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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
Earlier today the FDA authorized booster doses for the Pfizer or Moderna vaccine for all adults.
The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended adults over the age of 50 should receive booster doses of either the Pfizer-BioNTech or Moderna COVID-19 vaccine, while younger adults may receive the booster dose.
Both votes were 11-0.
John Perez, MD, representing Pfizer, opened the meeting by discussing adverse events associated with the vaccine. About 25% of patients who received the booster vaccine reported an adverse event, but there were very low rates of serious adverse events.
The Pfizer representative was touting a 95.3% efficacy in comparison to placebo.
Rituparna Das ipresented on behalf of Moderna for the 50 microgram dose. For comparison, Pfizer's booster is 30 micrograms.
The first two speakers in the public comment period spoke in favor of the booster doses.
Next was a report on the overall safety findings from the vaccines, using vaccine reporting and monitoring system data including V-Safe and VAERS.
The data shows individuals overwhelmingly choose to get boosted with the same vaccine they received during the primary series.
Generally, there were less reactions and events associated with the booster dose in comparison with what was associated with dose 2.
There is also more reactions associated with the Moderna booster than there is for Pfizer.
Overall, 5% of adverse events were deemed serious. There were 82 reports of death issued to VAERS of the 26.3 million booster doses administered with an average age of 79. However, the deaths cannot be confirmed to be caused by the vaccine. There were also only 54 reports of myocarditis, 12 of which are likely related to the booster vaccine.
As committee members closed in on a vote, there was concerns over some of the language as to whether the recommendations should suggest certain adults "should" get the booster as opposed to "may" get the booster.
Earlier today, the US Food and Drug Administration (FDA) authorized the Pfizer-BioNTech BNT162b2 booster shots for all adults 18 and older.
The updated recommendations state adults who received a regimen of Pfizer-BioNTech or Moderna are eligible for either mRNA booster 6 months after their second dose, and adults who received Janssen are eligible for a Pfizer-BioNTech or Moderna booster 2 or more months after their original shot.
Pfizer-BioNTech originally submitted a request for Emergency Use Authorization (EUA) to administer its booster to all adults on November 9. Never far behind, Moderna requested EUA for their COVID-19 vaccine booster shortly after.