Both vaccines will be given in two doses and stored at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
The approval is a crucial step in India’s effort to counter its outbreak of coronavirus, which has infected more than 10 million people, targeting the United States alone.
Serum Institute of India, the world’s largest vaccine manufacturer, produces AstraZeneca and Oxford vaccines locally, taking a huge risk of manufacturing the vaccine months before regulatory approval.
“It’s a wonderful day for India and the world, because it will be the most affordable vaccine, which will be distributed as equitably as possible around the globe,” the institute’s chief executive, Adar Poonawalla, told CNN on Sunday.
But the vaccines, the local Covishield brand, will not be available to other countries until March or April because the Indian government has restricted their exports, according to Poonawalla.
“This will not work in the private market, private hospitals and other places right now. We are granted a restricted license only to grant it and provide it to the government of India, because they want to give priority to the most vulnerable and the needy segments first, ”he said.
Coronavirus vaccines in India are an important alternative for developing countries, which may not be able to afford the more expensive vaccines produced in the West or have the cold storage capacity to transport vaccines that require ultra-cold temperatures, such as those developed. by Pfizer and Moderna.
In September, the Serum Institute of India committed to producing and delivering 200 million doses for COVAX – a World Health Organization vaccination alliance set up to ensure equitable access to Covid-19 vaccines. But the export of vaccines to “low- and middle-income countries” may not start until the restrictions are eased.
Poonawalla said Covishield will initially be sold to the Indian government for $ 2.74 per dose – about the cost of production. It will be priced between $ 3 and $ 5 per dose for export and $ 13.70 for the private market, he added.
Mass vaccination unit
India’s Serum Institute expects to sign a formal agreement with the “imminent” Indian government, and people will start being vaccinated in “the next seven to 10 days,” Poonawalla said.
The institute has already stockpiled 50 million doses of vaccine ready for distribution this month and is ready to send them to 30-40 government locations across the country. From there, they will be distributed to smaller centers and clinics that have been set up, he said.
India already has an extensive network established under its Universal Immunization Program, which inoculates approximately 55 million people a year. Analysts say this means that the country’s health system is relatively well prepared for Covid-19 vaccinations.
Prior to the mass vaccination campaign, the Indian government recruited and trained additional vaccinators and intensified its stocks of cold chain storage equipment, such as refrigerators and freezers, freezers and ice-cold refrigerators. .
Lack of data
The Indian Drug Regulatory Authority has also approved Covaxin, the first homemade coronavirus vaccine developed jointly by Bharat Biotech and the government-run Indian Medical Research Council.
But the government has faced fierce criticism from experts and opposition leaders for not disclosing the results of the vaccine’s effectiveness or any other data from its clinical trials.
“Its use should be avoided until full studies are completed. India may in the meantime start with the AstraZeneca vaccine,” he wrote on Twitter.
Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, agreed.
“I would say that in the first phase, we should focus mainly on the Serum Institute of India – the Astra Zeneca vaccine, and Bharat Biotech is only as a waiting or backup mode if there is an increase in the number of cases. , “said Guleria, a member of the national working group for the leadership of Covid-19.
“EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode. All COVAXIN recipients will be tracked, monitored as if in the study,” he wrote.
In a press release on Sunday, Bharat Biotech said its 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 statement said.
Launch of vaccines in Asia
Across Asia, a growing number of countries have started vaccinations against Covid-19.
The Chinese government aims to inoculate 50 million people against Covid-19 before the February Lunar New Year celebrations. The country has already administered 4.5 million doses of experimental Chinese vaccines since June as part of its emergency use program, which has included front-line workers such as health workers and customs officers.
The next step is to inoculate 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 began vaccinating target groups of the population, including front-line workers and students and employees who have to go overseas, on January 1. It has set up 220 vaccination sites across the city and inoculated 73,500 people since Saturday.
Compared to the rapid launches in India and China, the Japanese government has faced criticism about its slowdown in vaccines.