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Top Headlines FDA Review Confirms Pfizer Vaccine is Safe and Effective (Health & Science) AstraZeneca Covid-19 Vaccine Trial Data Reaffirms High Safety, Moderate Efficacy; AstraZeneca to File for Regulatory Approval in U.K. and Other Countries (Health & Science) Lombardy Study Finds Low Risk for Newborns Sharing Rooms with Covid-Positive Moms (Health & Science) Study of British School Reopenings Finds Low Risk of Coronavirus Transmission (Health & Science) Governor Cuomo Outlines Possible Restrictions as Cases and Hospitalizations Rise; Governor Roy Cooper Outlines New Restrictions for North Carolina (Health & Science) EU Might Need Another Summit to Work Out Stimulus Deal, Says Poland’s Foreign Minister (Around the World) Virus Infected 70% of People in a City in the Brazilian Amazon (Around the World) UAE Registers China’s Sinopharm Vaccine for Use (Around the World) Stimulus Update: White House Proposes Lower Unemployment Benefits but $600 Direct Checks (U.S. Government & Politics) Slaoui: I Can’t Explain Trump’s Executive Order on Vaccine Prioritization (U.S. Government & Politics) Stocks Rise on Vaccine News (U.S. Economy) Racial Disparities Apparent as New York City Schools Reopen with 12,000 More White Children Returning than Black Children (U.S. Society) How Mall Santas are Adapting to the Pandemic (U.S. Society) Health & Science There have been 15,172,602 coronavirus cases in the United States, and 286,338 people have died (Johns Hopkins). Around 5,786,915 people have recovered, and the United States has conducted 207,572,528 tests. Worldwide, there have been 68,321,808 confirmed cases of coronavirus, with 1,559,092 deaths. At least 44,051,723 people have recovered from the virus. FDA Review Confirms Pfizer Vaccine is Safe and Effective The U.S. Food and Drug Administration (FDA) met on Tuesday to review safety and efficacy data for the coronavirus vaccine made by Pfizer and its German partner BioNTech. Last month, Pfizer and BioNTech announced an efficacy rate of 95% after two doses of the vaccine, given three weeks apart. New details from the review show that the vaccine has an 88% efficacy against severe Covid-19 about a week after the first dose, with the second dose providing 95% efficacy. The vaccine also works well in people of any age, race, or weight. In briefing documents published Tuesday morning, the FDA affirmed that the vaccine “met the prescribed success criteria” and had “a favorable safety profile, with no specific safety concerns.” The FDA’s vaccine advisory panel will convene in an all-day meeting on Thursday to discuss the briefing document, meet with Pfizer executives and hear public comments. The expert panel will then vote on whether to recommend the vaccine for emergency use. An official authorization decision is expected within days of the Thursday meeting (NYT, Politico, WaPo, WSJ). AstraZeneca Covid-19 Vaccine Trial Data Reaffirms High Safety, Moderate Efficacy; AstraZeneca to File for Regulatory Approval in U.K. and Other Countries Full, peer-reviewed data on Phase 3 trials of the Covid-19 vaccine developed by AstraZeneca and the University of Oxford reaffirms that the vaccine is very safe and is moderately effective in preventing Covid-19. The new peer-reviewed data, published Tuesday in the medical journal The Lancet, includes data from trials in multiple phases and includes safety data on more than 20,000 participants. As earlier results suggested, the standard two-dose immunization regimen was 62% effective in preventing Covid-19. However, among a group who received first a half dose and then a full dose, efficacy was boosted to 90%. The reason for this discrepancy is unclear, and some experts believe the effect was merely one of statistical chance rather than a true effect. The data also reaffirm the safety of the vaccine. Only three serious adverse events were reported, with two potentially related to the vaccine. One, reported previously, was a case of transverse myelitis, a rare neurological disorder. Another individual developed a fever of over 104 degrees Fahrenheit. It is unknown whether this person received the vaccine or a placebo. AstraZeneca plans to submit its vaccine for approval by U.K. regulatory agencies and other agencies around the world. It is expected that the U.S. Food and Drug Administration will require the company to complete its ongoing U.S.-based trials before considering the vaccine for authorization. Although the AstraZeneca vaccine is less effective than the vaccines put out by Pfizer and Moderna, it still meets efficacy standards recommended by experts. It is also cheaper to produce and easier to store, making it an attractive option for low- and middle-income countries (WSJ, STAT, WaPo). Lombardy Study Finds Low Risk for Newborns Sharing Rooms with Covid-Positive Moms A study published in the medical journal JAMA Pediatrics found that new mothers with active Covid-19 infections were unlikely to pass the virus on to their newborn babies (CIDRAP). The study examined 62 babies born to 61 mothers in Lombardy, Italy earlier this spring. Mothers and babies were monitored for 20 days after birth, during which time parent-child pairs were housed in dedicated Covid-19 units and did not have outside