Covaxin 77.8% effective, claims Bharat Biotech after final phase of trial

[bhaigan]

Hyderabad-based Bharat Biotech said in a statement on Friday that it has completed the final Phase-3 analysis for Covaxin. Citing pre-print data from “India’s largest efficacy trial”, the manufacturer claimed that an overall efficacy of 77.8% against Covid-19 patients has been found in Covaxin.

The data, however, is yet to be peer-reviewed.

Elaborating its findings from the efficacy analysis, Bharat Biotech added that Covaxin also demonstrates 93.4% effectiveness against severe symptomatic Covid-19 cases. On the other hand, Covaxin provides 65.2% protection against the B.1.617.2 (Delta) strain, currently the most predominant variant in India, it said.

 

 

Against asymptomatic Covid-19 patients, Covaxin provides an efficacy of 63.6%, Bharat Biotech said at the conclusion of its Phase-3 efficacy trial.

The third phase of the trial was reportedly conducted across 25 hospitals in India as trial sites. The large-scale final analysis deployed a double-blind, randomized, multi-center clinical trial, using a sponsor-supplied randomization scheme where volunteers received two intramuscular doses of either the Covid-19 vaccine or a placebo — four weeks apart. It consisted of 25,800 volunteers from the age group of 18 to 98 years, the report said.

 

The vaccine was approved for emergency use in the Indian population in January, and the Hyderabad-based company had then said it would release phase III data by March.

Earlier, Bharat Biotech’s US partner Ocugen had reported similar findings regarding Covaxin, adding that adverse events reported in the study were low. Only 12.4% of the subjects experienced commonly known side-effects, it said. Both adverse events and severe adverse events reported in the vaccine group were found at similar rates to the placebo group, the company added.

[jawaani_jaaneman]

93% in reducing hospitalization...That's promising. 

[andhra_jp]

2 hours ago, jawaani_jaaneman said:

93% in reducing hospitalization...That's promising. 

Explained: Is the Data From Covaxin Trial’s Bhopal Site Tainted?

Bharat Biotech’s and ICMR’s responses are troubling because, by claiming there were no violations at all, they are implying that they plan to use data from People’s Hospital as-is in the calculation of the vaccine’s efficacy and safety.

Consider the claims of seventy-year old Man Singh Parihar, a construction worker, who joined the trial and received his first shot on 21 Dec. Parihar says that within two days, he became bedridden with fever, breathlessness and a headache.

If the People’s Hospital team was playing by the rulebook, they would have called Parihar on the first seven days to collect solicited adverse events, and learnt that he was ill. His illness may have been classified as Grade 3 or 4, given that he was incapacitated, and requiring him to come to the hospital. Also, since his symptoms looked a lot like Covid, he would have been given an RT-PCR test. If he was diagnosed with COVID-19, the data would be used for efficacy analysis and for VAERD assessment. If he wasn’t, it would still go into the data sets for solicited adverse events.

But not only did People’s Hospital skip the video-record, the informed consent process seems to have been rushed in several cases. Parihar and others have said they had no idea they were in a clinical trial, which is why it never struck them that they ought to report their symptoms to People’s Hospital, and were entitled to medical care.

A far bigger worry than the violations at People’s Hospital, however, is ICMR’s and Bharat Biotech’s blanket denial of them. Not only are these bodies overseeing the 25 other phase 3 trial sites, they are also collecting adverse event data from India’s Covid immunisation program, of which Covaxin is a critical part, points out Anant Bhan, a bioethics researcher at Mangaluru’s Yenepoya University. “To not acknowledge the problems, at all, is worrisome, because what does that tell us about how they handle potential concerns about data quality from other sites? If we are giving Covaxin on a large scale in clinical trial mode, and if this happens in a controlled trial, what about larger rollouts?” asks Bhan.

https://www.thequint.com/coronavirus/explained-is-the-data-from-covaxin-trials-bhopal-site-tainted-bharat-biotech-icmr
 

[Heroin]

Covishield paristhiti enti

[Battu123]

1st dose kosam vellali ika