Our live coverage of the coronavirus pandemic has?moved here.
Japan has recorded 3,030 new Covid-19 cases from Saturday, its highest single-day rise in infections since the pandemic began, the country’s Ministry of Health said Sunday.
Among the new cases, 621 were in the capital Tokyo, the highest number ever recorded in the city, the ministry said
Japan has now recorded 177,999 cases and 2,575 deaths, including 28 from Saturday.
The ministry said that 23,990 Covid-19 patients are currently receiving medical care in hospitals, while 578 of them are in critical condition.?
South Korea reported 1,030 new cases of Covid-19 on Saturday, its highest number since the pandemic began, according to the Korea Disease Control and Prevention Agency (KDCA).
Over 1,000 of the cases were locally transmitted and 28 were imported. More than 780 cases were in the Seoul Metropolitan area.
South Korea has now reported 42,766 cases in total and 580 deaths, including two from Saturday. There are 10,372 people in quarantine in the country, according to KDCA.
Dr. Nicole Alexander-Scott, the director of the Rhode Island Department of Health (RIDOH), tested positive for Covid-19 on Saturday.
Gov. Gina Raimondo is now among those quarantining due to possible exposure to the virus, according to Josh Block, Raimondo’s director of communications.
In a statement, Block – who is also quarantining due to possible Covid-19 exposure – confirmed that Alexander-Scott is asymptomatic and will work from home while she recovers.?
Rhode Island Commerce Secretary Stefan Pryor and Dr. Philip Chan with RIDOH are also?quarantining as a precaution, Block said.
Hospitals in Los Angeles are under huge pressure to deal with hundreds of new coronavirus patients a day, Los Angeles County Department of Public Health Director Barbara Ferrer said in a news release Saturday.
“This is an extraordinarily challenging time. Hospitals are stressed and filling up with hundreds of new Covid-19 positive patients each day, our healthcare workers are exhausted, and deaths are reaching an all-time high,” Ferrer said.
A month ago, the 5-day average of cases was 2,134. On Saturday, the 5-day average was 10,034. According to the release, this is an increase of 370% in one month.??
“Our daily case numbers are unlike any we have ever seen in our county and reflect extraordinarily high rates of community transmission; activities we were able to do just a few weeks back, now present far too much risk for virus transmission,” read the release.?
The Navajo Nation Indian Health Service (IHS) is expected to receive its first shipments of the Pfizer/BioNTech Covid-19 vaccine on Monday and Tuesday, according to a statement issued by the Navajo Nation on Saturday.?
“The shipment will be transported to Gallup Indian Medical Center, Chinle HIS, and Northern Navajo Medical Center,” where the vaccines will be stored at “deep freeze temperature” the statement said.
The vaccine distribution will be overseen by the Navajo Area IHS, according to the statement.
“IHS has had extensive planning in the works for quite some time and has also been doing practice runs at their hospital facilities,” Navajo Area Indian Health Service Chief Medical Officer Dr. Loretta Christensen said in the statement.
The Navajo Nation is currently under a 57-hour lockdown that started on Friday at 8 p.m. MST and runs through Monday at 5 a.m. MST.
“We have to remain united in the fight against Covid-19 and we have to do more to help our healthcare workers,” Navajo Nation Vice President Myron Lizer said in the release. “Our hospitals and health care workers are overwhelmed due to the high level of new Covid-19 cases.”
The Navajo Nation has struggled to control the virus in their community?CNN previously reported. A recent surge in cases forced the Navajo Nation to go into lockdown until December 6,?according to the report.
The Navajo Department of Health reported 203 new Covid-19 cases and 7 new deaths on Saturday, bringing its total confirmed coronavirus cases to 19,420 and total deaths to 718, according to the nation’s department of health.??
The US reported?108,487?current Covid-19 hospitalizations on?Saturday, setting a new record high, according to the Covid Tracking Project (CTP). This is the 11th consecutive day that hospitalizations in the US has remained above 100,000.
Here are the hospitalization numbers for the past five days, according to the CTP:
About 31,000 doses of the Covid-19 vaccine will be shipped to Washington and distributed to nearly 20 hospitals around the state early next week, the Washington State Hospital Association said in a press release Saturday.
Each hospital will receive an allotment of 975, 1,950, or 3,700 doses per location, the release said.
“We expect these staff will be offered vaccine mid to late next week,” said Cassie Sauer, CEO of the Washington State Hospital Association. “The speed of the Washington State Department of Health’s planning for vaccine deployment has been unprecedented. We appreciate the department and Governor Inslee’s efforts to ensuring vaccine will quickly reach health care workers from our largest cities to most rural hospitals.”
Healthcare professionals working in the intensive care unit and emergency department will receive priority for vaccination, according to the release.
Vaccine hesitancy is now the biggest challenge remaining in the fight against Covid-19, Dr. Susan Bailey, president of the American Medical Association,?said in a statement Saturday.
