AMID safety concerns raised by global health experts, the Department of Health (DOH) yesterday assured the public that the vaccine against the coronavirus disease (COVID-19) offered by Russia will undergo the country’s own strict regulatory processes.
Health Undersecretary Maria Rosario Vergeire said the DOH will treat the “Sputnik V” just like any other new medical product being introduced in the country, whether for clinical trials or commercial distribution.
“Even the President is aware of all our regulatory procedures when it comes to new technology, like a vaccine. So just like any product, it has to pass through our own regulatory procedures,” said Vergeire.
“With this, we can assure the public that we are going to study this very critically, properly, and have it undergo our own regulatory procedures so that we can be certain,” she added.
Russian President Vladimir Putin on Tuesday announced the approval of the vaccine, the first country to do so. But the decision to grant approval before completing trials prompted alarm among global health experts, who said that with no full trial data, the vaccine is hard to trust.
Russia has yet to conduct large-scale trials of the vaccine that would produce data to show whether it works – something immunologists and infectious disease experts say could be a “reckless” step.
Putin’s announcement came hours after President Duterte said Russia has offered to supply COVID-19 vaccines for Filipinos. Duterte said he is even willing to try the vaccine and take it in public, in a bid to show that he really trusts the Russians.
Vergeire said the vaccine will pass through a panel of vaccine experts and the Food and Drug Administration.
As to the trial of Sputnik V in the country, Vergeire said the lead agency for vaccine is the Department of Science and Technology (DOST) and it is set to meet with the manufacturer, Gamaleya Institute, and request a “complete dossier” on the vaccine.
“We will see if the allegations are true,” she told a regular briefing, referring to concerns that its approval was hasty.
“That is why were talking with them to understand this vaccine,” Vergeire said, adding that local regulatory approval is required for trials to take place.
“We cannot say yet who and how many people will be involved in the clinical trials. A protocol will still have to be made. So this will be among the subjects of their meeting with the manufacturers,” she also said.
More than half a dozen drugmakers globally are conducting large-scale, advanced human trials of their potential COVID-19 vaccines, each with tens of thousands of volunteers.
Presidential spokesman Harry Roque said President Duterte’s offering of himself to be a “guinea pig” for the vaccine “constitutes actionable policy and it’s a signal also to our local FDA to do everything and anything it can to make sure that it can be administered to the President safely.”
“But as to whether or not PSG will actually allow him is a different thing,” Roque said, adding the President volunteered to take the vaccine because he acknowledged that he is already old and at the end of his term, and can “sacrifice his life for the Filipino people.” – With Jocelyn Montemayor and Reuters