Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles
Pharma giant expects to ship half the doses it had originally planned after finding raw materials in early production didn’t meet its standards
Pfizer Inc. expects to ship half of the COVID-19 vaccines it originally planned for this year because of supply-chain problems, but still expects to roll out more than a billion doses in 2021. “Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.” Pfizer and Germany-based partner BioNTech SE had hoped to roll out 100 million vaccines worldwide by the end of this year, a plan that has now been reduced to 50 million. The U.K. on Wednesday granted emergency-use authorization for the vaccine, becoming the first Western country to start administering doses. The two-shot vaccine also is being reviewed by the Food and Drug Administration in the U.S., where a similar authorization could come later this month and a rollout before the end of the year. The U.S. regulator also is considering a vaccine developed by Cambridge, Mass.-based Moderna Inc. that could begin shipping before Christmas.
The doses are among an array of vaccines that have been developed this year as the coronavirus pandemic has raged across much of the world. Authorities estimate nearly 1.5 million people worldwide have died from the virus, including 273,836 in the U.S. as of Dec. 2.
“We were late,” said a person directly involved in the development of the Pfizer vaccine. “Some early batches of the raw materials failed to meet the standards. We fixed it, but ran out of time to meet this year’s projected shipments.” Pfizer sources its raw materials from providers in the U.S. and Europe. Scaling up production of these components proved challenging last month as the company awaited the results of its trials, which came in to be 95% effective and well-tolerated in a 44,000-subject trial. Pfizer wouldn’t say where shortfalls over ingredients arose as it ramped up production. Vaccines typically contain materials from suppliers that can include antivirus agents, antiseptic liquids, sterile water and elements of the DNA of the virus itself that won’t cause serious symptoms but trigger the immune system to make antibodies. In a typical vaccination campaign, pharmaceutical companies would wait until their product is approved before buying raw materials, establishing manufacturing lines and setting up supply chains to ship a vaccine. Pfizer has never manufactured a vaccine with technology that uses mRNA, the molecular couriers that carry genetic instructions to cells in the human body, so it has had to scale up production capacity even as research was still under way. “For this one, everything happened simultaneously,” the person familiar with the Pfizer development said. “We started setting up the supply chain in March, while the vaccine was still being developed. That’s totally unprecedented.” Pfizer and BioNtech are now on track to roll out 1.3 billion vaccines in 2021 and the 50 million dose shortfall this year will be covered as production ramps up. The company is setting up what it has described as its biggest ever vaccination campaign through two final assembly and distribution centres in Kalamazoo, Mich., and Puurs, Belgium, which will handle the European supply. The U.K. authorization marks a milestone in the effort to develop a promising new vaccine technology into a widely available shot in record time.
Compromise on stimulus within reach – McConnell
- Senate Majority Leader Mitch McConnell said he sees “hopeful signs” for striking a coronavirus stimulus deal before the end of the year.
- Democrats and Republicans in Congress have been scrambling to strike a pandemic relief deal before the end of the year.
- After House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer backed a bipartisan $908 billion stimulus package, while McConnell released his own roughly $500 billion plan.
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Senate Majority Leader Mitch McConnell said Thursday he has seen “hopeful signs” for striking a coronavirus stimulus deal before the end of the year.
“Compromise is within reach. We know where we agree. We can do this,” the Kentucky Republican said on the Senate floor.
Whether Democrats, who lead the House and can hold up any bill in the Senate, will accept McConnell’s vision of compromise remains to be seen. House Speaker Nancy Pelosi, D-Calif., and Senate Minority Leader Chuck Schumer, D-N.Y., cut their aid demands Wednesday when they embraced a $908 billion bipartisan proposal as a starting point for talks with McConnell. Still, the GOP leader rejected the proposal when a bicameral group released it this week. He put forward his own roughly $500 billion plan. On Thursday, McConnell called for a deal similar to the one he unveiled. It includes Paycheck Protection Program loan funding and money for education and vaccine distribution. Democrats have backed those provisions.However, it includes one piece Democrats find toxic: Covid-19 liability protections for businesses and universities. Pelosi and Schumer have also repeatedly pushed for state and local government aid and supplemental federal unemployment payments, which McConnell’s plan does not include. Speaking on the Senate floor after his Republican counterpart, Schumer said McConnell “does not seem inclined to compromise.”