CDC advisers voted to recommend the Pfizer/BioNTech Covid-19 vaccine in the US Saturday. While the AMA looks forward to the CDC director reviewing and approving the recommendation, Bailey said that the hard work is far from over.
“Manufacturing, distribution, and administration still pose challenges, but the biggest threat remaining may be people’s willingness to get vaccinated,” she said. “To be clear, these vaccines will reduce death and severe illness. They have been rigorously evaluated, and if enough of us roll up our sleeves and get vaccinated, we can eventually reclaim normalcy.”
Dr. Megan Ranney, a CNN medical analyst and Brown University emergency physician, is scheduled to receive the Pfizer/BioNTech Covid-19 vaccine next Thursday. The potential side effects of the vaccination are not a deterrent, according to Ranney.
“I?have really zero reservations about being one of the first people,” Ranney told CNN’s?Ana Cabrera on Saturday.?
“I’m willing to take those minor side effects to avoid having Covid, which I’ve seen at this point in thousands of people. It is a horrible disease,” she said. “I will take a little low-grade fever over having Covid.”
The authorization of the vaccine is cause for optimism, Ranney added.
“Throughout this pandemic, we’ve heard a lot of claims of magical cures, whether it was hydroxychloroquine or bleach or just, ‘This virus is going to magically disappear,’ ” she said. “Well, the vaccine is the real deal.”
Kentucky reports 3,558 new Covid-19 cases, according to a release from Gov. Andy Beshear.
The test positivity rate across the state is 8.79%.
The state reports a total of 2,192 coronavirus-related deaths since the start of the pandemic, with 1,711 people currently hospitalized with the virus.
“Late yesterday, the FDA approved Pfizer’s vaccine for COVID-19. That’s great news, but it will still be some time before everyone can get vaccinated and we have to stay vigilant until that time,” Beshear said.
There have been at least?16,014,839?cases of coronavirus in the US and at least?297,501?people have died from Covid-19, according to data compiled by?Johns Hopkins University.??
It took the US 268 days to reach 8 million Covid-19 cases, according to university data.??
It only took the nation 57 days to reach the second 8 million cases.?
FedEx Executive Vice President Richard Smith told CNN that the?delivery services company?will be using?a new?sensor-based tracking device when transporting Covid-19 vaccines for precision tracking.?
FedEx’s “SenseAware?ID” was launched in September and was developed in conjunction with Microsoft,?Smith said.??
SenseAware?ID uses a lightweight, compact sensor that transmits precise package location data every two seconds via Bluetooth Low Energy,?according to FedEx.?
“We’ll be able to know where they are at all times, we’ll have our priority alert agents monitoring them,” Smith said.??
Some context: Smith said the decision was made to begin shipping vaccines on Sunday, with deliveries going out on Monday.
This is because the administrative staff needed to receive packages at the various sites may be off or short-staffed on a Sunday, according to Smith.?
It’s “best we wait until Monday to deliver them to ensure they are all open and ready to receive,” he said.
Members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) said Saturday that their evaluation of Pfizer and BioNTech coronavirus vaccine was independent and transparent.
ACIP member Veronica?McNally,?assistant dean for experiential education at Michigan State University College of Law,?noted that the?group has held nine meetings and heard more than 70 presentations on Covid-19 and the Covid-19 vaccine since February.
“At this time, we are asked how to do the greatest good. As the pandemic continues to spread, hospitalizations are at record levels, I vote to make vaccines available by the CDC prioritization schedule,” said ACIP member Dr. Katherine Poehling, a pediatrics professor at Wake Forest University School of Medicine. “I will take this vaccine and will recommend it to my family members as well.”
Vaccine advisers to the US Centers for Disease Control and Prevention say they had little difficulty voting to recommend Pfizer’s coronavirus vaccine to people living in the United States.
Some context: The US Food and Drug Administration gave Pfizer and BioNTech’s vaccine emergency use authorization on Friday.
ACIP met Saturday and voted to recommend that CDC approve the vaccine for use in the US and add it to the vaccine schedule. Now the CDC must decide whether to accept the ACIP’s recommendation before vaccines can actually be given to people, but officials with the US federal government’s Operation Warp Speed say they are boxing up vaccines to ship them out for delivery on Monday.
Szilagyi said he felt strongly that 16- and 17-year-olds should be included in the recommendation.
“I also wanted to re-emphasize what many people and I have said today about the need for substantially increased government funding to actually implement the recommendation,” Szilagyi added.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has voted to recommend the Pfizer and BioNTech coronavirus vaccine for people age 16 and older, moving the United States one step closer to the vaccination of millions of people.
Vaccines cannot be administered until CDC Director Dr. Robert Redfield accepts the committee’s recommendation, which is expected to take place within hours.
