THE Philippines will conduct clinical trials for a Russian vaccine for the coronavirus vaccine (COVID-19) in October, with President Duterte expected to be inoculated as early as May next year, Malacañang said yesterday
Presidential spokesman Harry Roque also said that by April 2021, the vaccine is expected to be approved by the Food and Drug Administration.
Roque made the announcement a day after scientists met with representatives of Russian research facility Gamaleya, the developer of vaccine “Sputnik V,” to discuss trials and information about the inoculation.
Russia on Tuesday became the world’s first country to grant regulatory approval for a COVID-19 vaccine but its decision to grant approval before completing trials has raised concerns among some global experts, who fear it may be putting national prestige before safety.
Health Undersecretary Maria Rosario Vergeire has said all clinical trials would need to go through the regulatory process.
Phase three clinical trials in the Philippines are due to run from October to March 2021, after a panel of vaccine experts completes its review on Russia’s Phases 1 and 2 trials in September, Roque told a media briefing.
Duterte is keen to access a vaccine and in July made a plea to China to make the Philippines a priority if it develops one. Early this week, he expressed willingness to personally participate in trials.
The President has pledged that the Philippines, which suffered its biggest economic contraction in nearly three decades, would be “back to normal” by December even as it has been reporting record numbers of daily coronavirus infections since July.
The novel coronavirus has infected more than 143,000 people and killed 2,404 in the Philippines.
The Food and Drug Administration said a it is possible a vaccine against COVID-19 will be available by the end of the year.
FDA Director General Eric Domingo said a vaccine may be available by December under a “best case scenario.”
“In case one of the vaccines now undergoing clinical trial Phase 3 show good results, they might apply for registration before end of the year,” he said.
Asked if he is referring to the Russian vaccine, he said there are several vaccines in clinical trial Phase 3. “We have those from China, United States, United Kingdom, and Russia…
These vaccines all have the possibilities of completing Phase 3 of clinical trials,” he said.
Domingo also said Sputnik V will be subjected to strict regulatory scrutiny just like any other new product introduced in the country.
“Until it can complete the process and its safety profile has been cleared to us as well as its positive effects, that is the only time we can approve the vaccine,” said Domingo.
Dr Jose Santiago Jr., president of the Philippine Medical Association, reiterated doubts over Sputnik V.
“We don’t have to rush to get into the vaccine of Russia. We have to really see the reports, some trials that they have done. We are really not confident with the vaccine of Russia now,” he said. – Gerard Naval and Reuters