US panel rejects plan to give Pfizer booster shots to healthy under-65s

A US panel has voted against recommending extra Pfizer shots to healthy under 65s, arguing there’s not enough evidence they’re safe and effective.

The Covid-19 booster shot plan for people across the board has been unanimously rejected by a US government advisory panel. Picture: Joaquin Sarmiento/AFP

A US government advisory panel has overwhelmingly rejected a plan to give Pfizer-BioNTech Covid-19 booster shots across the board to all age groups.

The independent committee who advise the US Food and Drug Administration (FDA) voted unanimously on Friday to recommend approval of booster doses of the vaccine only for specific at-risk groups.

It endorsed emergency approval for the shot at least six months following the second dose among people ages 65 and older and those at high risk of occupational exposure and severe Covid-19.

A government advisory panel has rejected a plan to give Pfizer Covid-19 vaccine booster shots to healthy people aged under 65. Picture: Justin Tallis/AFP

The vote was 18-0. The vote will now go before the FDA to issue a final decision.

The panel earlier Friday afternoon voted to reject licensure of Pfizer’s booster vaccine in people ages 16 and older, at a vote of 2-16.

During the deliberations, panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16-17.

Medical staff workers prepare syringes with doses of Covid-19 vaccine while working behind beer taps at Fenway Park in Boston, Massachusetts. Picture: Joseph Prezioso/AFP

The committee was most recently charged with voting whether the safety and effectiveness data from Pfizer’s clinical trial supported emergency use authorisation of the company’s booster dose among people 65 years and older and people at high-risk for a severe course of Covid-19 disease.

The meeting 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), lsrael’s Health Ministry, vaccine experts and Pfizer representatives.

Dr William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted Phase 3 trial data indicating waning protection over time, from 96 per cent vaccine efficacy within two months after the second dose to about 84 per cent by six months and amid the dominant Delta variant.

While protection dropped against infections, it remained effective in preventing hospitalisation.

A mass vaccination site in Boston. Picture: Joseph Prezioso/AFP

Dr Gruber cited evidence suggesting reductions in efficacy owed to waning immunity over time as opposed to the delta variant escaping vaccine protection.

Additional data suggested a third Pfizer dose would ramp up protection on par or better than the second dose, however concerns were raised over the potential increased risk of myocarditis.

The FDA panel’s review included Pfizer’s trial results with some 300 participants ages 18-55 who received a booster dose about six months after the second dose.

To be clear, the role of the FDA and advisory panel in this case is to determine whether an additional dose can be used, whereas an expert panel advising the CDC (Advisory Committee on Immunisation Practices, ACIP), will convene Wednesday to weigh who should receive vaccine and when, following the FDA’s final review.

Top health officials last month said this group would likely include health care workers and nursing home residents who were targeted in the earliest phases of the rollout.

This article originally appeared on Fox News and was reproduced with permission