A coronavirus infection surge and record hospitalizations have led to new economic restrictions and fears of a weakening job market. At the same time, protections for unemployed Americans, renters and federal student loan borrowers put in place earlier this year expire at the end of December.
Congress has run short on time to send more help. Leaders have signaled they could attach relief measures to a government funding bill, which they need to approve by Dec. 11.
Earlier Thursday, the No. 2 Senate Democrat called for a vote on the $908 billion package. “We don’t want to go home and face the reality of what’s going to happen at the end of this month,” Sen. Dick Durbin of Illinois told MSNBC. “It’s inexcusable. We’ve got to move forward and we want our bill called,” he said. Durbin and President-elect Joe Biden have described the proposal as an imperfect down payment on stimulus as Democrats push for a sweeping aid package. Congressional leaders have acknowledged they will likely consider more relief after Biden takes office on Jan. 20. Some Republican senators have embraced little or no new stimulus spending, arguing that the economy has improved enough to sustain Americans until a large share of the population receives vaccines. Other GOP lawmakers say the federal government needs to offer more support at a time when more than 20 million Americans are receiving some form of unemployment benefits and food banks across the country see unprecedented demand. Rep. Tom Reed, R-N.Y., who helped to craft the $908 billion plan on the House side, told CNBC earlier Thursday that the price tag “is right in the range of reason.”
LA mayor announces city-wide lockdown
- Los Angeles County confirmed 24 new deaths and 4,544 new cases on Friday
- Officials banned most gatherings but stopped short of full shutdown on stores
- Restrictions were brought on by average of 4,751 cases a day for last five days
- Residents of nation’s most populous county are being urged to stay home
- People are also not allowed to gather with those from outside their household
- Exceptions are being made for church services and protests, officials said
- Non-essential retail businesses could stay open, but at 20 per cent capacity
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Los Angeles County announced a new stay-home order as coronavirus cases surged out of control in the nation´s most populous county, banning most gatherings but stopping short of a full shutdown on retail stores and other non-essential businesses. The three-week order takes effect Monday and advises residents to stay home ‘as much as possible’ and to wear a face covering when they go out. It bans people from gathering with others who aren’t in their households, whether publicly or privately. However, exceptions are made for church services and protests, ‘which are constitutionally protected rights,’ the county Department of Public Health said in a statement. It came as the county of 10 million residents confirmed 24 new deaths and 4,544 new confirmed cases of COVID-19. The county had set a threshold for issuing the stay-home order: an average of 4,500 cases a day over a five-day period, but hadn’t expected to reach that level until next month. However, the five-day average of new cases reported Friday was 4,751. ‘We know we are asking a lot from so many who have been sacrificing for months on end,’ Public Health Director Barbara Ferrer said. ‘Acting with collective urgency right now is essential if we want to put a stop to this surge.’ Indoor retail businesses, which make much of their profits during the Thanksgiving and Christmas holiday seasons, are allowed to remain open but with just 20 per cent of capacity, including nail salons and other personal care services. Restaurants in the county already were recently barred from in-person dining. They can still offer pickup, delivery and takeout services. Beaches, trails, and parks will remain open, with safety requirements.
The order, which runs through December 20, is more modest than a statewide closure order issued by Governor Gavin Newsom in mid-March. That order closed schools and most businesses and severely restricted movement except for essential workers or to perform essential chores such as buying groceries or picking up medications. The restrictions are said to have slowed the spread of COVID-19 and some restrictions were eased but the caseload picked up again in summer and in recent weeks has surged to record levels throughout most of the state – as well as throughout most states in the country.
Daily cases numbers in California have set records in recent days. Hospitalizations statewide have increased more than 80 per cent in the last two weeks.
Nearly 2,000 people in the county are now hospitalized and the new order is part of an effort to prevent the county’s health system from being overwhelmed. Meanwhile, public health officials are bracing for a wave of cases that could follow gatherings at Thanksgiving.
