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2 firms expressed intent to get EUA for Sinopharm vaccine —FDA

By JULIA MARI ORNEDO,GMA News

The Food and Drug Administration (FDA) on Friday said it has received two letters from two different companies expressing  intent to apply for emergency use authorization (EUA) of the coronavirus vaccine developed by China’s Sinopharm Group.

“I don’t know if it’s in behalf of Sinopharm. There are two companies [that] wrote us with a letter of intent to apply for an EUA for the product Sinopharm vaccine,” FDA chief Eric Domingo said in a briefing.

The FDA has responded to both letters, informing them of the requirements and the process of EUA application, he said.

“But neither of them have responded, so as of now, there is still no officially filed application with documents and requirements with the FDA when it comes to Sinopharm,” Domingo said.

The FDA chief earlier said one firm filed an online EUA application for the Sinopharm vaccine but later clarified that the applicant had not yet submitted the required documents. 

Malacañang has said President Rodrigo Duterte prefers the Sinopharm vaccine

Controversy erupted late last year after Duterte himself revealed that some military men had gotten vaccinated with Sinopharm

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despite its absence of regulatory approval. 

Last month, former special envoy to China Ramon Tulfo also claimed that several government officials received the Sinopharm vaccine as he expressed interest in becoming a local distributor. 

Moderna, J&J

Meanwhile, Domingo said American drugmakers Moderna and Johnson & Johnson have had discussions with the FDA about an EUA “but as of this date we have not received an application.”

Only the Pfizer-BioNTech, AstraZeneca, Sinovac, and Sputnik V vaccines have been approved for emergency use in the country. 

The Philippines has vaccinated over 240,000 health workers with Sinovac and AstraZeneca as of Tuesday. —KBK, GMA News