DGCI Approves The Vaccines By Serum Institute Of India And Bharat Biotech

The Drug Controller General of India Dr. V.G. Soumani on 3rd of January read out a short statement to the media stating that his office has approved the Covid-19 vaccines manufactured by the Serum Institute of India along with Oxford which is the Covishield and the vaccine manufactured by Bharat Biotech, the Covaxin, for restricted emergency use. However, there are certain questions which are yet to be answered. Also, the fact that both the vaccines got approval for their emergency use even as the third phase of the clinical trials are in place is the worrying factor.

India will be immunizing a vast population, however, is the vaccine actually safe or effective is still quite not clear. Although Dr. VG. Soumani said that, he assures that the vaccine is 110 per cent safe for use, but the main question is how can he be so sure when the third phase of the clinical trial of both the vaccines are going on, and on what grounds is he basing his statement? The Oxford AstraZeneca vaccine developed by the Serum Institute of India has 70.42 per cent efficacy, but the efficacy details of the Covaxin developed by Bharat Biotech has not been released yet, as the trials are still underway.

According to Dr. Sathyanarayana, the Head of the Department and Consultant of the Pulmonology department in Manipal Hospital, “the history of vaccine disasters dating back to centuries, the well proven and well effective vaccines have also been reported to have undesirable outcomes. This is due to the formulation defects, defective manufacturing, and defective storage conditions. The same stringent conditions will apply to the Oxford AstraZeneca Covid-19 vaccine too”.

Both the vaccines can be stored at 2-8 degrees, and the companies have been stockpiling of over 50 million doses at the moment, assuring that soon they will be manufacturing more dosage of the vaccine. After an adequate examination the Central Drugs Standard Control Organization (CDSCO) has decided to accept the recommendations of the subject expert committee, said Dr, VG. Soumani.  According to various media reports DGCI Soumani did not take any questions, after he read out his statement to the media.

There is a possibility that the Covaxin, maybe just a backup vaccine as the data from the clinical trials are being collected. The efficacy data is unblended once a commending number of Covid-19 positive cases appear in the sample population where a few people have received a placebo shot, while others have been given the vaccine. When a specific measure of Covid-19 vaccine positive cases occurs, the specialists unbind the data to analyze the efficacy of the vaccine in preventing the infections. Hence, it may require some more time for the information to be generated by the company and the organization should share it with the regulator on a rolling basis.