The total number of confirmed COVID-19 cases in Los Angeles County, the nation’s most populous, surpassed 383,00. Meanwhile, more than 7,600 residents of LA County have died after contracting COVID-19. Recent data also indicate a sharp spike in the number of hospitalizations due to COVID-19 With infections out of control, the other options for public officials to take are even more onerous and unlikely to be enacted in the US, said Dr. George Rutherford, an epidemiologist at the University of California, San Francisco. China, for example, tested millions of people and enforced quarantines. Italy brought in the military to enforce a shutdown. ‘It’s hard to imagine how much further you can go in a society like we have,’ he said. ‘It’s a balancing act, right? You want people to obey it but you don’t want to make it so draconian that people are trying to figure out ways around it all the time.’ The rate of hospitalizations – now at the highest since the pandemic began – has pushed some medical centers beyond capacity. The rapid increase comes after weeks of rising infection rates across the country and sees the total number of infections since the pandemic began pushed beyond 13 million, with 264,000 deaths.
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CDC director warns the next few months could be ‘the most difficult in the public health history of this nation’
- The next few months of the Covid-19 pandemic will be among “the most difficult in the public health history of this nation,” Dr. Robert Redfield, director of the CDC, said.
- Redfield, speaking at an event hosted by the U.S. Chamber of Commerce, said that about 90% of hospitals in the country are in “hot zones and the red zones.”
- He added that 90% of long-term care facilities are in areas with high level of spread.
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The next few months of the Covid-19 pandemic will be among “the most difficult in the public health history of this nation,” Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention, said Wednesday. Redfield, speaking at an event hosted by the U.S. Chamber of Commerce, said that about 90% of hospitals in the country are in “hot zones and the red zones.” He added that 90% of long-term care facilities are in areas with high level of spread. “So we are at a very critical time right now about being able to maintain the resilience of our health-care system,” Redfield said. “The reality is December and January and February are going to be rough times. I actually believe they’re going to be the most difficult in the public health history of this nation, largely because of the stress that’s going to be put on our health-care system.”
Redfield added that deaths caused by Covid-19 are already rising. He said the country is now in the range of reporting between 1,500 and 2,500 deaths everyday.
The U.S. reported more than 1,500 deaths on Tuesday, according to data compiled by Johns Hopkins University. And Covid-19 hospitalizations stand at an all-time high 98,600 across the country, according to data from the Covid Tracking Project, which is run by journalists at The Atlantic. Epidemiologists, emergency room physicians and public health specialists have warned for weeks that the latest surge of the virus could prove to be the deadliest yet. “The mortality concerns are real,” Redfield said. “And I do think unfortunately, before we see February, we could be close to 450,000 Americans [who] have died from this virus.” However, Redfield noted that the country has the tools it needs to reduce the severity of the outbreak. He advocated for the strategic closure of certain parts of society, such as indoor bars and restaurants. Redfield said he was “disappointed” when New York City briefly closed all of its public schools last month, adding that they do not appear to drive spread of the virus. He also pointed to university and college campuses, where he said outbreaks have been largely avoided through the strategic deployment of surveillance testing combined with infection prevention measures like mask wearing. “I used to think that the most difficult group that we were going to have to help contain this was basically college students,” Redfield said. “But what happened over the summer and the fall, is many of the colleges and universities really stepped up to developing comprehensive mitigation steps.” One factor that makes this virus so dangerous, Redfield said, is that it spreads largely through people who don’t have symptoms, or spreads before patients develop symptoms. That makes it difficult to control what he called “the silent epidemic” without testing broadly throughout the population, including people without symptoms but who might have been exposed to the virus. The CDC is working on guidance for institutions and workplaces that will help them strategically deploy testing, he said. Another bright spot, Redfield said, is that promising vaccines are on the way, but mitigation measures will still be necessary well into next year. He predicted that the country won’t be able to return to holding large gatherings until the fall of 2021. There are many lessons to be learned from the pandemic, Redfield said, adding that “I wasn’t prepared to understand how little investment had been made in the core capabilities of public health.” He said there has been inadequate investment in the public health labs around the country that process many diagnostic tests and in the digitization of public health records, which hindered the federal government’s response to the pandemic. “There’s a huge lack of investment, which I hope this pandemic will change,” he said. Redfield estimated the health crisis has cost the U.S. at least $8 trillion. “Probably one of our greatest casualties of the pandemic this year was the impact on the business community, and on just general health care, the impact on our children’s education.”
