Last month, the Food and Drug Administration cleared Pfizer-BioNTech booster injections for people 65 years of age and older, those at high risk of severe Covid-19, and those at high risk of exposure due to where they work or live. This decision was based on limited efficacy data.
The new findings appear to strengthen the evidence that booster shots are very effective, although trial participants were only followed for a median of two and a half months after receiving the booster.
“This important data adds to the body of evidence suggesting that a booster dose of our vaccine can help protect a large population of people against this virus and its variants,” said Dr Ugur Sahin, founder and director. General of BioNTech.
The results will be shared with the FDA and its European equivalent, the European Medicines Agency, as well as with other international regulatory agencies, according to Albert Bourla, chief executive of Pfizer.
The randomized controlled trial of the booster included more than 10,000 participants aged 16 and over, half of whom received a booster containing the same amount of vaccine as each of the two primary doses, and half of whom received a placebo.