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PARIS (Dec 11): Sanofi and Britain’s GlaxoSmithKline said on Friday that they will test their potential COVID-19 vaccine after clinical trials showed insufficient immune responses in older people, delaying its possible launch until the end of next year.
The two companies said they planned to start another study next February, hoping to find a more effective vaccine by the end of 2021, in a blow to efforts to fight the pandemic.
The news is a disappointment for one of a crop of vaccines in development that are based on more conventional proven designs, as the injection developed by Pfizer and BioNTech using cutting edge technology is implemented in Britain.
It’s also a blow to many governments, including the European Union, the United States, Canada, and Britain, which have reserved hundreds of millions of doses of the vaccine as they fight to tame the virus that has killed more than 1.5 million people. and crushed. economies.
The delays and additional trials are not unusual, but the reverse highlights the challenges in developing vaccines at record speed. It also underscores why governments have reserved many different shots so as not to respond to just one.
Friday’s results showed “an immune response comparable to that of patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to insufficient concentration of the antigen,” he said. Sanofi from France.
“With this type of vaccine, the result is not a surprise, we know that more antigen is needed in older patients. But in phase I and II, drug manufacturers test tolerance and strong doses cannot be tested,” he said. Jean-Daniel Lelievre. head of the clinic for immunology and infectious diseases at the Henri-Mondor hospital in Creteil, France.
“I think Sanofi and GSK will be able to improve their vaccine.”
Phase III studies were expected to begin this month.
Sanofi said it would launch a phase 2b study in February next year after a recent challenge study in non-human primates conducted with an improved antigen formulation demonstrated better effects.
“The study will include a proposed comparison to a licensed COVID-19 vaccine,” the company said.
“If the data is positive, a global phase III study could begin in the second quarter of 2021. The positive results of this study would lead to regulatory filings in the second half of 2021, delaying the potential availability of the vaccine from mid-2021. from 2021 to the fourth quarter of 2021 “.
The two companies said they had “updated governments and the European Commission where a contractual commitment has been made to buy the vaccine.”
The Sanofi-GSK vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be combined with an adjuvant, a substance that acts as a booster for the vaccine, manufactured by GSK.
The Phase I / II study tested the vaccine’s safety, tolerability, and immune response in 440 healthy adults at 11 research sites in the United States.
This week Britain began rolling out a vaccine that uses a revolutionary mRNA technology developed by Pfizer and BioNTech, ahead of the rest of the world in the race. Canada also gave the green light for the shot.
The data comes as a panel of outside advisers from the US Food and Drug Administration voted overwhelmingly Thursday to support emergency use of the Pfizer / BioNTech vaccine.
Rival developers AstraZeneca Plc and Moderna have also reported late-stage data showing their vaccines are effective in preventing the virus.
The French group is also working on another candidate vaccine to prevent COVID-19 with the American company Translate Bio, which will be based on a different technology called mRNA, similar to that developed by Pfizer and Moderna.
Phase I trials of this vaccine are expected to begin this month.
Sanofi and GSK have expanded manufacturing to be ready to produce up to 1 billion doses of their vaccine in 2021.
GSK is contributing adjuvants to two other COVID-19 vaccine projects, one with Medicago of Canada and the other with Clover Biopharmaceuticals of China.
Australia on Friday canceled production of a COVID-19 vaccine developed by the University of Queensland and the use of an adjuvant made by biotechnology firm CSL after trials showed it could interfere with HIV diagnosis.
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