Explained: Fast-track approval of foreign-produced vaccines

On Tuesday April 13 the central government announced it has fasttracked emergency approval for foreignproduced vaccines that have been granted similar clearances in other countries The aim is to expand the basket of Covid19 vaccines and boost the pace of inoculation in IndiaThe 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 farThe decision to fasttrack 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 Covid19 tally with over 13482023 casesWhat do we know about the decisionThis decision was made based on recommendations by an expert panel The panel said that COVID19 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 vaccinesIn a statement the Ministry said ldquoThis 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 userdquoCurrently what are the vaccines in use in IndiaPresently 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 Reddys Laboratories Ltd has received the permission from the Drug Controller General of India DCGI to import Sputnik V vaccine for restricted use in emergency situationsWhat do we know about the different foreign vaccines approved in other countriesThere are three vaccines in the WHO list mdash OxfordAstraZeneca produced in India as Covishield PfizerBioNTech and Johnson amp Johnson JampJ jab In preliminary clinical trials the PfizerBioNTech vaccine had efficacy of 94 percent JampJ 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 USThe US FDA too apart from JampJ has approved PfizerBioNTech and Moderna vaccine which was shown to have 941 per cent efficacy However currently the JampJ vaccine has been paused in the US due to reports of blood clots But it is unlikely that this will affect its application in IndiaFour approvals have been given by European Medicines Agency EMA including the three jabs approved by the US as well as OxfordAstraZeneca On the other hand UK has approved three mdashPfizerBioNTech Moderna and OxfordAstraZeneca Japan has approved the PfizerBioNTech while OxfordAstraZeneca and Moderna have applied for approval there We now have to wait and see which foreign vaccine India approves firstWith inputs from PTI and IANS