New Delhi: With India affirmatively move towards the final leg of Coronavirus vaccine distribution with dry runs being conducted in several states, it is believed that some leading candidates will get the emergency use authorisation for Covid-19 jabs in early 2021. A handful of vaccines are on the verge of getting emergency use approval in the country, while many more remain in development. “India is likely to have a COVID-19 vaccine in the New Year,” Drug Controller General of India (DCGI) V G Somani hinted on Thursday. ALSO READ | Coronavirus Vaccine Preparations In Last Stages, Says PM Modi
Currently, Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
As per reports, the approval process in the country has been fast-tracked in view of the pandemic by quickly processing all applications, allowing parallel phase 1 and 2 trials without waiting for complete data. However, authorities have also assured that there has been no compromise on the safety or efficacy of the data. The only thing is that the regulator has accepted partial data.
An expert panel in the Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday to consider emergency use authorisation applications by SII for the Oxford COVID-19 vaccine and Bharat Biotech’s ‘Covaxin’ will reconvene on January 1 to further deliberate on the matter.
The Subject Expert Committee (SEC) on COVID-19 on Wednesday deliberated and analysed the additional data and information submitted by the Serum Institute of India (SII) and Bharat Biotech.
Lets have a look at efficacy of some leading Covid-19 vaccines being developed:
Moderna Covid-19 vaccine
Results from the primary analysis of the ongoing phase 3 clinical trial of US biotechnology company Moderna’s COVID-19 vaccine have revealed 94.1 per cent efficacy of the therapeutic in preventing symptomatic infections and severe illness, according to a peer-reviewed study.
The study, published on Wednesday in The New England Journal of Medicine, found that among over 30,000 participants randomised to receive the vaccine or a placebo, 11 in the vaccine group developed symptomatic COVID-19 compared to 185 participants who received the placebo.
The researchers said this demonstrates 94.1 per cent efficacy in preventing symptomatic COVID-19, adding that cases of severe disease occurred only in participants who received the placebo.
Oxford-AstraZeneca Covid-19 Vaccine
AstraZeneca Plc will soon release data showing that the effectiveness of its covid-19 vaccine rises to as much as 95 per cent if the two shots are separated by about 2-3 months. On December 30, United Kingdom approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use, the second coronavirus vaccine to be cleared for rollout in Britain after the Pfizer/BioNTech jabs.
The Oxford vaccine, which also has a tie-up with Serum Institute of India (SII), was being evaluated by the British regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – after the final cut of data was submitted by the government last week.
Pfizer-BioNTech Covid-19 Vaccine
Pfizer and BioNTech today released data from a final efficacy analysis in their Phase III trial of BNT162b2 which showed efficacy of 95 per cent at preventing symptomatic Covid infection, measured starting from seven days after the second dose was administered.
That data, from the trial’s first interim efficacy analysis, showed the vaccine to be more than 90 per cent effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection.
Novavax Covid-19 Vaccine
The Phase 3 trial of another investigational Covid-19 vaccine developed by biotechnology company Novavax, Inc., has started enrolling adult volunteers, the US National Institutes of Health (NIH) announced. The randomised, placebo-controlled trial will enrol approximately 30,000 people at some 115 sites in the US and Mexico, reports Xinhua news agency.
The candidate made by Novavax Inc. is the fifth to reach final-stage testing in the U.S. Some 30,000 volunteers are needed to prove if this vaccine a different kind than its Pfizer and Moderna competitors really works and is safe.
Meanwhile the Central government has informed that a dry run for Covid-19 vaccination will be conducted by all state and union territory administrations on January 2 to test the linkages between planning and implementation and to identify the challenges. The activity is proposed to be conducted in all state capitals in at least 3 session sites.
The states and UTs have been asked to ensure that the data of these beneficiaries is uploaded in Co-WIN. These beneficiaries will also be available at the session site for the dry run. The states and UTs shall prepare the facilities and users to be created on Co-WIN application including uploading the data of Health Care Worker (HCW) beneficiaries.
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