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The announcement on Friday, which emphasized the challenges of developing shots at record speed, hinders attempts to develop the multiple options that experts say that the world needs to cancel a disease that has killed over 1.5 million people.
The news, which came on the same day as Australia axed a domestic vaccine project, can also be a blow for many governments that have booked hundreds of millions of doses of the shooter, such as the European Union, United States and Britain.
Both companies said they planned to start another study next February, hoping to think of a more effective vaccine by the end of 2021.
The setback affects one of the most recognized technologies in vaccines – utilized against the human papillomavirus, hepatitis B and pertussis among other pathogens – which aims to introduce lab-made proteins to the body to prod the immune system into creating a targeted defence against the novel coronavirus.
It cements the lead of more innovative approaches used by vaccines from the likes of Pfizer-BioNTech and Moderna, which use mRNA genetic technology to trick the body into producing those proteins. Both of those shots were found to be approximately 95% effective in successful large scale trials.
Delays and additional trials are not unusual but the Sanofi/GSK announcement highlights the exceptional set of challenges facing drugmakers in multitasking science, speed and logistics during a pandemic that has crushed global economies.
Additionally, it underscores why authorities have spread their bets by procuring shots from different developers.
Australia cancelled the production of a COVID-19 vaccine developed by the University of Queensland and using an adjuvant produced by biotech company CSL after trials showed it could interfere with HIV diagnosis.
Sanofi said Friday’s results from Phase I/II trials demonstrated”an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in elderly adults likely because of an inadequate concentration of the antigen”.
“With this sort of vaccine, the result isn’t a surprise, we understand that more antigen is necessary in older patients. But when in Stage I and II, drugmakers test tolerance and you can’t test powerful doses,” stated Jean-Daniel Lelievre, head of practice immunology and infectious diseases in Henri-Mondor hospital in Creteil, France.
“I’d think Sanofi and GSK will have the ability to improve their vaccine.”
Phase III studies were expected to begin this month. However Sanofi said it would rather launch a phase 2b study in February.
“The study includes a proposed comparison with a licensed COVID-19 vaccine,” the company said, declining to give further details on this.
“If data are favorable, an international Phase III study could start in Q2 2021. Positive results from this study would result in regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.”
Both companies said that they had”updated authorities and the European Commission in which a contractual commitment to buy the vaccine was made.”
The vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines. It will be combined with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.
Sanofi and GSK have scaled up manufacturing so as to be prepared to produce up to a billion doses of their vaccine in 2021. GSK said a goal to produce 1 billion doses of adjuvants – with some expected to be sent to other partners – in 2021 stayed in place but was under review.
The Stage I/II study tested the safety, tolerability and immune response of the vaccine in 440 healthy adults across 11 investigational sites in america.
This week, Britain began deploying the Pfizer-BioNTech vaccine, leaping ahead of the rest of the world in the race.
Canada has also given the green light for the shot, while a panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted to endorse emergency-use authorization.
Rival developers AstraZeneca Plc and Moderna have also reported late-stage data that shows their shots are effective at preventing COVID-19.
Sanofi is also working on another vaccine candidate to prevent COVID-19 with U.S. firm Translate Bio which will rely on a different technology called mRNA, like the developed by Pfizer and Moderna. Phase I trials for this vaccine are expected to start this month.
