Category: Breaking News

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US up premarket amid stimulus expectations

LONDON (Reuters) – World stocks rose to record highs on Wednesday on the prospect of effective coronavirus vaccines and more U.S stimulas

LONDON (Reuters) – World stocks rose to record highs. Markets will look to the U.S. Federal Reserve later to see whether it hints at an extension of its stimulus programme and it thinks the economy will suffer a double-dip recession or is on the cusp of a vaccine-inspired boom. “We are not expecting a lot of fireworks from the Fed today – they have already engineered very easy monetary conditions and the tone of their messaging has been persistently dovish,” said Marija Vertimane, senior strategist at State Street Global Markets. “This is unlikely to change … in this meeting.” MSCI broadest index of Asia Pacific shares outside of Japan had followed Wall Street’s latest rise to end 0.9% higher. The region is also near record highs and up 3.8% so far in December putting it track for its best yearly performance since 2017. E-mini futures for the S&P 500 were up 0.25%, after the Dow rose 1.1% overnight and the S&P 500 and the Nasdaq climbed 1.3% each. [.N].

Optimism over a $1.4 trillion U.S. spending package increased after House of Representatives Speaker Nancy Pelosi invited other congressional leaders to meet late on Tuesday to put together a deal to be enacted this week.

“The odds are that this deal is more than the $500 billion the Republicans proposed and likely less than the $900 billion of the joint Republican/Democrat committee proposal,” said Sebastien Galy, macro strategist at Nordea Asset Management. “It is rightfully welcomed by the markets, but the size of the fiscal package is the issue.” Progress on rolling out vaccines continued after Moderna Inc’s COVID-19 vaccine appeared set for regulatory authorization this week. The United States also expanded its rollout of the newly approved vaccine developed by Pfizer Inc. and BioNTech SE. Analysts expect guidance later in the day on when and how the Fed might change its bond purchases. The dollar fell to its lowest since April 2018 against a basket of currencies. Derek Halpenny, MUFG’s head of research, said that “underlines high expectations that the Fed will today deliver a message of continued loose monetary policy for a considerable period to come”. The euro rose above $1.22 for the first time since April 2018 and euro zone bond yields edged up, after data showed better-than-expected business activity in the bloc this month. [GVD/EUR] The pound rose to 12-day highs against the dollar and a one-week high against the euro. It gained after European Commission President Ursula von der Leyen said there was progress on a Brexit trade deal and the next few days would be critical. The dollar fell to a month-and-half low of 103.30 against the Japanese yen. In Asia, stock markets gained. Australian shares rose 0.8%, South Korea’s KOSPI was up 0.4% and Japan’s Nikkei added 0.2%. China’s blue-chip CSI 300 index added 0.15% and Hong Kong’s Hang Seng index climbed 0.86%.

 

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FDA: Moderna vaccine meets expectations for emergency use

  • Moderna’s vaccine could be administered to the public as early as next week if it wins emergency use authorization from the FDA.
  • The FDA staff endorsement comes two days before the agency’s Vaccines and Related Biological Products Advisory Committee, a group of outside medical advisors, is scheduled to review it.
  • The committee is expected to recommend Moderna’s vaccine for emergency use.

