November 30 coronavirus news

By Helen Regan, Brett McKeehan, Emma Reynolds, Ed Upright, Jo Shelley, Melissa Macaya, Mike Hayes and Meg Wagner, CNN

Updated 12:04 AM ET, Tue December 1, 2020
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6:47 p.m. ET, November 30, 2020

Moderna confirms it filed for FDA emergency authorization for its coronavirus vaccine

From CNN’s Maggie Fox

Moderna headquarters in Cambridge, Massachusetts.
Moderna headquarters in Cambridge, Massachusetts. Matthew Healey/AFP/Getty Images

Vaccine maker Moderna says it has filed for emergency use authorization for its coronavirus vaccine.

“Moderna’s data for the Emergency Use Authorization request for mRNA-1273 has been submitted to the U.S. FDA,” the company said in a tweet from its official Twitter account.

Earlier, the US Food and Drug Administration said it had scheduled a meeting of its vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, for December 17 to consider Moderna’s EUA. But the FDA cannot confirm the submission. Only the company can do so – and now it has.

6:58 p.m. ET, November 30, 2020

New York governor worried about "overwhelming the hospital system"

From CNN's Sarah Jorgensen

New York Gov. Andrew Cuomo delivers a Covid-19 update in Rochester, New York, on November 25.
New York Gov. Andrew Cuomo delivers a Covid-19 update in Rochester, New York, on November 25. Mike Groll/Office of Governor Andrew M. Cuomo/AP

New York Gov. Andrew Cuomo announced today that state will begin using hospitalizations as a main metric to determine cluster zones and closures across the state

Hospitalization rates are increasing across the state, Cuomo said, adding that "every region is dealing with a hospital issue now," and that capacity is the top concern.

“We are now worried about overwhelming the hospital system," Cuomo said.

The governor said he is talking to hospital administrators across the state.

"We want to know where they are today with their capacity, with their PPE, et cetera," Cuomo said. "We learned this lesson the hard way. We have about 54,000 hospital beds in this state, we were told we would need about 120,000. We lived this nightmare. We learned from this nightmare, and we're going to correct for the lessons we learned during this nightmare."

"We're not going to live through the nightmare of overwhelmed hospitals again," he later said.

New York state has a 4.5% positivity rate currently, Cuomo said.

In addition to using hospitalizations as a main metric to trigger zone designations and closures, Cuomo also outlined four additional strategies the state will employ to combat the spread of Covid-19: increasing testing across the state, working towards vaccine distributions, keeping schools open safely and keeping the 10 person limit on private gatherings that the governor announced earlier in the fall.

Cuomo said that the goal was to keep K-8 schools open wherever it was safe. The state will implement testing on a weekly basis for schools in orange and red zones.

He also emphasized the importance of having a balanced distribution of testing among various groups — health care workers, school workers and the general traveling population.

On the vaccine, he said that delivery could start in the next few weeks, and that he is working with fellow governors on distribution plans, but noting that widespread distribution will likely not occur until "late spring or early summer." He noted that the state will be doing outreach to Black and brown communities, as well as lower income communities.

6:42 p.m. ET, November 30, 2020

California governor says state's intensive care unit capacity could be overrun by Christmas Eve

From CNN's Holly Yan and Madeline Holcombe

Medical personnel treat a Covid-19 patient at Providence Holy Cross Medical Center in Los Angeles on November 19.
Medical personnel treat a Covid-19 patient at Providence Holy Cross Medical Center in Los Angeles on November 19. Jae C. Hong/AP

California Gov. Gavin Newsom said he is considering "drastic action," including reinstating a stay-at-home order, as projections show the surge of Covid-19 cases will cause the state's intensive care unit capacity to be overrun by Christmas Eve.

Hospitalizations could double or triple within the next month if there are no major changes, he said. They are expected to reach 78% of capacity statewide with even higher numbers in Southern California and other areas, Newsom said in a news conference.

