By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS
Biotechnology firm Moderna announced Monday that a preliminary analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases – a striking initial result that leaves the United States with the prospect that two coronavirus vaccines could be available on a limited basis by the end of the year.
The news comes a week after pharmaceutical giant Pfizer and its German partner BioNTech lifted the stock market and people’s hopes with the news that their coronavirus vaccine was more than 90 percent effective.
“It’s extremely good news. If you look at the data, the numbers speak for themselves,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who was one of three people briefed on the data by an independent committee Sunday morning. “I describe myself as a realist, but I’m fundamentally a cautious optimist. I felt we’d likely get something less than this. . . . I said certainly a 90-plus-percent effective vaccine is possible, but I wasn’t counting on it.”
Moderna’s vaccine, co-developed with Fauci’s institute, is being tested in 30,000 people. Half received two doses of the vaccine, and half received a placebo. To test how well the vaccine works, physicians closely monitored cases of covid-19 to see whether they predominantly occurred in people who received the placebo group.
Of the 95 cases of covid-19, the disease caused by the virus, 90 were in the group that received the placebo. There were 11 severe cases reported – all in people who received the placebo. With cases of covid-19 confined almost exclusively to trial participants receiving a placebo, that sends a strong signal that the vaccine is effective at thwarting the virus.
The data have not yet been published or peer reviewed, and the overall effectiveness of the vaccine may change as the study continues. But Fauci said the data on severe cases was “quite impressive” and effectively answers a question that has lingered: whether a vaccine measured by its success in preventing any case of covid-19 can prevent the most urgent cases, too.
An independent data committee, convened by the National Institutes of Health, analyzed the results Sunday morning. Stéphane Bancel, chief executive of Moderna, said in an interview that he spent the morning trying to distract himself from wondering about the results by working at his home in Boston, but instead he found himself constantly checking his phone and email. When he learned the results later in the morning, the evidence that the vaccine prevented severe disease stood out as most consequential.
“In this pandemic, what has been awful from a public health standpoint, an economic standpoint, is the worry people have to get so sick they have to go to the hospital – so sick they have to get to the ICU and have a high risk of dying,” Bancel said. “If a [vaccine] could prevent 95 percent of people to not get disease, but to not get severe disease, that would be a game-changer: the impact on hospitals, the impact on people’s psyche and the impact on deaths.”
Moderna has committed to completing its trial before applying for emergency-use authorization – which means waiting until there are 151 cases of covid-19 in the study. A previous projection showed that the trial might end sometime early next year, but it is instead expected to reach its endpoint in seven to 10 days, Bancel said, because of surging coronavirus cases in the United States. The explosion of virus cases translates into an expedited ability to ascertain whether a vaccine works.
The company will have enough safety data to support an application shortly before Thanksgiving. Bancel anticipates a vaccine might begin to become available to those at high risk in the second half of December.
Unlike Pfizer, which invested $2 billion of its own money in researching and developing a vaccine, Moderna is part of Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing upfront funding to companies and helping coordinate the trials. Moderna received $2.5 billion from the U.S. government to support research, development and manufacturing of its vaccine candidate, whereas Pfizer signed a contract to sell doses to the U.S. government.
Moderna projects it can produce 20 million doses by the end of the year – enough for 10 million people to get both shots. The company aims to produce at least 500 million doses next year, with the possibility of scaling up to 1 billion doses depending on the availability of raw materials.
The side effects of the two-dose vaccine were mostly mild or moderate, including pain at the injection site, fatigue, headache and muscle pain, according to the company’s news release.
Regulators at the Food and Drug Administration must review the evidence for the Moderna and Pfizer vaccines, but the robust early indication of success suggests both vaccines might become available to high-risk populations before the end of this year.
Fauci predicted that people such as health-care workers or people with conditions that raise their risk of developing severe disease could begin receiving doses before the end of the year. It could take about four months to vaccinate people in high-risk groups, and in April, the vaccine could expand to the rest of the population.
The focus on vaccines will now shift to the daunting logistics of manufacturing and distribution.
The Pfizer vaccine requires ultracold storage conditions – minus 70 degrees Celsius – not widely available in typical vaccination settings. The company has been working to overcome that limitation.
Moderna announced Monday that its vaccine can be stable at refrigerator temperatures for a month and frozen for up to six months. It will not require dilution at the point of care, unlike the Pfizer vaccine.
Saving Christmas from covid is critical for Britain
Health & BeautyNov 15. 2020A passerby talks a photograph as an employee wearing a face mask dresses a Christmas tree in a Selfridges & Co Ltd. department store window in London on Nov. 4, 2020. MUST CREDIT: Bloomberg photo by Chris Ratcliffe.
By Syndication Washington Post, Bloomberg · Deirdre Hipwell, David Goodman · WORLD, EUROPE Britain knows Christmas is coming when John Lewis Partnership launches its television ad. Selling the season as a time for acts of charity rather than any particular products, this year’s edition will focus on food poverty and struggling parents.
Yet as the coronavirus continues to wreak havoc, it’s the department store chain itself that’s now a window on the festive period in a country that relies more on consumer spending than any of the big European economies.
With a partial lockdown in England closing all non-essential stores until at least Dec. 2, rescuing the next six weeks from covid-19 is critical for the U.K.’s financial well-being and a government beset by accusations that it can’t get a grip on the pandemic.
Further disruption to what retailers call the “golden quarter” could be disastrous for an industry that’s already been battered. November and December account for one of every five pounds of retail spending.
The slump during the U.K.’s spring lockdown precipitated the record decline in gross domestic product. It then contributed to most of the recovery in third quarter reported by the Office for National Statistics on Thursday.
The latest lockdown could cost retailers about 9 billion pounds ($12 billion), making what happens next month all the more important, said Kyle Monk, director of insight at the British Retail Consortium, or BRC. Household spending increases by 25% as Christmas comes. “If December is spent in lockdown it would be pretty catastrophic,” Monk said.
As lights and decorations start to go up on shopping streets, no retailer knows the importance of Christmas more than John Lewis, the store of choice for many middle-class Britons. Last year about 14% of the partnership’s annual sales came in the last five weeks of the year.
This year matters more than most for a 91-year-old company that’s a microcosm of the economy’s malaise, with job cuts, the accelerated shift to doing things online and the repurposing of staff and shops.
John Lewis announced plans on Nov. 4 to cut as many as 1,500 jobs at its head office, taking the total toll this year just under 4% of the workforce. Those cuts only add to the bloodletting on Britain’s main streets, where close to 125,000 jobs were lost in just the first eight months of 2020, according to the Centre for Retail Research.
Sharon White, chairman of John Lewis, said in October when she revealed the partnership’s turnaround strategy that hard decisions were needed to arrest a decline in profitability at one of the country’s biggest private employers.
She announced the closure of eight out of 50 stores while permission from local authorities to convert nearly half of John Lewis’s flagship store on London’s Oxford Street into offices has been granted.
The company also canceled annual bonuses this year. It’s the first time in more than 70 years that its 78,000 staff members who collectively own the partnership will receive no payout.
