The European Medicines Agency (EMA) endorses the third dose of Pfizer for adults from six months after the second. And he recommends the third from Pfizer and Moderna for people with weakened immune systems 28 days after the second.
As announced by the EMA on Monday, its committee for human medicines (CHMP) has concluded that an additional dose of the COVID-19 vaccines Comirnaty (BioNTech / Pfizer) and Spikevax (Moderna) can be administered to people. with severely weakened immune systems.
The recommendation comes “after studies showed that an additional dose of these vaccines increased the ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems,” states the EMA.
The European agency acknowledges that “there is no direct evidence that the ability to produce antibodies in these patients protects against COVID-19”, but “expects that the additional dose increases protection at least in some patients.” In any case, the EMA affirms that it will continue to review “any data that arises about its effectiveness.”
“The product information for both vaccines will be updated to include this recommendation,” states the EMA, which insists that “it is important to distinguish between the additional dose for people with weakened immune systems and the booster doses for people with normal immune systems.” .
For this last segment, that of people with normal immune systems, the EMA “has evaluated data from Comirnaty that show an increase in antibody levels when a booster dose is administered approximately 6 months after the second dose in people aged 18 to 55 years”.
Based on these data, the EMA “concludes that booster doses can be considered at least 6 months after the second dose for people 18 years of age and older.”
The EMA recognizes that at the national level, public health agencies can issue official recommendations on the use of booster doses, taking into account emerging efficacy data and limited safety data: “The risk of inflammatory heart disease or other effects Very rare side effects after a booster dose is unknown and is being carefully monitored. As with all medications, the EMA will continue to analyze all data on the safety and efficacy of the vaccine. ”
The EMA is evaluating data to support a Spikevax booster dose, and will communicate the result when the evaluation is complete.