Clinical trials for Sinovac jab yet to start in Philippines — Vaccine Expert Panel
MANILA, Philippines — Late-stage clinical trials for the COVID-19 vaccine developed by Chinese pharmaceutical firm Sinovac Biotech have yet to start in the country, the head of the government’s vaccine expert panel said, citing changes in the protocols of the study.
“They haven’t started yet. They’re still laying the groundwork because they want an amendment, which is not yet fully submitted at this time,” Dr. Nina Gloriani, VEP head, said in a briefing Tuesday.
Gloriani said the study of CoronaVac is placebo-controlled, in which an inactive substance is given to one group of participants, while the vaccine being tested is given to another group.
“They may change some of these because there is a rollout already,” she said, adding the trials may begin in May.
The head of the VEP also said the planned trial in the Philippines will focus on the elderly.
In January, the country’s Food and Drug Administration approved the application of Sinovac to conduct clinical trials of its COVID-19 shot in the country.
While Phase 3 clinical trials for the jab have yet to start in the country, the local regulator has already approved CoronaVac for emergency use.
‘Safe’
Last week, the FDA allowed the use of CoronaVac on the elderly to give them protection as the Philippines faces a shortage of vaccines and a surge in infections. The Emergency Use Authorization issued for the jab last February cleared it for use only on “clinically healthy” individuals aged 18 to 59.
The Department of Health and the FDA said that “while current efficacy data for senior citizens from Phase 3 trials are insufficient, the benefits of using the vaccine for this particular group outweigh its risk, and more scientific data on use for senior citizens may soon become available.”
Gloriani stressed Monday that CoronaVc is safe across all age groups.
“The safety of Sinovac is remarkable across all age groups, including the elderly. Clinical trial findings showed that Sinovac’s CoronaVac is well tolerated among older individuals,”
Other trials
Belgian firm Janssen Pharmaceuticals has finished the recruitment of participants for the clinical trials of its vaccine in the country, Gloriani said. It began the clinical trials last February.
Meanwhile, the recruitment of participants for the clinical trials of the jab developed Chinese drugmaker Clover Biopharmaceuticals is still ongoing.
The country aims to inoculate up to 70 million people this year. But only over a million shots have been administered since the immunization campaign began last month. — Gaea Katreena Cabico
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