The US Food and Drug Administration on Friday authorized Pfizer and BioNTech’s coronavirus vaccine for emergency use in the United States.
California’s Covid-19 surge continues to break case count records, with increased hospitalizations, and intensive care unit admissions, according to new data released by the state’s public health department on Saturday.
The California Department of Public Health (CDPH) reported 35,729 new coronavirus cases on Saturday—breaking the record set on Friday of 35,468 new cases.
The number of new coronavirus cases across the state has sharply increased since the beginning of the week.
New Jersey reported 6,247 additional Covid-19 infections on Saturday, the highest single-day report of new infections since the pandemic began.
To date, New Jersey has recorded 396,496 cases of Covid-19, state data showed.
The data, reported by the New Jersey Department of Health, was posted on the state’s Covid dashboard Saturday afternoon. The department also reported 71 deaths of confirmed Covid-19 positive individuals.?
Note: These numbers were released by the?New?Jersey?Department of Health and may not line up exactly in real time with CNN’s database drawn from Johns?Hopkins?University and the Covid Tracking Project.?
New York City’s seven-day positivity rate has risen to 6.26%, Mayor Bill de Blasio?said Saturday.
In comparison,?city data?shows that the city’s weekly average percent positivity for the last four weeks had been nearly two percentage points lower at 4.29%.
City?data shows?that every metric that New York City uses to monitor the spread Covid-19, including positivity rate, case rates, hospitalizations, and deaths, are all currently increasing.
On Friday, de Blasio said the city’s daily positivity rate was 5.35% and city officials hope to get the rate below 5%.?
De Blasio said 2,575 new Covid-19 cases were reported on Saturday and 193 more people have been admitted into the city’s hospitals due to the virus.
“This weekend will be a pivotal moment in our fight. The vaccine is imminent. We need to keep our city safe in this last stretch,” de Blasio said.
Note: These numbers were released by New York City officials, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.
Because there’s limited information about how well the Pfizer/BioNTech vaccine works in the general population, vaccinated people should continue to follow all the current guidelines about how to protect themselves and others,?the?US Centers for Disease Control and Prevention’s Advisory Community on Immunization Practices?was told during a meeting on Saturday.
That guidance includes wearing masks, staying 6 feet away from others, avoiding crowds and washing hands frequently.
The CDC’s Dr. Sarah Mbaeyi said information is currently limited on?how much the vaccine may reduce disease severity or transmission, and how long protection lasts. Mbaeyi noted during the presentation that protection from the two-dose series of vaccine is not immediate, and no vaccine is 100% effective.
The US Army general in charge of distributing America’s first coronavirus vaccines says he’s confident it will be done safely, even if it’s not done perfectly.
Perna said the federal government was only delivering half the doses on hand, because Pfizer’s vaccine, which received US Food and Drug Administration emergency use authorization Friday, requires two doses.
“For me, it’s a moral responsibility and obligation to make sure that second dose is available for the American people,” Perna said. “We want to ensure the vaccine arrives safely and that it can be effectively administered once arrival occurs. I t is so important that all vaccine that’s available is utilized as a shot in an arm and nothing is wasted.”
Perna said vaccines should be delivered Monday.
“The reason why we’re holding on to the second dose, as well as some reserve, is that we don’t have absolute confidence in the cadence – not because Pfizer or Moderna or the supporting manufacturers and fill-finishes aren’t diligent in their process. But it is such a delicate process, we want to ensure perfection in the vaccine because we don’t want anything going into an arm that would be a problem,” Perna said.
Hear how the Pfizer vaccine will be distributed:
The Pfizer/BioNTech Covid-19 vaccine is not interchangeable with other Covid-19 vaccines, and the safety and efficacy of mixing vaccines has not been evaluated,?the?US Centers for Disease Control and Prevention’s Advisory Community on Immunization Practices?was told during a meeting on Saturday.
People who are vaccinated initially with the Pfizer vaccine should complete the series with that product, CDC’s Dr. Sarah Mbaeyi said during a presentation to the committee.
The CDC noted that both doses of the Pfizer/BioNTech are necessary for protection, and the efficacy of a single dose has not been evaluated in a systemic way.
Vaccine maker Moderna has submitted to the US Food and Drug Administration for emergency use authorization of its mRNA Covid-19 vaccine.
Data from clinical trials suggest the Pfizer/BioNTech Covid-19 vaccine is safe and likely effective in people who were previously infected with the coronavirus, and vaccination should be offered to them, the?US Centers for Disease Control and Prevention’s Advisory Community on Immunization Practices?was told during a meeting on Saturday.
Diagnostic or antibody testing is not recommended for vaccine decision-making, CDC’s Dr. Sarah Mbaeyi said during a presentation to the committee.
