Indian Council of Medical Research (ICMR) on Sunday said that data generated through pre-clinical studies and various phases of clinical trial shows COVAXIN is ‘safe.’
“Data generated through pre-clinical studies and various phases of the clinical trial from within India highlighted COVAXIN’s safety and immunogenicity. Potential of COVAXIN to mount a resistance against new mutants of SARS-CoV-2, the virus causing COVID-19, informed the decision making process for vaccine approval,” ICMR tweeted.
India’s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) on Vero cell platform, which has well established track record of safety and efficacy in the country & globally. Bharat Biotech is a well established company with an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. Having delivered more than 6 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.
Ocugen Inc., a leading US based biopharmaceutical company signed an MOU with Bharat Biotech to develop the vaccine for US Market. The decision was taken after a thorough review of the data from clinical trial of Phase 1 and Phase 2 which demonstrated a high degree of safety and immunogenicity.
“COVAXIN™ utilizes a historically proven approach to vaccine design. The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike (S1) protein, receptor-binding domain (RBD) and the nucleocapsid (N) protein of SARS-CoV-2 along with strong cellular responses in Phase 1 and 2 clinical trials. COVAXIN offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus” said Harvey Rubin, M.D. Ph.D. of the University of Pennsylvania, a member of Ocugen’s Vaccine Scientific Advisory Board.
David Fajgenbaum, M.D. of University of Pennsylvania’s Division of Translational Medicine & Human Genetics, Director of the Center for Cytokine Storm Treatment & Laboratory, and member of Ocugen’s Vaccine Scientific Advisory Board said, “The COVID-19 pandemic has caused unmatched devastation to individual patients and to the world. It is going to take the kind of unmatched collaboration and innovation that is occurring right now to effectively fight back. Vaccines such as COVAXIN™ that can potentially elicit a
broad immune response and may limit future COVID-19 severity could be important to have in our arsenal.”
Dr Harsh Vardhan, India’s Health and saftey Minister said:
“Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90% However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein So, it’s likely to have similar protective efficacy reported for others. COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein Inactivated virus from NIV also had D614G mutation.
The data from COVAXIN Phase I & II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response.”
He also tweeted asking opposition leaders to not politicise such a critical issue:
Disgraceful for anyone to politicise such a critical issue.
Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don't try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines
Wake up & realise you are only discrediting yourselves !
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Dr. Balram Bhargava, DG of ICMR while speaking to ANI said that “NIV scientists have successfully isolated the new virus strain & this will be tested against different vaccines. We hope potentially Bharat Biotech vaccine will have some advantages over other vaccines on this new strain because it is a whole virus. UK-strain is a whole virus. India-made vaccines target all the proteins on surface of virus, not just one S-GEN protein that has mutated. Therefore those vaccines that are targeting just the ‘SGEN’ may not work as well. But that is still scientific conjecture”
An association of private Brazilian clinics today announced plans to buy five million doses of the vaccine reiterating the faith in its efficacy and safety. Once the phase III trials are successful India can become the largest exporter for Corona Virus vaccines.
Below are the COVAXIN™ 5 publications in 8 months in notable peer review international journals.
https://www.medrxiv.org/content/10.1101/2020.12.21.20248643v1
https://www.medrxiv.org/content/10.1101/2020.12.11.20210419v1
https://www.biorxiv.org/content/10.1101/2020.09.09.285445v2
https://www.researchsquare.com/article/rs-76768/v1
https://www.researchsquare.com/article/rs-65715/v1
