Why is the FDA urging Pfizer to hold off on a third dose?

The FDA and CDC are against a third dose, arguing that there is no clear evidence from fully vaccinated Americans of a need for a booster.

On Thursday, 15 July 2021, Norman Baylor, President and Chief Executive Officer (CEO) of Biologics Consulting (US) and former Director of the Food and Drug Administration (FDA), said that the United States (US) does not have evidence that more booster shots for COVID-19 vaccines are needed. According to Norman, the FDA’s sentiments would be different if there was clear evidence of vaccine failures or a progressive loss of protective antibodies.

Furthermore, the FDA’s stance is supported by the Centers for Disease Control and Prevention (CDC), which released a joint statement with the administration saying Americans who have been fully vaccinated will not be needing a booster at the moment. This came after pharmaceutical company, Pfizer announced that it was developing a third dose to target the highly transmissible Delta variant, which has reportedly become the dominant strain in many countries, including the US.

The company reportedly worked with a German company called BioNTech to develop a vaccine that consists of two doses, given three weeks apart. The third dose was reportedly given emergency authorisation by the World Health Organisation (WHO) in December.

Moreover, Pfizer and BioNTech cited data from Israel’s health ministry that showed a decrease in effectiveness in their vaccine when it comes to preventing infection and symptomatic disease. According to the data, the decline in effectiveness coincided with the spread of the Delta variant, and led to the end of most COVID measures in Israel. Despite the concerns, the shot remains 93 percent effective in preventing hospitalisations and serious illness from COVID-19.

However, Baylor reportedly stated that close monitoring in the US has not revealed any significant vaccine failure. Even though COVID-19 cases are rising again in the US, doctors say the increase does not indicate a need for a third dose, as it is caused by the Delta variant spreading in unvaccinated populations.