visitors. Mothers were encouraged to breastfeed their babies if possible and instructed to wash their hands and wear masks before feeding. Of 62 infants, only one contracted coronavirus during the study period. This infant was given care in the neonatal intensive care unit after the mother developed severe illness requiring mechanical ventilation. The infant experienced mild shortness of breath for several days but did not exhibit more severe symptoms. The report stated that all infants remained in good clinical condition during the study. The authors of the study wrote, "We believe that SARS-CoV-2–infected mothers in good clinical condition and willing to take care of their babies should be encouraged to practice rooming-in and breastfeeding after being carefully instructed about the appropriate droplet and contact precautions." Study of British School Reopenings Finds Low Risk of Coronavirus Transmission A study published on Tuesday in The Lancet found that few English schools had confirmed outbreaks after reopening in the fall, adding to increasing evidence that schools are relatively low-risk environments for viral spread (NYT). After closing in March, many schools in England reopened in June and July after case numbers subsided. A prospective analysis of early education, primary and secondary schools found 55 outbreaks and about 450 cases of Covid-19 among staff and students. Student-to-student transmission was rare, and schools with higher incidence tended to be in areas with high community transmission. Several limitations of the study were noted, including the potential for low rates of testing among children, who often experience only mild symptoms, and the fact that relatively few secondary schools opened for in-person learning. However, the authors emphasized that good community control measures should be used to protect students and staff in order to support safety in in-person educational settings. Governor Cuomo Outlines Possible Restrictions as Cases and Hospitalizations Rise; Governor Roy Cooper Outlines New Restrictions for North Carolina New York Governor Andrew Cuomo said that new restrictions could be set for New York City as soon as Monday if conditions do not improve over the next several days (Politico). The city has seen a surge in hospitalizations and holiday-related viral transmission, and the governor has asked hospitals to increase their bed capacity by 25%. For now, restrictions will mostly focus on indoor dining, which will be shut down if hospitalizations do not stabilize by Monday. If hospitalizations are on track to reach 90% within three weeks, the state could shut down all nonessential businesses. The governor urged residents to “change their behavior and be more careful” in order to avoid these restrictions. In North Carolina, Governor Roy Cooper imposed a curfew on Tuesday in hopes of slowing the spread of the coronavirus that has continued to climb over the last month (NYT). The “modified stay-at-home order” requires residents to stay home between 10 p.m. and 5 a.m. except for essential trips and also orders most businesses to also close during those hours. The sale of alcohol for on-premise consumption must end at 9 p.m. The curfew takes effect Friday and Gov. Cooper warned that other measures could be put in place if daily case counts continue to increase. The number of people hospitalized in the state has nearly doubled in the past month and the daily number of deaths has also increased. Bonus Reads: “The Record Turnaround for Covid-19 Vaccines has Years of Extraordinary Science to Thank,”(WaPo); “A Nursing Researcher’s Experience in a COVID-19 Vaccine Trial,”(JAMA); “No, the Pfizer and Moderna Vaccine Development Has Not Been ‘Reckless,’”(NYT). Around the World Europe EU Might Need Another Summit to Work Out Stimulus Deal, Says Poland’s Foreign Minister Another European Council might be necessary to work out a deal on the EU budget, said Poland’s Foreign Minister Zbigniew Rau on Wednesday. Poland and Hungary are currently blocking a 1.8 trillion euros ($2.18 trillion) in funding for an EU stimulus package that will help nations overcome economic strains caused by the pandemic because they oppose linking the funds to the rule of law (Reuters). The issue will be discussed at an EU summit on Thursday but Rau told Polish state radio, “If we can’t reach an agreement in the next two days ... there will have to be another European Council this year or the negotiations will be moved to new circumstances under the Portuguese presidency.” Poland’s Prime Minister Mateusz Morawiecki and ruling party leader Jaroslaw Kaczynski met with Hungarian Prime Minister Viktor Orban in Warsaw on Tuesday evening. Orban said after the meeting that there was a “good chance” to work out a deal this week. Asia Cruise from Singapore Turns Around After Passenger Tests Positive A Royal Caribbean International cruise from Singapore was forced to turn back early after a passenger tested positive for the coronavirus, the company said late Tuesday (WaPo). The cruise ship operator began sailing short “cruises to nowhere” on Quantum of the Seas after developing health protocols with authorities in Singapore (Reuters). The first voyage was on Dec. 1 and marked the Royal Caribbean’s first cruise with paying