PH FDA expects to grant emergency use to Janssen COVID-19 vaccine this week

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Metro Manila (CNN Philippines, April 13) – The single dose COVID-19 vaccine developed by American drugmaker Johnson & Johnson (J&J) is expected to be granted with an emergency use authorization (EUA) by the Philippine Food and Drug Administration (FDA) this week.

This development was revealed by FDA Director General Eric Domingo to President Rodrigo Duterte during the Inter-Agency Task Force for the Management of Emerging Infectious Diseases meeting on Monday.

"Ito po ang ongoing evaluation natin (There is an ongoing evaluation of the vaccine) and we're hoping to finish all of these within the week," said Domingo.

Last March 31, J&J applied for emergency use for its Janssen COVID-19 vaccine to the Philippine FDA. The vaccine was made by Belgium-based firm Janssen Pharmaceuticals, J&J's vaccine arm.

The Janssen COVID-19 vaccine has also been granted with emergency use authorization in the United States, Canada, European Union, Switzerland, and the World Health Organization.

Once authorized, J&J will be the fifth vaccine manufacturer in the country to get regulatory approval, following Pfizer-BioNTech, Oxford-AstraZeneca, Sinovac, and Gamaleya-Sputnik V.

Meanwhile, Domingo said Chinese vaccine manufacturer Sinopharm has yet to submit requirements needed for its emergency use in the Philippines.

"Meron pong sumulat ho sa amin na gustong mag-apply pero noong hiningan po namin ng requirements, hindi pa nila binibigay and we're still waiting for that," he said.

[Translation: There was a letter sent to us seeking to apply. We asked for requirements but they have not yet submitted those to us and we're still waiting for that.]

Domingo also reported that American vaccine manufacturer Moderna told the FDA they are still completing their requirements, which can be submitted this week. He added the agency evaluators have begun to study the Moderna COVID-19 vaccine after it has been granted emergency use in the US and EU.

The FDA chief stated that Novavax, also an American-made COVID-19 vaccine, will apply for EUA in the second quarter of the year.

The Philippine government signed deals with Moderna and Novavax to deliver millions of doses to the country, divided between the government and the private sector, despite the absence of an EUA among the two American vaccine manufacturers.