Covid-19 Vaccines: The way for foreign vaccines like Pfizer and Moderna to enter India is clear, there will be no trial
Covid-19 Vaccines in India: Now foreign vaccines that have received emergency use approval from the World Health Organization or the US FDA, they will not have to undergo trials in India.
The way for foreign vaccines like Pfizer and Moderna to come to India is now cleared. The vaccines of both the companies will not have to go through local trials. The Drug Controller General of India (DGCI) has removed the conditions for conducting separate local trials on foreign vaccines like Pfizer and Moderna. That is, if a foreign vaccine has been approved for emergency use by the World Health Organization or the US FDA, then India will not have to undergo a trial.
A DCGI letter said it has done away with the need for foreign companies to conduct ‘post-launch bridging trials’ and test the quality of their vaccines in India if they have approval from specific countries or health bodies. DGCI chief VG Somani has said in the letter that this decision has been taken in view of the increase in Kovid cases in India and the need to increase the availability of vaccines.
It said, “The decision is made to approve vaccines in India for limited use in emergencies. Vaccines that are approved by the US FDA, EMA, UK MHRA, PMDA Japan or listed on the WHO emergency use list and which have already been used on millions of people are approved. Vaccine testing and bridging trial may be exempted by CDL, Kasauli.
Moderna seeks full approval from FDA for its vaccine
US pharmaceutical company Moderna has said that it has started the process to get the full approval of the US regulator for the use of the covid vaccine on adults. Moderna announced on Tuesday that it has begun providing research data on the two-dose vaccine to the FDA. FD and regulators of many other countries have already approved the emergency use of Moderna’s vaccine. So far more than 120 million doses of it have been given in America.
Large-scale research on Moderna’s vaccine continues even after emergency use has been approved. The FDA will investigate whether the vaccine meets the criteria for full approval. Moderna is the second pharmaceutical company to seek full approval for the vaccine. Earlier, Pfizer and its German partner company BioNTech have sought approval.
