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Questions raised on approval of covaxin, covishield vaccines

Questions raised on approval of covaxin covishield vaccines

Eastern Times, New Delhi: Serum’s Covishield and India Biotech’s approval of the use of Covaxin on an ‘emergency basis’ are raising multiple questions about how the vaccines were cleared before receiving the report of the third phase trial. However, according to the Union Health Minister, the vaccines will be used in clinical trial mode and that the use has been restricted keeping in mind the issue of safety.

Although, according to many scientists, report of the first and second stages of the vaccine are extremely encouraging.

However, report of the third phase of the vaccine trial, which began in November, has not yet arrived. There is also a big concern about the effectiveness of the vaccines in preventing virus attacks.

However, Adar Punawala, head of the Seram Institute of India said that there should be no doubt about the efficacy of Covishield vaccine which has been developed at the Serum Institute Vaccine Research Center in Pune following the Oxford-AstraZeneca vaccine formula.

Punawala added that “the effectiveness of Seram’s vaccine has been proven. Since the vaccine is based on an agreement with Oxford, it has been awaiting approval from the UK’s Vaccine Regulatory Committee for a long time. No problems were encountered during the trial in India”.

Dr Gagandeep Kang, vaccine scientist and professor at the Christian Medical College in Vellore, said, “If you look at the data published in September by the DCGI (Drug Controller General of India), there were some important issues for approval of the Covid-19 vaccine.

It was very clearly mentioned that they wanted safety and effectiveness and it was expected that there would be at least two months of follow-up for testing the safety of the vaccine. However, in the case of Covaxin, such a rule was not obeyed. Hence, where is that data based on what DCGI wanted? Obviously, there is no data based on effectiveness”.

Shahid Jamil, a virologist and director of the Trivedi School of Bioscience at Ashok University echoed the same concern saying that “Efficacy data is needed to approve emergency use”.

These Indian vaccines may eventually reach the international market. It is important to have confidence in our regulatory agencies. Otherwise, credibility of these companies will suffer”.

Although Randeep Guleria, director of the All India Institute of Medical Sciences and member of the National Covid-19 Task Force, said the covaxin was approved to check whether the covid infections were on the rise in the country and that the quantity of vaccines produced by Oxford University that reached India were insufficient.

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