uk-approved-a-vaccine-before-the-us-here’s-why.

UK approved a vaccine before the US. Here’s why.

Science
2 hr 18 min ago

The UK approved a Covid-19 vaccine before the US. Here’s why.

From CNN’s Zamira Rahim

The UK became the first Western country to authorize a Covid-19 vaccine yesterday, marking a pivotal moment in the global fight against coronavirus.

The Pfizer/BioNTech vaccine has been granted emergency authorization by British regulators, and the first doses are expected to be rolled out from early next week.

The UK leapfrogged both the European Union and the United States with this announcement.

The vaccine was granted emergency authorization in the UK by its independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), which has played a crucial part in the process.

The MHRA began a rolling review of Pfizer and BioNTech data from October, with each “package” of data reviewed as soon as it became available. This allowed regulators to examine the data in detail before a final authorization application was submitted.

According to the MHRA, a rolling review “can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible.”

This approach helped accelerate the authorization process, and a formal review of all the necessary information began in the UK on Nov. 23, leading to Wednesday’s announcement.

“I think the advantage is that the MHRA has been undertaking a rolling review, which means that as Pfizer accumulated data on how they manufactured the vaccine … MHRA could keep pace with that,” David Salisbury, associate fellow in Chatham House’s Global Health Programme, told CNN. “That has allowed the MHRA to be nimble and keep pace.”

1 hr 4 min ago

Here’s how CVS is preparing to distribute and store the coronavirus vaccine

From CNN’s Adrienne Vogt

A CVS Pharmacy sign is photographed on March 16 in Wantagh, New York. Bruce Bennett/Getty Images

CVS Chief Medical Officer Dr. Troy Brennan explained how the rollout of the coronavirus vaccine will actually work once one is approved.

Brennan told CNN’s Kate Bolduan that CVS is prepared to first administer vaccines to nursing facilities.

“Our plan is to be ready to go as early as December 15, waiting for the state approvals,” he said. 

On Tuesday, vaccine advisers to the US Centers for Disease Control and Prevention voted to recommend that both health care workers and residents of long-term care facilities be first in line for any Covid-19 vaccine.

Brennan said vaccinations on a state-by-state basis will be “challenging,” because each state’s plan is expected to be different.  

“Some states will say just vaccinate the people in the skilled nursing facility. Some states will want us to vaccinate not only the people in the skilled nursing facilities, but the health care workers in those facilities. … We’re working directly with the states now to understand sort of what the parameters are,” he said. 

Brennan also discussed the transportation and storage of the Pfizer vaccine. He said CVS will be using Pfizer’s special containers, utilizing dry ice to maintain the vaccine at very cold temperatures.

“We’re pretty comfortable that we’re going to be able to store [the vaccine] for up to 20 days…simply by reloading these special containers with dry ice. So it sounds very difficult, but it turns out, from a logistic point of view, to be really quite trackable,” Brennan said. 

He said once the vaccine is available to a wider population, people will need to make an appointment to receive it at stores. CVS will make phone calls and send texts to remind people about their second doses. 

“We will keep after you to make sure you come back for that second vaccination,” he said. 

Remember: The FDA’s Vaccines and Related Biological Products Advisory Committee, a panel of independent experts, will meet on Dec. 10 to review Pfizer’s coronavirus vaccine candidate and make a recommendation about whether to authorize the vaccine.

A similar FDA committee meeting for Moderna’s vaccine candidate is set for Dec. 17. FDA officials say their decisions on the vaccines could come days to weeks after the meetings — it depends on what questions come up.

See the interview on CNN:

2 hr 41 min ago

NYC mayor: “It’s quite clear the second wave is upon us”

From CNN’s Sheena Jones

NYC Media

The percentage of people that tested positive for Covid-19 citywide is 3.9%, New York City Mayor Bill de Blasio said, and the seven-day rolling average, which the mayor said has really increased, stands at 5.19%.

“It’s quite clear the second wave is upon us,” de Blasio said.

At least 174 people have been admitted into the hospital for suspected cases of Covid-19 in which the mayor referred to this number as a “serious increase” and the confirmed positivity rate is 49.07%, the mayor said.

The threshold for hospitalizations is 200, which would trigger more restrictions, according to de Blasio.

The mayor added the city isn’t seeing the stress that they saw on their hospitals in the spring, but the city is continuing to remain vigilant.

On a seven-day average, at least 1,962 new cases of Covid-19 have been reported, that number is above the 550 threshold, according to de Blasio.

The indicators show that “everyone needs to take maximum precautions now,” the mayor said.

Note: These numbers were released by the city’s health agency, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and our Covid tracker.

