As India pushes for clinical trials, Pfizer reassures on safety of its vaccine

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New Delhi: Pfizer pharmaceutical company on Monday said that it informed the Indian government that there are zero concerns over the safety of its COVID-19 vaccine, as the latter insists on holding local trails before it can be approved for use here.

Previously, the  Indian government had made it easier for the vaccines approved in the West and Japan to sell in India. But, the companies still have to initiate local clinical trials within 30 days to clear the approval.

US-based Moderna, Johnson Johnson and Pfizer have then been invited for applications. However, none of them came forward so far.

Pfizer, after withdrawing its interest in February, is holding renewed talks with India and is looking for ways to skip the local clinical trials. 

It argues that the safety and efficacy data had been backed by regulatory authorities in the United States, Britain, Japan and the World Health Organization – agencies that India endorses, Reuters reported, quoting an official spokesperson.

“Pfizer’s application for emergency use authorization was supported with data that shows an overall efficacy rate of 95 per cent with no safety concerns,” the spokesperson said.

Pfizer also emphasised that it would supply doses only through government contracts and explained that they will deliver the shot to vaccination centres using its specially designed, temperature controlled thermal devices, as the vaccine needs to be stored in minus 70 degree Celsius.

They also informed that the vaccination can be stored for up to six months if stored in ultra-low temperature freezers, or till five days in a common refrigerator and freezer.

India on Tuesday reported up to 3.57 lakh new cases and the highest single-day spike was reported on May 1 when the cases crossed 4 lakh to hit a new global record. Vaccine shortages are reported from several states, as the country stepped into its next leg of its immunization programme to vaccinate everyone above 18 years of age.