{"id":144886,"date":"2020-12-31T10:33:21","date_gmt":"2020-12-31T07:33:21","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/astrazeneca-vaccine-approval-unlikely-in-january-eu\/"},"modified":"2020-12-31T10:33:21","modified_gmt":"2020-12-31T07:33:21","slug":"astrazeneca-vaccine-approval-unlikely-in-january-eu","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/astrazeneca-vaccine-approval-unlikely-in-january-eu\/","title":{"rendered":"#AstraZeneca vaccine approval unlikely in January: EU"},"content":{"rendered":"

“#AstraZeneca vaccine app<\/a>roval unlikely in January: EU<\/strong>”<\/p>\n

\n The coronavirus vaccine developed by AstraZeneca and Oxford University, which was approved Wednesday in Britain, is unlikely to get a green light in the European Union in the next month, according to the European Medicines Agency (EMA).\n <\/p>\n

The regulator, charged with overseeing vaccines’ authorisation in the EU before they can be marketed, approved the Pfizer-BioNTech vaccine on December 21. It is expected to rule on Moderna’s vaccine on January 6.<\/p>\n

But an EU ruling on the AstraZeneca-Oxford jab will take some time.<\/p>\n

“Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation (CMA) and this has been requested from the company,” the EMA said in a statement.<\/p>\n

“Further information from the ongoing clinical trials is also expected from January.”<\/p>\n

The Amsterdam-based agency earlier told AFP that it had not yet received any formal marketing authorisation and that it had set no timetable for approving the vaccine.<\/p>\n

The regulator’s deputy executive director Noel Walthion told Belgian news<\/a>paper Het Nieuwsblad on Tuesday that a possible approval in January is “unlikely”.<\/p>\n

The AstraZeneca-Oxford vaccine is currently undergoing a “rolling review” which allows the EMA to examine safety and efficacy data as they are released, even before a formal application for authorisation is filed by the manufacturer.<\/p>\n

This procedure speeds up the evaluation of a marketing authorisation application once it is made, the EMA said.<\/p>\n

The agency said Wednesday it is “aware that the UK MHRA has granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation.”<\/p>\n

An AstraZeneca spokesperson told AFP it “has submitted a full data package to support an application for conditional marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Agency.”<\/p>\n

The spokesperson added: “AstraZeneca has been submitting data on a rolling basis and will continue to work closely with the EMA to support the start of a formal CMA application process.”<\/p>\n

Britain is the first country in the world to approve the vaccine, which is cheaper to produce and easier to store and transport than the Pfizer-BioNTech jab.<\/p>\n

For EU countries, it is up to the European Commission in Brussels to issue the final green light after EMA approval.<\/p>\n

Inoculations with the Pfizer-BioNTech vaccine began in the 27-member bloc over the weekend.\n <\/p>\n\n

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Oxford-AstraZeneca COVID vaccine submitted for UK approval\n <\/p><\/div>\n

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\n \u00a9 2020 AFP<\/p>\n

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Citation<\/strong>:
\n AstraZeneca vaccine approval unlikely in January: EU (2020, December 31)
\n retrieved 31 December 2020
\n from https:\/\/medicalxpress.com\/news\/2020-12-astrazeneca-vaccine-january-eu.html<\/p>\n

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