[ad_1]
Director General of the Food and Drug Administration Eric Domingo (screenshot)
MANILA – Food and Drug Administration (FDA) CEO Eric Domingo said Tuesday that the only emergency use authorization (US) request he has received so far was Pfizer’s 2019 coronavirus disease vaccine. (Covid-19).
“This (request) was sent to us late in the afternoon on December 23. It was sent online to the FDA and we downloaded their submissions yesterday, and have distributed them to the reviewers and regulators,” Domingo said at a conference. online press. .
He said the evaluation, which he expects to be completed in two weeks, will focus on both the regulatory aspect for the quality of the vaccine and the clinical trial for its efficacy and safety.
“Of course, that doesn’t include the possibility that we are still requesting documents for your application. But from what I can see, almost all of our requirements are included in your submission. We just have to review it.” Domingo said, adding that other vaccine manufacturers could be ready for US application in January 2021.
He said the FDA has already received three requests for clinical trials of the vaccine to be conducted in the country.
“Yesterday we already approved one and this is the clinical trial of Janssen (of Johnson & Johnson). This has received the signal from the FDA and maybe they will start with the clinical after the New Year,” said Domingo.
He said the application of China’s Clover biopharmaceuticals is still pending, as the FDA is “awaiting some documentation from the proponent to complete the requirements.”
Sinovac from China, he said, has requested some changes to its research protocol or design, so it was returned to the reviewers for final approval.
On Monday, Domingo directed the FDA’s Compliance Unit to investigate reports that certain people in the country have received injections of Covid-19 vaccines.
“We want to know the status of the vaccination and what vaccines were used. But of course that will probably take a few days, so we can’t give you updates yet,” he said. (PNA)
[ad_2]