In addition to dealing with covid-19, Britain also faces the potential cost of leaving Europe’s single market without a trade agreement in place. As Brexit talks drag on, retailers have had to activate contingency plans to try and mitigate any initial supply chain problems and disruption.
John Lewis said last year that it was prepared for a no-deal Brexit but warned it will have a “significant impact,” particularly on fresh food supplies at its Waitrose grocery chain. The BRC said the industry would face 3 billion pounds of tariffs on food should the U.K. and EU fail to reach an accord.
But for now the attention is on avoiding a bad Christmas. A Deloitte survey in 2019 found British consumers were forecast to spend nearly 39% more on average compared to shoppers in the rest of Europe in the period.
“People underestimate just how geared the department store is towards the Christmas shopping period,” said Ian Cheshire, chairman of Barclays U.K. and former chairman of department store group Debenhams Plc. “More than a year’s profit is effectively made in that period.”
John Lewis started its Christmas ads a little over a decade ago. The two-minute clip usually involves pairing music with a storyline evoking nostalgia for family and celebrations. This year’s production will start running on social media on Friday and on television at the weekend.
In a sign of the struggles faced by households as well as retailers, it will include a direct appeal to support two charities helping people through the pandemic. It’s called “Give a Little Love.”
By Syndication Washington Post, Bloomberg · Boris Groendahl · WORLD, EUROPE Austria will shut schools, most stores, and services such as hairdressers starting Tuesday, said Chancellor Sebastian Kurz, after attempts to rely on self-discipline and moderate restrictions failed to slow the coronavirus pandemic.
The new measures come two weeks after a soft lockdown similar to Germany’s was imposed, leaving large parts of the economy and society open. With Austria’s infections spiking, Kurz said he hoped to end the latest measures on Dec. 6 to allow some sort of Christmas celebrations.
“My urgent request: don’t meet anybody,” Kurz said at a news conference from the chancellery in Vienna on Saturday. “Every social contact is one too many.”
Finance Minister Gernot Bluemel said aid for lost business revenue due to pandemic restrictions will be at least doubled.
Austria’s gradual reaction this fall is a contrast to March, when the government acted assertively and was among the first European nations to reverse the Covid-19 wave. “This government has failed,” said Beate Meinl-Reisinger, head of Neos, Austria’s smallest opposition party.
The country had more than 550 new cases per 100,000 people in the last seven days, one of Europe’s highest rates. Less than a quarter of infections can still be traced, the positive-test rate is running at more than 20%, and hospitals and intensive care units are filling up.
The tighter rules are defined in a decree that’s being put to the Austrian parliament’s main committee on Sunday and include:
– People may leave their homes only for certain purposes including grocery shopping or other daily needs, to visit or support relatives, go to work, make urgent visits to court or official buildings, or go out for walks or exercise.These restrictions, which were applicable only at night until now, will apply round the clock under the new plan.
– Shops will close except grocery and drug stores, banks, post offices, gas stations, tobacconists and newsstands, and car repair shops, all of which will have opening hours restricted to 6 a.m. to 7 p.m.
– Office jobs should be done from home if possible.
– Distance learning will expand to under-14s, while schools remain open for parents who need child care.
– While religious services aren’t banned in the law, the Roman Catholic church will suspend normal services and is in talks with the other religious communities to do the same, Archbishop Franz Lackner said in a statement.
Austria will expand aid for businesses affected by the lockdown, Bluemel said. In addition to restaurants and hotels, which can claim 80% of the revenue they had in November 2019 as compensation, services such as hairdressers, cosmetic salons or masseurs will be able to claim the same. Stores will be able to claim 20% to 60%, depending on size, sector and other parameters, Bluemel said.
The extension and broadening of the lockdown will raise the cost of the compensation to at least 3 billion euros ($3.6 billion), from 1.5 billion euros earmarked under the earlier restrictions.
By The Washington Post · Ashley Parker, Josh Dawsey, Yasmeen Abutaleb, Philip Rucker · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT WASHINGTON – President Donald Trump finally received some good news this past week: Amid spiking coronavirus cases nationwide – more than 100,000 new cases a day since Nov. 4, with deaths rising, too – pharmaceutical giant Pfizer announced that its experimental coronavirus vaccine was more than 90% effective.
But the president was furious.
The news came six days after Election Day – too late to help Trump in his contest against President-elect Joe Biden – and he thought both Pfizer and his own Food and Drug Administration had withheld the announcement to prevent delivering him the sort of pre-election public-relations victory that could have helped him in the polls. Instead of touting the vaccine success as a crowning achievement of his administration, as advisers encouraged, Trump barely mentioned it except to gripe on Twitter that “the Democrats didn’t want to have me get a Vaccine WIN, prior to the election.”
Since Election Day and for weeks prior, Trump has all but ceased to actively manage the deadly pandemic, which so far has killed at least 244,000 Americans, infected at least 10.9 million and choked the country’s economy. The president has not attended a coronavirus task force meeting in “at least five months,” said one senior administration official with knowledge of the meetings, who spoke on the condition of anonymity to share candid details.
Now, as he fights for his political life, falsely claiming the election was somehow rigged against him, Trump has abdicated one of the central duties of the job he claims to want: leading the country through a devastating pandemic as it heads into a grim winter.
“I don’t know that I think that’s where his focus is,” said one senior administration official. “But I know that’s where our focus needs to get back to.”
This account of Trump’s indifference and inaction on the newly surging coronavirus pandemic is based on interviews with more than a dozen administration officials, Trump allies, health advisers and others familiar with the response, many of whom spoke on the condition of anonymity to discuss internal deliberations.
On Friday, Trump appeared in the Rose Garden to offer an update on Operation Warp Speed, his administration’s effort to fast-track a vaccine. The president and his team shared some encouraging news: that at least 20 million vaccine doses could be ready as early as December, with 25 million to 30 million doses coming each subsequent month. But Trump seemed deflated, with the dour disposition of a man who understood that the coronavirus progress was too late to help him in the polls. Biden is projected to win with 306 electoral votes, compared with Trump’s 232.
Until his Friday news conference, Trump had barely appeared in public since his Nov. 3 defeat, save for an angry, ranting news conference in which he lobbed baseless claims of voter fraud and a visit to Arlington National Cemetery for Veterans Day, where he violated the cemetery’s policy requiring all visitors to wear a mask. He also made no mention of the rising toll of the virus in his Rose Garden news conference, which included rambling criticism of Pfizer and attacks on New York Gov. Andrew Cuomo, a Democrat,.
In one social media missive, Trump retweeted an angry message that accused CNN of stopping its ” ‘COVID-COVID-COVID!’ drumbeat” after the election.
Trump has increasingly eschewed the advice of even his own public health and medical experts. Deborah Birx, the White House coronavirus response coordinator, has suggested several times reducing in-person dining in restaurants and bars, but Trump has dismissed her suggestions, a senior administration official said. He has also ignored the calls by Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, for more aggressive messaging on the importance of mask-wearing, officials said.
The president is no longer regularly briefed on the pandemic by his team of doctors, and he rarely reads the daily virus reports prepared by Birx, a senior administration official said. The reports have grown increasingly grim in recent weeks, aides said, but are largely ignored in the West Wing. Several of the administration’s top medical experts – including Birx, Fauci and Surgeon General Jerome Adams – have only infrequently visited the White House in recent weeks, multiple administration officials said.
