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Mixed reactions from healthcare experts, activists over REU for Covaxin, Covishield

Some ask for more transparency in the approval process and seek data related to vaccine trials while others say that grant of REU in clinical trial mode in an emergency situation is in public interest

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The DCGI’s approval of Serum Institute’s viral vector vaccine ‘Covishield’ and Bharat Biotech’s inactivated virus vaccine ‘Covaxin’ for restricted emergency use (REU) has received mixed reactions from experts in India.

The All India Drug Action Network (AIDAN) has issued a statement seeking clarifications from the DCGI pertaining to clinical trial safety and efficacy data. It AIDAN expressed “shock” over SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in ‘clinical trial mode’ and “specially in the context of infection by mutant strains”.

Similarly, Dr Babu KV, Founder Member, ADEH, expressed, “Whatever be the reason for emergency approval, the Government should place all the data related to vaccine trial in the public domain so that the citizens can take informed decisions on COVID vaccines. The authorities could have waited for a few more weeks for the completion of phase III trials. If phase III trials are not necessary, they could have given approval a few weeks back. What is more important is the trust of the citizens and the present hurry will not help it in any way.”

However, Prof Bejon Kumar Misra, Founder of Patient Safety & Access Initiative of India responded, “As citizens, we have full trust in the drug regulator of our country, which is the CDSCO. We are confident the experts on vaccines who looked into all the aspects of safety, quality and efficacy of Serum Institute and Bharat Biotech vaccines would have conducted due diligence in the manner prescribed as global best practices for emergency approval and would have never compromised on any aspect of safety and health of citizens.”

“We are sure both the vaccines manufactured are covered as per the law in case of adverse reactions and any kind of health consequences as Government is the sole purchaser today and citizens are made accessible to the vaccines free of cost. I do know that the reporting systems are in place and the restricted use is closely monitored by the healthcare COVID warriors. There should not be any worry as stated by the scientific community we are in touch with as potential users of the vaccines,” he said.

He added, “It is most unfortunate that certain sections of the community are mischievously misleading the innocent citizens who have full faith and trust in the existing system. We should never make such issues political and instead feel proud of our scientists in all such matters as they take full precautions before allowing any vaccines go commercial or made to be used on humans at times of emergencies like the present COVID-19 pandemic.”

Similarly, Vivek Padgaonkar, Independent Healthcare Consultant Former-Director OPPI (Project & Policy), opined, “The Subject Expert Committee (SEC), consisting of domain knowledge experts in the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, pan India has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest. It is as an abundant precaution, to have more options for vaccinations, on the ground that the existence of the pandemic, the detection of the UK strain and the vaccine’s safety profile meant that it could be approved in ‘clinical trial mode. Although, this is not the standard approval. The scheduled trial on 26,000 patients will continue and every person who gets the vaccine will be followed up and monitored for risk as well as benefit.”

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