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COVID-19 VACCINES

EU medicines agency approves Covid-19 booster vaccine for all adults

The European Medicines Agency has given its approval for a third Pfizer Covid-19 vaccine for all adults in order to increase immunity levels, paving the way for booster jabs to be rolled out across the EU.

A nurse administer a booster shot of the Pfizer Covid-19 vaccine
A nurse administer a booster shot of the Pfizer Covid-19 vaccine. Photo by JUSTIN SULLIVAN / GETTY IMAGES NORTH AMERICA / Getty Images via AFP

The EMA announced on Monday that its human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccine Comirnaty (BioNTech/Pfizer) may be given to all over-18s. It is studying data to see whether a third Moderna jab could also be administered as a booster vaccine.

The extra jab could be given a least six months after the individual received their second dose of the vaccine.

“The CHMP has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately 6 months after the second dose in people from 18 to 55 years old,” read the EMA statement.

“On the basis of this data, the Committee concluded that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older.”

It also concluded that an extra dose of the Pfizer or Moderna COVID-19 vaccines may be given to people with severely weakened immune systems, at least 28 days after their second dose.

Each country in the EU and has implemented its own policy towards Covid-19 vaccines and the goes for booster shots. Certain countries have already began booster campaigns for elderly residents with weakened immune systems.

“At national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data,” the EMA said.

“The implementation of vaccination campaigns in the EU remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State.

“These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.”

The EMA said there was no know side effects following a booster jab.

“The risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored. As for all medicines, EMA will continue to look at all data on the safety and effectiveness of the vaccine,” the regulator added.

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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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