India’s First Indigenous COVID-19 Vaccine – COVAXIN

A vaccine based on whole inactivated coronavirus has an efficacy rate of 77.8% against symptomatic COVID-19 infections, phase 3 trial data suggest.

Covaxin, also known as BBV152, was authorised for emergency 

COVAXIN, Indias indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration 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 virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection

Covaxin COVID-19 Vaccine To Be Available In First Quarter Of Next Year,  Says Bharat Biotech

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Bharat Biotech’s Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid and 65.2 per cent protection against the new Delta variant.

The company on Saturday said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic Covid cases while safety analysis shows adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side-effects and less than 0.5 per cent feeling serious adverse events.

The efficacy data demonstrates 63.6 per cent protection against asymptomatic Covid, a release from the city-based vaccine maker said.

Phase 3 clinical trials of the vaccine was an event-driven analysis of 130 symptomatic Covid cases, reported at least two weeks after the second dose, conducted at 25 sites across India.

The whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with Indian Council of Medical Research and National Institute of Virology in Pune.

Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccine’s trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global populations.”    

POSITIVE RESULTS

The Phase 3 trial involved 25,800 participants in India aged 18 to 98. Of these, 2,433 were over 60 years old, and 4,500 had pre-existing medical conditions (co-morbidities) such as cardiovascular disease, diabetes or obesity.

The study found that Covaxin had an efficacy of 93.4% against severe COVID-19 disease, and an overall vaccine efficacy of 77.8% against symptomatic infections confirmed by PCR tests. Against asymptomatic COVID-19, the efficacy was 63.6%. The vaccine also conferred 65.2% protection against symptomatic infection with the Delta variant, at least two weeks after the second dose.

As a rough comparison, recent figures from Public Health Scotland suggested that at least two weeks after the second dose, the Pfizer-BioNTech vaccine was 79% effective against the Delta variant, while the Oxford-AstraZeneca was 60% effective. However, different trial methodologies make it impossible to directly compare the relative efficacies of the various vaccines.

The main side effects from Covaxin were pain at the injection site, followed by headache, fatigue and fever. No severe or life-threatening adverse events were reported.

ICMR says, Covishield, Covaxin blend can give better outcomes

The examination was led on 18 individuals who have gotten two portions of two distinct vaccines and it has not yet been peer-assessed, reports said.

The Research:

The Indian Council of Medical Research has uncovered that a blend of Covishield and Covaxin, the two fundamental antibodies of India’s Covid inoculation program, can really yield better outcomes, news organization ANI detailed. The investigation was just led on 18 individuals of Uttar Pradesh’s Siddharth Nagar, who accidentally got two dosages of two separate immunizations / Vaccines. As indicated by the finding of the examination which is yet to be peer-checked on vaccination with a blend of an adenovirus vector stage-based antibody, trailed by inactivated entire infection immunization was protected as well as inspired better immunogenicity. Covishield, fabricated by Pune’s Serum Institute of India, is the adenovirus vector stage-based antibody and Covaxin, created and made by Bharat Biotech and the ICMR, is the entire infection immunization. Covishield and Covaxin have a place with two distinct sorts.

The investigation named ‘Fortunate Covid-19 Vaccine-Mix in Uttar Pradesh, India: Safety and Immunogenicity Assessment of a Heterologous Regime’ has been transferred on medRxiv. Under this investigation, 18 individuals got two dosages of two unique immunizations, the response of which was contrasted with 40 recipients of two portions of Covishield and 40 beneficiaries of two portions of Covaxin, news organization PTI announced. The examination length was from May to June 2021, it said.

Blending of immunizations is being talked about universally, all investigations are supportive of blending two antibodies to build the insurance against future contamination. The subject master panel of the Central Drugs Standard Control Organization has in July suggested a preliminary of blending Covishield and Covaxin, which will be led by the Christian Medical College in Vellore on 300 sound volunteers.

While that will be an appropriate clinical preliminary to examine the adequacy of the mixed drink of Covishield and Covaxin, the ICMR’s investigation depended on the goof-up that occurred in May. There was no prompt antagonistic effect of the misunderstanding of the recipients. Presently, further investigation has uncovered that the misunderstanding has really worked for insurance as these individuals have more security than the individuals who have gotten two shots of a similar antibody.

What WHO has to say:

The issue of blending antibodies is touchy as World Health Organization has cautioned that people ought not settle on blending immunizations. Niti Aayog part (wellbeing) Dr VK Paul had before said that hypothetically there is no issue in blending two antibodies as the second portion in such a case will function as a promoter shot. Yet, as the public authority began its immunization drive on January 16, it requested that wellbeing laborers practice outrageous alert to ensure that the recipients get the second shot of the very antibody that they got as their first shots.

What to Understand?

  • We don’t have to take two different doses of vaccine; second shot should be of the same vaccine which we got as first dose.
  • We should adhere to advice of WHO, it will benefit our health only.