The Covid vaccine development process was accelerated without compromising on quality, vaccine safety and efficacy standards by removing dead spaces within the development process, according to an official of US Food and Drug Administration (USFDA).
“Normally, vaccine development takes about 3-4 years through the entire process before it is made available for public use. But in the case of Covid-19 pandemic, life sciences companies managed to develop vaccines within a year. This was possible by removing the dead spaces within various phases of development,” Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), USFDA, said.
Delivering his keynote address at the BioAsia 2021 Summit, Marks said, “Normally, at every stage of vaccine development, there is a start-and-stop process. In the case of Covid vaccine development, these were eliminated and all the stages of development, including phase-1, -2 and -3 trials were conducted seamlessly, given the importance of vaccine development to tackle Covid. And life sciences companies worked on their manufacturing side to ensure that the vaccine rolls out at the shortest time.”
Now the focus is on not only ensuring equitable distribution of vaccines across the globe but also ensuring that the vaccine hesitancy gets addressed and people get administered without any fear, he said.
India’s role
The FDA played a critical role in the development stage, manufacturing and post marketing surveillance. The challenge now is to manufacture in big numbers for distribution across the world. This is where India as a major vaccine-maker could play a significant role in supplies, he said.
“As we address the Covid pandemic and administer vaccines, we also need to keep track of variants and ensure that the vaccines address new variants,” he said.
“With the emergence of Covid-19 variants, it may be necessary to introduce changes in vaccine either through altering the existing vaccine or addingsecond or third vaccine component. These changes will require careful consideration but not redoing studies involving clinical end points,” Marks said.
Challenges
“One of the challenges the FDA faced was the misinformation being spread about the vaccine efficacy, which is also one of the reasons for hesitancy. We are not afraid to fight against the wrong information being spread,” he said.
“We continue to ensure passive monitoring through the Vaccine Adverse Event Reporting System and the V-safe text monitoring system for Covid-19 vaccine safety. The Active Monitoring through Vaccine Safety data link is ensured by covering more than 100 million lives. This is by monitoring claims data and about 15 safety outcomes of interest,” he explained.