The nation’s top infectious disease expert said Sunday that the U.S. may see “surge upon a surge” of the coronavirus in the weeks after Thanksgiving, and he does not expect current recommendations around social distancing to be relaxed before Christmas. Meanwhile, in a major reversal, New York City Mayor Bill DeBlasio said the nation’s largest school system will reopen to in-person learning and increase the number of days a week many children attend class. The announcement came just 11 days after the Democratic mayor said schools would shut down because of rising COVID-19 cases. “We feel confident that we can keep schools safe,” he said. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told ABC’s “This Week” that the level of infection in the U.S. would not “all of a sudden turn around.” “So clearly in the next few weeks, we’re going to have the same sort of thing. And perhaps even two or three weeks down the line … we may see a surge upon a surge,” he said. Fauci addressed the school issue, saying that spread “among children and from children is not really very big at all, not like one would have suspected. So let’s try to get the kids back, but let’s try to mitigate the things that maintain and just push the kind of community spread that we’re trying to avoid,” he said. Fauci also appeared on NBC’s “Meet the Press,” where he made similar remarks, adding that it’s “not too late” for people traveling home after Thanksgiving to help curb the virus by wearing masks, staying distant from others and avoiding large groups of people.
The number of new COVID-19 cases reported in the United States topped 200,000 for the first time Friday, according to data from Johns Hopkins University. Since January, when the first infections were reported in the U.S., the nation’s total number of cases has surpassed 13 million. More than 265,000 people have died.
Fauci said the arrival of vaccines offers a “light at the end of the tunnel.” This coming week, the Advisory Committee on Immunization Practices will meet with the Centers for Disease Control and Prevention to discuss a rollout of the vaccine, he said. He added that President-elect Joe Biden should focus on distributing vaccines in an “efficient and equitable way.” Fauci also said he planned to push the new administration for a rigorous testing program. Health care workers will likely be among the first to get the vaccine, with the first vaccinations happening before the end of December, followed by many more in January, February and March, he said. “So if we can hang together as a country and do these kinds of things to blunt these surges until we get a substantial proportion of the population vaccinated, we can get through this,” Fauci said.
Other experts agreed that the coming weeks would be difficult, especially since so many traveled over the holiday and held in-person dinners indoors.
Dr. Deborah Birx, the White House coronavirus response coordinator, said Sunday on CBS’ “Face the Nation” that Americans who traveled this past week should try to avoid people over 65. She said that those who were around others for Thanksgiving “have to assume that you were exposed and you became infected and you really need to get tested in the next week.” Meanwhile, a busy travel weekend continued, despite warnings for Americans to stay close to home and limit their holiday gatherings. Aside from the Thanksgiving holiday itself, anywhere from 800,000 to more than 1 million travelers made their way through U.S. airport checkpoints on any day during the past week, according to Transportation Security Administration statistics. That’s a far cry from the 2.3 to 2.6 million seen daily last year. But it far surpasses the number of travelers early in the pandemic, when daily totals fell below 100,000 on some spring days. More COVID-19 restrictions were in store for California starting Monday. Los Angeles County will impose a lockdown calling for its 10 million residents to stay home. Santa Clara County, which includes San Jose, is banning all high school, collegiate and professional sports and imposing a quarantine for anyone traveling into the region from more than 150 miles away.
Ten corona vaccine candidates are now in late-stage trials. The world is already celebrating what could be the breakthrough in fighting COVID-19. Pharmaceutical companies are also cheering. The public sector has invested billions more in development. but it’s the private sector that will rake in the cash. Under existing agreements, they control the price and get the profits. Pharma firms say development is expensive
The excitement and enthusiasm for a COVID-19 vaccine by the end of 2020 is both palpable and understandable. We all hope for a rapid end to the pandemic and an effective vaccine would be a surefire solution. But there are risks that come with a fast-tracked vaccine delivered end of this year, not the least of which are the risks related to the safety of the vaccine itself.
Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many.
