Pfizer submits application for EUA to PH FDA, Janssen applies for clinical trial


The American pharmaceutical company Pfizer submitted an application for emergency use authorization (EUA) for their developed vaccine against the Coronavirus Disease 2019 (COVID-19) to the Philippine Food and Drug Administration (FDA).

According to FDA Director General Eric Domingo, the preliminary evaluation for the Pfizer vaccine may be completed within 2 weeks. Through the EUA, the process of approving the vaccine will be shortened as long as adequate evidence of its efficacy is presented.

Pfizer has already obtained an EUA from the United States (US) and United Kingdom (UK).

FDA Dir. Gen. Domingo also announced that the agency has approved the application for clinical trial in the country of Janssen vaccine from Belgium.

“The next step now is for the Department of Science and Technology (DOST) vaccine expert panel to assign an area where the trial will take place then start recruiting subjects for the clinical trial,” he disclosed.

Meanwhile, the FDA bared that the Sinopharm vaccine from China that is said to have been used on several Filipino soldiers and members of the Presidential Security Group (PSG) have not applied for clinical trials in the Philippines, but it is included in the list of the DOST expert panel.

The FDA further disclosed that the alleged vaccination of the said individuals have not been consulted with the agency or the Department of Health (DOH). While the FDA reiterated that it is illegal under the law to import, sell, distribute, and administer unregistered vaccines, it does not see any violation on the side of those who were vaccinated. – Report from Bea Bernardo

Popular

PAGASA announces start of Habagat season; heavy rains expected over MIMAROPA, Western Visayas

By Brian Campued Make sure to always bring your umbrella with you as it will be useful both for the intense hot weather and the...

PBBM: I have never turned up the ‘political heat’

By Brian Campued President Ferdinand R. Marcos Jr. on Friday stressed that he has not engaged in any political attack or declared “war” against any...

PH, Japan push shared dev’t initiatives in PBBM’s state visit

By Brian Campued On the sidelines of his state visit to Japan on Thursday, President Ferdinand R. Marcos Jr. met with representatives of key Japanese...

PBBM at Japan’s Diet: Seas must be ruled by law, not force

By Darryl John Esguerra | Philippine News Agency President Ferdinand R. Marcos Jr. on Thursday underscored the importance of upholding international law, maritime security, and...