Olivia Troye, a former adviser to Vice President Mike Pence and aide on the White House coronavirus task force who resigned from the administration and supported Biden’s presidential bid, described the current situation as “very upsetting.”
“You would think that now that his presidential campaign is over that he could perhaps leave a legacy of last-minute leadership during this time – an ounce of it, maybe,” Troye said. “He has an opportunity here to focus on the well-being of Americans.”
Jack Chow, a U.S. ambassador for global HIV/AIDS during the George W. Bush administration and a former World Health Organization assistant director general, was similarly alarmed by Trump’s handling of the crisis.
“The duty of a president is to protect the national security of the United States, and this is the most prominent disease of mass destruction America’s ever faced, and we have a commander in chief who has run away from the problem and has made it worse,” Chow said. “We had an opportunity twice over the past eight months to bring it down to safer levels, and we failed. We are on the verge of losing control of this pandemic.”
The White House disputed much of the criticism of Trump’s engagement with the coronavirus pandemic. The president is regularly briefed on the topic by Pence, one administration official said, and Birx has an office in the White House.
“President Trump and his entire administration remain intensely focused on defeating this virus and saving lives as Operation Warp Speed continues to fast track lifesaving treatments and vaccines in record time,” said White House spokeswoman Sarah Matthews, referring to the fast-track vaccine effort. “Thanks to President Trump’s leadership, we’re on track to deliver safe and effective vaccines to 20 million Americans in December and another 25-30 million per month after that. The Task Force continues to work with state and local jurisdictions to ensure communities have the tools and resources to better treat patients and protect the most vulnerable.”
Although many federal health officials firmly believe more needs to be done to strengthen the country’s virus response, most are too afraid to call publicly for firmer action, two people familiar with task force meetings said. For several weeks, Birx and Fauci pushed to dramatically expand testing, raised concerns about hospital overcrowding and sounded alarms both in public and private about the deadly winter the country is hurdling toward – to no avail.
Trump’s negligence on the pandemic comes at a particularly precarious time, just as his administration is winding down and Biden and his team are preparing to assume power, experts said. But Trump – who so far has refused to acknowledge the election results – is further hindering the process by refusing to start a formal transition.
One senior administration official described Trump’s government as performing an elaborate “Kabuki theater, pretending that Biden didn’t win,” a pantomime that has further hurt the administration’s virus efforts.
Trump – who has already fired Defense Secretary Mark Esper and other top Pentagon officials – has hinted that he may use his final weeks in office to purge the government of those he views as disloyal, leaving officials paralyzed by fear over who might be next, several administration officials said.
In internal emails, top officials are still refusing to acknowledge the election results. Some messages include phrases such as “if there’s a transition” and “if there’s a second term,” one senior administration official said, adding that there’s little discussion about the coronavirus at the White House.
Experts said both the Trump administration and the incoming Biden administration need to send a strong and united message emphasizing that the country is entering its worst stretch yet of the pandemic and urging people to take the virus seriously, including by wearing masks and avoiding large gatherings. They also said the administration needs to assess where personal protective equipment shortages are and direct resources to those areas, as well as rapidly expand testing and share information and resources with the Biden team about how to distribute the expected vaccine.
“If you’re going to confront the pandemic – and this campaign will extend beyond Jan. 20 – absolutely they ought to be preparing the Biden team, briefing them about the landscape of programs, any bottlenecks that they’ve encountered, so that the Biden team can develop their strategy,” Chow said, referring to Inauguration Day. “Right now, you have two parallel universes with an iron wall in between, and if that persists for much longer, the Biden strategy will be potentially slower and weaker than what is needed to take on the third wave.”
Career officials across several agencies – including the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health – are trying to quietly work on the pandemic response and take notes on shortcomings, one senior official said, in the hopes that the Biden administration can address the problems when it takes over.
Kavita Patel, a physician and former health adviser in the Obama White House, described “a lot of frustration” at the staff level in the Trump administration. Some Trump officials have reached out to her, she said, saying they want to be helpful to the incoming Biden administration, “but they’re being told very actively to not speak to anybody.”
“Members of the Biden-Harris task force are on TV, in the media, talking about the vaccine, talking about staying at home, making the public messages that I expected the White House coronavirus task force to do,” Patel said. “We have a task force now, [but] it’s just a task force from the transition team with unfortunately no power in the executive branch. The CDC can’t act on President-elect Biden’s word.”
A senior White House official said in addition to sending out Birx’s daily report, the administration has been focused on deploying personal protective equipment and therapeutics where needed and sending teams to hot spots across the nation. Subgroups within the broader task force have also continued to meet regularly, this person added, including a group that consists of Birx, Trump’s son-in-law and senior adviser Jared Kushner, Pence Chief of Staff Marc Short and Center for Medicare and Medicaid Innovation Director Brad Smith.
Behind the scenes, however, many administration officials paint a portrait of chaos, with senior advisers enabling some of Trump’s most questionable instincts on the pandemic.
Chief of Staff Mark Meadows has criticized Fauci and others for being what he viewed as too apocalyptic about the virus, two administration officials said. Meadows told others that he believed focusing on the coronavirus hurt Trump politically.
Some current and former aides said Meadows also has bizarre views on the virus. He has told others, for example, that he believes one of the main ways the virus is spread is through waiters touching the cups of different people at restaurants, according to people who have heard his comments.
Meadows tested positive for the virus just after the election, but he told others not to disclose his condition, according to one administration official.
Two former administration officials put some of the blame for the laggard White House response on Kushner. Scott Atlas – a Trump coronavirus adviser who has espoused the dangerous theory of herd immunity and clashed with the other doctors – was recruited by Kushner and often spent time in Kushner’s office suite before he officially took the job, these officials said. They added that Kushner had been one of the leading voices stressing to Trump the importance of moving on from the virus.
The White House – which probably hosted a superspreader event in late September celebrating the nomination of Supreme Court Justice Amy Coney Barrett – no longer consults health experts before planning events, including the East Room celebration on election night that appears to have led to several infections, two officials said. One person present at the party, who came in contact with at least two individuals who later tested positive for the virus, said she had not heard from any White House contact tracers.
Johnny McEntee, a Trump loyalist who started as the president’s body man and now is director of personnel for the entire U.S. government, has also told others he is not concerned about the virus, said people familiar with his comments. He is engineering much of Trump’s post-election purge of allegedly disloyal officials.
Yet the virus has breached the president’s inner sanctum, making it one of the nation’s notable pandemic hot spots. After an initial outbreak in October that sickened the president, the first lady and their teenage son, Barron, and other top White House and Republican officials, a second wave of illness has now hit close allies of Trump.
In addition to Meadows, David Bossie, the Trump adviser initially tasked with overseeing the presidential campaign’s post-election legal strategy, has tested positive for the coronavirus, as has Trump adviser Corey Lewandowski and about a half-dozen other administration officials. The chief of staff of the Republican National Committee also tested positive, along with at least seven additional RNC staffers.