However, people with a current infection should not be vaccinated until a person has recovered, if they had symptoms, and if they’re clear to leave isolation. There’s no recommended minimum period between infection and vaccination, but since it appears reinfection is uncommon in the 90 days after initial infection, vaccination could be delayed until near the end of that period.
People who have a known Covid-19 exposure shouldn’t seek vaccination until their quarantine period has ended, to avoid exposing health care workers and others.
However, residents of long-term care facilities, for example, are already in contact with workers and they can be vaccinated, even if they’ve been exposed.
More info: There’s no safety or efficacy data for the Pfizer/BioNTech vaccine in people who were treated for Covid-19 with monoclonal antibodies or convalescent plasma, Mbaeyi said, but vaccination should be deferred for at least 90 days “as a precautionary measure, until additional information becomes available to avoid interference of the treatment with vaccine-induced immune responses.”
Pfizer’s coronavirus vaccines are still being packaged before being shipped to states, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, said at a news conference Saturday.
Perna said federal officials and vaccine maker Pfizer were aiming to distribute the vaccine Monday, once the US Food and Drug Administration issued emergency use authorization, which came Friday evening.
Federal health officials have repeatedly promised a coronavirus vaccine would be rolling out within 24 hours of an EUA.?
McKesson is the medical supplies company the federal government has contracted with to help distribute coronavirus vaccines.
“The important part, as I said in my statement, was we want to make sure that the vaccine arrives at a time period where people, the professionals are available to receive it and then eventually administer it. So as a decision (was) made, and I adjusted the sliding scale hourly and daily,” Perna added. “Our ultimate goal was to get it there no later than Monday morning, through distribution. So as I speak today right now, vaccines are being packaged, with a lot of emphasis on the quality assurance. To that end, tomorrow morning vaccines will start rolling from manufacturing to distribution hubs. And then Monday, by Monday, vaccinations will be received.”
The US Centers for Disease Control and Prevention’s Advisory Community on Immunization Practices (ACIP) on Saturday discussed the willingness among nurses to receive the Pfizer/BioNTech Covid-19 vaccine.
The committee discussed a reluctance to get vaccinated among nurses included in focus groups and surveys – especially those from racial or ethnic minority groups.
Others said that they felt confident that nurses will be willing to get vaccinated, especially after receiving public health education.
Some states are planning to vaccinate health care workers and residents of long-term care facilities all together in one group as Covid-19 vaccines arrive at sites, a top Operation Warp Speed official said Saturday.?
It would be a more efficient way to use vaccines that must be stored carefully and used quickly, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, said at a news conference.
Some background: The US Centers for Disease Control and Prevention has said the very first vaccines should go to frontline health care workers most at risk of catching and transmitting the virus, and to residents of long-term care facilities such as nursing homes, who make up the bulk of those killed in the pandemic so far.
It’s up to states to decide who actually gets vaccines distributed to them. Operation Warp Speed expects to start shipping about 2.9 million doses of Pfizer’s vaccine Sunday.
Doses of Pfizer’s Covid-19 vaccines will start moving out within 24 hours, Gen. Gus Perna, chief operating officer of Operation Warp Speed, said Saturday.
The US Food and Drug Administration issued emergency use authorization for the Pfizer vaccine Friday evening.
“At the sites, the vaccine will marry up with the ancillary kits that we’ve already distributed. These kits include needles syringes, dilutant and other supplies necessary to administer the shots,” Perna said.
No vaccines were pre-positioned, Perna said.
“We did not want to presume EUA (emergency use authorization),” he said.
The Federal Aviation Administration said it has cleared pilots to receive the Pfizer coronavirus vaccine.?
There is a 48-hour waiting period after each dose of the vaccine before a pilot may resume duties.???
Until now, the FAA has required that vaccines and medications be approved for use by medical certificate holders.?
Earlier this week: The FAA told CNN it would quickly review the safety of each coronavirus vaccine following FAA authorization.???
This does not mean that pilots are actively in line to receive the vaccine imminently.?Industry organizations and unions this week urged the Centers for Disease Control and Prevention to put airline workers on priority lists for vaccination.?
A virtual?meeting?of the US Centers for Disease Control and Prevention’s Advisory Community on Immunization Practices has begun.
During the meeting, ACIP members?will discuss the Pfizer/BioNTech Covid-19 vaccine and there will be a public comment period.
The agenda says the group will vote on whether to recommend the vaccine at 2:30 p.m. ET.?
Pfizer has told reporters covering its rollout that it expects the first shipments of its Covid-19 vaccine to leave the Michigan facility Sunday morning.
The company originally predicted trucks rolling “within 24 hours” of Food and Drug Administration authorization.
The company did not provide an explanation for the later timeline.
The US Food and Drug Administration says the potential benefits of the Pfizer/BioNTech vaccine outweigh the risks for 16- and 17-year-olds,?Dr. Peter?Marks, director of FDA’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday.
