Introduction – COVID Vaccines in India

The pandemic of 2020 has indeed been a difficult year for the entire world, however with the production of Covid Vaccines in India, 2021 is seeming to be brighter as various treatments improve and vaccines have begun to roll out to the general public on a large scale. Countries are distributing vaccines, bringing new hope to fight against the pandemic. UNICEF, GAVI, WHO and several other partners are working to prepare vaccines. With planning, infrastructure and technical support, every country can systematically deploy vaccines to the nation. India has granted approval to M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd. This article gives a brief overview of the approved Covid Vaccines in India and how India plans to fight against this pandemic and emerge stronger in terms of Healthcare in future.

Types of  Covid Vaccines in India

  1. M/s Serum Institute of India in Pune has come up with a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) which encodes SARS-CoV-2 Spike(S) glycoprotein with the technology transfer from AstraZeneca/Oxford University. The overall vaccine efficacy was found to be around 71%. They were also granted permission to conduct Phase-II/III clinical trials in about 1500 patients in the country. The Institute has also submitted the safety and immunogenicity data which has been produced from this trial and this data is comparable to the data from overseas clinical studies.
  2. M/s Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) in Pune, from where they received the virus seed strains. This vaccine has been developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country & globally. The firm has generated safety and immunogenicity data in various animal species All this data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in about 1000 patients and the results have demonstrated that the vaccine is safe and provides a robust immune response.  
  3. M/s Cadila Healthcare Ltd., has developed a Novel CoronaVirus-2019- (nCov-Vaccine) using DNA platform technology. The firm has started Phase-I/II clinical trials in India with more than 1000 participants. The data collected up to now suggests that the vaccine is safe and immunogenic with three doses when it is administered intradermally. The firm has sought permission to conduct Phase-III clinical trials in about 30,000 participants in India, which has been recommended by the Subject Expert Committee. 

Effects of Covaxin

The side effects of Covaxin which have been reported so far are – injection site – pain; swelling; redness; site itching, stiffness in the upper arm, weakness in the injection arm,  ache in the body, migraine, pyrexia, malaise, rashes, nausea, body weakness and vomiting. Apart from these, there is a very small chance that Covaxin could cause severe allergic reactions as well. 

Effects of Covishield 

The side effects which have been reported for Covishield are pain, warmth, tenderness, redness, itching, swelling, or bruises where the injection is given, feeling unwell, fatigue, chills, or feeling feverish, headache, nausea, and joint pain or muscle ache. It may affect up to 1 in 10 people who have dizziness, decreased appetite, abdominal pain, enlarged lymph nodes, excessive sweating, itchy skin, or rash.

How do these vaccines work – 

Covaxin

Covaxin uses Whole-Virion Inactivated Vero Cell derived platform technology, which does not duplicate and is therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to produce a defensive reaction against an infection.

Covishield 

It is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S-glycoprotein of SARS-CoV-2. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralizing antibody and cellular immune responses.

nCov-Vaccine 

While Cadila’s plasmid DNA candidate doesn’t use an infectious agent, like other vaccines, it instead introduces the DNA sequence encoding the antigen, the other tests being done are for traditional delivery methods.

Conclusion

Clinical trial data show all authorized Covid Vaccines in India vaccines are preventing extreme illness, hospitalization, and death. However they will be studied to understand how they work in public, outside of the clinical trials. India has a steady supply of COVID-19 vaccines with its immunogenicity and efficacy proven. Apart from this, Bharat Biotech has been approached by several countries for the procurement of its vaccine. India has also mentioned that it will continue to supply vaccines all over the world after taking into account the internal requirements and international demands and obligations.

How can Morulaa Help?

Morulaa HealthTech is a successful Regulatory and Import Consultant. We have delivered high levels of professionalism towards our clients. If you are seeking to commercialise in India, please contact us to know more. 


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