"If these trends continue, California will need to take drastic action," Newsom said from home, where he is quarantined with his family.

Los Angeles County reported today a total of 400,919 confirmed cases of Covid-19 since the start of the pandemic, a grim new milestone as the virus continues to "run rampant through almost every part of the county,” the county's Health Director Barbara Ferrer said during a news conference.

Daily hospitalizations in Los Angeles also sharply increased 93% over the past week, according to latest county health data. There are currently 2,185 Covid-19 patients hospitalized in Los Angeles and it is very possible that the daily number of people hospitalized will soon be over 2,500, Ferrer said.

CNN's Alexandra Meeks contributed to this report.

6:14 p.m. ET, November 30, 2020

Pfizer almost finished enrolling volunteers in clinical trial of Covid-19 vaccine

From CNN's Samira Said

Pfizer is almost finished enrolling volunteers in its Phase 3 clinical trial of a Covid-19 vaccine.

The company has stated it plans to enroll approximately 44,000 participants. On Monday, it announced the addition of 270 more volunteers, bringing the current enrollment to 43,931 people.

More than 42,722 participants have received their second vaccination.

A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine showed it was 95% effective in preventing infections and caused no serious safety concerns, the company said previously.

  

5:58 p.m. ET, November 30, 2020

Pfizer sends empty vaccine transport boxes to states to help prepare for rollout

From CNN’s Elizabeth Cohen

Pfizer has sent states storage boxes for its Covid-19 vaccine so that health care workers can become accustomed to using them, according to a spokesperson for the US Centers for Disease Control and Prevention.

Unlike any other Covid-19 vaccine, Pfizer’s vaccine has to be kept at minus 103 degrees Fahrenheit. Doctors’ offices, pharmacies and state vaccination clinics don’t have freezers that go that low, so Pfizer invented special boxes they call “thermal shippers” that hold dry ice.

The boxes being sent to the states will be empty, with no dry ice and no vaccines.

“Pfizer is sending out the sample shippers so jurisdictions can feel better about what it is,” the spokesperson said.

Some states received the boxes Monday, and others will receive them in the next few days, according to the spokesperson.

State immunization clinics have been concerned about using the boxes because they must be regularly re-stocked with dry ice and can only be opened twice a day, each time for no more than a minute.

“Everybody’s worried about the timing and getting it right,” the CDC spokesperson said.

State immunization managers have for weeks expressed concern about administering Pfizer’s vaccine because of the temperature requirements.

"We all are going into this expecting that there are going to be major glitches," Dr. Kelly Moore told CNN earlier this month. Moore is associate director of the Immunization Action Coalition, which is supporting the frontline workers who will administer the coronavirus vaccine.

Pfizer’s vaccine will likely be the first to receive emergency use authorization from the US Food and Drug Administration.

Americans could start receiving Pfizer’s vaccine, as well as one made by Moderna, by Christmas, US Department of Health and Human Services Secretary Alex Azar said Monday.

  

5:55 p.m. ET, November 30, 2020

Large shipment sizes of Pfizer's vaccine present challenges for small and rural communities, experts say

From CNN's Lauren Mascarenhas

The large shipment sizes of Pfizer’s Covid-19 vaccine will complicate an already complex distribution process for small and rural communities, experts say.

Pfizer has planned for the ultra-cold storage requirements of its vaccine, with thermal shippers that can hold at least 975 and up to 5,000 doses.

“That’s not workable from a small town, rural perspective,” Alan Morgan, chief executive officer of the National Rural Health Association, told CNN Monday. “It just isn’t.”

Smaller communities will have to spread those doses among multiple providers, Claire Hannan, executive director of the Association of Immunization Managers, told CNN Monday.

“States that have smaller providers or rural communities, they’re looking for ways to break up those 975 doses, spread them across more providers, without endangering the cold chain,” she said. 

