Both vaccines are administered in two doses and stored at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
The approval is a major step in India’s effort to curb the coronavirus outbreak, which has infected more than ten million people and left only the United States’ total tax burden.
The Serum Institute of India, the largest vaccine manufacturer in the world, manufactures the AstraZeneca and Oxford vaccine locally, after taking a huge risk to manufacture the vaccine months before regulatory approval.
“This is a wonderful day for India and the world because it is going to be the cheapest vaccine, which will be distributed around the world as much as possible,” Adar Poonawalla, chief executive of the institute, told CNN.
But the vaccines, locally branded Covishield, will only be available to other countries in March or April, as the Indian government has restricted them for export, according to Poonawalla.
“It’s not currently going to the private market, private hospitals and other places. We are getting a limited license to just give it and give it to the Government of India because they want to prioritize for the most vulnerable and needy segments first, he said.
The coronavirus vaccines in India are a major alternative for developing countries, which may not be able to afford the more expensive vaccines in the West, or have the cold storage capacity to transport vaccines that require ultra-cold temperatures, such as those developed by Pfizer. and Modern.
In September, the Serum Institute of India pledged to manufacture and deliver 200 million doses for COVAX – a World Health Organization vaccine alliance set up to ensure equitable access to Covid-19 vaccines. But the export of vaccines to ‘low- and middle-income countries’ only begins before the restrictions are eased.
Poonawalla said Covishield would initially be sold to the Indian government for $ 2.74 per dose – about its cost of production. It will be between $ 3 and $ 5 per dose for export and at $ 13.70 for the private market, he added.
Mass vaccination
The Serum Institute of India expects to sign a formal agreement with the Indian government ‘immediately’, and people will be vaccinated within the ‘next seven to ten days’,’ Poonawalla said.
The institute has already compiled 50 million doses of the vaccine ready for distribution this month and is ready to send it to 30 to 40 government offices across the country. From there, they will be distributed to the smaller centers and clinics that have been set up, he said.
India already has an extensive, established network under its Universal Immunization Program, which vaccinates approximately 55 million people a year. Analysts have said that this means that the country’s health care system is relatively well prepared for the vaccinations against Covid-19.
Prior to the mass vaccination, the Indian government had also recruited and trained additional vaccines over the past few months, wrapping up the supply of cold-chain storage equipment such as walk-in coolers and freezers, freezers and refrigerators. .
Lack of data
India’s medical regulator has also approved Covaxin, the country’s first homemade coronavirus vaccine developed by Bharat Biotech and the Government’s Indian Council for Medical Research.
But the government has faced fierce criticism from experts and opposition leaders for not disclosing the results of the vaccine’s efficacy or any other data from its clinical trials.
“Its use should be avoided until full trials are over. In the meantime, India could start using the AstraZeneca vaccine,” he tweeted.
Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, agrees.
“I would say that in the first phase we should focus mainly on the Serum Institute of India – the Astra Zeneca vaccine, and the Bharat Biotech is only an assistance or a backup if there is an increase in the number of cases, “said Guleria, a member of the national task force on Covid-19 management.
“EUA for COVAXIN differs from COVISHIELD because its use will be in clinical trial mode. All COVAXIN recipients should be monitored, monitored as if they were in the trial,” he wrote.
In a news release on Sunday, Bharat Biotech said the Phase 3 clinical trial for Covaxin began in mid-November, with the aim of including 26,000 volunteers.
“COVAXIN ™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals,” the publication reads.
Vaccine blast in Asia
Across Asia, a growing number of countries have begun vaccinations against Covid-19.
The Chinese government aims to vaccinate 50 million people against Covid-19 before celebrating the new lunar year in February. The country has already administered 4.5 million doses of experimental Chinese vaccines since June under its emergency use program, which includes front-line workers such as health care workers and customs officials.
The next step is to vaccinate vulnerable groups such as the elderly and people with underlying diseases before vaccinating the general population, officials said last week.
In Beijing, the municipal government vaccinated on January 1 with the vaccination of targeted groups of the population, including frontline workers and students and employees who have to go overseas. It has erected 220 vaccination sites across the city and vaccinated 73,500 people as of Saturday.
Compared to the rapid implementation in India and China, the Japanese government has been criticized for the inertia of vaccination vaccines.