Palace: Philippine clinical trials of Russian COVID-19 vaccine to start in October
MANILA, Philippines (Updated 3:32 p.m.) — Widespread trials in the Philippines of a COVID-19 vaccine developed by a Russian research institute may be held from October 2020 to March 2021 Malacañang said Thursday even if a government review of previous trials is not yet done.
Russia announced Tuesday that it had approved a coronavirus vaccine dubbed “Sputnik V,” in a world first, raising concerns about the speed of development of the vaccine.
In a press briefing, presidential spokesperson Harry Roque said the country’s vaccine expert panel will review the results of Phase 1 and Phase 2 clinical trials for the vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology in September.
Moscow claimed Sputnik V works even though it has not undergone Phase 3 clinical trials—an essential testing phase before receiving regulatory approval.
Roque said widespread trials, known as Phase 3, will be conducted in the Philippines from October 2020 to March 2021.
“Sabay po itong gagawin sa Russia. Ang Russia ang mag-popondo ng clinical trial na gagawin sa Pilipinas,” he said.
(It will be simultaneously conducted in Russia. Russia will finance the clinical trials that will be conducted in the country.)
Officials from the Department of Science and Technology met with the Russian vaccine developer Wednesday.
According to the World Health Organization, a total of 168 candidate vaccines against coronavirus are being developed worldwide with the Russian vaccine listed as only being in Phase 1.
DOST: Trials on vaccines developed by other countries also welcome
The DOST, which heads the sub-technical working group on vaccine development, said it would still welcome clinical trials on coronavirus vaccines that are being manufactured by other countries as long as these would get the approval of the FDA.
The department said it is also pursuing collaborations with bilateral partners.
“We have already committed to the World Health Organization WHO Solidarity Trial for Vaccine where the Philippines will undertake the clinical trials Phase 3 for four or five vaccines that are pre-qualified by WHO,” DOST Secretary Fortunato de la Peña said.
Out of the 28 candidate vaccines in clinical evaluation, six are already in Phase 3. These include the vaccine candidates of University of Oxford/AstraZeneca, Sinovac, Wuhan Institute of Biological Products/Sinopharm, Moderna/NIAID and BioNTech/Fosun Pharma/Pfizer, CanSino.
The department also called on local pharmaceutical firms to establish a fill-and-finish manufacturing plant for COVID-19 vaccine.
Duterte not part of clinical trials
President Rodrigo Duterte has indicated that he would be the first to try the COVID-19 vaccine but that might only happen in May 2021 and only if the country’s Food and Drug Administration approves Sputnik V for commercial use by April of that year.
"It's not a metaphorical statement. He’s willing to undergo it," Roque said.
The FDA and the Department of Health said Wednesday the Russian-made vaccine will undergo regulatory process once it reaches the country.
“Once an application for clinical trial or registration of the Russian vaccine is filed at the [Food and Drug Administration], we will evaluate it accordingly, FDA Director General Eric Domingo told Philstar.com in a text message Wednesday.
Public trust in immunization remains an issue in the Philippines.
In 2016, the Philippines used dengue vaccine Dengvaxia—which took 20 years to be developed—in a mass vaccination program. But adverse findings in the post-clinical trial study led to claims that children had died after being immunized.
The country’s “highly-politicized response” to the vaccine’s reported risks also resulted in the erosion of overall public trust in immunization, according to a 2018 study of the London School of Hygiene and Tropical Medicine.
READ: How the Dengvaxia scare helped erode decades of public trust in vaccines
Dr. Lulu Bravo, executive director of the Philippine Foundation for Vaccination, advised caution as scientists race to produce COVID-19 vaccines at unprecedented speed.
“Vaccines may be available but these would be questionable with regards to its safety, efficacy, effectiveness and impact,” she said.
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