2 hr 53 min ago

McConnell says compromise on stimulus “within reach,” but two sides still far apart

From CNN’s Lauren Fox, Manu Raju, Ted Barrett and Daniella Diaz

Senate Majority Leader Mitch McConnell walks to the Senate Floor at the U.S. Capitol in Washington, D.C. on Thursday, December 3. Stefani Reynolds/Bloomberg/Getty Images

Senate Majority Leader Mitch McConnell said on the Senate floor this morning “compromise is within reach” on stimulus talks.

“This has always been about policy differences,” McConnell said..

“Compromise is within reach. We know where we agree. We can do this. Let me say it again, we can do this. And we need to do this. So let’s be about actually making a law,” he said

Where things stand: There are three separate attempts happening right now on Covid relief and all of them — at least at this point — are a long shot.

McConnell released his own new economic relief proposal Tuesday, a bill he has been working on closely with the White House, House Republican Leader Kevin McCarthy and Mnuchin. The bill includes many of the same provisions from the earlier, targeted $500 billion proposal that failed along party lines. It’s not expected to win support of Democrats now.

3 hr 44 min ago

US is “tracking just as badly” as 1918 flu pandemic, Dr. Sanjay Gupta says

From CNN’s Adrienne Vogt

Dr. Sanjay Gupta, CNN chief medical correspondent, on December 3. CNN

The United States health care system is quickly heading toward a “breaking point” as the country reported its highest one-day death toll since the coronavirus pandemic began, CNN chief medical correspondent Sanjay Gupta said.

Gupta said he fears hospitals and health workers will be overwhelmed and Americans will not be able to get the level of care they are used to. 

Gupta also said that the US is “tracking just as badly” as it was during the 1918 influenza pandemic.

“We’re three times the population that we were back then. But we also have better hospitalizations, ICUs, therapeutics, an ambulance system. And despite that, just if you look at the numbers, we are tracking just as badly as back then,” Gupta said. “Which speaks to the fact that no matter how good we get scientifically, in terms of these therapeutics and all of the wonderful things that medicine can do, despite all that, human behavior is still sabotaging us.”

Gupta said that there were more alternatives as Covid-19 emerged in the spring, when patients were mainly concentrated in the Northeast — such as sending patients elsewhere or bringing in health care workers from less-affected areas.

“If the entire country is on fire, what is the escape hatch? It’s becoming increasingly hard to find one,” Gupta said. 

An ensemble forecast released Thursday by the US Centers for Disease Control and Prevention now projects there will be 303,000 to 329,000 coronavirus deaths in the US by December 26.

“I don’t know where this peaks at this point. I mean, this is starting to defy the models — even the aggressive ones — in terms of how bad things could get,” he said. 

He said “circuit breaker” lockdowns in hotspots would help ease the spread of the virus. 

Watch:

3 hr 19 min ago

House Democratic leaders say lawmakers won’t leave until they pass a Covid-19 stimulus deal 

From CNN’s Manu Raju

House Majority Leader Steny Hoyer, left, and House Majority Whip Jim Clyburn. Al Drago/Bloomberg/Getty Images

On a caucus call this morning, two top Democratic leaders — House Majority Leader Steny Hoyer and House Majority Whip Jim Clyburn — tell their members the US House of Representatives won’t adjourn for the year until a Covid-19 relief bill is passed, a source on the call tells CNN. 

House Speaker Nancy Pelosi didn’t give much of a readout on the state of talks, this source said. 

Remember: There are three separate attempts happening right now on Covid relief and all of them — at least at this point — are a long shot.

  • The bipartisan framework: These talks between Republican Sens. Lisa Murkowski, Susan Collins, Bill Cassidy and Mitt Romney alongside Democratic Sens. Joe Manchin, Mark Warner and Jeanne Shaheen and Angus King, an independent who caucuses with the Democrats, have been going on for weeks and were born out of a frustration that nothing was getting done. Eventually, a group of House members from the Problem Solver’s Caucus got engaged making the effort bicameral. But, the $908 billion framework released Tuesday is just a starting point.
  • McConnell’s plan: Senate majority Leader Mitch McConnell released his own new economic relief proposal Tuesday, a bill he has been working on closely with the White House, House Republican Leader Kevin McCarthy and Mnuchin. The bill includes many of the same provisions from the earlier, targeted $500 billion proposal that failed along party lines. It’s not expected to win support of Democrats now.
  • The Democratic leadership offer to McConnell: While substantive discussions between Speaker of the House Nancy Pelosi, Senate Democratic Leader Chuck Schumer, McConnell and McCarthy haven’t occurred still, Democrats did quietly send an offer to Republican leaders Monday evening. The proposal was a non-starter in part because it didn’t include the language on liability protections, a red line for McConnell. The existence of the offer became public after McConnell alluded to it during his news conference.
3 hr 56 min ago

Delta will contact trace international travelers coming into the US

From CNN’s Pete Muntean

A Delta Air Lines plane lands at John F. Kennedy International Airport in Queens, New York, on October 19. Nik Oiko/SOPA Images/LightRocket/Getty Images

Delta Air Lines said it will begin asking international travelers coming into the United States for coronavirus contact tracing information.

