US FDA panel recommends Covid-19 vaccine authorization

By Julia Hollingsworth, Adam Renton, Emma Reynolds, Nada Bashir, Melissa Macaya and Meg Wagner, CNN

Updated 7:50 a.m. ET, December 11, 2020
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11:23 a.m. ET, December 10, 2020

1 in 3 US hospitals nationwide topped 90% ICU capacity last week, newly released HHS data reveals

From CNN Health’s Deidre McPhillips

A CNN analysis of newly released data from the US Department of Health and Human Services shows that at least 200 hospitals across the country were at full capacity and more than 90% of intensive care unit beds were occupied in one-third of hospitals nationwide last week.

Patients confirmed to have Covid-19 occupied 28% of inpatient beds and 46% of staffed ICU beds, on average, up from 19% and 37% in the first week of November. 

HHS had previously reported Covid-19 hospitalization data at the state level, but this dataset – released Monday – is the first from the national government to report local, facility-level data.

The Covid Tracking Project also reports hospitalization data – including data from the HHS – but only at the state level.

Data will be reported weekly, with data aggregated each Friday through Thursday; the most recent seven-day collection period started on Nov. 27, and the time series goes back to August 1, 2020.

The dataset includes facilities that self-reported data, and this analysis excludes hospitals for which data was suppressed due to small counts. 

 

11:52 a.m. ET, December 10, 2020

The US is sharing Covid-19 vaccine information with UK and Canada, CDC official says

From CNN's Jacqueline Howard

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

Health officials in the United States have been working with collaborators in the United Kingdom and Canada to share Covid-19 vaccine information, said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the US Centers for Disease Control and Prevention.

"We are working directly with collaborators in the UK and Canada to make sure that we're sharing information as quickly as possible," Messonnier said during the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee meeting on Thursday. 

The committee is convening to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate.

The Pfizer vaccine already has been authorized in the United Kingdom and Canada.

11:20 a.m. ET, December 10, 2020

CDC official outlines how Covid-19 vaccines will be ordered and distributed once authorized 

From CNN’s Amanda Watts

Anita Patel on December 10.
Anita Patel on December 10. Food and Drug Administration

Anita Patel with the US Centers for Disease Control and Prevention Vaccine Task Force said “all vaccines will be ordered through CDC’s Covid vaccine ordering systems — for the Pfizer vaccine, we will be providing those vaccine orders directly to the manufacturer, for distribution to administration sites.” 

Speaking during the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Thursday, Patel outlined some of the “challenging requirements” of the vaccine.  

“The additional planning that is needed for distribution, storage, handling and use has been underway for the last few months, based on the information that we know for the Pfizer product,” Patel said.  

“There is a required, dedicated cold chain,” given the ultra-low temperature requirements of the vaccine, she said.  

“In addition, the timing of the vaccine ancillary supplies — which includes the diluent, as well as dry ice replenishment — has also been a challenge. We have built the distribution system in a way that all three of these elements will arrive within a 36-hour period of time,” she said. 

“So, once a vaccine is there, these additional pieces will also be delivered to the vaccination site," she added.

11:26 a.m. ET, December 10, 2020

This is Melinda Gates’ biggest concern about the Covid-19 pandemic right now

From CNN's Adrienne Vogt

Melinda Gates.
Melinda Gates. CNN

Melinda Gates, co-chair of the Bill and Melinda Gates Foundation, said she and her husband have been speaking with President-elect Joe Biden directly about the coronavirus pandemic. 

While Gates said she has deep concerns about the pandemic, she told CNN’s Poppy Harlow that she’s “much more optimistic about the President-elect and the Covid task force.”

“I think we're going to see a lot more sensible policy-making in the United States, but that starts … Jan. 20, and we have still some dark months to live ahead until then,” she said. 

The Gates’ foundation today pledged another $250 million in the fight against coronavirus 

She said her biggest concern right now is getting vaccines out to the “far corners of the globe.”

Gates' comments come as the US Food and Drug Administration's advisory committee is holding a key meeting to consider emergency use authorization for Pfizer/BioNTech’s Covid-19 vaccine. The Pfizer vaccine has already been authorized in the United Kingdom and Canada.

