On Monday, the FDA approved the two-dose Pfizer BioNTech COVID-19 vaccine. This opens the door to more mandates in the country.
Pfizer's COVID-19 vaccine is the first to be approved by FDA. The shots were previously allowed to be administered under an Emergency Use Authorization. This authorization is used in cases of public health emergencies and requires that companies prove that the vaccine is safe, effective, and there is no alternative. In order to be eligible for FDA approval, vaccine manufacturers will need to continue gathering data about safety and monitoring the vaccine's effectiveness over time.
Moderna and Pfizer both submitted their applications in May for the COVID-19 vaccine. Moderna followed in June. Johnson & Johnson will likely file its approval application in the latter part of this year. Before Monday's approval, FDA scientists reviewed thousands of pages worth of clinical trial data in order to determine the safety, efficacy and manufacturing quality for Pfizer's vaccine.
Pfizer's vaccine for children aged 12-15 years will be available as an emergency authorization. The company is also continuing clinical trials for these age groups.
In the US, more than 204 million doses COVID-19 vaccine by Pfizer have been administered.
Health officials believe that the approval will encourage more schools, hospitals, businesses, and other entities to issue vaccine mandates. Although the Office of Legal Counsel at the Department of Justice argued that vaccines with EUAs were legal, the FDA's approval is likely to convince both public and private entities to implement vaccine mandates.
New York City Mayor Bill de Blasio announced that he would require all employees in city schools to have their vaccines administered within a few hours of the FDA's Monday announcement. De Blasio stated, "We know that this will help ensure that everybody is safe," and that everyone would need to be vaccinated by Sept. 27, just after the school year begins.
"This is a moment of great significance. "We've been waiting for it for a while," de Blasio stated about the FDA's approval for Pfizer's vaccine. "This allows us to move forward."
Experts in health hope that the move will convince some people who are hesitant about getting a vaccine without the FDA's full approval.
"While this and all other vaccines have met FDA's strict, scientific standards for emergency authorization, the FDA approved this COVID-19 vaccine as the first FDA-approved COVID-19 vaccination. The public can be very sure that the vaccine meets FDA's high standards for safety and effectiveness. This was stated by Janet Woodcock, acting FDA Commissioner. We recognize that millions of people have received COVID-19 vaccinations safely, but some may feel more confident about getting vaccinated now that the FDA has approved a vaccine.
This move follows a recommendation by top US health officials to make booster shots available to all Americans beginning in September. The recommendation was made amid concerns about the decline in immunity due the the highly contagious Delta virus. Some scientists criticized the recommendation, saying that the data didn't support the need for boosters. The vaccines are still very effective in preventing severe illness, hospitalizations and deaths.
Pfizer's request for approval was based upon clinical data from over 20,000 patients 16 years and older who were given the vaccine and another 20,000 who were administered placebo shots. Over half of participants in clinical trials were followed for safety concerns at least four months following the second dose. Around 12,000 vaccine recipients were monitored for at least six month.
Matt Berman contributed reporting to this story.
