Issue of September 13, 2020
     
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DOH continues discussions w/ COVID-10 vaccine developers
by PNA release

The Department of Health is holding continuous talks with U.S. pharmaceutical firms Pfizer, Moderna, and other Covid-19 vaccine developers.

In a virtual media forum, DOH Usec. Maria Rosario Vergeire said the department has not made any commitments yet with Pfizer, which is now on phase 3 clinical trials.

“They (Pfizer) gave information that they’ll not perform clinical trials in the Philippines because they’re well advanced already with their Phase 3 clinical trial and accordingly, they said by October, their Phase 3 clinical trial is already done,” Vergeire said.

During the meeting, she said the department has explained the regulatory processes on vaccines and discussed confidentiality disclosure agreements (CDA).

“Most of the discussions centered on the CDA that they were able to provide to the DOH and we already had our comments to that. We had a meeting together with DOST (Department of Science and Technology), there were also comments from them,” she added.

During their discussions, Vergeire said Pfizer asked if the DOH could give estimates on the pre-order of the vaccines.

Citing that pre-ordering in the absence of the products have limitations under Republic Act 9184, Vergeire said concerned “government agencies will have a discussion on it, finalize the CDA and have a meeting again.”

“As to Moderna, we also have a CDA that we’re studying, so, dalawa na sila ng (there’s two of them together with) Pfizer,” she added.

Vergeire also reported that the Philippine Embassy in Russia is planning to coordinate with the Russian government for a meeting with Gamaleya Research Institute, the developer of Sputnik V.

“We explained to them the process, that we have a vaccine expert panel, we have a process in the Food and Drug Administration, and they’ve taken note of that. Our vaccine experts had a technical meeting about Sputnik V which highlighted their clarifications on the documents and the review of the vaccine’s technical details and these were sent to Russian government for Gamaleya’s response to our vaccine experts panel’s questions,” she said.

The government is also coordinating with Australia for a potential vaccine against Covid-19 being developed by the University of Queensland which is already in the pre-clinical phase, she added.

All clinical trials in the country, including independent clinical trial, World Health Organization solidarity trial, and clinical trials in partnership with other governments, would go through regulatory processes, Vergeire said.

“And, we have added another layer and that is notifying DOH. It is the objective of the government that we’ll be informed of all these trials so we can monitor and ensure that all these vaccines that will be used in the country will be safe for our population,” Vergeire said.

“Kaya po matagal makipag-usap kasi gusto natin siguruhin na safe ang bakuna sa ating mga kababayan and it’s going to give our population the desired effect that they’ll have the antibodies and they can be protected from the coronavirus,” she added.


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