The Pfizer/BioNTech alliance announced on Tuesday that it has submitted a request to U.S. health authorities for authorization to administer a third booster dose of its COVID-19 vaccine to all adults over 18 years old. The alliance had published results in October from a clinical trial involving 10,000 participants, showing that the booster dose of its vaccine is 95.6% effective in preventing symptomatic infection. Based on this study, the alliance requested the U.S. Food and Drug Administration (FDA) on Tuesday to amend the emergency use authorization currently limiting the third dose to individuals over 65, as well as adults aged 18 to 64 who are at risk of severe disease or at higher risk of virus exposure due to their occupation.
Several other countries have already allowed the administration of a booster dose of COVID-19 vaccines to strengthen the immunity of vaccinated individuals, which some studies suggest wanes after a few months. In Europe, the European Medicines Agency approved in principle at the beginning of October the administration of a third booster dose of the Pfizer/BioNTech vaccine for those over 18, leaving it to EU member states to decide individually on the populations eligible for this third dose. For example, France decided to provide the third dose to residents of nursing homes, individuals over 65, and those at high risk of severe symptoms. Since the beginning of October, France has expanded the eligibility for the third dose to include healthcare professionals, firefighters, and relatives of immunocompromised individuals, with plans to further extend eligibility starting in December to all individuals over 50.