On Tuesday, amid complaints of shortage of the Corona vaccine, the central government changed the rules and opened the country’s doors for all foreign vaccines. This will enable many corona vaccines to be available in the country, while it will also help in achieving the vaccination target of all adults soon.
What are the rules for vaccines?
According to the New Drug and Clinical Trial Rules-2019, whenever a foreign manufacturer applies for emergency production of a vaccine in India, it will have to submit a local clinical trial report. This is called a bridging trial. In this, the manufacturers collect the safety and immunity data of the second and third phases. The number of participants was low in number when the vaccine was tried abroad.
On this basis, the serum institute underwent a bridging trial of Sputnik-V by Covishield and Dr. Reddy, developed by Oxford-AstraZeneca. It is also the provision that the national authority can give relaxation to the rules to foreign companies if they wish. However, this would be possible only when severe adverse effects of the vaccine have not been reported. However, the provision of second and third-phase local trials has now been scrapped.
What does the change mean?
Any foreign manufacturer whose vaccine has received limited use permission from the health authorities of the US, European Union, UK, and Japan can apply for emergency use permission in India. In addition, companies listed on the World Health Organization’s Emergency Use List can also apply directly. Rapid action will be taken on their application.
How will security be determined
Foreign companies will have to test 100 people and monitor them for seven days before starting vaccination across the country. Vaccination can be allowed across the country if the report is satisfactory, but the parallel trial will continue and the report will have to be submitted to the authority.
Which company will benefit
American-based Johnson & Johnson is the only company that has said that it is going to start clinical trials in India soon. It has also got the green signal from WHO on 12 March. In addition, Pfizer and Moderna can also apply for emergency use of their vaccine. Covovax is also in the queue for the serum developed by Novavax.
How much will be the cost of the vaccine?
Private hospitals are currently providing Covishield and Covaxin at Rs 250. According to experts, a dose of Pfizer’s vaccine will be available for around Rs 1,400, Moderna’s 2,800, Chinese Vaccine Sinopharm and Synovac for Rs 5,500 and 1,000, and Sputnik-V respectively. However, these vaccines will not be available in the market right now. The government has not taken any decision in this regard yet.
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