The U.S. Food and Drug Administration (FDA) approved the emergency use of the COVID-19 vaccine developed by Pfizer and BioNTech this Friday. free for distribution in the country.
The decision comes after an FDA advisory committee recommended on Thursday that the Pfizer vaccine against COVID-19 be approved as a matter of urgency, as a key step for its distribution to millions of North American teams. Americans.
The FDA said in a letter that the known benefits of the Pfizer-BioNTech vaccine outweigh its potential risks for people over 16 years of age. “By making this determination, the FDA can assure the public already that the medical community has conducted a thorough evaluation of the available information on safety, efficiency, and manufacturing quality.”
The vaccine is expected to begin being distributed as early as this weekend, initially aimed at front-line health care workers as well as staff working in medical centers.
“The first vaccine will be administered in less than 24 hours. Governors will decide where and who will receive it first. This will quickly and dramatically reduce deaths,” President Donald Trump said in a video posted on your Twitter account in which he celebrated historical history.
The Pfizer vaccine has been shown to be safe and very effective. Phase 3 clinical trials of the vaccine revealed that the injection is 95% effective in a variety of ages, racial groups and ethnicities when given in doses, approximately three weeks apart.
Trump said in his message that the vaccine will be free for all Americans and that it has already begun distribution through Fedex and UPS to all states in the country.
In a vote of 17 in favor and 4 against with one abstention, the expert group concluded the Jews that the inoculation of Pfizer and its German partner BioNTech appears safe and effective against coronavirus in people 16 years and older.
He was backed by questions about the allergic reactions of two people who received the vaccine this week in Britain, the first country to start Pfizer-BioNTech inoculations.
People will receive two doses. Here are the details.
Although there are still things unknown about the vaccine, in an emergency “the question is whether enough is known” to move forward, said Dr. Paul Offit of the Philadelphia Pediatric Hospital, a panel member who concluded that the potential benefits outweigh the risks.
The decision was made at a time when coronavirus cases reached recent levels in the United States, where the death toll in one day reached my enemy’s all-time high of 3,100.
Pleasant Plains, in Wisconsin, is where the vaccine pending for Food and Drug Administration (FDA) approval is stored.
Pfizer has said they have about 25 million doses of the vaccine – which requires two injections – for the United States by the end of December.
But the initial supplies will be reserved mainly for health workers and residents of nursing homes, which will be followed by other vulnerable groups, until the increase in production allows vaccines to be available on demand, something that is unlikely to happen. happen before the boreal spring.
Next week the FDA will review a second vaccine, from Modern and National Institutes of Health, that appears to be as effective as that from Pfizer-BioNTech. A third candidate, from Johnson & Johnson, which would require a single dose, is in the process. In addition to these is the AstraZeneca vaccine and Oxford University.
People over the age of 18 can buy without a prescription.
U.S. health experts are confident that a combination of vaccines will allow the United States to double the pandemic in the long run.
However, experts estimate that less than 70% of the country’s population will need to be vaccinated to achieve collective immunity, the point at which the virus can be kept under control.
So that means we could spend several months before things started to return to normal and Americans stopped using their masks.
It is the first country in the world to approve the Pfizer vaccine.
Dr. William Moss of the University, Johns Hopkins, who did not participate in the review by the panel of experts, said that “given the current severity of the pandemic, we must mobilize.”
The independent review by a group of non-governmental experts on vaccine development, infectious diseases, and medical statistics was considered key to increasing Americans’ confidence in the safety of the vaccine developed at breakneck speed in less than a year. after the virus is identified.