Experts worry that Trump’s mishandling of the virus so far is only going to get worse as the nation heads into winter. Scott Gottlieb, the former FDA commissioner under Trump, said it was clear the federal government was unlikely to change its approach, so states need to step up their own efforts.
“The numbers are going to get very big in terms of hospitalizations and deaths,” Gottlieb said. “We are just going to have a lot of death and disease.”
At dinner parties and game nights, casual American life is fueling the coronavirus surge
Health & BeautyNov 12. 2020Members dine at a club in August in Annapolis, Md. MUST CREDIT: photo for The Washington Post by Craig Hudson.
By The Washington Post · Karin Brulliard · NATIONAL, HEALTH, HEALTH-NEWS
A record-breaking surge in U.S. coronavirus cases is being driven to a significant degree by casual occasions that may feel deceptively safe, officials and scientists warn – dinner parties, game nights, sleepovers and carpools.
Many earlier coronavirus clusters were linked to nursing homes and crowded nightclubs. But public health officials nationwide say case investigations are increasingly leading them to small, private social gatherings. This behind-doors transmission trend reflects pandemic fatigue and widening social bubbles, experts say – and is particularly insidious because it is so difficult to police and likely to increase as temperatures drop and holidays approach.
The White House coronavirus task force has been urging states that are virus hot spots to curtail maskless get-togethers of family and friends, saying in reports that asymptomatic attendees “cause ongoing transmission, frequently infecting multiple people in a single gathering.”
As new daily cases in the United States surpassed 145,000 on Wednesday, New York Democratic Gov. Andrew Cuomo announced a 10-person limit on gatherings in private homes, calling them a “great spreader.” Similar restrictions have been imposed in states including Ohio, Utah, Connecticut and Colorado, where one recent cluster involved seven people infected while playing the dice game bunco, and Rhode Island, whose governor has pledged to fine violators. Oregon last week announced a “pause” in hard-hit counties on most groups larger than six people.
“Earlier in the outbreak, much of the growth in new daily cases was being driven by focal outbreaks – long-term care facilities, things of that nature,” said Nirav Shah, director of the Center for Disease Control and Prevention in Maine, where cases have soared in the past two weeks. “Now, the kitchen table is a place of risk.”
In Maine, as in other states, case investigators are seeing a new and related pattern: People who are infected list more close contacts than they did earlier, making the work of contact tracers more time-consuming and complicated. From March through September, the average number of contacts identified in Maine coronavirus investigations was 3.5. In October, that rose to 5.8.
“We’ve all gotten used to our bubbles, but I don’t think we’ve really asked whether someone who’s in our bubble is also in another person’s bubble,” Shah said. “People’s bubbles are getting big enough to burst.”
For months, the danger of large events has been a focus of state and local restrictions and of media coverage. Experts say less attention has been paid to the peril of small gatherings among family and friends, who may appear healthy and take similar precautions to avoid the virus.
But each additional contact increases a person’s risk, said David Rubin, the director of PolicyLab at Children’s Hospital of Philadelphia, which warned in a blog post last week that small indoor gatherings create “perfect conditions for a virus that can spread among people who are crowded into a poorly ventilated space.” Rubin said a person’s “bank” of risk should be even lower in winter because respiratory viruses like the coronavirus are more stable in dry, colder air.
“Often, they’re with people we know really well,” Rubin said of these gatherings. “We let our guard down.”
Amber Calderon now knows she did that in October. The 24-year-old was excited to see some of her relatives for the first time in months at her nephew’s birthday party – and she felt safe. The Conroe, Texas, resident knew her relatives wore masks and socially distanced in their day-to-day lives, she said, so she “trusted everyone.”
About 25 people attended the party at a house, and Calderon said just one person wore a mask – her 81-year-old grandmother. Calderon started to feel ill a few days later, and she tested positive for the coronavirus on Oct. 20. Ten other people who were there also got sick, she said, including her grandmother.
“When I tested positive, I was mad at the situation I put myself in,” Calderon said. “I should’ve never attended that party that day. None of us should have. I knew better.”
In some places, the sheer volume of cases is so great that public health departments cannot connect the dots between them or discern whether a gathering attended by one infected person is the same as one reported by another.
In Minnesota, which reported a single-day record of nearly 6,000 cases on Sunday, the state’s infectious-disease director, Kris Ehresmann, described what she called a “circular” problem: Social gatherings are leading to more community spread, and more spread is making those events ever riskier.
“It’s getting more and more difficult to really tease out an interpretation of these data, because our community transmission just keeps going up,” said Amy Westbrook, the public health director of St. Louis County, Minn.
In her county, she said, 30 percent of people who test positive say they don’t know where they caught the virus, and a rapidly growing number haven’t even spoken to overwhelmed contact tracers. Westbrook said she is stepping up public education efforts, but she knows residents are somewhat numb to messages about masks, hand-washing and staying home. And local law enforcement agencies, she said, have other matters to focus on than dinner parties.
“Once there’s community transmission that’s so widespread, there’s not a lot of good, targeted interventions,” Westbrook said.
Timothy McDonald, public health director in the Boston suburb of Needham, said he is considering a campaign centered on the idea of a “social budget,” reminding residents that, according to guidance from the Centers for Disease Control and Prevention, they should avoid spending more than 15 minutes within six feet of most other people in a 24-hour period.
McDonald said he hopes that might help with an alarming widening of social groups and casual encounters, particularly among youths. In-school transmission is not the problem, he said. Instead, spread is happening after school – at play dates, sleepovers and, especially, socializing and carpooling connected to youth sports, he said.
“If your son or daughter is playing on a town soccer team and a travel soccer team, plus lacrosse, and is also on an ice hockey team, they’re exposed and in close proximity to dozens of other kids,” McDonald said. “Instead of counting the contacts on single digits, it’s now getting to two or three dozen in some cases. And those are only people who are defined as close contacts.”
Beyond gathering caps and public pleas, officials and experts say it is unclear what can be done to persuade pandemic-weary Americans to tighten their circles. Capacity limits in bars or mask requirements in stores can be enforced through fines and closures. Cracking down on baby showers or poker nights in private homes is another matter.
Connecticut Democratic Gov. Ned Lamont last week announced a 10-person limit on all indoor and outdoor gatherings, saying informal, private gatherings were “where we’re seeing ignition taking off in terms of the infection rate.” But he acknowledged that enforcement would be “on the honor system.”
In neighboring Rhode Island, Democratic Gov. Gina Raimondo has for weeks admonished residents to shrink their bubbles and skip casual gatherings. Some people have reported 50 close contacts, she said at a briefing in mid-October. A high school slumber party involving at least 20 youths led to at least five infections and put hundreds of people in quarantine, she said as she announced a 10-person limit on social gatherings Oct. 30.
Raimondo said she would not hesitate to fine hosts of gatherings found to fuel transmission $500 for each person over the limit. No such fines have been issued yet, a state health department spokesman said Tuesday.
“It seems strange to wear your mask in your house with your best friend,” Raimondo said. “It’s human. It’s understandable. It’s got to stop.”
Calderon now agrees. Her bout with covid-19, the disease caused by the coronavirus, involved a litany of symptoms: loss of taste and smell, devastating headaches, a cough, congestion, stomach pain, muscle aches, fatigue.
