EUROPEAN UNION: The European Medicines Agency (EMA) on Friday approved the use of Moderna’s Covid vaccine for children aged between 12 and 17 in the European Union (EU).
The Moderna jab is the second Covid vaccine after Pfizer to be approved for adolescents in the EU by the regulatory body.
Use of the U.S. made Moderna vaccine, called Spikevax, will be the same in adolescents as in people over 18, i.e. two doses, four weeks apart, the EMA said, adding the shot produced a comparable antibody response to that seen in 18- to 25-year-olds.
According to the regulator, common side effects in teenagers after vaccination with Spikevax were similar to those seen in older people. But due to the smaller study size, uncommon side effects such as the risk of heart inflammation, could not be assessed among the trial group for the 12-17 aged.
“The overall safety profile of Spikevax determined in adults was confirmed in the adolescent study; the CHMP (Committee for Medicinal Products for Human Use) therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks,” the EMA said.
But from BBC it was understood that the move is likely to raise criticism, as with a far lower vaccination rate in most of Asia and Africa – where millions of adults risk serious illness or death from Covid, EU has more than half of adults now fully vaccinated.
However, supporters assert that expanding vaccination to children is important now that the highly infectious Delta variant is widespread in Europe and some areas are seeing a spike in cases. Children also have to be included if the goal of herd immunity is to be reached – i.e. when a high level of vaccination shuns the spread of the virus in the population.
Covid-19 in children only leads to mild symptoms or none, yet they remain at risk and can pass it on.
Teens around the world
Pfizer and German partner BioNTech’s vaccine was approved for the use of adolescents in May.
Spikevax is already being used in the EU for adults. Like the Pfizer vaccine, it contains RNA, a molecule that triggers new antibodies so that the body is trained to attack any real Covid infection.
Spikevax is also being given to adults in the U.S. and Canada, and the company has also sought authorisation in the U.S. and Canada for use in adolescents. Moderna is seeking authorisation there to begin its vaccination drive for teens too.