Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP. There is a four-month lag time for Covaxin to translate into actual vaccination, a statement by the company said
Responding to public outcry on the dearth of vaccines available for vaccinations, Bharat Biotech has released a detailed statement on the production scale-up of the vaccine.
According to the statement, 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. For vaccines to result in actual vaccination of people, highly coordinated efforts are required from 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). 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. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June, it added.
The statement also said that based on the 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 (CDL), 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.
It further stated that 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 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.