The world is suffering from the terror of the deadly coronavirus. India is one of the worst-hit countries right now. The nation is striving hard to fight the virus. Indian pharmaceuticals company, Bharat Biotech International Limited which is engaged in the manufacturing of bio-therapeutics, vaccines, and health care products developed a vaccine to treat coronavirus, the COVAXIN. This vaccine is developed in collaboration with the National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR).
COVAXIN™, India's 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.— BharatBiotech (@BharatBiotech) June 29, 2020
@ICMRDELHI @DBTIndia @icmr_niv #BharatBiotech #COVAXIN #covid19 #Collaboration #Indiafightscorona #makeinindia #ICMR #coronavirusvaccine pic.twitter.com/MSehntuE8d
About Bharat Biotech
The Indian biotechnological company, Bharat Biotech Limited was founded by Indian Scientist Krishna Ella in the year 1996 and it’s headquarter is located in Hyderabad. It’s one of the pharmaceutical manufacturing plants is the largest of its kind in Asia-Pacific. Bharat biotech is said to be a reputed drug manufacturer that delivers 4 billion doses across the globe for infections like hepatitis, Japanese encephalitis, Zika, rotavirus and, many more. It is India’s first bio-pharma facility to be audited and approved by KFDA i.e. Korean Food and Drug Administration.
About the development of COVAXIN
According to the company, the COVAXIN is an inactivated vaccine developed from an Indian strain of the ongoing COVID-19 isolated by the National Institute of Virology. Details about the nature of the vaccine, how it is developed or any further information about the same has not been provided. No prior announcement was made about when a process of developing such a vaccine begun.
On the 9th of May, the Indian Council of Medical Research transferred the strain National Institute of Virology had isolated to Biotech Bharat. On the 29th of June, a press release was published by the company. So during this time of 50 days the company underwent the developing procedure of the vaccine:
- Developed the inactive vaccine
- Conducted preclinical animal trials (on hamsters and mice)
- Sent the reports for the evaluation
- And got approved by Drug Control General of India
Although there were concerns raised that whether Bharat Biotech is rally capable to proceed for the human trials phase within 50 days of receiving the inactivated virus from the National Institute of Virology because animal trials with mice typically take a minimum of 3 months. On the 7th of April, the founder Krishna Ella said in an interview that “it will take at least three months to do animal trials to establish the safety properly.”
And the most important fact is that normal mice can get infected with COVID-19 and hence the animal trials for the same is needed to be conducted on hACE2 transgenic mice and these mice are shipped from the US, China, and Europe.
COVAXIN availability for public
The pharmaceutical company received permission from DCGI i.e. Drug Control General of India to start human trials and that was expected to commence in August. The date was confirmed when the company received a letter from the Director-General of Indian Council of Medical Research, Mr. Balram Bhargava saying “It is envisaged to launch the vaccine for public health uses latest by 15th August 2020 after completion of clinical trials.”
The government’s top medical research body said that for the clinical trials of the BBV152 COVID vaccine or the indigenous coronavirus vaccine a dozen institutes have been selected. The Indian Council of Medical Research has asked these institutes to set up the clinical trials as a priority project which will be monitored at the topmost level of the government.
The availability of the virus by 15th of August remains questionable
- Amulya Nidhi of Jan Swathya Abhiyan wondered that “How can ICMR say that the vaccine will be launched for public use by August 15? How can the clinical trial be completed in just one month for a vaccine?”
- The in-charge of the clinical trial in SRM Hospital and Research Centre, Mr. Satyajit Mohapatra said that “ICMR has given a timeframe for completion of Phase 1 of the trial by August. Phase 2 of the study will start after completion of Phase 1, followed by phase 3.”
- When the application for a clinical trial by Bharat Biotech was accessed by a media house it revealed that 1 year and 3 months is the estimated time needed for the trial.
No vaccine has yet been approved for commercial use to treat coronavirus. Over hundreds of vaccines been developed globally as a cure but around a dozen possible vaccines are being tested on humans. Scientists all over the globe are racing to develop a vaccine for the treatment of COVID-19. The situation has taken a very ugly turn where ten million people are infected which includes six lakh Indians and has killed more than five lakh people. The nation looks forward with hope and optimism…