The European Medicines Agency (EMA) on Monday recommended a third vaccination against the coronavirus for the BioNTech and Moderna vaccines. A third vaccination, or booster vaccination, may be given to people with severely weakened immune systems, at least 28 days after their second dose, said the EMA in a press release. The recommendation comes after studies showed that an extra 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, it noted. Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients, it said. EMA, based in Amsterdam, added that it would continue monitoring any data that emerges on its effectiveness. The EMA's human medicines committee (CHMP) had concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. It is important to distinguish between the extra dose for people with weakened immune systems and booster doses for people with normal immune systems. For the latter, the CHMP has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately 6 months after the second dose in people from 18 to 55 years old. On the basis of this data, the committee concluded that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older. At national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data. The risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored. As for all medicines, EMA will continue to look at all data on the safety and effectiveness of the vaccine. The implementation of vaccination campaigns in the EU remains the prerogative of the national immunization technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU member state. These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems. EMA will continue working closely with national authorities and the European Centre for Disease Prevention and Control (ECDC) to evaluate available data and provide recommendations to protect the public during the ongoing pandemic. — Agencies
