While the vote is an important step in the vaccine authorization and distribution process, the FDA still needs to issue an emergency use authorization, which will allow shipments to begin.
Shots still can’t be administered until the US Centers for Disease Control and Prevention advisory committee recommends the vaccine. The final step in the process is for CDC Director Dr. Robert Redfield to sign off on the committee recommendation.
10:50 a.m. ET, December 11, 2020
Miami will begin enforcing a curfew this weekend as coronavirus cases surge
From CNN's Tina Burnside
Starting this weekend, the city of Miami will begin enforcing a citywide curfew in response to the surge in coronavirus cases, the city announced in a press release.
The nightly curfew will run from midnight to 6 a.m. ET until further notice, the release stated.
The curfew is in line with Miami-Dade County's existing nightly curfew order and was voted and approved by the Miami City Commission on Thursday.
The city of Miami stopped enforcing the curfew back in October. However, under the new order, the Miami Police Department will be enforcing the curfew and violators — whether individuals or business establishments — are subject to fines and other enforcement actions.
10:27 a.m. ET, December 11, 2020
Here's where things stand on US stimulus talks
From CNN's Manu Raju and Lauren Fox
The 116th Congress is entering a make-or-break moment: It can either collapse in a colossal failure or it can all come together quickly to give struggling Americans some desperately needed relief.
While there are some signs of progress on state and local aid in bipartisan relief talks, prospects are still grim for Congress to get a deal both sides can live with, get drafted quickly and jammed through Congress — and then onto the desk of a mercurial President who has had no role in the negotiations but can upend them at any given moment.
Here's what we're watching today:
Leaders need to start talking: To get a deal done by next week, House Speaker Nancy Pelosi and Senate Majority Leader Mitch McConnell need to come to terms quickly. But they aren't even talking with each other and instead are bitterly trading blame as the leadership remains at sharp odds about what can even pass, meaning there's no guarantee any deal reached by a bipartisan group of lawmakers will even get through Congress.
Why today is crucial: Friday is turning out to be a critical day on two fronts: Both on the Covid relief talks and to keep the government from shutting down for the fourth time in President Trump's time in office.
Sticking points on stimulus: The snafu over the stopgap portends the challenges ahead for much thornier issues — namely on a Covid relief package that has dogged Congress for several months in addition to the $1.4 trillion omnibus spending bill to fund the federal government through September 2021, a massive proposal that the two sides have struggled to finalize, prompting leaders to try to pass the week-long continuing resolution. The bipartisan group of senators and House members that have tried to finalize a deal are expected to release legislative language today on their $160 billion deal to aid states and cities hit hard by the pandemic, resolving a key sticking point, aides said. But there's one big problem: Most GOP senators detest that aid — and McConnell has warned that most Republicans won't support it, meaning it's unlikely to pass the Senate.
9:52 a.m. ET, December 11, 2020
Don't gather with people from outside your home for Christmas, professor says
From CNN's Adrienne Vogt
Erin Bromage, a biology professor at UMass Dartmouth, advised Americans to not have any large gatherings on Christmas, even if they gathered for Thanksgiving and had no resulting positive Covid-19 cases.
You should stay close to only the family members or group that you’ve been in contact with for the past 10 days, he said in an interview on CNN.
“We are looking much worse than what we were at Thanksgiving, much worse. And so now the risk is much higher,” Bromage said. “And you got away with it at Thanksgiving because you were lucky it didn't come into your home. If you do this again…you're chancing too much fate at this stage bringing it into your house.”
Bromage also explained the “Swiss cheese model” of protection from the coronavirus.
“No one protective layer is 100% effective,” he said. “Masks plus distance is additive in regards to its safety. If we're in well-ventilated spaces, that adds another layer of safety. … We make sure that we put as many layers as possible between each person in order to stop the spread of infection.”
9:45 a.m. ET, December 11, 2020
As the US vaccine process continues, Fauci reminds Americans "normality" won't come until at least summer 2021
But even as the vaccine process progresses, it's likely the US won't see any meaningful, widespread impacts from vaccinations until well into 2021.
Just how quickly the country will be able to 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 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.
9:16 a.m. ET, December 11, 2020
FDA could issue emergency use authorization for Pfizer vaccine tomorrow
From CNN's Elizabeth Cohen
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 Saturday, according to a federal government source close to the situation.
The source cautioned that anything is possible, and the FDA decision could still come today.
The Saturday timing is in line with a meeting set for Sunday by the Advisory Committee on Immunization Practices, whose vote will inform a final decision by the US Centers for Disease Control and Prevention.
The FDA EUA allows shipping to begin, but shots still can’t be administered until the US CDC advisory committee recommends the vaccine.
The final step in the process is for CDC Director Dr. Robert Redfield to sign off on the committee recommendation. The source expects that to happen within hours of the Sunday meeting.
8:52 a.m. ET, December 11, 2020
A US FDA panel recommended Covid-19 vaccine authorization. Here's what that means — and what happens next.
While the vote is an important step in the vaccine authorization and distribution process, it doesn't mean the vaccine will be authorized immediately.
Here's what happens next:
The FDA EUA: The FDA will now decide on whether or not to issue an emergency use authorization for the vaccine. The FDA EUA allows shipping to begin, but shots still can’t be administered until the CDC advisory committee recommends the vaccine. Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.
The CDC committee meeting: In anticipation of an EUA, the CDC's Advisory Committee on Immunization Practices has scheduled emergency meetings for Friday and Sunday. This committee — which is separate from FDA's advisory committee — will recommend whether the CDC should offer the vaccine to the American public. The committee is expected to vote on Sunday.
Administering vaccines: After the CDC accepts that recommendation, Pfizer shots may start to be administered.
An important note: An EUA is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine.
8:30 a.m. ET, December 11, 2020
US Health secretary says FDA intends to proceed toward authorization of Pfizer’s Covid-19 vaccine
From CNN Health’s Naomi Thomas
“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” US Health and Human Services secretary Alex Azar told ABC’s George Stephanopoulos on Friday.
HHS confirmed to CNN that Azar was referencing a tweet posted on Friday morning, which links to a Friday US Food and Drug Administration news release from the FDA’s Dr. Stephen Hahn and Dr. Peter Marks.
Azar said that “in the next couple of days, probably,” as they work to negotiate with Pfizer and get information the doctors need to prescribe it appropriately, “we should be seeing the authorization of this first vaccine.”
Azar said that they will work with Pfizer to get it shipped out and “so we could be seeing people get vaccinated Monday, Tuesday of next week.”
“So, it’s very close. It’s really just the last dotting of I’s and crossing of T’s,” Azar added.