Johnson & Johnson's single dose COVID-19 vaccine gets approval for emergency use in India, Health Minister Mansukh Mandaviya said on Saturday, 7 August.
"India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines," the health minister tweeted.
The US pharma major had said on Friday that it had applied to the Central Drugs Standard Control Organisation (CDSCO) seeking emergency use approval of its single dose COVID-19 vaccine in India.
This is an important milestone that paves the way for bringing the company's single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited, the company had said.
Here's what we know about the single-shot COVID-19 vaccine
What is it’s efficacy?
The J&J vaccine was 66.3 percent effective in clinical trials (efficacy) at preventing laboratory-confirmed COVID-19 illness in people who had no evidence of prior infection 2 weeks after receiving the vaccine. People had the most protection two weeks after getting vaccinated.
The vaccine was proven to be 72 percent effective against moderate and severe disease in the United States.
However, the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.
How is it different from other vaccines?
Johnson & Johnson vaccine is an adenovirus vector vaccine, while the Moderna and Pfizer vaccines are both mRNA vaccines.
Messenger RNA vaccines use genetic instructions from the coronavirus to tell a person’s cells to make the spike protein, but these don’t use another virus as a vector.
How is it administered?
It is administered as a single dose, into the muscle.
What are its side effects?
Injection site reactions include pain, redness of the skin, and swelling.
General side effects include headache, feeling very tired, muscle aches, nausea, fever.
There is a remote chance that the Vaccine could cause a severe allergic reaction.
Signs of a severe allergic reaction can include difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness.
How can it be stored?
It doesn’t require a freezer, making it much easier to ship and store.
The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C), the company said.
How effective is it against COVID-19 variants?
Last month, the company said it's vaccine is effective against the highly contagious Delta variant and other emerging strains, and also provided durable protection against the infection more broadly.
The data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date, the company added.
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