FDA has a long history of evaluating pediatric vaccines and extrapolating data from adults to children, he said.
Although teens rarely become seriously ill from Covid-19, Marks acknowledged some do become very sick and die. And, teens are able to transmit the virus “quite easily” – even if they’re asymptomatic.
“Since some of those 16- and 17-year-olds, at least that I know of, are out there as checkout people, or interacting with communities, it may be wise that we are able to vaccinate them,” Marks said. “So we think the known and potential benefits outweigh the known and potential risks.”
It will take a few months before it’s clear how the vaccine impacts transmission of the virus, Marks said.
On pregnant women: Decisions about whether pregnant women should take?Pfizer and?BioNTech’s Covid-19 vaccine should be considered on an individual basis,?Marks said.?
“Covid-19 in a pregnant woman is not a good thing, so someone might decide that they would like to be vaccinated, but that’s not something that we’re recommending at this time. That’s something we’re leaving up to the individual,” Marks said.
Marks said that the clinical trials of the vaccine, which did not enroll pregnant women but included women who became pregnant during the trials, did not yield enough data to make a determination for that population.
“For pregnant women and the immunocompromised – just at this point – it will be something that providers will need to consider on an individual basis for patients,” said Marks.
The benefits of the?Pfizer and BioNTech vaccine outweigh its risks,?US Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said Saturday.
Hahn said the FDA has been transparent about the data.
“We’ve also posted important information to help healthcare providers understand the benefits, risks and proper use of this FDA authorized vaccine,” Hahn said.?
CNN health reporter breaks down FDA’s comments:?
Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research,?said during a news briefing on Saturday that FDA is “pretty convinced” the extreme cold conditions required for the Pfizer/BioNTech vaccine can be maintained, based on planning and past experience.
Some background: The Pfizer/BioNTech vaccine needs to be stored at about minus 75 degrees Celsius – far colder than any vaccine currently used in the United States.
The vaccines are using specially designed shippers with dry ice, and they can remain refrigerated for a few days once thawed.
FDA made clear in the labeling how the vaccine will need to be handled, Marks said, and the US Centers for Disease Control and Prevention and Operation Warp Speed “are making sure that things are in place to make sure that the cold chain is maintained.”?
Food and Drug Administration Commissioner Dr. Stephen Hahn said that the organization “is very concerned about vaccine hesitancy.”
The FDA has addressed the hesitancy, Hahn said, by being transparent about the science behind Pfizer and BioNTech’s Covid-19 vaccine and the process for authorizing it.
Hahn said that the FDA believes in “transparency” and “the rigorous scientific review that we’ve done.”
Watch:
US Food and Drug Administration Commissioner Dr. Stephen Hahn denied on Saturday that political pressure led to a quicker than normal decision to issue emergency use authorization for Pfizer’s coronavirus vaccine.
The FDA issued the EUA Friday evening, a day after its Vaccine and Related Biological Products Advisory Committee voted to recommend the authorization. But as the FDA considered the vote, Hahn was summoned to the White House.
The FDA said it reviewed not just Pfizer and BioNTech’s summary of their clinical trial involving around 40,000 volunteers, but went through to original source data. It showed the vaccine was safe and provided 95% protection.
“Our incredible team, heroic efforts, night and day worked to get this out the door,” Hahn said. “As Dr. Marks said, thousands of people are dying a day.”
Hear FDA commissioner’s answer when asked about political pressure:?
Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday that there’s “been a lot of noise” about the protection provided by one dose of Pfizer/BioNTech’s coronavirus vaccine and whether that could help extend the vaccine supply.
The FDA’s stance is that people should take two doses.?
Marks added: “So at least from the FDA perspective, we would be recommending that people complete the two-dose series so we actually know that they’re truly protected at the rate of approximately 95% of efficacy.”
Watch:
Months of planning culminate this weekend with the first deliveries of Pfizer coronavirus vaccine doses – and the UPS executive overseeing his company’s efforts says it is an emotional experience.??
Wheeler said the process that soon gets underway at the Pfizer facility in Kalamazoo, Michigan, will be highly choreographed.?
“We have people embedded at the Pfizer location in Michigan, and they will be helping Pfizer to dispatch packages,” he explained.?“They will be loaded onto a trailer, a dedicated trailer, with an escort. They will drive five hours to Louisville, Kentucky, and then there’ll be dispatched around to the states that we’re assigned.”
In Louisville, many of the shipments will be loaded onto UPS planes.?Wheeler said the company’s extensive delivery network means it can ship doses overnight for delivery by 10:30 the next morning.?UPS is handling delivery to sites on the Eastern side of the U.S.?
The company is also creating 24,000 pounds of dry ice daily that are packed into special Pfizer containers to keep the vaccine at the required sub-zero temperature.?
