NEW DELHI – India on Sunday approved two coronavirus vaccines, one made by AstraZeneca and Oxford University and the other developed in India for emergency use. This is an important step in stopping the spread of the coronavirus in one of the hardest hit countries in the world.
The permits were announced at a press conference in New Delhi on Sunday. Dr. VG Somani, the Indian drug control officer, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech was made after “careful review” of both by the Central Drugs Standard Control Organization, India’s Indian medicines agency .
Indian regulators are still considering approvals for other vaccines. One made by Pfizer and BioNTech has already been approved in the US and Europe. Another, Russia’s Sputnik V, seems less far away.
The UK became the first country to issue emergency approval for the Oxford-AstraZeneca vaccine on Wednesday. Argentina soon followed.
Officials in India moved quickly for several reasons. The country ranks number 2 in confirmed infections behind the United States, and the outbreak is widely believed to be worse than official numbers suggest. The pandemic has devastated the economy and the unemployment rate is at a 45-year high. Education has been disrupted, leading to concerns about the long-term impact on the country’s youth.
India is now facing major challenges. Cans for more than 1.3 billion people have to be paid for and distributed over a vast country. Government officials may also have public doubts about the vaccine’s safety and effectiveness, partly due to the government’s lack of transparency about clinical trial protocols.
Criticism of the ambiguity of the data examined by the regulator came quickly after the two emergency vaccines were approved.
All India Drug Action Network, a public health watchdog, immediately issued a statement requesting more information on the scope of clinical trials and dosage regimens for both vaccines.
Regarding the Bharat biotech vaccine called Covaxin, the group said it was “baffled to understand the scientific logic that motivated the top experts” to approve a vaccine that is still in clinical trials.
Dr. Somani, the regulator, said the vaccine had been given to 22,500 study participants and “found safe” to date.
Both the AstraZeneca vaccine and the Bharat Biotech vaccine require two doses, said Dr. Somani. He did not state whether participants in Bharat Biotech’s ongoing clinical trials received both doses.
The effort has already been fraught with setbacks. The Serum Institute, an Indian drug company that had an agreement to make the Oxford vaccine before it was proven to be effective, has managed to produce only about a tenth of the 400 million doses it promised to make before the end of the year.
The government says it’s ready. To get the vaccine to a country known for its size and sometimes unreliable roads, officials will leverage knowledge from nationwide campaigns against polio and newborn vaccinations, as well as the skills and flexibility used in India’s mammoth general election where ballot boxes are delivered to the US furthest from the country.
The Serum Institute says it is on the right track to ramp up production of the vaccine known in India as Covishield. With $ 270 million of its own funds and $ 300 million from the Bill and Melinda Gates Foundation, Serum plans to increase production capacity to 100 million doses per month by February, said Mayank Sen, a company spokesman.
First, the Serum Institute signed a pact with AstraZeneca to manufacture one billion doses of the vaccine for low and middle income countries. The vaccine is attractive to developing countries because it is cheaper to manufacture and easier to transport than those which require colder temperatures during storage and transportation.
The Serum Institute experienced production delays when it built new facilities to manufacture the vaccine. It is said to have produced between 40 and 50 million cans for the world. The company’s chief executive Adar Poonawalla told reporters on Monday that the majority of the cans will be given to India.
Indian officials were unsure of how many doses to receive and when. Mr Sen said the Serum Institute had no firm agreement with the Government of India, but had committed to reserve most of its existing inventory for India.
“The government has not yet signed the papers and the final dotted line, but this is based on initial discussions we had because we have always said India will be the priority,” said Sen.
Until the vaccine is approved by the World Health Organization, serum will begin shipping doses at manufacturing cost to other developing countries, Sen said.
India’s approval process has also been delayed. The Serum Institute filed for emergency approval earlier last month, but regulators requested additional details from clinical trials, including whether any person involved in the trials had had any medical complications.
The details of this claim are not clear. After receiving the Covishield vaccine on October 1, a 40-year-old volunteer from Chennai, India, publicly reported neurological symptoms to the Serum Institute in a legal notice. The company threatened defamation lawsuits and required volunteers to pay approximately $ 13.7 million. While negative health effects from vaccine trials are rare, health professionals risked the Serum Institute promoting misinformation by punishing someone for speaking up.
Mr Poonawalla said Monday that the Serum Institute had submitted the additional information that regulators had requested. It has denied that the problems reported by the Chennai trial participant had anything to do with Covishield but refused to comment on allegations of intimidation.
Indian officials have drawn up an ambitious plan to vaccinate the country’s huge population. This is the greatest effort of this kind in the country’s history.
India plans to launch a vaccination campaign in the first three months of the year that will cover about a quarter of the population by August. The first 30 million people vaccinated will be health care providers, then police and other frontline workers. For the remaining 270 million people, authorities will focus on those over 50 who are suffering from conditions that may make them more vulnerable.
The rest of the population will be immunized based on the availability of vaccines and the latest scientific knowledge.
India has a long history of vaccinating its people. India’s first mass vaccination took place in 1802 to combat smallpox. Subsequent efforts suffered from misinformation and slow adoption.
The country has made progress in recent years. In the fight against polio, government officials ran informational campaigns to religious leaders to almost eradicate the disease. According to a study, a mass measles vaccination campaign between 2010 and 2013 saved the lives of tens of thousands of children.
For the coronavirus campaign, the national government has asked the states to prepare vaccination strategies. Some have established task forces at the state, district and block levels. To date, more than 20,000 health workers in around 260 districts have been trained to administer the vaccine, according to the Indian Ministry of Health.
The government plans to use the framework of its universal vaccination program for pregnant women and newborns – one of the largest and cheapest public health interventions in the world.
Indian civil aviation minister Hardeep Singh Puri said Tuesday that airlines, airports and ground handlers have been asked to develop plans to transport vaccine bottles in cold temperatures.
This week, health workers in four Indian states conducted an exercise to iron out wrinkles. Health officials in various locations distributed over 100 doses of placebo vaccine to trainers. They then tracked the temperature of the cans on the way from the train depot to the vaccination site, as well as the time and whether they reached the intended patient.
India has yet to improve its ability to store and transport vaccines under temperature controlled conditions known as the cold chain network, as well as improve distribution methods and train new workers.
India may need to double its health care workforce from its current 2.5 million, said Thekkekara Jacob John, a senior virologist in southern Tamil Nadu state.
“This is a Herculean task,” said John of the vaccination effort. “And the challenge is not in densely populated cities, but in rural areas – home of real India.”
Government officials must also stop the rumor, he said. Chat groups on WhatsApp, Facebook’s widespread messaging service in India, have already become misinformation about side effects.
A month ago, Prime Minister Narendra Modi urged citizens to look 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, throwing the continued fight against the virus as one against an unknown enemy.
“Be careful of rumors,” he said, “and as a responsible citizen, you must not post messages on social media without checking.”