More than one vaccine is being administered in several countries in the world, but vaccine recipients do not currently have the option of selecting the shots of vaccines in any region. In the U.S., vaccines both from Pfizer and Moderna are available options for COVID-19 vaccines, recipients of the vaccines, who are healthcare workers and nursing staff do not have an option to choose from these vaccines. In India, two vaccines are approved by the government of India, Pune-based Serum Institute’s Covishield and Hyderabad’s based Bharat Biotech’s Covaxin. And just like any other country, healthcare workers and the vulnerable are given priority without them having to choose shots of Covaxin and Covishield. 

The emergency usage permit issued by the U.S. FDA and the U.K. to Pfizer and Moderna The three vaccine regulators, Pfizer, Moderna, and AstraZeneca, was based on interim safety and efficacy evidence from broad phase 3 studies with a median follow-up of at least two months after the second dose. Although both Pfizer and Moderna have an almost identical 95 percent efficacy, the efficacy of the AstraZeneca vaccine is 62 percent even if the first and second dose standard dose is considered, which is more than 50 percent required for approval. In comparison, the Indian regulator granted restricted use approval based on safety and immunogenicity tests in India for the Pune-based Serum Institute’s Covishield on a limited number of participants and safety and efficacy data from large trials of more than 24,000 participants in Brazil, South Africa, and the United Kingdom. The bridging research did not enable the Serum Institute to assess Covishield’s efficacy in India, but to focus on data on efficacy from studies outside India. The Hyderabad-based Bharat Biotech’s Covaxin was given restricted use approval even in the absence of any data on efficacy. The approval was focused primarily on a limited number of participants tested during phase 1 and phase 1 trials; the effectiveness of the vaccine was only studied during a phase 3 study. In addition, as a matter of “abundant precaution,” Covaxin was greenlighted in the “clinical trial mode” with little clarification as to whether medical treatment will be given in the event of adverse effects and compensation, and informed consent must be sought from the patient prior to immunization. In the case of Covishield, no such requirements or riders exist. Is it right, therefore, to equate India’s situation with other countries using vaccines with known interim protection and efficacy levels?

Vaccine Dilemma

Healthcare workers and researchers are worried about every country seeking ‘emergency use’ approvals and its effects on people’s health. But scientists are worried that the ongoing clinical trials that aim to demonstrate conclusively how well the vaccines perform could compromise this kind of early deployment. Such competition for vaccine production between a clinical trial for a vaccine and its emergency use is recent. Just this month did the World Health Organization allow the first-ever emergency use of immunization, against a form of poliovirus that is spreading in the Southern Hemisphere, that is still being studied. But phase III trials have not yet begun for that.

Although some are prepared for either Covaxin or Covishield, some say that they are not prepared for it because of safety concerns. We talked at various hospitals to several hospital staff, including physicians, nurses, and Group-D employees. While most shared satisfaction with the drive, not all healthcare workers hold the same opinion.