Synopsis- Concerns regarding hasty approval granted to the COVID-19 vaccines despites the lack of adequate efficacy data.
- The Drug Controller General of India (DCGI) approved the Subject Expert Committee’s recommendation for emergency use of Serum Institute of India’s Covishieldand Bharat Biotech’s Covaxin.
- Covishieldis the same vaccine as developed by Oxford- AstraZeneca, which has got emergency use approval in the UK.
- In the case of Covaxin, concerns have been raised about the absence of efficacy data, which is generated during Phase 3 of human clinical trials.
However, experts have voiced their concerns on the approval process and the lack of publicly released efficacy data for Covaxin.
How India’s credibility as manufacturer of vaccine is at stake?
The hasty nod for Covaxin has put India’s credibility as a manufacturer of vaccines is at a stake and has raised eyebrows in the scientific and healthcare communities about a “public rollout of an untested product.
- First, Covaxinhas no clinical efficacy data- Bharat Biotch’s Covaxin vaccine is still in stage 3 clinical trials in India and the final results are yet to be released. The recommendation comes despite the lack of efficacy data for Covaxin.
- Efficacy data is an indication of how effective the vaccine is in preventing the virus attack.
- Moreover, the decision is a violation of the criteria in the draft regulatory guidelines for the development of COVID-19 vaccines published by CDSCO, in which it is clear that safety and efficacy data is required for approval of vaccine, but the indigenous vaccine from Bharat Biotech does not have efficacy details because the trials are underway.
- Second, credibility of regulator at stake-This lack of transparency could lead to a lack of trust in the vaccine. There are several issues with the way the approval has been granted, which can lead to people losing confidence in the regulatory system.
- Third, approval an untested vaccine makes it nearly impossible to conduct a proper phase-3 trial.
- It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere.
- Fourth, Pharmaceutical giants like Pfizer, Moderna and AstraZeneca have given a go-ahead only after partial results of vaccine’s abilities in their own populations.
- Whereas in India similar data for vaccine ability among Indian population has not been published. As it is a possibility that vaccine response among India population may not be the same as among the European Population.
The rush to approve COVID-19 vaccine without proper clinical trial may do more harm than good. So, it would be better to wait for the preliminary data from the phase-III trials to come in, and then grant the approval.
What is the way forward?
- In light of the intense concerns arising from the absence of efficacy data, the Use of Covaxinshould be treated as extended clinical trials.
- For the larger scale implementation of vaccines, Government needs to carefully monitor immune response to different vaccines and assess the efficacy across populations.