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Friday, April 19, 2024

PH mulls Sputnik vaccine trial

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Philippine medical authorities are currently reviewing the first batch of documents on Russia’s Sputnik V vaccine against COVID-19, but may take a week before a decision could be made whether or not a clinical trial could be done here.

Dr. Jaime Montoya, executive director of the Philippine Council for Health Research and Development, said Russia has already released the first batch of documents on the vaccine.

Montoya, however, said it could take a week to know whether or not “there is a high likelihood that a trial will be done” in the country.

The Philippines is scheduled to conduct Phase 3 of clinical trials of Sputnik V vaccine from October 2020 to March 2021.

Filipinos' participation in clinical trials does not guarantee they will be the first to get the potential vaccines against the novel coronavirus, Montoya said.

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"Conducting clinical trials in the Philippines is not an assurance that we’ll be the first one to get the vaccine," he told ANC. "A more important assurance is if we have negotiations with them as far as procurement is concerned, maybe special arrangements with their priorities, prices, et cetera.”

In related stories:

• The clinical trials for the anti-flu drug Avigan as possible treatment for COVID-19 has not yet started in the Philippines, Health Undersecretary Maria Rosario Vergeire clarified on Monday.

“Our Avigan trial has not started. It was supposed to start August 17, but there were a lot of processes that are not yet done,” Vergeire said during a virtual briefing, a week after the experiment was supposed to have begun.

• Vergeire on Monday said that COVID-19 is not a “death sentence”, as the government continues to work on fighting the disease, citing a high incidence of recoveries in recent times.

“The stigma attached to the coronavirus is more worrisome,” the Health Undersecretary said, as the DOH reported 16,459 recoveries following the implementation of the time-based recovery strategy of Oplan Recovery, bringing the national total to 131,367.

* Medical front-liners assigned in hospitals and healthcare facilities and are directly attending to COVID-19 patients will still receive special risk allowance (SRA), Health Undersecretary Roger Tong-An said Monday.

Tong-An said deployed human resources for health, such as Nurse Deployment Project nurses and Doctors to the Barrios, are not covered by the SRA suspension, as they are entitled to it by the nature of their functions or assignment.

“We already received the first batch of documents for review. Currently, we are reviewing the said documents,” Montoya said during an interview on ANC.

The human testing phase will be funded by the Russian government and will be done simultaneously in Manila and Moscow.

Before trials start, however, vaccine experts in the country must first review the protocols and guidelines. This must also be approved by the Food and Drug Administration (FDA).

“Maybe there will be some exchange of questions with our vaccine expert panel and those in Russia, and maybe in the next few days , we’ll have an idea whether there is a chance or a high likelihood that the protocols will be implemented here in the Philippines,” Montoya said.

The Philippines is negotiating with manufacturers of 16 potential vaccines that are at different stages of development, said Vergeire.

The country is also part of the COVAX Facility testing 9 vaccines and the World Health Organization's trial of 5 vaccines, she said in a separate ANC interview.

COVAX will “provide only 20 percent of what we require as far as the national population is concerned” to make sure that all countries "will have equitable access,” said Montoya.

“The remaining 80 percent or so will be dependent on the country’s negotiation with the vaccine developers individually," he said.

Russia and the US have committed to include the Philippines in its priority list for their vaccine distribution, said Vergeire.

Vergeire said there would be effectiveness surveillance, and informed consent and information drive for those participating in the trial "so that we can ensure that it is still going to be safe when we do this and waive the phase 4."

While the vaccine remains unavailable, governments are left trying to control the spread through social-distancing measures, quarantines, travel bans, and restrictions on businesses.

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