Thai FDA asks Pfizer Thailand to seek full approval of its mRNA vaccine
The Thai Food and Drug Administration (TFDA) is urging Pfizer Thailand, the sole distributer of Pfizer-BioNTech’s mRNA vaccine in Thailand, to submit additional information for full approval registration.
TFDA Secretary-General Dr. Paisal Dunkhum said today that the agency had granted Emergency Use Authorization (EUA) for the Pfizer vaccine on June 24th, adding that it will take no more than 30 days to grant full approval if the representative company in Thailand provides more data on its effectiveness, safety, production quality and undesirable side effects, especially information about the use of the vaccine in people over 12 years old.
He said that, once full approval of the vaccine is granted in Thailand, it can be commercially marketed, like the vaccine for flu.
Dr. Paisal’s move follows the US FDA’s full approval of the vaccine, making it the first COVID-19 vaccine in the US to win the coveted designation.
“The FDA’s approval of this vaccine is a milestone, as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorisation, as the first fully FDA-approved COVID-19 vaccine, the public can be very confident that it meets the high standards of safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.
EUA allows a vaccine to become available prior to full approval during public health emergencies.