EU watchdog assesses Moderna COVID-19 vaccine for under-6s

THE HAGUE, Netherlands - The European Union's drug watchdog said Thursday that it is assessing the possible use of Moderna's COVID-19 vaccine for children aged under six, the only group not yet eligible for the jab in most countries.

"We have just started the evaluation of an application from Moderna to extend the use of Spikevax to children from six months of age to five years," said Marco Cavaleri, head of anti-infectives and vaccines at the European Medicines Agency (EMA).

"This is the first application for this young age group," Cavaleri said.

In February, the EMA's human medicines committee had already recommended granting an extension of indication for the Spikevax vaccine to include use in children aged six to 11.

The jab, developed by US-based biotech firm Moderna, had already been approved for adults and children aged 12 and above.

Only last week, Moderna submitted a request for an emergency use authorization in the United States for Spikevax for children aged six months to under six years, saying that the jab was safe and produced a strong immune response.

Young children are less vulnerable to COVID-19 than older people but can still fall ill and transmit the virus.

They can also develop severe cases of pediatric multisystem inflammatory syndrome (MIS-C), which can affect the heart, blood vessels and other organs.

The Amsterdam-based EMA has so far approved five coronavirus vaccines for use in the EU: Pfizer and Moderna, which use messenger RNA technology, AstraZeneca and Johnson & Johnson, which use viral vector technology, and Novavax, which is based on a spike protein produced in a laboratory.

Separately, the EMA also said that it was "still too early" to give the go-ahead for a fourth dose of mRNA vaccines in the general population as a whole.

In April, EU authorities approved second so-called booster injections using the Moderna and Pfizer vaccines for people aged 80 and over.

The EMA underlined the importance of vaccines against COVID-19, saying that inoculation had helped save "nearly half-a-million lives in Europe in age categories of 60 and over.

Millions of people are still catching COVID-19 worldwide and the pandemic "is far from over," the watchdog said.

As of the end of last year, COVID-19 had caused the deaths of 13-17 million people worldwide, a much bigger number than the official total, according to a new estimate by the World Health Organization. -- Agence France-Presse