The staff of the Food and Drug Administration on Tuesday endorsed the emergency use of Moderna’s coronavirus vaccine, a critical step forward in winning formal clearance to be administered to the public as early as next week. The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday to review Moderna’s request for emergency use authorization. The group of outside medical advisors recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it the next day. The committee is expected to recommend Moderna’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does. The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.” “FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” it said. The announcement helped Moderna’s stock rise 1.5% just before the opening bell. The documents are “enormously encouraging,” said Dr. Paul Offit, a voting member on the committee, adding they show there are now two highly effective vaccines. He voted in favor of recommending Pfizer’s vaccine last week. Moderna is asking the FDA to approve the use in people age 18 and over, while Pfizer’s vaccine was cleared for use in people age 16 and older. The scant data in younger teens was a sticking point for the few members of the advisory committee who voted against authorizing Pfizer’s vaccine last week. The FDA said it recommends tracking cases of Bell’s palsy, a condition that causes a sudden freezing or weakness in facial muscles, if the vaccine is cleared for use. The agency said there were three cases in the vaccine group and one in the placebo group among the 30,000 trial participants. “Currently available information is insufficient to determine a causal relationship with the vaccine,” the agency wrote. The most common side effects were pain at the injection site, fatigue, headache, muscle pain and chills, the FDA said, adding more severe reactions were more common after the second dose. Trial participants told CNBC in September the symptoms were uncomfortable, and at times intense, the participants said they often went away after a day, sometimes sooner, and that it was better than getting Covid-19. The FDA said 13 deaths were reported as of Dec. 3, with six in the vaccine group. Two deaths in the vaccine group were people over age 75 with preexisting conditions, the agency said. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure. Moderna submitted its Covid vaccine data to the FDA on Nov. 30. It said a final analysis of its phase three clinical trial found the vaccine was more than 94% effective in preventing Covid, was safe and appeared to fend off severe disease. Its vaccine uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response. The documents published offer a glimpse of the FDA’s view of the vaccine. If the FDA approves the vaccine, it would be the second one for emergency use in the U.S., behind the Pfizer-BioNTech vaccine. Gen. Gustave Perna, who oversees logistics for President Donald Trump’s vaccine program Operation Warp Speed, said Monday that the U.S. plans to ship just under 6 million doses of Moderna’s vaccine once the FDA approves emergency use. Such an authorization isn’t the same as a full approval, which can typically take months longer. Moderna, like Pfizer, has only submitted two months of follow-up safety data, but the agency usually requires six months for full approval. Pfizer’s vaccine was authorized for people 16 and older. Cambridge, Massachusetts-based Moderna has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit. The federal government announced last week that it will purchase an additional 100 million doses of Moderna’s vaccine. The U.S. entered an agreement with Moderna in August to acquire 100 million doses for about $1.5 billion. Moderna said that month it was charging $32 to $37 per dose for its vaccine for some customers, under cheaper “pandemic pricing.” The company said it was in discussion for larger volume agreements that will have a lower price.

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New Covid strain ripping through the South is forcing 11million more Brits into Tier 3 lockdowns

