem Türeci and their teams, will now be used to prevent Covid-19 in people aged 16 years and older under the name Comirnaty. The vaccine also continues to be available under emergency use authorization for children aged 12 – 15 and for a third dose in certain immunocompromised people.

For Some People, FDA Approval Now Provides Full Confidence to Receive the Vaccine

FDA official Janet Woodcock said of this approval: “The FDA’s approval of this vaccine is a milestone in our ongoing fight against the Covid-19 Pandemic. Although 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 also be very confident that this vaccine meets the high standards of safety, effectiveness and manufacturing quality that the FDA considers necessary to approve a product. Although millions of people have safely received Covid-19 vaccines, we know that for some people, having a vaccine approved by the FDA now means full confidence to receive it. Today’s milestone brings us one step closer to changing the course of this pandemic.”

Since December 11, 2020, the Pfizer-BioNTech Covid-19 Vaccine had been administered under emergency use authorization to people aged 16 and older, and the authorization was expanded on May 10, 2021, to include children aged 12 to 15. The FDA may use Emergency Use Authorizations during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided it determines that the product’s known and potential benefits outweigh its known and potential risks when used to prevent, diagnose or treat the disease.

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 the data and information in the manufacturer’s biologics license application (BLB) submission. The BLB is a comprehensive document submitted to the agency that meets very specific requirements.

What Is Comirnaty’s Mechanism of Action?

Comirnaty contains messenger RNA (mRNA), a type of genetic material. The body uses this mRNA to mimic one of the proteins in the virus that causes Covid-19. This enables the immune system of a person receiving the vaccine to respond protectively against the virus that causes Covid-19. The mRNA in Comirnaty is present in the body for only a short time and is not incorporated into or does not alter the individual’s genetic material. Comirnaty has the same formulation as the Emergency Use Authorization vaccine and is administered as a two-dose series three weeks apart.

Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said of the rapidly approved vaccine: “Our scientific and medical experts conducted an exceptionally thorough and careful evaluation of this vaccine. We evaluated scientific data and information spanning hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of manufacturing processes, including inspections of manufacturing facilities. We also considered the continuing Covid-19 public health crisis in the US and the public’s reliance on safe and effective vaccines. The public and medical community can be assured that, although we approved this vaccine rapidly, it is fully consistent with our existing high standards for vaccines in the US.”

FDA Evaluation of Safety and Efficacy Data for Approval in People Aged 16 and Older

The initial Emergency Use Authorization issued on December 11 for the Pfizer-BioNTech Covid-19 vaccine in people aged 16 and older was based on safety and efficacy data from a randomized, controlled, blinded clinical trial involving thousands of people. To support today’s approval decision, the FDA reviewed updated data from the clinical trial that supported the Emergency Use Authorization, including a longer follow-up period in a larger clinical trial population.

In its review specifically for approval, the FDA analyzed data from approximately 20,000 vaccinated people and 20,000 placebo recipients aged 16 and older who had no evidence of infection with the Covid-19 virus within one week after the second dose. Comirnaty’s safety was also evaluated in approximately 22,000 vaccinated people and 22,000 placebo recipients aged 16 and older. According to the clinical trial results, the vaccine was 91% effective in preventing Covid-19. More than half of trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 people were followed for at least 6 months.

The most common side effects reported by clinical trial participants receiving 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 consequences, including hospitalization and death.

The FDA also conducted a detailed evaluation of postauthorization safety surveillance data on myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine, and determined that the data showed increased risks, particularly within seven days after the second dose. The observed risk was higher in males under 40 than in females and males over 40. The highest observed risk was in males aged 12 to 17. Available short-term follow-up data showed that most people’s symptoms resolved. Some people, however, required intensive care support. Information on potential long-term health outcomes is not yet available. The Comirnaty Prescribing Information contains a warning about these risks. Nevertheless, Covid-19 itself causes far more myocarditis and pericarditis than mRNA vaccines do.

Ongoing Safety Monitoring

The FDA and the Centers for Disease Control and Prevention have monitoring systems to ensure continued timely identification and assessment of any safety concerns. The FDA has also required the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis after Comirnaty vaccination. These studies will include an assessment of long-term outcomes among people who develop myocarditis after receiving Comirnaty. In addition, although not required by the FDA, the company has committed to additional postmarketing safety research, including a pregnancy registry study to evaluate pregnancy and infant outcomes after Comirnaty vaccination during pregnancy.