Blow to Biden Admin: 16-2 Vote Rejects Pfizer and BioNTech Proposal for General Public COVID Booster Shot
Posted on 09/17/2021
The Biden administration has put pressure on the U.S. Food and Drug Administration (FDA) to get COVID mRNA-based booster shots out. Criticism from experts and the U.S. population have questioned the need for boosters, as well as Pfizer’s role in the COVID vaccine rollout. On September 17, 2021, an advisory panel for the U.S. Food and Drug Administration (FDA) rejected a proposal from Pfizer and BioNTech on to allow a third mRNA COVID dose, or booster shot. The FDA advisory panel cited a lack of sufficient data on the safety and efficacy of the measure. The panel may, however, consider extra vaccine doses for limited age groups, according to reports. U.S. health officials had pushed back in recent weeks against the Biden administration’s plan to roll out booster shots on Monday, according to reports. In recent times, the FDA announced the resignations of Marion Gruber and Philip Krause, long-veterans of the regulatory agency.
The FDA advisory panel did recommend the third shots to people age 65 and older and other vulnerable Americans.
There was not enough evidence that a third dose was safe and effective for use in all Americans, according to the panel’s findings. The FDA is not bound to follow the advisory group’s recommendations but the agency rarely goes against the guidance of Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Dr. Paul Offit, said he would support boosters for people over 60, but had trouble supporting third COVID shots for younger groups due to a higher risk of myocarditis. Myocarditis is an inflammation of the heart muscle (myocardium). The inflammation can reduce your heart’s ability to pump and cause rapid or abnormal heart rhythms (arrhythmias). Untreated, myocarditis can damage your heart’s muscle so that it can’t pump blood effectively. In severe cases, myocarditis-related heart failure may require a ventricular assist device or a heart transplant. Severe myocarditis can cause permanent damage to the heart muscle