passengers since the pandemic began. The cruise that was forced to turn back on Monday was supposed to last four days and three nights, but as of Wednesday morning passengers were still onboard and being told to stay in their cabins. Bonus Read: “A Covid-Free Cruise Takes Planning, but the Strip Show Goes On,” (NYT). South Korea Battles Third Wave of Infections South Korea reported 686 new coronavirus cases on Wednesday in what health officials are calling a third wave of infections (Reuters). The daily tally was the second-highest since the start of the pandemic and new cases have hovered around 600 per day over the past week. Authorities believe the healthcare system is on the verge of being overwhelmed and enacted tougher social distancing rules on Tuesday, including unprecedented curfews on restaurants and other businesses. The government is also using a new testing method to respond to surging demand. Americas Virus Infected 70% of People in a City in the Brazilian Amazon Just seven months after the first coronavirus case in Brazil’s Amazon, it has infected more than 70% of the population in the city of Manaus, according to a study published on Tuesday. The first case in Manaus was diagnosed on March 13 and from there tore through the population largely unchecked. The percentage of people with antibodies indicating past infection jumped from less than 5% in April to nearly 45% in June, according to the study, which was published in the journal Science. The New York Times writes: “In October, only 26 percent of the population tested positive for antibodies. But antibodies to the coronavirus can wane over time, complicating efforts to assess how widely the virus has spread. The researchers attempted to account for this decline, and estimated that 66 percent of the population in Manaus had been exposed to the virus by July and 76 percent by October.” The researchers said their estimate is “conservative.” Middle East UAE Registers China’s Sinopharm Vaccine for Use The Ministry of Health for the United Arab Emirates announced Wednesday that they had registered China’s Sinopharm coronavirus vaccine for use even though it has not been officially approved in China yet (WaPo). Health officials reviewed the company’s interim analysis of the vaccine’s Phase 3 trial results that said it was 86% effective against coronavirus infection. It had already been approved for emergency use and was used to inoculate UAE health workers beginning in September. The state news agency said the registration of the vaccine marks “a significant vote of confidence by the UAE’s health authorities in the safety and efficacy of this vaccine.” The UAE has had 178,837 confirmed cases of coronavirus since the beginning of the pandemic with 596 deaths.
U.S. Government & Politics Bonus Read: “Introducing his Health Team, Biden Sets Ambitious Goals for Pandemic Response in his First 100 Days” (NYT). Stimulus Update: White House Proposes Lower Unemployment Benefits but $600 Direct Checks On Tuesday, the White House proposed a new plan amid continuing efforts to break the deadlock on a stimulus package to help relieve the economic impact of the pandemic (WaPo). The plan would reduce unemployment benefits compared to other plans being examined, but include a $600 direct check. The Washington Post reports, “Treasury Secretary Steven Mnuchin has proposed that lawmakers approve another stimulus check worth $600 per person and $600 per child, the people familiar with the plan said, speaking on the condition of anonymity to share details of private deliberations.” The proposal seems unlikely to break the deadlock over stimulus with the Post reporting, “The new White House proposal was a nonstarter for Democrats and a sharp rejection of the bipartisan efforts that have brought the two parties closer to a compromise on a legislative package amid signs that the U.S. economy is deteriorating under the increasing strain of the coronavirus.” The current bipartisan proposal being floated would include about $180 billion for expanded unemployment benefits providing $300 per week in federal aid and extending other efforts. In contrast, Mnuchin’s proposal would provide only $40 billion. Speaker of the House Nancy Pelosi and Senate Minority Leader Chuck Schumer, stated, “The bipartisan talks are the best hope for a bipartisan solution,” adding, “The President’s proposal starts by cutting the unemployment insurance proposal being discussed by bipartisan Members of the House and Senate from $180 billion to $40 billion. That is unacceptable.” Slaoui: I Can’t Explain Trump’s Executive Order on Vaccine Prioritization On Tuesday, Moncef Slaoui, the chief scientist for Operation Warp Speed, the United States’ vaccine development effort, said he could not explain Trump’s executive order aimed at prioritizing shipments of vaccines to the U.S. (Politico). Slaoui told ABC’s “Good Morning America,” “Frankly, I don’t know, and frankly, I’m staying out of this. I can’t comment” adding, “We have plans. We feel that we can deliver the vaccines as needed. So I don’t know exactly what this order is about.” The executive order came amid news that the Trump administration had not ordered sufficient numbers of the Pfizer vaccine to cover the American population and that Pfizer’s commitments