• Tuesday, 12 November 2024

EU regulator evaluates benefit of Covid-19 booster vaccinations

EU regulator evaluates benefit of Covid-19 booster vaccinations
The European Medicines Agency (EMA) is evaluating the benefit of a booster dose of the coronavirus vaccine made by Pfizer/BioNTech for fully vaccinated people aged 16 and over. Results of the accelerated assessment, for which data from the vaccine manufacturer and ongoing clinical trial are being evaluated, should be available in a few weeks, the EMA said on Monday. The clinical trial includes 300 adults with healthy immune systems who received a booster dose about six months after the second dose. Last week, the EMA said it saw no urgent reason for booster shots for the general population at the moment. Analysis of the new data coming in will help underpin further assessments, it said. The Amsterdam-based EMA emphasized that national health authorities can already decide in favour of a booster vaccinations before any formal recommendation by the regulator. For instance, Italy will begin offering a third coronavirus vaccine shot to vulnerable groups starting at the end of this month, while Germany is also making plans to offer the booster soon. In a second study, the EMA is assessing data on the use of a third vaccine dose from Pfizer/BioNTech or Moderna to see if it helps people with with severely weakened immune systems who may not achieve sufficient vaccine protection with the first two doses.