India uses 2 COVID vaccines despite doubts about one

While India is launching an ambitious effort to vaccinate 300 million people against the coronavirus in six months, it is employing two vaccines – both manufactured in the country, but approved under very different circumstances.

One is CoviShield, the vaccine developed by Britain’s AstraZeneca and the University of Oxford, whose clinical tests show it to be about 70% effective in preventing COVID-19 and is being manufactured in India by the Serum Institute, the largest pharmacist in the world. parents.

The other is Covaxin, developed by an Indian company jointly with the government, but whose performance in clinical trials in the final stage has not yet been published. However, health officials have approved the vaccine for “restricted emergency use”.

Government health officials promise that the two drugs are effective and say that Indians who line up for the first round of injections will not be able to choose which drug they will receive.

“Many countries around the world are using more than one vaccine,” Health Secretary Rajesh Bhushan told reporters on Wednesday. “This option does not exist [of choice] available to any of the beneficiaries in those countries. “

The uncertainty about Covaxin injection is just one of the challenges that India faces in launching one of the biggest vaccination initiatives in world history.

Hindu pilgrims pass through a tent with a banner that says

Hindu pilgrims pass a temporary coronavirus testing site in Calcutta, India.

(Bikas Das / Associated Press)

Starting on Saturday, the vaccines will be administered to 30 million medical professionals and frontline workers, followed by another 270 million people aged 50 or over or at risk from other illnesses. Prime Minister Narendra Modi’s promise to complete the first phase by August would put India, which has the highest number of coronavirus cases in the world after the United States, on the right track to defeat COVID-19, experts say.

But populist Modi is known for bold pronouncements that do not always materialize. Experts warn that the lack of transparency around Covaxin threatens to undermine public confidence in the vaccination campaign.

“Whatever happened, it created a perception that vaccines are not the same,” said Prashant Yadav, a senior researcher at the Center for Global Development in Washington who studies India’s health supply chain. “This has the potential to create delays and more friction in a process that ideally we want to be as smooth as possible.”

Although China and Russia have also started to administer domestically produced vaccines while the drugs are still in the testing phase, India stands out for approving two drugs based on different standards.

The AstraZeneca-Oxford injection was approved on January 1 by a panel of experts based on data from tests in Great Britain and Brazil. On the same day, the panel asked Bharat Biotech, based in Hyderabad, a well-known manufacturer of more than a dozen vaccines sold worldwide, to provide more information on the effectiveness of its Covaxin injection, which was still in its third stage. critical of clinical trials.

The panel granted approval to Covaxin the next day – but offered little public explanation of why. Indian media also reported irregularities in vaccine testing, with some volunteers saying they were led to believe that they were receiving an approved injection, not participating in a test. The company denies allegations of irregularities.

The opaque process has led to claims that the government has hastened the use of the vaccine to promote the nationalist Modi mantra of a self-sufficient India.

“Controversies always raise doubts,” said K. Sujatha Rao, a former Indian health secretary. “Therefore, the government is definitely trying to communicate confidence in the security aspects. But the process can impact perceptions. “

One woman in a sari holds her child at the door while another measures her temperature with a forehead thermometer.

A health worker examines people for symptoms of COVID-19 in Dharavi, one of Asia’s largest slums, in Mumbai in September.

(Rafiq Maqbool / Associated Press)

The stakes are high for a country that registered more than 10 million coronavirus infections and 151,000 deaths, among the highest in the world. India’s economy shrank 10.3% in 2020, according to the International Monetary Fund, and weeks of protests against new agrarian policies have further hit Modi’s government.

However, the first fears that the coronavirus would devastate overcrowded slums and overburden rural areas with poor health infrastructure have not materialized. The daily count of new infections in India peaked in mid-September and has been steadily declining ever since, which officials see as a sign that collective immunity may be starting to establish. In the southern state of Tamil Nadu, for example, studies suggest that 60% to 70% of people have been exposed to the virus, making it unlikely that they can be reinfected.

“The number of susceptible people has exhausted or is almost exhausted, so the curve is falling,” said Chandra Mohan, a senior health official in Tamil Nadu. “In these circumstances, the vaccine launch is good, but a little more time spent here or there to ensure a proper launch will make no difference.”

To prepare for vaccines, India has conducted general trials across the country in recent weeks, with health professionals gathering in medical centers, registering patients, rolling up their sleeves and recording data – everything except injected people.

India is relying on an existing immunization program that administers routine vaccines to 55 million people each year. Health officials have trained more than 200,000 vaccinators, prepared 90,000 refrigerators and freezers to store vaccines, and have rushed to create an online portal to track containers and supplies of medicines.

“If all goes well and the plans are actually carried out as designed, it may very well become an example of how to do a large-scale implantation of the vaccine,” said Yadav of the Center for Global Development.

Among the obstacles is the availability of vaccines. The Serum Institute injected 70 million doses of CoviShield, the AstraZeneca-Oxford injection, and is expected to increase production to 100 million doses per month by March, but that would still fall short of the 600 million doses India needs for the first phase. The company has indicated that it will focus on supplying India for several months before exporting doses to other countries.

Bharat Biotech reportedly has a stock of 20 million doses of Covaxin, with the goal of producing another 700 million by the end of the year.

Indian officials have indicated that they do not plan to inoculate 1.3 billion people in India, believing that the country could achieve collective immunity after the first phase of vaccines, which will cover less than a quarter of the population.

Experts say the country has enough health professionals, syringes and refrigerators – vaccines must be kept at a temperature of 35.6 to 46.4 degrees – but fear that other immunizations may be delayed or forgotten, as the system is concentrated on COVID-19.

Anant Phadke, senior adviser to a health charity in the western city of Pune, said the infrastructure for vaccinating newborns and pregnant women is already overburdened.

“In the past 40 years, the number of employees has not increased according to the population,” he said. “The existing public health system is barely able to manage the workload. If the existing team bears a heavy burden of [COVID-19] inoculation unit, could eliminate routine vaccinations. “

Pune, in the state of Maharashtra, is among the most affected districts in India, with more than 350,000 cases of coronavirus. Officials said their biggest challenge would be reaching rural areas, where people often need to travel for hours to reach a health center.

Bhagwan Pawar, a local health official in the city of Maan, 160 kilometers from Mumbai, said health centers in the region have sufficient storage facilities and 48 hours of backup electricity in the event of a power outage. Health professionals plan to vaccinate 100 people per location per day, he said.

Local health officials declined to comment on the safety of the government-backed Covaxin vaccine. But Avinash Bhondve, former president of Indian Medical Assn. in Maharashtra, said the medical community had its doubts.

“The government has not guaranteed it to be 100% safe,” he said.

The staff writer for the Times, Bengali, reported from Singapore and special correspondent Parth MN from Mumbai.

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