Lacking submission to FDA delays review of Sinopharm COVID-19 jab
MANILA, Philippines — The country’s Food and Drug Administration has yet to evaluate the application of Sinopharm for the emergency use of its COVID-19 vaccine due to incomplete documents.
The application of Southmed Pharma, which seeks to the firm’s distributor in the Philippines, lacked documents such as clinical trial results and certificate of good manufacturing practice, FDA Director General Eric Domingo said. The local company also needs to present proof it is the distributor of Sinopharm in the country.
“Once they submit the documents, we will begin the evaluation,” Domingo said in a public briefing Wednesday.
“Until we see scientific evidence, we see the population involved in their Phase 3 clinical trials, their experience in using the vaccine in other countries, that’s the only time we can give recommendation on the use of the vaccine,” he added.
The drug regulator confirmed Tuesday the receipt of an online application seeking emergency use authorization for the jab developed by China’s state-owned pharmaceutical company.
Domingo earlier said it may take “around four to six weeks” before the agency can decide on the application because Sinopharm has yet to receive EUA from a stringent regulatory authority or from the World Health Organization. The lack of relevant documents may delay it further.
“We’re very objective in approving vaccines. We have a checklist of what we’re looking for: safety, efficacy and quality,” he said.
Interim analysis of Phase 3 clinical trials showed that Sinopharm’s COVID-19 vaccine was 79.3% effective in preventing the disease, lower than the reported efficacy rates of Pfizer-BioNTech and Moderna of 95% and 94.1%, respectively. The data, however, have not been peer-reviewed.
So far, only the vaccines of Pfizer-BioNTech, AstraZeneca and Sinovac Biotech have obtained EUAs from the FDA. The application of Russia’s Gamaleya for its COVID-19 vaccine remains pending.
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 country began its delayed 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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