Covaxin production takes 120 days depending on technology framework, regulatory guidelines: Bharat Biotech

By Shalini Bhardwaj
New Delhi [India], May 28 (ANI): Amid reports of shortage of its COVID-19 vaccine in the country, Bharat Biotech on Friday said that the timeline for manufacturing, testing, and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met.
In an official release, the COVID-19 vaccine manufacturer said the production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June, approximately after 120 days.
"There is a four-month lag time for Covaxin to translate into actual vaccination. The timeline for manufacturing, testing, and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. The manufacturing, testing, release, and distribution of vaccines is a complex and multifactorial process with hundreds of steps, requiring a diverse pool of human resources," read the release.
Bharat Biotech said the production scale-up of vaccines is a step-by-step process, involving several regulatory Standard Operating Procedures (SOPs) of Good Manufacturing Practices (GMP).
"After its production, the timeline for vaccine supplies to reach the depots of the State and Central Governments from the manufacturing unit is around two days. The timeline for vaccine supplies to reach the depots of the State and Central Governments from Bharat Biotech's facilities is around two days," read the release.
"The vaccines received at these depots have to be further distributed by the State Governments to various districts within their respective states. This requires an additional number of days. Pandemic vaccines are distributed by respective governments equitably across all sections of the population. Vaccines once available at the vaccination centres are then administered to recipients over a period of time, based on demand," it said.
Bharat Biotech further stated that based on Central Drugs Standard Control Organisation (CDSCO) guidelines, all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory, Government of India.
"All batches of vaccines supplied to State and Central Governments are based on the allocation framework received from the Government of India," the company asserted. (ANI)