FASTER ROLLOUT DUE TO REMOVAL OF ‘DEAD SPACES’ IN VAX DEVELOPMENT

One of the outcomes of the race against time to develop vaccines for Covid-19, has been the realisation that there was a lot of “dead space” between various stages of vaccine development. And eliminating these dead spaces cut down the time taken to get a vaccine from the lab to the people much faster than the time taken in pre-Covid-19 pandemic days.

Explaining this process, Dr Peter Marks, director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration, taking out the time periods between the different phases of vaccine development and making the process seamless with respect to conduct of trials, has helped in faster arrival of the vaccines into the market.

Delivering the keynote address online at the BioAsia 2021 on Monday, Dr Marks said vaccine manufacturers too were willing to scale up production in anticipation of being successful. This was an acceptable risk for them in a pandemic condition, he said.

The emergency use authorisations, however, were based on sound knowledge generated from well designed and well conducted clinical trials. The authorisations, he said, were issued without compromising on vaccine safety, and not requiring large scale clinical outcome studies and by adopting a transparent process to increase confidence in the vaccines.

To a question on India’s role in vaccine distribution globally, Dr Marks said the US needs to export Covid-19 vaccines as much as possible and India too needs to produce as much as it can to help the rest of the countries. “The two countries should use our mutual pharmaceutical manufacturing capacities to bring an end to this pandemic,” he said.

● DELIVERING THE keynote address online at the BioAsia 2021 on Monday, Dr Marks said vaccine manufacturers too were willing to scale up production in anticipation of being successful. This was an acceptable risk for them in a pandemic condition, he said.