The news the last couple of days has centered on some experts recommending altering the COVID vaccine schedule approved by the FDA. Using 1/2 doses of the Moderna vaccine in some folks, delaying the second shot in other folks, etc. Now the FDA and the companies have strongly disagreed with these suggestions.
People need both doses of coronavirus vaccines, FDA officials say
CNN reports, “Anyone who receives the Moderna or Pfizer [coronavirus] vaccine must get two full doses, two top U.S. Food and Drug Administration officials said Monday.”
Additionally, FDA Commissioner Stephen M. Hahn, M.D., and Dr. Peter Marks, who heads FDA’s vaccine division, “dismissed other ideas for stretching the vaccine supply and said people who are speculating about the possibility of making do with just one dose or cutting doses in half are misinterpreting the data.”
Pfizer, BioNTech say there is no evidence their vaccine will continue to protect against COVID-19 if the booster (2nd) shot is given later than tested in trials
Reuters reports Pfizer and BioNTech “warned on Monday that they had no evidence that their jointly developed vaccine will continue to protect against COVID-19 if the booster shot is given later than tested in trials.” The companies said in a joint statement referring to prime and booster shots three weeks apart, “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.”
Health officials reject COVID-19 vaccine dosing changes
The Washington Post and Reuters are adding that top US health officials, including HHS Secretary Alex Azar and National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., and the FDA have dismissed suggestions to alter the two-dose regimen for existing COVID-19 vaccines in an effort to maximize the number of people with partial protection against the virus as cases continue to climb.
FDA Commissioner Stephen Hahn, M.D., and Center for Biologics Evaluation and Research Director Peter Marks, M.D., said changing the authorized dosing schedules is “premature and not rooted solidly in the available evidence.”