The European Union’s drug regulator on Monday gave the approval to administer booster shots of the Pfizer-BioNTech COVID-19 vaccine dubbed Comirnaty to people aged 18 and older.
“On the basis of this data, the Committee concluded that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older,” it added.
The health agency also confirmed it backs giving a third dose of either Comirnaty or Moderna’s Spikevax COVID-19 vaccine to people with severely weakened immune systems at least 28 days after their second shot.
The agency said its decision came after studies showed that an extra dose of the vaccines increased people’s ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems.
“Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients,” EMA said.
The EMA recommendations go to the European Commission for approval and then to health authorities in all 27 EU nations, whose national health authorities decide on vaccination strategies. Some countries already have begun administering booster shots.
The authors warned that if booster shots are introduced too soon, they may cause more side effects in the general population, including myocarditis or Guillain-Barré syndrome. Should that occur, the researchers said, it would create even more problems with vaccine acceptance in the general population.
“A month ago, I called for a global moratorium on booster doses, at least until the end of September to prioritize vaccinating the most at-risk people around the world who are yet to receive their first dose,” Tedros said.
“So today, I’m calling for an extension of the moratorium until at least the end of the year to enable every country to vaccinate at least 40 percent of its population,” he added.
