Until now, the drug had been used thanks to an emergency authorization from the Food and Drug Administration. The vaccine can now be marketed under the Comirnaty brand. Chrysants: The doors are opened to the obligation of vaccination
The vaccine of BioNTech / Pfizer crossed the line first: it has been definitively approved by the American Food and Drug Administration, for all people aged 16 and over. Therefore, the emergency phase (not experimental, as some no vax affirm) of the use of this vaccine ends and we enter the normal iter of marketing and use, even if Pfizer has announced that only the federal government will distribute the doses to the various states.
A decision that will probably be taken in a short time also by the EMA (European Medicines Agency) and the Italian Aifa. The green light from the FDA comes in the midst of a new wave: in the United States the Delta variant is slowing the progress made in recent months, with infections and hospitalizations on the rise. New cases per day are on average 150 thousand and more than 90 thousand hospitalized patients. Deaths are a thousand a day. The infections also affect children under 12 years old. There are still 85 million unvaccinated Americans and the Biden administration hopes that final approval will be a stimulus, at least for the hesitant and doubtful. If you are not yet vaccinated, now is the time, the president wrote on Twitter.
The consequences are not only psychological, but also practical and the vaccination obligation is no longer a tab. The Pentagon has announced that it will give orders to vaccinate all military personnel on active duty and United Airlines will ask employees for proof of vaccination within five weeks. The State of Oregon requires coverage on all state workers, as well as several universities in Louisiana and Minnesota. In New York, Mayor Bill de Blasio said teachers and public school staff will be required to get vaccinated: the 148,000 members of the largest school district in the United States will have to receive at least one dose by September 27.
The start of the school is set for September 13th. Meisha Porter, from the NY School District, said at least 63 percent of employees are already vaccinated. The vaccination obligation for school staff is also in force in Chicago, Los Angeles and Washington. In some people, the approval of the vaccine by the FDA can instill further confidence, said Janet Woodcock, the agency’s acting commissioner. The milestone set today brings us closer to the goal of changing the course of the pandemic in the United States. In fact, according to a recent survey by the Kaiser Family Foundation, 3 out of 10 unvaccinated people are more likely to get immunized after full approval.
Pfizer and BioNTech submitted to the FDA data relating to 44 thousand participants in the clinical trial in the United States, the European Union, Turkey, South Africa and South America. The Comirnaty vaccine was 91% effective in preventing infection – a slight drop from the 95% rate that emerged from the first studies last December. So far, more than 92 million Americans – 54% of fully vaccinated individuals – have received Pfizer. The rest, for the most part, had Moderna. Peter Marks, head of vaccines at the FDA, said the approval comes at the end of the review of hundreds of thousands of pages of data, with inspections of the plants where the vaccine is produced. The public and the scientific community can rest assured that even if we approved this vaccine quickly, it is fully in line with our high standards, Marks said.
The Pfizer / BioNTech vaccine will continue to be authorized as an emergency for 12-15 year olds, but manufacturers are collecting data to seek full approval even in this age group. Federal health agencies will continue to monitor the safety of the vaccine (as is the case with all drugs and vaccines in phase 4, called post marketing) and the FDA will ask Pfizer to continue studying the rare cases of myocarditis, an inflammation of the heart muscle. , and pericarditis, an inflammation of the membrane surrounding the heart. In the coming weeks, the FDA will also have to rule on the hypothesis of the third dose, after the Biden administration announced the possibility of the booster for adults who have received the second dose of Pfizer and Moderna for at least 8 months, starting on September 20. .
Recalls are already authorized for some categories of immunosuppressed patients. Finally, the FDA is reviewing Moderna’s application for full approval of its vaccine and Johnson & Johnson is expected to apply soon. I think the approval eliminates a number of ambiguities, ”he said Andrea Crisanti,
professor of microbiology at the University of Padua -: I have heard many times people say that they do not get vaccinated because the authorization is only emergency. There is no longer this alibi: the vaccines have been administered in four billion doses and have minimal and reversible side effects. From a legal point of view, Pfizer’s becomes an approved vaccine and this opens the door to legal provisions that can lead to the obligation of vaccination.
August 23, 2021 (change August 23, 2021 | 19:53)