The regulator said it had come to the decision to recommend a third shot after studies showed an extra dose of the two vaccines “increased the ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems.”
The EMA statement added that there was “no direct evidence” that being able to produce antibodies protected against coronavirus, but “it is expected that the extra dose would increase protection at least in some patients.”
The agency said it would continue to watch for data on the effectiveness of protection.
It also drew a distinction between people with weakened and normal immune systems. For people with normal immune systems, the EMA concluded that booster doses of BioNTech/Pfizer “may be considered at least 6 months after the second dose for people aged 18 years and older.”
According to data it evaluated, an extra dose of the BioNTech/Pfizer vaccine caused a rise in antibody levels when the dose is given “approximately 6 months after the second dose in people from 18 to 55 years old.” The EMA said it is currently evaluating data to support a booster dose for the Moderna vaccine for those with normal immune systems.
The EMA directed European Union nations to issue “official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data.” However, it cautioned that the “risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored.”
This is a breaking story, more to follow.