FDA approves Sea Lion Group to import Sinovac vaccine NEWS

News date: 11 November 2021Source: https://elevenmyanmar.com/news/fda-approves-sea-lion-group-to-import-sinovac-vaccine

A private healthcare company, the Sea Lion Group, announced they have officially licensed the Sinovac COVID-19 vaccine in Myanmar.

The Myanmar Food and Drug Administration (FDA) officially allowed the Sea Lion Group to import and distribute the vaccine on November 1.

Sea Lion Group, partnered with Sinovac Biotech Ltd. to sell Sinovac COVID-19 vaccine from mid-November, according to the Ministry of Health (MOH).

The first batch of vaccine is scheduled to arrive in Myanmar in November.

The MOH urges people to use only those vaccines that are officially licensed by the ministry as counterfeit vaccines sold via online in the market or vaccines sold by other means are not immune and can be dangerous as they are not legally imported.

The COVID-19 vaccines, including Covishield, which is sold in the market, are not legally imported vaccines and may be counterfeit and unprotected due to poor quality assurance in transport, according to the MOH.

Vaccines need to be legally sold and stored in the freezer to ensure high quality and safe vaccines.

If private pharmaceutical companies want to distribute and vaccinate high quality and safe COVID-19 vaccines available in Asia, they can apply to the FDA with the required documents.

The license holder is required to have a Drug Import Approval Certificate (DIAC) and is required to comply with the provisions of the National Drug Law and needed to follow rules and regulations. The cold chain method specified for the COVID-19 vaccine should be strictly adhered to. Providing necessary training and the installation of refrigerators must be carried out in accordance with the guidelines of the MOH.

The ministry made an announcement on February 11 that the private sector can import and distribute vaccines, and private sector can be applied for the import of COVID-19 vaccines in March.