DOH to file EUA for Sinopharm COVID-19 vaccine---Duque


Department of Health (DOH) Secretary Francisco Duque III said that he instructed his agency to file for an emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine developed by Chinese firm Sinopharm.

Department of Health Secretary Francisco Duque III (PCOO / MANILA BULLETIN FILE PHOTO)

The Health chief made the statement when asked if the government is still planning to return the donated Sinopharm vaccines to China after the World Health Organization (WHO) approved the vaccine brand for emergency use.

“I have already instructed the public health services office of the DOH to file with FDA for issuance of emergency use authorization for the Sinopharm donated vaccines so that there would be no need to return them,” said Duque in a press briefing on Saturday, May 8.

President Duterte on May 5 requested the Chinese Embassy to withdraw the Sinopharm donated vaccines after his inoculation drew public criticisms. The vaccine brand has yet to secure an EUA with the Philippine FDA.

In a statement on Friday, May, 7, the WHO said it “listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally.”

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Health Products.

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution,” she added.

The WHO said that its Emergency Use Listing (EUL) “is a prerequisite for COVAX Facility vaccine supply.”

“The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements,” it said.

The WHO said that the Sinopharm vaccine’s “easy storage requirements make it highly suitable for low-resource settings. It is also the first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.”

“On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79 percent, all age groups combined,” the WHO said.