Renata Pharmaceuticals has sought permission from the government to import the coronavirus vaccine developed by US drug manufacturing company Moderna.
"Renata Pharmaceuticals has submitted an application seeking permission to import Moderna's Covid vaccine. The relevant documents have been sent to the Directorate General of Drug Administration (DGDA), which is verifying the company's capacity," said Dr ABM Khurshid Alam, director general of the Directorate General of Health Services.
Noting that the vaccines need to be preserved at a temperature of below zero degrees, the health directorate chief said "We can preserve this vaccine in Dhaka, but there is no arrangement to store it outside Dhaka."
He made the disclosure talking to reporters in the capital on Monday.
Earlier on 30 April, the World Health Organization (WHO) listed the Moderna COVID-19 vaccine (mRNA 1273) for emergency use, making it the fifth vaccine to receive emergency validation from WHO.
WHO's Emergency Use Listing (EUL) assesses the quality, safety, and efficacy of COVID-19 vaccines, a prerequisite for supplying vaccine to the global COVAX initiative. WHO's EUL also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The vaccine was reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), which made recommendations for vaccine use in populations (i.e. recommended age groups, intervals between shots, and advice for specific groups such as pregnant and lactating women).
SAGE recommended the vaccine for all age groups 18 and above in its interim recommendations dated 25 January 2021.
The US Food and Drug Administration issued an emergency use authorization for the Moderna vaccine on 18 December 2020, and a marketing authorisation valid throughout the European Union was granted by the European Medicines Agency on 6 January 2021.