S&P 500 Claws Back Losses to End at Record High on Stimulus Hopes
Investing.com – The S&P 500 closed at a record high Wednesday, as renewed optimism over a stimulus relief package and ongoing positive news on Pfizer ‘s Covid-19 vaccine lifted investor sentiment. The Dow Jones Industrial Average rose 0.20%, or 60 points. The S&P 500 was up 0.20% higher, while the Nasdaq Composite slipped 0.05%.
In a boost to hopes that lawmakers may roll out a fiscal package to support the economy U.S. House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer backed the bipartisan $908 billion stimulus deal that includes support for small businesses and unemployed Americans. The deal should be used “as the basis for immediate negotiations,” Pelosi and Schumer said in a joint statement.
The positive update on stimulus arrived on the back of positive vaccine news after the U.K. approved temporary emergency use authorization for Pfizer (NYSE:PFE)’s and development partner BioNTech (NASDAQ:BNTX)’s vaccine. Approval from the U.S. is not far behind, with many expecting the Pfizer vaccine to get approval from the U.S. Food and Drug Administration before year-end. Moderna (NASDAQ:MRNA), meanwhile, is expected to begin trials of its Covid-19 vaccine in children aged 12 to 18, The New York Times reported. Renewed action on the value trade in the wake of positive vaccine news – bullish bets on stocks tied to the progress of the economy– also benefited cruise lines, casinos, and airlines. As well as vaccine optimism, positive comments on a stimulus for the aviation industry lifted sentiment on the sector. U.S. Treasury Secretary Steven Mnuchin said Wednesday he supported another $20 billion in additional government payroll support for U.S. airlines. “I think that would be very meaningful in terms of employment and saving the industry,” Mnuchin said at a House hearing, according to Reuters. American Airlines Group (NASDAQ:AAL) and United Airlines (NASDAQ:UAL) were up more than 4% and 3%, respectively. On the economic front, a weaker-than-expected private sector jobs report for November was largely downplayed by analysts. “The ADP employment report showed a 307,00 increase in private employment below our forecast of 750,000… but it also showed that the “broad-based job gains across firm size continued,” Morgan Stanley (NYSE:MS) said in a note.
Merck divests direct holding in Moderna
(Reuters) – U.S. drugmaker Merck & Co said on Wednesday it had sold its equity investment in vaccine developer Moderna Inc. Merck said it had achieved a substantial gain on its direct holding in Moderna, particularly this year, as the company moved closer to developing a coronavirus vaccine. Merck did not disclose the details of the sale proceeds, but said it expects to record a small gain from the sale in the fourth quarter of 2020. Moderna’s shares have risen more than seven-fold this year, valuing the company at $55.80 billion as of Tuesday’s closing price. Moderna is one of the front-runners in the race to develop a coronavirus vaccine, and on Monday filed for U.S. emergency use authorization of its vaccine. Merck, which had invested $50 million in Moderna in 2015, said it would retain exposure to the company indirectly through its investment in venture funds.
UK approves Pfizer’s coronavirus vaccine
The UK has become the first country in the world to approve the Pfizer/BioNTech COVID-19 vaccine for use.
