Bangladesh
Janssen Covid-19 Vaccine DGDA approves usage of Johnson & Johnson’s single-dose coronavirus vaccine
Dhaka, June 16: Directorate General of Drug Administration (DGDA) have approved the emergency use of the single-shot coronavirus vaccine produced by Janssen Pharmaceuticals, owned by US-based multinational corporation Johnson & Johnson (J&J), on Tuesday, according to a press release issued by DGDA chief Maj Gen Mahbubur Rahman.
The application was submitted to the Drug Administration through MNC & H, Line Director, Department of Health, Ministry of Health and Family Welfare, for the issuance of the Covid-19 vaccine Emergency Use Authorization (EUA) produced by Janssen-Cilag International NV, Belgium.
In this context, the Department of Drug Administration evaluated the dossier (clinical part, CMSpart and regulatory status) of the vaccine and formed a committee to evaluate the investigation of drugs, vaccines and medical devices in public health emergencies for the treatment of Covid-19.
The vaccine was approved for emergency use by the World Health Organization on March 12. On February 27, the US Department of Drug Administration and on March 11, the European Union approved Janssen's vaccine for emergency use.
The vaccine is suitable for people 18 years of age and older. The one-dose vaccine, made in Belgium, will be given to people of a certain age in accordance with the government's deployment plan, the statement said. Its storage temperature is 2-8 degrees Celsius.
