Pfizer not holding clinical trials in PH; negotiations with other developers continue

Kristine Sabillo, ABS-CBN News

Posted at Sep 07 2020 11:34 AM

In this file photo Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020, one of the labs developing a vaccine for the coronavirus, COVID-19. The US on July 7, 2020 announced it was providing $1.6 billion in funding for the development and manufacture of a COVID-19 vaccine candidate produced by biotech firm Novavax, the largest amount awarded under Operation Warp Speed. Separately, the US also said it was providing $450 million to Regeneron for its experimental COVID-19 treatment and prophylaxis, a combination of two antibodies. Andrew Caballero-Reynolds, AFP

MANILA — US drug maker Pfizer has no plans of running clinical trials in the Philippines, the Department of Health on Monday said, but negotiations with Russian and other COVID-19 vaccine developers continue. 

“Yung first na meeting with Pfizer walang commitments na nangyari pa (During the first meeting with Pfizer, there were no commitments yet). We just had to explain to them our regulatory processes,” Health Undersecretary Maria Rosario Vergeire said of the scheduled meeting.

“Nagbigay sila ng information na hindi sila gagawa ng clinical trial sa Philippines because they are well advanced already with their Phase 3 clinical trials. Baka end of October tapos na ang kanilang clinical trial,” Vergeire added.

(They gave information that they won’t run clinical trials in the Philippines because they are well advanced already with their Phase 3 clinical trials. Perhaps they will be done with their clinical trial in October.)

Phase 3 clinical trials are large-scale testing to check the efficacy and safety of vaccines on thousands of people. It is often the last step before a vaccine gets regulatory approval from its country.

Vergeire said that during the meeting, they talked about the required Confidential Disclosure Agreement and pre-ordering.

OTHER VACCINE SUPPLIERS

Vaccine negotiations with Russia's representatives are on track, DOH meanwhile said, as Philippines' vaccine expert panel sought clarifications in the documents and their review of the Sputnik V’s initial test results.

“Ipinadala na ito sa Russian government para sa response naman ng Gamaleya (Institute) dito sa response,” the health official said.

Vergeire said talks with other vaccine developers are also ongoing.

“Ang DOST (Department of Science and Technology) may scheduled na sila na meeting with Australian group naman…Itong vaccine ng Australia is developed apparently by the University of Queensland na ngayon ay nasa pre-clinical phase pa lang,” she said.

(The DOST has a scheduled meeting with the Australian group…This vaccine from Australia is developed apparently by the University of Queensland that is now still in its pre-clinical phase.)

Vergeire said the country also has filed a Confidential Disclosure Agreement with the US company Moderna, which is also one of the COVID-19 vaccine frontrunners.

“Once these confidentiality agreements are finalized we can move forward to further meetings,” she said.

She said they are also now requiring all proponents to notify the DOH of clinical trials, on top of seeking the approval of the FDA and the DOST’s vaccine expert panel.