Regulator says it has not started reviewing Sinopharm application

THE LOCAL Food and Drug Administration (FDA) has yet to start evaluating Sinopharm Group Co. Ltd.’s application for the emergency use of its coronavirus vaccine, according to the regulator.

The Chinese drug maker had only submitted a letter of intent and the results of its phase 1 clinical trials FDA Director General Rolando Enrique D. Domingo told a televised news briefing on Wednesday.

“We are still asking for additional documents before we can start evaluating their application,” he added.

Southmed Pharma Corp., a Philippine-based company, applied for an emergency use authorization (EUA) for the Sinopharm vaccine via e-mail, he said.

Mr. Domingo earlier said it would take as long as six weeks for the FDA to decide on Sinopharm’s application since it had not received an emergency use authorization from any stringent regulatory bodies in other countries.

“We are very objective in approving vaccines,” he said in Filipino. “We have a checklist on safety, efficacy and quality that must be ticked.”

Presidential spokesman Herminio L. Roque, Jr. this week said President Rodrigo R. Duterte would wait for the regulator’s approval of the Sinopharm vaccine before getting vaccinated.

The FDA is reviewing the emergency use applications for vaccines made by Russia’s Gamaleya Research Institute and India’s Bharat Biotech.

It has approved the vaccines made by Pfizer, Inc., AstraZeneca Plc and Sinovac Biotech Ltd. for local emergency use.

Meanwhile, Mr. Domingo said the Presidential Security Group had not responded to the agency’s queries about the unauthorized use of Sinopharm shots last year.

Ramon T. Tulfo, Jr., the country’s special envoy to China, earlier said he and other high-ranking government officials had been injected with the Chinese vaccine last year. — Kyle Aristophere T. Atienza