The United States could be back to normal by next summer or early fall if everyone gets a Covid-19 vaccine, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, predicted Thursday.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted to recommend emergency-use authorization (EUA) for Pfizer’s Covid-19 vaccine Thursday. The FDA is expected to approve an EUA for the vaccine in the next couple of days.
Japan has reported a record number of new Covid-19 infections for the second straight day.
Japan’s Ministry of Health announced it recorded 2,955 new Covid-19 cases and 37 related deaths for Thursday.
That brings Japan’s total reported Covid-19 infections to 172,255 – including 2,515 dead.
The Ministry’s data shows 543 patients are in intensive care, while a further 22,272 are receiving treatment in hospitals.
The capital Tokyo posted its highest number of daily infections yet with an additional 602 cases. At least 59 patients remain in critical condition, with 1,826 more in hospital.
Osaka counted 415 new cases. Osaka Gov. Yoshifumi Yoshimura said Thursday he was expecting the Self-Defense Forces’ medical support team to be dispatched to local hospitals.
Japan’s medical expert advisory board was critical about the effectiveness of the government’s prevention measures to fight the recent surge in cases.
The vote by the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to recommend emergency use authorization for Pfizer’s Covid-19 vaccine is important, Dr. Anthony Fauci said.
It shows that the process in the US is based on decisions and recommendations made by independent bodies, the director of the National Institute of Allergy and Infectious Diseases told CNN.
The next step is FDA consideration and decision about an EUA. Then the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide whether to recommend the vaccine for use. The Advisory Committee on Immunization Practices has meetings scheduled for Friday and Sunday.
Pending Food and Drug Administration emergency use authorization of the Pfizer coronavirus vaccine, CVS is preparing to begin vaccinations in long term care facilities on Dec. 21.
It is not clear which states have chosen to begin vaccinations immediately.
CVS will use a “hub and spoke” model, with around 1,100 CVS Pharmacy locations storing vaccines based on geographic need, Slavin said.
“Pharmacy teams will go to these locations to pick up the necessary doses on their way to long-term care facilities. We’ll know how much we need for each facility and bring extra for new residents or staff members who may not have been included in the data that was shared in advance,” he said.
The data used to determine need comes from coordination between CVS and each long-term care facility, CVS spokesman TJ Crawford said.
“More than 40,000 long-term care facilities have selected CVS Pharmacy to provide vaccinations,” Slavin said.
Some context: An advisory committee to the US Centers for Disease Control and Prevention expects to vote Sunday whether to recommend Pfizer’s coronavirus vaccine, according to an agenda posted on the agency’s website.
US Food and Drug Administration advisers voted Thursday to recommend the FDA issue emergency use authorization to the vaccine.
The influential coronavirus model at the University of Washington has projected 502,000 Americans will have died from Covid-19 by April 1, down from its prediction of 539,000 deaths last week.
The model from the Institute of Health Metrics and Evaluation predicts a new coronavirus vaccine can save 25,000 or more lives. And if 95% of Americans wore masks, the death count would drop by 56,000 by April 1 compared to the “most likely” scenario.
On the other hand, if states ease coronavirus mandates, the model projects 598,000 cumulative deaths by April 1.
The model projects 25,200 lives will be saved by the vaccine rollout and if the distribution occurs rapidly, 44,500 lives could be saved compared to a no-vaccine scenario.
The Covid-19 epidemic in the Midwest is leveling off but is increasing on the West Coast and in the Northeast, IHME said.
There was sobering news for Canadians Thursday as public health officials in several provinces said they were coping with an increase in infections despite new restrictions and lockdowns.
Prime Minister Justin Trudeau underscored the need to keep up with public health protocols as he announced that vaccines would arrive in Canada by Monday.
Canada is not disclosing logistics or tracking information on the Pfizer/BioNTech vaccine as it enters the country because of what officials say are “credible” security concerns.
But Trudeau stressed he does not believe there will be any disruptions as the vaccines make their way from Belgium to Canada.
The timeline on vaccines in Canada comes as several provinces, including Canada’s two largest, Quebec and Ontario, logged record-setting new cases of Covid-19 in recent days with officials saying that lockdowns in both Toronto and Montreal are having little effect on the rise in new cases.
The province of Ontario broke another record for the highest number of Covid-19 cases reported in a single day, with Toronto and its suburbs logging most new cases.
Ontario released new modeling Thursday and confirmed that according to mobility data throughout the province, people are traveling outside their homes at close to normal levels and likely not limiting contacts as much as needed to stop the spread of the virus.
Montreal broke a single-day record Thursday with 648 new cases of Covid-19, a growth rate the city’s public health director called “alarming.”