A NEW Covid strain which may spread even quicker is ripping through the South – as Matt Hancock last night plunged 11million more Brits into Tier 3. The Health Secretary told MPs more than 1,000 cases of the new “variant” has been discovered in up to 60 places across the UK – and the World Health Organisation has been informed.London, parts of Essex and Hertfordshire, will move into Tier 3 from midnight tonight. It now means 34million people – 61 per cent of the population – will face the toughest rules. Brits in those areas can’t see friends and family they don’t live with indoors or outdoors – unless they are in a support bubble. But shops, gyms and schools will remain open. Pubs and restaurants will be forced to shut, except for takeaway and delivery. Mr Hancock last night urged Londoners to follow the example of Liverpool and Manchester to drive the virus down again. In a bombshell announcement, Mr Hancock said the mutation was spreading at a quicker pace than the original virus. But experts stressed that the new strain was not the cause of the tier changes. Mr Hancock said: “We have identified a new variant of coronavirus which may be associated with the faster spread in South East England. “It is growing faster than existing variants, with over 1,000 cases. He told the Commons: “Initial analysis suggests that this variant is growing faster than the existing variants.” There are over 60 areas affected, which is “growing rapidly” and similar strains have been identified in other countries, he said. He added: “We’ve seen very sharp exponential rises of the virus across London, Kent parts of Essex and Hertfordshire. “We must take fast and decisive action.” At last night’s press conference he said the “rise in transmission and this new variant should be a warning to all” that “personal responsibility” was needed going into Christmas. He warned: “Respect the rules where you are, don’t ease up on simple things. “When the virus is growing exponentially, there is not a moment to spare.” However, the Government insisted Covid rules will still be lifted for five days over Christmas. Mr Hancock begged everyone to reduce their social contacts in the next few weeks to crack down on cases. He also recommended Brits self-isolate as much as they can before seeing elderly or other vulnerable relatives over Christmas. He told the Downing Street press conference: “Be extremely careful now about who you see. That’s the way to see loved ones in a socially distanced way.” The new measures take the total number of people in Tier 3 in England to 34million, and he suggested more areas could be plunged into the highest tier later this week too. There are hopes some areas in the North could be downgraded to Tier 2, which currently covers 21.5million. He said: “This moment is a salutary warning for the whole country.”This isn’t over yet.” Professor Whitty insisted it was difficult to know if the new variant was spreading quicker or not – and that it would be “surprising but not impossible” it would not react to a vaccine. And he suggested the reason Tier 3 has not worked in areas like Kent was because London – where many people travel in and out for work – was still in Tier 2. He said there was no point in surrounding counties being in a higher tier than London while the captial’s cases are rising so quickly. However, he slapped down suggestions that the reason the Tiers were being ramped up was because of the new strain – and insisted that cases were rising across the board. The World Health Organsiation and Public Health England are continuing to look into the new killer strain. But there was no evidence to suggest the mutation is more deadly. Crucially, there is also no suggestion it cannot be beaten by the vaccine. TOP scientists have urged Brits not to panic over the new strain of Covid. Virus experts Prof Alan McNally and Dr Jeremy Farrar both played down the threat of the latest mutation. Prof McInally, from the University of Birmingham, said: “It is important to keep a calm and rational perspective on the strain as this is normal virus evolution and we expect new variants to come and go and emerge over time. “It’s too early to be worried or not by this new variant, but I am in awe of the surveillance efforts in the UK that allowed this to be picked up so fast.” Dr Farrar, from the Wellcome Trust, added: “This is to be expected. The pressure on the virus to evolve is increased by the fact that millions of people have now been inf Mr Hancock said: “It shows we’ve got to be vigilant and follow the rules and everyone needs to take personal responsibility not to spread this virus,” he said. He added that in some areas the doubling time of the number of new cases is as short as seven days. The strain was first detected in Kent last week – and it’s not yet known if it’s a home-grown mutation or has come in from abroad. And it’s understood that two weeks of lab testing is needed for experts to be completely sure that it will still be able to be tackled by the vaccine. Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said it was too early to draw any conclusions yet and stressed it could be by chance. He said: “The genetic information in many viruses can change very rapidly and sometimes these changes can benefit the virus – by allowing it to transmit more efficiently or to escape from vaccines or treatments – but many changes have no effect at all. “Even though a new genetic variant of the virus has emerged and is spreading in many parts of the UK and across the world, this can happen purely by chance. “Therefore, it is important that we study any genetic changes as they occur, to work out if they are affecting how the virus behaves, and until we have done that important work it is premature to make any claims about the potential impacts of virus mutation.” Alan McNally, a professor in microbial evolutionary genomics at the University of Birmingham, stressed that Brits should remain “calm and rational” following the news. He said: “Huge efforts are ongoing at characterising the variant and understanding its emergence. “It is important to keep a calm and rational perspective on the strain as this is normal virus evolution and we expect new variants to come and go and emerge over time. “It’s too early to be worried or not by this new variant, but I am in awe of the surveillance efforts in the UK that allowed this to be picked up so fast.” The decision to put the capital in Tier 3 came three days earlier than expected because ministers and officials were shocked by rising cases. ]Experts said the main driver behind the spike was Christmas shopping and increased socialising. Mr Hancock suggested Londoners should avoid Oxford Street and shop for their gifts online to help stop the spread of the virus. And he said travel to and within Tier 3 areas is discouraged. T]he Health sec said: “It is recommended that people should minimise travel unless it is necessary in a Tier 3 area and should minimise travel where it is necessary to a Tier 3 area.

