FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Over Age 50
Wednesday, March 30, 2022
On Tuesday, the U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people over age 50 and certain immunocompromised individuals.
The FDA previously authorized a single booster dose for certain immunocompromised individuals following the completion of a three-dose primary vaccination series. This latest authorization now makes a second booster dose of these vaccines available to people at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.
This second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second dose may also be administered to individuals 12 years of age and older with certain kinds of immunocompromised conditions.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTThe functioning of our immune system and response to vaccines decline as we get older. 93% of COVID deaths in the U.S. to date have been in those over 50, making booster shots especially important in this age group.
“Current evidence suggests some waning of protection overtime against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals. Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so”, said Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
A number of clinical studies including by the Centers for Disease Control have shown that vaccine effectiveness against the Omicron variant now dominant wanes after four months.
The new more transmissible variant BA.2 has recently become dominant, and now accounts for about half of cases in Massachusetts, Connecticut, and Rhode Island. As a result of BA.2, there are warnings of another possible surge. The Mayo Clinic forecasts a 12% increase in cases nationally over the next 2 weeks.
A growing number of countries have already been offering fourth doses of the COVID vaccines in an effort to combat the more transmissible BA.2 variant, and especially the even more easily transmitted BA.2 variant, including Israel, the U.K., Denmark, South Korea, Australia, Sweden, Chile, El Salvador, and others.
Nick Landekic is a retired scientist and biotechnology executive with over 35 years of experience in the pharmaceutical industry.
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