Mumbai: In an exclusive interview with The Free Press Journal, Dr Shashank Joshi, member of the state's Covid-19 task force explains the vaccination process and speaks about its safety in the wake of the DCGI’s restrictive emergency use approval. Incidentally, Dr Joshi is also a member of the state-level coordination committee led by the Chief Secretary for the vaccination process.

Q: How do you view the DCGI’s approval?

A: Congratulations to Team India for having approved vaccinations for Covid-19. Let’s look at each limited drug approval from two standpoints - one is safety and the second is public health implications in a pandemic.

The Serum Institute Oxford vaccine (biosimilar made by transfer of technology) is a chimpanzee-adenovector platform. There is Global Phase 3 in place in the UK, South Africa, Brazil and the USA. Indian Phases 2 and 3 are ongoing, with a limited number of 1,600. Immunogenicity data has been submitted. It has been given approval for emergency use while the clinical trials continue in India.

As for the Bharat Biotech-ICMR Phase 2 data, it is public domain under peer review. In Phase 3, 15,000 patients’ interim data has been presented to the subject expert committee, based on which limited research mode emergency use approval has been granted. The vaccine is safe and also effective against the mutant strain.

In the case of the Zydus Cadila DNA vaccine, Phase 2 is over while Phase 3 has commenced.

DRL Sputnik is an ongoing adenovector, while Pfizer did not appear before SEC for reasons best known to them.

Covishield and Covaxin have efficacies of more than 50 per cent and storage condition cold chains are economical. Safety data is possibly best in inactivated virion, followed by the chimpanzee adenovector.

Possibly due to the pandemic, a decision was taken to fast-track an already fast-tracked process, to make it available for the population.

Q: Are Covishield and Covaxin safe?

A: Yes.

Q: Are they effective?

A: More than 50 per cent effectiveness meets the global regulatory requirement.

Q: Do they need vigilance and research modes?

A: Yes, it's already in place.

Q: Is more data needed?

A: Yes, it has to continue and be published in peer-reviewed journals.

As I understand, Oxford will be ready and out for use. Bharat Biotech use will still be in research mode in an open-label way. Cadila will be in pure Phase 3 mode.

Let's hope we can vaccinate all healthcare workers and Covid frontliners with Oxford alone, as Serum Institute claims to have stockpiles of the same.

Source link