India rolls-out self manufactured vaccines against Covid-19

Dr. Reepa Agrawal
18 Jan, 2021

Joining several other countries in its fight against COVID-19, India had a historic rollout of vaccines on 16 January 2021. The Drug Controller General of India (DGCI) granted emergency use authorization to Covishield vaccine ; and Covaxin vaccine ( in clinical trial mode) on 3rd January 2021 . Both Covishield and Covaxin vaccines are being manufactured in India itself by Serum Institute of India ,Pune and Bharat Biotech , Hyderabad respectively and have been given restricted emergency use of authorization for individuals 18 years and above only.

The Covishield vaccine is the Indian manufactured version of Oxford AstraZeneca viral vector vaccine. This contains a recombinant non replicating chimpanzee adenoviral vector (ChAdOx1) which contains the Spike protein gene of SARS-CoV-2. Adenoviruses have been studied for being used as vaccine vectors extensively. Human adenovirus is one of the common cold viruses, as there is a substantial amount of human population which has pre-existing immunity against it, therefore, chimpanzee adenovirus is being used as a vector so that optimum immune response can be elicited.

The efficacy of Oxford AstraZeneca vaccine is around 73% and has a good safety profile according to the Phase 3 clinical trials conducted in UK, Brazil, South Africa which included around 20,000 participants. A bridging trial was also conducted in India on 1600 participants and it showed similar results according to Serum Institute of India website. The dose is 0.5 ml intramuscular, 2 doses 4 to 6 weeks apart, can be given upto 12 weeks apart. The common side effects reported are fatigue, swelling and/ or redness at the site of administration, headache, nausea, joint and muscle pains, fever etc. There are few reports of neuroinflammatory diseases post vaccination however no causal relation is determined yet. Although seroconversion has been reported to be 98% 28 days after first dose and 99% 28 days after second dose, its not known how long the protection will last exactly. The clinical trial also demonstrated that this vaccine would prevent symptomatic COVID , with no hospitalisations and no severe cases 14 days post second dose. This is a very cost- effective vaccine and will be available at a cost of approximately $2 to the government of India. Unlike mRNA vaccines, it can be stored at a temperature of 2 – 8 degree celsius for 6 months ,which makes it easy to store and transport.

Covaxin manufactured by Bharat Biotech has also been given restricted emergency use authorization in clinical trial mode by DGCI and has developed in collaboration with the National Institute of Virology and Indian Council of Medical Research. It is a traditional type vaccine which contains inactivated SARS-CoV-2. This vaccine is still undergoing Phase 3 trials and the vaccine recipients will have to give consent for participating in the said trial if they take this particular vaccine. The manufactures claim it to be safe and efficacious but no efficacy data is available yet.

India plans to prioritise vaccinating its healthcare workers and frontline workers first and then moving on to protecting those above 50 years of age or with any high-risk conditions in individuals 18 years and above.

There has been tremendous progress in the development of vaccines against COVID-19 globally however evidence regarding lasting immunity and sterilizing immunity is unclear hence hand hygiene, physical distancing, and face coverings are quite important to keep this pandemic bug at bay.

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