Sinovac cleared for COVID-19 vaccine clinical trials in the Philippines
MANILA, Philippines — China's Sinovac has secured approval to hold clinical trials in the country for its coronavirus vaccine, local regulators said Tuesday.
Such trials, which would involve a certain number of participants, are done to determine if candidate vaccines for the deadly virus that has infected and killed millions are safe and effective.
Five drugmakers had initially applied to conduct the tests at home last year, but the British-Swedish AstraZeneca and Russia's Gamaleya pulled out and opted to directly apply for emergency use.
This then left Janssen Pharmaceuticals and Chinese manufacturers Clover and Sinovac in the trials, all of which had been given the FDA's nod.
"Lahat po ng nag-apply ng clinical trials sa FDA na-approve na po 'yan," Director General Eric Domingo said in a Laging Handa briefing. "I would presume nag-umpisa na po 'yan."
(All of those applying for clinical trials are now approved by the FDA, so i would presume it has already begun.)
Janssen had been the first to secure authorization for the trials in late-December, Clover in the first week of January and Sinovac recently.
Domingo had then said that the science and technology department's vaccine expert panel would be the one to assign the site of the trials, including the recruitment of volunteers.
The Chinese-made Sinovac has faced public scrutiny in the country over the Duterte administration's seeming preference for the jabs, despite its efficacy rate still unclear and its final price yet to be disclosed by officials.
Palace has sought to deny that it has favorites on vaccine preference, but it was President Rodrigo Duterte who backed the Chinese jabs and claimed that they are all the same.
A term sheet for some 25 million doses was also recently signed by the administration, which had alarmed lawmakers who aired concern over uncertainties still looming over Sinovac.
At a Senate hearing on the government's vaccination program, officials said the administration could still back out of the deal with the Chinese.
But days later, the Palace refuted such pronouncements by its own men, saying the purchase is already a done deal and is only waiting for the FDA's approval.
Sinovac had also applied for emergency use authorization along with two other vaccine manufacturers. It has, however, yet to turn in to local regulators the results of its crucial Phase 3 clinical trials.
The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.
Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)
Health Officer-in-Charge Maria Rosario Vergeire says the general population may now get their second booster jab.
"We're just waiting for the release of implementing guidelines, then we'll start rolling out our second booster for the general population," she says. — Gaea Katreena Cabico
Amid questions on vaccines being administered, the Department of Health assures the public all doses are safe and effective as the “process of extending shelf life goes through thorough stability studies.”
“The government ensures that every vaccine that is injected with an extended shelf life has gone through studies, and is still safe and effective against COVID-19,” it adds.
Government must increase vaccination capacity across the Philippines in anticipation of a surge of COVID-19 cases caused by the Omicron variant of the corona virus, Sen. Risa Hontiveros says.
She says local government units and the private sector can work together to put up more vaccination centers and deploy more vaccination teams to get more people inoculated against COVID-19.
"The active COVID cases have nearly doubled in three days. The positivity rate is almost four times the ceiling set by the World Health Organization. Huwag na nating hintayin na sobrang lumala pa ang sitwasyon bago tayo gumawa ng paraan para mapabilis ang ating pagbabakuna."
FDA chief Eric Domingo says that its agency has given emergency approval for the use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
The United States immunized around 900,000 children aged five-to-11 against Covid in the first week the Pfizer vaccine was authorized for them, a White House official says Wednesday.
Roughly 700,000 more have made appointments at pharmacies, White House Covid coordinator Jeff Zients tells reporters.
"The program is just getting up to full strength," he says, adding most of the shots were given in the last couple of days alone. — AFP
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