December 9 coronavirus news

By Ben Westcott, Adam Renton, Eoin McSweeney, Nada Bashir, Mike Hayes, Meg Wagner and Melissa Macaya, CNN

Updated 12:00 a.m. ET, December 10, 2020
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9:48 a.m. ET, December 9, 2020

Vaccines will begin moving within 24 hours of authorization, distribution official says

From CNN's Naomi Thomas

Paul Ostrowski — who serves as the deputy chief of supply, production and distribution for Operation Warp Speed — said on Wednesday that within 24 hours of emergency use authorization, “we will begin moving the vaccines.”

“So, for Pfizer at Kalamazoo, the trucks will roll right out of there to the nearest airports, and we’ll begin distributing the vaccines across the entire country to locations that the jurisdictions have requested,” Ostrowski told ABC’s George Stephanopoulos on “Good Morning America.”

As for how quickly they will get to the jurisdictions and people will begin getting vaccinated, Ostrowski said that the intent is to get the trucks moving within 24 hours and “then overnight, basically overnight, within 48 hours the vaccines have arrived at the locations that they’ve been designated by the jurisdictions, and the administration of the vaccine can occur immediately afterward.”

Remember: There has not been a vaccine approved in the US yet, but the FDA's Vaccines and Related Biological Products Advisory Committee is set to meet tomorrow to discuss Pfizer’s application for an emergency use authorization for its coronavirus vaccine.

9:48 a.m. ET, December 9, 2020

What to watch today in stimulus negotiations as lawmakers scramble to get another Covid-19 relief package

From CNN's Lauren Fox

The United States Capitol is pictured in Washington, DC, on December 7.
The United States Capitol is pictured in Washington, DC, on December 7. Mandel Ngan/AFP/Getty Images

We've entered the part of the negotiations over stimulus relief to the Covid-19 pandemic and its economic fallout where everyone is putting their ideas on the table. That's productive, but with just nine days to go until the next spending deadline, there's not much time left for it.

There are a lot of proposals and none of them are ready to be voted on: The White House is officially back in the game on stimulus talks for the first time since the election. Senate Majority Leader Mitch McConnell is suggesting his own path forward, and the bipartisan group is still trying to solve for the problem of liability insurance that has confounded negotiators for months.

The bottom line: The White House offer is dead on arrival by Democrats. All eyes on the bipartisan group and whether they can close their deal. The sticking point? Money for state and local governments and liability protections.

Key things to watch today: We are waiting on the bipartisan group to release a series of summaries on their proposal. Why? Because putting it down on paper means the negotiations are serious.

The summaries are not expected to include liability and state and local aide, but will be a snapshot of how they plan to structure other programs including the small business loan Paycheck Protection Program, education funding, transportation funding, opioid funding, unemployment extenders and the student loan payment freeze.

A word of warning that the group involves a lot of players. Therefore any announcements on when these will be rolled out should be taken with caution as there are just a lot of members who have to agree before anything is seen publicly.

More on the bipartisan group: While the group does include Republicans and Democrats and it's grown to include members like Sen. Lindsey Graham, a South Carolina Republican who has been helping on the liability piece, the Republicans in the bipartisan group don't represent the views of the GOP conference at large on some of these issues. What might work for Sen. Mitt Romney, a Republican from Utah, or Maine Republican Sen. Susan Collins may not work for Wyoming GOP Sen. John Barrasso.

Even if the group irons out a final proposal and has bill text, it's not the end of the agreement. There was some pushback in GOP lunch Tuesday over the path the bipartisan group is taking, according to aides. And, there is a recognition that leadership will eventually have to get involved in it. McConnell isn't one to bring bills to the floor that only have a handful of Republican votes. He's going to have to get broader buy-in from the conference.

Here's more about where stimulus negotiations stand here.

9:34 a.m. ET, December 9, 2020

Pfizer's Covid-19 vaccine study excluded people with a history of severe allergic reactions, data shows

From CNN's Health’s Keri Enriquez

A needle is filled from a vial of the Pfizer-BioNTech Covid-19 vaccine in Newcastle, England, on December 8.
A needle is filled from a vial of the Pfizer-BioNTech Covid-19 vaccine in Newcastle, England, on December 8. Owen Humphreys/Pool/AFP/Getty Images

The company excluded people with a history of severe allergic reactions to vaccines from their SARS-COV-2 RNA vaccine trial, according to Pfizer data released by the US Food and Drug Administration on Tuesday.

