[The approvals, which include a shot
developed by Bharat Biotech, an Indian pharmaceutical company, begin a vast
campaign to inoculate the hard-hit nation’s 1.3 billion people.]
By Emily Schmall and Sameer Yasir
The approvals were announced at a
news conference in New Delhi on Sunday. Dr. V.G. Somani, the drugs controller
general of India, said the decision to approve the Oxford-AstraZeneca vaccine
and a local vaccine developed by Bharat Biotech came after “careful
examination” of both by the Central Drugs Standard Control Organization,
India’s pharmaceutical regulator.
Indian regulators are still
considering approvals for other vaccines. One, made by Pfizer and BioNTech, has
already been approved in the United
States and Europe.
Another, Russia’s
Sputnik V, appears to be less far along.
On Wednesday, Britain became the
first country to
grant emergency approval for the Oxford-AstraZeneca vaccine. Argentina
soon followed suit.
Officials in India moved quickly
for a number of reasons. The country is No.
2 in confirmed infections behind the United States, and the outbreak
is widely believed
to be worse than the official figures suggest. The pandemic has devastated
the economy, and the unemployment rate is at a 45-year high. Education has
been disrupted, leading to worries about the
long-term impact on the country’s youth.
India will now face some steep
challenges. Doses for more than 1.3 billion people must be paid for and
distributed across a vast country. Government officials could also face doubts
among the public about the safety and efficacy of the vaccine, fueled in part
by the government’s lack of transparency about clinical trial protocols.
Criticism about the lack of clarity
on the data that the regulator examined came swiftly after the two vaccines
were authorized for emergency use.
All India Drug Action Network, a
public health watchdog, immediately issued a statement requesting more information
about the scope of clinical trials and dosing regimens for both vaccines.
On the Bharat Biotech vaccine,
called Covaxin, the group said it was “baffled to understand what scientific
logic has motivated the top experts” to authorize a vaccine still in clinical
trials.
Dr. Somani, the regulator, said the
vaccine had so far been administered to 22,500 trial participants, and “has
been found to be safe.”
Both the AstraZeneca vaccine and
the Bharat Biotech vaccine require two doses, Dr. Somani said. He did not
specify whether the participants in Bharat Biotech’s continuing clinical trials
had received both doses.
Already the effort has faced
setbacks. The Serum Institute, an Indian drug maker that struck
a deal to produce the Oxford vaccine even before its effectiveness had
been proven, has managed to make only about one-tenth of the 400 million doses
it had committed to manufacturing before the end of the year.
The government says it is ready. To
get the vaccine across a country famous for its size and its sometimes
unreliable roads, officials will tap into knowledge from nationwide polio
vaccination and newborn immunization campaigns, and the skill and flexibility employed
in India’s
mammoth general elections, where ballot boxes are delivered to the furthest
reaches of the country.
The Serum Institute says it is on
track to increase production of the vaccine, which is known as Covishield in
India. With $270 million of its own funds and $300
million from the Bill and Melinda Gates Foundation, Serum plans to ramp up
manufacturing capacity to 100 million doses per month by February, said Mayank
Sen, a company spokesman.
Initially, the Serum Institute
signed a pact with AstraZeneca to make one billion doses of the vaccine for
low-and-middle-income countries. The vaccine holds appeal to developing
countries because it is cheaper to make and easier to transport than those that
require colder temperatures during storage and transportation.
The Serum Institute hit production
delays as it built new facilities to make the vaccine. It says it has already produced between 40 million and 50 million
doses for the world. The company’s chief executive, Adar Poonawalla, told
reporters on Monday that a majority of the doses would be given to India.
Indian officials have been vague on
how many doses they expect to receive and when. Mr. Sen said the Serum
Institute did not have a firm agreement with the Indian government, but had
pledged to reserve most of its existing stockpile for India.
