Clinical trial does not guarantee Philippines will be first to get coronavirus vaccine: expert

ABS-CBN News

Posted at Aug 24 2020 02:06 PM

Vaccine available by mid 2021 in ‘best case scenario’ 

Health workers administer flu and pneumonia vaccines to 78-year-old Sonia Olayta as part of their community immunization drive in Barangay Pembo, Makati City on August 12, 2020. George Calvelo, ABS-CBN News/File

MANILA -- Filipinos' participation in clinical trials does not guarantee that they will be the first to get the potential vaccines against the novel coronavirus, an official said Monday. 

Authorities on Sunday received preliminary data on a vaccine developed by Russia and would determine within the week "if there’s a high likelihood" that its Phase 3 mass testing could be done in the Philippines, said Jaime Montoya, science department's Council for Health Research Development executive director.

"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.” 
 
The Philippines is negotiating with manufacturers of 16 potential vaccines that are at different stages of development, said Health Undersecretary Maria Rosario 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. 

SPUTNIK V 

The Food and Drug Administration will make the final decision on whether or not to let Filipinos join the trial for Russia's vaccine dubbed Sputnik V, said Montoya. 

The Phase 3 trial usually takes 3 to 6 months, after which developers need to analyze the data and submit papers to the FDA, which might take another month, he said. 

"Maybe at the earliest, best case scenario, it (vaccine) will be [available] sometime [in the] early part of the third quarter next year," Montoya said. 

The health department earlier sought to waive off the required Phase 4 of the vaccine trial to speed up its procurement. This stage concerns additional studies after a vaccine is approved and licensed. 

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." 

The Philippines as of Sunday confirmed 189,601 coronavirus infections, of which 55,236 were active cases. 

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

— With reports from Jamaine Punzalan, ABS-CBN News; Agence France-Presse