'Shot well tolerated in participants; adverse events balanced between vaccine and placebo arms of the trial'
Bharat Biotech International Ltd came out with the first interim analysis of its novel coronavirus disease (COVID-19) vaccine, Covaxin, March 3, 2021. It claimed an efficacy of 80.6 per cent.
Some 25,800 participants have enrolled for the trial that is still going on. The first interim analysis is based on 43 participants who had tested positive for the novel coronavirus, SARS-CoV-2.
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 per cent efficacy.
The press release issued by Bharat Biotech said an additional interim analysis was planned for 87 cases and the final analysis was planned for 130 cases testing positive.
“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,” the press release said.
“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.
The press release also did not mention as to how many of the totally enrolled participants were actually enrolled in the trial.
The first interim data by Moderna Inc for its COVID-19 vaccine was announced by analysing the results of 95 cases. For the vaccines manufactured by Pfizer Inc-BioNTech SE and AstraZeneca plc-University of Oxford COVID-19 vaccines, the corresponding numbers were 170 and 131 cases respectively.
The first interim analysis for the Sputnik V vaccine, however, was announced by taking into account as low as 20 cases of COVID-19.
The Bharat Biotech press release claimed the vaccine was well-tolerated. “The interim analysis included a preliminary review of the safety database, which showed that severe, serious and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups,” it said. The details are expected as the pre-print is published.
The statement also claimed that the BBV152 (Bharat Biotech COVID vaccine candidate) is based on an established manufacturing platform with a ‘better safety profile when compared to other vaccine platforms.’
BBV152 uses the whole virus platform while others have used a part of the virus for antibody formation. It is not clear on what basis on what basis the claim has been made. No comparative data of a vaccine being more safer than the other is available as of yet.
A pre-print (non-peer reviewed) paper published last month claimed the vaccine worked well against the UK variant of the novel coronavirus.
The trial of this vaccine had come under the scanner at Bhopal after many trial participants claimed various adverse events. One of the participants died. However, the company had rubbished the allegations saying the adverse events were not linked to vaccination. The government has not said anything on this. The Indian Council of Medical Research is a co-sponsor of this trial.
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