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Stimulus negotiations face a stormy week ahead

Pressure to pass a last-ditch COVID-19 relief bill before the end of 2020 is coming from all sides. Is America any closer to a vote? By Monday evening, the bipartisan group of Senators that introduced a $908 billion proposal for emergency COVID-19 relief will have a fully fledged bill. Whether Congress will vote to pass it is another story. “We’re going to introduce a bill tomorrow night,” Republican Sen. Bill Cassidy said Sunday on CNN State of the Union. “What Leader [Mitch] McConnell decides to do, I don’t have control over. I only can do what I can do.” Democratic and Republican lawmakers have been working together through the weekend in an effort to nail down legal language for the COVID-19 rescue bill before the end of 2020. But they’re unlikely to face a warm welcome from either party. The deep divisions that have stymied a stimulus package since May have taken new forms in the past week, with both sides breaking ranks to voice their demands as to what absolutely should and shouldn’t be in the final package. The $908 billion proposal won’t include a second direct payment, which presents a steep hurdle among some lawmakers. Funding for state and local budgets, and debate over liability protection to keep businesses and institutions from being sued over COVID-19 transmission are other hot button issues that could delay or derail the bill. For the mixed group working on the package, now is the time to unify, not to dig in heels. “We must act. It is irresponsible that we have not acted to date. It is absolutely a failure of the Congress,” House Majority Leader Steny Hoyer said Sunday on CNN Inside Politics. “We want to get aid out to people who are really, really struggling. A coronavirus aid proposal before Jan. 1 is now considered emergency legislation to institute a safety net for expiring benefits that could leave tens of million of unemployed Americans without an income and millions of households facing eviction. A sweeping deal like the $2 trillion CARES Act from March, which authorized a $1,200 stimulus check for most Americans, is more likely to return to the table in early 2021, top US leaders have implied. “This relief package won’t be the total answer even if it gets passed, but it’s an important first step. There’s so much we have to do,” President-elect Joe Biden said Friday. With or without a bill, Biden has some executive actions at his disposal to push for more aid after he takes office Jan. 20. “We’ve been meeting day and night for the last month. We were on a call all day yesterday. We’ll get on a call this afternoon to finish things up,” Democratic Sen. Joe Manchin said on Fox News Sunday . “There is no way, no way, that we are going to leave Washington without taking care of the emergency needs of our people. And that’s all of our country.” It may not be that simple. The stimulus check argument is raring to surface again this week with renewed force. Republican Sen. Josh Hawley and Sen. Bernie Sanders, an independent, are teaming up to amend the $908 billion proposal with another round of $1,200 payments, following the template set out in spring’s CARES Act. “If the Senate of the United States can find hundreds of billions of dollars to give to big government and big business, surely it can find some relief for working families and working individuals,” Hawley said Dec. 11. In an effort to find middle ground, an alternate $918 billion package from Treasury Secretary Steven Mnuchin and the White House proposed to send $600 checks to qualifying adults, plus an additional $600 for each qualified child dependent. However, the offer comes at the expense of $300 of federal unemployment aid per week for four months. “If you’re send a stimulus check of $600 or whatever it may be — it was $1,200 before — you’re sending it to people who still have a paycheck and still have a job. If you send a check to an unemployment person, you are sending to a person who has no lifeline — it’s done at the end of this month, they’ve got nothing,” Manchin said. On the Republican side, McConnell proposed several times this week that the bill should drop the two thorniest issues — funding for state and local programs and a liability shield to protect businesses from COVID-19 related lawsuits — and instead pass a bill focusing on the areas of agreement. But McConnell’s opponents view the trade-off as a dealbreaker, arguing that state funding is necessary to help pay for firefighters and sanitation workers. Other lawmakers seem to be warming up to the idea of stripping out funding for the issue most likely to capsize talks in order to pass the emergency bill now, and pick up other measures after the new year. Though Congress is hoping to wrap up its business next week, House Speaker Nancy Pelosi said if lawmakers don’t pass more aid by next Friday, Dec. 18, Congress could keep working through the end of the month. “We’ve been here after Christmas, you know. We were here five years ago,” Pelosi said Thusday during her weekly press conference. “People do want to get home for the holidays, such as that is. But what’s more important is that we get the job done for the American people before the holidays.

