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No quick green light on vaccines

Gabbie Parlade

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The Food and Drug Administration (FDA) on Thursday assured that vaccines applied for an emergency use application (EUA) in the country by the various pharmaceutical firms would undergo thorough checks for their efficacy and integrity.

Eric Domingo, FDA Director-General, said all processes will be followed accordingly to ensure their safety to balance the urgency of their approval.

“We assure the public that we take it seriously and we assure everyone that the benefits will outweigh the risk to make sure to safeguard the public,” he said.

The approval of an EUA will depend on how fast the vaccine manufacturers would be able to submit their products’ credentials.

It will likewise depend if they’ve acquired the green light from recognized stringent agencies like those in the United States, United Kingdom and Japan.

Experts will also check if the vaccine has undergone the World Health Organization’s (WHO) analysis and if it has received approval from the pre-qualification committee.

Domingo said that once they’ve submitted their application, it will usually only be weeks before a decision is made — shorter than the initial process that takes months.

We assure the public that we take it seriously and we assure everyone that the benefits will outweigh the risk to make sure to safeguard the public.

“We can approve an EUA within 21 to 28 days,” he said.

Among the data that will be checked include the efficacy rate identified in their prior trials; if the participants had a similar ethnic race to Filipinos like Asians; and the vaccine’s stability considering the disparity in the climate.

The approval of an EUA will depend on how fast the vaccine manufacturers would be able to submit their products’ credentials.

After it has been approved in the country, the post-marketing surveillance will be reviewed to know whether any adverse effects will occur as it is being implemented.

Dr. Jaime Montoya of the Department of Science and Technology-Philippine Council for Health Research Development said an EUA may be revoked or suspended if any serious adverse effects are found.
This will be counter-checked with the manufacturers and the respective regulatory team of the vaccine’s country of origin.

Domingo also said that the WHO will be consulted on any adverse event to determine whether it would be paused or stopped.

China’s Sinovac Biotech, Sinopharm and the US’s Moderna are likewise expected to submit their application.

At present, he said that they are expecting applications from Pfizer after it has recently received an EUA from the UK government following its initial report of a 95 percent efficacy rate.
China’s Sinovac Biotech, Sinopharm and the US’s Moderna are likewise expected to submit their application.

He noted that the earliest supply of the vaccine may probably arrive by March or the first quarter of next year.

On Tuesday, President Rodrigo Duterte signed an executive order allowing the FDA the power to grant an EUA but only for COVID-19 vaccines and treatments as the country is under a health crisis brought by the pandemic.

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