January 15, 2021 With more than 10 million coronavirus infections, India has the second-highest number of reported cases after the US. As the country gets its logistics in place for one of the world’s largest vaccination drives, what remains is to build public faith and understanding of both the vaccine candidates.
On January 3, Aarti Morya, a 42-year old Anganwadi (primary health centre) worker, one of 25 participants chosen for a Covid vaccination dry run, walked into the Daryaganj urban public health centre in Delhi. Thirty seconds later, she walked out again, terrified. Though she eventually went through the procedure, she says she did so only because all her colleagues were going ahead with it. She recounts seeing several television crews and photographers at the entrance of the centre. “The attention made me nervous. I don’t know why there was so much media,” she says. What she didn’t realise at the time was the significance of this dry run—it was among the first tests to see if India’s health system was prepared to vaccinate the country’s 1.32 billion citizens.
Before being allowed in, all 25 participants had their details checked and their temperatures noted. Then, they met with a vaccination officer who re-verified their identities before allowing them to proceed. “A nurse put a syringe against my arm and then disposed of it. She told me I was vaccinated and to call her if I developed any side effects. She also said I should continue wearing a mask. It was a frightening experience—I know I should be immunised as I am a frontline worker, but I was scared,” explains Morya over a phone call. (No actual vaccines were given in these dry runs; they are tests of processes and protocols.)
Across the country, states have been conducting dry runs of the vaccine rollout to test the quality of their cold storage systems, the smoothness of the actual vaccination process and to iron out any wrinkles in the process of immunisation. Uttar Pradesh has conducted one of the largest such trials, with six sites in every one of the state’s 75 districts chosen for dry runs on January 5. In total, 180 vaccination sessions were conducted by 350 teams. Two days before that, six sites in Lucknow conducted dry runs, which saw police escorts and GPS trackers for the vehicles transporting the vaccines from cold storage to the clinics, with each site having a nodal officer present and an observation room to check the beneficiary after vaccination. Nearly 45 million syringes have arrived in the state for the drive, with another 15 million to be procured later.
“The entire vaccination process was assessed. We will address the issues noted before the actual drive begins,” says additional chief secretary for health, Amit Mohan Prasad. One issue that has been noted across the country—such as in Maharashtra, which held dry runs at three locations each in four districts on December 4—was that of internet connectivity. The CoWin app is an integral part of the process, being used to note vaccination details and track participants, but its use is hampered by patchy internet connections. Officials at vaccination centres in Maharashtra say they hope an offline option for tracking and recording will be made available to address this issue.
Even as the dry runs were being conducted, the DCGI (Drug Controller General of India) approved the use of two vaccines—Oxford’s Covishield and Bharat Biotech’s Covaxin—on January 3. Both vaccines have to be administered in two doses and stored at temperatures between 2 and 8 degrees Celsius. When the actual vaccinations begin, the government will reportedly give priority to 10 million healthcare workers and 20 million frontline workers.
The Pune-based Serum Institute, which is developing Oxford’s Covishield in the country, has conducted its Phase II and III trials on 1,600 volunteers in India and has been found to be 70.4 per cent effective. Bharat Biotech is conducting trials of its Covaxin vaccine in collaboration with the ICMR (Indian Council of Medical Research). The DCGI has said that its Phase I and II trials were conducted on around 800 people and that the results showed that it was ‘safe and provides a robust immune response’. The Phase III trial is currently ongoing, with about 24,000 of 25,800 participants vaccinated. According to the MoHFW (ministry of health and family welfare), Covaxin has been reviewed for safety and immunogenicity and can be used in emergency cases. The idea is to have ‘more options for vaccinations, especially in case of infections by mutant strains’, according to a statement by the MoHFW. Balram Bhargava, chief of the ICMR, says, “Covaxin may have benefits against the new virus strain which has been isolated by NIV (National Institute of Virology), Pune.”
Covaxin is a whole virion inactivated Covid-19 vaccine, which produces the virus’s surface spike protein, priming the immune system. Such vaccines are generally considered safe. In China, a similar vaccine, Sinovax, was also administered before its Phase III data was made available and, according to available information, has not shown any side-effects. “We will never approve [a vaccine] if there is [even] the slightest safety concern. The vaccines are 110 per cent safe,” says Drugs Controller General of India V.G. Somani. However, it remains unclear what the DCGI meant in its notice that Covaxin would be administered in a ‘clinical trial mode’. There has as yet been no clarification issued on this.
For now, scientists are more concerned about the efficacy of Covaxin than its safety, though many also question the decision to clear a vaccine for which even interim Phase III trial data has not been published. “In the absence of data, how can the efficacy of the vaccine be determined?” asks Dr Gagandeep Kang, a vaccine expert who has raised doubts over the approval process. “How does one even know if two doses are the right amount?” To date, no vaccine has been approved before its clinical trial data has been made available. Even the emergency-use approvals given for vaccines by the WHO (World Health Organization) during the Ebola pandemic were only granted after data on their safety and efficacy was reviewed.
Bharat Biotech has a track record of clinical trials in 20 countries, involving more than 700,000 volunteers. The company has a stockpile of 20 million doses of Covaxin and is aiming to make 700 million doses by the end of 2021. “I don’t think safety will be a concern,” says Dr Virander Chauhan, a scientist at ICGEB (the International Centre for Genetic Engineering and Biology). “The consequence of an unsafe virus being injected is too great to take a risk with. But efficacy is doubtful. Even if the vaccine [produces] an immune response, we don’t know yet if it is a protective immune response or how long it will last.” He adds, “Phase III trials are continuing—they haven’t been halted for Covaxin. Inactivated vaccines are generally safe. RNA vaccines haven’t really been used before and their safety has only recently been shown. We forget that the virus is raging and still killing people, so we need immunisation.”
Others aren’t as convinced. “If the due process was done and more transparency is shown about the approval—who was on the committee and what data was given—then the public would have more confidence in the vaccine,” says Dr Mira Shiva of the All India Drug Action Network. “With our cases decreasing, it would anyway take a long time for those vaccinated to get infected, so we won’t know if it is the vaccine that is working or if the person just hasn’t been exposed to the virus. Such haste was not needed.”
With more than 10 million coronavirus infections, India has the second-highest number of reported cases after the US. As the country gets its logistics in place for one of the world’s largest vaccination drives, what remains is to build public faith and understanding of both the vaccine candidates. Misinformation and social media scepticism need to be dealt with for the vaccine to reach enough people. Else, we might have the resources but not the recipients.