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EU Regulators Recommend Authorization Of AstraZeneca’s COVID-19 Vaccine

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The European Union’s medicines regulator on Friday recommended authorizing the Oxford-AstraZeneca Covid-19 vaccine for use among its 27 member states, capping off a turbulent week which saw the bloc attack the drugmaker over delays to supply.

The long-awaited decision from the European Medicines Agency (EMA) came after several EU countries warned they were running out of vaccine doses, and as coronavirus deaths pile up across the continent.

In a bid to tackle concerns over supply, the European Commission also adopted new measures Friday that could restrict the exporting of Covid-19 vaccines outside the bloc in some situations.

Read also: US To Approve AstraZeneca-Oxford Covid-19 Vaccine

The EMA’s authorization of the vaccine for use in all adults stands in contrast to an announcement by the German vaccine commission on Thursday that it would not recommend the AstraZeneca vaccine for people aged 65 or over because of insufficient data.

In a statement, the EMA said most of the participants in AstraZeneca’s clinical trials were between 18 and 55 years old, meaning there was limited data on how well the vaccine would work in older people.

“However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, 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 authorization recommends giving the second dose within four and 12 weeks after the first.




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