Monday, April 19, 2021

SII seeks trial nod for Novavax Covid-19 shot: Efficacy, advantage, availability

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The Serum Institute of India (SII) has applied to India’s drugs controller to conduct a small domestic trial of Novavax Inc’s Covid-19 vaccine, which was found to be 89.3% effective in a UK trial. SII’s chief executive officer Adar Poonawalla has said his company is hopeful of launching Covovax by June this year.

US biotech firm Novavax said on Thursday that NVX-CoV2373, its two-shot Covid-19 vaccine, showed an overall efficacy of 89.3% in a major Phase 3 clinical trial in Britain and was highly effective against a variant first identified there. However, other results have shown it offered significantly less protection against a highly transmissible variant of the coronavirus first identified in South Africa.

Also read | Serum Institute applies for bridging trial approval for Novavax Covid vaccine

Novavax said it began working on new vaccines against emerging strains in early January and expects to select ideal candidates in the coming days, then begin clinical testing in the second quarter of the year. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible,” Stanley Erck, the company’s president and CEO, has said.

Here’s what you need to know about the Novavax vaccine:

1. The vaccine was one of six candidates backed by a US government project formerly known as Operation Warp Speed, which has provided the company $1.75 billion. It’s also being tested in a trial in the US and Mexico, which has recruited 16,000 of 30,000 participants.

2. The Novavax shot injects the same molecules directly into the body to evoke an immune response. The Pfizer, Moderna and AstraZeneca vaccines deliver the genetic instructions to make a protein of the virus to human cells.

3. The trial in the UK involved 15,000 people aged 18 to 84, including 27% who were over the age of 65. The first interim analysis was based on 62 cases, of which 56 cases of Covid-19 were observed in the placebo group versus six cases among people who received NVX-CoV2373.

4. NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’s recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the Sars-CoV-2 spike (S) protein and is produced in insect cells.

5. It can neither cause Covid-19 nor can it replicate, is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

Also read | In boost for India, Novavax finds vaccine 89% effective

6. The company’s preliminary analysis indicated the variant first identified in Britain, B.1.1.7, was detected in more than 50% of the confirmed cases.

7. Efficacy by strain was calculated at 95.6% against the original Covid strain, and 85.6% against B.1.1.7. But the efficacy was much lower in a smaller, mid-stage trial conducted in South Africa.

8. This study enrolled just over 4,400 patients from September to mid-January, during which time the B.1.351 variant, which contains critical mutations along with the virus’ spike protein, was spreading rapidly through the country.

9. In this trial the overall efficacy was 49.4% but the figure rose to 60% among the 94% of trial participants who were HIV-negative.

10. Novavax has a deal with Pune-based SII for the manufacture of at least a billion doses of its vaccine for low- and middle-income countries and India.

(With agency inputs)

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