THE Department of Health (DOH) yesterday said it is finalizing an application for emergency use authorization (EUA) for the vaccine made by Sinopharm, China’s state-owned pharmaceutical firm.
The Sinopharm vaccine was recently included in the emergency use listing of the World Health Organization (WHO).
Health Secretary Francisco Duque III on Saturday ordered the DOH to seek an EUA so the country will not have to return the Sinopharm vaccines donated by China.
President Duterte has received his first dose of the Sinopharm vaccine despite the absence of an EUA from the Food and Drug Administration. Duterte later ordered the return of all donated Sinopharm doses after getting criticisms for using a vaccine that did not undergo safety and efficacy evaluation from the FDA.
“This is the pathway we are looking right now for Sinopharm because it will be faster.
Instead of manufacturers, it is the government applying for the EUA,” Health Undersecretary Maria Rosario Vergeire said in a briefing yesterday.
She said the DOH is applying for an EUA in anticipation of more Sinopharm doses coming to the country in the coming months.
“We are doing this because there is a possibility for government t–government transactions or negotiations for Sinopharm,” she said.
She said it would not be the first time that DOH will apply for an EUA for a specific medical technology, such as a vaccine.
“We did this for COVAX Facility, and for the donated vaccines from Sinovac. It is something that we do so we can facilitate the process of getting the vaccine,” she said.
Vergeire said the DOH is just waiting for the completion of documents before their the EUA application.
“We can only apply when we have complete documents already. There are documents required in applying for EUA. For now, we are asking documents from the WHO. Once we complete it, we will apply immediately,” she said.
Vergeire said an approval of the EUA application will be faster because of the WHO listing.
“The process of the WHO, plus the data to be submitted by Sinopharm, will hasten the evaluation of the application,” she said.
In addition, Vergeire said being included in the WHO listing will make Sinopharm vaccines accessible through the COVAX Facility.
Earlier given UAEs were the US firm Pfizer-BioNTech, British-Swedish company AstraZeneca Plc, China’s Sinovac Biotech, Russia’s Gamaleya, Janssen/Johnson & Johnson, India’s Bharat Biotech, and the US firm Moderna.
The country expected the arrival of the first batch of Pfizer vaccines, amounting to 193,000 doses, on Monday night.
These will go to Metro Manila, Cebu City and Davao City.
The country now has 7.571 million doses of vaccines, which started arriving in February.
The 194,000 Pfizer doses will be the “trial vaccine” to determine if the Philippines can handle the drug which requires a temperature of negative 20 degrees. — With Jocelyn Montemayor
