New Delhi – India on Sunday approved two coronavirus vaccines, one manufactured by AstraZeneca and Oxford University and another developed in India, for emergency use, a major step to stop the spread of coronavirus in one of the world’s hardest-hit countries.
The approvals were announced at a news conference in New Delhi on Sunday. India’s Drug Controller General Dr. V.G. Somani said the decision to approve the Oxford-AstraZeneca vaccine, developed by Bharat Biotech, and the local vaccine was taken after a “careful examination” of both by the pharmaceutical regulator Central Drugs Standards Control Organization of India.
Indian regulators are still considering approval for another vaccine. One, created by Pfizer and Bioentech, has already been approved in the United States and Europe. Second, Russia’s Sputnik V, appears with very little.
On Wednesday, Britain became the first country to grant emergency approval for the Xford-AstraZeneca vaccine. Argentina sued soon.
Officers in India moved quickly for a number of reasons. The country ranks second in confirmed infections behind the United States and the epidemic is believed to be worse than official figures suggest. The epidemic has devastated the economy, and the unemployment rate is at a 45-year high. Education has been disrupted, raising concerns about the long-term impact on the country’s youth.
India now has to face some tough challenges. Doses for more than 1.3 billion people must be paid for and distributed across a wide country. Government officials may also raise doubts among the public about the safety and effectiveness of vaccines, due to the government’s lack of transparency regarding clinical trial protocols.
Criticism of the lack of clarity about the data examined by the director came after both vaccines were quickly authorized for emergency use.
The All India Drug Action Network, a public health watchdog, immediately issued a statement requesting more information about the scope of clinical trials and the dosing resins for both vaccines.
On the India biotech vaccine called covacin, the group said it was still in clinical trials wondering what top experts are encouraged by scientific logic to validate the vaccine.
Director Dr. Somani said the vaccine had been given to 22,500 trial participants so far and was “found to be safe.”
D Ast. Somani said both the AstraZeneca vaccine and the Bharat Biotech vaccine require two doses. He did not specify whether participants in India Biotech’s ongoing clinical trials received both doses.
Already the effort has suffered a setback. The Indian Pharmaceutical Serum Institute, which struck a deal to produce the Oxford vaccine long before its effectiveness was proven, made only one-tenth of the 400 million doses committed for production before the end of the year. .
The government says it is ready. To get vaccinated in a country famous for its size and incredible ways for it, officials will gain knowledge for the nationwide polio vaccination and neonatal vaccination campaign, and for the skills and relief employed in India’s wide general elections, where ballot boxes are delivered. Reaches far from the country.
The Serum Institute says it is aiming to increase production of a vaccine known as Covishield in India. With 27 270 million of its own funding and 300 300 million from the Bill & Melinda Gates Foundation, Serum plans to increase production capacity to 100 million doses per month by February, company spokesman Mayank Sen said.
Initially, the Serum Institute signed an agreement with AstraZeneca to create one billion doses of the vaccine for low- and middle-income countries. The vaccine appeals to developing countries because it is cheaper and easier to transport than to require cold temperatures during storage and transport.
The serum organization delayed production while creating new facilities for the vaccine. He says he has already produced millions and millions of doses for the world. “Most of the dose will be given to India,” Adar Poonawala, chief executive of the company, told reporters on Monday.
Indian officials have been vague about how many doses they expect to receive and when. Mr Sen said there was no concrete agreement with the Serum Institute with the Government of India, but it had promised to reserve most of India’s existing stock piles.
“The government has so far signed the papers and the final dotted line, but this is based on the initial discussions that we have always said that India will be a priority,” Mr Sen said.
With the vaccine approval pending by the World Health Organization, the serum will start supplying other developing countries with doses at production cost, Mr Sen said.
India’s approval process has also been delayed. The serum organization applied for emergency use approval early last month, but regulators sought additional details of clinical trials, including whether the person involved in the trial had experienced medical difficulties.
The details of that claim are not clear. After receiving the Covishield vaccine on October 1, a 40-year-old volunteer from Chennai, India, publicly reported the neurological symptoms to the Serum Institute in a legal instruction. The company threatened defamation suits and demanded that the trial volunteer pay about $ 13.7 million. While the negative health effects of vaccine trials are rare, health experts said the serum organization risked raising misinformation by claiming to be punishing anyone for calling.
Mr Poonawala said on Monday that the serum institute had submitted additional information requested by the regulators. The problems reported by the trial participant in Chennai have nothing to do with Covishield, but declined to comment on the allegations of attempting to intimidate the person.
Indian officials have come up with an ambitious plan for the inoculation of the country’s large population, which they say will be the largest such effort in the country’s history.
India plans to launch a vaccination campaign in the first three months of the year which will cover about a quarter of the population by August. The first 30 million people inoculated will be health care providers, then the police and other frontline workers. For the remaining 270 million people, the authorities will focus on people over the age of 50 or whose conditions may make them more vulnerable.
The rest of the population will be vaccinated on the basis of vaccine availability and latest science.
India has a long experience of inoculating its own people. India’s first mass vaccination against smallpox took place in 1802. Subsequent efforts suffered from misinformation and slow acceptance.
The country has made progress in recent years. In the fight against polio, government officials are targeting religious leaders’ information campaigns to help eradicate the disease. According to one study, a massive measles vaccination campaign saved the lives of thousands of children between 2010 and 2013.
For the coronavirus campaign, the national government has asked the states to prepare a vaccination strategy. Some have formed task forces at the state, district and block levels. The Indian Ministry of Health has said that more than 20,000 health workers have been trained in about 260 districts for vaccination.
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.
Airlines, airports and ground handlers have been asked to come up with plans for transporting the vaccine vials in cold temperatures, India’s Civil Aviation Minister Hardeep Singh Puri said on Tuesday.
This week, health workers in four Indian states conducted an exercise to remove any wrinkles. Health officials at various locations gave more than 100 placebo vaccine dose trainers. They then checked the dose temperature from the train depot to the vaccination site, as well as the time and whether they reached the desired patients.
India will still need to improve its ability to store and move vaccines under temperature-controlled conditions – known as the cold chain network – as well as to improve distribution methods and train new workers.
Thekkekara Jacob John, a senior virologist from Tamil Nadu, South India, said, Millions could double the number of health workers.
“This is a Herculean task,” Mr. John said of the vaccine effort. “And the challenge is not the densely populated cities but the rural areas – the real home of India.”
He said government officials also have to stop spreading rumors. Chat groups on WhatsApp, Facebook’s proprietary messaging service, which is widely used in India, have become home to misinformation about side effects.
A month ago, Prime Minister Narendra Modi urged citizens to keep an eye out for people trying to spread rumors about the vaccine, which he called “anti-national and anti-human” and urged politicians to help bring awareness.
Shri Modi on Thursday renewed his appeal and continued his fight against the virus against an unknown enemy.
“Beware of rumors, and as responsible citizens, avoid investigating without sending messages on social media,” he said.