It has been given the go-ahead by the health regulator MHRA and will be rolled out from early next week. Studies have shown the jab is 95% effective and works in all age groups. The government has secured 40 million doses of the vaccine, which needs to be refrigerated at -70C (-94F). Ten million doses are expected in the UK by the end of the year and patients need two each. Care home residents and their carers will be first in line to be vaccinated, the government’s Joint Committee on Vaccination and Immunisation (JCVI) has confirmed. Studies have shown the jab is 95% effective and works in all age groups. The government has secured 40 million doses of the vaccine, which needs to be refrigerated at -70C (-94F). Ten million doses are expected in the UK by the end of the year and patients need two each. Care home residents and their carers will be first in line to be vaccinated, the government’s Joint Committee on Vaccination and Immunisation (JCVI) has confirmed. Speaking to Sky News this morning, health secretary Matt Hancock said the approval of the vaccine is “fantastic news”. He added: “The MHRA – the fiercely independent regulator – has clinically authorised the vaccine for rollout. “The NHS stands ready to make that happen so from early next week we will start the programme of vaccinating people against COVID-19 here in this country. “As we know from earlier announcements, this vaccine is effective, the MHRA have approved it as clinically safe and we have a vaccine, so it’s very good news.”
Yellen: We are facing historic crisis
U.S. President-elect Joe Biden’s treasury secretary nominee Janet Yellen said on Tuesday the country is facing a historic crisis from the pandemic and the subsequent economic fallout.
Dec 1 (Reuters) – President-elect Joe Biden’s treasury secretary nominee Janet Yellen said on Tuesday the United States is experiencing a historic crisis due to the coronavirus pandemic and its economic fallout that requires urgent action to avert a “self-reinforcing” downturn. Yellen, who previously served as U.S. Federal Reserve Chair, spoke at an event in Delaware where Biden formally introduced his top economic policy advisers as he prepares to take office on Jan. 20 amid a battered economy and large-scale job losses. “It’s an American tragedy and it’s essential that we move with urgency. Inaction will produce a self-reinforcing downturn, causing yet more devastation,” Yellen said. Yellen said the pandemic has disproportionately impacted the most needy Americans. Yellen said it is important to make sure the economic recovery leaves out no one as she pledged to “find collective purpose to control the pandemic and build our economy back better than before.” Earlier on Tuesday, outgoing Treasury Secretary Steven Mnuchin urged the U.S. Senate to support $300 billion in new grants to small businesses to keep them from failing amid the intensifying public health crisis. “These businesses cannot wait two or three months” for aid, Mnuchin said. Mnuchin defended his action to end some Fed lending programs, a move that will limit Yellen’s options in backstopping credit markets if she is confirmed to the post by the Senate after being nominated by Biden. Mnuchin said his action was not an “economic decision” but one based on the aid law passed by Congress. Meanwhile, deadlocked negotiations over a new coronavirus economic aid package picked up some picked up momentum, as a bipartisan group of lawmakers floated a $908 billion relief proposal. Senate Majority Leader Mitch McConnell also said he was circulating among his fellow Republicans the outlines of relief legislation that President Donald Trump would be willing to sign into law during his remaining weeks in office. “I think we all know that after the first of the year there’s likely to be a discussion about some additional package of some size,” proposed by the new Biden administration, McConnell said. It remains unclear whether Yellen would be the main negotiator for future coronavirus aid, a role that Mnuchin played this year for Trump’s administration in talks with House of Representatives Speaker Nancy Pelosi. Yellen and other Biden advisers have expressed support for government stimulus to maximize employment, reduce economic inequality and help women and minorities, who have been hurt disproportionately by the economic downturn. “I pledge as treasury secretary to work every day towards rebuilding their dream for all Americans,” Yellen said. “To the American people, we will be an institution that wakes up every morning thinking about you, your jobs, your paychecks, your struggles, your hopes, your dignity and your limitless potential.”