“The day after the vaccines arrive, we deliver 40 pounds of dry ice to replenish what is sublimating from the box,” Wheeler said.?“The Pfizer package is good for 10 days with it with the 50 pounds of dry ice in it. And with the 40 pounds that we send the following day. It’ll give you another several days if necessary so the box becomes the storage medium at the dosing center.”
More details: Tracking devices on each container and truck send real-time information back to the UPS command center in Louisville.?
The tracking tags have four radios and a Bluetooth device that transmit data including GPS location, “atmospheric pressure, motion detection, light detection, and of course temperature,” he said.?That data gives the company insight into the condition of each package and the dry ice inside of it.?
“We have eyes on these shipments all the way from origin to the final dosing destination,” he explained.???
Now that the Pfizer and BioNTech’s Covid-19 vaccine has been authorized in the US, clinical trial participants can find out whether they received the vaccine or placebo,?Dr.?Peter?Marks, who heads the FDA’s Center for Biologics Evaluation and Research, said during a virtual news conference on Saturday morning.?
“We have to balance the amount of blinded data that we received with the need to protect people,” Marks said.
The US Food and Drug Administration’s emergency use authorization for Pfizer and BioNTech’s Covid-19 vaccine was based on science and data, FDA Commissioner Dr. Stephen Hahn said during a virtual news conference on Saturday morning.
Hahn added that efficiency does not mean the cutting of corners while review teams continue to comb through data.
More context: The US government is now working to distribute Pfizer’s Covid-19 vaccine, after the FDA authorized it for emergency use on Friday, Hahn said.
“With this authorization, we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country,” Hahn said.
Hahn said the authorization is a significant milestone for families battling the coronavirus pandemic in the United States and around the world.
“While this year has been marked by tragedy, sadness and sacrifice, it is also a year that has generated unparalleled scientific achievement that will resonate for many future generations,” he added.
Hear FDA commissioner’s remarks:?
The US Food and Drug Administration is scheduled to hold a press conference on the first Covid-19 vaccine authorization at 9 a.m. ET.
FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research Director Dr. Peter Marks will be taking questions.
The US Food and Drug Administration’s emergency use authorization of Pfizer and BioNTech’s coronavirus vaccine is a crucial step in developing the new-generation vaccine, BioNTech CEO Ugur Sahin said.
The FDA authorized the vaccine late Friday night after its advisers recommended the go-ahead. The US follows several other countries in authorizing the vaccine, including Britain, which has already immunized at least 2,000 people.
The EUA was fast by US regulatory standards – especially for a vaccine using new technology.
How does it work? BioNTech’s vaccine uses messenger RNA, genetic material that codes for a piece of the virus’s spike protein – the outside hook that attaches to the cells the virus attacks. This mRNA prompts the human body to produce little pieces of the protein, and then produce an immune response against it.
Clinical trials in more than 40,000 people showed it was 95% effective in preventing symptomatic disease.
Pfizer has only been able to produce a few million doses for the US so far, so it will not immediately affect the pandemic, Sahin said. But after more people get vaccinated, the effects will kick in, he predicted.
Read the exclusive story here.
Watch:
Things were looking up for Jason Zenga in late 2019 and in early 2020.
The personal trainer worked out of a gym based in Santa Monica, California, where he taught classes twice a week. He also worked as an independent corporate trainer through a partnership with his friend, where they’d go to offices and train employees at companies across Los Angeles.
But business began to dry up in March, as local and federal governments began?implementing stricter policies?to mitigate the spread of the?coronavirus. All of a sudden, the gym that employed Zenga closed. There were no offices to go to train employees at, and Zenga could only train the last few of his clients virtually. He had to apply for unemployment benefits.
“All the uncertainty was frustrating,” Zenga told CNN.
Meanwhile, across the country, Atlanta-based trainer Bria Young found her business booming during the pandemic. When gyms began to close, Young transitioned to packaging workouts into online digital programs on her website, and began selling them.
“It completely flip-flopped, I didn’t even need to go back to in-person training,” Young told CNN. “I was able to find a new passion during this pandemic.”
There’s no question that?the fitness industry has been upended by the pandemic?– and for some trainers like Zenga, the last 10 months have proved to be financially devastating.
For others, like Young, the pandemic has turned into a fruitful opportunity to pivot to virtual full time.
Read the full story:
If the current trend in rising coronavirus cases continues, then raising the social distancing measure to the highest level would be unavoidable, South Korean Prime Minister, Chung Sye-kyun warned on Saturday.
He posted the warning on his verified Facebook account as he held an?emergency meeting to discuss surging coronavirus cases on Saturday.
A raise in the alert level would mean a ban on gathering of more than 10 people, work from home for all non-essential employees and a shift to online for all schools and church services.
South Korea?was widely praised as a Covid-19 success story, and initially managed to keep the pandemic largely under control.
