As the nation’s physicians and health professionals respond to surging cases of COVID-19 while preparing to administer vaccines that could end the pandemic, the AMA has been hosting webinars featuring high-ranking experts from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to keep physicians informed on the latest COVID-19 developments.
Moderated by AMA President Susan R. Bailey, MD, the “COVID-19: What Physicians Need to Know” webinar series includes presentations from the FDA and CDC’s top career officials, followed by questions from the webinars’ physician audience.
- The first webinar (watch video or read transcript) dealt with what Dr. Bailey described as “the big elephant in the room”: how patients and physicians can be assured that politics won’t affect the vaccine-approval process. “Vaccine confidence is the ultimate goal here,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
- The final determination on whether a vaccine is safe and effective will not be made by politicians but by FDA career scientists who want to “make sure that our greater American family gets the same quality, safe, effective vaccine that we want for our own family,” Dr. Marks said. He added that the FDA is committed to making the approval process as transparent as possible.
- It’s not known when COVID-19 vaccines will be widely available for patients, but the steps physicians can do to prepare for the expected rapid rollout were outlined by the CDC (watch video or read transcript). Dr. Bailey was joined by Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), and Amanda Cohn, MD, the NCIRD’s acting chief medical officer and executive secretary for the CDC’s Advisory Committee on Immunization Practices.
- They described how the CDC is working with state and local partners to prioritize the early allocation of the initial vaccine distribution and that health care organizations should begin prioritizing which workers need to be vaccinated first. The public health impact of COVID-19 vaccines relies on rapid, efficient and high uptake of a complete vaccine series, Dr. Cohn explained, while Dr. Messonnier added that “a vaccine that is safe and effective sitting on a shelf is not helpful.”
- Every day during this COVID-19 pandemic, physicians and other health professionals go to work knowing there is a risk they may be infected with a deadly disease. The CDC is partnering with the AMA, local health departments and others on Project Firstline, a new national infection-control training program to lower that risk.
- Mike Bell, MD, deputy director of the CDC’s health care quality promotion division, talked with Dr. Bailey about the initiative that provides front-line health care workers with the needed training to protect themselves, their families, and their communities from infectious-disease threats (watch video read transcript). Project Firstline materials will include a series of town hall discussions and online training modules detailing infection-control practices and strategies and the science and reasoning behind them.
- The emergency use authorization (EUA) process has helped expedite vaccine approval. The FDA’s Dr. Marks rejoined Dr. Bailey to explain how the process works and how it has helped shorten the timelines for vaccine approval without compromising safety (watch video or read transcript).
- The two leading candidates for vaccine approval were developed with clinical trials that enrolled 43,000 and 30,000 people, providing “clear and compelling” evidence of their efficacy, Dr. Marks said.
Stay informed by visiting the AMA COVID-19 resource center for physicians, which features frequently updated information on clinical questions, advocacy, medical ethics and more.
Read more from Dr. Bailey about why the effort to restore trust in science must begin now.
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