Pfizer expects to request authorization to use its COVID-19 vaccine by the end of November

The North American pharmaceutical company Pfizer hopes to request a emergency authorization for the use of your COVID-19 vaccine by the end of November, as announced on Thursday by the CEO of the company, Albert Bourla, in a open letter. However, this action will occur only if the safety and efficacy of the drug can be guaranteed created together with the BioNTech company.

“First, the vaccine must prove its effectiveness, which means it can help prevent COVID-19 disease in at least the majority of vaccinated patients. Second, and equally important, the vaccine must prove your safety, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be manufactured consistently with the highest quality standards, ”wrote Bourla.

Once all these steps have been completed, we will proceed to request your approval: “Assuming positive data, Pfizer will request the use of emergency authorization in the US shortly after the safety milestone in the third week of november. All data contained in our US application will be reviewed not only by the scientists of the FDA, but also by an external panel of independent experts in a public meeting called by the agency ”.

Pfizer’s predictions mean that its vaccine, called BNT162b2, may not be ready before the US elections, as the president of the country, Donald Trump, had stated on some occasion, who said that he expected that this drug, which already has reserved 100 million doses, was the first to be approved in the United States.

Complete immune response

Luis Jodar, global medical director of vaccines at Pfizer and a former WHO official in Vaccine R&D, explained a month ago in The world that your vaccine candidate “is based on the Messenger RNA that encodes a glycoprotein S full optimized SARS-CoV-2. This protein is what the virus uses to penetrate the cells of our body and replicate ”.

A very interesting technology that, according to Jodar, has several “Potential benefits” with respect to the rest of the candidates, among which two stood out. On the one hand, he pointed out that “it induces a complete immune response, so much humoral (neutralizing antibodies) such as cell phone (mediated by T lymphocytes) ”. On the other, if necessary, “booster doses may be given repeatedly and, finally, its manufacture in large quantities can be done quickly and efficiently ”, explained the expert.

Teen testing

The researcher leading the trial, Robert Frenck, revealed this Tuesday in CNN what Pfizer plans to start testing its experimental vaccine in children from the age of 12 and that many parents have already shown interest in registering their children. The company itself confirmed on its website that it had the aUS Food and Drug Administration (FDA) approval to enroll children 12 and under in your essay. In this way, it will be the first coronavirus vaccine trial that includes children in the United States.

The director of the hospital’s Vaccine Research Center assured that “A vaccine for adolescents and children will be essential to keep COVID-19 under control”, since “it is not a non-existent infection in children”, since more than half a million children have been infected in the United States. In addition, he stressed that “although the mortality rate of children with COVID-19 is lower than in older adults, it is not zero,” so it is important to also take this sector into account.

Two vaccinations by the end of the year?

Pfizer’s recent announcement assumes that the United States could have two vaccines ready by the end of the year, since the biotechnology firm Modern he hopes to have his by November 25th.

Both Pfizer and Moderna began phase three of their clinical trials in late July and both have started dose production, to be in a position to distribute tens of millions in the United States by the end of the year. As long as they overcome, yes, the Food and Drug Administration requirements (FDA), who, Bourla explains, “requires companies to provide two months of safety data on half of the participants of the trial after the final dose of the vaccine and based on your current enrollment in the trial and dosing schedule.

As reported by the North American chain CNBC, five American participants in the trials of these two vaccines experienced major side effects, as high fever, body aches The headlong Y exhaustion, after receiving the injection. Three were in Moderna’s trial, while the other two were in Pfizer’s. However, all symptoms they lasted a short time. This disclosure did not seem to affect the development of the trials and the forecasts of both companies to obtain their vaccine against COVID-19 before the end of the year are maintained.

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