to other countries’ orders would mean it could not provide more to the U.S. until June or July. Senator Johnson Questions Vaccine Science On Tuesday Senator Ron Johnson (R-WI) assembled a series of witnesses who have put forward questionable views of science regarding the virus to appear before the Homeland Security and Governmental Affairs Committee, according to the New York Times (NYT). The Times writes of the witnesses and the senator’s approach, “There is a prominent vaccine skeptic, an outspoken critic of masking and social distancing, and at least two doctors who have promoted the use of an anti-parasitic drug that government scientists have recommended against using to treat the coronavirus. It is the latest example of how Mr. Johnson, a Wisconsin Republican who has used his powerful investigative panel to amplify groundless accusations pushed by President Trump, has now embraced the role of the Senate’s leading Covid contrarian.” The Times also notes that Senator Johnson “has suggested that the dangers of the coronavirus have been overblown and excessively regulated. And twice in the past three weeks, Mr. Johnson has used his gavel on the Homeland Security and Governmental Affairs Committee to elevate voices who public health experts say represent fringe beliefs.” U.S. Economy Stocks Rise on Vaccine News The stock market rose on Tuesday amid news that the United Kingdom had started its mass vaccination effort using the Pfizer-BioNTech vaccine and reports that Congress is still making an effort to pass stimulus (WSJ). The Wall Street Journal reports, “The S&P 500 added 10.29 points, or 0.3%, to 3702.25, while the Nasdaq rose 62.83 points, or 0.5%, to 12582.77, both closing at their highest levels ever. The Dow Jones Industrial Average also traded higher, gaining 104.09 points, or 0.3%, to 30173.88, falling short of a new milestone.” Bonus Read: “Covid-19, Remote Work Makes Austin a Magnet for New Jobs,” (WSJ). U.S. Society Racial Disparities Apparent as New York City Schools Reopen with 12,000 More White Children Returning than Black Children Racial disparities in efforts to reopen schools are becoming clear as New York City moves to return to in person schooling, according to the New York Times (NYT). The Times reports “That gulf is illustrated in a startling statistic: There are nearly 12,000 more white children returning to public school buildings than Black students — even though there are many more Black students than white children in the system overall. Latino students are returning at a rate roughly proportional to their overall representation in the school system.” Jamila Newman, a project director with TNTP, a consulting firm advising school districts, told the Times, “It’s the perfect storm of marginalization.” Latino students are the most likely to return to schools, but the Times notes that whites are disproportionately represented with “white children, who are less likely to be low-income than many of their peers, make up a quarter of students back in classrooms, even though they represent just 16 percent of overall enrollment, the smallest percentage of any racial group” while “Black and Asian-American families are significantly underrepresented in reopened classrooms.” The Times notes that there is not a single reason for the disparity, but reports that its interviews suggest it may be partially due to a lack of trust in the government’s reopening plans on the part of Black and Asian parents of schoolchildren. Bonus Read: “How to Motivate Teens Struggling With Remote School,” (WSJ). How Mall Santas are Adapting to the Pandemic Taking children to see a mall Santa will look very different for families that try to do so this year amid the pandemic (WSJ). The Wall Street Journal reports that adaptations in the mall Santa industry include face shields for Mr. Claus and plexiglass barriers, and in some cases, virtual visits. Gone is the tradition of sitting on Santa’s lap. The adaptations come with new challenges. Kennison Kyle, a Santa performer who is working from behind a plexiglass snow globe barrier, told the Journal, “I’m on the younger side of the professional Santa crowd and I’ve got good hearing, but it’s tough.” The adaptations may seem just an odd human interest story, but according to the Journal, mall Santas are an important part of stores’ sales efforts. The Journal reports, “Retail analysts say store Santas help drive foot traffic, resulting in more consumer impulse purchases, which drive 25% of holiday sales, says Marshal Cohen, NPD retail analyst.” Bonus Read: “Going It Alone in Two of America’s Agricultural Towns,” (WaPo). Analysis & Arguments The New York Times editorial board weighs in on the deadlocked stimulus negotiations (NYT). Amy Bernstein examines how working women who have been hit hard by the pandemic can benefit from changes that have resulted (NYT). Yasmeen Serhan argues that vaccine nationalism will fail in the end (Atlantic). Readers can send in tips, critiques, questions, and suggestions to coronavirusbrief@newamerica.org. The Brief is edited by David Sterman and Emily Schneider with Jessica Scott and Senior Editor Peter Bergen. Read previous briefs here and stream and subscribe to our weekly podcast here. 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