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NEW DELHI – India announced on Sunday that it has 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 coronavirus from spreading in one of the toughest in the world. countries hit.
The permits were announced at a press conference in New Delhi on Sunday. Dr. V.G. 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 scrutiny” of both by the Central Drugs Standard Control Organization, India’s pharmaceutical regulatory 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, appears to be less far.
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 is # 2 in confirmed infections behind the United States, and the outbreak is widely viewed as 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 to date and “found safe”.
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 manufacturer who reached an agreement to manufacture the Oxford vaccine before it was proven effective, managing to make 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 parliamentary elections 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 says it has already 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 You said it would be the greatest effort of this kind in the history of the country.
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 One study, a mass measles vaccination campaign, saved the lives of tens of thousands of children between 2010 and 2013.
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.
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