The Food and Drug Administration warns that the injection of Johnson & Johnson’s COVID-19 vaccine in Sa Kaeo province was illegal despite its registration with the FDA because the vaccine was smuggled into the country.
FDA deputy secretary-general Dr. Surachoke Tangwiwat issued the warning when he referred to a private clinic that injected the Johnson & Johnson vaccine into its patient in Aranyaprathet district of Sa Kaeo.
As the provincial health office suspected a patient of carrying the vaccine from Cambodia and seeking injection service at the private clinic, Dr. Surachoke said that the unauthorized import of the vaccine was considered as violating Section 12 of the Drug Act and the wrongdoer was liable to a jail term of up to five years and a fine of up to 10,000 baht.
Although the FDA registered the Johnson & Johnson vaccine, it must be imported by a licensed importer to guarantee the quality of the vaccine which must be stored at a proper temperature, Dr. Surachoke said.
Janssen-Cilag Co applied for the registration of the vaccine and had not imported it, he said.
The Johnson & Johnson vaccine was among the main COVID-19 vaccines that the government was acquiring for general people and it did not allow any unauthorized administration of the vaccine, he said.
The doctor who injected the vaccine into the patient violated a law of the Department of Health Service Support and breached ethics because the vaccine was smuggled, Dr. Surachoke said.