Covaxin India's 1st Indigenous Covid-19 Vaccine

Covaxin India's 1st indigenous Covid-19 vaccine. / Bharat Biotech Bharat Biotech, which is yet to publish the data of its COVID-19 vacci...

Covaxin India's 1st indigenous Covid-19 vaccine. / Bharat Biotech

Bharat Biotech, which is yet to publish the data of its COVID-19 vaccine Covaxin phase-3, expects a peer review of the jab in two to four months after it was given to scientific journals, Raches Ella Project Lead COVID-19 Vaccines at Bharat Biotech said on Wednesday.

In a series of tweets, Ella said there were nine publications on Covaxin so far and the efficacy paper of phase-3 trials would be the tenth one. To remain unbiased, Bharat/ICMR cannot access any data. Our service provider IQVIA has started the final statistical analysis. After submitting efficacy and 2 months of safety to CDSCO (July), it is expected to instantly reach a pre-print server. Peer review takes 2-4 months, he tweeted.

A medic shows a Covaxin vaccine vial, after the virtual launch of the COVID-19 vaccination drive by Prime Minister Narendra Modi. / Vishal Bhatnagar.

According to his tweet, as many as 25,800 participants took part in phase-3 trials and there were 30 separate forms pertaining to each volunteer amounting to individual data points of 70.4 lakh. "The last participant (participant #25,800) received the second dose in mid-March, add two months (based on CDSCO/FDA requirements for 2-months post-dose-2 safety follow-up), and we are in mid-May with sufficient data for quality checks and analysis, he said in another tweet.

Meanwhile, Suchitra Ella, Joint Managing Director of Bharat Biotech, in a tweet, said Covaxin has reached private hospitals in as many as 28 cities. 

What is COVAXIN

COVAXIN is India^'s indigenous COVID-19 vaccine developed by Bharat Biotech company under BSL-3 (Bio-Safety Level 3) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The indigenous vaccine is already gone through several trials with high efficacy of 100%.

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 able to instruct the immune system to mount a defensive reaction 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 more than 300 million doses of supplies to date. It is the well-established, and time-tested platform in the world of vaccine technology.

Key Attributes:

• COVAXIN is included along with immune-potentiators, also known as vaccine adjuvants, which are added to the vaccine to increase and boost its immunogenicity.
• It is a 2-dose vaccination regimen given 28 days apart. 
• It is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8^oC.
• Pre-clinical studies: Demonstrated strong immunogenicity and protective efficacy in animal challenge studies conducted in hamsters & non-human primates. For more information about our animal study, please visit our blog page on Non-Human Primates. 
• The vaccine received DCGI approval for Phase I & II Human Clinical Trials in July 2020. 
• 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. For further information, visit our blog page on phase 1 study.
• 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. Know more about our phase 2 study.
• A total of 25,800 subjects have been enrolled and randomized in a 1:1 ratio to receive the vaccine and control in an Event-Driven, randomized, double-blind, placebo-controlled, multicentre phase 3 study.
• The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of COVAXIN in volunteers aged ≥18 years.
• Of the 25,800 participants, >2400 volunteers were above 60 years of age and >4500 with comorbid conditions.
• COVAXIN demonstrated 78% vaccine efficacy against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% with an impact on reduction in hospitalizations.

COVAXIN effective against UK variant strain:

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains.

Global Acceptance of COVAXIN:

Bharat biotech has been approached by several countries across the world for the procurement of COVAXIN.

• Clinical trials in other countries to commence soon.
• Supplies from the government to government in the following countries to take place: Mongolia, Myanmar, Sri Lanka, Philippines, Bahrain, Oman, Maldives, and Mauritius.