Even as announcing sketchy results of vaccine trials through press releases has become the troubling norm during the pandemic, Serum Institute has moved further down on the transparency scale even as the company seeks an emergency use approval. The Pune-based vaccine manufacturer has so far not shared any information about vaccine safety and efficacy even through press releases.
A day after Pfizer sought the Indian regulator’s nod for emergency use authorisation for its mRNA vaccine, the Pune-based Serum Institute on December 7 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 despite completing the interim analysis of phase-3 trial involving 131 Covid-19 cases and sharing bare details through a press release.
No safety, efficacy data released
Even as announcing sketchy results of vaccine trials through press releases has become the troubling norm during the pandemic, Serum has moved further down on the transparency scale even as the company seeks an emergency use approval. The Pune-based vaccine manufacturer has so far not shared any information about vaccine safety and efficacy even through press releases.
The company’s record on transparency with regard to Covishield vaccine trial leaves much to be desired particularly after a phase-3 trial participant developed serious adverse events. The silence of the Indian regulator in this case is also a concern unlike when it intervened when trail in India continued even as AstraZeneca halted the trials for investigating the serious neurological illnesses in a trial participant.
Gaining public trust
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. However, the speed of development and testing is causing concern particularly as 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 public 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 a stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen is required 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.
No room for hasty approvals
It will be unfortunate if the Indian regulator misreads the announcement by Prime Minister Narendra Modi announced a few days ago that a vaccine against COVID-19 would be available in the next few weeks as a signal to grant approval in haste. 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 therefore important that those seeking emergency use authorisation share the safety and efficacy data immediately with the public.