Coronavirus live updates: Ex-CDC head warns of 'bumps in the road' with vaccination
Myriam Borzee/iStockBy MORGAN WINSOR, ERIN SCHUMAKER and IVAN PEREIRA, ABC News
(NEW YORK) — A pandemic of the novel coronavirus has now infected more than 63.3 million people and killed over 1.4 million worldwide, according to real-time data compiled by the Center for Systems Science and Engineering at Johns Hopkins University.
Here’s how the news is developing Tuesday. All times Eastern:
Dec 01, 11:47 am
November marks worst month on record for cases, hospitalizations in US
More than 4.2 million people in the United States were diagnosed with COVID-19 in the month of November alone — a figure that’s higher than the total number of confirmed cases for every other country in the world except Brazil and India, according to data collected by Johns Hopkins University.
The number is roughly equivalent to one in every 76 Americans testing positive for COVID-19 in November, or 99 Americans testing positive every minute.
Throughout the month of November, the country saw a sharp increase in COVID-19 cases, recording more than 100,000 each day since Nov. 4 — 27 straight days. At least 40 U.S. states and Puerto Rico reported a record number of daily cases in November.
The United States is currently averaging 158,000 new cases per day, a 96% increase from the start of November. However, it’s difficult to know exactly where the country stands given the data inconsistencies due to lags in reporting over Thanksgiving followed by backlogs from the holiday.
November also marked the deadliest month for COVID-19 in the United States since May, with 36,745 fatalities from the disease. The country currently accounts for 18.3% of the global death toll in the coronavirus pandemic. The nation’s seven-day average of daily COVID-19 deaths has increased by nearly 80% since the beginning of November.
Last week, there were two days with over 2,000 new deaths reported nationwide — the first time that threshold had been crossed on consecutive days since late April.
Meanwhile, more Americans are currently hospitalized with COVID-19 now than ever before. That figure topped 96,000 on Monday and is well on track to surpass 100,000 before the end of the week.
The number of COVID-19 patients hospitalized in western states is now the highest it’s been since the beginning of the pandemic, while that figure is reaching near records in midwestern and southern states. In turn, states across the country are warning that hospital systems are on the brink of collapse.
ABC News’ Benjamin Bell, Brian Hartman, Soorin Kim and Arielle Mitropoulos contributed to this report.
Dec 01, 10:44 am
FDA commissioner meets with White House chief of staff amid tensions over vaccine approval
Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration, was seen arriving at the White House on Tuesday morning ahead of his scheduled meeting with President Donald Trump’s chief of staff, Mark Meadows.
It’s unclear if Trump is participating in the meeting.
A source told ABC News that the meeting was called amid frustrations that the FDA hasn’t moved faster in authorizing emergency use of a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.
Hahn issued a statement ahead of the meeting, defending his agency’s timeline.
“Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision,” Hahn said. “We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”
The FDA is already moving at an accelerated pace in going through data related to the vaccine candidate, but it’s a process that takes weeks given the sheer volume and the stakes for getting it right.
“The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review,” a spokesperson for the agency told ABC News in a statement Tuesday. “Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects.”
Meanwhile, an FDA spokesperson also confirmed to ABC News that Hahn had recently self-quarantined “out of an abundance of caution,” following potential exposure at the agency’s campus in White Oak, Maryland. He chose a remote location and continued working.
“Dr. Hahn has worked every single day of this pandemic, including weekends, holidays and more,” the spokesperson said in a statement Tuesday.
ABC News’ Katherine Faulders, Anne Flaherty and Jordyn Phelps contributed to this report.
Dec 01, 10:16 am
F1 champion Lewis Hamilton tests positive, will miss Sakhir Grand Prix
Formula One champion Lewis Hamilton said he will miss the Sakhir Grand Prix in Bahrain this weekend after testing positive for COVID-19.
After having three negative test results this past week, the 35-year-old British racing driver said he woke up Monday morning with “mild symptoms” and requested another test which came back positive. He said he has immediately gone into self-isolation for 10 days.
“I’m devastated that I won’t be racing this weekend,” Hamilton said in a statement posted on his official Instagram account Tuesday. “Since we started the season in June, my team and I have been taking all the precautions we possibly can and following the regulations everywhere we’ve been in order to stay safe.”
Hamilton, whose victory at the Turkish Grand Prix in Istanbul on Nov. 15 sealed the Formula One championship and his record-equaling seventh world title, said he considers himself “really lucky” to only have mild symptoms and that he will do his best “to stay fit and healthy.”
“Please look after yourselves out there, you can never be too careful,” he said. “These are worrying times for everyone and we need to make sure we are looking after ourselves and each other.”
Dec 01, 8:57 am
Netherlands makes face masks mandatory indoors
People are now required to wear face masks in all indoor public spaces in the Netherlands.
