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EMA finds no specific age risk for AstraZeneca, 'updated recommendation' due next week

The company now plans to submit applications to regulators for approval in this age group.

Image: Nick Potts/PA Images

Updated Mar 31st 2021, 4:05 PM

EXPERTS EXAMINING LINKS between the AstraZeneca vaccine and blood clots have found no specific risk factors, including age, but are carrying out further analysis, the EU’s drug regulator said today. 

The European Medicines Agency (EMA) said however that its safety committee expected to issue an “updated recommendation” on the controversial vaccine after its monthly meeting next week.

Germany yesterday became the latest in a series of countries to advise against using the AstraZeneca jab for younger people after rare reports of clotting, despite the EMA saying it is safe.

“At present the review has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events,” the Amsterdam-based EMA said in a statement.

“A causal link with the vaccine is not proven, but is possible and further analysis is continuing.”

The EMA statement came after experts met on Monday to discuss their latest findings on the AstraZeneca vaccine. Their comments will be discussed at the safety committee’s meeting next week.

The watchdog reiterated the view it gave in a keenly-anticipated statement on March 18, saying “its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks.”

Pfizer trial

Earlier today a new study suggested the Pfizer/BioNTech jab is “100% effective and well tolerated” among children aged 12 to 15.

Pfizer said it now plans to seek approval for use of the vaccine in this age group from regulators around the world and hopes youngsters will start to receive the jab before the next school year.

Researchers examined the use of the Pfizer/BioNTech vaccine in a trial of 2,260 teenagers in the US.

Half were given the jab and the other half were given a placebo drug.

There were no Covid-19 cases seen in the group who received the vaccine and 18 infections among those who did not.

Albert Bourla, chief executive of Pfizer, said: “We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.

“We plan to submit these data to FDA (the US Food and Drug Administration) as a proposed amendment to our emergency use authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

Ugur Sahin, chief executive and co-founder of BioNTech, added: “Across the globe, we are longing for a normal life. This is especially true for our children.

“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant.

“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”

Pfizer said the jab “demonstrated 100% efficacy and robust antibody responses exceeding those reported in trial of vaccinated 16-25-year-old participants in an earlier analysis”.

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Participants in the Phase 3 trial, conducted in the US, showed “strong immunogenicity” a month after the second dose of the jab.

It added that “administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age”.

All participants in the trial will be monitored for two years after their second dose.

Pfizer and BioNTech said they plan to submit the data for scientific peer review for potential publication.

Meanwhile, the companies also announced they have dosed the first children in a trial assessing the safety and effectiveness of the jab in youngsters aged six months to 11 years.

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