Health experts urge authorities to revoke 'compassionate special use' permits of COVID-19 vaccines

ABS-CBN News

Posted at May 07 2021 08:22 PM

Health experts urge authorities to revoke 'compassionate special use' permits of COVID-19 vaccines 1
The University of the Philippines - Diliman in Quezon City converts its gymnasium into a COVID-19 vaccination center for university workers and members of its community on May 4, 2021. The center is manned by qualified volunteers including university alumni. Mark Demayo, ABS-CBN News/file

MANILA — Several health experts on Friday urged Philippine authorities to revoke the compassionate special use for COVID-19 jabs which have yet to receive regulatory approval in the country, stressing the importance of such process.

In a statement, a group of physicians emphasized that a vaccine that has no emergency use authorization (EUA) from the Food and Drug Administration (FDA) "poses risks to the health of any individual." 

The main purpose of an EUA and the process of regulatory approval, according to the group, is to make sure that the vaccine candidate met the standards of being safe and effective based on scientific evidence. 

"After careful study by the Department of Science and Technology's Vaccine Expert Panel and by the [FDA], EUAs have already been issued to several vaccines....The EUA mechanism provides assurance to the public that the vaccines are safe and effective," the statement read, which was signed by 39 physicians and health experts. 

"We believe in 'Tamang Bakuna, Tamang Proseso.' The collective efforts of government agencies, supported by independent scientists and medical experts, are worthy of the people’s trust in vaccines and in the vaccination process," they said.

The statement came following President Rodrigo Duterte's inoculation this week using China's Sinopharm COVID-19 vaccine, which has yet to be cleared for use in the country. 

The EUA of Sinopharm, officially known as China National Pharmaceutical Group Co., is still under review and being processed, according to FDA Director-General Eric Domingo. 

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But Duterte's aides earlier said the dose is covered by the compassionate use license in February for the Presidential Security Group. The permit is good for 10,000 doses.

An EUA will also allow a vaccine under development to be used for the government's vaccination program.

But the health experts urged the country's officials to cancel all existing compassionate special permits (CSPs) for COVID-19 vaccines without an EUA. 

"We recommend to policymakers that existing CSPs for any COVID-19 vaccines without EUAs be rescinded, and that the said vaccines undergo the proper EUA process before being administered to any Filipino," the doctors said.

"This will ultimately improve vaccine uptake since it will assure the people that any COVID-19 vaccine that is offered to them for vaccination is safe, effective and equitable," they pointed out. 

In the Philippines, the following COVID-19 vaccine products from the following have been cleared for emergency use by the country's drug regulator: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, and Bharat Biotech.

The country has received supplies of COVID-19 vaccines developed by Sinovac, AstraZeneca and Russia's Gamaleya Institute.