EMA gives the green light to Covid-19 vaccination for babies and toddlers

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The EU Medicines Agency (EMA) has cleared the way for two Corona vaccines for babies six months and older. The EMA announced Wednesday in Amsterdam that the vaccines made by Pfizer/Biontech and Moderna, respectively, could also protect such children from corona infection. Both vaccines were approved for adults and children five and six, respectively. However, the doses for babies and young children are significantly lower.

The EU Commission must still agree to the approval; this is considered a formality. Whether babies are offered a Corona vaccination at all, however, is a decision for the respective EU member states. Austria’s National Vaccination Committee has so far followed the EMA recommendations. According to EMA experts, studies have shown that even babies and young children would be protected from infection at a shallow dose. In the U.S., these vaccines already received emergency approval in June – we reported here. In Austria, children under five could also be vaccinated, which fell into the so-called off-label area. This is particularly common with medicines for children.

Lower dosages
The dosages recommended for the youngest age group are lower than those for the other groups. For example, children receive a dose of three micrograms for the Biontech/Pfizer vaccine. The first two doses are given three weeks apart, and the third dose, and thus the completion of primary immunization, should be given at least eight weeks after the second dose. The vaccination schedule for Moderna’s preparation includes two doses administered four weeks apart (25 micrograms per dose).

After vaccination, people may experience fatigue, loss of appetite, skin rash, or pain at the injection site, according to the EMA. However, it said that these side effects are usually very mild and last only a few days. EMA experts will continue to monitor and evaluate the safety and efficacy of both vaccines.

Both vaccines have already shown efficacy in adults, the EMA said. They prevented severe disease progression, hospital admissions, and deaths following corona infection.