Covaxin: Why the controversy?

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Dr. Shuvomoy Banerjee, PhD; Neucrad Health Desk 15th Jan, 2021

Recently, many leading companies from different countries of the world have developed vaccines for the novel coronavirus. Among them, the Indian company named Bharat Biotech has developed its own indigenous, inactivated coronavirus vaccine named “Covaxin” in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Despite any published Phase-3 data demonstrating this vaccine’s safety and effectiveness, the Indian Government authorized Covaxin’s use on 3rd January 2021 for emergency uses. Covaxin will be given in 2 doses in a time-gap of 4 weeks. After receiving the necessary approval from DCGI (Drugs Controller General of India), Bharat Biotech has recently air-shipped the 1st batch of Covaxin to 11 Indian cities like Delhi, Bengaluru, Pune, Bhubaneswar, Jaipur, Guwahati, Chennai.

Controversy surrounding “Covaxin”

The Subject Expert Committee (SEC) of CDISCO (Central Drugs Standards Control Organization) recommended the use of Covaxin in case of emergency to the DCGI and DCGI nodded for the approval after negotiating for some days. Even if declared both safe and effective by the Biotech Chairman and Managing Director, Covaxin has come under the controversial scanner in the public eye and scientific communities for the following reasons mainly;

  • Lacking Phase-3 clinical trial data/test-results has undoubtedly been the main point of controversy.
  • Controversy is also erupting right now about the hurriedness and exact basis on which the vaccine was approved for emergency use.
  • Based on the DCGI approval for Covaxin, it has been said that Covaxin may provide protection against the modified strain of covid-19 virus, although experts are quite skeptical about the rationale behind such belief. Reports say that India Biotech is working on to demonstrate the safety and efficacy of Covaxin against the new mutations within a week.
  • According to Dr. Ella, India Biotech has sufficient data for the development of this vaccine which has already been published and that Covaxin is 200% safer than other coronavirus vaccines in the world. But a number of experts have voiced doubts and raised concerns about the hurried Covaxin approval, saying that Pfizer, Moderna, Oxford-AstraZeneca had previously announced different efficiency levels for their coronavirus vaccines but India Biotech did not!
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Covaxin Approval Basis

It has been said that only after a high-level Government-official meeting that established safety and immunogenicity through a well prescribed regulatory process. Dr. Ella from the company made it clear that Covaxin was allowed on the basis of immunogenicity data. Moreover, the vaccine’s tests on hamsters and monkeys showed better results than the other Indian vaccines. Dr. Ella explained that India Biotech is still continuing research works and will soon submit a new Human Clinical Trial Protocol.

How safe is Covaxin and What may be its side-effects (if any)?

The definite hole in the clinical trial of Covaxin is Phase-3. Now that both Covishield and Covaxin have received its emergency use approvals and their vaccination drive has also started, people are wondering over who is safer over whom. At the same time, the Union health ministry has made it clear that recipients can’t get to choose the vaccine for themselves and they can get either of the 2 COVID-19 vaccines!

At this stage, the Covaxin vaccination Phase-3 trial is going on for several thousand people. However, in Bhopal, the Covaxin trial is said to have claimed 1 life and caused severe side-effects in many participating. In this regard, Bharat Biotech stated that the preliminary investigations showed no connection between the mentioned participant’s death to their vaccine trial. 

About the side effects: The immediate problems (within 48 hours) following the vaccine injection can be the so-called side effects. The minor side-effects may include local pain, redness or swelling at the site of injection, headache, fever, muscle pain, etc. The major side effects may vary from seizures, convulsion, allergic reactions etc.

As India’s leading virologist, Dr Shahid Jamil said that the exact effectiveness of Covaxin is not fully known due to lack of a third-stage test, we can only hope that this vaccine doesn’t cause any harm to the participants at this point!

References

  1. https://www.bharatbiotech.com/covaxin.html
  2. https://vaccine.icmr.org.in/covid-19-vaccine
  3. Dutta AK. Vaccine Against Covid-19 Disease – Present Status of Development. Indian J Pediatr. 2020;87(10):810-816. doi:10.1007/s12098-020-03475-w
  4. https://www.bbc.com/news/world-asia-india-55534902
  5. Bakhiet M, Taurin S. SARS-CoV-2: Targeted managements and vaccine development [published online ahead of print, 2020 Dec 1]. Cytokine Growth Factor Rev. 2020;S1359-6101(20)30227-6. doi:10.1016/j.cytogfr.2020.11.001
  6. https://www.bbc.com/news/world-asia-india-55526123
  7. Rawat K, Kumari P, Saha L. COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies. Eur J Pharmacol. 2021;892:173751. doi:10.1016/j.ejphar.2020.173751

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