The regulator said the decision to recommend the third shot came after studies showed an additional dose of the two vaccines “increased the ability to produce antibodies against the virus that can cause COVID-19 in organ transplant patients with weakened immune systems.” causes -19.”
The EMA’s statement said there was “no direct evidence” that antibodies against the coronavirus were able to be produced, but “it is expected that additional doses will increase protection in at least some patients.”
The agency said it would continue to look at data on the effectiveness of the protection.
It also differentiated between people with weakened and normal immune systems. For people with normal immune systems, the EMA concluded that a booster dose of BioNTech/Pfizer “may be considered for at least 6 months after a second dose for people 18 years of age and older.”
According to data from its evaluation, an additional dose of the BioNTech/Pfizer vaccine resulted in increased antibody levels when the dose was given “approximately 6 months after the second dose in people aged 18 to 55”. The EMA said it is currently evaluating data to support a booster dose for Moderna Vaccine for people with normal immune systems.
The EMA directed EU countries to “issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and limited safety data”. However, it cautioned that “the risk of inflammatory heart conditions or other very rare side effects following the booster is not known and is being monitored carefully.”
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