First COVID-19 Vaccine Heads to US Patients

The first COVID-19 vaccine started shipping to states for immediate distribution to frontline healthcare workers and other high-priority populations on Dec. 13, 2020, following FDA’s issuance of an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s messenger RNA-based vaccine, a determination of the target population, and a warning about potential allergic reactions.

FDA determined that the potential benefits of the vaccine outweigh the risks and issued the EUA on December 11. The EUA is based on two months of clinical trial data showing the vaccine was safe and 95% effective in preventing COVID-19.

FDA’s independent Vaccines and Related Biological Products Advisory Committee reviewed the safety data and recommended the issuance of an EUA on December 10. The Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention voted on December 12 to recommend the vaccine be limited to people 16 years of age and older.

FDA warned medical professionals in a fact sheet (PDF) that the vaccine should not be administered to individuals with a history of severe allergic reactions to any component of the vaccine. In addition, facilities administering the vaccine must have appropriate medical treatments available to address acute anaphylactic reactions.

While the clinical trials determined the safety and effectiveness of the vaccine, it is not known how long the vaccine will provide protection, or if it prevents transmission of SARS-CoV-2 from person to person.

"Pfizer's purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19,” said Albert Bourla, chairman and chief executive officer, Pfizer, in a press statement. “As a US company, today's news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”

“We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Ugur Sahin, CEO and co-founder of BioNTech, in a press statement. “Today we are another step closer to our vision. We believe that today’s Emergency Use Authorization, and the subsequent distribution of our vaccine that has demonstrated an efficacy rate of 95% and a favorable safety profile, will help to save lives across the United States and could accelerate a return to normality.”

In a press statement, the companies said that their combined manufacturing network has “the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization).”

FDA seeks to build public confidence in vaccine

The vaccine was developed at a record pace—and under pressure from policymakers—causing some public distrust in the safety of the vaccine. In announcing the EUA, FDA leaders reiterated that the agency was committed to independent, science-based decisions.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, in an FDA press statement. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support Emergency Use Authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

“While not an FDA approval, today’s Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA press statement. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”

A pharmacovigilance plan submitted by Pfizer-BioNTech includes plans for longer-term safety follow-up for clinical trial participants, monitoring the safety profile of the vaccine, and measures to identify and evaluate safety issues. The companies noted in a press statement that they plan to collect additional data and potentially file a Biologics License Application for a full regulatory approval in 2021.

Sources: FDA and Pfizer