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Historic U.S. COVID vaccine campaign launches with convoy of trucks

(Reuters) -The first shipments of Pfizer Inc’s COVID-19 vaccine left a factory in Michigan early on Sunday on a convoy of semi trucks, kicking off a historic effort to stop a surging pandemic that is claiming more than 2,400 lives a day in the United States. Mask-wearing workers at a Pfizer factory in Michigan began packing the first shipments of its vaccine in dry ice shortly after 6:30 a.m. ET (1130 GMT) on Sunday. Three trucks carrying pallets of boxed, refrigerated vaccines rolled away from the Kalamazoo facility at 8:29 a.m., escorted by body armor-clad security officers in a pickup truck and a SUV. The United States expects to immunize 100 million people, or about 30% of its population, by the end of March, U.S. Operation Warp Speed chief adviser Dr. Moncef Slaoui said in an interview with Fox News Sunday. In a novel process that will need to become daily routine, workers removed pizza-boxed sized cartons containing vaccine vials from a freezer. They placed them in large, blue coolers, before these were boxed and labeled, as shown on a network television video feed. The massive logistical effort is complicated by the need to transport and store the vaccine developed with German partner BioNTech SE at minus 70 Celsius (minus 94 Fahrenheit), requiring enormous quantities of dry ice or specialized ultra-cold freezers. Workers clapped and whistled as the first boxes headed to the trucks. The long-awaited moment comes as the U.S. death toll was approaching 300,000 and infections and hospitalizations set daily records. It will take months before most U.S. residents can get a COVID-19 vaccine. The federal government plans to release the nation’s first 2.9 million doses to 64 states, U.S. territories and major cities, as well as five federal agencies. Although the federal government is coordinating distribution efforts, states have the final say over who gets the first shots. The federal government is sending the first shipments to more than 600 locations. Companies in a range of industries are lobbying state and federal officials to give priority to their workers as millions wait for the vaccine and a return to life free from the fear of the deadly illness. The Pfizer/BioNTech vaccine in a large clinical trial was 95% effective in preventing illness. It is not yet known if it prevents infection or transmission of COVID-19 by those who are vaccinated. U.S. regulators late on Friday authorized emergency use of the vaccine, following similar moves by the UK and Canada, less than a year after the first cases were reported in the United States. “We have spent months strategizing with Operation Warp Speed officials and our healthcare customers on efficient vaccine logistics, and the time has arrived to put the plan into action,” Wes Wheeler, president of UPS Healthcare, said on Saturday Pfizer’s dry-ice cooled packages can hold as many as 4,875 doses. The first leg of their journey will be from Kalamazoo to planes positioned nearby. The aircraft will shuttle vaccine packages to United Parcel Service or FedEx air cargo hubs in Louisville, Kentucky, and Memphis, Tennessee, respectively. From there, they will be trucked or flown to facilities close to the 145 U.S. sites earmarked to receive the first doses. Familiar UPS and FedEx package delivery drivers are giving the vaccine top priority over holiday gifts and other parcels. They will deliver many of the “suitcases” into the hands of healthcare providers on Monday. The shipments are the first of three expected this week. Both companies have expertise handling fragile medical products and are leaving little room for error. They are providing temperature and location tracking to backup devices embedded in the Pfizer boxes, and tracking each shipment throughout its journey. Healthcare workers and elderly residents of long-term care homes are first in line to receive the inoculations of a two-dose regimen given about three weeks apart.

