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UPDATE 2-GSK and Sanofi start with new COVID-19 vaccine study after setback

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Pushkala Aripaka and Matthias Blamont
·2 min read
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* Phase II trial underway, Phase III aimed for Q2

* Testing in 720 volunteers aged 18 and older in multiplesites

* Sanofi also begins work against coronavirus variants(Writes through with new details)

By Pushkala Aripaka and Matthias Blamont

Feb 22 (Reuters) - GlaxoSmithKline and Sanofion Monday said they had started a new clinical trialof their protein-based COVID-19 vaccine candidate, revivingtheir efforts against the pandemic after a setback in Decemberdelayed the shot's launch.

The British and French drugmakers aim to reach final testingin the second quarter, and if the results are conclusive, hopeto see the vaccine approved by the fourth quarter after havinginitially targeted the first half of this year.

In December, the two groups stunned investors when they saidtheir vaccine would be delayed towards the end of 2021 afterclinical trials showed an insufficient immune response in olderpeople.

Disappointing results were probably caused by an inadequateconcentration of the antigen used in the vaccine, Sanofi and GSKsaid, adding that Sanofi has also started work against newcoronavirus variants to help plan their next steps.

Global coronavirus infections have exceeded 110 million ashighly transmissible variants of the virus are prompting vaccinedevelopers and governments to tweak their testing andimmunisation strategies.

GSK and Sanofi's vaccine candidate uses the same recombinantprotein-based technology as one of Sanofi's seasonal influenzavaccines. It will be coupled with an adjuvant, a substance thatacts as a booster to the shot, made by GSK.

"Over the past few weeks, our teams have worked to refinethe antigen formulation of our recombinant-protein vaccine,"Thomas Triomphe, executive vice president and head of SanofiPasteur, said in a statement.

The new mid-stage trial will evaluate the safety,tolerability and immune response of the vaccine in 720 healthyadults across the United States, Honduras and Panama and testtwo injections given 21 days apart.

Sanofi and GSK have secured deals to supply their vaccine tothe European Union, Britain, Canada and the United States. Italso plans to provide shots to the World Health Organization'sCOVAX programme.

To appease critics after the delay, Sanofi said earlier thisyear it had agreed to fill and pack millions of doses of thePfizer/BioNTech vaccine from July.

Sanofi is also working with Translate Bio onanother COVID-19 vaccine candidate based on mRNA technology.

(Reporting by Pushkala Aripaka in Bengaluru and MatthiasBlamont in Paris; editing by Jason Neely and Barbara Lewis)