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Pfizer / BioNTech vaccines go through another step as the FDA issues an emergency license | Health
Issued by the US Food and Drug Administration Emergency use permission For the first usa Coronavirus By vaccination on Friday night, state and federal officials are planning to give people the first injection and convince those who are hesitant to get it.
Operation Warp Speed’s chief adviser, Monsef Slawi, urged Americans on Friday to look up numbers that indicate the effectiveness of the Pfizer and BioNTech vaccines.
“In order to explain the characteristics of vaccines and their performance, and hopefully engage with people and persuade them, we need to get out there and engage with all leaders at all levels of the community. “Slawi said. “Frankly, I couldn’t do it effectively before because I couldn’t be concrete.”
Slawi concludes that experts reviewing data on Pfizer vaccines have “extraordinary efficacy” and “a good safety profile comparable to many approved vaccines” in this shot. I emphasized that.
A Pfizer spokesperson confirmed on Friday that CNN was granted an emergency license in accordance with the recommendations of the FDA’s Vaccine and Related Biologics Advisory Board.
EUA, authorities Ship the dose of vaccineHowever, shots cannot be administered until the CDC’s Advisory Committee on Immunization and Implementation (ACIP) meets and recommends a vaccine.
ACIP will meet on Saturday at 11:00 am to vote on vaccine recommendations. The final step in the approval process is the green light from the CDC. The injection can be given in a few days.
Secretary of Health and Welfare Alex Azar told ABC that the FDA will work with Pfizer to ship the vaccine. “We can see people vaccinated next Monday and Tuesday.”
The governor prioritizes who will be vaccinated first in the state. The most vulnerable people, including health care workers and residents of long-term care facilities, are Expected to line up.
According to Slawi, the state will initially receive a weekly shipment of Pfizer vaccine after the shot is deployed.
The number of vaccines will increase “weekly” as production increases, Slawi said.
He said the governor would be informed of the expected number of doses a week ago.
States and communities tighten social restrictions
While the country is anxiously waiting for the approval of the first Covid-19 vaccine, local and state leaders are responding to increasing case rates by tightening or expanding social restrictions.
Governor Andrew Cuomo has announced that the restaurant canteen will be closed starting next week, citing increased hospitalizations across New York City.
He added that outdoor dining and takeaways may continue.
The Mississippi Supreme Health Authority, which said the state’s ICU was full, ordered some selective procedures to be postponed.
In a tweet posted Friday afternoon, Dr. Thomas Dobbs said all selective surgery requiring hospitalization would be postponed from Tuesday.
Ohio Governor Mike DeWine announced Thursday that the state will extend the state-wide curfew until January 2, and authorities believe the curfew and face masks have had an impact. Said.
In Florida, Miami said it would re-enforce the Miami-Dade County curfew starting this weekend in response to the surge in coronavirus cases.
The county enforced a curfew from midnight to 6 am earlier this year, but the city stopped enforcing it in October.
Rapid increase in cases, hospitalizations and deaths
The green light of the Covid-19 vaccine will give hope, but top experts warned that the worst days of the pandemic are still ahead of the United States. As a result of Thanksgiving trips, a surge in more cases could materialize, and future holiday gatherings could increase in number, they say.
Cases, hospitalizations and deaths are already on the rise.
• According to data from Johns Hopkins University, the United States has recorded an average of 210,201 new Covid-19 cases daily in the past week. This is the highest average ever recorded in the United States.
• The United States set another record on Friday for the number of Covid-19 patients in hospitals on a particular day-according to 108,044. COVID tracking project.
• More than 85% of hospitals across the country had more Covid-19 patients last week than they did a month ago, according to new data from the Department of Health and Human Services.
• The county’s average death toll reported daily over the week was 2,259 on Thursday, just below the pandemic peak reported the day before.
• The highest number of coronavirus deaths reported by the United States this week was Wednesday at 3,124.
“Currently, we’re probably in the next 60 to 90 days, with more deaths per day than 9/11,” said Dr. Robert Redfield, director of the CDC. “As with everything so far, this will be a truly unfortunate loss of life, and in reality, this week’s vaccine approval will not really affect it.”
A CNN analysis of newly released data from the US Department of Health and Human Services last week showed that at least 200 hospitals were in full operation across the United States. In addition, more than 90% of ICU beds accounted for one-third of all hospitals.
Future timeline
One of them, Moderna, will get an emergency license later this month. The FDA Advisory Board will meet next week to consider whether to recommend this.
Another product from GlaxoSmithKline and Sanofi Pasteur will be postponed until at least late 2021 after the interim results show an “insufficient immune response” in the elderly, the companies said Friday.
Hazard told ABC on Friday that the delay in GSK / Sanofi would not affect US expectations of how many Americans would be vaccinated by early 2021.
“We are seeing 20 million Americans vaccinated to a total of up to 50 million people in the coming weeks (and) by the end of January,” he told ABC. “I believe we can actually get 100 million vaccinations by the end of February.”
At the Rush University Medical Center in Chicago, 10 vaccination stations have already been set up in a corridor with temporary partitions. Hospital staff will get the Covid-19 vaccine when the dose arrives.
“I feel it’s the beginning of the end of this crazy pandemic, and frankly, it’s great to see it,” RUMC respiratory therapist Brady Scott told CNN on Friday. “It feels like the moment we turn a curve and return to normal.”
In the United States, vaccination may not have a significant and widespread impact until 2021. But how quickly a country can recover depends on how quickly Americans get vaccinated and how many people are willing to get the vaccine.
“With a smooth vaccination program where everyone can quickly step into the plate, they can get back to some normal state quickly, in the summer, and certainly in the fall,” said the National Institute. The director, Dr. Anthony Fauci, said. I told CNN on Thursday about allergies and infectious diseases.
“My hope and prediction is that if you vaccinate people all at once and get the majority of the population, then in the fall you will get a real sense of security that people are at school and safe at school. That means you can do that K-12, or college, “he added.
CNN’s Haley Brink, Elizabeth Cohen, Ventinker, Daedle McPhillips, Adrian Broaddas, Bill Carcos, Amanda Watts, Melissa Alonso, Andrea Diaz and Tina Burnside contributed to this report.
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