The European Medicines Agency (EMA) endorses the third dose of Pfizer for adults from six months after the second. And, in addition, he recommends the third from Pfizer and Moderna, in this case, 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 [inmunodeprimidos] protect against COVID-19, “but” expect the additional dose to increase protection in at least some patients. “In any case, the EMA says 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, insisting 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 [Pfizer] that show an increase in antibody levels when a booster dose is given 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.” Of course, the EMA recognizes that, at the national level, public health organizations can issue official recommendations on the use of booster doses or third doses, taking into account the available data, which is still “limited”.
On the other hand, the agency states: “The risk of inflammatory heart disease or other very rare side effects after a booster dose is not known and is being carefully monitored. As with all drugs, 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.