Transparency is vital: On authorisation of coronavirus vaccines

Safety and efficacy data must be known before emergency-use authorisation for vaccines

December 08, 2020 12:02 am | Updated 12:13 pm IST

A day after Pfizer sought the Indian regulator’s nod for emergency-use authorisation for its mRNA vaccine, the Pune-based Serum Institute of India has approached the regulator for a similar nod for its vaccine, Covishield , developed by Oxford University. Unlike Pfizer, 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, and perhaps necessitated by the toll the virus has taken on lives and livelihoods. But this is not without cause for concern at a time when governments are putting pressure on regulatory bodies to fast-track the entire process. Lack of transparency about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated. While 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. While 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, 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.

Prime Minister Narendra Modi announced a few days ago that a vaccine would be available in the next few weeks bringing some cheer in an otherwise desolate scenario. The sooner a vaccine is available, the better it is for everyone, but pushing through an 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. While the Indian government is aware of vaccine hesitancy among a certain section of people, the concerns are best addressed when all stakeholders are transparent at every stage and not by merely sharing guidelines regarding vaccine safety with the States. It is important that those seeking emergency-use authorisation share the safety and efficacy data immediately.

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