Sinopharm vaccine gets EUA from FDA

MANILA, Philippines — Chinese-made Sinopharm vaccines donated to the Philippines have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA), according to Science and Technology Undersecretary Rowena Cristina Guevara.

“Sinopharm was issued EUA for the donated doses. It was issued by the FDA on June 7. Then another EUA was issued Aug. 19 for the recent batch of Sinopharm doses donated,” said Guevara, chair of the Task Group on Vaccine Evaluation and Selection (TG-VES).

“For donations, the applicant for EUA is DOH (Department of Health). Each donation, even for the same vaccine, may come from a different manufacturing plant, and requires a different EUA for each manufacturing plant,” she added.

Other COVID-19 vaccines that had been granted EUA are Pfizer-BioNTech, AstraZeneca (Chadoz1-S Recombinant), Sinovac’s Coronavac, Gamaleya Sputnik V (Gam-COVID-Vac), Janssen’s COVID-19 vaccine AD26.Cov2-s (Recombinant), Bharat Biotech Covaxin with a conditional grant and Moderna’s mRNA vaccine.

FDA director general Eric Domingo said the agency has granted an EUA to Sputnik Light, a single-dose vaccine made by the Gamaleya Research Institute for adults 18 years old and up.

Domingo, however, said the single-dose Sputnik Light cannot be given as second dose to recipients of the first dose of Sputnik V vaccines administered earlier.

Phase 3 trials

Guevara likewise said that Phase 3 clinical trials are now underway for vaccines made by US pharma giant Janssen, as well as Chinese-made jabs from Clover Biopharmaceutical, Shenzhen Kangtai Biological Products and West China Hospital of Sichuan University.

She said the Janssen trials involve 1,553 Filipino participants, Clover trials have as many as 10,000 Filipino participants, West China Hospital had just started participant recruitment while Shenzhen Kangtai just secured FDA approval and submitted target recruitment sites to the TG-VES.

She also disclosed three more vaccine developers are keen on doing Phase 3 clinical trials in the country.

More jabs expected

About 40 million doses of Pfizer and 20 million Moderna shots that the country ordered are scheduled to arrive by September, according to Cabinet Secretary and IATF co-chairman Karlo Nograles.

He also confirmed that Sinovac will finish delivering the rest of the 25 million doses ordered by government, 21 million of which have already arrived.

“I assume by September Sinovac will complete their deliveries. Also coinciding with this are the deliveries from Pfizer and Moderna and then it will ramp up from September... all the way to December,” he added.

For his part, Cagayan de Oro Archbishop Jose Cabantan appealed to the Catholic faithful not to let fake news about the jabs dissuade them from getting vaccinated.

Meanwhile, the Bureau of Customs and FDA have conducted a virtual seminar titled “Webinar on Policies and Procedures of BOC & FDA on Importation of COVID-19 Critical Commodities” to emphasize the importance of collaboration between implementing agencies during the pandemic. – Sheila Crisostomo, Rudy Santos, Evelyn Macairan