But the nation reported 950 new cases of coronavirus on Saturday, marking the highest jump in single day cases since the beginning of the pandemic, according to the Korea Disease Control and Prevention Agency (KDCA).
Seoul Metropolitan Area accounts for the majority of the total with a record 669 new cases.
Currently the national alert level in South Korea is under Level 2 which is the?third highest level. It’s higher for the?Seoul Metropolitan Area – at under 2.5 –?the second highest level.
Alert levels in South Korea range from 1, which denotes the least concerning situation, to 3 signifying the situation requires toughest measure. Each time the alert level is raised it goes up by 0.5.
“A very serious situation:” South Korean President, Moon Jae-in also warned that the surge in Covid-19 cases presents a “very serious situation.”
“In fact, we cannot but say that it’s an emergency situation,” he said on Saturday via a post on his verified Facebook and Twitter account.
In a press briefing on Saturday, KDCA official, Im Suk-yeong said 90 new coronavirus cases were found in a religious facility in the Western district of Seoul and 66 new cases were found in a nursing hospital in outskirts of Seoul.
An additional 14 cases were discovered while investigating a cluster originating in a restaurant in central Seoul, bringing the total cases linked to the restaurant to 230, she added.
Testing centers boost: In a bid to get a jump on the rising cases, 150 testing stations will be installed around Greater Seoul’s high risk areas.
These will come online on December 14 and operate for three weeks, Im added.
The testing will be conducted anonymously to encourage public participation.
Im also said 810 government workers, including members of the military, police have been deployed to aid epidemiological investigation. 480 more workers will join the effort in the future.
Despite the stricter social distancing measures that came into effect on December 5 in the capital city of Seoul, movement of people has not reduced sufficiently, Im added.
Im warned the current trend will likely continue for a week before showing the result of the increased social distancing measures.
Trucks and planes loaded with Pfizer and BioNTech’s vaccine will soon be departing from Kalamazoo, Michigan, to hospitals around the country, following the Food and Drug Administration’s?emergency use authorization (EUA).
“We need to take a moment, I think, and just consider that we are having this mass casualty event every day here in the US, but now we have this vaccine developed in record time that can in time really save us and save our country and save the world from this awful pandemic,” emergency physician Dr. Leana Wen told CNN’s Chris Cuomo moments after the authorization.
“This is?really a monumental moment?for us,” she added.
US grapples with highest cases and deaths: The news comes during the most difficult weeks the US has faced since the pandemic’s start. Friday saw the highest number of new cases, hospitalizations and daily deaths since the pandemic’s start. More than 3,300 American deaths were reported.
There are just two key steps left before vaccinations can start: a Centers for Disease Control and Prevention advisory committee – scheduled to meet Saturday morning – must vote to recommend the vaccine and the agency must then accept that recommendation.
Then, vaccinations can begin.
Brutal months ahead: But it’ll be months before most Americans will get a vaccine.
Last week, vaccine advisers to the CDC voted to recommend that?both health care workers and long-term care facility residents?be first in line for Covid-19 vaccines that get the green light from the FDA. Health and Human Services Secretary Alex Azar has said about 20 million Americans should be vaccinated by the end of the month, 50 million by the end of January and at least 100 million people should be vaccinated by the end of the first quarter.
Officials “remain confident,” he added, that there will be enough doses for any American who wants to get vaccinated by summertime.
In the meantime, the US – already ravaged by a rampant spread of the virus – is projected to face brutal days ahead.
Japan reported 2,790 new coronavirus cases in the previous 24 hours, the country’s Ministry of Health said Saturday – its third-highest?single-day surge?since the pandemic began.
The nation’s capital, Tokyo, accounted for 595 new coronavirus cases, the second-highest single-day surge for the city yet.
The biggest jump was on December 10, when Tokyo logged 602 new cases.?
Japan’s second-biggest prefecture,?Osaka, confirmed 357 new coronavirus cases, its third consecutive day of infections above the 300 mark.
Overall, the national coronavirus case tally stands at 175,011 confirmed infections, of which 174,299 are reported on land and 712 on the Diamond Princess cruise ship.?
Japan’s coronavirus death toll also increased by 32 on Friday, the ministry said, taking the overall tally to 2,547.
The US reported record-high numbers of fresh Covid-19 cases, deaths and hospitalizations on Friday, according to data from Johns Hopkins University (JHU) and the Covid Tracking Project (CTP).
On Friday,?231,775?new confirmed Covid-19 cases?were reported nationwide, according to JHU.
In addition, there were?3,309?more related deaths?– a record since the pandemic began.?
The US also hit a record number of?Covid-19 hospitalizations with?108,044 reported by the CTP.
According to JHU data, the top five days for new US cases were all in December:
Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) announced Friday it has granted emergency use authorization (EUA) for the Pfizer and BioNTech vaccine.
Deputy Health Minister Hugo López Gatell, who is leading the country’s Covid-19 response, told reporters the announcement is “cause for hope … It is good news.”
