Moderna Inc applied for European authorization of its COVID-19 vaccine in children aged 6-11 years, weeks after it delayed a similar filing with US regulators.
Vials with a sticker reading, “COVID-19 / Coronavirus vaccine / Injection only” and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020.
(photo credit: REUTERS/DADO RUVIC/ILLUSTRATION/FILE PHOTO)
France’s public health authority has recommended people under 30 be given Pfizer’s Comirnaty COVID-19 vaccine when available instead of Moderna’s Spikevax jab, which carried comparatively higher risks of heart-related problems.
The Haute Autorite de Sante (HAS), which does not have legal power to ban or license drugs but acts as an advisor to the French health sector, cited “very rare” risks linked to Myocarditis, a heart disease, that had shown up in recent data on the Moderna vaccine and in a French study published on Monday.
“Within the population aged under 30, this risk appears to be around five times lesser with Pfizer’s Comirnaty jab compared to Moderna’s Spikevax jab,” HAS said in its opinion published on Monday.
The decision in Paris came after regulators in several other countries, including Canada, Finland and Sweden, had also taken a more defensive stance on Spikevax over heart-related safety concerns affecting younger people.
The European Union’s drug regulator EMA last month approved Moderna’s booster vaccine for all age groups over 18, at least six months after the second dose.
The EMA earlier this year said that it had found a possible link between the very rare inflammatory heart condition and COVID-19 vaccines from both Pfizer’s and Moderna’s vaccines.
However, according to the EMA, the benefits of both mRNA shots in preventing COVID-19 continue to outweigh the risks, the regulator said, echoing similar views expressed by US regulators and the World Health Organization.
France’s HAS said that its recommendation, which would apply regardless of the vaccine’s use as a first, second or third “booster” dose, would be valid until more scientific findings on the matter are known.
For persons aged over 30, however, the authority explicitly recommended the use of the Moderna vaccine, saying its effectiveness was slightly superior.
Moderna Inc on Tuesday applied for European authorization of its COVID-19 vaccine in children aged 6-11 years, weeks after it delayed a similar filing with US regulators.
The European Union had in July authorized the vaccine for use in teens aged 12 to 17 years, but several countries including Sweden paused its use for people aged 30 and younger due to rare heart-related side-effects.
Moderna said in late October the US drugs regulator needed more time to complete its review for use in the 12-17 age group as it studies the risk of a type of heart inflammation called myocarditis after vaccination.
The drugmaker delayed the US application for children aged 6 to 11, while the FDA completes its review for the vaccine’s use in the 12-17 age group.
Earlier in October, the company said its vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon.
Moderna said on Tuesday it had applied to the European Medicines Agency for use of a 50 micrograms dose of the vaccine in children, half the strength used in the adult vaccinations.