The US alone plans to vaccinate hundreds of millions of people with the first successful candidate. One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people. Aside from questions of safety that attend any vaccine, there are good reasons to be especially cautious for COVID-19. Some vaccines worsen the consequences of infection rather than protect, a phenomenon called antibody-dependent enhancement (ADE). ADE has been observed in previous attempts to develop coronavirus vaccines. To add to the concern, antibodies typical of ADE are present in the blood of some COVID-19 patients. Such concerns are real. As recently as 2016, Dengavxia, intended to protect children from the dengue virus, increased hospitalizations for children who received the vaccine. Questions also arise around the efficacy of a potential vaccine. The little we know of the current generation of COVID-19 vaccines raises serious questions regarding their ability to protect people from infection. We know all the candidates tested to date in non-human primates failed to protect any of the monkeys from infection of the nasal passages, the primary route of human infection. Failure to protect entirely from infection fits with all we know about attempts to protect monkeys from two other deadly coronaviruses, those that cause SARS and MERS. As many of the most serious COVID symptoms do not appear until late in the disease course, sometimes four to five weeks following exposure, there is a possibility that we will not have sufficient time to judge efficacy of a new vaccine, even by the lower standard of symptom amelioration. An effective COVID-19 vaccine also faces several hurdles beyond our control. The older we get the poorer our ability to respond to vaccines. Resistance to vaccination begins early at age 30 and becomes progressively more profound with time. That is especially troubling as those over 60 are the population most at risk. Vaccination of the elderly may sometimes succeed by administering repeated doses and by increasing the potency of the vaccine with powerful adjuvants. But these adjuvants can be especially risky for the very old.
It seems a folly then to rush our way towards a vaccine in 2020 if it is likely to have only limited benefit to the population most in need and may put otherwise healthy people at risk. The risk goes far beyond the dangers a COVID vaccine alone may hold.
Public support for vaccines in general is already an issue. Trust in other lifesaving vaccines will be eroded even further if a COVID vaccine goes wrong and many more people—children especially—will be at risk if vaccination rates fall. Yes, we are all increasingly longing for an end to the outbreak. But a safe vaccine, effective for all those at risk, is worth the wait, especially when we have other solutions in hand. We already know from the experience of countries in Asia that the epidemic can be stopped in its tracks with basic public health measures: widespread testing, contact tracing, and mandatory controlled quarantine—not necessarily in a dismal public health facility as many imagine, but in our own homes with virtual supervision or in a hotel environment. These efforts alone could bring new infections down to almost zero within just weeks.
There is no doubt we need an urgent end to the pandemic. Economies around the world are crashing. Governments are piling up trillions of dollars in debt. And, in the US alone, tens of millions are without work or income. But there are still costs that are too great, even when compared to such numbers. When we have solutions to the pandemic in hand we cannot risk the potential lives lost of rushing a COVID vaccine to market.
Several scientists have raised doubts about the robustness of results released on Monday showing the experimental vaccine was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.Soriot said he did not expect the additional trial to delay British and European regulatory approvals.Asked about the Bloomberg report, an AstraZeneca spokesman said there was strong merit in continuing to investigate the half-dose/full dose regimen. Any further insights from the data would be added to those from existing trials that are being prepared for regulatory submission, he said. Running an additional trial might not be too much of a complication for the British drugmaker in the race to develop a vaccine to help tame the pandemic, which has killed more than a million people and roiled the global economy. Helen Fletcher, professor of immunology at the London School of Hygiene & Tropical Medicine, said another trial would not necessarily delay getting a green light as efficacy in the higher dose regime still met the World Health Organization’s target. It was not unusual to run new studies on approved vaccines, she said. The vaccine is one of three that could get approved before the end the year. This month, Pfizer and Moderna reported that their vaccines were about 95% effective in preventing illness, setting the bar sky-high.Even so, the AstraZeneca shot developed with Oxford University is cheaper to make, easier to distribute and faster to scale up than its rivals. Britain on Friday asked its medicine regulator to assess if the vaccine candidate met rigorous safety standards with a view for temporary supply, a step towards beginning a roll-out of the vaccine before the end of the year.AstraZeneca expects 4 million doses to be available in Britain by the end of next month. A peer-reviewed analysis of data from the new trial will be published in a medical journal in coming weeks. The European Medicines Agency did not immediately respond to requests for comment.AstraZeneca told Reuters earlier on Thursday that administering of the half dose had been reviewed and approved by independent data safety monitors and the British regulator, adding that the regulator publicly confirmed there was “no concern”. Clearance from the U.S. Food and Drug Administration (FDA) may take longer, though, because the agency is unlikely to approve the vaccine based on studies carried out elsewhere, especially given the questions over the results, Soriot said.AstraZeneca research chief Mene Pangalos told Reuters on Monday the firm would start discussions with the FDA to change the design of its trial to add the more-effective dosage regime.Authorisation in some countries is still expected before the end of the year.Astrazeneca has struck deals to supply the vaccines in several countries, including 120 million doses to Japan and 85 million doses to Australia. Australian Prime Minister Scott Morrison, talking to media, expressed confidence about the vaccine, which is being manufactured by the country’s biomedical giant CSL Ltd.The Serum Institute of India is conducting trials of the vaccine there. “Even the lowest efficacy results are at 60-70%, making it a viable vaccine against the virus,” the institute said in a statement, adding that the trials were running smoothly.
