Pfizer vaccine, definitive approval in the USA

Full approval for Pfizer vaccine in the US for individuals over the age of 16. After the emergency use authorization (Eua) came full approval by the US Food and Drug Adminstration (Fda) for Pfizer-BioNTech’s anti-Covid vaccine for ages 16 and up. The vaccine also continues to be available with authorization for emergency use even for the age group between 12 and 15 years and for the administration of a third dose in some immunocompromised subjects, such as the FDA in a note. The vaccine “will now be marketed as Comirnaty for the prevention of Covid disease in people aged 16 and over,” Fda said in the note. The full approval of the first Covid vaccine by the FDA in the US is a “milestone”: this is how Janet Woodcock, Acting Commissioner of the agency defines it. “This and other vaccines – he clarifies – have met the rigorous scientific standards for the authorization of emergency use. And now the public” can also be sure of the fact “that this first vaccine approved by the FDA meets” also “the high standards. of safety, efficacy and production quality required for a “definitively” approved “product. EUA is used by the FDA in case of public health emergencies. The first was published on 11 December for the Pfizer-BioNTech vaccine for over 16. To support today’s approval decision, the FDA has reviewed updated data from the clinical trial underpinning the EUA and included a longer duration. follow-up in a larger clinical trial population. All data and information included in the submission by the producer of the license application for organic products (Bla) are evaluated, a complete dossier that meets very specific requirements. The agency analyzed data on the efficacy of approximately 20,000 vaccine recipients over 16 and 20,000 placebo recipients. Safety was assessed in approximately 22,000 people for each of the two groups. Based on the results of the clinical trial, the vaccine was 91% effective in preventing Covid. More than half of the participants in the clinical trial were followed up on safety for at least 4 months after the second dose. And overall, about 12 thousand vaccinated people were followed for at least 6 months. In addition, the FDA has conducted a rigorous evaluation of post-authorization safety surveillance data related to myocarditis and pericarditis, which demonstrate an increased risk, particularly within 7 days after the second dose, which is higher among males under 40. Available data from short-term follow-up suggests that most people have had symptom resolution. However, some people have requested critical care support. The prescribing information for Comirnaty includes a warning about these risks. Additionally, the FDA requires the company to conduct post-marketing studies to further assess the risks of post-vaccine myocarditis and pericarditis. And, while not required, the company has engaged in further post-marketing safety studies, including one on the pregnancy registry. “Our experts have conducted an incredibly thorough and thoughtful evaluation of this vaccine – assured Peter Marks. Director of the Fda’s Center for Biologics Evaluation and Research – We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own safety and efficacy analyzes of Comirnaty, and performed a detailed assessment of manufacturing processes, including inspections of manufacturing facilities. The public and the medical community can rest assured that, while we quickly approved this vaccine, it was fully in line with existing high standards for vaccines in the United States. “This FDA step paves the way for new vaccination obligations, is explained in the US media. For example, some universities and hospitals may impose them. And the Pentagon itself said it planned to make Covid vaccinations mandatory after the vaccine was fully approved. Pfizer-BioNTech also announced plans to swiftly seek approval for the third dose as a booster.