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EU regulator approves AstraZeneca vaccine

  • Published at 03:32 pm January 29th, 2021
AstraZeneca vaccine
File photo: A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken on September 9, 2020 Reuters

'EMA's scientific experts considered that the vaccine can be used in older adults'

The EU's medicines regulator on Friday gave AstraZeneca's coronavirus vaccine the green light to be used on adults of all ages, saying it believed it would be safe for older people too.

All eyes had been on whether the European Medicines Agency (EMA) would follow the lead of Germany, which on Wednesday declined to recommend the vaccine for over-65s, citing insufficient data.

"EMA has recommended granting a conditional marketing authorisation for Covid-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 in people from 18 years of age," the Amsterdam-based EMA said in a statement.

The watchdog said that there were "not yet enough results in older participants" over 55 to show how it would work, but that "protection was expected" as an immune response was found in them, and based on experience with other vaccines.

"EMA's scientific experts considered that the vaccine can be used in older adults," it said.

"More information is expected from ongoing studies, which include a higher proportion of elderly participants."

The EMA has already approved the Pfizer/BioNTech and Moderna jabs for the 27-nation European Union, plus the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.

The deployment of British-Swedish firm AstraZeneca's vaccine has been awaited with impatience by European countries as it is cheaper to produce than its rivals, and easier to stock and transport.

An age limit on the jab, developed with Oxford University, would have been a blow for governments that have based their vaccination campaigns on prioritising the frail and elderly.

'Accelerated timeline'

AstraZeneca has defended its vaccine's efficacy for all ages, along with Britain, which has already used the shot widely on older people.

Casting a shadow over the EMA decision is the bitter row over the supply of AstraZeneca doses between the EU and Britain.

The firm says there is not enough to go around as production issues have slowed promised deliveries.

The European Commission published a redacted copy of its contract with the drugs giant on Friday, demanding the company meet its prior commitments.

The EMA has meanwhile been under huge pressure to authorise vaccines as quickly as possible as frustration and pressure grow over Europe's stumbling start to the inoculation campaign.

While it has been working under what it calls an "accelerated timeline", the watchdog insists that ensuring safety and efficacy are paramount.

AstraZeneca formally applied for authorisation on January 12. The EMA had already been carrying out a "rolling review" of data on the vaccine since October.

Oxford and AstraZeneca had previously been criticised over a lack of clarity and transparency on trials that had shown varying outcomes in the jab's efficiency.

The EMA reached the decision after a four-day meeting of its Committee for Medicinal Products for Human Use (CHMP), which gathers experts from all EU and EEA countries.

Formal authorisation must be granted by the European Commission in Brussels but that could come within hours.

The EMA said separately on Friday that it had found no link between the Pfizer/BioNTech vaccine and a number of deaths of older people.

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