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A Million Americas Dead By Spring

COVID kills 3,309 people in the US on the most lethal day of the pandemic so far while a record 232k new cases are recorded – as FDA chief tells public that doctors ARE prepared for allergic reactions to vaccine after UK patients were affected
  • US death toll from COVID-19 approaching 300,000 as Johns Hopkins researchers say 3,309 died on Friday
  • As of Saturday morning, there have been 15,851,735 confirmed cases of COVID-19 and 295,539 deaths
  • New figures come as US regulators gave the final go-ahead on Friday to the nation’s first COVID-19 vaccine
  • Researchers in Washington State released projections showing that 502,000 Americans will die by April 1
  • Institute for Health Metrics and Evaluation says peak daily deaths have not yet been reached and will come in mid-January
  • The IHME models predicts that 48 states are expected to have high or extreme stress on ICUs at some point in the next four months as hospitalizations continue to grow

The United States recorded more than 3,300 deaths from COVID-19 on Friday – the largest single-day toll since the start of the pandemic – as it authorized the use of Pfizer’s vaccine, with the first inoculations expected within days, marking a turning point in a country where the pandemic has killed more than 295,000 people. The Food and Drug Administration granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95 per cent effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and older. Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses this month. According to researchers at Johns Hopkins University, 3,309 Americans died from coronavirus on Friday. The US also reported 231,775 new cases as the pandemic shows no signs of ebbing – despite the FDA’s approval of a new vaccine. As of early Saturday morning, there have been 15,851,735 confirmed cases of COVID-19. So far, 295,539 Americans have died.

Based on the percentage infected in each state, as pictured above, the University of Washington's Institute for Health Metrics and Evaluation revealed that 15 percent of Americans have been infected with coronavirus as of December 7

Based on the percentage infected in each state, as pictured above, the University of Washington’s Institute for Health Metrics and Evaluation revealed that 15 percent of Americans have been infected with coronavirus as of December 7 New daily deaths dropped to 2,749 on Friday, yet the seven-day average climbed to 2,379, according to the COVID Tracking Project. The 7-day average for the three metrics that mark the severity of the nation’s outbreak – new cases, new deaths and overall hospitalizations – all broke new records for the second day in a row and a record was also set for hospitalizations

‘Once you start implementing the actual utilization of the vaccine in a clinical setting, you’re talking about millions of individuals getting vaccinated. You might start seeing effects that might not have been picked up.’ Hahn on Saturday said he was ready for a vaccination as soon as available. The FDA chief also defended the fastest-ever vaccine process, saying the agency did not sacrifice safety in return for speed. FDA chief says COVID vaccine is safe and ready for distribution. On Friday, Nevada overtook South Dakota as the state with the highest number of hospitalizations per million people, as of IHME data up until December 7. Hospitalizations in Arizona are also climbing again and have almost reached the levels seen at the state’s peak during the summer. The record number of hospitalizations is placing extreme pressure on intensive care units throughout the country.

The IHME models predicts that 48 states are expected to have high or extreme stress on ICUs at some point in the next four months. Forty-two states will also have high or extreme stress on hospital beds at some point in December through February

The models, and predictions on death rates, could change if states increase mask use and introduce more intervention policies, the IHME said.

They estimated that, on average, 73 percent of people always wore a mask when leaving the home, but the practice was far lower in certain states. For example, mask use was lower than 50 percent in Wyoming, while it remains higher on the east and west coasts. After two days in which at least 3,000 Americans died from coronavirus, new daily deaths dropped to 2,749 on Friday, the seven-day average climbed to 2,379, according to the COVID Tracking Project. Deaths in North Dakota spiked in the past 24 hours, as it climbed above New York to become the state with the fifth highest death rate per million people. New Jersey’s death rate is still the highest in the country. The IHME predicted that there will be 221,000 additional deaths in the US from December 7 to April 1. This model, however, assumes that 32 states will re-impose mandates by April 1, lessening the number of new infections, it warns. It predicts that many of these states will implement mandates by the end of December. It also predicted that universal mask coverage – where 95 percent of the country wears a mask when they leave home – would result in 56,000 less Americans dying from COVID-19 in the coming months. If mask mandates are eased, however, the total number of deaths by April 1 could potentially reach 598,000.

