What did the UK study find?

The study enrolled more than 15,000 participants between 18-84 years of age, including 27 percent over the age of 65, the company shared on 28 January. The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus six cases observed in the vaccine group, resulting in a point estimate of vaccine efficacy of 89.30 percent. Of the 62 cases, 61 were mild or moderate, and one was severe (in placebo group).

How effective was the vaccine in South Africa?

In the South Africa Phase 2b clinical trial, 60 percent efficacy for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94 percent of the study population that was HIV-negative. This study enrolled over 4,400 patients beginning in August 2020. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6 percent (25 out of 27 cases) were of the South African variant.

When is it expected to apply for authorisation?

Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom’s regulatory agency, the MHRA, in mid-January.

Is 60 percent efficacy good enough?

Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said the results were indeed positive.

What does this mean for India?

The SII has applied to Indian regulators to conduct a small trial of the vaccine in India, and expects to hear back soon, Chief Executive Adar Poonawalla told Reuters on Friday after the UK trial data had been shared. The vaccine is expected to be launched in India in June, he added.

What type of vaccine is this the Novavax candidate?

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

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Novavax Vaccine: How Effective Is It? When Will It Be Approved?

What exactly did the studies say? Why is this important for India? FIT breaks it down.

FIT

Updated: 30 Jan 2021, 3:30 PM IST

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The COVID-19 vaccine developed by US firm Novavax has demonstrated overall efficacy of 89.3 percent in a phase 3 clinical trial in the United Kingdom, revealed interim data shared by the company.

The vaccine was also found to be highly effective against the possibly more contagious variant that was identified there earlier. However, it offered significantly lesser protection against the one that was originally identified in South Africa, AFP reported.

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Published: 30 Jan 2021, 1:49 PM IST