London, Sep. 25, 2020 (AltAfrica)-US biotech firm Novavax said Thursday it was initiating its final Phase 3 clinical trial for its experimental Covid-19 vaccine.

Novavax is the eleventh Covid-19 vaccine candidate to reach the Phase 3 stage globally.

The vaccine in question is called NVX-CoV2373, a stable, prefusion protein made from the genetic sequence of SARS-CoV-2 — the virus that causes COVID-19 — with nanoparticle technology

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It has shown some success in preclinical trials, demonstrating the ability to bind with receptors targeted by the virus. Those results showed high immunogenicity and high levels of neutralizing antibodies, meaning the candidate could be highly protective for humans.

The trial will be carried out in the United Kingdom and aims to enroll 10,000 volunteers, aged 18-84, with and without underlying conditions, over the next four to six weeks.

“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Gregory Glenn, the company’s president of research and development, using the technical name for the formulation

The company has been awarded $1.6 billion by the US government to develop and fund the drug, which is administered by two intramuscular injections.

The Maryland-based company uses insect cells to grow synthesized pieces of the spike protein of the virus, which it hopes will evoke a robust human immune response.

It also uses an “adjuvant,” a compound that boosts the production of neutralizing antibodies.

The company says the drug, which is a liquid formulation, can be stored at two degrees celsius to eight degrees celsius, refrigerator temperature.

In the spring, the company said it had proven the efficacy of a seasonal flu vaccine it had developed using the same technology.

Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.

For more information and to find out about new vaccines on the horizon, see the World Health Organization’s (WHO’s) Development of New VaccinesExternal

AFP