Food and Drug Administration (Food and Drug Administration (FDA): Media Call – Third COVID-19 VaccineFDA) Media Call – Third COVID-19 Vaccine

Food and Drug Administration (FDA): Media Call – Third COVID-19 Vaccine

Meeting Link: https://youtu.be/m_eSKpm19zk

The meeting was held on 28^TH of February 2021 to discuss the emergency use authorization (EUA) issued for the Janssen Biotech Inc. COVID-19 vaccine for individuals 18 years and older. In attendance were Dr. Janet Woodcock, who is the Acting FDA Commissioner, and Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research.

The meeting discusses the process for approval of a vaccine which includes a thorough review of the data by the agency career staff, but also input from external scientific and public health experts. Hundreds of pages of technical data about this vaccine were reviewed thoroughly, efficiently, and transparently by the scientific and medical review staff.

It was determined by the FDA that the Janssen vaccine’s known and potential benefits outweigh the known and potential risks. There is clear evidence that the vaccine is effective in preventing the virus. The transparency around the research should assure the public that this vaccine met the FDA’s rigorous standards for quality, safety, and efficacy

Dr. Marks noted that the work of evaluating vaccines does not end with authorization. Vaccine manufacturers should continue studying their vaccines and move forward toward licensure. Active follow-up for safety, including monitoring for any significant adverse events to inform ongoing benefit-risk assessments, is also required.

The vaccine should not be given to any individuals with a known history of severe allergic reactions to any of its components. The most common allergens are polysorbate 80 and polyethylene glycol. Appropriate medical treatment should be available in the event of an acute anaphylactic reaction.

Impact

The authorization expands the availability of vaccines which are one of the best tools for preventing COVID-19. This helps to fight the pandemic. Authorization of this vaccine, coupled with continued public health measures and progress in treatment, holds promise to further battle the pandemic

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Food and Drug Administration (FDA): Media Call – Third COVID-19 Vaccine

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