“I know we’re all tired, but we need to make an effort,” said Dr. Mylène Drouin, Montreal’s public health director, during a news conference Thursday.
The US Food and Drug Administration said Thursday’s vote by its vaccine advisers to recommend emergency use authorization of the Pfizer Covid-19 vaccine was an “important step” in the review process.
The FDA said its Vaccines and Related Biological Products Advisory Committee, made up of independent scientists and public health experts, provides “valuable advice and input” for the agency to help make its decision on the vaccine.
“Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement.
“The whole of the FDA—myself included—remains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.”
The United States reported 107,248 Covid-19 hospitalizations on Thursday, setting a new record high since the pandemic began, according to the Covid Tracking Project (CTP).
This is the ninth consecutive day that the US has remained above 100,000 hospitalizations.
The following, according to CTP data, are the highest hospitalization numbers:
Three members of the Food and Drug Administration vaccines advisory committee explained why they voted to recommend the agency grant emergency use authorization to Pfizer/BioNTech’s coronavirus vaccine.
He also said he feels comfortable with the mRNA technology used with the vaccine.
Dr. Paul Offit said the vaccine is highly effective.
Dr. Ofer Levy also said “the efficacy looked very, very good.” He expects the FDA to accept the recommendation in a matter of days.
Noting the beginning of Hanukkah, Levy said, “It’s the Festival of Lights, and we’re hoping we now have light at the end of the tunnel.”
Watch:
Advisers to the US Food and Drug Administration may have just voted to recommend emergency use authorization for Pfizer/BioNTech’s coronavirus vaccine, but FDA Commissioner Dr. Stephen Hahn said the agency needs to take a beat before deciding.
It’s not clear when the FDA will actually decide to issue an emergency use authorization, although Hahn and other senior staff have widely signaled that the agency will grant it.
“FDA staff feel the responsibility to move as quickly as possible. However, they know they must carry out their mandate to protect the public health & ensure any authorized vaccine meets our rigorous safety and effectiveness standards that the American people have come to expect,” he said.
The benefits of Pfizer’s Covid-19 vaccine outweigh the risks, Dr. James Hildreth, a member of a US Food and Drug Administration vaccine advisory committee, said Thursday after the panel voted to recommend authorization of the vaccine.
Hildreth, the president and chief executive officer of Meharry Medical College, voted to recommend the FDA grant emergency use authorization.
“I wish there could have been slightly more enrollment of minorities in the trial, but I think the numbers are sufficient,” he said. “I also think that based on use of mRNA technology and other kinds of medical applications, I feel comfortable that the technology itself does not pose any real risk. I just feel that we need this vaccine and the benefits outweigh the risks,” he added.
Another member of the FDA’s Vaccines and Related Biological Products Advisory Committee, Dr. Ofer Levy of Boston Children’s Hospital, also voted in favor of an EUA.
“I voted yes based on the safety and efficacy data presented by the sponsor to FDA,” Levy said. “We reviewed it carefully.”
“FDA did an independent analysis. The safety largely indicated only, you know, mild or moderate adverse events, typical ones after a vaccine, in the soreness in the arm, maybe some fever, et cetera, and the efficacy looks very, very good. And on that basis, I voted yes,” he added.
The vote on granting Pfizer an EUA for its Covid-19 vaccine was 17-4 in favor with one abstention.
The FDA will now decide whether to accept the recommendation but has signaled that it will issue the EUA for the vaccine.
Pfizer’s chairman and CEO said he’s pleased that the US Food and Drug Administration’s vaccine advisers have voted to recommend the agency grant emergency use authorization for the company’s coronavirus vaccine in the US.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” Pfizer chairman and CEO Albert Bourla said in a statement to CNN.
What’s next: The FDA will now decide whether to accept the recommendation but has signaled that it will issue the EUA for the vaccine.
Then, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices must meet to decide whether it recommends that the vaccine be deployed for use. ACIP has a meeting scheduled for Friday, and expects to vote during another meeting, scheduled for Sunday.
Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.
President-elect Joe Biden has issued a statement on the US Food and Drug Administration panel’s recommendation of the Pfizer vaccine.
“We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” Biden writes.
More on the vaccine: The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine.
Seventeen members voted yes, four voted no and one abstained.
This vote doesn’t mean the vaccine will be authorized immediately.
The FDA will now decide whether to accept the recommendation but has signaled that it will issue the EUA for the vaccine.
An advisory committee to the US Centers for Disease Control and Prevention expects to vote Sunday whether to recommend Pfizer’s coronavirus vaccine, according to an agenda posted on the agency’s website.
If the panel votes in favor of the vaccine, that’s the last step needed before shots can go into arms.
