Green light for Oxford vaccine and domestically produced Covaxin by Prime Minister hailed as ‘game changer’
For both the Oxford/AstraZeneca coronavirus vaccine and domestically produced Covaxin, India has given emergency clearance, setting off one of the world’s largest Covid-19 immunization campaigns.
India’s Pharmaceuticals Inspector General said at a press conference on Sunday that the decision to approve both the Oxford vaccine and Covaxin, developed by the Indian company Bharat Biotech and co-funded by the government, was taken after the data was “careful consideration”
This makes India the second country after the United Kingdom to approve the emergency use of the Oxford/AstraZeneca vaccine, known as Covishield in India. It gave Wednesday the green light.
At a critical moment, the approval comes.
More than 10.3 million cases of Covid-19, the world’s second-highest number, and 149,000 deaths have been reported in India, a nation of more than 1.3 billion people. Prime Minister Narendra Modi called the approval of the vaccine a “crucial turning point.” on Sunday.
In the first step, India aims to vaccinate 300 million people, prioritizing 30 million health care staff, police and armed forces. The vaccine is then given to persons over the age of 50 and others with comorbid illnesses. The vaccine is administered free of charge.
However, there have been some questions regarding the approval of Covaxin, as the vaccine is still in Phase 3 clinical trials and full data on the effectiveness of the vaccine have not yet been released.
A public health organisation, All India Drug Action Network, said it was ‘puzzled’ by the decision to approve a vaccine that is still in the testing process. The government had previously promised that by August 2020, Covaxin, developed in partnership with the Indian Council of Medical Research, a government agency, would be ready for distribution.
“Senior opposition leader Shashi Tharoor tweeted his Covaxin concerns, saying, “Covaxin has not yet undergone phase 3 trials.
The approval was premature and may have been risky,’ he wrote.
India’s Drug Controller General, VG Somani, tried to ease some concerns. He said Sunday, “We will never approve anything if there is even the slightest safety concern. The vaccines are 110 percent safe.”
It is critical that both Covishield and Covaxin are manufactured in India, a country that is already one of the world’s largest producers of pharmaceuticals and produces around 60 percent of the vaccines in the world.
The Oxford/AstraZeneca vaccine will be manufactured by the Serum Institute of India, where 40 million doses have already been stored prior to approval. By July, the company committed itself to manufacturing 300 million doses and consistently ensured that 50% of the vaccines produced would be reserved for India.
On Sunday, Serum Institute India CEO Adar Poonawalla tweeted:
Adar Poonawalla Poonawalla
Everyone, happy New Year! Eventually, all the chances that @SerumInstIndia took in stockpiling the vaccine paid off.
COVISHIELD, India’s first COVID-19 vaccine, pic.twitter.com/TcKh4bZIKKK/TcKh4bZIKKK, is approved, safe, efficient and ready for roll-out in the coming weeks.
3rd January 2021
However, in administering the vaccine in the vast country, India faces major challenges. Health care is uneven, funding and energy are lacking, and access in rural areas is often difficult. The government has started educating approximately 20,000 healthcare staff to administer the vaccine, and last week performed test runs of placebo vaccines delivered by qualified clinicians in four states.
It is only necessary to store Covishield and Covaxin at temperatures between 2 and 8 degrees Celsius, which is much more feasible than vaccines sold in Europe and the United States by Pfizer and Moderna.
There are concerns, however, that India’s cold chain – the refrigerated resources that allow the vaccine to be safely transported and stored – does not yet have the capacity for 1.3 billion people to handle the vaccines. In order to make preparations on how to distribute the vaccine across the world, the government has brought in the aviation and transport ministries.
The government said it wants to expand on its highly successful program to eliminate polio and the infant vaccination program, which annually vaccinates about 27 million children.