French-made Sanofi Covid vaccine moves a step closer to use in EU
The European Medicines Agency is now evaluating the vaccine based on results of preliminary studies and trials, opening the way for the lab to submit a formal request for EU use
The EMA said it was ready to begin the monitoring process of the Sanofi Pasteur vaccine based on preliminary results of the study in laboratory conditions and clinical trials Pic: Rafapress / Shutterstock
The French-made Covid-19 vaccine, by the Institut Pasteur and pharmaceutical brand Sanofi, is one step closer to launch after the European Medicines Agency (EMA) announced plans to monitor the jab.
The EMA confirmed this week that it was starting a “continued monitoring” procedure of the vaccine, which has also been developed with British pharmaceutical giant GSK.
This is another step on the path towards a formal request for authorisation for use within the European Union.
The EMA said it was ready to begin the monitoring process based on preliminary results of the study in laboratory conditions, and results of clinical trials in adults.
It said: “[These results] suggest that the vaccine kicks off the creation of antibodies against SARS-CoV-2, the virus that causes Covid-19, and could contribute towards protection against the illness.”
The EMA will now continue its monitoring until it has enough information to allow the laboratory to submit a formal request for authorisation to sell and use the vaccine on the European Union market.
It said: “The EMA cannot predict the overall calendar, but the evaluation of the new request will likely take less time than normal, because of the work done during this examination stage.”
There are currently four vaccinations that the EMA has authorised for use in Europe. These are Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson (Janssen).
Why is the French-made vaccine so far behind the others?
Research on the Sanofi Pasteur vaccine began at the start of 2020, and the lab has been working on specific vaccine technology since 2011. Yet, in July 2021, its Covid-19 vaccine has not yet come to fruition.
France Télévisions journalist Jean-Christophe Batteria, who has been following the development of the vaccine, summarised: “The technique chosen by Sanofi Pasteur at the start doesn’t produce results, that is why there has been a year of delays.”
He also suggested that the laboratory had struggled with funding and staffing issues. He said: “According to [workers’ union] Force Ouvrière, the Research and Development department of Sanofi Pasteur has had three rounds of redundancies in the past 10 years.”
Yet, he explained that work was now progressing well on the vaccine, which will have several advantages compared to those that are currently on the market.
He said: “The laboratory is working on a vaccine that will be much more stable and easy to store. If we have to go through recurring, long-term vaccination campaigns, it could therefore have its ‘revenge’.”
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