FDA Director General Eric Domingo (File photo)
MANILA – Only two pharmaceutical companies have pending applications for emergency use authorization (EUA) for their coronavirus disease 2019 (Covid-19) vaccines, Food and Drug Administration (FDA) Director General Eric Domingo said on Wednesday.
In a Laging Handa briefing, Domingo said these are Johnson & Johnson and Bharat BioTech.
He added that Bharat BioTech, the manufacturer of Covaxin vaccine, still lacks requirements for evaluation.
“Kailangan ma-prove nila na sumusunod sila sa good manufacturing practice, ‘yung certification, mukhang naaantala yata ang pagkuha nila ng (They need to prove that they observe good manufacturing practice, their certification, it seems that there’s delay in getting their) certification from the inspecting body,” he said.
As for Johnson & Johnson, Domingo reported that its clinical trial in the country is still ongoing and there are no interim results yet.
Earlier, Domingo said FDA is expected to complete its evaluation of Johnson & Johnson’s Janssen Covid-19 vaccine EUA application.
“Pero, itong EUA na nakuha nila sa Estados Unidos (But, this EUA they got from United States), Europe and WHO (World Health Organization) is based on their previous clinical trials in other countries and so far this is what was submitted to us," he said.
Citing the fact that the Janssen vaccine has passed the standards of the US and the WHO, Domingo said this means that the "benefits of using the vaccine outweigh the harm."
He added that evaluators are closely looking into the reports of blood clotting allegedly caused by the Janssen jabs in coming up with their recommendations.
"This Janssen vaccine is very similar with AstraZeneca, these are adenoviral vector vaccines. What we see are very rare cases of blood clotting, so once the evaluation is done and recommendations are made, we will probably have recommendations on how to guide vaccinators and vaccinees, to watch out for such (adverse) events, and what to do with these," he said.
This came in the wake of the suspension of the rollout of Janssen vaccines in the United States and Europe over incidents of blood clots. (PNA)