Calderon came out of it feeling lucky. She and all of her relatives recovered. Her grandmother was hospitalized for a week but is on the mend.
Calderon said she also came out of it with renewed resolve to remind others to be vigilant – and tell them “that the party they are about to have is not a good idea.”
Everyone is tired of leading hemmed-in lives, Calderon said. But she views her experience as a painful reminder that “this virus spreads, and it spreads fast,” she said. “And if you continue to ignore it, it will catch up to you, just like it did me.”
Russia says early data show its covid-19 shots 92% effective
Health & BeautyNov 12. 2020A heath worker draws the ‘Gam-COVID-Vac’, also known as ‘Sputnik V’, COVID-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) at a clinic in Moscow on Sept. 23, 2020. MUST CREDIT: Bloomberg photo by Andrey Rudakov.
By Syndication Washington Post, Bloomberg · Henry Meyer, Stepan Kravchenko · BUSINESS, WORLD, HEALTH, EUROPE, HEALTH-NEWS
The developer of Russia’s flagship vaccine against covid-19 said it shows a 92% efficacy rate in preventing cases of the illness, as the country pushes for a top slot in the fight against the coronavirus after a rival product by Pfizer reported a similar breakthrough.
The preliminary Phase 3 findings are based on results from 20,000 volunteers who were given the first dose, including more than 16,000 who also received a second injection, its developers Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund said in an announcement on Twitter Wednesday.
Russia, which said it was the first in the world to do so when it registered Sputnik V in August, has faced skepticism from scientists and pharmaceutical companies, who say that more testing is necessary to prove the inoculation is safe and effective.
“The Russian vaccine has been vilified so much, it’s developed immunity itself to criticism,” RDIF head Kirill Dmitriev said in a phone interview.
The latest data is based on results 21 days after the initial injection and will be published in a peer-reviewed medical journal, according to the statement. The 92% efficacy rate was based on 20 confirmed covid-19 cases split across vaccinated subjects who got two doses and those who got the placebo. No unexpected adverse events have been reported in the trial and monitoring is continuing, the backers said. The trial is to include a total of 40,000 subjects, but not all have yet been vaccinated.
“The percentage of the infected can change significantly after they inoculate more volunteers and the trial goes into the final phase,” said Ilya Yasny, head of scientific research in Inbio Ventures, a biotech venture capital fund with a Moscow-based scientific team.
“The timing suggests it was motivated in part in response to Pfizer,” said Jeremy Rossman, a senior lecturer in virology at the University of Kent in the U.K. “This seems more about public relations than reporting medical data on the Phase 3 trial.”
The RDIF didn’t immediately respond to a request for comment on the timing of Wednesday’s announcement.
The Sputnik V shots have also been given to more than 10,000 health workers, teachers and officials outside the trial. Preliminary observations from this group show effectiveness over 90%, the Health Ministry said hours after Pfizer’s announcement this week.
“The bottom line is that until we see a peer-reviewed article, we must view the claims with skepticism,” said Arthur Caplan, director of medical ethics at NYU School of Medicine, of the latest announcement.
Pfizer’s vaccine candidate, developed with BioNTech SE, is at least 90% effective, according to an interim analysis published this week in what was hailed as the most encouraging scientific evidence supporting an inoculation to date.
In comparison to the Sputnik V trial, Pfizer enrolled almost 44,000 people in its study and dropped the initially planned 32-case interim analysis in favor of a minimum of 62 Covid-19 cases, eventually publishing the report when the case count reached 94.
“Although based on fewer cases than the recent Pfizer data, the vaccine looks as efficient,” said Ian Jones, professor of virology at the University of Reading in the U.K. “We still need to know about the longevity of the response and the efficiency in different age groups, but the result bodes well for the other trials currently in progress.”
With the world’s fifth-largest number of Covid-19 cases, Russia is also hoping to capture a share of the global market for a tool to control the pandemic that has killed more than 1.2 million people across the planet. Domestic output aims to reach over 70 million a year by April 2021, according to Deputy Prime Minister Tatyana Golikova. Russia also plans to manufacture more than 500 million doses of the Sputnik V vaccine per year in other countries through local production including in India, South Korea, Brazil and China.
Still, since it was approved for use, Sputnik V has faced challenges ramping up production as other inoculations globally prepare for widespread roll-out.
By The Washington Post · Joanna Slater · WORLD, HEALTH, ASIA-PACIFIC NEW DELHI – Adar Poonawalla is an Indian billionaire whose family-owned firm makes more vaccines a year than any other company on Earth. Ask him about the race for a coronavirus vaccine and he will offer some unvarnished opinions.
One prominent vaccine candidate is “a joke” that will not work for the developing world. Anyone who declares how long a vaccine will confer immunity is talking “nonsense.” The world’s entire population will not be immunized until 2024, he says, contrary to rosier predictions.
Poonawalla is equally frank about the gamble his company, Serum Institute of India, is making in the pandemic. He is putting $250 million of his family’s fortune into a bid to ramp up manufacturing capacity to 1 billion doses through 2021.
“I decided to go all out,” said Poonawalla, 39. Among the initial skeptics: his father, Cyrus, the company’s founder. “He said: ‘Look, it’s your money. If you want to blow it up, fine.’ “
It is a bet with global repercussions. In the quest for effective coronavirus vaccines, India is poised to play a critical role in supplying the developing world, which is starting the race with a distinct disadvantage.
Wealthy countries have already grabbed a major chunk of the available supply. The United States, the United Kingdom, Japan and Canada have struck deals large enough to vaccinate their entire populations. By contrast, a pooled global effort to distribute vaccines equitably to more than 150 countries – including dozens of low-income nations – has secured only 700 million doses.
Pfizer, which announced stellar early results for its vaccine candidate Monday, has not struck any deals to supply its product to developing countries, according to an analysis of publicly available data by Airfinity, a research firm in the United Kingdom. Pfizer’s vaccine must also be stored at ultra-cold temperatures, a major challenge in much of the world.
Rich nations are “all cutting in line and hoarding vaccine supply to immunize as many people as possible, even if this leaves other countries unable to immunize those at highest risk,” said Nicholas Lusiani, a senior adviser at Oxfam America, a nonprofit group devoted to fighting poverty.
Enter Indian vaccine makers, led by Serum Institute, the largest manufacturer in the world by volume. Well before the pandemic, India was a “vaccine powerhouse” specializing in affordable exports to low- and middle-income countries, said Andrea Taylor, an assistant director at the Duke Global Health Innovation Center.
Taylor said countries such as Brazil and China also have manufacturing capacity, but she singled out Indian vaccine makers because they moved so quickly to form tie-ups with global companies and increase their own production. India is “going to be the absolute star in the story,” she said.
Anthony Fauci, the top infectious-disease specialist in the United States, shared that sentiment during a panel earlier this year. India’s manufacturing capability is “going to be very, very important” as effective vaccines emerge, he said.
Four major pharmaceutical companies – AstraZeneca, Novavax, Johnson & Johnson and Sanofi – have reached agreements to produce at least 3 billion vaccine doses for low- and middle-income countries, Airfinity’s research shows. Serum Institute is set to manufacture more than two-thirds of those doses.
