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India approved two coronavirus vaccines. Only one has completed phase 3 trials.
India will begin vaccinating 300 million people following the emergency approval of two coronavirus vaccines earlier this week.
The country becomes the second after the United Kingdom to rubber-stamp the inexpensive and easy-to-store AstraZeneca/Oxford vaccine. But the approval of a second, the domestically developed Covaxin vaccine, is raising concerns because it was given while phase 3 trials of the drug are still underway and before its efficacy data has been made public.
Indian Prime Minister Narendra Modi cheered the approval of both vaccines on Twitter, calling it “a decisive turning point to strengthen a spirited fight” against the pandemic. Modi also congratulated the country’s “hardworking scientists and innovators” for their efforts, which he said would make India healthier and Covid-19-free.
But many health experts and activists are demanding more transparency and the release of data on the efficacy of the drugs.
In the coming weeks, all eyes will be on India, the world’s second-most populous country with the second-highest number of coronavirus infections after the United States, as it begins its vaccine rollout.
According to data from Johns Hopkins, more than 10 million cases and 150,000 deaths have been reported in the country of 1.4 billion as of January 5. Lockdowns aimed at curbing the spread of Covid-19 have had a deleterious impact on India’s economy, which was already hurting before the pandemic began. About 24 percent of India’s GDP was erased from April to June 2020, so getting the virus under control is critical for improving the country’s economic outlook.
The Indian government and the pharmaceutical companies say both vaccines are safe to use and will prove invaluable to India’s fight against Covid-19, especially after some experts have suggested the potentially more infectious strain of the coronavirus might already be in the country.
To meet the challenge of one of the biggest vaccination efforts in history, experts say the Indian government needs a credible scientific voice — a Dr. Anthony Fauci for India, if you will — to help with transparency and ensure that best standards are met and that vaccines get to those in need.
India’s two coronavirus vaccines, briefly explained
Although India has granted emergency authorization to two vaccines, Covaxin, developed by the Indian company Bharat Biotech in partnership with the Indian Council of Medical Research and the country’s National Institute of Virology, is the one causing some controversy.
In a January 3 press statement, the Drug Controller General of India (DCGI), the government body responsible for implementing new drugs and overseeing clinical trials in the country, said that the results from the phase 1 and 2 clinical trials of the drug show it is safe and provides immune defense from Covid-19.
Per the World Health Organization’s guidelines, phase 1 of an experimental vaccine trial includes giving the vaccine to a “small number of volunteers to assess its safety, confirm it generates an immune response, and determine the right dosage.”
In phase 2, “the vaccine is usually given to hundreds of volunteers, who are closely monitored for any side effects, to further assess its ability to generate an immune response.” Phase 3 is when researchers get a look at how the vaccine behaves in the real world.
Covaxin’s phase 1 and 2 trials involved far fewer participants — approximately 800 individuals, according to the DCGI press statement — than the bigger phase 3 trial, which is still underway. About 22,500 people have participated as part of the phase 3 trial, which began in mid-November 2020.
But that trial is still ongoing and the data from it has not been publicly released — and though Covaxin is built on an inactivated virus platform, which have been used to develop well-known vaccines for diseases like polio and the hepatitis A, experts and activists are still concerned.
That’s because, as Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy in Washington, DC, told me, “It is difficult to reach any definitive conclusion without safety and efficacy data.”
“Phase 3 data are not yet in the public domain, and until then it would not be advisable to use this vaccine outside of clinical trial settings,” he added.
In a January 5 interview with the Indian news outlet the Wire, Dr. Gagandeep Kang, one of India’s foremost vaccine experts, said she wouldn’t take the Covaxin vaccine until data on its efficacy is made public.
All India Drug Action Network (AIDAN), a health watchdog group, also expressed shock at Covaxin’s impending emergency authorization in a letter posted to Twitter the day before the approval was officially made. The group has asked the DCGI to reconsider its decision, arguing there hasn’t been enough data presented on the drug’s efficacy.
Despite the objections, though, India’s Drugs Controller General VG Somini told reporters on January 4 that he would “never approve any vaccine if there are any safety concerns. Covid-19 vaccines are 110% safe,” according to the Hindustan Times.
Bharat Biotech’s CEO Dr. Krishna Ella responded to criticism of his company’s vaccine in a press conference on January 4, in which he blamed much of the negative response to the vaccine on what he called “a backlash against Indian companies.”
“That is not right for us. We don’t deserve that,” he said.
Ella also said his company was being transparent with data and had produced more than 70 articles if people could be patient enough to read them.
But AIDAN, the watchdog group, also took issue with the AstraZeneca/Oxford vaccine, requesting more specific data from trials both abroad and within India. The group also asked for estimates of how effective the “dosing regimen and dosing schedule” would be in India.
The AstraZeneca/Oxford vaccine, called Covishield in India, will be produced by the Serum Institute of India, the world’s largest vaccine producer. Also known as AZD1222, that vaccine might be a particularly strong option to help less-wealthy countries curb the coronavirus pandemic because it is cheaper and easier to store.
As Vox’s Julia Belluz and Umair Irfan explained, the AstraZeneca vaccine is “among the most likely to be affordable to low- and middle-income countries. And considering much of the world’s population currently lives in low- and middle-income settings, it’s the jab that — with a 90 percent efficacy result — could make a big dent in the pandemic worldwide.” (There are continued questions, however, around just how effective the vaccine is, given dosage problems that arose in the vaccine’s phase 3 trial.)
Unlike the two leading vaccines by Moderna and Pfizer/BioNTech, which must be stored at really cold temperatures, the Covishield vaccine can be kept in a standard refrigerator for up to six months, making large-scale distribution easier. Both Covishield and India’s homegrown Covaxin can be kept at a temperature between 2 and 8 degrees Celsius (35.6 to 46.4 Fahrenheit) and require two doses.
Still, distributing vaccines to all of India’s population is going to be a gargantuan challenge.
The vaccine distribution numbers in India are challenging
As in the US, workers on the front lines of the pandemic in India will be the first to receive the shots. But India will also include people over the age of 50 alongside health care workers in the first batch. After that initial phase, people under 50 with underlying conditions like heart disease, which increase the risk of death from Covid-19, will be vaccinated. Everyone else will get the vaccine based on available supply and how the pandemic develops.
Officials will use electoral rolls to identify people over 50. People who are eligible for the vaccine must preregister to receive their shots at one of thousands of local centers, which are run like polling places. Mobile teams will be deployed to help administer the vaccine in more remote and tough-to-reach locations.
According to the government’s plans, successful implementation requires effective training and organization of all workers involved in the vaccination process. Because the scale of the plan is so massive, all steps in the vaccine introduction will be supervised and monitored.
The Indian government will digitally track who has received the vaccine using the COVID-19 Vaccine Intelligence Network (Co-WIN) system, a platform that can trace vaccination “on a real-time basis.”
Although such a big effort will have considerable challenges in procurement, delivery, and vaccine demand, Laxminarayan says India’s success with the eradication of polio and the country’s “steady strengthening of its immunization program over the years” will be apparent during the Covid-19 vaccination campaign.
“I have little doubt that India will capably manage the procurement and delivery of vaccines, including of getting a cold chain system in place, but the public communication aspect is still lacking,” he said.
On January 3, mock vaccinations were held across India to iron out any bumps in the process before hundreds of millions get real shots.
For now, as the controversy over the emergency approval of Covaxin suggests, the most immediate challenge is one of public communication.
As Laxminarayan said, “There needs to be a credible scientific voice at the very top that is clear, transparent, and reassuring that the best standards are being met to make sure that vaccines reach everyone.”
Author: Jariel Arvin