FDA chief assures Americans of Govt vaccine protection after Pfizer approval | World News


Stephen Hahn, Commissioner for Food and Drug Administration (FDA), marked the historic first U.S. recognition of the Govt-19 vaccine – one of the worst days of the Govt-19 epidemic – by reassuring the U.S. public about the safety of the vaccine. In a major development in the fight against corona virus infection, the vaccine developed by Pfizer / Bioentech was approved for emergency distribution on Friday evening. Han said the FDA should “congratulate” on the speed and completeness of the scientific review of the vaccine. But even if the vaccine is approved, a tired American public will meet, bombed by misinformation for almost a year, most of which comes from US President Donald Trump, while witnessing a weak federal response and failure to have the Covit-19 transmission. “Although this year has been marked by tragedy, tragedy, and sacrifice, it has been a year of unparalleled scientific achievement that will resonate with many future generations,” Han told a news conference Saturday. “The availability and distribution of this Govit-19 vaccine is pending,” Han later said. “We acted quickly on the urgency of this epidemic, not by any other external pressure.” The FDA-approved vaccine Pfizer is expected to be shipped directly to states within hours from U.S. production facilities, with health workers and long-term care facility residents queuing up to receive the lowest initial dose. Guz Berna, chief operating officer of Operation Warp Speed, said first vaccine doses are expected to arrive at 145 vaccination sites on Monday, while high doses will reach 636 sites nationwide on Tuesday and Wednesday. “Make no mistake, distribution has begun,” Berna added. Stephen Hahn, FDA Commissioner. Photo: Graeme Jennings / AB vaccine is a two-dose regimen that is given at 21-day intervals. Pfizer is expected to deliver the 2.9m dose at the first dose. , Then an additional 2.9m dose will be given as a booster shot.The goal is to vaccinate 20 million people by the end of the year – which is still low for the nearly 24 million people who make up the first group defined to receive the vaccine.This vaccine comes in the same week, the same week the vaccine was approved, to date. More than 3,000 Americans are infected with Covid-19, more than 200,000 are infected with Covid-19 each day, and a total of nearly 300,000 die in the United States. He described the disease as “basically out of control”. The epidemic has not been under national control at any time since the first known cases were reported in January. Despite the extraordinary number of those figures, officials from the U.S. Centers for Disease Control and Prevention (CDC) said this week that the actual number of Govt-19 would be two to seven times higher. The vaccine comes after the White House reportedly pressured the FDA to move quickly to approve the vaccine. “Because of the suffering caused by this epidemic, FDA staff felt an urgent need to go through the accreditation process,” said Peter Marks, director of the FDA’s Center for Biological Assessment and Research at the same press conference. “The FDA’s review process is that Americans can and do rely on vaccines, not just the Govt-19 vaccine, but all vaccines reviewed by the United States,” he said. Peter Hodes, dean of the National School of Tropical Medicine at Baylor College, Texas and a vaccine expert not involved in vaccine development, said FDA officials “have done an extraordinary job of balancing the response to a public health emergency and releasing the vaccine.” The public they know is useful and safe. ” Even when vaccine exports begin, Americans will not return to normal immediately. Experts believe that about 80% of Americans will need to be vaccinated to achieve herd immunity, which can take months. This means Americans should regularly wear masks, hand wash, social distance and avoid crowds, especially indoor gatherings. Public health departments, many of which will now be vaccinated, need to be constantly contacted and tracked. Furthermore, in order for vaccines to significantly change the direction of infection, the FDA must accredit other vaccine candidates. The FDA Vaccine Advisory Committee will consider nominating a candidate for the next week’s vaccination against Allergy and Infectious Diseases in Modern, Inc. The federal government has already ordered a 200m dose. The Pfizer / Bioentech vaccine introduces the body into the spike protein that carries the corona virus to the surface using an innovative messenger RNA technology. The vaccine should be sent in special containers at extreme cold temperatures of -70C (-94F). The vials, each in five sizes, must be used within a few days of being removed. Scientists continue to collect data on the vaccine used in pregnant women and breastfeeding mothers, although no reasons have yet been found for pregnant women to publish a contraindication against vaccination. Following two cases of an allergic reaction in the UK, the FDA recommends that people with severe allergic reactions to vaccines in the past talk to their healthcare providers before receiving the vaccine. The third phase of clinical trials of the vaccine, which involved 43,000 people, and published in the New England Journal of Medicine, show that the vaccine has a 95% efficacy in preventing Govit-19. There will be several monitoring systems to monitor safety and performance. Pfizer is expected to apply for a full license for its vaccine next April. .

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