Pfizer is not conducting clinical trials at HP; negotiations with other developers continue

MANILA – US drug maker Pfizer has no plans to conduct clinical trials in the Philippines, the Health Department said Monday, but negotiations continue with Russia and other developers of the COVID-19 vaccine.

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

“They provided information that they will not conduct a clinical trial in the Philippines because they are already well advanced with their phase 3 clinical trials. Perhaps by the end of October their clinical trial will be finished,” Vergeire added.

(They gave information that they will not conduct clinical trials in the Philippines because they are already well advanced with their Phase 3 clinical trials. They may end their clinical trial in October.)

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

Vergeire said that during the meeting, they discussed the required Confidential Disclosure Agreement and the advance order.

OTHER VACCINE PROVIDERS

Vaccine negotiations with Russian representatives are under way, DOH said, while the Philippine panel of vaccine experts sought clarification from the documents and their review of the results of the initial Sputnik V test.

“It has been sent to the Russian government for the response (Institute) Gamaleya here,” said the health official.

Vergeire said that discussions with other vaccine developers are also ongoing.

“DOST (Department of Science and Technology) has scheduled a meeting with the Australian group … This Australian vaccine was apparently developed by the University of Queensland, which is now in the preclinical phase,” he said.

(DOST is scheduled to meet with the Australian group … This Australian vaccine was apparently developed by the University of Queensland and is now still in its preclinical phase.)

Vergeire said the country has also filed a confidential disclosure agreement with the American company Moderna, which is also one of the pioneers in the COVID-19 vaccine.

“Once these confidentiality agreements are finalized, we can move on to more meetings,” he said.

She said they are now also requesting all proponents to notify DOH of clinical trials, in addition to seeking approval from the FDA and DOST’s panel of vaccine experts.