Signalling further delay in the release of the next batch of Covaxin, the Hyderabad-based manufacturer Bharat Biotech said on Friday that the production batches of the vaccine that were initiated during March this year will be ready for supply only during the month of June.
“The timeline for manufacturing, testing and release for a batch of the vaccine is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. It is a complex and multifactorial process with hundreds of steps, requiring a diverse pool of human resources,” the company said in a statement issued late Friday.
For vaccines to result in actual vaccination of people, highly coordinated efforts are required from the international supply chain, manufacturers, regulators and State and Central government agencies. Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices). Therefore, there is a four-month lag time for Covaxin to translate into actual vaccination, the company said.
The company’s statement was in the context of the rising concerns from across the country about the shortage of CoViD-19 vaccines and indefinite delays in supply by the manufacturers.
“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,” Bharat Biotech said in the Friday statement.
The timeline for vaccine supplies to reach the depots of the State and Central Governments from Bharat Biotech’s facilities is around two days. 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 centers are then administered to recipients over a period of time, based on demand, the company said.