AstraZeneca applies for vaccine authorization in EU

ANKARA

The European Medicines Agency (EMA) on Tuesday received an application from AstraZeneca and Oxford University for authorization of their COVID-19 vaccine, it said in a statement.

EMA said the decision could be announced on Jan. 29 at the meeting of its Committee for Medicinal Products for Human Use (CHMP) if the vaccine is proven to be safe and effective.

“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the press release said.

EMA has assessed analysis from the UK, Brazil, and South Africa, the countries that approved the vaccine previously, on its safety and efficacy, said the agency, adding that it also reviewed "data from laboratory studies (non-clinical data), data on the vaccine’s quality (on its ingredients and the way it is manufactured).”

The EU authorized the use of COVID-19 vaccines from Pfizer-BioNTech on Dec. 21, and Moderna on Jan. 6.

ANKARA

The European Medicines Agency (EMA) on Tuesday received an application from AstraZeneca and Oxford University for authorization of their COVID-19 vaccine, it said in a statement.

EMA said the decision could be announced on Jan. 29 at the meeting of its Committee for Medicinal Products for Human Use (CHMP) if the vaccine is proven to be safe and effective.

“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the press release said.

The EU authorized the use of COVID-19 vaccines from Pfizer-BioNTech on Dec. 21, and Moderna on Jan. 6.