"Everybody needs this vaccine," Gates said. “If we only get it to the high-income countries, this disease is going to bounce around; we're going to see twice as many deaths.”

This influx of funding will go toward buying 200 million doses for low- and middle-income countries.

“The world needs to put up more money to make sure that low-income countries can get the vaccine,” she said. 

Gates said that she was “disappointed” when President Trump signed an executive order aimed at prioritizing the shipment of the coronavirus vaccine to Americans before other nations.

“That's exactly what we were worried about. Instead what should be done is the Defense Production Act … They should be scaling up lots and lots of manufacturing so that not just the U.S. gets vaccines, but everybody gets vaccines. So this reservation system is exactly the type of thing we were concerned about,” she said.

Watch:

11:05 a.m. ET, December 10, 2020

CDC official says “on day one” of vaccine program, systems will be in place to monitor safety

From CNN’s Amanda Watts

Dr. Nancy Messonnier on December 10.
Dr. Nancy Messonnier on December 10. Food and Drug Administration

“On day one of the Covid-19 vaccine programs, systems will be in place to monitor the safety of vaccine recipients,” Dr. Nancy Messonnier, director of the US Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases, said.

Messonnier added that there is “quite an extensive plan for safety monitoring.”

“The rapid implementation of safety monitoring under an EUA requires a whole of US government approach, with an initial focus on the early populations targeted for vaccination, voluntary active surveillance of adverse events, focused on healthcare worker vaccination, and rapid follow up of reported serious adverse events,” Messonnier said during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee.

“As the program continues, and more vaccine is given, active surveillance systems who provide increasingly useful information on safety in different populations. Close collaboration of safety experts across the US will facilitate data sharing and rapid recognition of responses to safety signals,” she added.

11:35 a.m. ET, December 10, 2020

US regulators are on the cusp of authorizing a Covid-19 vaccine. Here are key dates to watch.

From CNN's Jamie Gumbrecht

The United States is suffering a devastating rise in cases and deaths from the coronavirus and hopes for a return to a more familiar life are pinned on vaccines. US regulators are close to authorizing a Covid-19 vaccine — possibly as soon as this week.

A US Food and Drug Administration vaccine advisory committee is meeting right now to discuss emergency use authorization for the vaccine developed by Pfizer/BioNTech, and next week it meets to discuss the Moderna vaccine. Both vaccines are about 95% effective after two doses given a few weeks apart.

Once a vaccine is authorized by the FDA, Operation Warp Speed, the federal government's initiative to develop a vaccine, can start shipping and distributing the vaccine to states.

Vaccinations won't begin until after a US Centers for Disease Control and Prevention committee recommends the vaccine.

Here are key dates and events to watch for:

Today:

  • Who: FDA's Vaccines and Related Biological Products Advisory Committee, or VRBPAC — a committee of independent experts with no stake in any of the companies developing Covid-19 vaccines
  • What's expected: A vote on a recommendation to the FDA on EUA for Pfizer's Covid-19 vaccine
  • When: 9 a.m. ET start; key testimony at 1 p.m. and 2 p.m.; Discussion/vote session starts at 3:10 p.m.; 6 p.m. end
  • What you'll see: Public and livestreamed remote Zoom meeting -- expect audio, slideshows, possibly some video
  • Draft agenda for December 10 meeting here.

Today, tomorrow or later:

  • Who: FDA's emergency use authorization decision
  • What's expected: The FDA's EUA allows shipping to begin, but shots still can't be administered until the US Centers for Disease Control and Prevention advisory committee recommends vaccine
  • When: FDA will announce this at any time, likely without warning.

Tomorrow and Sunday, Dec. 13:

  • Who: CDC's Advisory Committee on Immunization Practices, or ACIP
  • What's expected: A vote that the CDC should offer the vaccine to the American public; for recommendation to be made official, it must be accepted by CDC and published in CDC's Morbidity and Mortality Weekly Report.
  • When: 12 p.m.- 5 p.m. ET Friday, December 11; 12 p.m.- 4 p.m. ET Sunday, December 13; vote is currently expected at 3:30 p.m. Sunday
  • What you'll see: Public and livestreamed remote Zoom meeting -- expect audio, slideshows, minimal video
  • Draft agenda for both meetings here.

