The Pfizer / Bioentech vaccine goes one step further as the FDA allows emergency use :: WRL.com


– [Breaking news update, published at 9:35 p.m. ET]

U.S. The Coronavirus vaccine of Pfizer and Bioentech has been authorized by the Food and Drug Administration for emergency use in the United States.

A Pfizer spokesman confirmed to CNN on Friday that the emergency use had been approved following a recommendation from the FDA’s Vaccine and Related Biological Products Advisory Committee.

On Saturday, the CDC’s Advisory Committee on Immunization Practice (ACIP) is to meet and vote on the vaccine recommendation.

[Previous story, published at 9:21 p.m. ET]

People outside of clinical trials first visited the U.S. Before the coronavirus can be vaccinated, two government agencies need to step in – and it looks like one will do so in the coming hours.

According to a federal government source close to the situation, key players in the vaccine decision-making process will be in the U.S. by Saturday. The Food and Drug Administration is expected to allow emergency use for the Pfizer / Bioentech vaccine.

The EU will allow shipping to begin, but shots cannot be administered unless the vaccine is recommended by the CDC’s Advisory Committee on Immunization Practice (ACIP).

Dr. Amanda Cohen of ACIP said she expects the FDA to allow emergency use by 10 a.m. Saturday.

“We assume it’s possible,” he said.

If the FDA decides after that time, the AICP meeting will probably take place on Sunday.

Koh’s comments come a day after the FDA’s advisory panel recommended that the agency allow emergency use of the vaccine. According to an administrative official and a source familiar with the situation, the FDA commissioner has been asked to resign on Friday or he has also arrived.

Once the FDA approves the use of the vaccine, the pace of operation – the federal government’s initiative to develop a vaccine – could begin distributing the vaccine to the states.

Health and Human Services Secretary Alex Azar told ABC that the FDA would work with Pfizer to send the vaccine “so that we can see that people are vaccinated on Mondays and Tuesdays next week.”

Governors have their preference on who will get the vaccine first in their states. The most vulnerable, including healthcare workers and residents of long-term care facilities, are expected to be ranked first.

Monsef Sloy, chief adviser at Operation Led Speed, said the state would receive a Pfizer vaccine shipment once a week after the shots began.

Sloe said the number of vaccines will increase “on a weekly basis” as production increases.

Governors will be notified a week in advance of what to expect, he said.

States and communities lift social restrictions

While the country anxiously awaits the first Covid-19 vaccine authorization, local and state leaders are raising the case rate by raising or increasing social sanctions.

Citing an increase in hospital admissions in New York City, Gov. Andrew Cuomo announced on Friday that the dining room in Ethereum will be closed next week.

Outdoor dining and takeouts can continue, he added.

A top Mississippi health official, who said the state’s ICUs are full, issued an order postponing some alternative procedures.

In a tweet posted Friday afternoon, D Tho. All alternative surgeries for hospitalization will begin Tuesday, Thomas Dobbs said.

Ohio Governor. Mike Dewey announced Thursday that the state is extending its statewide curfew until Jan. 2, with officials believing the curfew so far has had an impact with facial masks.

In Florida, Miami said it would re-impose a Miami-Dead County night curfew this weekend, in response to a surge in coronavirus cases.

The county enforced a curfew from midnight to 6 p.m. earlier this year, but the city stopped enforcing it in October.

Increase in cases, hospitalizations and deaths

While Lilizandi will give hope for the Covid-19 vaccine, leading experts have warned that the worst days of the epidemic are in the U.S. For is still ahead. More cases are likely to take shape as a result of the Thanksgiving trip, and the number could increase with future holiday gatherings, he says.

Cases, hospitalizations and deaths are already on the rise:

According to Johns Hopkins University data, the U.S. has an average of 210,201 new Covid-19 cases per day per week – the highest ever recorded for the country.

V USA set a further record for the number of Covid-19 patients in hospitals on Friday – 108,044, according to the Covid Tracking Project, according to the Covid Tracking Project.

New published data from the Department of Health and Human Services shows that Kovid-1 patients were in more than 85% of hospitals across the country last week than a month ago.

The county average number of deaths per day during a week was 2,259 on Thursday, just below the peak of an epidemic the day before.

પણ This week, the U.S. The highest number of coronavirus deaths was recorded at 4.44 in a single day on Wednesday.

Dr. Robert Redfield, Director of the CDC, said: “We are now in the deadline, perhaps from the next 0 to 10 days, we have died more days than we did on 9/11. “This is going to be a real unfortunate loss of life, because that’s what we did so far, and the reality is that the approval of the vaccine this week won’t really affect it.”

A CNN analysis of newly released data from the U.S. Department of Health and Human Services showed that at least 200 U.S. hospitals were at full capacity last week. And more than 90% of all hospitals occupy ICU beds.

Timeline for the future

U.S. In addition to Pfizer and Bionetak, six other coronaviruses are supporting vaccine development.

One of them, from Modern, could be in line for emergency use approval later this month. An FDA advisory panel will meet next week to consider whether to recommend this.

Second, GlaxoSmithKline and Sanofi Pasteur’s interim results will be delayed at least until the end of 2021 after the elderly show an “inadequate immune response,” the companies said on Friday.

Azar told ABC on Friday that the GSK / Sanofi delay would not affect the United States’ expectations of how many Americans will be vaccinated in early 2021.

“We’ll be back next week,” he told ABC. Millions of Americans are being vaccinated (and) a total of 50. million million are being vaccinated by the end of January. “We believe we will be able to do 100 million actual vaccinations by the end of February.”

Hospital systems and pharmacies are preparing to vaccinate healthcare workers and residents of long-term care facilities, respectively.

At Chicago’s Rush University Medical Center, 10 vaccination stations with temporary parts have already been set up in the temporary lobby. Hospital staff would take their Covid-19 vaccines there when the dose arrived.

R.M.M.C. “I think this is the beginning of the end of the insane epidemic, and obviously, it’s a pleasure to see it,” Brady Scott, a respiratory therapist, told CNN on Friday. “It looks like a moment (where) we’ll turn around and we’ll be back to normal.”

Probably the U.S. No significant, far-reaching effects will be seen from vaccination until 2012. But how the country can recover so quickly depends on how quickly Americans are vaccinated – and how many people are willing to be vaccinated.

“If we have a simple vaccination program where everyone moves quickly to the plate, we can return to some form of normalcy. In the summer and certainly in the fall,” said Dr. Krishna Kumar, director of the National Institute. Anthony Fauci told CNN on Thursday about allergies and infectious diseases.

“My hope and my guess is that if we get people vaccinated on masonry so that we can get a bigger share of the population, we get real comfort about people being in schools, being safe in school.” K-12, or K-College Ledge, ”he added.

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