 

 

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Viral spread: Americans paying the price for Thanksgiving

https://youtu.be/tLlv9jfL3ME

With some Americans now paying the price for what they did over Thanksgiving and falling sick with COVID-19, health officials are warning people — begging them, even — not to make the same mistake during the Christmas and New Year’s season. “It’s a surge above the existing surge,” said Ali Mokdad, a professor of health metrics sciences at the University of Washington in Seattle. “Quite honestly, it’s a warning sign for all of us.” Across the country, contact tracers and emergency room doctors are hearing repeatedly from new coronavirus patients that they socialized over Thanksgiving with people outside their households, despite emphatic public-health warnings to stay home and keep their distance from others. The virus was raging across the nation even before Thanksgiving but was showing some signs of flattening out. It has picked up steam since, with new cases per day regularly climbing well over 200,000. The dire outlook comes as the U.S. stands on the brink of a major vaccination campaign against COVID-19, with the Food and Drug Administration giving the final go-ahead Friday to use Pfizer’s formula against the scourge that has killed over 290,000 Americans and infected more than 15.8 million.

White House chief of staff Mark Meadows had pressed FDA chief Stephen Hahn to grant authorization by the end of the day or face possible firing, according to two administration officials speaking on condition of anonymity.

President Donald Trump, who has been fuming at the FDA for not moving faster on the vaccine, called the agency a “big, old, slow turtle” on Twitter, adding: “Get the dam vaccines out NOW, Dr. Hahn. Stop playing games and start saving lives.” Hahn has said he would be guided by “science, not politics.” COVID-19 deaths in the U.S. have climbed to a seven-day average of almost 2,260 per day, about equal to the peak seen in mid-April, when the New York City area was under siege. New cases are running at about 195,000 a day, based on a two-week rolling average, a 16% increase from the day before Thanksgiving, according to an Associated Press analysis. In Washington state, contact tracers counted at least 336 people testing positive who said they attended gatherings or traveled during the Thanksgiving weekend. More are expected. The virus could still be incubating in someone who was exposed while traveling home the Sunday after Thanksgiving; the end of that two-week incubation period is this Sunday. The next round of festivities could yield even more cases. Wall-to-wall holidays started this week. Hanukkah began Thursday evening and ends Dec. 18, followed by Christmas, Kwanzaa and New Year’s Eve. “This is not the time to invite the neighbors over for dinner. This is not the time to start having parties,” said Dr. Joshua LaBaer, an Arizona State University researcher. In parts of New York state, contact tracers are regularly hearing from the newly infected that they attended Thanksgiving festivities, said Steuben County Public Health Director Darlene Smith. Still unknown is how many they will infect and how many eventually will need a bed in intensive care, she said. “It’s the domino effect,” Smith said. The surge around the country has swamped hospitals and left nurses and other health care workers exhausted and demoralized. “Compassion fatigue is the best word for what we’re experiencing,” said Kiersten Henry, an ICU nurse practitioner at MedStar Montgomery Medical Center in Olney, Maryland. “I feel we’ve already run a marathon, and this is our second one. Even people who are upbeat are feeling run down at this point.” While some hospitals are scrambling to find beds and convert storage rooms and other places for use in treating patients, they are also dealing with dire staff shortages. “We know how to make new beds,” said Dr. Lew Kaplan, a critical care surgeon at the University of Pennsylvania’s Perelman School of Medicine. “We don’t know how to make new staff.”

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Take Your Vitamin D

Professor Roger Seheult, MD explains the important role Vitamin D may have in the prevention and treatment of COVID-19. Dr. Seheult illustrates how Vitamin D works, summarizes the best available data and clinical trials on vitamin D, and discusses vitamin D dosage recommendations. Roger Seheult, MD is the co-founder and lead professor at https://www.medcram.com He is an Associate Professor at the University of California, Riverside School of Medicine and Assistant Prof. at Loma Linda University School of Medicine Dr. Seheult is Quadruple Board Certified: Internal Medicine, Pulmonary Disease, Critical Care, and Sleep Medicine