Thursday, Dec. 17:

  • Who: FDA VRBPAC meeting
  • What's expected: A vote on a recommendation to the FDA on EUA for Moderna's Covid-19 vaccine
  • When: Details not posted, expect it to mirror 9 a.m.- 6 p.m. ET schedule of the Pfizer meeting
  • What you'll see: Public and livestreamed remote Zoom meeting -- expect audio, slideshows, minimal video
  • Draft agenda: Not yet posted
10:52 a.m. ET, December 10, 2020

CDC official says Covid-19 cases and deaths are underestimated in the US 

From CNN’s Amanda Watts

People in cars line up to be tested for Covid-19 on December 3 in Paramus, New Jersey.
People in cars line up to be tested for Covid-19 on December 3 in Paramus, New Jersey. David Dee Delgado/Getty Images

Aron Hall, chief of the Respiratory Viruses Branch at the US Centers for Disease Control and Prevention's Division of Viral Diseases, said the number of cases and deaths from Covid-19 in the United States are underestimated. 

Speaking during the FDA's Vaccines and Related Biological Products Advisory Committee meeting on Thursday, Hall said over 15 million cases and over 285,000 deaths have been associated with Covid-19 in the US.

“However, based on seroprevalence surveys and models, the total estimated number of infections, is likely two to seven times greater than reported cases,” Hall said. “Though less than 10% of the population in most states had evidence of previous infections through September.” 

“We do feel, as with hospitalizations and illnesses, that the reported number of deaths is likely an underestimate of the true number of deaths,” he said later in his presentation. 

“Even with the promising advent of Covid-19 vaccines, there's continued need for non-pharmaceutical interventions, including mask use, physical distancing, hand hygiene and environmental disinfection to help bring an end to this devastating pandemic,” he added. 

10:34 a.m. ET, December 10, 2020

The FDA's advisory committee meeting is in a short break

From CNN's Jacqueline Howard

A meeting of the FDA's Vaccines and Related Biological Products Advisory Committee has taken a nine-minute recess and will resume shortly with a presentation by Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases.

The FDA advisory committee is convening to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate.

If you are just catching up on today's meeting, here are key things to know:

  • Who is on the panel? The Vaccines and Related Biological Products Advisory Committee is made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative — 17 regular members and 13 temporary voting members. 
  • What is expected to happen today? The panel is expected to vote on a recommendation to the FDA on an emergency use authorization for Pfizer’s Covid-19 vaccine. The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.
  • What main points will they consider? The only real questions will be about whether the advisers recommend restrictions to the EUA — perhaps leaving children off the lIst for now, for example. They'll also discuss how to conduct the post-EUA safety surveillance and whether to offer the shot to clinical trial volunteers who got placebo doses.
  • What comes next? The FDA will then 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. 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. After the CDC accepts that recommendation, Pfizer shots may start to be administered.
10:43 a.m. ET, December 10, 2020

FDA has found Pfizer vaccine manufacturing quality is “adequate” to support emergency use authorization

From CNN’s Amanda Watts

Pfizer’s manufacturing facility in Kalamazoo, Michigan.
Pfizer’s manufacturing facility in Kalamazoo, Michigan. Pfizer

The US Food and Drug Administration has found the manufacturing quality of Pfizer’s Covid-19 vaccine to be adequate to support emergency use authorization, but will not discuss the “ongoing review” of manufacturing during the committee meeting on Thursday, said Dr. Doran Fink, deputy director of the FDA's division of vaccines.

During the Vaccines and Related Biological Products Advisory Committee meeting happening now, Fink said, “in information submitted prior to the EUA FDA has been conducting an ongoing review of manufacturing quality, consistency and control, and we have found the information to be adequate to support emergency use authorization of the vaccine.” 

“We are not intending to discuss details of the manufacturing process, many of which are proprietary, during today's meeting,” he said. 

But Fink added, “our review of the manufacturing information is an ongoing process and will continue, even after the vaccine is authorized — if that is the decision that we make.”