Some of the agreed-upon supply to low- and middle-income countries will come through the pooled initiative backed by the World Health Organization, known as the Covid-19 Vaccines Global Access Facility, or Covax. Covax includes higher- and lower-income countries, more than 150 in total. The United States declined to join.
Covax is being co-led by Gavi, a nonprofit vaccine alliance. In September, Gavi announced a partnership with the Bill and Melinda Gates Foundation to pay Serum Institute in advance for 200 million vaccine doses, at a cost of $3 each, to be distributed in developing countries, hopefully in early 2021. The $600 million infusion will help Serum ramp up production.
Gavi and the Gates Foundation “want to assure vaccine supply at an affordable price,” said Poonawalla, Serum’s chief executive. His aim, meanwhile, is to cover some of his costs. “At least my risk is taken away so I can sleep at night,” he said.
The partnership with Serum, given its size, is “crucial” to Gavi’s larger goal of ensuring that no country is left behind in the quest for vaccines, said Dominic Hein, who works on Gavi’s efforts to make vaccines more readily available in low-income countries.
Under the agreement, more than 60 countries – largely in Africa and Asia – would receive the vaccine developed by Oxford University and AstraZeneca or the vaccine under development by Novavax.
Serum Institute has struck deals to manufacture both vaccines, which are in Phase 3 trials. It has also inked deals to make two other vaccines, developed by the American biotechnology company Codagenix and Britain’s SpyBiotech, and is working on its own vaccine candidate that it hopes will enter trials late next year. While the Indian company has reached manufacturing agreements with American companies such as Novavax and Codagenix, it is not currently exporting its vaccines to the United States.
India has recorded the second-highest number of coronavirus cases in the world – more than 8.5 million. Those numbers mean India is a crucial market for future vaccines and an effective place to test them.
Advanced clinical trials of three vaccine candidates are underway in India: the AstraZeneca vaccine and vaccines developed by two Indian pharmaceutical companies, Zydus Cadila and Bharat Biotech. An Indian company is also starting clinical trials of Russia’s vaccine candidate, Sputnik V.
“Whether India makes a vaccine by itself or not, from a manufacturing standpoint, it’s going to be playing a very, very important role,” said Mahima Datla, managing director of Biological E., a 67-year-old vaccine producer based in the city of Hyderabad. Datla also sits on the board of Gavi.
India’s health minister recently predicted that the country would be in a position to start distributing a vaccine within the next six months. The government is working on a plan to immunize as many as 250 million people by July, he said.
Reaching that goal will require the manufacturing heft of Serum Institute. The company has diverted capacity from existing vaccines and started work on a new production facility to be completed next year at its headquarters in the western Indian city of Pune.
Poonawalla said the company has pledged to keep half of the vaccines it makes for use within India. It has already begun manufacturing the AstraZeneca vaccine, he said. About 20 million doses have been made, and he expects to have 10 times that amount ready in the next four months.
He is optimistic that in 2021, a new coronavirus vaccine will be licensed for public use every couple of months. “That’s the good news,” Poonawalla said. The less-good news is that it remains unclear which vaccine, if any, will offer long-term protection from the virus. “Nobody wants a vaccine that is only going to protect you for a few months,” he said.
By The Washington Post · William Wan · NATIONAL, POLITICS WASHINGTON – Trump administration officials Tuesday promised to fairly and swiftly distribute the first covid-19 treatment that helps to protect people with mild illness from developing severe symptoms. But the drug’s extremely limited supply and logistical difficulties in administering it could restrict how many people get access to it.
The Eli Lilly & Co. drug is similar to an experimental treatment President Donald Trump received when he was infected with the novel coronavirus. It is a laboratory-brewed antibody that imitates the immune system’s attack on the virus.
The federal government Monday granted emergency use authorization for the drug, seen as a powerful tool that could save people from developing the worst symptoms of covid-19 until a vaccine against the novel coronavirus is widely available.
The federal government has more than 80,000 doses ready for allocation and distribution this week, Health and Human Services Secretary Alex Azar said in a briefing Tuesday. The medication “has the potential to save thousands of lives and significantly reduce the disease’s burden on the health-care system,” he said.
The government has negotiated a contract to buy 300,000 doses through December, with an option to buy 650,000 more through June. But that comes as the nation records more than 100,000 new coronavirus cases each day.
Because of the limited supply, the number of doses each state receives will be determined by the number of confirmed cases and hospitalizations in a given week, federal officials said.
For example, this week, Vermont – with among the fewest cases – will receive only 20 doses. Meanwhile, South Dakota, where the virus is spreading uncontrollably, will get 820. Each week’s allocation will be made on a Wednesday.
By allocating the drug this way, officials hope to drive down hospitalizations because fewer patients will progress from mild symptoms to severe illness.
Federal officials said that before they order more medication for next year, they need to see whether hospitals have the staffing and capacity to give patients the drug, known as a monoclonal antibody.
The medication, bamlanivimab, must be delivered by intravenous infusion early in the illness. It is authorized for patients with mild or moderate cases of covid-19, the illness caused by the novel coronavirus, who also are at high risk of severe disease or hospitalization. Risk factors include being older than 65, having diabetes, obesity with different body mass index cutoffs depending on age, a suppressed immune system, and cardiovascular disease or high blood pressure in people over age 55.
But getting the drug to patients is a challenging proposition. It must be given over the course of an hour.
The Trump administration on Tuesday sent guidelines addressing those problems to hospitals and states. A government document on payment policy released last month mentions that providers could give the drugs in “temporary expansion sites, such as an erected tent, a retrofitted convention center, or the beneficiary’s home.”
“This is something we’ve never done before on this scale,” said Jeanne Marrazzo, the director of the infectious-diseases division at the University of Alabama at Birmingham. “You don’t just need the facilities, but the dedicated staffing to administer this drug. And a lot of hospitals are going to be trying to do this at a time when cases are shooting up and straining capacity in their system.”
Because of those challenges, some experts worry whether patients in poor and disadvantaged communities will receive equal access to the drug.
“In some populations, you have half the people who will meet that high-risk criteria, so who you give it to and how you make that decision isn’t clear,” said Helen Boucher, the chief of infectious diseases at Tufts Medical Center in Boston. “The worry is whether black and brown people get access who we know are being disproportionately affected by this disease.”
Because most people recover from covid-19 without serious symptoms, giving the drug to a general population would waste the limited supply. And the medication is not helpful to patients with severe symptoms. The FDA warned that the drug “may be associated with worse clinical outcomes” in people requiring high-flow oxygen or who are on ventilators.
“For this drug to be helpful, we have to identify and reach people quickly, and sadly, nine months into this pandemic, we have a large proportion of the country that still doesn’t have adequate testing capacity,” Boucher said.
Federal officials said they are basing distribution on a strategy similar to what is used for remdesivir, an antiviral drug administered to hospitalized patients. The Trump administration’s rollout of remdesivir was plagued by problems in its early phases. Doctors reported a confusing and unfair process, marred by incomplete medical information.