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DA approves Pfizer’s COVID-19 vaccine for emergency use

The Food and Drug Administration approved the emergency use of Pfizer’s COVID-19 vaccine Friday as a second surging of the coronavirus continues to batter a pandemic-weary nation. The approval clears the way for the first wave of American recipients — millions of health workers and nursing home residents — to begin getting shots in mere days. “The first vaccine will be administered in less than 24 hours,” Trump said Friday night at 9:30 p.m. “The governors decide where the vaccines will go in their state, and who will get them first. We want our senior citizens, health care workers and first responders to be first in line.” The historic go-ahead marks the beinning of the end of the pandemic in the United States, where more than 294,000 people have died of COVID-19. The vaccine, developed by the Manhattan-based Pfizer and the German company BioNTech, and designed to be given in two doses that are three weeks apart, will be the first vaccine against the coronavirus distributed in the U.S. “Today our nation has achieved a medical miracle,” President Trump said in a statement tweeted Friday night. “We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history.” Ongoing trials involving some 44,000 recipients show it is indeed 95% effective in warding off illness, including for the elderly and for people with pre-existing health conditions; detailed data also show it is safe to take. The rollout, however, will be slow, as initial supplies are scarce. An estimated three million doses are expected in the first shipments around the country. Earlier Friday, a review of the clinical trial data ordered by Gov. Andrew Cuomo found that there were no problems with the vaccine, clearing the way for its distribution in New York. Trump credited Friday night’s success to “Operation Warp Speed,” which he called “the greatest medical manufacturing endeavor in American history.” The program channelled $14 billion in federal funds into the race to develop, manufacture and distribute effective vaccines. Nearly $2 billion funded Pfizer’s effort to produce 100 million doses now, with an option to produce an additional 500 million doses, Trump said Friday night. The doses will be free of charge, he said. “It will save millions of lives and soon end the pandemic once and for all,” Trump said of the start of vaccinations. “We have given Pfizer and other companies a great deal of money hoping this would be the outcome,” he said. “And it was. On behalf of the American people, I would like to thank all of the brilliant scientists, technicians, doctors and workers who made this all possible. Pfizer and Moderna have announced their vaccines are approximately 95 percent effective, far exceeding expectations,” he noted. “These vaccines are also very safe. American citizens participated in clinical trials that were far larger than normal, and had no serious side effects. “The dedicated and independent experts at the FDA meticulously studied the results of the trials and it has now passed the gold standard of safety,” he said. “The United States is the first nation in the world to produce a verifiably safe and effective vaccine. Today’s achievement is a reminder of America’s unlimited potential when we have the will and the courage to pursue ambitious goals,” he said. “As I’ve said from the beginning, a vaccine will vanquish the virus, and return life back to normal.” Friday night’s FDA approval comes after a government advisory panel backed the use of the vaccine, which paved the way for the FDA to grant its green light. In a 17-4 vote with one abstention Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee concluded that the shot appears safe and effective for emergency use in people 16 and older. Earlier Friday, Health and Human Services Secretary Alex Azar hinted approval was right around the corner and said people could be receiving the shot as early as Monday or Tuesday. “I’ve got some good news for you,” Azar said on ABC’s “Go “I’ve got some good news for you,” Azar said on ABC’s “Good Morning America.” “Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine.” Last week, the booster was approved and immediately rolled out to citizens in the UK. Some British recipients have reported severe allergic reactions to the vaccine, but Pfizer reps told the FDA panel Thursday they’d seen no signs of such reactions in their trial.

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FDA to approve Pfizer vaccine late Friday after Trump threat

Nick Bit: this is a braking story. The FDA to approve Pfizer vaccine for emergency use today. This was after Trump threatened to fire FDA director Hahn. and led the FDA to speed up its timetable for potential emergency approval of the Pfizer/BioNTech vaccine from Saturday morning to later on Friday, according to the Post. The vaccine would be the first to roll out across the US, after also being approved in the UK and Canada.