FDA advisory panel rejects 'widespread' booster shot for all except those aged 65 & older

On Friday, United States Food and Drug Administration (FDA) advisory panel rejected the ‘widespread’ administration of the COVID-19 booster shots. It gave approval to Pfizer for inoculating only those over the age of 65, who were co-morbid and most vulnerable to Coronavirus. FDA endorsed the emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months after the second dose among those who were categorically at a high risk of exposure to novel coronavirus and risked severe ailment from the disease due to age factor, several reports on Friday confirmed.

The vote was held by a panel for approval that saw an 18-0 majority, and another poll will now be conducted before the FDA gives its final decision. A separate vote for booster shot licensure for individuals aged 16 and older received 2-16, failing to gain majority consent for a go-ahead. The panel included members of the FDA's Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), Israel's Health Ministry, vaccine experts, and Pfizer representatives, according to the US broadcasters.

Decision subject to CDC review 

FDA cited a lack of safety data on administering the booster doses for everyone, particularly the younger population. But the second approval for the older population is still subject to review by the Centers for Disease Control and Prevention (CDC). CDC had earlier propagated the booster dosages for high-risk groups and older people, nursing home residents, and front-line health care workers, denying that there was a need for everyone to take it. US top infectious diseases expert and director of the National Institute of Allergy and Infectious Diseases, Dr Anthony Fauci meanwhile supported the third dose in televised remarks, saying that it "will actually be durable, and if it is durable, then you're going to have very likely a three-dose regimen being the routine regimen.”

A joint statement from HHS Public Health and medical experts from the US Department of Health and Human Services (HHS) had earlier last month had stated that the available data “makes it very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant.” Therefore, the committee recommended a booster shot to maximize vaccine-induced protection. It said, that many health care providers, nursing home residents, and other seniors at long-term care facilities, will likely be eligible for a booster. “We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine,” the committee said. 

(Image: AP)