The 24-member COFEPRIS committee voted unanimously to approve the EUA.
Mexico announced part of its vaccination distribution plan – which calls for prioritizing the country’s health care workers – earlier this week.
A total of 250,000 doses of the vaccine are expected to arrive in Mexico before the end of the month.?An additional 15 million doses are expected to arrive by April.
Mexico’s government recently announced it had signed an agreement to secure 34.4 million doses of Pfizer/BioNtech?vaccine.
South Korea reported 950 new coronavirus cases on Saturday – the most infections in a single day since the beginning of the pandemic, the Korea Disease Control and Prevention Agency (KDCA) said in a press release.
Of those, 928 confirmed cases are local infections, while 22 are imported.?
The Seoul Metropolitan Area accounts for the majority of the total with a record 669 new cases, the KDCA said.
Meanwhile, three more cases have been linked to the church cluster in Daegu city, according to the local government’s press release on Saturday.
There have now been 32 cases linked to the church cluster, where contact tracers said members of the choir didn’t wear masks and parishioners shared snacks.
Earlier this year, the Daegu branch of the Shincheonji religious group became one of the country’s biggest single clusters, linked to more than 5,200 cases.
The country has recorded 41,736 cases in total so far.
South Korea’s related death toll also increased by six on Saturday, bringing total fatalities to 578.
The US Food and Drug Administration will hold a news conference at 9 a.m. ET Saturday with Commissioner Dr. Stephen Hahn and Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, to discuss the agency’s decision to grant emergency use authorization for Pfizer’s Covid-19 vaccine.
“FDA Commissioner?@SteveFDA?and?@FDACBER?Director Dr. Peter Marks will be taking questions,” the agency said on its Twitter account. The news conference will be livestreamed on Twitter, the FDA said.
The US Food and Drug Administration’s approval of an emergency use authorization for Pfizer’s Covid-19 vaccine is “really a monumental moment,” Dr. Leana Wen, a CNN medical analyst and emergency room physician, said Friday.?
“I think it’s really amazing,” Wen, the former Baltimore health commissioner, told CNN’s Chris Cuomo.
“We?also need to make sure that every safeguard was followed, and that’s what all these scientists and?all these committees are here to do,” she added.
FDA vaccine advisers met Thursday and voted to recommend an EUA for the vaccine. Now the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Saturday.?
The CDC committee must vote to recommend the vaccine, and the agency must accept that recommendation, in order for vaccinations to begin.
Watch:
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting will now begin at 11 a.m. ET Saturday, according to an update on the CDC’s website.
The meeting was previously scheduled for Sunday.
Following the US Food and Drug Administration’s emergency use authorization of Pfizer and BioNTech’s coronavirus vaccine, the CDC committee must vote to recommend it. The CDC must then accept that recommendation for vaccinations to begin.
The vote is expected to take place about 2:30 p.m. ET Saturday.
The US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine is a “significant milestone” in fighting a pandemic that has killed nearly 300,000 Americans, FDA Commissioner Dr. Stephen Hahn said Friday.
“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” Hahn said in a statement.
The emergency use authorization allows the Pfizer-BioNTech Covid-19 vaccine to be distributed in the US, the FDA said in a news release.
It’s not an FDA approval, but the EUA “holds?the promise to alter the course of this pandemic in the United States,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” Marks said.
The US Food and Drug Administration has authorized Pfizer and BioNTech’s coronavirus vaccine for emergency use.
A Pfizer spokesperson confirmed to CNN on Friday?that an EUA had been granted, following the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee.
On Thursday, 17 committee members voted to recommend the FDA issue an EUA for the vaccine. Four voted no and one abstained.
Dr. Gupta discusses:
Florida health system Orlando Health says it will begin vaccinating its employees against Covid-19 on December 18.?
Orlando Health said vaccinations will be administered at Orlando Regional Medical Center and will continue on December 21-23.?
The first round of vaccinations will go to those at highest risk for Covid-19.
Residents of Orlando Health’s long-term care facilities will be among the first to receive vaccines.
The system’s chief medical officer, Dr. George Ralls, said that after Moderna’s vaccine is available, Orlando Health expects to be able to vaccinate its entire workforce.
The US Federal Aviation Administration is urging airports nationwide to be ready for flights carrying the coronavirus vaccine even if the airport is not scheduled to receive it.??
The agency told airports “to ensure they are fully prepared for aircraft carrying Covid-19 vaccines.”
FAA Administrator Steve Dickson directed airports to ensure delivery trucks have priority access to the airfield, and that adequate security is in place for vaccine shipments.
On Thursday, the FAA told CNN it would direct air traffic controllers to give priority clearance to flights carrying the vaccine. The agency said the flights will be monitored from its command center in Warrenton, Virginia, outside Washington, D.C.
