Swissmedic approves COVID-19 vaccine from Pfizer/BioNTech for children aged 5 to 11 years

Bern, 10.12.2021 - Swissmedic has carefully examined all the data submitted with the application for an indication extension for the COVID-19 vaccine from Pfizer/BioNTech (Comirnaty®). The clinical trial results show that the vaccine is safe and effective in this age group. During its meeting held on 7 December 2021, the independent Human Medicines Expert Committee (HMEC) backed the agency's decision. The COVID-19 vaccine for children is given in two doses of 10 micrograms three weeks apart. This is one-third of the dose given to adolescents and adults. It will thus be possible for children aged 5 years and older to be vaccinated against the new coronavirus (SARS-CoV-2) in accordance with the federal government’s updated vaccination recommendations.

The COVID-19 vaccine for children is given in two doses three weeks apart for basic immunisation. The dosage is lower than for children aged 12 years and over: instead of 30 micrograms, one dose contains 10 micrograms of mRNA (0.2 ml) following appropriate dilution. The vaccine for the 5–11-year-old age group is less concentrated and contains other buffer salts. This new formulation of Comirnaty® with modified excipients is more stable and can be stored for up to ten weeks at refrigerator temperatures.

High clinical efficacy in younger children

The ongoing authorisation study involving more than 1,500 participants shows that the COVID-19 vaccine offers almost complete protection against serious illness caused by the SARS-CoV-2 virus in 5-11-year-olds. Side effects tended to occur less frequently than in adolescents or adults. They included pain at the injection site and tiredness or, less frequently, headache, aching limbs or fever. As a rule, these side effects were of short duration and occurred somewhat more frequently after the second dose.

Market surveillance of COVID-19 vaccines

The marketing authorisation holders must continue to provide Swissmedic with information on the safety, efficacy and quality of their authorised COVID-19 vaccines on an ongoing basis. Swissmedic is continuing to very closely monitor the benefits and risks of all vaccines for preventing coronavirus disease both in Switzerland and internationally.

Vaccines are used in accordance with the recommendations from the Federal Commission for Vaccination (FCV). The FCV continually adapts the recommendations for the COVID-19 vaccines in line with the latest medical and scientific findings.

Since the end of November 2021, Swissmedic has also been examining an application to have the indication for the COVID-19 vaccine Spikevax® from Moderna extended for children aged 6 to 11 years. Evaluation of the risk-benefit ratio is still under way. The decision will be made once all the data needed to assess the safety, quality and efficacy of the vaccine have been submitted.

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