Lisa Maragakis, MD, MPH, Senior Director for Infection Prevention, and Gabor Kelen, MD, Director of Johns Hopkins Office of Critical Events Preparedness and Response, answered questions on safety at SEC.
FDA is conducting an intensive surveillance effort on the COVID-19 vaccine safety in the U.S. using several approaches. Afterthe COVID-19 vaccine is licensed by FDA, a number of vaccine safety monitoring systems monitor adverse events (possiblead verse events). Although these side effects are extremely unlikely, the COVID-19 vaccine continues to be monitored for safety by the public health community and regulatory agencies. All currently licensed vaccines in use in the U.S. are very
effective at protecting against serious COVID-19, which can result in hospitalizations and deaths.
Worldwide, vaccines like those from AstraZeneca and Johnson & Johnson/JanssenAstraZenecaJohnson & Johnson/Janssen have been used to protect millions against COVID-19. All three of these vaccines, which are either licensed for use during an emergency
situation or approved by the FDA, have been rigorously tested and found safe and effective at preventing severe COVID-19.
Clinical trials showed the Pfizer vaccine, the Moderna, was approximately 95% effective at preventing COVID-19 disease.
Currently, FDA has determined the Pfizer/BioNTech vaccine meets the standards of efficacy and safety required to receive an
emergency use authorization for use in children aged 5 years or older.
FDAs Center for Biologics Evaluation and Research (CBER) is monitoring the safety of licensed COVID-19 vaccines using both
passive and active safety monitoring systems. To preserve public confidence and to support vaccine policies, dynamic,
reliable, and continuous evaluations are required to assess the benefit-risk balance of the vaccines that are available.7
Established safety surveillance systems are being strengthened and will continue to be a keystone for COVID-19 vaccine safety
surveillance. Confidence in vaccines, and thus in successful vaccine programs, can be achieved only with transparency of the
decision-making process, an understanding of how vaccine safety will be monitored, and prompt communication of the status of
safety monitoring and the benefit-risk balance of COVID-19 vaccines. In the present COVID-19 emergency situation, where the
prompt distribution of new vaccines has been required and had to pass emergency approval schemes, the focus has been placed on activities to ensure the vaccines safety.
FDA and CDC have an established process to monitor the vaccines safety, because the two other vaccines were given to millions
after they were authorized. Throughout this process, the FDA works closely with the companies producing the vaccines to
assess vaccine safety and efficacy. Before FDA approves a vaccine for use, they thoroughly review available safety data and
the results of clinical trials of that vaccine. They monitor serious adverse events (or adverse events) using vaccine safety
monitoring systems, such as the new V-Safe After Vaccination Health Checker application.
One example of this critical safety monitoring process is the recent suspension of the J&J; vaccine, so FDA and the CDC can
look at data about the six reported cases of severe blood clots following vaccination with J&J.; All safety concerns should
be addressed before FDA authorizes or licenses the vaccine.