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COVID-19 VACCINES

EU approves first Covid jab for children aged 5 to 11

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

A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine
A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine Andrej Ivanov / AFP

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

“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.

“This is based on a different dose in the one used in adults, essentially it’s a much lower dose,” he told an online public meeting.

The vaccine was already cleared for use in people aged 12 and over in the 27-nation EU.

Children aged five to 11 will be given one third of the dose that older people receive, with two injections, three weeks apart, the EMA said in a statement.

The vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age, it added.

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.”

The EU Commission will now likely approve the vaccine for children aged 5 to 11 but the ultimate decision over whether to roll out the Covid jab to yound kids will rest on the government of each member state.

France on Thursday said ministers were examining rolling out the vaccine to the age group but said there would be no decision before 2022.

But the Pfizer jab’s safety in children “will continue to be monitored closely”.

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 come down with symptoms.

In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children up to the age of 12.

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

“Moreover, high transmission results in increased hospitalisation in children of all ages.”

While children with underlying health conditions were more likely to become ill, the majority of children in hospital with Covid were otherwise healthy, said Cavaleri.

They 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 6-11 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.

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COVID-19 VACCINES

Covid-19: Danish research finds improved protection from updated vaccine

Denmark’s infectious disease control agency State Serum Institute (SSI) says that a second booster or “fourth dose” with an updated form of the Covid-19 vaccine will significantly improve protection against the virus.

Covid-19: Danish research finds improved protection from updated vaccine

The fourth dose will offer markedly better protection than if a person has only received a “third” dose or single booster jab, SSI said in a press statement.

SSI researchers, working with colleagues from the other Nordic countries, have analysed the effect of the additional booster jab with the vaccine, which has been updated in line with newer dominant subvariants of the coronavirus.

When the Danish population was first vaccinated against Covid-19, the vaccines were designed to offer protection against the original form of the virus, SSI writes.

But newer variants have made the original vaccines less effective. The updated vaccines are designed to have the best possible effect against both the original variant as well as the Omicron variant.

There are currently two versions of the updated vaccine. One is adapted towards the BA.1 Omicron subvariant, with another adapted to the BA.4-5 subvariant.

In the Nordic countries, the updated vaccines were offered during autumn 2022 to all persons over the age of 50 in Denmark and Sweden, over 60 in Finland and over 65 in Norway.

A fourth dose with the BA.1-updated version reduced the risk of hospitalisation with Covid-19 by 74 percent and the risk of death by 80 percent compared to the third dose, SSI found.

The BA.4-5 updated version reduced the risk of hospitalisation by 81 percent and the risk of death by 78 percent.

The latter of the two updated versions (BA.4-5) was found to reduce the risk of hospitalisation with Covid-19 by 32 percent compared to the BA-1 version.

“This is maybe not so surprising because BA.4-5 subvariants were dominant in autumn 2022,” SSI head of department Anders Hviid said in the statement.

“But I think we are among the first [countries] to be able to measure this based on the large quantities of data we have available from working across four countries,” he said.

The research was supported by the EU’s European Medicines Agency (EMA).

SSI notes that the frequency of hospitalisation and particularly death due to Covid-19 was very low after both the third and fourth doses of the vaccine.

The academic paper resulting from the study can be read in English here.

READ ALSO: Denmark’s health authority scraps isolation guidelines for Covid-19

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