The European Medicine Agency (EMA) human medicines committee (CHMP) just recommended granting an extension of indication for the COVID-19 vaccine Comirnaty, the mRNA-based vaccine, to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and above. Children will be given a lower dose of 10 µg versus 30 µg used in higher age cohorts.

The Data

A main study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen with the higher dose (30 µg) in 16- to 25-year-olds (as measured by the level of antibodies against SARS-CoV-2). The efficacy of Comirnaty was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. These children received either the vaccine or a placebo.

Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received a placebo. This means that, in this study, the vaccine was 90.7% effective at preventing symptomatic COVID-19 (although the true rate could be between 67.7% and 98.3%).

CHMP Decision

The CHMP, therefore, concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19. Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

The CHMP will now send its recommendation to the European Commission, which will issue a final decision.

What about Safety?

Comirnaty has become the preferred vaccine across Europe as the AstraZeneca vaccine has fallen out of favor due to safety concerns, and Moderna’s mRNA-1273 has been halted, at least temporarily, in several countries for young people under the age of 30. Concerns of myocarditis also accompany the Pfizer vaccine; however, EMA’s risk-benefit analysis directs the European-wide regulatory body to make the decision in favor of the vaccine. The take-away: any concern of myocarditis or other adverse event is superseded by concerns of SARS-CoV-2 infection or transmission. TrialSite notes that with Comirnaty, the durability issues still suggest that over a period of time the vaccine wanes in effectiveness. This means that breakthrough infections still occur and those that are afflicted can transmit the virus.

Moving Forward

The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and by European authorities.

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