Thai FDA hopes to grant full approval to Pfizer vaccine imminently
Thailand’s Food and Drug Administration is seeking more information from Pfizer about its Covid-19 vaccine, in the hope of granting it full approval shortly. The vaccine, along with the other Covid-19 vaccines in use in the Kingdom, currently only has emergency use authorisation. The US Food and Drug Administration recently granted the Pfizer vaccine fully approved status.
The Bangkok Post reports that if fully approved in Thailand, the vaccine could be purchased by private hospitals without the involvement of government agencies like the Government Pharmaecutical Organisation. There has been widespread criticism of the government’s slow procurement of mRNA vaccines like Pfizer, while private hospitals have been prevented from ordering them directly from the manufacturer due to the fact that they did not have full FDA approval.
Paisarn Dunkum from the FDA says Pfizer has been invited to submit additional information to the administration. He says that if the manufacturer submits an application for full approval, Thailand will likely follow the US in fully approving the vaccine for use in people over the age of 16. Like the US, the vaccine will remain approved for emergency use only in people between the ages of 12 and 15.
“The US FDA approved the use on people aged 16 years and more, but still keeps the emergency use condition on children aged 12-15 years. So, we will initially follow the same procedure.”
Paisarn adds that the process of granting full approval could be done in as little as 30 days and will make it a lot easier for hospitals to order the vaccine directly from the manufacturer.
“If approved, it will be a general vaccine, like the avian flu vaccine, that hospitals can purchase directly from suppliers.”
SOURCE: Bangkok Post
