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Rolling reviews of Novavax's COVID-19 vaccine begin across the globe

And the FDA is planning rapid reviews for COVID-19 vaccine boosters

A number of rolling reviews of Novavax’s COVID-19 vaccine – NVX-CoV2373 – have begun with regulatory authorities across the globe, the company announced yesterday.

This includes rolling reviews with the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.

In January, Novavax revealed that its vaccine demonstrated an efficacy rate of 89.3%, also finding that the jab is effective against the UK variant.

The phase 3 clinical trial, conducted in partnership with the UK’s Vaccines Task Force, enrolled over 15,000 people aged 18 to 84.

The first interim analysis is based on 62 PCR-confirmed, symptomatic COVID-19 cases. Within this case number, 56 cases were observed in the placebo versus six in the vaccinated group – resulting in a vaccine efficacy of 89.3%.

In addition, preliminary analysis found that the UK variant was detected in over 50% of the PCR-confirmed cases – with 32 cases being caused by the UK variant, 24 by the non-variant and six ‘unknown’.

The UK government signed a deal with Novavax in August 2020 for an initial 60 million doses of NVX-CoV2373. As part of that deal, Novavax partnered with the UK’s National Institute for Health Research (NIHR) for the phase 3 trial.

The FDA plans rapid reviews for COVID-19 vaccine boosters

The FDA is planning a rapid review process for COVID-19 booster doses aimed at combatting emerging variants of the disease.

The FDA’s acting commissioner Janet Woodcock said that if new variants emerge that require boosters or alterations to existing vaccines, the agency will not require large-scale trial data for emergency use authorisation.

“With emergence of multiple variants and their potential impact on the performance and efficacy of vaccines, therapeutics, and diagnostics, it is critical that the FDA is transparent about its thinking in this space so that all parties know they are receiving consistent advice and other individuals have insight into the agency’s decision-making process,” added Woodcock.

COVID-19 vaccine developers, including Pfizer/BioNTech and Moderna, have already disclosed that they are planning for the emergence of variants which will require a booster dose.

Despite the concern surrounding existing variants – including strains discovered in the UK, South Africa and Brazil – currently approved vaccines appear to be effective against the UK strain, while the South Africa variant has been found to slightly reduce the effect of some vaccines.

Article by
Lucy Parsons

5th February 2021

From: Regulatory



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