FDA says China's Sinopharm applied for emergency use of COVID-19 vaccine
MANILA, Philippines — China’s state-owned pharmaceutical company Sinopharm submitted an application for the emergency use of its COVID-19 vaccine in the Philippines, the country’s Food and Drug Administration said Tuesday.
“An online application was filed yesterday afternoon and the FDA is checking the contents of the submission now,” FDA Director General Eric Domingo told Philstar.com.
Presidential spokesperson Harry Roque announced Monday that Sinopharm filed an application for EUA in the country. Domingo, however, said he had no information about the matter at the time.
The FDA chief earlier said it may take more than 21 days before the agency can decide on the application of the Chinese drugmaker.
“Maybe a month, around four to six weeks because Sinopharm has yet to receive EUA from a stringent regulatory authority or from the World Health Organization,” Domingo said.
Sinopharm reported that 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.
So far, only the vaccines of Pfizer-BioNTech, AstraZeneca and Sinovac Biotech have obtained emergency use authorization from the FDA. The EUA application of Russia’s Gamaleya Institute for its Sputnik V vaccine remains pending.
Duterte’s preference
The jab developed by Sinopharm is the one preferred by President Rodrigo Duterte.
It was the same vaccine used by members of the Presidential Security Group, special envoy to China Mon Tulfo, some “Cabinet-level” officials and a senator in an unauthorized vaccine activity last year.
The FDA and the National Bureau of Investigation launched separate investigations into the illegal inoculations. But Domingo told ANC’s Matters of Fact that its probe into the smuggling of COVID-19 vaccines for use of the president’s guards has hit a “blank wall” due to the non-cooperation of PSG personnel.
In February, the FDA issued a “compassionate use license” for Duterte’s security detail to take 10,000 Sinopharm jabs.
The country finally began its COVID-19 vaccination campaign Monday, with health workers, government officials and uniformed personnel the first in the line to receive donated 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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