How India plans to vaccinate 300 million people against the coronavirus

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

The country was the second (after the UK) to automatically approve the inexpensive and easy to store AstraZeneca / Oxford vaccine. But the approval of a second vaccine, developed at the national level Covaxin is causing concern because it was administered while phase 3 trials of the drug are still ongoing and before its efficacy data was made public.

Indian Prime Minister Narendra Modi applauded approval of two vaccines on Twitter, calling it a “decisive turning point to strengthen an energetic fight” against the pandemic. Modi also praised 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 publication 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 it begins the deployment of his vaccine.

According to data from Johns Hopkins, the country of 1.4 billion people reported more than 10 million cases and 150,000 deaths as of January 5. The lockdowns aimed at curbing the spread of Covid-19 have had a detrimental impact on the Indian economy, which was already hurting before the start of the pandemic. About 24% of India’s GDP was wiped out from April to June 2020, so bringing the virus under control is key to improving the country’s economic outlook.

The Indian government and pharmaceutical companies say both vaccines are safe to use and will prove invaluable in India’s fight against Covid-19, especially after some experts have suggested that the potentially more infectious strain of coronavirus may already be 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 contribute to transparency, as well as to guarantee the best standards. encountered and that vaccines reach those who need them.

India’s two coronavirus vaccines, briefly explained

Although India has granted emergency clearance for two vaccines, Covaxin, developed by Indian company Bharat Biotech in partnership with the Indian Council for Medical Research and the country’s National Institute of Virology, is the one sparking a controversial.

In a Jan. 3 press release, the Drug Controller General of India (DCGI), the government body responsible for implementing new drugs and overseeing clinical trials in the country, said the trial results Phase 1 and 2 clinics of the drug show it to be safe. and provides immune defense against Covid-19.

According to World Health Organization guidelines, phase 1 of an investigational vaccine trial involves administering the vaccine to “a small number of volunteers to assess its safety, confirm that it is generating an immune response, and determine the right dosage ”.

During phase 2, “The vaccine is typically 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 find out how the vaccine behaves in the real world.

The Phase 1 and 2 trials of Covaxin involved far fewer participants – around 800 people, according to the DCGI press release – than the larger Phase 3 trial, which is still ongoing. About 22,500 people received the vaccine 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 made public – and although Covaxin relies on an inactivated viral platform, which has been used to develop well-known vaccines against diseases like polio and ‘hepatitis A, experts and activists are still concerned.

This is because, as Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy in Washington, DC, told me, “It is difficult to come to a definitive conclusion without data on safety and efficacy. .

“The data from phase 3 are not yet in the public domain, and until then, it would not be desirable to use this vaccine outside of clinical trials,” he added.

In an interview with Indian media outlet The Wire on January 5, Dr Gagandeep Kang, one of India’s leading vaccine experts, said she would not take the Covaxin vaccine until data on its effectiveness was released. not made public.

All India Drug Action Network (AIDAN), a health watchdog group, also expressed shock at the impending emergency clearance of Covaxin in a letter posted on Twitter the day before official approval. The group asked DCGI to reconsider its decision, arguing that there was not enough data presented on the drug’s effectiveness.

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

Bharat Biotech CEO Dr. Krishna Ella responded to criticism of his company’s vaccine at a press conference on Jan. 4, in which he blamed much of the negative response to the vaccine on what he called “a backlash against Indian companies.”

“It’s not good for us. We don’t deserve this, ”he said.

Ella also said her company is transparent with data and has produced over 70 articles, if people could be patient enough to read them.

But AIDAN, the watchdog group, also challenged the AstraZeneca / Oxford vaccine, asking for more specific data from trials abroad and in India. AIDAN also requested estimates of the effectiveness of the “regimen and regimen” 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 could be a particularly strong option to help poorer countries curb the coronavirus pandemic because it is cheaper and easier to store.

As Julia Belluz and Umair Irfan de Vox explain, the AstraZeneca vaccine is “among the most likely to be affordable for low- and middle-income countries. And given that a large portion of the world’s population currently lives in low- and middle-income settings, this is the shot that – with a 90% efficiency score – could do. a blow in the pandemic in the world. (There are still questions about the vaccine’s efficacy, however, given the dosing issues that arose in the Phase 3 trial of the vaccine.)

Unlike the two main vaccines from Moderna and Pfizer / BioNTech, which must be stored at very cold temperatures, the Covishield vaccine can be stored in a standard refrigerator for up to six months, making it easy to distribute widely. Covishield and Covaxin, grown in India, can be stored between 2 and 8 degrees Celsius (35.6 to 46.4 Fahrenheit) and require two doses.

However, distributing vaccines to the entire Indian population is going to be a huge challenge.

India’s vaccine distribution figures are tough

India plans to provide voluntary vaccinations to 300 million people this year, using many of the same tools and practices it uses to hold elections, which are the most important in the world.

As in the United States, workers on the frontlines of the pandemic in India will be the first to receive the vaccines. But India will also include people over 50 alongside health workers in the first batch. After this initial phase, people under the age of 50 with underlying illnesses such as heart disease, which increase the risk of death from Covid-19, will be vaccinated. Everyone else will receive the vaccine depending on the supply available and the progress of the pandemic.

Officials will use the voters’ lists to identify people over 50. People eligible for the vaccine must pre-register to receive their vaccines at one of the thousands of local centers, which function as polling stations. Mobile teams will be deployed to help deliver the vaccine to more remote and hard-to-reach locations.

According to government plans, successful implementation requires effective training and organization of all workers involved in the vaccination process. Due to the scale of the plan, all stages of vaccine introduction will be supervised and followed.

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

While such a large effort presents considerable challenges in vaccine procurement, delivery and demand, Laxminarayan says India’s success in polio eradication and “the continued strengthening of its program vaccination 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 establishment of a cold chain system, but the public communication aspect is still lacking,” did he declare.

On January 3, mock vaccinations were held across India to iron out any bumps in the process before hundreds of millions of people received actual vaccines.

Sanjay Kanojia / AFP via Getty Images

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

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