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“We have a date. Albert bourla, managing director of Pfizer, write that if all goes well, you will send a request for emergency authorization of the vaccine against Covid 19 in the third week of November 2020. Power! “. The virologist writes it on twitter Roberto Burioni.
The pharmaceutical company Pfizer plans to apply for‘authorization for its anti-Covid vaccine to the US agency Fda in the third week of November. This is what Pfizer CEO Albert Bourla announces in a letter posted on the company’s website and relaunched by Professor Roberto Burioni.
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“There are three areas in which, as with all vaccines, we must demonstrate success to first obtain approval for public use – writes Bourla – First, the vaccine must be effective, which means that it can help prevent Covid 19 in the majority of vaccinated patients. Second, the vaccine must be demonstrated to be safe, with reliable data generated from thousands of patients. Finally, we must demonstrate that the vaccine can be produced consistently to the highest standards quality “.
“I wanted to speak – continues Albert Bourla – to billions of people, millions of companies and hundreds of governments around the world who are investing their hopes in a safe and effective vaccine to overcome this pandemic. I know there is confusion about what it will take to get approval and given critical public health considerations and the importance of transparency I would like to provide more clarity on the timelines for Pfizer regarding our COVID-19 vaccine from partner BioNTech . “” We could know if our vaccine is effective – explains the CEO – or not by the end of October. To do this, we need to accumulate a series of Covid 19 cases in our study to compare the effectiveness of the vaccine in individuals vaccinated with those who received a placebo. As we have to wait for several cases to occur, this data may come sooner or later, depending on changes in infection rates. A committee of independent scientists will review the complete data and inform us if the vaccine is effective or not based on predetermined criteria. Pfizer will continue to run the process awaiting final analysis, even if declared effective at an earlier stage. We will share any final readings (positive or negative) with the public as soon as possible, a few days after independent scientists tell us. report the results. A key point that I would like to clarify is that if the efficacy only satisfies one of the three requirements, it is Only, it will not be enough for us to request approval for its use. ” “The second requirement is to show that the vaccine is safe. Our internal standards for vaccine safety and those required by regulatory authorities are high. In the case of the US emergency use authorization for a potential COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants after the final dose of the vaccine. We currently expect to reach this milestone in the third week of November. Safety is and will continue to be our number one priority and we will continue to monitor and report the safety data of all study participants for two years. “Ultimately, if we get a positive efficacy reading and a robust safety profile, the final requirement will be the submission of manufacturing data demonstrating the quality and consistency of the vaccine that will be produced … Let me be clear: Pfizer will require the use of authorization in the United States immediately after reaching the safety milestone in the third week of November All data contained in our US application will be reviewed not only by FDA scientists, but also by a external panel of independent experts at a public meeting called by the agency. The schedules shown reflect our best estimates. Pfizer has been known for its high quality standards for 171 years. Our goal is to make life-changing discoveries for patients. I can’t think of a breakthrough that is more meaningful to more people than an effective and safe COVID-19 vaccine, ”Bourla concludes.
Last update: Saturday, October 17, 2020, 09:01
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