India approves two vaccines as it prepares for unprecedented immunization push

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NEW DELHI – India on Sunday granted emergency approval to its first vaccines, Oxford-AstraZeneca and homegrown Covaxin, as it gears up to undertake an unprecedented immunization program for the country of more than 1.3 billion.

The announcement of India’s approval of the Oxford-AstraZeneca vaccine came days after the regulators in Britain gave their nod to the vaccine and marks a big step forward for the world’s second worst-affected country by the coronavirus pandemic. India aims to administer the vaccine to 300 million people in the first phase and the rollout could begin in the coming days.

The Oxford-AstraZeneca vaccine, known as Covishield in India, is being produced locally by the Serum Institute of India, the world’s largest vaccine manufacturer. It has stockpiled 40-50 million doses and plans to produce 300 million doses by July. Its billionaire owner, Adar Poonawalla, has pledged 50 percent of its production for India. On Sunday, Poonawalla said on Twitter that his company’s risks “paid off” and the vaccine is “ready to roll out.”

Interim results published by Oxford-AstraZeneca researchers in the U.K. showed that the vaccine was 62 percent effective among those administered two doses. A different dosage proved 90 percent effective; scientists are actively studying that dosage and its efficacy. Pfizer-BioNTech and Moderna, which have rolled out vaccines in the United States, reported a 95 percent efficacy rate.

According to a statement by the Indian drug regulator, the company conducted phase 2 and 3 trials on 1600 participants in the country and the data was found to be “comparable” with the data from overseas studies. The approval is subject to regulatory conditionalities, though details of that were not shared immediately.

Prime Minister Narendra Modi said it was a matter of pride for “every Indian” that both vaccines are “made in India.”

But the announcement was marred by questions over the fast track approval to Covaxin, which has not completed its third phase of human clinical trials. The vaccine is being developed by Hyderabad-based Bharat Biotech in collaboration with two government backed institutes. The drug regulator shared that the first two phase trials demonstrated the vaccine was safe but did not share any efficacy data.

“Detailed analysis documents need to be put in the public domain,” said public health expert Giridhar Babu, who said terms like “restricted use” in the announcement need to be explained.

“Regulatory conditions need to be spelt out much more clearly,” he said. “That should not be subject to interpretation.”

Shashi Tharoor, a politician of the opposition Congress party tweeted that the approval to Covaxin was “premature and could be dangerous.”

Bharat Biotech in a statement said that the vaccine addresses “an unmet medical need” and their goal is to provide “global access to populations that need it the most.”

India hopes to play a big role in the supply of coronavirus vaccines to the developing world through its homegrown vaccine candidates. Even as wealthy countries such as the United States and the United Kingdom have snapped up vaccines for their entire population, poorer regions are struggling to secure supplies.

Both the vaccines require two doses – like the Pfizer-BioNTech vaccine – but are cheaper and do not require the extremely low temperatures to store.

Health Minister Harsh Vardhan told reporters Saturday that the vaccine will be given free of cost for 30 million health care and other essential workers who will be the first in line to get vaccinated.

With over 10 million cases, India’s covid-19 caseload is second only to the United States. More than 148,000 people in India have lost their lives to the disease. However, the number of daily infections in India have fallen drastically since the early stages of the pandemic. The country confirmed the presence of the new U.K. strain of the virus among recent arrivals from Britain that has led to renewed worries about a possible resurgence of infections.

For the rollout of the program, India will first vaccinate 30 million health care workers and other first-responders including police and armed forces. This will be followed by individuals above the age of 50 and those with co-morbid conditions – another estimated 270 million people.

India’s health care system is patchy especially in rural parts and under strain from the pandemic. Logistics and delivery will be an uphill task. In September, at the peak of the pandemic, hospitals in some states faced oxygen shortages for lack of storage and delivery facilities. It also lacks the infrastructure for vaccines such as Pfizer’s that require storage at extremely low temperatures.

But the challenges are outweighed by other factors, experts in the field say.

“I think India’s biggest advantage is its vaccine manufacturing capacity,” said Shahid Jameel, director of Trivedi School of Biosciences at Ashoka University near Delhi. “India will have sufficient doses of vaccine of various types without spending huge amounts of money to preorder vaccines.”

India is a global leader when it comes to vaccine manufacturing and claims to produce 60 percent of the world’s vaccines. Its experience in running large-scale immunization programs will also come in handy. Its child immunization program targets 27 million newborn babies annually.

For effective distribution of the coronavirus vaccine, India is looking to its experience in conducting the world’s largest electoral exercise every five years.

“The procedure of the vaccination drive is the same as the election,” said Vardhan, the minister for Health on Friday, involving thousands of workers who receive training in a standardized operating procedure carried out nationwide. Step-by-step processes have been outlined and roles demarcated for vaccination teams.

For seamless tracking and delivery of vaccines, India has developed a digital platform called Co-WIN, which will maintain the database of beneficiaries, cold chain points and post-vaccination symptoms. Identification of beneficiaries, physical sites for administering vaccines and training of tens of thousands of vaccination workers is being carried out by state governments.

According to government guidelines, about 100 people will receive vaccination shots at every site in a day. Last week, four state sites held dry runs that went off smoothly.

“We were able to create vaccine sites, link to cold chains and upload beneficiary data who received (text messages) with details,” said Rajesh Bhaskar, the officer incharge of pandemic management in the state of Punjab. He said the state, which was one of the four to hold a dry run last week, had identified 150,000 health care workers for the first round who can be vaccinated within two days.

In the southern state of Andhra Pradesh, Mohammed Imtiaz, a high-ranking official said the test run was conducted in rural and urban areas at government and private facilities. The focus was on ensuring the vaccination officers were well-versed with protocols to validate identities, follow biomedical waste norms and monitor for any adverse reactions.

The rest of the country conducted similar test runs this week before the rollout formally begins.

Jameel, the virologist from Ashoka University, says there may not be a need to vaccinate everyone. Areas where 70 percent of population have antibodies for the coronavirus won’t require vaccinations, while those with a lower percentage of people with antibodies should be given priority, he said. The current government plan for vaccination will take nine to 12 months to complete, and scientists should conduct periodic sero-surveys to assess the antibody levels. “That will guide us,” he said.