FDA anticipating Moderna, 2 Indian firms’ EUA application

MANILA, Philippines — The country’s Food and Drug Administration (FDA) is expecting US drugmaker Moderna, India’s Serum Institute and Bharat Biotech to apply soon for an emergency use authorization (EUA) for its COVID-19 vaccines, FDA director-general Eric Domingo said Tuesday.

“Yun pa rin po, wala pa naman pong nadagdag pero nagpaparamdam na rin po sa amin ‘yung ibang mga kumpanya katulad po ng Moderna, ‘yun pong Serum Institute of India,” Domingo said in an interview over Teleradyo.

(No company has applied again but other companies have expressed desire like Moderna, Serum Institute of India.)

“‘Yun pong sa India, dalawa ‘yun e, ‘yung Bharat Institute at ‘yung Serum Institute, nagpapahiwatig na din po,” he added.

(From India, there are two companies signifying interest, Bharat Institute and the Serum Institute.)

Domingo said these companies have already been provided the list of requirements to secure an EUA for their respective COVID-19 vaccines.

So far, only American drugmaker Pfizer has secured an EUA for its vaccine in the Philippines.

Other pharmaceutical firms that have applied for an EUA are China’s Sinovac, British drugmaker AstraZeneca and Russia’s Gamaleya Institute.

JPV