Pfizer/BioNTech's vaccine passes another step as FDA issues emergency use authorization

In the wake of vaccine advisers to the US Food and Drug Administration voting to recommend the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine, Dr. Anthony Fauci explains why the approval process matters.

Posted: Dec 11, 2020 9:50 PM
Updated: Dec 11, 2020 9:50 PM

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

The US Food and Drug Administration has authorized Pfizer and BioNTech's coronavirus vaccine for emergency use in the United States.

A Pfizer spokesperson confirmed to CNN on Friday that an emergency use authorization had been granted, following the recommendation of the FDA's Vaccines and Related Biological Products Advisory Committee.

On Saturday the CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet and vote on recommending the vaccine.

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

Before people outside of clinical trials can get the first US coronavirus vaccine, two government agencies need to give the go ahead -- and it looks like one will do that in the coming hours.

Key players in the vaccine decision process have been told to expect the US Food and Drug Administration to issue an emergency use authorization for Pfizer/BioNTech's vaccine by Saturday, according to a federal government source close to the situation.

The EUA would allow shipping to begin, but shots still can't be administered until the CDC's Advisory Committee on Immunization Practices (ACIP) meets and recommends the vaccine.

Dr. Amanda Cohn of the ACIP said that she expects the FDA to issue the emergency use authorization by 10 a.m. Saturday.

"We do anticipate that it is likely," she said.

If the FDA decision comes after that time, then the AICP meeting will probably take place Sunday.

Cohn's comments come a day after a panel advising the FDA recommended the agency grant an emergency use authorization for the vaccine. They also come as the FDA commissioner was told to green light the vaccine Friday or resign, according to an administration official and a source familiar with the situation.

Once the FDA authorizes vaccine use, Operation Warp Speed -- the federal government's initiative to develop a vaccine -- can start distributing the vaccine to states.

Health and Human Services Secretary Alex Azar told ABC that the FDA would work with Pfizer to get the vaccine shipped "so we could be seeing people get vaccinated Monday, Tuesday of next week."

Governors are prioritizing who would get the vaccines first in their states. Healthcare workers and the most vulnerable, including residents of long-term care facilities, are expected to be first in line.

States will receive shipments of Pfizer's vaccine once a week to begin with after the shots are rolled out, Operation Warp Speed Chief Adviser Moncef Slaoui said.

The number of vaccines will increase "week-on-week" because manufacturing will ramp up, Slaoui said.

Governors will be notified a week in advance how many doses to expect, he said.

States and communities ramp up social restrictions

While the country anxiously awaits the first Covid-19 vaccine authorization, local and state leaders are responding to rising case rates by ramping up or extending social restrictions.

Citing increased hospitalizations across New York City, Gov. Andrew Cuomo on Friday announced that beginning next week dining rooms in eateries will be closed.

Outdoor dining and takeout may continue, he added.

Mississippi's top health official, who said the state's ICUs are full, issued an order to postpone some elective procedures.

In a tweet posted Friday afternoon, Dr. Thomas Dobbs said all elective surgeries requiring hospitalization will be postponed starting Tuesday.

Ohio Gov. Mike DeWine announced Thursday the state is extending its statewide curfew until January 2, saying officials believed the curfew so far, along with face masks, have had an impact.

In Florida, Miami said it will again enforce Miami-Dade County's nightly curfew, starting this weekend, in response to a surge in coronavirus cases.

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

Cases, hospitalizations and deaths soar

While a green light for a Covid-19 vaccine will offer hope, leading experts have warned the worst days of the pandemic are still ahead for the US. More case surges are likely to take shape as a result of Thanksgiving travels, and future holiday gatherings could drive numbers even higher, they say.

Cases, hospitalizations and deaths already are soaring:

• The US has averaged 210,201 new Covid-19 cases daily over the past week -- the highest average ever recorded for the country, according to Johns Hopkins University data.

• The US on Friday set another record for the number of Covid-19 patients in hospitals on a given day -- 108,044, according to the COVID Tracking Project.

• Newly released data from the Department of Health and Human Services shows that more than 85% of hospitals nationwide had more patients with Covid-19 last week than they did a month ago.

• The county's average number of deaths reported daily across a week was 2,259 Thursday, just below a pandemic peak reported a day before.

• This week also saw the most coronavirus deaths reported by the US in one day -- 3,124, on Wednesday.

"We are in the time frame now that probably for the next 60 to 90 days, we're going to have more deaths per day than we had in 9/11," CDC director Dr. Robert Redfield said. "This is going to be a real unfortunate loss of life, as all that we've had so far, and the reality is the vaccine approval this week is not going to really impact."

A CNN analysis of newly released data from the US Department of Health and Human Services showed that at least 200 hospitals across the US were at full capacity last week. And more than 90% of ICU beds were occupied in a third of all hospitals.

A timeline for the future

The US has been supporting the development of six other coronavirus vaccines besides the one from Pfizer and BioNtech.

One of them, from Moderna, may be in line for an emergency use authorization later this month. The FDA advisory panel is set meet next week to consider whether to recommend this.

Another, from GlaxoSmithKline and Sanofi Pasteur, will be delayed until at least late 2021 after interim results showed "insufficient immune response" in the elderly, the companies said Friday.

Azar told ABC on Friday that the GSK/Sanofi delay won't affect the United States' expectation about how many Americans will be vaccinated by early 2021.

"We're looking at 20 million Americans being vaccinated just in the next coming weeks (and) up to 50 million total by the end of January," he told ABC. "We believe we could have 100 million actual vaccinations in arm by the end of February."

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

At Chicago's Rush University Medical Center, 10 vaccination stations have already been set up in a hallway, with temporary partitions. Hospital staff would get their Covid-19 vaccines there when doses arrive.

"I just feel like it's a beginning of the end of this crazy pandemic, and it's ... nice to see it, frankly," an RUMC respiratory therapist, Brady Scott, told CNN Friday. "It feels like a moment (where) we're going to turn the curve and we're going to get back to normal."

It's likely the US won't see any meaningful, widespread impacts from vaccinations until well into 2021. But just how quickly the country can recover depends on how quickly Americans get vaccinated -- and how many people are willing to get the vaccine.

"If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly. Into the summer, and certainly into the fall," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN Thursday.

"My hope and my projection is that if we get people vaccinated en masse so that we get that large percentage of the population, as we get into the fall, we can get real comfort about people being in schools, safe in school -- be that K-12, or college," he added.

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Indiana Coronavirus Cases

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