Some doses went to the wrong hospitals, to hospitals with no intensive care units and therefore having no eligible patients, and to facilities without the needed refrigeration for storage, meaning some doses were returned to the government
On Tuesday, Trump administration officials said they had learned from those mistakes.
“We’re building on lessons learned during remdesivir,” said John Redd, the chief medical officer in the office of the assistant secretary for preparedness and response at HHS. For example, allocation decisions could be made in five hours compared with a matter of days during the early days of remdesivir distribution.
Redd said the distribution of the antibody drug would be “fair, accessible, understandable and equitable.”
As with remdesivir, patients will receive the antibody drug free of charge, federal officials said, but their insurance could be charged for the administration of the medication.
Pfizer coronavirus vaccine could be cleared by mid-December following release of data showing it is more than 90% effective
Health & BeautyNov 10. 2020A logo sits on a sign outside the headquarters of BioNTech in Mainz, Germany, on July 17, 2020. MUST CREDIT: Bloomberg photo by Alex Kraus
By The Washington Post · Laurie McGinley, Lena H. Sun, Carolyn Y. Johnson · NATIONAL, HEALTH, HEALTH-NEWS
The news Monday that Pfizer’s coronavirus vaccine is more than 90% effective sharply increased prospects that federal regulators will authorize the vaccine on an emergency basis as early as mid-December, and that the first shots will be administered before the end of the year or early next year.
The findings, announced by drug giant Pfizer and German biotechnology firm BioNTech, provided much-needed hope for a nation battered by surging virus cases, a stumbling economy and a bitterly fought presidential campaign. It augers well for other vaccines and could accelerate the timetable for reining in the pandemic, said scientists, who cautioned that any successful vaccine will still face obstacles, notably distribution to hundreds of millions of people.
“It’s stunning,” said Eric Topol, director of the Scripps Research Translational Institute, one of several scientists who said they were heartened by the results, which far exceeded the Food and Drug Administration’s standard that a vaccine be more than 50% effective at protecting people compared with a placebo saline shot. “We could have a rollout in December.”
Even with the welcome development, experts warned that the longed-for return to normalcy will take many months or more, and that the path is certain to contain unexpected twists and turns. Even after a vaccine is approved, they said, people will need to wear masks and social distance for some time – in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading.
As if to underscore the difficult days ahead, the United States on Monday hit the latest grim milestone in the pandemic, surpassing 10 million confirmed cases of covid-19, the disease caused by the coronavirus, along with more than 238,000 deaths.
The unchecked spread of the virus threaten to make the coming weeks and months particularly dangerous for the nation, which still has little semblance of a coherent federal strategy to stem the tide of infections. And as yet another member of the Trump administration – Housing and Urban Development Secretary Ben Carson – tested positive for the virus, President-elect Joe Biden on Monday named his coronavirus task force, made up of scientists and physicians, vowing in a speech to “follow the science” when he takes office in January. But he warned that the nation still faces “a very dark winter.”
Still, the vaccine news buoyed scientists who have spent months battling a seemingly implacable foe.
“We will be giving vaccines to people very likely before the end of this year,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, predicted on CNN.
Scott Gottlieb, a former FDA commissioner in the Trump administration and member of Pfizer’s board, said if a vaccine were authorized by mid-to-late December, it would be available for the general public late in the second quarter or early in the third quarter of next year. In addition to Pfizer, Moderna, a biotech firm using a technology similar to Pfizer’s, might apply to the FDA for authorization in the next several weeks, company officials have said.
Fauci said in a separate interview with The Washington Post that although it was too soon to predict when the world would return to normal, “The more effective a vaccine is, the quicker you get to the point where you can get a degree of immunity in the general population, to allow you to get back to some sort of normalcy.” He predicted that a highly effective vaccine means “there will be more enthusiasm” among the public about receiving it.
Still, experts said, more information is needed on the Pfizer vaccine, including how long its protection lasts, how well it protects people in specific groups such as the elderly, and whether it causes side effects. Company officials said Monday it didn’t seem to cause serious safety problems.
In announcing the vaccine data, Pfizer and BioNTech said they plan to submit an application for emergency authorization to the FDA probably the third week of November, after receiving additional information on safety and the manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of the coronavirus, which Jansen said could take a few weeks. The additional data could influence the effectiveness of the vaccine.
The agency has said it will convene its outside advisory committee to consider each vaccine application; a meeting on the Pfizer vaccine could occur in early December, with the agency making a final decision days or weeks afterward.
If the vaccine is cleared by the FDA, an advisory panel to the Centers for Disease Control and Prevention – the Advisory Committee on Immunization Practices – is expected to hold a public meeting within 24 to 48 hours to vote on how the vaccine should be used and who should get the first shots. Its recommendations will go to the CDC director for approval. After that, federal officials have said, they plan to start shipping vaccine vials as soon as possible – probably within a day or two.
Pfizer has projected having 50 million doses – enough for 25 million people – by the end of the year, and 1.3 billion doses in 2021. On CNBC, Pfizer chief executive Albert Bourla said the company was examining ways to increase production.
“We are aware that the demand will be much higher than anything we can produce. We are also looking right now to see if there are other ways, thinking out of the box, that we can increase even further the manufacturing capacity,” Bourla said.
In talking about multiple vaccine candidates, officials with Operation Warp Speed, the government initiative designed to expedite development of vaccines and therapeutics, have repeatedly projected having 100 million doses available by the end of the year, and 600 million to 700 million doses by March or April. That does not ensure that all those vaccine candidates will be proven safe and effective. Along with Pfizer and Moderna, several other companies are working on coronavirus vaccines.
The challenges in distributing the Pfizer vaccine, which must be stored at ultracold temperatures of -70 degrees Celsius (-74 Fahrenheit) can’t be overstated.
“It’s a nontrivial thing to distribute tens of millions of doses, and it has to be given twice,” said John Moore, a virologist at Weill Cornell Medicine. “We won’t be going to motor-biker rallies in the foreseeable future.”
The CDC, which is coordinating the distribution with the Defense Department, has asked states to provide a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine with these ultracold requirements. The ultracold requirement and minimum orders of about 1,000 doses mean that most doctors’ offices will not have the ability to stock it. Hospitals and other institutions that have the necessary freezer storage are likely to be the first to administer the shots.
“It needs to be a perfectly choreographed dance, and we haven’t even started rehearsals yet,” said Soumi Saha, vice president of advocacy at Premier, a major group purchasing organization for hospitals.
Limited initial doses are likely to go first to health care workers, members of the advisory committee on immunization have said. Three additional groups are likely to be close behind: essential workers, people 65 and older, and individuals with underlying medical conditions that put them at higher risk of getting very sick with covid-19.
Close to 200 million people total are in those groups, according to immunization committee estimates.
The federal government will make recommendations on who should have priority to get the vaccine, and make allocations to the states. The final decision rests with states, which have been planning in earnest in recent weeks to get shots into arms.
Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times – most vaccines will require two shots – and to monitor for adverse events.
Beth Bell, a member of the immunization committee who also chairs the panel’s covid-19 vaccines work group, said she was hopeful Americans would start having more-normal lives next summer or fall. That assumes, she said, the nation has several effective vaccines by then and that the “virus doesn’t throw us any curveballs and, very importantly, that people have confidence in the vaccination program and are willing to be vaccinated.”
