Thai health ministry accelerates vaccine registration, allowing private sector to import COVID-19 vaccines

The FDA has fully facilitated the registration of the COVID-19 vaccines by mobilizing internal and external experts to consider them.

Bangkok – Dr. Narong Saiwong, the Deputy Permanent Secretary and spokesperson of the Ministry of Public Health (MOPH), dismissed a claim that the importation of two million doses of the COVID-19 vaccine from AstraZeneca is unfair to private hospitals, because the volume is too small and those receiving the vaccine are in a limited range. Also, the private hospitals which order vaccines from other companies still can’t import them, because the Food and Drug Administration (FDA) has not yet registered them and it is considered a risk to preventing the spread of COVID-19.

He said the FDA insisted that registration of the COVID-19 vaccines has not been delayed, but adheres to safety and quality standards. The documents must be complete because it is a product related to the life of the people. The FDA has fully facilitated the registration of the COVID-19 vaccines by mobilizing internal and external experts to consider them, so that the vaccines can be approved as soon as possible. It is not possible to relax regulations or reduce supervision because it is a product related to people’s lives.

For AstraZeneca’s COVID-19 vaccine, the FDA received registration application documentation on December 22, 2020, and sent it to experts to assess and approve the vaccine registration on January 20, 2021. The consideration took about one month. The vaccine, registered by the FDA, has been approved for emergency use. It is necessary to have a system for continual supervision and monitoring. Currently, two companies, namely AstraZeneca (Thailand) Co., Ltd. and Sinovac Biotech Co., Ltd., have submitted applications for registration of their COVID-19 vaccines through the Government Pharmaceutical Organization (GPO). The FDA is waiting for additional documents. It confirms that it is not preventing any company from applying for registration of their vaccine and is ready to provide advice and answer questions to facilitate the registration.

The GPO has purchased two million doses of COVID-19 vaccine from Sinovac Biotech Limited, from the People’s Republic of China, which has already applied for registration by the FDA. The FDA is gathering additional information. The GPO will purchase amounts of vaccine according to the Department of Disease Control’s demand. The vaccine will be distributed in accordance with the national allocation plan. The provision of COVID-19 vaccines must be done carefully and is subject to global demand. Moreover, the existing vaccines have just entered the production process and there is a high global demand. It is now known that other private companies have also applied for registration of vaccines from Chinese manufacturers. (NNT)