Explained: Fast-track approval of foreign-produced vaccines

The photo is for representational purpose only

On Tuesday, April 13, the central government announced it has fast-tracked emergency approval for foreign-produced vaccines that have been granted similar clearances in other countries. The aim is to expand the basket of Covid-19 vaccines and boost the pace of inoculation in India.

The Union Health Ministry said that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before the jabs are rolled out for immunisation programmes within the country. As approvals have yet to begin, potential pricing has not been discussed so far.

The decision to fast-track comes at a time when coronavirus cases are on a record rise and some parts of the country are also witnessing vaccine shortage . Also, in terms of number of cases, data from Johns Hopkins University (JHU) showed that India has overtaken Brazil, which is now at the third spot in the Covid-19 tally with over 1,34,82,023 cases.

What do we know about the decision?

This decision was made based on recommendations by an expert panel. The panel said that COVID-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan, or which are listed in the WHO Emergency Use Listing, may be granted emergency use approval in India too. However, after approval, there will be parallel bridging clinical trials in the Indian population for such foreign vaccines.

In a statement, the Ministry said, "This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use)."

Currently, what are the vaccines in use in India?

Presently, two vaccines, Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII), are being used for immunisation in India. The third vaccine, Sputnik V, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, also got emergency use approval in India. In India, Dr. Reddy's Laboratories Ltd. has received the permission from the Drug Controller General of India (DCGI) to import Sputnik V vaccine for restricted use in emergency situations.

What do we know about the different foreign vaccines approved in other countries?

There are three vaccines in the WHO list - Oxford-AstraZeneca (produced in India as Covishield), Pfizer-BioNTech and Johnson & Johnson (J&J) jab. In preliminary clinical trials, the Pfizer-BioNTech vaccine had efficacy of 94 percent. J&J had recently been in talks with the Indian government about beginning clinical trial of its single dose vaccine in the country. The current decision by the centre may speed this up. That vaccine has shown overall efficacy of 66 percent globally, and 72 percent in the US.

The US FDA, too, apart from J&J, has approved Pfizer-BioNTech and Moderna vaccine, which was shown to have 94.1 per cent efficacy. However, currently, the J&J vaccine has been paused in the US due to reports of blood clots. But it is unlikely that this will affect its application in India.

Four approvals have been given by European Medicines Agency (EMA) including the three jabs approved by the US as well as Oxford-AstraZeneca. On the other hand, UK has approved three - Pfizer-BioNTech, Moderna and Oxford-AstraZeneca. Japan has approved the Pfizer-BioNTech, while Oxford-AstraZeneca and Moderna have applied for approval there. We now have to wait and see which foreign vaccine India approves first.

(With inputs from PTI and IANS)