In a new memo released Thursday, Delta Air Lines CEO Ed Bastian said passengers can voluntarily submit their name, address, email and two phone numbers to “provide essential tracing information directly to the Centers for Disease Control, if needed.” 

No major coronavirus outbreaks have been traced to a commercial airline flight in the United States — but there have not been any widespread tracing efforts.

Delta’s move is a first by a US carrier after the White House coronavirus task force asked airlines to administer contact tracing programs themselves rather than having the government handle.

In June, Vice President Mike Pence told major airlines to move forward with an industry-led solution for contact tracing of passengers.

3 hr 19 min ago

More Americans died yesterday from coronavirus than ever before. Here’s a look at the latest figures. 

From CNN’s Amanda Watts, Steve Almasy, Jason Hanna and Madeline Holcombe

The total number of coronavirus deaths reported in a day set a new record yesterday and hospitalizations also reached an all-time high. Doctors and nurses across the US are trying to find creative ways to handle the surging number of patients.

The numbers are grim and those totals have never been higher.

Here’s a look at the latest figures:

Deaths:

  • There were more than 2,800 deaths reported Wednesday, according to Johns Hopkins University. The highest single day total since the pandemic began.
  • The nation is seeing an average of 1,603 reported deaths per day, according to JHU.
  • The nation has averaged over 1,000 reported deaths for 22 straight days.   

Hospitalizations:

  • More than 100,200 patients were in US hospitals Wednesday, according to the COVID Tracking Project.
  • This is the first time the nation has recorded over 100,000 current hospitalizations and the highest this metric has ever been.
  • The US is now averaging 94,311 hospitalizations over the last seven days.
  • 16 states and one territory reported record high hospitalizations on Wednesday. 

Here’s a look at how new daily Covid-19 deaths have progressed over time:

Here’s a look at how Covid-19 hospitalizations have progressed over time:

3 hr 46 min ago

Here’s where things stand in the vaccine approval and distribution process

A health worker is pictured in a lab during clinical trials for a Pfizer coronavirus vaccine in Hollywood, Florida, on September 9. Eva Marie Uzcategui/Bloomberg/Getty Images

The UK became the first Western country to authorize a Covid-19 vaccine yesterday, marking a pivotal moment in the global fight against coronavirus.

As coronavirus cases rise across the US and the world, here’s a look at the latest on the race to approve and distribute a vaccine

  • Vaccines are on their way to the UK: The UK is set to receive its first batch of the Pfizer-BioNTech Covid-19 vaccine today, just one day after the vaccine was approved, England’s deputy chief medical officer said. Yesterday, On Wednesday, the UK Department of Health said up to 800,000 doses of the vaccine — enough to inoculate 400,000 people — would be made available next week. 
  • European health experts are reviewing possible vaccines: The European Medicines Agency (EMA) began its review process of the Pfizer data in October and BioNTech and Pfizer submitted an application to complete the review process on Tuesday. The EMA has said it will conclude its review by Dec. 29 at the latest. EU member states cannot distribute a Covid-19 vaccine until it has been authorized by the EMA and signed off by the European Commission, according to EMA rules.
  • US health advisers meet next week to discuss candidates: The FDA’s Vaccines and Related Biological Products Advisory Committee, a panel of independent experts, will meet on Dec. 10 to review Pfizer’s coronavirus vaccine candidate and make a recommendation about whether to authorize the vaccine. A similar FDA committee meeting for Moderna’s vaccine candidate is set for Dec. 17. FDA officials say their decisions on the vaccines could come days to weeks after the meetings — it depends on what questions come up.
  • Russia is starting large-scale vaccination efforts: Russian President Vladimir Putin on Wednesday ordered his government to start large-scale vaccinations against Covid-19 from next week. Russia became the first country in the world to approve its coronavirus vaccine, Sputnik V, in August, authorizing the treatment for public use even before crucial Phase 3 trials were conducted. The move drew criticism from scientific circles.

Dr. Sanjay Gupta talks with Moderna Covid-19 vaccine trial participant: