Late-stage clinical trials for China’s Sinovac coronavirus vaccine have yet to begin in the Philippines months since the Food and Drug Administration (FDA) gave clearance to do so last January 2021. 

“Unfortunately yung mga clinical trials ng Sinovac sa Philippines ay hindi pa umaandar (Unfortunately, Sinovac’s clinical trials in the Philippines haven’t started),” FDA Director General Eric Domingo told reporters in a press briefing on Friday, April 9. 

“Nagkaroon sila ng bagong change doon sa kanilang (They mad new changes to their) clinical trial protocols and they told us that they will submit revisions,” he said, adding “So wala pang resulta yun (So there have been no results from that yet.)

Sinovac had first expressed interest in carrying out Phase 3 trials in the Philippines last October 2020, with the FDA approving its application last January 15. Inclusion in late-stage trials is one of the Philippine government’s strategies to gaining access to scarce shots, alongside efforts to procure doses and joining multilateral initiatives like the COVAX global facility. 

While Phase 3 trials for Sinovac’s vaccine have yet to begin in the country, the FDA earlier cleared its COVID-19 vaccine, CoronaVac, for use in the Philippines. Sinovac has so far served as one of two main vaccines in the country’s inoculation campaign, along with AstraZeneca’s vaccine, as other vaccines eyed by the country for use have not yet arrived. 

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Why it matters

Among the benefits vaccine experts eyed in pushing for the Philippines’ inclusion in Phase 3 vaccine trials included having information on how well a coronavirus shot would work on Asian populations, including Filipinos. 

Such data could be of use for officials not only in considering which vaccines to use in the government’s inoculation drive, but also in deciding to adjust how the vaccine is used in the country.

The lack of data from trials earlier eyed comes as the FDA decided to expand the use of Sinovac on senior citizens or those aged over 60, following the scarcity of other vaccines and high transmission rates in the Philippines. 

The FDA had allowed for its use but stressed “stringent evaluation” of a person’s health and risks should be done before deciding to proceed with vaccination. 

Domingo said among the factors behind the decision to expand Sinovac’s use for seniors include data so far on the safety of the vaccines after some 700 senior health workers in the Philippines received the vaccine with limited side effects, along with similar safety data from its use in countries including Turkey, Indonesia, and China. 

While available data addressed the safety of Sinovac’s vaccine for seniors, Domingo acknowledged there was still limited data on how well the shot protected people aged 60 and above. 

Upon issuing the new guidance, the FDA and Department of Health said approval to move forward with its use for seniors was done “considering the limited availability of vaccines and the growing need to protect seniors amid the increasing number of COVID-19 cases in the country.” – Rappler.com