Participants with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)” were not included in the pool of 44,000 trial volunteers.

According to the US Food and Drug Administration's evaluation of the Pfizer data, there was a slight increase in events that may be considered allergic reactions in the vaccine group. The FDA’s independent analysis said “A slight numerical imbalance of adverse events potentially representing allergic reactions, with more participants reporting hypersensitivity-related adverse events in the vaccine group (137 [0.63%]) compared with the placebo group (111 [0.51%])”

Some background: The UK issued new guidance on Wednesday, now advising that people with a “significant history of allergic reactions” not receive the Pfizer/BioNTech coronavirus vaccine after two health workers who received the vaccine suffered allergic reactions.  

British health authorities are conducting an investigation into the two incidents. In a statement, Pfizer said “As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.” 

Both staff members reportedly had a significant history of allergic reactions and carried adrenaline autoinjectors, according to PA Media. Thousands overall are believed to have been vaccinated in the UK on Tuesday.

The FDA's vaccine advisory group is meeting on Thursday to discuss a possible emergency use authorization of the Pfizer-BioNTech Covid-19 vaccine in the US.

10:12 a.m. ET, December 9, 2020

US Covid-19 cases and deaths continue to rise ahead of key FDA vaccine meeting. Here's where things stand.

From CNN's Amanda Watts and Elise Hammond

The FDA's Vaccines and Related Biological Products Advisory Committee will meet in less than 24 hours to discuss Pfizer and BioNTech's application for emergency use authorization for a coronavirus vaccine in the US.

Pfizer says its vaccine is 95% effective and doses are already being rolled out in the UK.

But, in the meantime, the US continues to report a record number of hospitalizations as Covid-19 cases and deaths rise across the country.

Here's a look at where things stand:

New cases

  • A total of 33 states are showing upward trends in new cases in the past week compared to the previous week. Eight of those are increasing by 50% or more – including California, Georgia and Pennsylvania. Only 3 states are showing downward trends in new cases.
  • There were at least 215,860 Covid-19 cases reported in the US on Tuesday, according to Johns Hopkins University. It was the third highest single day of new cases since the pandemic began.
  • The US currently averages about 206,191 new cases per day, per JHU data. This is up 28% from the previous week.  

Deaths

  • There were at least 2,546 reported deaths in the US on Tuesday, according to Johns Hopkins.
  • There have been a total of at least 286,338 deaths in the US related to the virus since the beginning of the pandemic, JHU data says. The nation currently averages about 2,230 reported deaths per day.
  • Average reported deaths have increased 123.4% over the last four weeks.   

Hospitalizations

  • A record-breaking 104,600 hospitalizations were reported on Tuesday, according to data from the Covid Tracking Project.
  • The US is now averaging at least 101,685 hospitalizations over the last 7 days – this is up 7.70% since last week.  That's is the highest this metric has ever been.
  • So far in December, 28 states have reported at least one record high day of Covid-19 hospitalizations this month, according to CTP data. 

Here's a look at where cases are rising across the country:

9:57 a.m. ET, December 9, 2020

How Walgreens is preparing to administer a coronavirus vaccine in nursing homes

From CNN's Adrienne Vogt

Rick Gates, senior vice president of pharmacy and healthcare at Walgreens, on December 9.
Rick Gates, senior vice president of pharmacy and healthcare at Walgreens, on December 9. CNN

Rick Gates, Walgreens’ senior vice president of pharmacy and healthcare, said that the company has been working closely with states as nursing homes and long-term care facilities prepare for coronavirus vaccinations. 

The federal government made a deal with Walgreens and CVS to distribute vaccines to nursing homes once they are approved by the US Food and Drug Administration.

More than 30,000 long-term care facilities have signed up with Walgreens to administer vaccines, Gates said. Once the FDA approves a vaccine, “we’ll be in long-term care facilities within one to two days, tops, to start vaccinating,” he said.

Gates said that Walgreens is planning to increase staffing in certain areas for the care facilities. 

Gates also said Walgreens is in the process of creating apps and ways to sign up online so people can schedule vaccinations once it becomes more widely available. 

