How India plans to vaccinate 300 million people against coronavirus

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

The country was the second (after the UK) to stamp the cheap and easily storable AstraZeneca / Oxford vaccine with the rubber stamp. But the approval of a second vaccine, the local developed Covaxin is of concern because it was given while Phase 3 trials with the drug were still ongoing and before its efficacy data were released.

Indian Prime Minister Narendra Modi has welcomed the approval of both vaccinations on Twitterand calls it “a decisive turning point in intensifying a spiritual battle” against the pandemic. Modi also congratulated the country’s “hard-working scientists and innovators” on 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 effectiveness of the 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 – when it begins vaccination.

According to Johns Hopkins data, the 1.4 billion country reported more than 10 million cases and 150,000 deaths on January 5th. Connections aimed at spreading Covid-19 have had a detrimental effect on India’s economy, which has already caused damage. before the pandemic began. About 24 percent of India’s GDP was wiped out from April to June 2020, so getting the virus under control is critical to improving the country’s economic prospects.

The Indian government and the pharmaceutical companies say both vaccines are safe to use and will be invaluable to India’s fight against Covid-19, especially after some experts suggested that the coronavirus in the country may be more contagious.

To meet the challenge of one of the largest vaccination attempts 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 as well as to ensure that the best standards are met. reach and that vaccines get the needy.

India’s two coronavirus vaccines, briefly explained

Although India has granted emergency authorization 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 causing controversy.

In a January 3 press release, the Drug Controller General of India (DCGI), the governmental body 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 shows that it is safe and provides immune defense of Covid-19.

According to the guidelines of the World Health Organization, phase 1 of an experimental vaccination study includes giving the vaccine to a “small number of volunteers to determine its safety, confirm that it elicits an immune response and determine the correct dose. “

In Phase 2, “The vaccine is usually given to hundreds of volunteers, who are closely monitored for any side effects, to further evaluate its ability to generate an immune response.” Phase 3 is when researchers look at how the vaccine behaves in the real world.

According to the DCGI press release, Covaxin’s Phase 1 and 2 trials involved far fewer participants – about 800 individuals – 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 the trial is still ongoing and the data from it has not been made public – and although Covaxin was built on an inactivated virus platform, which was used to develop known vaccines for diseases such as polio and hepatitis A, experts and activists are still concerned.

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

“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 trials,” he added.

In a January 5 interview with the Indian news agency The Wire, dr. Gagandeep Kang, one of India’s leading vaccine experts, said she would not take 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 looming authorization in a letter posted on Twitter the day before approval was officially given. The group asked the DCGI to reconsider its decision, arguing that not enough data had been presented on the effectiveness of the drug.

Despite the objections, the Indian Drug Control General, VG Somani, told reporters on January 4 that he would ‘never approve a vaccine if there were safety issues. “Covid-19 vaccines are 110% safe,” according to the Hindustan Times.

Bharat Biotech CEO Dr Krishna Ella responds to criticism of his company’s vaccine during a press conference on January 4, during which he blamed the negative reaction to the vaccine for a setback against Indian companies. ‘

“It’s not right for us. We do not deserve it, “he said.

Ella also said that his company is transparent with data and has produced more than 70 articles, if people could be patient enough to read it.

But AIDAN, the watchdog group, also addressed the AstraZeneca / Oxford vaccine and requested more specific data from trials abroad and within 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, is manufactured by the Serum Institute of India, the largest vaccine manufacturer in the world. Also known as AZD1222, the vaccine may be a particularly strong option to help less affluent countries curb the coronavirus pandemic because it is cheaper and easier to store.

As Julia Belluz and Umair Irfan of Vox explained, the AstraZeneca vaccine ‘is one of the most likely affordable countries in low and middle incomes. And since many of the world’s population currently live in low- and middle-income conditions, this is a blow that – with an efficiency result of 90 percent – could make a major dip in the pandemic worldwide. ‘(However, there are still questions about how effective the vaccine is, given the dose problems that arose in the phase 3 test of the vaccine.)

Unlike the two leading Moderna and Pfizer / BioNTech vaccines, which have to be stored in very cold temperatures, the Covishield vaccine can be kept in a standard refrigerator for up to six months, which facilitates large-scale distribution. Both Covishield and the homemade Covaxin from India can be kept at a temperature between 2 and 8 degrees Celsius and require two doses.

The distribution of vaccines among the entire Indian population is still going to be a major challenge.

Vaccine distribution numbers in India are challenging

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

As in the US, workers on the front line of the pandemic in India will be the first to receive the shots. But India will also include people over 50 with health workers in the first group. After the initial phase, people under 50 will be vaccinated with underlying conditions such as heart disease, which increases the risk of Covid-19. Everyone else will get the vaccine based on the available stock and how the pandemic develops.

Officials will use menu to identify people over 50. People eligible for the vaccine must pre-register to receive their shots at one of thousands of local centers, which are managed like polling stations. Mobile teams will be deployed to administer the vaccine in more remote and hard-to-reach places.

According to the government’s plans, the successful implementation requires effective training and organization of all workers involved in the vaccination process. Because the scope of the plan is so large, all steps in vaccinating the vaccine will be 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 detect vaccination on a real-time basis.

Although such a major effort will pose significant challenges in terms of delivery, delivery and vaccine, Laxminarayan says India’s success in eradicating polio and the country’s “steady strengthening of its vaccination program over the years” during the vaccination Covid -19 clearly shows campaign.

“I have little doubt that India will be able to manage the procurement and delivery of vaccines, including getting a cooling chain system in place, but the public communications aspect is still lacking,” he said.

On January 3, sham vaccinations were held across India to iron out any bumps in the process before hundreds of millions get actual shots.

Sanjay Kanojia / AFP via Getty Images

For the time being, as the controversy over Covaxin’s emergency permit indicates, the most immediate challenge is one of public communication.

As Laxminarayan said: ‘There must be a credible scientific voice at the top that is clear, transparent and reassuring that the best standards are met to ensure that vaccines reach everyone.’