India’s plan to vaccinate 300 million people against the coronavirus, explained

Members
of ground staff walk past a container stacked at a cargo terminal
of the Indira Gandhi International Airport in New Delhi on December
22, 2020. The airport will be used as a handling and distribution
center for coronavirus vaccines.Sajjad Hussain/AFP via Getty Images

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 was the second (after the United Kingdom) to
rubber-stamp the
inexpensive and easy-to-store AstraZeneca/Oxford vaccine. But
the approval of a second vaccine, the domestically developed
Covaxin, 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 drugs’ efficacy.

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, the country of 1.4 billion has reported more than 10
million cases and 150,000 deaths 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 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, as well as to ensure 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 the results from 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 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 publicly released — and though Covaxin is built on an
inactivated virus platform, which
has been used to develop well-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 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 approval was officially given. 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, India’s Drugs Controller General VG
Somani told reporters 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 CEO Dr. Krishna Ella responded
to criticism of his company’s vaccine in a January 4 press
conference, during 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, took issue with the
AstraZeneca/Oxford vaccine as well, requesting more specific data
from trials both 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,

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 , 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

India plans
to provide voluntary inoculations to 300 million people this year,
using many of the same tools and practices it uses to conduct

elections, which are the world’s biggest.

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.

Sanjay
Kanojia/AFP via Getty Images Volunteers and health officials are
seen during a dry run for the Covid-19 coronavirus vaccine, at a
private hospital in Allahabad on January 5, 2021.

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.”

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