The Dutch government is one of the last in Europe to introduce such a mandate.
The new rule, which came into force Tuesday, applies to everyone over the age of 13 when in publicly accessible, covered places such as airports, barber shops and hair salons, covered car parks and gas stations, public transportation including platforms, town halls and retail stores. Students and teachers will also have to wear masks when walking around school buildings but not when seated during lessons.
Places of worship and buildings not accessible to the general public are exempt.
Those who ignore the mask mandate face a fine of up to 95 euros (about $114).
Dec 01, 7:47 am
Ex-CDC head says this is ‘the single most complicated vaccination program in American history’
The former director of the U.S. Centers for Disease Control and Prevention said that although he expects a COVID-19 vaccine to be approved soon, he also anticipates “some bumps in the road.”
“When you vaccine millions of people, some people get really sick after the vaccination and you don’t know whether that was the vaccine or that was just coincidence. So that has to be studied carefully or you’re going to get all sorts of wild rumors flying around,” Dr. Tom Frieden, who is now the president and CEO of Resolve to Save Lives, told ABC News chief anchor George Stephanopoulos in an interview Tuesday on Good Morning America.
“There may be production problems, there may be rumors, there may be people who don’t want to take it even if you do have the vaccine,” he added. “So this is probably, George, the single most complicated vaccination program in American history.”
Although a vaccine may be right around the corner, Frieden said people must remain vigilant this winter by wearing masks, washing hands, practicing social distancing and avoiding indoor gatherings.
“We have to double down on safety protocols or we’re going to see the worst season we’ve yet had for COVID,” he warned. “We can all do more.”
Dec 01, 7:26 am
Europe’s regulator to decide on Pfizer/BioNTech vaccine by Dec. 29, Moderna’s by Jan. 12
The European Medicines Agency (EMA) said Tuesday that it could decide by Dec. 29 whether to recommend granting a conditional marketing authorization for a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.
Meanwhile, the European drug regulator said its assessment of another COVID-19 vaccine developed by American biotechnology company Moderna, which has also applied for a conditional marketing authorization, could be completed by Jan. 12.
In the European Union, conditional marketing authorizations allow for the approval of medicines or vaccines “that fulfill an unmet medical need on the basis of less complete data than normally required,” according to the EMA. However, the data must show that the benefits outweigh any risks, and companies must provide further data from ongoing or new studies once a conditional marketing authorization has been granted.
The EMA said its reviews of both vaccine candidates “will proceed under an accelerated timeline” and that decisions could be issued “within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.”
“Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the agency said in a statement Tuesday. “These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds.”
If the EMA decides to recommend granting a conditional marketing authorization, the agency said the European Commission will then fast-track its decision-making process with a view to granting an authorization that’s valid in all EU and European Economic Area member states “within days.”
Dec 01, 5:56 am
Pfizer, BioNTech seek vaccine approval in Europe
U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have submitted an application for conditional approval of their COVID-19 vaccine with the European Medicines Agency.
The submission, which occurred Monday, completes the rolling review process that the two companies initiated with the regulator on Oct. 6.
“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Pfizer chairman and CEO Albert Bourla said in a statement Tuesday. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”
If the vaccine candidate, called BNT162b2, is approved, the companies said it could potentially be available for use in Europe before the end of the year.
“As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” BioNTech CEO and co-founder Ugur Sahin said in a statement Tuesday. “We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”
Dec 01, 5:27 am
US reports over 157,000 new cases
There were 157,901 new cases of COVID-19 confirmed in the United States on Monday, according to a real-time count kept by Johns Hopkins University.
It’s the 28th straight day that the country has reported over 100,000 newly diagnosed infections. Monday’s count is down from a peak of 205,557 new cases last Friday.
An additional 1,172 fatalities from COVID-19 were also registered nationwide on Monday, less than the all-time high of 2,609 new deaths on April 15.
COVID-19 data may be skewed in the coming days and weeks due to possible lags in reporting over Thanksgiving followed by a potentially very large backlog from the holiday.
A total of 13,545,017 people in the United States have been diagnosed with COVID-19 since the pandemic began, and at least 268,087 of them have died, according to Johns Hopkins. The cases include people from all 50 U.S. states, Washington, D.C. and other U.S. territories as well as repatriated citizens.
Much of the country was under lockdown by the end of March as the first wave of pandemic hit. By May 20, all U.S. states had begun lifting stay-at-home orders and other restrictions put in place to curb the spread of the novel coronavirus. The day-to-day increase in the country’s cases then hovered around 20,000 for a couple of weeks before shooting back up over the summer.
The numbers lingered around 40,000 to 50,000 from mid-August through early October before surging again to record levels, crossing 100,000 for the first time on Nov. 4 and reaching 200,000 for the first time on Nov. 27.
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