How India plans to vaccinate 300 million people against coronavirus

India will start vaccinating 300 million people after the emergency approval of two coronavirus vaccines earlier this week.

The country was the second (after the United Kingdom) to stamp the cheap and easy to store AstraZeneca / Oxford vaccine. But the approval of a second vaccine, the one developed internally Covaxin is raising concerns because it was administered while phase 3 trials of the drug were still in progress and before its efficacy data was published.

Indian Prime Minister Narendra Modi applauded the approval of both vaccines on twitter, calling it “a decisive turning point to strengthen a vigorous fight” against the pandemic. Modi also congratulated the country’s “dedicated scientists and innovators” for their efforts, which he said would make India healthier and free from Covid-19.

But many health experts and activists are demanding more transparency and disclosure of data on the effectiveness of drugs.

In the coming weeks, all eyes will be on India, the second most populous country in the world – with the second highest number of coronavirus infections, after the United States – as its vaccine launch begins.

According to data from Johns Hopkins, the 1.4 billion country reported more than 10 million cases and 150,000 deaths as of January 5. The blockades aimed at containing the spread of Covid-19 had a deleterious impact on India’s economy, which was already suffering before the pandemic began. About 24% of India’s GDP was eliminated from April to June 2020, so controlling the virus is critical to improving the country’s economic prospects.

The Indian government and pharmaceutical companies say the two vaccines are safe to use and will be invaluable in India’s fight against Covid-19, especially after some experts have suggested that the potentially most infectious strain of coronavirus may already be in use. parents.

To meet the challenge of one of the greatest vaccination efforts in history, experts say the Indian government needs a credible scientific voice – a Dr. Anthony Fauci for India, if you prefer – to help with transparency, as well as to ensure that the best standards are met and that vaccines reach those in need.

Two coronavirus vaccines from India, briefly explained

Although India has granted emergency authorization for two vaccines, Covaxin, developed by the Indian company Bharat Biotech in partnership with the Indian Medical Research Council and the country’s National Institute of Virology, is the cause of some controversy.

In a January 3 press release, the General Controller of Medicines of India (DCGI), the government agency responsible for implementing new drugs and overseeing clinical trials in the country, said the results of phase 1 and 2 clinical trials of the drug show that it is safe and provides immune defense against Covid-19.

According to World Health Organization guidelines, phase 1 of an experimental vaccine trial includes giving the vaccine to a “small number of volunteers to assess its safety, confirm that it generates an immune response and determine the right dosage”.

In phase 2, “The vaccine is generally administered to hundreds of volunteers, who are closely monitored for any side effects, to further assess their ability to generate an immune response.” Phase 3 is when researchers take a look at how the vaccine behaves in the real world.

Covaxin’s phase 1 and 2 studies involved far fewer participants – approximately 800 individuals, according to the DCGI press release – than the largest phase 3 study, which is still ongoing. About 22,500 people received the vaccine as part of the phase 3 study, which began in mid-November 2020.

But that test is still in progress and his data has not been made publicly available – and although Covaxin is built on an inactivated virus platform, which has been used to develop known vaccines for diseases like polio and 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 conclusions without data on safety and effectiveness.”

“Phase 3 data is 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 an interview on January 5 with the Indian media The Wire, Dr. Gagandeep Kang, one of India’s leading vaccine experts, said she would not get the Covaxin vaccine until data on its effectiveness were released.

All India Drug Action Network (AIDAN), a health watchdog group, also expressed shock at Covaxin’s imminent emergency clearance in a Letter posted on Twitter the day before official approval. The group asked DCGI to reconsider its decision, arguing that there was insufficient data presented on the drug’s effectiveness.

Despite the objections, India’s General Medicines Controller VG Somani told reporters on January 4 that he “would never approve any vaccine if there were any safety concerns. Covid-19 vaccines are 110% safe, ”according to the Hindustan Times.

Bharat Biotech CEO, Dr. Krishna Ella responded to criticisms of his company’s vaccine at a press conference on January 4, during which he attributed much of the negative response to the vaccine to what he called a “reaction against Indian companies”.

“This is not right for us. We don’t deserve this, ”he said.

Ella also said that her company was being transparent with the data and produced more than 70 articles, if people could be patient enough to read them.

But AIDAN, the watchdog group, also questioned the AstraZeneca / Oxford vaccine, requesting more specific data from tests abroad and in India. AIDAN 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, this vaccine may be a particularly strong option for helping the least wealthy countries to contain the coronavirus pandemic because it is cheaper and easier to store.

As Julia Belluz and Umair Irfan, from Vox, explained, the AstraZeneca vaccine is “among the most likely to be accessible to low- and middle-income countries. And considering that a large part of the world population currently lives in low and middle income environments, it is the blow that – with a 90 percent effectiveness result – could do a major reduction in the global pandemic. ”(However, there are constant questions about the vaccine’s effectiveness, given the dosage problems that arose in the phase 3 vaccine trial.)

Unlike the two leading vaccines from Moderna and Pfizer / BioNTech, which must be stored at very low temperatures, the Covishield vaccine can be kept in a standard refrigerator for up to six months, facilitating large-scale distribution. Both Covishield and Covaxin, grown in India, 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 the entire population of India will be a huge challenge.

India’s vaccine distribution numbers are challenging

India plans to supply voluntary vaccines to 300 million people this year, using many of the same tools and practices it uses to conduct the elections, which are the largest in the world.

As in the US, workers on the frontline of the pandemic in India will be the first to receive vaccines. But India will also include people over 50 alongside health professionals in the first batch. After this initial phase, people under 50 with underlying diseases such as heart disease, which increase the risk of death from Covid-19, will be vaccinated. All others will receive the vaccine based on the available supply and the development of the pandemic.

Officials will use electoral lists to identify people over 50. People who are eligible for the vaccine must pre-register to receive their vaccines at one of the thousands of local centers, which function as polling places. Mobile teams will be deployed to help administer the vaccine in more remote and difficult to reach locations.

According to government plans, successful implementation requires effective training and organization for all workers involved in the vaccination process. As the scale of the plan is so large, all stages of vaccine introduction will be supervised and monitored.

The Indian government will digitally track who received the vaccine using the COVID-19 Vaccine Intelligence Network (Co-WIN) system, a platform that can track vaccination “in real time”.

Although such a major effort has considerable challenges in vaccine procurement, delivery and demand, Laxminarayan says India’s success with polio eradication and the “steady strengthening of the country’s immunization program over the years” will be evident during the Covid-19 vaccination campaign.

“I have little doubt that India will competently manage the procurement and delivery of vaccines, including the implementation of a cold chain system, but the public communication aspect is still lacking,” he said.

On January 3, mock vaccinations were carried out across India to resolve any problems in the process before hundreds of millions received real vaccines.

Sanjay Kanojia / AFP via Getty Images

For now, as the controversy over Covaxin’s emergency approval suggests, the most immediate challenge is public communication.

As Laxminarayan said, “There needs to be a reliable scientific voice at the top that is clear, transparent and reassuring that the best standards are being met to ensure that vaccines reach everyone.”