“Government has yet to sign the
papers and the final dotted line, but this is based on initial discussions we
have had because we’ve always said that India was going to be the priority,”
Mr. Sen said.
Pending approval of the vaccine by
the World Health Organization, Serum will begin supplying other developing
nations with doses at manufacturing cost, Mr. Sen said.
India’s approval process has also
been delayed. The Serum Institute applied for emergency use approval early last
month, but regulators asked for additional details from clinical trials,
including whether a person involved in the trials had experienced medical
complications.
The details of that claim are not
clear. After receiving the Covishield vaccine on Oct. 1, a 40-year-old
volunteer from Chennai, India, publicly reported neurological symptoms in a
legal notice to the Serum Institute. The company responded by threatening a
defamation suit and demanding the trial volunteer pay about $13.7 million.
While negative health effects from vaccine trials are rare, health experts said
the Serum Institute risked fostering misinformation by appearing to punish
somebody for speaking out.
Mr. Poonawalla said on Monday that
the Serum Institute had submitted the additional information regulators had
requested. It has denied that the problems reported by the trial participant in
Chennai had anything to do with Covishield, but has declined to comment on
accusations of trying to intimidate that person.
Indian officials have laid out an
ambitious plan to inoculate the country’s huge population, which they have said would be the largest such effort in the
country’s history.
India plans to begin a vaccination
campaign in the first three months of the year that will cover about
one-quarter of the population by August. The first 30 million people inoculated
will be health care providers, then police and other frontline workers. For the
remaining 270 million people, the authorities will focus on those over 50 or
who have conditions that might make them more vulnerable.
The rest of the population will be
immunized based on vaccine availability and the latest science.
India has long experience with
inoculating its people. India’s first mass vaccination took place in 1802, to
fight smallpox. Subsequent efforts suffered from misinformation and slow
acceptance.
The country has made strides in
recent years. In the fight against polio, government officials aimed
information campaigns at religious leaders, helping to nearly eradicate the
disease. According to one
study, a mass measles vaccination campaign saved the lives of tens of
thousands of children between 2010 and 2013.
For the coronavirus campaign, the
national government has asked states to prepare vaccination strategies. Some
have formed task forces at the state, district and block levels. Over 20,000
health workers in about 260 districts have been trained so far to administer
the vaccine, the Indian Health Ministry said.
The government plans to use the
framework of its universal immunization program for pregnant women and newborns
— one of the largest and cheapest public health interventions in the world.
India’s civil aviation minister,
Hardeep Singh Puri, said on Tuesday that airlines, airports and ground handlers
had been asked to draw up plans for transporting vials of vaccines at cold
temperatures.
This week, health workers in four
Indian states carried out an exercise to iron out any wrinkles. Health
officials in different places handed out over 100 placebo vaccine doses to
trainers. They then tracked the doses’ temperatures through the journey from
train depot to vaccination site, as well as the time and whether they reached
the intended patients.
India will still need to improve
its ability to store and move vaccines in temperature-controlled conditions —
known as a cold chain network — as well as improving distribution methods and
training new workers.
India may have to double the number
of health workers from the current 2.5 million, said Thekkekara Jacob John, a
senior virologist in the southern state of Tamil Nadu.
“This is a herculean task,” Mr.
John said of the vaccine effort. “And the challenge is not going to densely
populated cities but the rural areas — home to real India.”
Government officials will also have
to put a stop to rumor-mongering, he said. Chat groups on WhatsApp, the
Facebook-owned messaging service that is widely used in India, have already
become home to misinformation about side effects.
One month ago, Prime Minister
Narendra Modi urged citizens to keep an eye out for those trying to spread
rumors about the vaccine, which he called “anti-national and anti-human,” and
urged politicians to help raise awareness.
Mr. Modi renewed that appeal on
Thursday, casting the continuing fight against the virus as one against an
unknown enemy.
“Be careful about rumors,” he said,
“And as responsible citizens, refrain from forwarding messages on social media
without checking.”
