EU regulator evaluating Moderna vaccine for use in 5-11-year-olds

THE NETHERLANDS – The European Union’s drug regulator has announced that it has begun evaluating whether to approve Moderna’s COVID-19 vaccine for children aged 5 to 11, a decision that could significantly expand COVID-19 vaccination for young children across the continent.

The vaccine developed by Pfizer-BioNTech is already being evaluated by the European Medicines Agency in Amsterdam for use in children aged 5 to 11.

The EMA said in a statement that it expects to make a recommendation about Moderna’s vaccine in about two months, unless more data or analysis is required.

Moderna and Pfizer-BioNTech coronavirus vaccines have already been approved for use in children aged 12 to 17, and many countries are administering shots to teenagers.

The EMA’s announcement comes at a time when coronavirus infection rates are increasing across much of Europe.

It is the only World Health Organization region where COVID-19 cases have steadily increased over the last six weeks; the number of cases recorded in WHO’s 61-country Europe region accounted for roughly two-thirds of the 3 million new infections reported globally in the past week.

In October, the company stated that its low dose vaccine elicited a strong immune response in children and is safe and appears to work in children aged 6 to 11. Its vaccine is still awaiting approval for use in children under the age of 18 in the United States.

The U.S. Food and Drug Administration (FDA) has been investigating the risk of myocarditis among younger men vaccinated with Moderna’s shot, particularly when compared to Pfizer’s vaccine, after certain Nordic countries restricted use of the shot.

Due to reports of myocarditis, Finland, Sweden, and Denmark halted the use of Moderna’s shot for younger males earlier this month, though the Danish Health Agency later stated that the vaccine was available to under-18s.

In July, Europe’s drug regulator discovered that such inflammatory conditions could occur in very rare cases after vaccination with Moderna’s vaccine or Pfizer/BioNTech’s shot, more frequently in younger men after the second dose.

Global implications

What the approval of a vaccine for Europe’s children aged 5–11 means for the rest of the world remains to be seen.

The United States began rolling out coronavirus vaccines for young children earlier this month, after authorities approved lower doses of the Pfizer-BioNTech shot for children aged 5 to 11.

Almost 70 countries have vaccinated less than one-fifth of their populations and will most likely not vaccinate younger children for months, if not years.

However, some countries, including Israel, are awaiting the decision of US regulators before approving their own vaccines.

Other countries, on the other hand, are already vaccinating children under the age of 12. Chile, China, Cuba, and the United Arab Emirates, for example, have begun inoculating children with various COVID-19 vaccines in the last three months.

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