The DGDA has approved the vaccine following the scrutiny of documents related to its clinical trial and upon completion of necessary procedures
Amid a growing demand for Covid-19 vaccines, Bangladesh's drug authorities have approved the emergency use of the single-dose Covid-19 vaccine produced by Janssen Pharmaceuticals, owned by US-based multinational corporation Johnson & Johnson (J&J).
The Directorate General of Drug Administration (DGDA) approved the Emergency Use Authorization (EUA) for the Janssen vaccine on Tuesday afternoon, according to a press release issued by DGDA chief Maj Gen Mahbubur Rahman.
The development comes a day after Health Minister Zahid Maleque announced that the nationwide Covid-19 vaccination campaign, which stalled due to a suspension of supply back in April, would resume on June 19.
The approval for the Janssen vaccine came after the DGDA scrutinized the documents related to the vaccine's clinical trial, CMC part, regulatory status and also after receiving recommendations from a public health emergency panel which examined the efficacy of the vaccine.
Other than this, five more vaccines -- all double-dose ones -- have so far been cleared by the DGDA for use in Bangladesh.
They are: the Oxford-AstraZeneca vaccine, Russia’s Sputnik V, China’s Sinopharm and Sinovac, and the Pfizer-BioNTech vaccine.
As yet, the government has administered the Oxford-AstraZeneca and Sinopharm vaccines in the country.
According to the press release, the Maternal Neonatal Child and Adolescent Health (MNCAH) unit under the DGDA will act as the local agency of the company.
The single-dose vaccine will be preserved at 2-8 degrees Celsius.
People aged 18 or above will get the vaccine once the process of administering the vaccine gets underway.
Produced by Janssen-Cilag International NV of Belgium, the vaccine was enlisted by the European Medicine Authority for emergency use on February 11 and later by the US FDA on February 27, and the World Health Organization (WHO) on March 12.