Paul-Ehrlich-Institut

Go to:

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

CHMP Recommends Marketing Authorisation Extension for COVID-19 Vaccines Comirnaty and Spikevax for Children 6 Months and Older

On 19 October 2022 the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended extending the use of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) for the EU and thus also for Germany. So far, the vaccines have been approved for 5 and 6 years of age, respectively. With the approval extension, these vaccines can be used in a reduced dose from the age of 6 months. The EU Commission approved this marketing authorisation extension for both vaccines on 20 October 2022.

COVID-19 Vaccine Ampoules (Source: MPhoto/Shutterstock.com)

  • Comirnaty: For children 6 months to 4 years of age, primary vaccination consists of three doses of vaccine (of 3 micrograms each). The first two doses of vaccine should be given three weeks apart, followed by a third dose given at least eight weeks after the second dose. For comparison, the single vaccine dose for children 5 to 11 years of age is 10 micrograms, and 30 micrograms for children 12 years and older.
  • Spikevax: For children 6 months to 5 years of age, primary vaccination consists of two vaccine doses (of 25 micrograms each) four weeks apart. For comparison, the single vaccine dose for children 6 to 11 years of age is 50 micrograms, and for children 12 years and older, 100 micrograms for primary vaccination and 50 micrograms for booster vaccination.

Data basis for the marketing authorisation extensions

For Comirnaty, a main study in children 6 months to 4 years of age showed that the immune response to the lower dose of Comirnaty (3 micrograms) was comparable to that to the higher dose (30 micrograms) in 16- to 25-year-olds.

For Spikevax, a main study in children 6 months to 5 years of age showed that the immune response to the lower dose of Spikevax (25 micrograms) was comparable to that to the higher dose (100 micrograms) in 18- to 25-year-olds.

In both studies, the immune response elicited by the vaccines was assessed by measuring the concentration (titer) of antibodies to SARS-CoV-2 in the blood.

Observed side effects

The most common adverse reactions to both vaccines in children 6 months to 4 or 5 years of age were similar to those observed in older age groups. Irritability, sleepiness, loss of appetite, rash and tenderness at the injection site were common adverse reactions in children 6 months to 23 months of age after vaccination with Comirnaty. Irritability, crying, loss of appetite, and sleepiness were common adverse reactions in children 6 to 36 months of age after vaccination with Spikevax.
For both vaccines, these reactions were usually mild or moderate and improved within a few days after vaccination.

Therefore, the CHMP concluded that the benefits of Comirnaty and Spikevax in children aged 6 months to 4 years and 5 years, respectively, outweigh the risks.

The safety and efficacy of both vaccines in both children and adults will continue to be closely monitored as they are used in vaccination campaigns in EU member states. This is being done using the EU pharmacovigilance system, as well as ongoing and additional studies conducted by the companies and by European authorities.

The originally authorised vaccines, Comirnaty and Spikevax, are both effective in preventing severe disease, hospitalisations and deaths associated with COVID-19 and will continue to be used in vaccination campaigns in the EU, particularly for primary vaccinations.

Updated: 20.10.2022