Americans are choosing death over deprivation
This past week, millions of Americans joined together in total defiance of all public health advice for another round of infecting and killing their loved ones, while ensuring that the nation’s medical professionals will face several more months of risky, grueling, emotionally draining labor trying to keep a country full of heedless jerks and credulous conspiracy-mongers alive. Many doctors, nurses, and hospital staff are increasingly hopeless and disillusioned. Gone are the 7’oclock cheers and “Thank you essential workers” signs in every window. That fleeting solidarity has been replaced by a cold, selfish indifference to the staggering and seemingly pointless sacrifices these heroic workers continue to make on our behalf. And many of them are wondering how much longer they can keep it up. Never has this been more clear than it was over the long Thanksgiving weekend. While many Americans did the sensible — if heart-wrenching — thing and stayed home or limited their gatherings to small, pre-existing “pods,” more than 8 million people traveled through airports the day before Thanksgiving. In one poll, 40 percent of respondents told researchers they were planning on attending a large, in-person gathering. All of this while a record 90,000 people were already hospitalized with COVID-19, and public health professionals begged people to stay home so as not to exacerbate the problem. How can people do this, knowing that their actions risk their own lives and the lives of others? It would be one thing if the incredible, worldwide scientific effort to create a vaccine for this terrible virus was failing and there was no hope on the bleak horizon. But it looks like multiple vaccines will be deployed beginning next month, with the possibility of a return to some kind of normalcy by the end of next year. The end of this thing is now tantalizingly in sight. This is not to minimize what people have been through, or the misery that awaits those who hunker down for the winter, still cruelly shorn of nearly all social contact and ordinary joys. But the reality is that many Americans are now consciously choosing to spread death and suffering over finding the strength to endure for a few more months. And they aren’t just harming themselves: They are putting unimaginable strain on the country’s health-care system, as burned out doctors, nurses, and staff ask themselves why they are martyring themselves on behalf of such a venal society. One viral immunologist told me that, “I feel upset with these folks because this is inevitably going to cause more death and harm and not just to them but others who did stay home and followed guidelines.” He added that much of the blame rests with national and state political leaders determined to play down the gravity of the problem so they could rush economic re-openings. A palliative medical counselor said that the staff at her facility “is wonderful but furious when it is the patients’ reckless behavior that puts them in the ICU for COVID.” Fury gives way to exhaustion and resignation. “They still provide superhuman care,” she says, “but it’s only human to be frustrated.” Health-care workers are not in the army. No one is forcing them to suit up and plunge themselves into another 16-hour shift of watching a deadly virus suffocate people to death. There is no law that says they must carry on even when COVID patients show up convinced the whole thing was a plot designed to harm President Trump’s re-election prospects. Health-care providers know perfectly well that a lot of the patients they are treating scoffed at the danger and shrugged off expert guidelines and did whatever they wanted anyway.
This kind of behavior is evil, selfish, and cartoonishly destructive. It fills me with incoherent rage. This is a country full of people who have completely lost their way. One of the most infuriating things about it all is that the gob-smackingly selfish actions of your friends and neighbors will serve to counteract the sacrifices of those who have spent the past 9 months trying to do the right thing.
It means your friends, parents, and grandparents could get infected with this disease and then die from it, all because millions of your selfish fellow citizens plainly lacked the fortitude to weather temporary adversity, and because the depraved ghouls currently in charge of the federal government refused to spend the money needed to help the riskiest places — bars, restaurants, and gyms — stay closed and financially whole. We know now where this is headed over the next few months. Hospitals will be taxed beyond capacity, spiking the death rate from COVID and delaying or canceling care for tens of thousands of others. There will be mobile morgues and mass graves and countless Zoom funerals and an entire generation of health-care workers with permanent emotional trauma. People will show up to the ER after car accidents and heart attacks and allergic reactions and die waiting. The overall coronavirus death toll, now at more than 266,000, will surpass 400,000 or more by March and could ultimately reach half a million or more. The economic fallout could last years. So much of this suffering will ultimately have been needless. Tens of thousands will perish weeks or even days before they could have been saved. More and more frontline workers will succumb. And it is all because so many of our fellow citizens have revealed themselves to be both pathetic and decadent. It is truly hard to believe that the millions of people who are too weak-willed to go a year without sitting down for a meal inside a restaurant are the descendants of the brave men and women who fought and won World War II with five years of painful sacrifices and solidarity. A lot of Americans circa 2020 wouldn’t have made it three weeks past Pearl Harbor before protesting rationing and demanding our surrender to the Axis powers, and they deserve neither our sympathy nor the extraordinary heroism of doctors, nurses, and staff in hospitals and care homes across the country.