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COVID19: EU starts approval process for Novavax

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Hopes the European Union can bolster its struggling vaccination rollout against coronavirus before the summer is out were reignited as a fourth COVID-19 vaccine came under review for approval.

The European Medicine Agency’s (EMA) human medicines committee (CHMP) announced it has started a rolling review of a COVID‑19 vaccine being developed by Novavax.

If given the green light, Novavax will be the fourth COVID-19 vaccine to be approved by the EMA after Pfizer, Moderna and AstraZeneca.

The Novavax jab has shown to be 89% effective in large-scale UK trials while proven that it is also effective against the new Kent virus variant.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults.

These studies suggest the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.

The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19.

The EMA will evaluate data from these and other clinical trials as they become available.

A rolling review is a regulatory tool the EMA uses to speed up the assessment of a promising medicine during a public health emergency.

EMA said it cannot predict the overall timelines, but it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

The rolling review will continue until enough evidence is available for a formal marketing authorisation application, in which case it will be joining the three vaccines already approved and used in EU vaccination programs.

The Health Ministry said Cyprus, like other EU states, has yet to put in an order for the Novavax COVID-19 vaccine.

Currently, the EMA has approved Pfizer/BioNTech and Moderna’s mRNA vaccines and AstraZeneca’s vaccine, which employs similar technology with the one developed by Novavax.

How is the vaccine expected to work?

Like other vaccines, NVX-CoV2373 is expected to prepare the body to defend itself against infection.

The vaccine is a protein-based vaccine which contains tiny particles made from a laboratory-grown version of the spike (S) protein found on the surface of SARS-CoV-2 coronavirus.

It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein particles as foreign and produce natural defences — antibodies and T cells — against them.

If later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it.

The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.