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 The data, however, have not been peer-reviewed.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.