8,041,239 (97%)
An increase in cases of COVID-19 has sent San Francisco into the purple level of California’s color-coded reopening plan, officials announced on November 28. As a result, the county must now join most of the rest of the state’s limited stay-at-home order, which requires that “non-essential work, movement, and gatherings,” including outdoor dining, cease between 10 p.m. and 5 a.m. from November 30 until December 21. This isn’t a surprise to city and county health officials, who warned on November 20 that the region was on track to move from the red (“substantial risk” of COVID-19 exposure) to the most restrictive, purple tier (“widespread risk”) in coming days. Counties that enter the purple tier, Gov. Gavin Newsom announced on November 19, must follow a state-mandated shelter-in-place order “designed to reduce opportunities for disease transmission,” including the weeks-long curfew. “Activities conducted during 10 PM to 5 AM are often non-essential and more likely related to social activities and gatherings that have a higher likelihood of leading to reduced inhibition and reduced likelihood for adherence to safety measures like wearing a face covering and maintaining physical distance,” the state said in a statement regarding the curfew, which now applies to 99.1 percent of the state’s population, including every county in the Bay Area but Marin (which, as of publication time, remains red). You can see a full list of tier assignments here.
Beginning Monday, Nov. 30th at 10pm, SF will comply with the State’s required Limited Stay at Home Order that requires non-essential businesses to close and prohibits members of different households from gathering indoors or outdoors between 10:00pm & 5:00am until December 21st.
— London Breed (@LondonBreed) November 28, 2020
According to the announcement of the shutdown from the city, customers must leave restaurants by 10 p.m., but restaurants may remain open for takeout or delivery. Other non-essential businesses must close and gatherings must cease, but businesses like grocery and convenience stores may remain open, with a capacity limit of 50 percent.
“This is the most aggressive surge SF has seen to date,” Breed says, as “we’re currently averaging 118 new cases per day compared to 73 per day in the first week of November…For the week of November 16th, we had 768 diagnosed cases compared to 217 diagnosed cases the week of October 12th.”
Breed’s remarks follow those of San Francisco Health Director Dr. Grant Colfax, who said on November 27 that the number of San Franciscans that have tested positive for COVID-19 “in the last 4 weeks has increased 265 percent.” It’s also expected — but still tough — news for the city’s restaurants, many of which rely on dinner service to remain afloat. In a statement, the Golden Gate Restaurant Association, the lobbying group for San Francisco’s dining industry, says that the 10 p.m. curfew means that “although outdoor dining in San Francisco will remain open…restaurants will in reality not be able to take reservations past 8 or 8:30 p.m., therefore severely limiting their ability to do business.” “Although our foremost concern remains with the health and well-being of our community, we expect immediate negative effects to our industry and continue to call on our city leaders to help us survive by making financial relief available for our restaurants and our employees,” the GGRA says. “We also call on Congress to pass a relief package that includes the Restaurants Act and additional PPP funding immediately.”
Traffic at stores on Black Friday fell by 52.1% compared with last year, as Americans by and large eschewed heading to malls and queuing up in lines for shopping online, according to preliminary data from Sensormatic Solutions. For the six key weeks of the holiday season this year, traffic in retail stores is expected to be down 22% to 25% year over year, an earlier forecast by Sensormatic Solutions said. “We knew Black Friday [traffic] was going to be down, we just didn’t know how much it was going to be down,” said Brian Field, a senior director of global retail consulting at Sensormatic Solutions. “Shoppers are spreading out their shopping throughout the holiday season because of concerns about social distancing and the pandemic.” The Covid pandemic has pushed a record number of consumers to shop online, instead, as retailers place many of their top holiday doorbuster deals online and encourage shoppers to buy on the web and then pick up purchases curbside. The Centers for Disease Control and Prevention also recommended that Americans shop online the day after Thanksgiving.
