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PHOTOPfizer pharmaceutical company plans to request authorization for its Covid vaccine from 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. “There are three areas in which, as with all vaccines, we must demonstrate success to obtain approval for public use in the first place – writes Bourla – First, the vaccine must be effective, which means that it can help prevent Covid 19 in the majority of vaccinated patients. Second, we must demonstrate that the vaccine is safe with reliable data generated by thousands of patients. Finally, we must demonstrate that the vaccine can be produced consistently to the highest standards of 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 will be necessary securing approval, and given critical public health considerations and the importance of transparency, I would like to provide more clarity on timelines for Pfizer regarding our COVID-19 vaccine from partner BioNTech. ” “It is possible that we will know if our vaccine is effective – explains the CEO – or not at the end of October. To do this, we need to accumulate a certain number of Covid 19 cases in our study to compare the effectiveness of the vaccine in individuals vaccinated with those who have received a placebo. Since we have to wait for several cases to occur, these 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 whether it is effective or not based on predetermined criteria. Pfizer will continue to run the process pending final analysis even if it is declared effective at an earlier stage. We will share any conclusive (positive or negative) reading with the public as soon as possible, a few days after independent scientists will have notified us of the results. A key point I would like to clarify is that if the efficacy satisfies only one of the t These requirements alone will not be sufficient for us to seek approval for their use. ” “The second requirement is to demonstrate 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 possible vaccine COVID: On October 19, 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 strong safety profile, the final requirement will be to submit 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 shortly after reaching the safety milestone in the third week of November. All data contained in our application in the United States will be reviewed not only by FDA scientists, but also by an outside group of independent experts at a public meeting convened by the agency. Reported timelines 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. Think about it. in an advance that would be more meaningful to more people than an effective and safe COVID-19 vaccine, “concludes Bourla.
“We have an appointment. Albert Bourla, CEO of Pfizer, writes that, hopefully, he will submit an application for an emergency authorization of the Covid 19 vaccine in the third week of November 2020. Let’s go!” Virologist Roberto Burioni writes it on twitter.
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