[ad_1]
Advisers to the independent committee of the FDA, the drug regulatory agency in the United States, recommended on Thursday (10) authorization for the emergency use of the vaccine by the American pharmaceutical company Pfizer and the German company BioNTech against Covid-19 in the country.
The move paved the way for a final endorsement by the body on the distribution of the immunizer, which may happen in the coming days.
With the green light, the elderly and health professionals can begin receiving doses of the vaccine next week, according to the American press.
The announcement was made after a meeting of more than eight hours. from the FDA advisory committee to review data on vaccine safety and efficacy, at a time when the pandemic reaches the highest rates in the US.
In total, 17 councilors voted in favor and 4 against authorizing the emergency use of the vaccine in people 16 years of age and older in the US There was one abstention.
After the FDA formally announces that it is following the recommendation of its advisory council, the CDC (Center for Disease Prevention) must give its approval to begin vaccination – the prognosis is that this will happen in the end. week.
If that happens, the United States will become the fourth country to authorize the use of the immunizer, after the United Kingdom, Canada and Bahrain.
According to The New York Times, the final word from the FDA must be received no later than Sunday (13), and the first shipment of 2.9 million doses of the vaccine must be shipped within 24 hours of authorization. agency. There are 6.4 million doses ready for distribution in the United States; immunization is carried out in two doses, given with an interval of up to three weeks.
With more than 280 thousand accumulated deaths, the US saw on Wednesday (9) the record of 3.1 thousand victims of Covid-19 in a single day, surpassing those of the September 11 attack, when 2,977 people died.
Even in the face of such a bleak scenario, President Donald Trump is following the negligent stance he maintained throughout most of the pandemic – downplaying the virus and spreading misinformation – and so far has not commented publicly on the new figures for the public health tragedy.
The FDA panel on Thursday acted as a kind of scientific cut, broadcast live, to debate data and statistics about the vaccine and conclude if the immunizer is really safe and effective enough for its emergency use to be authorized in the States. United. UNITED STATES.
Experts in vaccine development, infectious diseases and medical statistics attended the meeting and gave a positive signal to the agency, two days after the FDA itself had already confirmed, in an independent opinion, the safety and efficacy of 95% of the vaccine Pfizer.
The process in the US is slower than in other countries – the United Kingdom and Canada have already authorized the use of the Pfizer vaccine – and had pressure from the White House from the beginning, with Trump seeking positive data to boost his re-election campaign . The president was defeated by Joe Biden in November.
The immunizer, produced by the American Pfizer and the German BioNTech, concluded their tests on November 18, and the companies indicated that the vaccine is safe and has 95% effectiveness in groups of different ages, men, women, blacks, Latinos . and white, even with diabetes and obesity.
Following the start of the mass vaccination process in the UK this week, British officials warned that people with severe allergic reactions should not receive the vaccine; two cases are being investigated and studies should continue to answer questions. . Despite this, there are no other indications of strong side effects or contraindications.
Last weekend, the Trump administration unveiled an ambitious schedule for the immunizer launch, amid criticism from Biden that “there was no detailed plan” to immunize Americans.
The program to develop and distribute vaccines in the United States was called Operation Warp Speed, and the FDA released the vaccine this week. The first to receive the vaccine should be the elderly who live in rest centers, first responders and health professionals, between the end of December and January.
The second group, scheduled to receive the first dose in February or March, should be made up of employees of services considered essential, such as the postal service.
In an optimistic scenario, the US government promises that by the middle of next year, all Americans will have been vaccinated against Covid-19, despite signs that initial vaccine offerings will not be as extensive in all 50 states.
Since the election campaign, Biden has tried to counter Trump’s denial behavior in the face of the pandemic. The democrat advocates the use of a mask, measures of social detachment and has pledged to apply 100 million doses of the vaccine in his first 100 days in office: he takes office on January 20.
Biden also said that he will require the use of a mask whenever possible, although this is a prerogative of the governors.
On the same day that the Democrat made health promises to start his government this Tuesday, Trump gave a speech to talk about the vaccine, despite having used much of the time to echo his fanciful thesis that the November presidential election was disappointed and who was the winner.
Biden was declared elected after reaching the more than 270 votes required in the Electoral College. The result must be confirmed by the referee on December 14.
According to IHME, an institute for metrics at the University of Washington, which has been part of the White House health policies, the number of deaths in the United States may double and exceed 539,000 in April, even with the distribution of the vaccine. .
Data released by the institute shows that the vaccine is expected to prevent just 9,000 deaths in the US by April, while wearing a mask by 95% of the population could save 66,000 lives in the same period. The most effective way to prevent contamination and control mortality rates at this time, therefore, is to wear a mask, as immunization will take place gradually, prioritizing specific groups initially.
Last week, the CDC (Center for Disease Prevention) recommended for the first time the universal use of a mask when people are not at home, whether in open or closed environments. The agency also said that this year, Americans received the flu vaccine in record numbers, amid warnings from health officials that flu and coronavirus could rise together during the winter in the Northern Hemisphere.
Research shows, however, that Americans have mixed feelings about the Covid-19 vaccine. Between 33% and 37% say they are unlikely to want to receive doses of the immunizer.
Pfizer is expected to deliver 100 million doses to the United States in the coming months, enough to vaccinate 50 million Americans at two doses per person.