If there are setbacks, “People need to be a little bit calm and to expect bumps in the road and not overreact to them,” said Bell, a global health professor at the University of Washington and former top CDC official overseeing infectious diseases. “I know we’re all sick of the pandemic . . . but we need to keep at it, go forward deliberatively and calmly.”
Peter Lurie, a top FDA official during the Obama administration, agreed much more information is needed about the Pfizer vaccine and that challenges in distributing it lie ahead. “But today is a brighter day,” he said. “And as the scientific and regulatory processes unfold, we will soon know how bright.”
The immunization committee has been holding special meetings to review data on the virus and the vaccines in development, including one last month. Members will review demographic data about the people receiving the vaccine, how different groups responded and side effects before making recommendations.
William Schaffner, an infectious-disease expert at the Vanderbilt University School of Medicine, said he hoped Thanksgiving 2021 would be far different from this year’s holiday.
“We will get back to something that is near normal, but it won’t be exactly the old normal,” he said. “This and the other vaccines won’t be a magic wand – they will be additional barriers to the transmission of the virus.”
Still, he and others said, the virus will become like the flu – it won’t go away, but humans will have learned to live with it.
Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, noted that tens of thousands of people die of the flu every year, but it doesn’t end Americans’ activities.
“We live with that, I go to Eagles games,” he said. “I feel comfortable I’m not going to be one of those people who die of the flu. The question is – when will we feel that way about the coronavirus?”
By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT A front-runner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90% effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday.
The early look at the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.
“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Hearing that at the interim analysis we are over 90% effective – it was almost stunning to hear.”
In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19, the illness caused by the coronavirus, in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy. The company’s shares soared more than 13% in premarket trading.The data is not yet published or peer-reviewed.
“The results are really quite good, I mean extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that the results might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, “which gives you hope we might even have two vaccines.”
Fauci said he had spoken with Pfizer chief executive Albert Bourla about the results, but had not yet reviewed the individual data.
The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier – and faster.
The race for a vaccine had become inextricably tied to election-year politics, and for months, outside experts had worried that Pfizer’s vaccine might be an “October surprise” pushed prematurely through the regulatory process. In the end, the data arrived nearly a week after the election, and shortly after the race was called for President-elect Joe Biden.
President Donald Trump, who had called Bourla to ask about the vaccine and previously accused regulators of a “political hit job” for slowing down a vaccine, celebrated the news. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Trump tweeted Monday morning.
The data committee noted no serious safety concerns. Jansen said the side-effect profile of the vaccine was similar to what was reported in an earlier study. That included pain at the injection site and fatigue, chills and fever – which occurred more frequently in younger trial participants than in adults over age 65.
Pfizer and BioNTech said they plan to submit an application for emergency authorization from the Food and Drug Administration after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of covid-19, which Jansen said could take a few weeks.
Vaccine development typically takes many years, even decades. But the coronavirus vaccines have been a rare success story in the response to the virus, able to move forward because of a flourishing of new vaccine technologies, a backbone of prior work on emerging pathogens and a mentality that rarely exists in the world of vaccine development – of governments and companies willing to devote nearly unlimited resources to make sure that a vaccine succeeds.
Outside experts said crucial details of the data need to be examined: How did the vaccine perform in high-risk populations, such as elderly people? Were the cases of disease mostly mild, or did the vaccine also prevent severe disease? Will the effectiveness hold up at this high level as the trial moves toward completion? How long will protection last? What do detailed safety data show?
Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said the data look encouraging. The trial’s faster-than-expected progress to 94 cases, he said, was “the upside of having a virus that’s out of control.”
David Benkeser, a biostatistician at Emory University Rollins School of Public Health, said in an email that he was still digesting the news.
“It looks to be an incredibly promising result,” Benkeser wrote, noting that the two biggest questions are how long the effect lasts and how well the vaccine works to prevent severe cases of covid-19. “Both will still require more data to get a definitive answer, but for now, I think this is really good news.”
Regulators had set a far lower bar for the minimum performance of a vaccine, requiring it be at least 50% effective. The FDA has also set forth a requirement for five severe cases of the disease in the placebo group, but Jansen said that to preserve the integrity of the trial, Pfizer’s scientists remain blind to the details of the cases at this time.
The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech are working around-the-clock to scale up production, in hopes of having 50 million doses – enough for 25 million people to receive both shots – by the end of the year, and 1.3 billion doses in 2021.
The vaccine uses a new technology never before deployed in an approved medical product. Each injection contains lipid nanoparticles – fat bubbles – that surround a strip of genetic material called messenger RNA. The genetic material carries the blueprint for the distinctive spiky protein that studs the coronavirus surface. After being injected into a person’s arm, the fat capsule delivers its payload to the body’s cells, and the messenger RNA instructs those cells to build the spike protein, effectively teaching the immune system how to recognize and block the coronavirus.
Pfizer’s early signal is encouraging not just for messenger RNA, Fauci said, but as a proof of concept that vaccine candidates that present the spike protein – the approach being pursued by essentially all the major candidates – can succeed.
Pfizer, unlike its competitors, did not join Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing funding to companies and helping coordinate the trials. Instead, Pfizer plowed $2 billion of its own money into the project and then struck a $1.95 billion contract with the U.S. government to provide 100 million doses, contingent on the vaccine being effective.
Its trial initially had a more aggressive design than other late-stage studies in the United States, allowing earlier and more frequent peeks at the data. That raised concern from outside scientists that the company might seek authorization of its vaccine when there were only 32 cases among participants.
The FDA shared those concerns, according to Jansen, and urged the company to wait to do its first data look until there were more cases. Pfizer scientists were initially concerned it would take too long to reach that milestone, particularly as it appeared the pandemic might be coming under control in late summer, thus depriving the study of potentially infected participants. But Pfizer scientists amended their protocol to wait to look at the data until they reached 62 cases as the virus began to surge, and they completed that paperwork last week.
“We saw that huge upswing, we realized that maybe we should listen and come back to the suggestion of the FDA to have more cases,” Jansen said. “It just shows you the enormous uptick right now of the pandemic, that certainly it took us by surprise – how quickly it really went.”
Once the independent data committee met Sunday, there were 94 cases in the trial – meaning the study is more than halfway done.
A passerby talks a photograph as an employee wearing a face mask dresses a Christmas tree in a Selfridges & Co Ltd. department store window in London on Nov. 4, 2020. MUST CREDIT: Bloomberg photo by Chris Ratcliffe. 
Members dine at a club in August in Annapolis, Md. MUST CREDIT: photo for The Washington Post by Craig Hudson. 
A heath worker draws the ‘Gam-COVID-Vac’, also known as ‘Sputnik V’, COVID-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) at a clinic in Moscow on Sept. 23, 2020. MUST CREDIT: Bloomberg photo by Andrey Rudakov. 
A logo sits on a sign outside the headquarters of BioNTech in Mainz, Germany, on July 17, 2020. MUST CREDIT: Bloomberg photo by Alex Kraus 
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