What will change after America’s final okay to Pfizer’s Covid vaccine
The U.S. Food and Drug Administration has given final approval to Pfizer and BioNTech's Covid-19 vaccine. What will American companies do now
The Food and Drug Administration (Fda) has given complete and final approval to Pfizer's Covid vaccine . So far it has been used thanks to an emergency clearance. Here are all the details.
ALL THE DETAILS ON THE FDA DECISION ON THE PFIZER VACCINE
The vaccine "will now be marketed as Comirnaty * for the prevention of Covid disease in people aged 16 and over," Fda explains 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 authorizing emergency use. And now the public "can also be sure of the fact" that this first FDA-approved vaccine also meets "the high standards of safety, efficacy and production quality required for a product" definitively "approved". 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 16s.
DATA REVIEW
To support today's approval decision, the FDA has reviewed updated clinical trial data underpinning Eua and included a longer duration of 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.
SURVEILLANCE
In addition, the FDA 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.
THE FDA COMMENT
"Our experts have conducted an incredibly thorough and thoughtful evaluation of this vaccine – assured Peter Marks, director of the Center for Biologics Evaluation and Research of the Fda – We evaluated the scientific data and information included in hundreds of thousands of pages, conducted the our analyzes of Comirnaty's safety and efficacy and performed a detailed assessment of manufacturing processes, including inspections of manufacturing facilities. The public and the medical community can rest assured that although we quickly approved this vaccine, it was fully in line with the existing high standards for vaccines in the United States. "
NEXT STEPS ON VACCINES IN AMERICA
This step by the FDA paves the way for new vaccination obligations, it 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 their intention to quickly seek approval for the third dose as a booster.
WHAT WILL HAPPEN AFTER THE FDA OK TO THE PFIZER ANTI COVID VACCINE
The green light of the US agency in charge of drug control – wrote the New York Times – could convince many skeptics and pave the way for a series of vaccination obligations by public and private organizations, from schools to barracks, from companies to state and local administrations. So far the vaccine has been used thanks to an emergency authorization.
HOW COMPANIES WILL MOVE ACCORDING TO THE NYT
United Airlines has already announced that within five weeks of full approval it will ask all its employees to show proof of vaccination. Similar obligations should be adopted by the states of Oregon, Louisiana and Minnesota.
THE STEPS OF THE PENTAGON
Even the Pentagon has announced that it will impose the vaccination obligation for its staff in service (1.3 million people) after obtaining full authorization for use by Pfizer. The latter pharmaceutical company presented to the FDA the data of the tests conducted on 44,000 participants in the United States, the European Union, Turkey, South Africa and Latin America.
THE NUMBERS OF THE VACCINE
Based on the results, the vaccine was 91 percent effective in preventing Covid-19 infection (down slightly from the 95 percent effectiveness reported last December). Pfizer and BioNTech will now also seek full approval for the use of vaccines on minors between the ages of 12 and 15.
THE OPERATION OF PFIZER
Meanwhile Pfizer has reached an agreement for the acquisition of Trillium Therapeutics, a company specializing in the development of anticancer therapies for 2.260 billion dollars, approximately 1.931 billion euros. Under the terms of the agreement between the two companies, Pfizer will pay $ 18.50 in cash for each Trillium Therapeutics share it does not yet control, which is more than three times the stock value last week ($ 5.8). "The proposed acquisition of Trillium builds on our strong history of leadership in oncology, enhancing our hematology portfolio as we strive to improve outcomes for people with blood cancers around the world," said Andy Schmeltz, president Global and CEO of Pfixer Oncology.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/fda-usa-vaccino-pfizer/ on Mon, 23 Aug 2021 13:55:01 +0000.