By The Nation
The FDA chief confirmed that AstraZeneca (Thailand) and Sinovac Biotech have submitted approval applications with the FDA for their vaccines, which are being purchased by the government.
Manufacturers or importers of other vaccines that have already been registered by foreign food and drug agencies could also apply for approval, said Paisan. The state does not have a monopoly on Covid-19 vaccines and would not block their import, he added. Private hospitals could purchase a vaccine that is registered with the FDA or, as licensees, register the vaccine themselves.
“People can be confident that vaccines registered by the FDA are safe, high-quality, effective, and can prevent disease. In order to protect consumers, the FDA is preparing to tightly monitor vaccines for safety,” he said.
To register vaccines with the FDA, Thai licence holders are required to present safety information, plans for use, and contingencies in case of side effects.
The FDA’s safety assessment will consider results from the vaccine study, including dosage size and vaccination period, plus quality control in the production process. Paisan said the FDA would not be responsible for the price of vaccines offered by private companies.