The US Food and Drug Administration has given urgent approval to the Corona virus vaccine, developed by Pfizer and Bioendech, the first drug to prevent Covit-19 approved in the United States. FDA Commissioner Dr. Stephen Hahn confirmed the news in a statement Friday night. “FDA accreditation for the urgent use of the first Govt-19 vaccine is a significant milestone in combating this devastating epidemic that has affected many families in the United States and around the world,” Han said. The acknowledgment marks a turning point for an epidemic that has killed more than 294,000 American lives and 1.5 million worldwide. The United States follows in the footsteps of other countries, including the United Kingdom, Canada and Mexico, which have approved the Pfizer / Bioentech vaccine for widespread public use. “Although not approved by the FDA, today’s emergency use of the Pfizer-BioTech Covit-19 vaccine is a pledge to change the course of the epidemic in the United States,” said Peter Marx, director of the FDA’s Biological Assessment Center. “As science guides our decision-making, the available safety and efficacy data support the recognition of the Pfizer-Bioentech Kovit-19 vaccine because the known and potential benefits of the vaccine outweigh its known and potential risks.” In a video posted on Twitter on Friday night, Donald Trump hailed the vaccine as “one of the greatest scientific achievements in history” and said the first dose would be administered within 24 hours. The FDA approved a vaccine called PND162B2, which was effective in preventing 95% of the corona virus after a trial involving more than 43,000 people. The vaccine uses innovative messenger RNA technology to introduce the body to the spike protein on the surface of the corona virus. The results of the investigation were published in the New England Journal of Medicine on Thursday. Scientists are still studying how long the vaccine-induced immune response lasts, which is the “period” of immunity, the rate of asymptomatic disease among vaccinated people, and whether the vaccine can prevent the spread of COV-19. The vaccine is approved for people 16 years of age and older in the United States. Pfizer continues to study the vaccine for children ages 12-15. States will receive an initial allocation of 2.9 m, which will be shipped directly from Pfizer within a few days of approval. Those drugs will be distributed among health care workers and long-term care residents at the U.S. Centers for Disease Control and Prevention (CDC), which considers vaccination a high priority. Pfizer then sends out a second 2.9m dose allotment weeks later, which is necessary for the same individuals to achieve the booster shot, achieving 95% effectiveness of the vaccine. The administration aims to vaccinate 20 million health workers and residents of long-term care homes by the end of this year. The distribution of the vaccine is expected to be one of the most complex public health campaigns in history. The vaccine requires savings at -94F (-70C), and Congress has failed to provide the necessary funding to advance this initiative, leaving public health officials to distribute it themselves. Even before the delivery of the most effective vaccine, experts continue to warn that it will not return to normal immediately. While some experts predict that the vaccine will not reach low-risk adults by mid-late 2021, the initial ingredients of the vaccine will be highly restricted. That means individual Americans are constantly meeting with masks, social distance, hand washing and avoidance, public health agencies are constantly testing and contact traces, eventually bringing the infection to the heels. Experts believe that the United States should vaccinate 80% of adults to achieve “herd immunity”. It is an exceptionally high-dose vaccine that has never been achieved, for example, during the seasonal flu campaign. The FDA’s decision to approve the vaccine on Friday night may cause confusion among experts, who say the company should closely balance the momentum needed to save lives against a public perception that the vaccine is rushing. The move comes after White House Chief of Staff Mark Meadows reportedly called Han on Friday evening to press for approval. The FDA Vaccine Advisory Committee on Thursday evening recommended that the company be given emergency accreditation to distribute the vaccine. The administration’s move to increase pressure was strongly criticized by health experts, some of whom argued that waiting for the FDA would save more lives because it would not trigger vaccination reluctance among the American population. In all, federal health officials believe 20 million people will be vaccinated by the end of the year. That number will be further reduced by vaccinating all of the country’s 21 million health workers and 3 million long-term care residents. An FDA advisory panel will ask for evidence on the second vaccine next week, which was developed by Modern and National Allergy and Infectious Diseases and is called MRNA-1273. The Trump administration on Friday evening released another signal to support the modern vaccine, announcing that the government has purchased an additional 100m. This brings the total volume purchased to 200 meters, and will allow the vaccine to be “continued” until June 2021.
Source