Since the original publish date, the FDA has granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine and will decide whether to grant EUA for Moderna’s in the coming days, potentially making it the second vaccine available to help fight COVID-19 in the United States.
After nine months of battling the COVID-19 pandemic, a glimmer of hope is on the horizon after an advisory panel for the U.S. Food and Drug Administration (FDA) granted emergency use authorization for Pfizer and BioNTech’s vaccine in the United States.
“We sincerely hope this signals the beginning of the end of the pandemic,” said Luis Ostrosky, MD, professor of medicine and vice chair for healthcare quality at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth).
The FDA usually follows the advice of the advisory panel within days. Emergency use authorization is granted by the FDA after rigorous review of clinical trial data to allow the use of unapproved medical products in emergency situations without alternatives. The authorization allows patients outside of clinical trials to receive the vaccine.
“Emergency use authorization is granted when the benefits appear to outweigh the risk of use for any authorized product in specific situations, but it’s not the same as approval and licensure where you have the full body of additional data for subgroups and specific populations,” said Michael Chang, MD, an infectious disease pediatrician with McGovern Medical School at UTHealth and UT Physicians. “After authorization is granted, data will continue to be collected by the FDA and Pfizer/BioNTech from the patients who receive the vaccination. The CDC will continue to monitor and collect data as well to work towards licensure and full approval from the FDA.”
Experts caution that even though the vaccine will be available in the coming months, it doesn’t mean people can discontinue safety measures. Until a large number of people are vaccinated and more is known about the effectiveness of the vaccines, Americans will need to continue to follow the guidelines from the Centers for Disease Control and Prevention (CDC) to prevent spread: wear masks, physical distance, be vigilant about hand hygiene, and stay home when feeling sick.
“While it is a positive step in the right direction, we cannot let our guard down. The current situation is fluid and will certainly change in coming weeks. The safety and effectiveness of these vaccinations are paramount, which is why it is critical to communicate updates as we receive them,” said Ostrosky, an infectious disease specialist with UT Physicians, the clinical practice of McGovern Medical School.
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