Bharat Biotech develops first Covid19 vaccine in India; to start phase I and II human clinical trails

[email protected], 1st July 2020

The world is waiting for Covid19 cure as the number of cases crosses over 1 crore across the world, and over 5 lakhs cases in India.

It’s been over 3 months since first lockdown imposed in India and with relaxation the number of cases are soaring high. Everyone are hoping against hope that a permanent cure in the form of vaccine or antiviral is found at the earliest.

Across the world scientists are working hard to find a vaccine. Along with that, they are also striving to find antivirals to combat Covid19.

Difference between vaccine and treatment drugs(antiviral):

Vaccine is a substance given to stimulate the body’s production of antibodies and provide immunity against a disease. Vaccine prevents the disease.

Treatment drugs cures a diseases that is already contracted. Drugs cures the disease.

Covid19 vaccines under clinical trail so far:

Covaxin by Bharat Biotech India:

  • First vaccine developed by India in collaboration with Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
  • The indigenous, inactivated vaccine (killed virus) developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
  • The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
  • Human clinical trials are scheduled to start across India in July 2020.

For more information on Covaxin click here

Oxford Covid 19 vaccine:

  • The team in Oxford University is led by Prof. Sarah Gilbert, Prof. Andrew Pollard, Prof. Teresa Lambe, Dr Sandy Douglas and Prof. Adrian Hill
  • Started work designing a vaccine on Saturday 10th January 2020
  • It is a chimpanzee adenovirus vaccine vector (ChAdOx1), developed at Oxford’s Jenner Institute. It was chosen as the most suitable vaccine technology for a SARS-CoV-2 vaccine as it can generate a strong immune response from one dose and it is not a replicating virus, so it cannot cause an ongoing infection in the vaccinated individual.
  • In April 23 they began testing on humans in Oxford.
  • April 30, University of Oxford announced an agreement with the UK-based global biopharmaceutical company AstraZeneca for the further development, large-scale manufacture and potential distribution of the COVID-19 vaccine
  • Clinical trails in Brazil and South Africa begins this week.

More information on Oxford vaccine group click here

In India, apart from Bharat Biotech, other companies working towards developing Covid 19 vaccine include Zydus Cadila, Serum Institute of India (SII) and Panacea Biotec. Currently, they are in preclinical development stage, according to a report Clinical Trails Arena.

AstraZeneca reached a licensing agreement with SII to supply Oxford vaccine of one billion doses for low and middle-income countries, with a commitment to provide 400 million before the end of 2020.

There are over 100 projects across the world working towards covid19 cure. To mention few include Moderna (will begin phase III clinical trial in July), Inovio (to start a phase II/III clinical trial soon), University of Queensland in Australia (phase I clinical trial to begin in July), according to media report Healthline. Chinese biotech firm CanSino Biologics to start phase III on Chinese soldiers for a year, according to reports.

What is Clinical Trial Phase?

  • Phase I. Testing on healthy volunteers for safety. Typical number include 20–100 normal healthy volunteers. Aims to determines whether drug is safe to check for efficacy.
  • Phase II. Testing of drug on patients to assess efficacy and side effects. Typical number include 100–300 patients with specific diseases. Determines whether drug can have any efficacy; 
  • Phase III. In this large-scale trial, the drug is given to 300–3,000 patients with specific diseases. Determines a drug’s therapeutic effect; at this point, the drug is presumed to have some effect. The trial is usually randomized and can take 1 to 4 years. This stage provides the best evidence of how the drug works and the most common side effects.
  • Phase IV. Post marketing surveillance – watching drug use in public. Given to anyone seeking treatment from their physician. Watch drug’s long-term effects.

Antivirals

Some of the antivirals available to treat covid19 include Remdesivir and favipiravir. Remdesivir founded a decade ago was used in USA with approval from US Food and Drug Administration (FDA) to treat covid19.

In India, last month Cipla Ltd and Hetero Drugs have got authorisations for antiviral Remdesivir for restricted emergency use. Glenmark Pharmaceuticals also got authorisation for Favipiravir and are introducing under the brand name fabiflu in India. This was used in Japan to treat influenza. This is the first oral medication available in India and used for mild and moderate symptoms, according to media reports.

However, as the clinical trials are still going on, there is no full guarantee to cure the covid19 with the usage of above drugs.

Stay safe at home, maintain social distancing, wear mask and use hand sanitisers and don’t forget to wash your hands.

 

 

 

 

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