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The Trials of Covaxin

Covaxin is one of the seven vaccines approved for use in India. It is India’s first indigenous Covid-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

It is a 2-dose vaccination regimen given 28 days apart. Covaxin has shown a 77.8% efficiency against the Covid-19 disease and has been proven to neutralize the Alpha variant that was first isolated in the UK, Gamma and Zeta variant first isolated in Brazil, the Kappa, Beta, and Delta variants, isolated in India and South Africa. 

As opposed to Covishield, which was an Oxford-Astrazeneca formulation, Covaxin is India’s first Covid-19 vaccine. Moreover, all processes leading to the manufacture of said vaccine were completed by the company itself, in India, as opposed to some other vaccines.

Covaxin was approved by the World Health Organization (WHO) for Emergency Use Listing (EUL) on 3/11/2021, despite receiving approval for Clinical trials in July 2020. Dr. Krishna Ella, Chairman of Bharat Biotech, has been transparent about the events that lead to the approval of Covaxin.

At the Times Now Summit, Krishna Ella gave several clarifications regarding the Covaxin vaccine. He explained that Covaxin faced bad publicity. People criticized the vaccine and the resulting negativity led to the delay of their publications and WHO pre-qualification.

According to him, the resulting bad press made the WHO investigate deeply. When questioned about the political reasoning for Covaxin’s delay, Dr. Ella revealed that since the Honourable Prime Minister of India, Mr. Narendra Modi, took the vaccine, the vaccine got dubbed as a “BJP vaccine” and other synonymous names. He strongly felt that the bad publicity, by ‘negativists in India who were working towards a political project’, had contributed to the additional scrutiny faced by Covaxin. 

While discussing the political factors to Covaxin’s delay, Dr. Ella maintained complete professionalism and simply said, We are scientists, we don’t understand the politics. What we understand is the science”. When referring to the WHO, he said that They [WHO] wanted to be doubly sure about what they were doing was right or wrong, so they wanted to review much more intensely. Every small issue is a major issue for them.

Another point of concern was that the WHO claimed that the data for Covaxin for application to pregnant women was ‘insufficient’.

Dr. Ella claims that more than a million pregnant women were vaccinated through the CoWin program, without significant side effects. He has ‘assured’ the safety of the vaccine.

The insufficiency was on account of WHO’s procedures. They wanted Bharat Biotech to conduct tests in a clinical manner, conducted in setup systems, not publicly, the data for which Dr. Ella feels it would be submitted in 2-3 months.

One of the greatest concerns was the fact that Covaxin was lacking approval for children. Countries like China, as he stated, were moving forward on a global scale, while their vaccine’s publication for use in children was still unapproved by the Drug Controller General of India (DCGI).

If the DCGI doesn’t approve their publication, Bharat Biotech will not be able to take said documents for approval from the WHO. 

Where the entire world looks to injections for immunity, Bharat Biotech has plans for a ‘nasal vaccine’. As he explained, the first dose would be administered via needle while the second dose, through a nasal vaccine.

This would lead to protection of the upper lungs while successfully preventing the transmission of the virus from a vaccinated person, and allowing them to stop practicing the use of masks. Dr. Ella claims it is an idea that no other country has considered, and that their tests regarding the same were going well. 

by Aman Agrawal

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