Many malls looked bleak, and parking lots were more empty than full, across much of the country during the early hours of the morning Friday.
Some reported traffic picking up later in the day, especially at outlet and open-air shopping centers, as some consumers felt more comfortable heading out. The warmer weather that blanketed much of the country also helped. The typical peak time for shopping on Black Friday remained the same this year, hitting at about 2 p.m., Sensormatic Solutions said. On Thanksgiving Day, when many retailers including Walmart and Target closed their stores this year due to the pandemic, traffic dropped 94.9% year over year, according to the firm. Week-to-date, traffic is down 45.2% across the U.S. “Black Friday this year, from a traffic impact perspective, looked a lot like a typical Saturday after a Black Friday,” Field said.
https://youtu.be/Aw6egSqLp3I
The deadly reality of America’s bitter battle against coronavirus was obvious to families that gathered across the country for Thanksgiving dinner: There were empty seats around the table. In Deer Park, New York, Vivian Zayas replaced a seat from the table at her home with her late mother’s walker. She scrolled through photos of last Thanksgiving, when her mother, Ana Martinez, who died in April of COVID-19, stood at the stove making a pot of rice and beans. For Jessica Franz, a nurse who works the graveyard shift at Olathe Medical Center in a Kansas suburb, a typical year would have her mother-in-law laying out a feast for her children. That didn’t happen this year: Elaine Franz died of the coronavirus on Nov. 10, a day before her 78th birthday. The number of COVID-19 hospitalizations continues to rise, hitting a record for the 17th straight day Thursday with more than 90,400 admissions, according to the COVID Tracking Project. Tuesday and Wednesday saw record deaths of over 2,100 each day, according to John Hopkins University data. Every minute, 114 Americans are testing positive for COVID-19, according to Johns Hopkins University data. Every hour, 65 Americans are dying. The turnaround time for test results is lagging, too. Amid a record demand ahead of the Thanksgiving weekend, Quest Diagnostics said this week that it’s taking up to three days to complete a test after receiving a sample. LabCorp, another large private lab company, reported tests now taking up to two days. The U.S. has reported more than 12.8 million cases and over 263,400 deaths, according to Johns Hopkins University data. This week week, five states set death records and 23 states had higher case counts than last week. The global totals: more than 61 million cases and 1.4 million deaths.
LONDON (AP) — AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine. A statement describing the error came days after the company and the university described the shots as “highly effective” and made no mention of why some study participants didn’t receive as much vaccine in the first of two shots as expected. In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90% effective. In the group that got two full doses, the vaccine appeared to be 62% effective. Combined, the drugmakers said the vaccine appeared to be 70% effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts. The partial results announced Monday are from large ongoing studies in the U.K. and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.
DID RESEARCHERS MEAN TO GIVE A HALF DOSE?
Before they begin their research, scientists spell out all the steps they are taking, and how they will analyze the results. Any deviation from that protocol can put the results in question.
In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half dose.
The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement. Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, AstraZeneca said. A total of 8,895 people received two full doses. Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose. Another point of confusion comes from a decision to pool results from two groups of participants who received different dosing levels to reach an average 70% effectiveness, said David Salisbury, and associate fellow of the global health program at the Chatham House think tank. “You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ he said of the figure. “I think many people are having trouble with that.″
WHY WOULD A SMALLER FIRST DOSE BE MORE EFFECTIVE?
Oxford researchers say they aren’t certain and they are working to uncover the reason. Sarah Gilbert, one of the Oxford scientists leading the research, said the answer is probably related to providing exactly the right amount of vaccine to trigger the best immune response. “It’s the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well,” she said. “So you want just the right amount and it’s a bit hit and miss when you’re trying to go quickly to get that perfect first time.” Details of the trial results will be published in medical journals and provided to U.K. regulators so they can decide whether to authorize distribution of the vaccine. Those reports will include a detailed breakdown that includes demographic and other information about who got sick in each group, and give a more complete picture of how effective the vaccine is. Moncef Slaoui, who leads the U.S. coronavirus vaccine program Operation Warp Speed, said Tuesday in a call with reporters that U.S. officials are trying to determine what immune response the vaccine produced, and may decide to modify the As results. AstratraZeneca study in the U.S. to include a half dose. “But we want it to be based on data and science,” he said.
