The BA.4/BA.5 booster has been approved in the EU since mid-September. Clinical data on the effect in humans have not yet been available. According to the manufacturer, the first study results now indicate better protection against omicron variants.
About a month after the EU approval of their to the Omikron sub-variants BA.4./BA.5. adapted boosters, Biontech and its US partner Pfizer have published the first clinical data. These data suggested that a booster dose of this vaccine could provide better protection against the two variants than the original vaccine in adults, the two companies said. The vaccine was well tolerated.
“These preliminary results are consistent with our preclinical data and show a substantial increase in the neutralizing antibody response directed against the omicron subvariants BA.4 and BA.5,” said Biontech CEO Ugur Sahin. Further data on the immune response one month after the booster vaccination are expected to be published in the coming weeks. Biontech and Pfizer initially presented data on the immune response one week after vaccination. The antibody response in adults between the ages of 18 and 55 was similar to that in adults over 55.
In the USA, the BA.4/BA.5 booster from the two companies was approved for ages twelve and over at the end of August, and the green light followed in the European Union in mid-September. The European Medicines Agency’s recommendation for this booster dose was based on clinical data from Biontech and Pfizer’s omicron variant BA.1 vaccine, which had been approved recently, as well as preclinical data and data on the production of the BA.4/BA .5 boosters.
In Germany, the Standing Vaccination Commission STIKO recommends a vaccine adapted to Omikron for all booster vaccinations from the age of twelve. This applies to both the BA.1. as well as the BA.4/5 vaccine. However, Stiko member Christian Bogdan had criticized the fact that at the time the BA.4/BA.5 booster was approved – unlike the BA.1 vaccine – no data from clinical studies on humans were available, only preclinical data from animal studies. Despite limited study data, Stiko assessed the new boosters as safe and well tolerated, but asked the manufacturers to provide and publish further studies.