Hannan said immunization managers are looking into various solutions, like using a hub-and-spoke model, where the vaccine is stored in a central location for providers to pick up, or having doses sent to a warehouse site, where they will be repackaged before distribution.

Morgan said another option would be to find a way to ship the vaccines in much smaller containers with dry ice, “where you can, in effect, treat them like Omaha Steaks and get them out.”

If rural communities don’t come up with workable plans for distribution, the danger is that rural hubs will be sidelined, Morgan said.

“That type of approach just sets up these rural communities across the US for really unacceptable mortality rates and the potential for the collapse of the health care system,” he said.

Pfizer did not have an immediate response questions about the concerns over shipment sizes.

  

5:29 p.m. ET, November 30, 2020

FDA schedules advisory meeting to discuss Moderna's coronavirus vaccine application

From CNN’s Ben Tinker and Maggie Fox

The US Food and Drug Administration says it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Dec. 17 to discuss the request for emergency use authorization (EUA) for a Covid-19 vaccine from biotech company Moderna.

“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” FDA Commissioner Dr. Stephen Hahn said in a statement.

“The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential Covid-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”

Moderna said earlier Monday it would apply for an EUA from the FDA for its vaccine, which it says is more than 94% effective.

“The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer, industry, and sometimes a patient representative,” Hahn added.

VRBPAC meetings are livestreamed. The FDA has promised to consider the VRBPAC’s advice on coronavirus vaccines. The same panel is meeting Dec. 10 to discuss Pfizer’s application for an EUA for the vaccine it and BioNTech have developed.

5:26 p.m. ET, November 30, 2020

California expects to receive 327,000 doses of Pfizer's Covid-19 vaccine in next two weeks

From Cheri Mossburg

California Gov. Gavin Newsom speaks during a press conference on November 30.
California Gov. Gavin Newsom speaks during a press conference on November 30. Pool/KCRA

California expects to receive about 327,000 doses of Pfizer’s Covid-19 vaccine by mid-December, and a second dose within three weeks, according to Gov. Gavin Newsom, who declined to give an exact date the doses are expected.

“We sprint with light, very bright light at the end of the tunnel not a marathon but a sprint to the vaccine,” said Newsom.

Recommendations on how to distribute the first doses of the vaccine will be made this week, as guidelines on how exactly to prioritize distribution are still being drafted. The state’s task force is also working on the challenge of keeping the vaccines at ultra-low temperatures. Decision-makers are looking at the plan with a specific eye on equity.

Health care sectors and those working with vulnerable populations will be prioritized, but a more detailed breakdown of who gets the vaccine first will be outlined later this week, Newsom promised. He did not have an estimate on when the broader public could expect to be vaccinated.

“Some of our most vulnerable, our frontline workers, could be getting vaccinated in a matter of weeks,” said Mark Ghaly, the state's Health and Human Services secretary.

As many residents are expected to have questions about the safety of the vaccine, California has convened an 11-member Scientific Safety Committee than will review the same data the US Food and Drug Administration has, but from a California perspective. Newsom classified the group’s work as “basically a stamp of approval.”

5:19 p.m. ET, November 30, 2020

Georgia governor extends Covid-19 health emergency and restrictions

From CNN’s Jamiel Lynch

Georgia Gov. Brian Kemp holds a news conference on November 24 at the Georgia State Capitol in Atlanta. 
Georgia Gov. Brian Kemp holds a news conference on November 24 at the Georgia State Capitol in Atlanta.  Ben Gray /Atlanta Journal-Constitution/AP

Georgia Gov. Brian Kemp extended the state’s health emergency and Covid-19 restrictions for another 15 days, according to a release from his office.

The orders take effect Dec. 1.

Part of the executive orders signed today include changes that allow nurses and pharmacists to administer the pending Covid-19 vaccine, including in a drive-thru setting, and permits any nurse or pharmacist to observe patients for the requisite 15-minute window after receiving the vaccine.

The latest extension runs through Dec. 15, the release said.