The latest’ Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech’s Covaxin is “October 2021.”
According to the WHO, submissions to WHO for prequalification or listing under the emergency use procedure are confidential.
The World Health Organisation said, “In October, the decision on Bharat Biotech’s submission seeking emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made”.The status of assessment for Covaxin is “ongoing”. Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.
The latest’ Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech’s Covaxin is “October 2021″.
The WHO said it began rolling data of the vaccine on July 6. Moving data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
According to the WHO, submissions to WHO for prequalification or listing under the emergency use procedure are confidential. If a product submitted for assessment meets the criteria for listing, the WHO will publish the results widely.
According to the agency, the duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria. Bharat Biotech’s Covaxin and AstraZeneca, and Oxford University’s Covishield are widely used vaccines in India.
Bharat Biotech recently said it submitted all data about Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog.” #COVAXIN clinical trial data was fully compiled & available in June 2021.
In early July, all data was submitted for Emergency Use Listing (EUL) Application to World Health Organization. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech had tweeted earlier this month.
“We are diligently working with the WHO to obtain EUL at the earliest,” the company had said on Tuesday.
More About Co-vaxin:
India’s indigenous Covid-19 Vaccine by Bharat Biotech is developed with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine is developed using Whole-Virion Inactivated Vero Cell-derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still instruct the immune system to react against an infection.
Why develop Inactivated Vaccine? Conventionally, inactivated vaccines have been around for decades. Numerous vaccines for diseases such as Seasonal Influenza, Polio, Pertussis, Rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines with a safe track record of >300 million doses of supplies to date.
It is the well-established and time-tested platform in the world of vaccine technology.
1. Covaxin is included along with immune-potentiators, also known as vaccine adjuvants, added to the vaccine to increase and boost its immunogenicity.
2. It is a 2-dose vaccination regimen given 28 days apart.
3. It is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8oC.
4. pre-clinical studies: Demonstrated strong immunogenicity and protective efficacy in animal challenge studies conducted in hamsters & non-human primates.
5. The vaccine received DCGI approval for Phase I & II Human Clinical Trials in July 2020.
6. A total of 375 subjects have been enrolled in the Phase 1 study and generated excellent safety data without any reactogenicity. Vaccine-induced neutralizing antibody titers were observed with two divergent SARS-CoV-2 strains. The percentage of all the side effects combined was only 15% in vaccine recipients.
7. In the Phase 2 study, 380 participants of 12-65 years were enrolled. Covaxin led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses.