As millions of Californians are traveling and gathering for Thanksgiving, the state is experiencing an unprecedented surge in infections and hospitalizations. The state has seen its three highest tallies of new cases ever in the past five days. On Tuesday, the number of new infections was 15,329. That’s down slightly from what was the all time high of 15,442 on Saturday, but Wednesday’s number dwarfed them both at 18,350. That’s a 17% jump in cases in 24 hours and a rise so steep that the state’s line graph for daily cases is nearly vertical.
“Statewide, I don’t think we’ve ever seen hospital admissions increase like we did just over the past 24 hours,” said California Director of Health and Human Services Dr. Mark Ghaly on Tuesday. “I hope but don’t expect that it’s the highest we’ll ever have.”
Ghaly was right. Just 24 hours later, the number of hospitalizations jumped another 5%, with 408 new patients recorded. As Deadline reported Tuesday, the daily number of hospitalizations due to the virus in California had increased 81% in the 14 days prior, to 6,641. Wednesday’s number brought the number of Covid-19 patients hospitalized in the state to 7,049, which is approaching the all-time high of 8,820 hospitalizations seen on July 21.
California COVID-19, By The Numbers:
🔹 Confirmed cases to date: 1,144,049
🔹 Note: Numbers may not represent true day-over-day change as reporting of test results can be delayed
Ghaly reminded that today’s hospitalizations are the result of the number of infections seen two weeks prior. So Tuesday’s patients are based on a case number of 7,000 that we saw on November 10. Tuesday’s daily new case count was 15,329, more than double that from two weeks ago. “We’re concerned,” said Ghaly about what lies ahead. According to Ghaly and others, Covid-19-related hospitalizations down the road have worked out to be 12% of the daily infections number. That means the number of new hospitalizations resulting from Tuesday’s new case count will be 1,839. The number of new hospitalizations resulting from Saturday’s new cases will be 1,853 in two weeks. According to Gov. Gavin Newsom, 44,369 of the state’s 73,867 hospital beds were occupied on Monday. That seems like a good cushion, but even just a week of new admissions in the range of 1,800 is another 12,600 beds occupied. Two weeks at that rate is another 25,200 beds taken up. Adding that to the Monday’s total would have about 70,000 of the state’s 73,867 beds full. And those are just Covid-19 cases. That number does not account for the state’s usual daily demand due to other maladies. Test positivity rates present more evidence of the state’s crisis. In the past week, California is delivering far more tests per day than it ever has, yet the positivity rate continues to grow. That means the actual number of infections in the population is growing. The 14-day test positivity rate is now 5.9%. That’s up 2% over the past two weeks. California has 40 million residents. A 2% jump in infections in a population that size could represent up to 800,000 additional cases. Despite pleas from state and local officials urging residents not to travel for Thanksgiving due to the coronavirus, millions of Southern Californians are still expected to do just that, with this afternoon anticipated to be the busiest time on Southland freeways. The Automobile Club of Southern California estimated that 3.86 million Southern California residents will be traveling for the holiday weekend, a 13% drop from last year. Health authorities have been recommending against travel this Thanksgiving due to surging COVID-19 cases. The state has issued a travel advisory, urging people who do travel to quarantine for 14 days upon their return. Travelers coming through Los Angeles International and Van Nuys airports and Union Station beginning Wednesday will be required to sign a form acknowledging California’s recommended 14-day self quarantine in response to rising coronavirus rates. During a Monday briefing, Mayor Eric Garcetti urged people to not travel over the Thanksgiving holiday, not even to go across town because of how widespread Covid-19 cases have been recently.
We’re asking everyone to cancel non-essential travel. If you must travel, travelers arriving at LAX or Van Nuys Airport from another state or country will be required, starting tomorrow, to fill out an online form to acknowledge California’s recommended 14-day self-quarantine.