An advisory panel to the US Food and Drug Administration voted to recommend emergency use authorization of Pfizer’s vaccine on Thursday.
If the FDA does follow the advice of its Vaccines and Related Biological Products Advisory Committee – and it usually does – then it’s the CDC’s turn to review the data.
The CDC’s Advisory Committee on Immunization Practices will meet virtually Friday to discuss Pfizer’s data, according to the agenda. Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, will make a presentation to the group.
The company’s clinical trials have shown the vaccine to be 95% effective with no severe side effects.
Once the FDA issues an EUA, then ACIP – a panel of independent experts – can vote on whether to recommend it.
CDC Director Dr. Robert Redfield has to sign off on ACIP’s recommendation before it’s an official recommendation.
ACIP will also vote on whether any groups should not receive the vaccine. The vaccine has not yet been studied in several groups, including children under age 16, pregnant and breastfeeding women, and people who are immunocompromised.
On Dec. 1, the panel voted that the first two groups to receive the vaccine should be health care workers, and residents of nursing home and assisted living facilities.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted Thursday to recommend the agency grant emergency use authorization to Pfizer’s coronavirus vaccine.
Seventeen members voted yes, four voted no and one abstained.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is moving to vote.
Each member will then explain his or her vote.
The Federal Aviation Administration will tell its air traffic controllers that flights carrying the coronavirus vaccine should be handled as a priority.
UPS and FedEx will carry Pfizer’s vaccine by air and ground as part of Operation Warp Speed, the Trump administration’s vaccine development and distribution effort, once it is authorized.
The FAA told CNN that air carriers will provide lists of flights carrying vaccines to a command center in Warrenton, Virginia, outside Washington, DC, “which will alert air traffic control facilities in the field that these are priority flights.”
“The Command Center will closely track the flights along their routes to ensure they are given priority to the degree possible,” the FAA said in a statement.
Air carriers say swift transportation of the coronavirus vaccine by air is critical as they could be moving the vaccine the furthest distances and need to remain at ultra-cold temperatures.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is discussing whether to recommend that the FDA grant emergency use authorization (EUA) to Pfizer’s vaccine.
A reminder this is not full approval, and the FDA makes that decision separately from the committee vote. The FDA usually follows VRBPAC recommendations and has signaled it will grant EUA quickly. However, it is not known when the FDA would make that decision.
The VRBPAC is made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative — 17 regular members and 13 temporary voting members.
Pennsylvania Gov. Tom Wolf announced during a news conference Thursday afternoon a slew of new temporary Covid-19 restrictions amid the state’s Covid-19 surge.
Starting Dec. 12 through Jan. 4, all indoor dining, along with indoor operation of gyms and fitness facilities, will be prohibited. Outdoor dining and takeout services will still be permitted.
Indoor gatherings will be capped at 10 people, and outdoor gatherings at 50 people, while places of worship will be “specifically excluded,” a release from the governor’s office explained.
In-person businesses in the entertainment industry, meanwhile, such as movie theaters, museums, and casinos will also be prohibited from operation.
“We need to slow the spread right now in order to save lives. If we don’t, we’re going to be in big trouble,” Wolf said.
Additionally, all in-person businesses serving the public must operate up to 50% maximum occupancy, unless an existing local rule limits occupancy further.
Finally, all K-12 sports will be paused, along with in-person extracurricular activities.
Professional and collegiate sports may continue, albeit without in-person spectators, and in accordance with Centers for Disease Control and Prevention and state health guidance.
By the numbers: The new restrictions come as the state health department reported a record daily increase of 248 coronavirus-related deaths earlier Thursday, along with 11,972 additional Covid-19 cases.
The statewide totals now stand at 12,010 associated fatalities and 457,289 cases, including probable ones.
The fact sheet and prescribing information provided with Pfizer’s Covid-19 vaccine will warn that people with a history of severe allergic reactions to any the vaccine’s components should not get it, an official at the US Food and Drug Administration said on Thursday.
“Over the last couple of weeks, we have been working with Pfizer on generating fact sheets and prescribing information,” Dr. Marion Gruber, director of the Office of Vaccines Research and Review in the FDA Center for Biologics Evaluation and Research, said during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting.
The advisory committee is discussing a possible emergency use authorization for Pfizer’s Covid-19 vaccine candidate.
“So that has made it already in the fact sheets and prescribing information weeks ago,” Gruber said. “We, however, will consider any additional information that we’re going to be receiving over the next couple of days and factoring this into our decision-making.”
On Wednesday: Reports emerged out of the United Kingdom about two health care workers with a significant history of allergic reactions having reactions following Covid-19 vaccination. The health workers have since recovered.
