The delay in emergency use authorisation of vaccine indicate regulatory standards are not being diluted


Vaccine makers Serum Institute and Bharat Biotech, who had applied for emergency use authorisation (EUA) of their locally produced vaccines, Covishield and Covaxin respectively, have been asked by the relevant authority to produce more data. Consequently, we are unlikely to see the roll out of a vaccine in the next few days.

ย This should not be viewed as a setback. Instead, it should be seen as an indication that the regulatory authorities in India are not bending over backwards to approve a vaccine. Given the scale of the pandemic and the lack of options, governments and pharmaceutical firms have prioritised resources to find a vaccine to combat the novel coronavirus. Years of normal lead time in vaccine development have been compressed to develop a new vaccine to combat Covid-19.. Therefore, it is important that regulators satisfy themselves about the safety and efficacy of the vaccine before emergency authorisation.

Also read: Covid-19: Vaccine makers asked to submit more data

The request for more data is a sign that the regulatory standards are not being diluted in the backdrop of an unprecedented rush to introduce a vaccine.

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