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Context: Safety and efficacy data for the new vaccine must be known before emergency-use authorisation for vaccines.
Why in news?
- The Pune-based Serum Institute of India has approached the regulator for nod for its vaccine, Covishield, developed by Oxford University.
- AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies.
- AstraZeneca recently gave details of the interim safety and efficacy data involving 131 COVID-19 cases in the phase-3 trials in the U.K. and Brazil. But details of the trials in India are not out yet.
- The unprecedented speed in taking the vaccine from the development stage to approval process in less than a year is remarkable but also necessitated by the toll the virus has taken on lives and livelihoods.
- To reduce mortality and morbidity.
- Regulatory bodies under pressure: to fast-track the entire process.
- Lack of transparency: Opaqueness about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated.
- For example, Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol, the time points at which interim analysis of phase-3 trial in India will be carried out for safety and efficacy is unclear.
- No checks: the U.S. FDA has clearly spelt out at least 50% efficacy and stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen to assess a vaccine’s benefit-risk profile for emergency-use approval. However, no such conditions have been mentioned by the Indian regulatory agency. The phase-3 trial of Covishield began on September 21 and completed the enrolment on November 12.
- Fear of side effects and vaccine hesitancy: ineffective or unsafe vaccine is worse than not having one.A survey by the London-based Vaccine Confidence Project revealed that though the intent to get vaccinated was 87% in India, 34% respondents were worried about side-effects while 16% were concerned about fast-moving trials.
What needs to be done?
- Need to engage all stakeholders in a transparent manner at every stage and not by merely sharing guidelines regarding vaccine safety with the States.
- It is also important that those seeking emergency-use authorisation share the safety and efficacy data immediately.
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