The recommendation by an advisory panel of the US Food and Drug Administration (FDA) that the regulator provide emergency use approval for Pfizer Inc and BioNTech’s Covid-19 vaccine will strengthen their case when they seek similar authorisation by Indian authorities, according to regulatory experts.
“This will definitely give them some added advantage if Pfizer-BioNTech vaccine candidate application is put before the subject expert committee (SEC) here in India with the US FDA approval already in place,” said a senior official in the Central Drugs Standards Control Organisation (CDSCO) with knowledge of the matter.
The official, who spoke on condition of anonymity, added: “However, whether it will guarantee a waiver from India trials of their vaccine candidate or not cannot be claimed for sure as this decision is to be made purely by the expert committee looking into the emergency use authorization applications.”
So far, the Indian regulator has not granted regulatory approvals to any vaccine candidate based on data generated during trials held in other countries, and without any clinical trial data generated from within the country on tests having been conducted on the local population.
The UK has already rolled out the Pfizer-BioNTech vaccine, named BNT162b2.
“It has not happened so far that the approval has been granted for sale and distribution without clinical trials on Indian population. The number of participants can remain comparatively smaller like between 10 and 40 but the results of tests conducted locally were sought. However, there is always a provision to waive local trials and go by the data generated globally in case of a pandemic situation when the processes have to be expedited. The committee is authorized to take a call on this,” the cited above said.
Among the vaccine manufacturers in India, Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd, Dr Reddy’s Laboratories Limited and Wockhardt Limited are involved in Covid-19 vaccine development and manufacturing, of which two have applied for EUA.
Pfizer was the first company to apply in India for emergency use authorisation of theCovid-19 vaccine developed by it and BioNTech.
Apart from Pfizer’s application, Wednesday’s SEC meeting also looked at Bharat Biotech’s application for its Covaxin, based on data from Phase1/2 trials, and SII’s application for Covishield, based on Phase 3 trial data conducted outside India, and the Phase 1/2 trials data conducted in India.
The committee asked Bharat Biotech to submit data from its ongoing Phase 3 trials and SII to get more updated data on the Phase 3 trials, and also approval status from the UK’s drug regulator.
The 10-member SEC, however, is yet to hear back from SII and Bharat Biotech, following the meeting on Wednesday where these companies were asked to submit more trial data on their vaccine candidates for the committee to make a decision on whether emergency use approval should be granted.
“They had to come back with the relevant data as we had already communicated recommendations of the committee to them. The committee usually keeps meeting from time to time to analyse data on other products, but for Covid-19 we already are looking at accelerated review process for fast-tracking the approvals so it will convene as soon as the companies get back. It could be in 10 days or even a month; the ball is entirely in their court,” the official cited above said.
The World Health Organization (WHO) also held a meeting with national regulatory authorities and vaccine manufacturers in WHO’s South-East Asia Region on Friday to discuss fast tracking of a Covid-19 vaccine roll-out in member-countries.
“The vaccine manufacturing and regulatory sectors have a critical role to play in equitable and efficient deployment of vaccines,” said Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia Region, at the two-day virtual meeting that ended on Friday.
Source: Read Full Article