FDA allows booster vaccination with Comirnaty

27.9.2021

The Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech’s vaccine to allow for the use of a single booster dose. The second dose must have been administered at least six months previously. The FDA not only allows booster vaccinations for people over 65 but also for younger people with health or occupational risk factors. This also includes other target groups such as healthcare workers, teachers and educators, supermarket employees and people in homeless shelters or prisons, said FDA officer Janet Woodcock. People receiving home care or living in nursing homes, those over 80 years old, and people with immunodeficiencies are sometimes already being offered a third vaccination in Germany. A recommendation from the Standing Committee on Vaccination (STIKO) is still pending. To ensure that the booster dose is safe, data has been collected from 306 study participants between the ages of 18 and 55 as well as twelve other participants over 65 years old. Participants were followed up on for an average of two months after vaccination. Those who were vaccinated most often reported pain, redness and swelling at the injection site as well as fatigue, headache, muscle or joint pain and chills. Notably, the FDA explains, swollen lymph nodes in the armpit were seen more frequently after the booster dose than after the first series of two doses.