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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.

COVID-19 VACCINES

EUROPEAN UNION

PFIZER

PFIZER-BIONTECH

As It Happens
LATEST UPDATE: June 16, 2022 - 8:48am

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)

June 16, 2022 - 8:48am

A panel of experts convened by the US Food and Drug Administration unanimously recommends Covid-19 vaccines  for children under five, the final age group awaiting immunization in most countries.

Formal authorizations should follow soon, with the first shots in arms expected early next week, just over a year-and-a-half after the first Covid vaccines were greenlighted for the elderly in December 2020.

"This recommendation does fill a significant unmet need for a really ignored younger population," says Michael Nelson, a professor of medicine at the University of Virginia, one of the 21 experts asked to vote for the milestone meeting. — AFP

June 15, 2022 - 9:24am

A panel of US medical experts recommends the Moderna COVID-19 vaccine for use in children aged six through 17.

Formal authorization should soon follow, at which point families will have a second option against the coronavirus, as Pfizer's vaccine was given the greenlight for teens and younger children last year.

After weighing available data, 22 experts convened by the US Food and Drug Administration unanimously agreed that the known benefits outweighed the known risks when Moderna's vaccine was administered as two shots at the adult dose of 100 micrograms to those aged 12-17, and half of that for children 6-11. — AFP

June 8, 2022 - 10:16am

A panel of experts convened by the US drug regulator recommends the Novavax COVID-19 shot, a late runner in the fight against the virus that could nonetheless play a role in overcoming vaccine hesitancy.

Three vaccines are currently approved in the United States: Pfizer and Moderna, which are based on messenger RNA, and Johnson and Johnson, which recently received a recommendation against broad use becase of links to a serious form of clotting.

Experts voted 21 in favor of the Novavax vaccine, with none against, and one abstention, despite some concerns it may be linked to rare cases of heart inflammation. — AFP

June 4, 2022 - 6:04pm

The Food and Drug Administration voices concern about myocarditis being potentially linked to the Novavax COVID-19 vaccine, just as experts are to weigh its use in the United States. 

The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened at the request of the FDA is to meet Tuesday to evaluate data from the clinical trials of Novavax and give its recommendation. 

In advance of that, the agency published a lengthy document on Friday analyzing these results, as it had done for the three other vaccines already authorized in the country. — AFP

April 14, 2022 - 9:19am

The head of US pharmaceutical giant Pfizer says a COVID-19 vaccine effective against multiple variants is possible before the end of 2022.

Chairman Albert Bourla says the firm was also working on producing a vaccine that could provide good protection for a whole year, meaning people would come back annually for boosters, as with influenza shots.

"I hope, clearly by autumn... that we could have a vaccine" that worked against not only the dominant Omicron but all known variants, he says. — AFP 

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