Sputnik has an efficacy of 91.6%, next only to Pfizer and Moderna (File)
The Drug Controller General of India (DCGI) approved the Sputnik V vaccine for emergency use in India on Tuesday. After Covishield and Covaxin, the Russian drug is the third vaccine to be approved in the country. India is the 60th country to have approved Sputnik V. The decision comes as the country continues to see a massive surge in daily COVID-19 cases. On Monday, India overtook Brazil to become the second-worst hit country in the world.
Sputnik V
Now, with the DCGI's approval, the Sputnik V vaccine can be produced locally. The vaccine - which is currently undergoing Phase 3 trials in India - is being manufactured by Dr Reddy's Laboratories.
The Russian Direct Investment Fund (RDIF) said in a statement that five pharma companies in India - Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech - had reached agreements with it and were aiming to produce over 85 crore doses per year.
"Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators," the statement further read.
Sputnik V Doses and how they work
Sputnik is a two-dose vaccine. Its second dose needs to be administered after a gap of 21 days. It uses two different vectors for each of the two jabs. Two different disarmed strains of the adenovirus, which causes common cold, are used as vectors to deliver the vaccine doses. Delivering two different vectors, according to experts, minimises the risk of the immune system developing resistance to the initial vector.
According to RDIF, compared to other vaccines that use the same delivery mechanism, Sputnik V provides immunity for a longer duration. Besides, the adenoviruses are also weakened so that they cannot replicate in human cells and cause disease. The peak immunity develops somewhere between day 28 to day 42, says Deepak Sapra of Dr Reddy's Laboratories.
Side-effects
Researchers said that rarely did anyone report a serious adverse after-effect requiring hospitalisation. If at all there were any side effects, they were not associated with the vaccine. Alexander Gintsburg, Director, the Gamaleya National Research Centre, had said that there were no concerns about the vaccine potentially causing any harm to a person's health. He said some people naturally get a fever after their immune system gets a powerful boost.
This "side-effect", he says, can easily be overcome by taking paracetamol.
The vaccine doesn't cause any serious allergy.
Efficacy
Sputnik has an efficacy of 91.6%, next only to Pfizer and Moderna. Clinical trials showed that Pfizer and Moderna shots had shown an efficacy of about 95% against symptomatic COVID-19 in lab settings, and Sputnik V is only the third to have registered such a high efficacy rate.
Covishield
Developed by the University of Oxford in partnership with AstraZeneca and produced at the Serum Institute of India (SII) in Pune, Covishield is one of the first two vaccines approved for emergency use by the Government of India. Several countries in Europe are also using the drug.
How it works
Covishield, too, follows the same formula as Sputnik V -- a weakened version of adenovirus, a common cold virus, from chimpanzees. The dose has been modified to look more like coronavirus, but it can't cause illness. Once injected, the shot prompts the immune system to produce antibodies.
Efficacy
The initial results of the Phase-3 trials released in December last year showed the efficacy of the vaccine to be 70.4 percent. The data was based on the results shown by 11,636 volunteers across the UK and Brazil. The international clinical trials of the vaccine showed that if people were given first a half dose and then the full dose, the efficacy could go up to 90%.
After-effects
The European Medicines Agency (EMA) and Danish Health Authority had said recently that some incidents of blood clots were noted after the first dose of the vaccine was administered. But on March 18, the EMA concluded that Covishield was safe and didn't increase the overall risk of blood clots.
No cases of blood clotting have been reported from India, where Covishield remained one of the two vaccines approved for emergency use against the virus before Sputnik V joined the list.
Side-effects
The Serum Institute of India says that "very common" side effects such as tenderness, pain, warmth, redness, itching, swelling, or bruises where the injection has been given, generally feeling unwell, fatigue, chills, or feeling feverish, headache, nausea, and joint pain or muscle ache may affect more than 1 in 10 people.
Feeling dizzy, decreased appetite, abdominal pain, enlarged lymph nodes, excessive sweating, itchy skin, or rash have been categorised as "uncommon" side effects by the SII and may affect up to 1 in 100 people.
Doses
The two doses are administered between four and 12 weeks apart, and they can be stored at temperatures of 2-8 degree Celsius.
Covaxin
Cleared in January for emergency use, Bharat Biotech's Covaxin is India's homegrown vaccine against the coronavirus. The vaccine was granted emergency approval while its third phase trials were still underway.
How it works
Bharat Biotech, in partnership with the National Institute of Virology and the Indian Council of Medical Research (ICMR), developed an inactivated coronavirus vaccine. To create this vaccine, the pharma company used a sample of the coronavirus, which was isolated by the National Institute of Virology. The vaccine prompts the immune system to produce antibodies against SARS-CoV-2, which causes Covid-19.
Bharat Biotech says that immune-potentiators, also known as vaccine adjuvants, are added to the vaccine to boost its immunogenicity.
Efficacy
Last month, the company revealed a "first interim analysis" of Phase 3 trial results for the vaccine and claimed its efficacy rate was 81 percent and the jab was effective against the UK variant too.
Side-effects
Bharat Biotech says that among the side-effects reported with Covaxin are pain, redness, itching at the injection spot, stiffness in the upper arm, weakness in the arm, body ache, headache, fever, malaise, weakness, rashes, nausea, and vomiting.
The company has also said that there was a "remote chance" that the vaccine may cause severe allergic reactions such as difficulty in breathing, swelling of your face and throat, a fast heartbeat, rashes all over the body, and dizziness and weakness.
Doses
Covaxin is a 2-dose vaccination regimen given 28 days apart.