The approval was given scrutinizing the documents related to clinical trial and upon the completion of necessary procedures
Amid a growing demand for coronavirus vaccines, Bangladesh’s drug authorities have approved the emergency use of Janssen Covid-19 vaccine.
American multinational corporation Johnson & Johnson (J&J) is producing the vaccine.
The Directorate General of Drug Administration (DGDA) approved the Emergency Use Authorization (EUA) for Janssen vaccine on Tuesday afternoon, confirmed a press release issued by DGDA chief Maj Gen Mahbubur Rahman.
The development came just a day after the health minister announced that the nationwide Covid-19 vaccination campaign, which stalled due to a suspension of supply back in April, is going to resume on June 19.
The latest approval was given scrutinizing the documents related to clinical trial, CMC part, regulatory status and also after receiving recommendation from a public health emergency panel which examined the efficacy of the vaccine.
This is the first single-dose vaccine to get approval for emergency use in the country. Other than this, four more vaccines– all double dose ones– have so far been cleared by the DGDA.
The other vaccines that got the approval in the country are Oxford-AstraZeneca vaccine produced by Serum Institute of India (SII), Sputnik V of Russia, Sinopharm and Sonovac of China and Pfizer of Belgium.
However, the Bangladesh government has administered the UK’s Oxford-AstraZeneca and China’s Sinopharm vaccines only as yet.
According to the press release, the Maternal Neonatal Child and Adolescent Health (MNCAH) unit under the DHDA would act as the local agency of the company.
The single-dose vaccine would be preserved at 2-8 degrees Celsius.
People aged 18 or above would get the vaccine jabs when its administration starts.
Produced by Janssen-Cilag International NV of Belgium, the vaccine was enlisted by European Medicine Authority for emergency use on February 11 and later, by the US-FDA on February 27 and the World Health Organizationon March 12.