After months of careful and stringent review, the U.S. Food and Drug Administration approved the first COVID-19 vaccine on Tuesday. The Pfizer-BioNTech COVID-19 vaccine, an mRNA vaccine which will now be marketed as Comirnaty, has been given the nod of approval for the prevention of COVID-19 in individuals ages 16 and older. Emergency use authorization continues to be available for individuals ages 12 to 15.
“This is a huge milestone in our fight against COVID-19 and could not have come at a better time. FDA approval boosts confidence in the vaccine,” said Guam Department of Public Health and Social Services director Art San Agustin. “Although our island has achieved success in vaccinating over 80% of our adult population, highly contagious variant strains of COVID-19 threaten our community, especially among the unvaccinated. We are seeing a surge of cases and the hospital census continues to rise. It is imperative that more of our eligible population get vaccinated.”
The Pfizer-BioNTech COVID-19 vaccine has been available under EUA since Dec. 11, 2020, for individuals 16 and older. In Guam, it became available on Dec. 17, 2020. This vaccine was then expanded to adolescents 12 to 15 years of age on May 10, 2021.
“DPHSS has been advocating for vaccination not only because we believe in the safety and efficacy of these vaccines, but also because we know how much it can reduce the number of hospitalizations. These vaccines are the most heavily scrutinized vaccines in the world, having followed every strict scientific step necessary to create it. While we understand the initial concerns with a new vaccine, more than 4.95 billion shots have been given worldwide, with very few short-term side effects. Meanwhile, the risk of death or serious complications from COVID-19 is significantly higher. Science has shown that the benefits of the vaccine outweigh the risk of subjecting your unvaccinated body to COVID-19,” said Dr. Felix Cabrera, DPHSS chief medical officer.
FDA-approved vaccines undergo standard process for reviewing the quality, safety, and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application.
According to the FDA, to support its approval decision, it reviewed updated data from a randomized, controlled, blinded clinical trial of thousands of individuals, which supported the EUA first issued on Dec. 11, 2020. The updated data included a longer duration of follow-up in a larger clinical trial population. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
“The evidence is clear; the science is clear. Vaccines are our No. 1 protection against COVID-19 and other public health interventions. More unvaccinated people are ending up in the hospital. More children who are not eligible are testing positive. If these reasons weren’t enough, we hope FDA approval will motivate you to get the shot,” DPHSS chief public health officer Chima Mbakwem said. (PR)