DOH to Seek Emergency Use Authorization for Sinopharm Vaccine

After WHO listing.
Photo/s: Shutterstock

The Department of Health said Monday it would file an application for emergency use authorization for China's Sinopharm COVID-19 vaccine in the Philippines after the jab was approved by the World Health Organization.

The vaccine, which was used by President Rodrigo Duterte without an EUA, is the first Chinese jab to gain WHO approval. Granting an EUA will expedite its availability to the people who need it the most but it is not a license to sell the drugs commercially. 

The WHO earlier gave emergency use authorization to vaccines from Pfizer-BioNTech, Moderna, Johnson and Johnson, and the AstraZeneca jab being produced at sites in India and in South Korea, which it counts separately.

"Ngayong umaga, ang DOH mag-aapply ng EUA (emergency use authorization) sa FDA (Food and Drug Administration) for Sinopharm dahil mayroon nang EUL (emergency use listing) na nilabas ang WHO kahapon o nung makalawa,” Health Sec. Francisco Duque III said in an interview on ABS CBN’s TeleRadyo.

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So far, the FDA had only granted a "compassionate special permit" for the Sinopharm vaccine for use of the Presidential Security Group.

What WHO approval means

An emergency use listing by the WHO paves the way for countries worldwide to quickly approve and import a vaccine for distribution, especially those states without an international-standard regulator of their own.

It also opens the door for the jabs to enter the COVAX global vaccine-sharing scheme, which aims to provide equitable access to doses around the world and particularly in poorer countries.

"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 Mariangela Simao, the WHO's assistant director-general for access to health products.

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"We urge the manufacturer to participate in the Covax facility and contribute to the goal of more equitable vaccine distribution."

Currently only AstraZeneca and some Pfizer jabs are flowing through the scheme.

The WHO recommended that the two Sinopharm shots be taken three to four weeks apart.

The vaccine's efficacy for symptomatic and hospitalized cases of COVID-19 was estimated to be 79% when all age groups are combined, it said.

The agency said few adults over 60 were enrolled in clinical trials of the vaccine, so its efficacy could not be estimated in that age group.

Nevertheless, "there is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations," it said.

The Sinopharm vaccine is already in use in 42 territories around the world, fourth behind AstraZeneca (166), Pfizer-BioNTech (94), and Moderna (46), according to an AFP tally.

Besides China, it is being used in Algeria, Cameroon, Egypt, Hungary, Iraq, Iran, Pakistan, Peru, the United Arab Emirates, Serbia, and the Seychelles, among others.

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