COVID-19 | Pfizer Booster Dose “Safe and Effective” But Not Required, EMA Clarifies

The European Medicines Agency (EMA) considers that the booster dose of Pfizer’s vaccine against COVID-19 it is “safe and effective”, but has left the decision on its administration to each country.

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“The Pfizer booster dose is safe and effective, as data shows an increase in antibody levels when a booster is given approximately 6 months after the second dose in people 18 to 55 years of age. But currently ”, Marco Cavaleri, head of Strategy for Biological Health Threats and Vaccines of the EMA, commented at a press conference on Tuesday.

In this sense, Cavaleri has pointed out that “The implementation of vaccination campaigns against COVID-19 in the EU continues to be that direct the vaccination campaigns in each Member State “, thus leaving the decision in the hands of each country.

Yesterday, the EMA concluded that the third doses of Pfizer and Moderna can be given to people with severely weakened immune systems 12 years of age or older, at least 28 days after their second dose. But, in any case, they consider it “important” to distinguish between the third doses for people with and the booster doses for the general population.

Currently, the EMA also needs to be given at least 6 months after the second dose in people 12 years of age and older. At the moment, there is no decision on this. “The EMA will communicate the result of the evaluation”, Cavaleri clarified.

Nor has the European regulatory body clarified whether a third dose could increase the risk of side effects, such as myocarditis.

“It is the main safety concern that comes up with mRNA vaccines, especially after the second dose. Most reported cases of myocarditis are mild and self-limited. We still cannot quantify this risk after the third dose because it occurs very rarely ”, has riveted the EMA.

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