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In March 2020, the National Institute of Virology located in Pune successfully isolated the SARS-CoV-2 virus. Soon after Indian Council of Medical Research (ICMR) entered into a partnership with Bharat Biotech to develop the virus isolate into an effective vaccine candidate.

The phase 1 and phase 2 clinical trials conducted in 755 participants demonstrated a high safety profile of the candidate vaccine with seroconversion rates of 98.3 percent and 81.1 percent on days 56 and 104, respectively.

In early January when India made Chinese coronavirus vaccine- Covaxin was given a clinical trial approval by the COVID-19 task force of the government as a backup to the SII vaccine in case of a surge in cases or if SII reaches a limit in manufacturing, a large amount of doubt and skepticism was raised against the proven efficacy and safety of it as phase 3 trials of the same was still a work in progress.

This theory was particularly latched up by opposition and a section of media that Modi is doing what they called “Vaccine Nationalism “and playing with the health of ordinary people. This propaganda was done despite the AIIMS chief and head of COVID-19 task force Randeep Guleria assuring that the clinical trial approval is only given as a backup to the SII vaccine. This created a lot of fear in the minds of people and in turn affected the international sales of the vaccine too. To date only 11% of the total vaccinated people have been given Covaxin.

Though the safety of it was approved by relevant experts still the government could have communicated well regarding the aspersions or waited till March for the phase 3 trial results. There were also reports of how poor people in Bhopal were tricked into participating in the trials with even one reported death that was hushed up under the carpet, though the company had categorically denied the same.

Bharat Biotech has released the interim Phase 3 trial results for Covaxin and one can say it has passed the same in flying colors. Not only has it been proven to have an efficacy of 81 % but also is effective against new strains such as the UK one which other vaccines had failed to protect against.

A pre-print (non-peer-reviewed) paper published last month claimed the vaccine worked well against the UK variant of the novel coronavirus. The reason was that this vaccine uses a whole inactivated virus rather than targeting spike proteins.

"Covaxin demonstrated 81 percent interim efficacy in preventing COVID-19 in those without prior infection after the second dose," said the company in a statement

The point to be noted that the trials were the largest to be conducted in India, with the enrolment of 25,800 participants from 18 to 98 years of age. As many as 2,433 were over 60 years and 4,500 were with comorbidities.

But one should take the results with a pinch of salt as the first interim analysis is based on 43 participants who had tested positive for the novel coronavirus, SARS-CoV-2 which is the least after the Russian-based vaccine.

Of the 43 cases, 36 cases of COVID-19 were observed in the placebo group while seven cases observed in the group had actually got a COVID-19 shot. This resulted in a point estimate of 80.6 percent efficacy.

“Data from 25,800 participants who received a vaccine or placebo in 1:1 ratio showed that the vaccine was well-tolerated, “the firm said. Though the interim results of the efficacy can be debated upon due to the very less size it has been proven that it is a safe vaccine and will not endanger public health.

“All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication,” stated a press release by the company.

"Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication," said the company in the same press release.

“The results are good but a detailed paper would give better details about many things such as how much progression to severe disease was reduced due to the vaccine and how many hospitalisations were prevented,” Gagandeep Kang, a virologist at Christian Medical College-Vellore said.

In a video message issued by the company, the chairman and MD addressed the earlier criticism and said that “"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants. Remembering people criticising us saying our data is not transparent, not in the public domain, I am today proud to say that our data are in the public domain in six publications. If people have got patience, they should read those articles. “

The results were evaluated and monitored by an independent safety board. The same vaccine was taken by PM Modi earlier to boost up the confidence of it regarding the safety aspect in the common public mind space. Also, with these results, 40 countries have expressed their interest to procure the same vaccines. Sources tell that Bharat Biotech is even developing a nasal vaccine similar to the polio drops which could be a game-changer, one hopes that if developed it is not drawn into a political controversy again by the government and the opposition.