EU approves first COVID-19 jab for kids aged 5 and up

Danny Kemp - Agence France-Presse
EU approves first COVID-19 jab for kids aged 5 and up
This photograph taken on December 22, 2020 in Puurs shows the logo of US multinational pharmaceutical company Pfizer at the production site of the Covid-19 vaccine that was given the European Union's green light the day before, paving the way for vaccinations to finally start in the 27-nation bloc on December 27.
AFP / John Thys

THE HAGUE, Netherlands — The EU's drug regulator cleared Pfizer's Covid-19 vaccine for use in children aged five to 11 on Thursday, the first jab to be authorised for a cohort where the virus is rapidly spreading.

Only a handful of countries had previously given the nod for coronavirus vaccinations in younger children, including the United States, Israel and Canada.

The move paves the way for the 27-nation EU to extend its vaccination campaign as it battles a spike in cases. Pfizer is currently authorised for people aged 12 and over in the bloc.

"I'm glad to tell you that Comirnaty from today has received approval for children five to 11 years of age," said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine's brand name.

Children in the new age bracket will get one third of the dose that older people receive — 10 microgrammes compared with 30 microgrammes — with two injections, three weeks apart.

"Essentially, it's a much lower dose," Cavaleri told an online public meeting.

The European Commission must now sign off on the approval, which is usually a formality that happens within days, so that member states can decide themselves if they will give kids the vaccine.

EU Health Commissioner Stella Kyriakides said the EMA "is clear the BioNTech/Pfizer vaccine is safe and effective for young children, and can offer them additional protection."

French Health Minister Olivier Veran however said that he had asked national health regulators to examine the issue before taking any decision on vaccinating children.

"This vaccination, if it is decided on in France, will not start before the beginning of 2022," Veran said.

'Rare in children'

Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic.

Children are also considered key drivers of infections even when they themselves do not display symptoms.

The EMA said the vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age. 

Side effects were usually "mild or moderate" lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.

The EMA "therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19."

But the Pfizer jab's safety in children "will continue to be monitored closely".

"We know that severe Covid-19 and death remain quite rare in children, however disease of all severity occurs in all the paediatric ages," the EMA's Cavaleri said.

Children were also at risk of so-called "long Covid" symptoms dragging on for months after infection, and multisystem inflammatory syndrome, he added. 

The EMA is separately reviewing Moderna's coronavirus vaccine for children aged six to 11 and expects to reach a decision in January.

The regulator has so far approved four vaccines for use for adults in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.

As It Happens
LATEST UPDATE: December 4, 2021 - 11:34am

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

December 4, 2021 - 11:34am

A Canadian government immunization advisory committee urges COVID-19 booster shots for people 18 and older who are at greater risk of infection, while also strongly recommending those 50 years-plus to get the third jab.

The updated guidance comes after two provinces -- Ontario and Alberta, with half the population of Canada -- this week said they would start offering third jabs to people 50 and 60 years and over, respectively, and planned to further expand eligibility in the new year, amid concerns over the Omicron variant.

Eleven cases of the Omicron variant have so far been recorded in Canada, linked to travel abroad, public health officials say. — AFP

December 2, 2021 - 1:51pm

The WHO issued stern warnings Wednesday on the dangers of vaccination apathy and the European Union put mandatory jabs on the table as the United States registered its first case of the fast-spreading Omicron strain of the coronavirus.

The new variant, first reported to the World Health Organization by South Africa a week ago, has quickly popped up across continents, darkening economic forecasts and deepening fears of another difficult winter in the northern hemisphere.

"Globally, we have a toxic mix of low vaccine coverage, and very low testing — a recipe for breeding and amplifying variants," said WHO chief Tedros Adhanom Ghebreyesus, reminding the world that the Delta variant "accounts for almost all cases". — AFP

December 1, 2021 - 10:11am

Pfizer announces it was seeking US authorization for Covid booster shots among adolescents aged 16 and 17, as concerns grow about the impact of the new Omicron variant.

The Food and Drug Administration (FDA) has so far only granted emergency use authorizations (EUAs) for boosters to people aged 18 and over, six months after their primary series of the Pfizer or Moderna Covid vaccine, or two months after the Johnson & Johnson shot.

"Today, we submitted a request to the @US_FDA to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds," Pfizer CEO Albert Bourla wrote on Twitter. — AFP

November 30, 2021 - 3:58pm

Existing Covid-19 jabs will struggle against the Omicron variant and it will take months to develop a new shot that works, the head of US vaccine manufacturer Moderna tells the Financial Times.

Stephane Bancel tells the newspaper in an interview published Tuesday that data would be available on the effectiveness of current vaccines in the next two weeks but scientists were not optimistic.

"All the scientists I've talked to ... are like 'this is not going to be good'," he tells the newspaper. — AFP

November 26, 2021 - 8:06am

Chile on Thursday announces it would start vaccinating children aged three and up against the coronavirus, after successfully innoculating around 90 percent of its initial target population.

Children under the new rollout will receive the Chinese CoronaVac shot already used for kids aged six to 15, the Public Health Institute says. 

For 16 to 18-year-olds, Chile uses the Pfizer/BioNTech vaccine. — AFP

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