(SitNews) - Anchorage, Alaska – The U.S. Food and Drug Administration (FDA) today granted full approval of the Pfizer COVID-19 vaccine for individuals aged 16 years and older. The vaccine had previously been authorized under an emergency use authorization (EUA), which allowed the vaccine to be used during the pandemic while more data continued to be collected and analyzed. The EUA will continue for individuals aged 12 through 15 years and for the administration of a third dose in immunocompromised people.

“Robust clinical trials have shown that the COVID-19 vaccines were safe and effective when they were first authorized in December of 2020. Now we have even more data supporting the benefits and safety of the Pfizer vaccine – enough to grant full licensure,” said Alaska’s Chief Medical Officer Dr. Anne Zink. “Alaskans have important questions about the vaccines, and we know some people have been waiting for full approval. We hope this instills confidence and encourages more Alaskans to now get vaccinated.”

“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.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

“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."

According to the FDA, the first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. 

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. 

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, 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 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.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has 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 and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Quoting a news release from the Alaska Dept. of Health & Social Services, choosing vaccination is the single most important action Alaskans can take to help stop the pandemic and save lives. To find a convenient vaccination location, visit covidvax.alaska.gov or vaccines.gov. 

Currently 54% of eligible Alaskans (age 12+) are fully vaccinated against COVID-19 while nearly 60% have received at least one dose of one of the three vaccines available in the United States. According to the CDC’s COVID Data Tracker, Alaska ranks 32nd among U.S. states for vaccinations based on the share of the eligible population that has received at least one dose. 

The Pfizer vaccine, which will now be named Comirnaty by the company, is the first COVID-19 vaccine to receive full FDA approval. It will continue to be available to all who are eligible at no cost. Regulators are still reviewing the application for full approval of the Moderna mRNA vaccine; a decision on that application is expected soon. 

On the Web:

 FDA’s answers to frequently asked questions about the COVID-19 vaccine

The status of Alaska’s vaccination progress:  DHSS vaccine monitoring dashboard.

 

Source of News:

Alaska Dept. of Health & Social Services
www.dhss.alaska.gov

Federal Drug Administration
fda.gov

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