FDA assures ‘objective’ analysis of COVID-19 vaccines, says bribes not welcome

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Metro Manila (CNN Philippines, December 15) — The Food and Drug Administration will not welcome any bribery attempt from coronavirus vaccine developers, amid recent reports that claim one of the applicants, China's Sinovac Biotech, had a history of paying off other drug regulators to get an approval.

During the Laging Handa virtual briefing on Tuesday, FDA Director General Eric Domingo assured that they will be objective in their evaluation of vaccine candidates, and will treat them, including Sinovac, as "legitimately doing business."

"Sa atin naman po, very objective ang ating gagawing pagsusuri diyan. Depende lamang po sa datos at sa evidence na ipapakita po nila," Domingo said.

[Translation: For our part, we will be very objective in our analysis. It depends on the data and evidence that they will present to us.]

"Dito po sa Pilipinas ay huwag nilang susubukang manuhol dahil magkakaproblema po sila. Sila po ay lalong hindi maaapprove (Here in the Philippines, they should not attempt to bribe us because they will be in trouble. All the more that they will not be approved). Sa FDA po we are going to be very objective about it," he added.

"We will treat the company as a company that is legitimately doing business, but of course, once they try something, eh sila na po ang mananagot at magkakaproblema po sila ng malaki (they will be liable for it and there will be a big problem)."

A Washington Post report on December 4 said Sinovac Biotech's CEO gave out money to receive speedy approvals during the time the company was coming out with its SARS vaccine in 2003 and swine flu vaccine in 2009. However, the report said there was no evidence the vaccines involved in the bribery issue were faulty. It added that the company has acknowledged the bribery case and the CEO said in testimony he could not refuse demands for money from a regulatory official.

Health Secretary Francisco Duque III earlier said local authorities will hold an investigation on the matter.

In a separate briefing on Tuesday, Presidential Spokesperson Harry Roque admitted that while the government has "no favorites," only China can readily supply the country with a COVID-19 vaccine for now.

"Kaya natin binibili ang Sinovac, kasi wala naman tayong makuha agad na [bakuna] mula sa Pfizer, AstraZeneca o Moderna (We are buying Sinovac because we still could not get a vaccine from Pfizer, AstraZeneca or Moderna.]

In a television interview, Dr. Anthony Leachon, a former adviser to the National Task Force Against COVID-19, raised suspicion about the "unusual speed" in the processing for local use of Sinovac's vaccine without any peer-reviewed document, compared with Pfizer, Moderna, and AstraZeneca that have already published the results of their trials in medical journals.

Leachon recently received tirades from Roque after warning against Sinovac's lack of credible efficacy and safety data. Leachon, however, said he was just making a "fair and scientific" observation on the matter.

Sinovac has yet to get an FDA approval before proceeding with its Phase 3 clinical trial in the Philippines. Vaccine czar Carlito Galvez Jr. has said that Sinovac is only "a few more documents" away from holding its trials, which could make it the first vaccine to be distributed in the country with at least 25 million doses for the public.