KUALA LUMPUR, Sept 17 — Scientists from the United States Food and Drug Administration (FDA) are sceptical about the need for a third dose of Pfizer’s Covid-19 vaccine for everyone who received the shot.
FDA staff’s assessment comes ahead of an expert meeting that will be convened by the FDA later today to discuss coronavirus booster shots.
“Data indicate that currently US-licensed or authorised Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” Stat quoted FDA scientists as saying.
Stat reported that FDA is likely to consider advice from the agency’s advisory panel even though it will not be binding. If the FDA authorises Covid-19 vaccine boosters, a separate advisory committee convened by the Centers for Disease Control and Prevention (CDC) will later decide on whether to give these jabs to the general US population.
US president Joe Biden’s administration last month announced plans to offer booster shots to all adults, ahead of decisions by the FDA and CDC on the matter.
In briefing documents made available by the FDA, Pfizer said efficacy of its coronavirus vaccine in its Phase 3 clinical study slightly waned over time — from 96.2 per cent (between seven days and two months after the second dose) to 90.1 per cent (between two and four months after the second dose), declining further to 83.7 per cent (more than four months after the second dose).
The US pharmaceutical company argued that, based on the booster vaccination programme in Israel that saw waning immunity at a time when Delta was the dominant variant, a third Pfizer shot restored protection back to the 95 per cent efficacy level seen in clinical trials.