FDA waiting for EUA application of 3 vaccine manufacturers
The Food and Drug Administration (FDA) is anticipating three vaccine manufacturers to apply for emergency use authorization (EUA) for their respective coronavirus disease (COVID-19) vaccines.
FDA Director General Rolando Enrique Domingo said that his office already had meetings with the representatives of US pharmaceutical firm Moderna, Belgium-based Janssen Pharmaceuticals, and India’s Serum Institute.
“Nakausap na po namin several times iyan at alam na (nila) ang requirements and encouraged them to start applying already pero until now hindi pa rin sila naga-apply (We already talked to them several times and (they) already know the requirements and encouraged them to start applying already but until now have not),” said Domingo during the Cabinet meeting on Wednesday night, March 24.
“So, fina-follow namin sila regularly and sinasabi na nagpre-prepare palang sila ng kanilang application (So, we do follow ups on them regularly and what they replied-- they are just preparing their application),” he added.
Currently, Domingo said that the FDA was reviewing the EUA application of India’s Bharat Biotech.
So far, the FDA has granted an EUA to the COVID-19 vaccines made by US-drugmaker Pfizer, British firm AstraZeneca, Russia’s Gamaleya Research Institute, and China’s Sinovac Biotech.
Sinovac vaccine still for aged 18 to 59
In a related development, Domingo reiterated that the Sinovac vaccine was still currently intended for healthy individuals aged 18 to 59.
Domingo said that the Sinovac vaccine was approved for use in 15 countries, but four of these countries, including the Philippines, were not recommending it for the elderly population as of this time.
“Hanggang ngayon yung Sinovac, wala pa silang binibigay sa amin na clinical trial data nila para sa mga ages 60 and above. Kaya hindi pa natin ma-expand yung kanilang EUA (Until now, Sinovac has not given us their clinical trial data for those 60 years old and above. So we can't expand their EUA yet),” said Domingo.
“Totoo na sa ibang bansa ginamit muna nila sa 18 to 59 tapos nag expand sila sa mga elderly---sa 11 countries. However, meron apat na bansa na hindi pa ito ginagamit sa above 59 years old kasama ang Pilipinas, Thailand, Chile, at China--ayang bansa na pinanggalingan nya hindi pa sya ginagamit sa 60 and above dahil kulang pa sila ng datos for the elderly (It is true that in other countries they first used it to 18 to 59, and then they expanded its use to the elderly --- in 11 countries. However, there are four countries that have not used it for those above 59 years old including the Philippines, Thailand, Chile, and China---- which is the country of origin of this vaccine. They (China) have not used it yet for those 60 years old and above because they still lack data for the elderly sector),” he added.