Bharat Biotech. Committed to data transparency on Covaxin . published 9 papers in 12 months | Bharat Biotech shared the data of all the research done so far on the vaccine, said- we are committed to transparency

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  • Bharat Biotech. Committed To Data Transparency On Covaxin . Published 9 Papers In 12 Months

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Bharat Biotech says that they have published 9 research studies on the efficacy and safety of Covaxin in 5 world-class journals in 12 months.

Bharat Biotech has released the data of all the research on Saturday after the questions arising about the indigenous corona vaccine ‘Covaxin’. According to Bharat Biotech officials, India’s regulatory authorities have examined complete and partial data of Phase I and II trials of Covaxin and part of Phase III trials. The company has published 9 research studies on the efficacy and safety of Covaxin in 5 world-class journals in just 12 months.

However, the data of Phase 3 trial has not been released yet. The company can release the data on June 20. Bharat Biotech’s clarification has come when questions were being raised about the non-release of data for the Phase-3 trial of Covaxin. This dispute is going on for the last 6 months. Covaxin got emergency approval 6 months ago. The company has extended the date of release of data 2 times.

Bharat Biotech’s side in 5 points

  • Covaxin, built on an inactivated platform, is now at the forefront of data transparency. This is the first and only vaccine that has published any data from human clinical trials in India. Bharat Biotech said in a statement that only Covaxin in the country has newly emerging variants and efficacies data on the Indian population.
  • While developing the vaccine, it was tested on animals in preclinical studies. Bharat Biotech has completed 3 preclinical studies. These studies have been published in the journal CellPress.
  • According to the company, complete data from the Covaxin neutralization study on the variant has already been published in the Clinical Infectious Diseases and Journal of Travel Medicine bioRxiv.
  • Study on neutralization of beta and delta variants (B.1.351 and B.1.617.2), B.1.1.28 variant, while study on B.1.617 variant and alpha variant (B.1.1.7) Journal of Clinical Infectious Diseases and Published in Travel Medicine.
  • The published study mentions extensively about the rigor and depth Bharat Biotech uses in its clinical trials. Currently, data analysis and compilation of both the efficacy and safety follow-up of the Phase III trial of Covaxin is underway. The company will soon make public the data of the third phase of the trial.

what is the meaning of this step
Covaxin has not yet been approved by the WHO and the US. Because of this, people who have got this vaccine are not able to go abroad. Apart from this, questions are also being raised due to non-availability of data of third phase trial. To end such controversy, Bharat Biotech has recently announced the release of data of the third phase of Covaxin and conducting the fourth trial.

Questions raised on making antibodies
A study has claimed that CoviShield is capable of producing more antibodies after the first dose than Covaxin. This has been claimed in the initial study conducted by the Corona Virus Vaccine-Induced Antibody Titre (COVAT).

The study included 552 healthcare workers. The study claimed that the seropositivity rate to the amount of anti-spike antibodies in people who received the CovaShield vaccine was significantly higher than those who received the first dose of CovaShield.

Expected to get emergency use approval from WHO
Covaxin is expected to receive emergency use approval from the World Health Organization between July and September. The company has said that the application has been given in WHO-Geneva for approval. Covaxin has been approved in 13 countries so far.

US refuses to approve
International approval for Covaxin may be delayed. The US Food and Drug Administration (USFDA) has refused emergency approval to Covaxin after the number of corona cases decreased in the US. The USFDA is in no mood to approve any new vaccine.

Now Bharat Biotech Company is left with the option of taking biological license. The company has clarified after the controversy about not getting visas of many countries to people who got the vaccine. Bharat Biotech said that they are trying to get biological license. This is considered a kind of approval only. It will be processed by their subsidiary company, Occugen Inc.

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