[The Indian government granted emergency approval to two vaccines — a locally manufactured version of the Oxford-AstraZeneca vaccine and a vaccine called Covaxin developed by Bharat Biotech, an Indian pharmaceutical company.]
By Joanna Slater and Niha Masih
India on Saturday is set to launch
one of the world’s largest vaccination campaigns with the aim of immunizing 300
million people by this summer.
The mammoth undertaking is a leap
forward in the fight against the coronavirus in India, second only to the United States
in its total number of cases.
The effort is being buoyed by two
locally made vaccines and India’s prior experience with large-scale
immunization campaigns. But what might have been a triumph for the country’s
vaccine industry has been dogged by controversy.
The Indian government granted
emergency approval to two vaccines — a locally manufactured version of the
Oxford-AstraZeneca vaccine and a vaccine called Covaxin developed by Bharat
Biotech, an Indian pharmaceutical company.
Only the Oxford-AstraZeneca vaccine
has completed a Phase 3 clinical trial for safety and efficacy. Bharat Biotech
has finished earlier-stage trials on its vaccine but has so far provided no
data on whether it works. Yet both vaccines will be administered starting
Saturday, and people being immunized will not be able to choose which they
receive.
Complicating matters further,
Indian regulators have said that the Bharat Biotech vaccine will be used in
“clinical trial mode,” a phrase that left experts baffled. One of India’s
foremost vaccine experts, Gagandeep Kang, told
an interviewer that she had “no clue” what it meant.
Unlike the United States and the
United Kingdom, India is starting its vaccination campaign at a moment when the
virus is in retreat. New cases have dropped drastically since peaking in
September: India is recording about 14,000
cases a day and fewer than 200 deaths.
The massive vaccine push is
expected to kick off at 3,000
sites across the country on Saturday, a number that authorities
say will grow in the coming weeks.
To start, the Indian government has
purchased 11 million doses of the AstraZeneca vaccine, manufactured by the
Serum Institute of India, and 5.5 million doses of the Bharat Biotech vaccine.
Both vaccines were sold at $2.75 a dose (the Pfizer vaccine, by
comparison, costs $19.50). If targets are met, 300,000 people could
receive doses on Saturday.
The first to
receive vaccines will be approximately 30 million health-care workers,
soldiers, paramilitary personnel and municipal employees dealing with
sanitation. They’ll receive it free of cost. Then the immunization drive will
target 270 million people over the age of 50 as well as those below 50 who have
co-morbidities.
The rollout of the vaccine program
matters not just for India, but for
the entire developing world. India is a vaccine powerhouse with a proven
track record of low-cost manufacturing. The Serum Institute of India is the
world’s largest vaccine maker by volume.
The Serum Institute will be a major
supplier to COVAX, a global initiative backed by the World Health Organization
to distribute vaccines equitably to poorer countries. Several countries —
including Brazil, Bangladesh and Nepal — are looking to purchase vaccines
directly from Indian companies.
Adar Poonawalla, the chief
executive officer of the Serum Institute, said that the company would start
delivering doses to COVAX by the end of January. The company has also forged
deals to supply the AstraZeneca vaccine to Saudi Arabia, Bangladesh, Myanmar
and Morocco, he said.
In India, health officials have
been preparing for weeks — registering recipients, training vaccinators and
conducting dry runs. Neither the AstraZeneca vaccine nor the Bharat Biotech
vaccine requires ultracold storage, a crucial plus in a country such as India.
Rajesh Bhaskar, the official in
charge of covid-19 management in the state of Punjab, said he expected to be
able to vaccinate 30,000 people Saturday and to complete the immunization of
the state’s health-care workers within 10 days.
“There is a sense of relief, big
relief,” Bhaskar said. “We hope this will suppress the pandemic and eventually
we will get rid of it.”
The distribution effort has already
spread across the country. In Chandrapur, a predominantly rural district in
central India, an initial shipment of 20,000 doses of the AstraZeneca vaccine
arrived by road in a government van earlier this week.
They were stored in an ice-lined
refrigerator guarded by a private security firm specially hired for the
occasion, said Rajukumar Gahlot, the district’s health officer. Nearly 100
health-care personnel in the district have contracted covid-19, he said. Six of
them died.
The AstraZeneca vaccine will
represent the large majority of vaccines administered on Saturday, but Covaxin
is also a key part of the launch, particularly in cities. There remains “a lot
of conjecture” around how regulators reached the decision to grant emergency
approval to the Bharat Biotech vaccine in the absence of efficacy data, said
Anant Bhan, a public health and bioethics expert.
Bhan said that by granting approval
to Bharat Biotech’s vaccine in “clinical trial mode,” regulators raised many unanswered questions. Critics of the government
went further. “Indians are not guinea pigs,” Manish Tewari, a spokesman for the
opposition party,
told Asian News International.
Bharat Biotech declined to respond
to questions about concerns over the efficacy of its vaccine, but it has
pointed to the results of early-stage studies showing an immune response as an
indicator of future results.
Bharat Biotech’s vaccine is
“incredibly safe but I don’t know if the d--- thing works,” said one expert on
India’s vaccine industry, who spoke on the condition of anonymity to comment
frankly. Both vaccines are “less than ideal,” the expert added, noting that the
data on the efficacy of the AstraZeneca vaccine showed huge variations, partly as the result of a dosing mistake.
Some experts worry that the lack of
transparency in the process of approving vaccines for emergency use could
undermine confidence in them more broadly. That would represent a break from
the past in India, a place where vaccine skepticism is low and immunization is
seen as an essential tool in reducing mortality.
Taniya Dutta contributed to this
report.
Read more
India
approves two vaccines as it prepares for massive immunization push
Who
will make coronavirus vaccines for the developing world? India holds the key
The
virus is on the march in much of the world. In India, it’s in retreat.
