MANILA, Philippines — The Department of Health (DOH) on Monday said it has started the process of the filing of the application for emergency use authorization (EUA) of the coronavirus disease (COVID-19) vaccine developed by Chinese drug maker Sinopharm.
In an online briefing, Health Undersecretary Maria Rosario said they are just waiting for the dossier of Sinopharm to complete the application process.
“We were already instructed to process and facilitate the application for the EUA of Sinopharm,” she said.
“Ito po ay inaayos na natin ngayon, kailangan lang natin makuha yung mga dokumento, the dossier of Sinopharm so we can complete the process of applying for this EUA,” she added.
Health Secretary Francisco Duque III earlier said that the EUA application will be filed after the World Health Organization (WHO) approved the Sinopharm vaccine for emergency use.
A WHO emergency listing means that a product’s safety and efficacy have been rigorously evaluated. It will also allow the product to be included in the COVAX facility – a global program that seeks to provide vaccine supply mainly for poor countries.
The emergency use listing will also allow countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The DOH, however, stressed that the vaccine will still undergo a thorough evaluation and strict regulatory process by the country’s vaccine experts panel and the Food and Drug Administration (FDA) even if it has been granted WHO emergency use listing.
Vergeire also emphasized that this is not the first time that the DOH will be applying EUA for a certain vaccine product and that it has existing policies supporting the process.
“Hindi lang ito ang unang pagkakataon na mag-a-apply ng EUA ang DOH para sa mga new technologies like these vaccines. We have done this for the COVAX facility, ginawa rin po natin ito para sa mga donasyon na bakuna from China, yung Sinovac,” she said.
“This is actually something that we do so that we can facilitate the process of receiving vaccines but of course, everything undergoes the strict regulatory process,” she added.
The FDA earlier said that three firms have expressed intent to seek EUA for the Sinopharm but they have yet to submit the required documents.
With the EUA application through the DOH, Vergeire said the agency will not be representing any manufacturer.
“We are not going to represent any manufacturer for that matter. The reason why we are doing this is merong posibilidad na magiging government to government ang transaksyon o negotiations for Sinopharm,” she said.
“When you say it’s government to government, it is like the donations, pag sa donasyon, sasabihin ng isang gobyerno sa abroad ‘magdo-donate ako sa inyo,’ kami na ang mag-a-apply para doon. Walang manufacturer na kasama dito, gobyerno sa ibang bansa ang kausap namin,” she explained.
“This is the pathway na tinitingnan namin ngayon for Sinopharm baka pwedeng dito na rin kami dadaan, mas magiging mabilis ang proseso. But of course, as I’ve said, we’ll still go through the usual regulatory process, it’s just that instead of the manufacturers applying for this EUA, it’s the government through the DOH who’s going to apply for this emergency use authority,” she further stated.
The Philippines has so far granted EUA to COVID-19 vaccines manufactured by Pfizer/BioNTech, Sinovac, AstraZeneca, Bharat Biotech, Gamaleya Institute, and Johnson&Johnson.