EMA approve Comirnaty®and Spikevax booster doses

The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.

Comirnaty COVID-19 vaccine vial

The European Medicines Agency (EMA) has concluded that an extra dose of the COVID-19 vaccines Comrinaty® and Spikevax may be given to people with severely weakened immune systems, at least 28 days after their second dose.

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.

Although the EMA state that 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 of Comirnaty or Spikevax would increase protection at least in some patients. EMA will continue monitoring any data that emerges on its effectiveness.

However, the EMA also emphasises that 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 EMA’s human medicines committee, CHMP, has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately six 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 six 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 will remain the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State.