Moderna to apply for EUA next week, FDA confirms

Food and Drug Administration (FDA) Director-General Eric Domingo Sunday said Moderna is set to apply for emergency use authorization (EUA) next week, which will boost the country’s vaccination campaign.

“Moderna is scheduled to apply for EUA next week. It still collating all the necessary documents before submitting its application,” Domingo said.

Moderna secured its EUA from the United States (US) FDA on 18 December 2020. It has an efficacy rate of94.1% against coronavirus disease (COVID-19).

Also, FDA is still reviewing the EUA application of the Indian-based vaccine, Bharat Biotech.

“They still need to submit additional documents that is why we have yet to approve the EUA application. Once the company completes the documents, we can finish the review,” Domingo said.

Even the Janssen by Johnson and Johnson is still in the evaluation stage, the official said.

“Janssen was the last to apply for EUA and it only needs a single dose, so it is under evaluation by our experts,” he added.

Domingo has also allayed fears raised by local government units and private companies over FDA’s decision to temporarily halt the use of AstraZeneca for aged 59 and below.

“Our vaccine expert panel will come up with a recommendation this week if we will resume the vaccination using AstraZeneca, then we will have new guidelines to follow,” he said clarifying that the agency did not actually order the total suspension of the use of AstraZeneca.

“We will not stop the use. We just need additional guidance before we can start using the vaccine. It is really the best time to review it since we are still waiting for the arrival of AstraZeneca,” he said.

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