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Moderna to begin pivotal phase 3 trial of COVID-19 vaccine in July

Large-scale study will include 30,000 individuals

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The US National Institute of Allergy and Infectious Diseases’ director Anthony Fauci has revealed that a large-scale phase 3 trial of Moderna’s COVID-19 vaccine is set to begin in July.

Fauci disclosed the information about the study in an interview with the editor of JAMA on Tuesday, adding that the trial will involve the study of 30,000 individuals aged 18 to 55, and will also include elderly participants who are at risk of serious illness caused by the virus.

The study is set to primarily include US sites, as well as some international sites, with the individuals set to be enrolled in a controlled trial of Moderna’s vaccine, mRNA-127.

Preliminary data from a phase 1 trial of mRNA-1273 showed that Moderna’s vaccine stimulated COVID-19 antibodies in healthy volunteers and provided full protection against visual replication in the lungs in a preclinical mouse challenge model.

Moderna also said that the vaccine was well-tolerated by the participants, although there were some case of moderate toxicity in the higher dose group (250mcg). As a result, Moderna has removed that dose from its studies of the vaccine going forward.

With that promising initial data in hand, NIAID and Moderna are moving full steam ahead into the phase 3 study, with the hopes that it can continue to demonstrate good outcomes.

Fauci also revealed in the JAMA interview that manufacturing of the vaccine will start “way before we even know the vaccine works”, adding that “we may know whether it’s efficacious by November or December…by that time, we hopefully would have close to 100 million (doses)”.

Although Moderna is one of the leading developers of a potential coronavirus vaccine at the moment, a host of big pharma companies also have their own candidates in the works.

That includes AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Pfizer, as well as researchers at the University of Oxford and Imperial College London.

At the end of May, pharma industry leaders pledged to put all their resources into fast-tracking development of their respective vaccine candidates, and also ensure equitable access to any vaccine which proves effective against the disease, during an IFPMA industry association virtual media briefing.

“We have a deep sense of responsibility in that we need to ensure no-one is left behind,” commented IFPMA director general Thomas Cueni. “The notion of an equitable and affordable vaccine is a truly important one.”

Article by
PMGroup

3rd June 2020

From: Research

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