Palace says Sinopharm files EUA for COVID-19 jab but FDA has no info yet
MANILA, Philippines (Updated 1:31 p.m.) — The country’s Food and Drug Administration said it has yet to receive an application from China’s Sinopharm for the emergency use authorization of its COVID-19 vaccine, contrary to the pronouncement of Malacañang that it has already sought for an approval.
In a briefing Monday, presidential spokesperson Harry Roque said the Chinese state-owned company has submitted an application for the emergency use of its COVID-19 vaccine.
“They have already filed with the FDA an application for EUA for Sinopharm vaccine,” Roque said.
FDA: No info as of Friday
But FDA Director General Eric Domingo said he has not seen any application from Sinopharm as of Friday.
“I have not seen one as of Friday. I’m not sure if they filed online… FDA is closed [today] because it’s Araw ng Muntinlupa holiday here in Alabang,” Domingo told Philstar.com.
“As far as I know, we have yet to evaluate EUA application from Sinopharm,” he also said in Filipino during a Laging Handa briefing.
The FDA chief noted that in case the firm applies for EUA, it may take more than 21 days before the agency can decide on its application.
“Maybe a month, around four to six weeks because Sinopharm has yet to receive EUA from a stringent regulatory authority or from WHO,” he said.
Last December, Sinopharm said its vaccine was 79.3% effective in preventing COVID-19, lower than the reported efficacy rates of Pfizer-BioNTech and Moderna of 95% and 94.1%, respectively.
Duterte’s choice
The jab developed by Sinopharm is the vaccine preferred by President Rodrigo Duterte. The 75-year-old chief executive cannot receive Sinovac’s CoronaVac—the only vaccine available in the country at the moment—since his age falls outside the range of 18 to 59 suitable to get the shot.
The Sinopharm vaccine was the one used by the Presidential Security Group in an unauthorized inoculation activity last year despite lacking regulatory approval.
Special envoy to China Mon Tulfo also revealed last month the he received smuggled Sinopharm shots along with some “Cabinet-level” officials and a senator. He said a friend had smuggled the vaccines into the country.
The FDA and the National Bureau of Investigation launched separate investigations into the unauthorized inoculations.
In February, the FDA issued a “compassionate use license” for Duterte’s security detail to take 10,000 Sinopharm jabs.
The country finally kicked off its COVID-19 vaccination campaign Monday, with health workers and government officials among the first in the line to receive Sinovac shots.
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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