9:38 a.m. ET, December 9, 2020

Pfizer say it's supporting investigation into allergic reactions to Covid-19 vaccine in UK

From CNN's Emma Reynolds

A vial containing the Pfizer-BioNTech Covid-19 vaccine is seen on December 8 in Glasgow, Scotland.
A vial containing the Pfizer-BioNTech Covid-19 vaccine is seen on December 8 in Glasgow, Scotland. Jeff J. Mitchell/Pool/Getty Images

Pfizer said it was supporting British health authorities in their investigation of two reported cases of allergic reaction to the Pfizer/BioNTech coronavirus vaccine in the UK.

“We have been advised by MHRA [Medicines and Healthcare products Regulatory Agency] of two yellow card reports that may be associated with allergic reaction due to administration of the COVID-19 BNT162b2 vaccine,” Pfizer said in a statement Wednesday.

“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation,” it added. 

The statement concluded: “In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”

The two health workers – who both carried an adrenaline auto injector and had a history of allergic reactions – developed symptoms of anaphylactoid reaction after receiving the vaccine on Tuesday.

 

10:05 a.m. ET, December 9, 2020

FDA will look at data on allergic reactions to Covid-19 vaccine, US health secretary says

From CNN's Naomi Thomas

Alex Azar, US Health and Human Services secretary, on December 9.
Alex Azar, US Health and Human Services secretary, on December 9. CNN

US Health and Human Services Secretary Alex Azar on Wednesday told CNN’s Alisyn Camerota that he was learning of the allergic reactions experienced by two people in the UK to the Covid-19 vaccine “just with you, right now.”

Camerota asked Azar if he thought it would change anything in the United States, such as a pending emergency use authorization for Pfizer/BioNTech’s vaccine candidate by the US Food and Drug Administration.

Azar said he wanted to make sure the FDA had an opportunity to look at that data, adding he is certain they’ll be speaking with UK regulators, like always.

“FDA is going to not cut any corners,” Azar said. “They’re looking at the data. They’re looking under the hood at everything. So I’m sure that’ll be something the FDA looks at here, because we want to make sure that any vaccine that comes out in America has the full gold-standard stamp of approval of the FDA career people.”

Yesterday: The United Kingdom became the world's first nation to begin vaccinating its citizens with a fully vetted and authorized Covid-19 shot, a landmark moment in the coronavirus pandemic.

The first Briton to get the Pfizer/BioNTech vaccine received the first of two doses Tuesday, less than a week after the UK became the first country to approve it.

8:37 a.m. ET, December 9, 2020

Men face "almost three times the odds" of ICU admission for Covid-19, new study finds

From CNN's Jacqueline Howard

Men with Covid-19 appear to face higher odds of needing intensive care and dying compared with women who have the disease, according to a new study.

The study, published in the journal Nature Communications on Wednesday, suggests that even though there is no significant difference in the proportion of men versus women testing positive for Covid-19, men have "almost three times the odds" of requiring intensive treatment, and higher odds of death. 

The study included data on more than 3 million Covid-19 cases reported from around the world between January and June. The researchers – from the University College London and the University of Cape Town – took a close look at the data by sex and severity of disease.

More on the study: The data showed that among the cases in the study, about 1.57 million were women and about 1.53 million were men. Yet when it came to data on more than 12,000 intensive care unit admissions, about 8,000 of those were men and 4,000 were women, the researchers found. Among more than 200,000 Covid-19 deaths in the study, about 120,000 were men and 91,000 were women.

The researchers determined that while both sexes have an equivalent risk of infection, the male sex was associated with a higher risk of severe disease and death.

The study comes with some limitations, including that more research is needed to determine which specific biological factors may be driving these differences.

 

8:26 a.m. ET, December 9, 2020

Pfizer Covid-19 vaccine could be authorized within days, US Health secretary says

From CNN's Adrienne Vogt

Health and Human Services Secretary Alex Azar said the US Food and Drug Administration could approve the Pfizer coronavirus vaccine in a “matter of days.” 

Azar said the vaccine would then be shipped to “wherever the governors have told us they want it to go.”

The initial focus is health care workers and nursing home residents.

“20 million people should get vaccinated in just the next several weeks and then we’ll just keep rolling out vaccines through January, February, March as they come off the production lines,” Azar said. 

Azar said the general population should start seeing vaccines available to around February and March. 

“The governors will decide how to prioritize and get that out there,” he said. 

Remember: The US FDA has not yet approved a coronavirus vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee is set to meet tomorrow to discuss Pfizer’s application for an emergency use authorization for its coronavirus vaccine.

Watch: