Category: Breaking News

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FDA to announce tougher standards for a coronavirus vaccine

The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day. The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted. The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that made missteps in its handling of those clearances. With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.

The agency also is looking for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people, as a sign the vaccine works.

These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable for any vaccine to be authorized before the election. The agency has previously said any vaccine would have to be 50 percent more effective than a placebo.

“It’s hard to imagine how an EUA could possibly occur before December,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines. The guidance is just one way of trying to shore up confidence in the agency. FDA allies, intent on building trust, are also spotlighting agency career scientists, noting that the one overseeing the vaccine-approval process has threatened to quit if he is pressured to greenlight a vaccine before he is convinced it is safe and effective. But, administration critics note, such efforts are undercut on an almost daily basis by overly rosy and contradictory comments by Trump and continued revelations about administration actions to strong-arm government scientists and regulators, and curb their independence.In addition, the FDA guidance is unlikely to satisfy some critics, who say the agency should not use an emergency authorization for a vaccine at all. “Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.” The FDA career staff itself is trying to reassure the public. In a highly unusual move, Peter Marks, the head of the center that oversees vaccine regulation, and seven other senior career officials vowed in a column to maintain “independence to ensure the best possible outcomes for public health.” The agency also has pledged to take any vaccine data to its panel of outside advisers, called the Vaccine and Related Biological Products Advisory Committee, before making decisions. The agency has scheduled a public meeting of the panel for Oct. 22 and said others sessions can be held as needed, depending on when data is available. But some FDA watchers say those steps are not enough and that the agency should forswear use of an emergency authorization for a vaccine and instead require a full approval. “If we don’t get this right, we’ll see a deep corrosion of trust over the long term — and that will be the darkest legacy for a post-covid world,” said Lawrence Gostin, a public health expert at Georgetown University’s law school.

Eric Topol, founder and director of Scripps Research Translational Institute, opposes using an emergency authorization in the next several weeks or months. “We are not in a high-trust mode, and the last thing you want to do is take a short cut and put everything at risk,” he said.

He said the agency should not consider such an authorization until at least early next year to ensure it has adequate safety data.

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CDC “mistakenly” modifies its COVID-19 guidance

sell out….again

The Centers for Disease Control and Prevention “erroneously” said on Monday the coronavirus could spread through the air beyond 2 meters, and not just through close person to person contact as initially supposed.

“There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet,” the CDC’s updated COVID-19 guidance noted, but was corrected shortly after.

“A draft version of proposed changes to these recommendations was posted in error to the agency’s official website,” the CDC stated, adding that it “is currently updating its recommendations regarding the airborne transmission of SARS-CoV-2. Once this process has been completed, the updated language will be posted.”

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CDC study highlights threat of coronavirus spread on lengthy flights

“The risk for on-board transmission of SARS-CoV-2 during long flights is real and has the potential to cause COVID-19 clusters of substantial size, even in business class-like settings with spacious seating arrangements well beyond the established distance used to define close contact on airplanes,” the study concluded.

A single airline passenger unknowingly sickened with coronavirus managed to infect 15 other people aboard the 10-hour trip to Vietnam, highlighting the dangers of travel amid the pandemic. The global health crisis had only just begun its spread across Europe when the plane took off from a London airport back in March. By the time it touched down in the Vietnamese city of Hanoi, 12 passengers in business class, two in economy and a single crew member had contracted the fast-spreading disease. Researchers behind a new Centers for Disease Control study, slated to be published in November, identified a 27-year-old business woman from Vietnam to be the likely source of the outbreak. She’d been based in London since early January and was experiencing a sore throat ahead of her return home. “On February 22, case 1 and her sister returned to Milan, Italy, and subsequently traveled to Paris, France, for the yearly Fashion Week before returning back to London on February 25,” they wrote in the journal Emerging Infectious Diseases. Around that time, few cases had been reported in Britain and masks had not yet been required for the flight, which departed on March 1. “She was seated in business class and continued to experience the sore throat and cough throughout the flight,” the researchers added. Five days later, she went to the hospital and tested positive for coronavirus. CDC researchers then tracked down all 217 passengers and crew, tested them for the virus and ordered them quarantine. Investigators said there was no other likely way any of the 15 people could have been infected aside from exposure to the sick patient. “The most likely route of transmission during the flight is aerosol or droplet transmission from case 1, particularly for persons seated in business class,” they wrote. “Contact with case 1 might also have occurred outside the airplane at the airport, in particular among business class passengers in the predeparture lounge area or during boarding.” And while researchers believe masks are an effective tool to prevent the spread of the virus, they called for additional on-board precautions and screening procedures.

“The risk for on-board transmission of SARS-CoV-2 during long flights is real and has the potential to cause COVID-19 clusters of substantial size, even in business class-like settings with spacious seating arrangements well beyond the established distance used to define close contact on airplanes,” the study concluded.

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Biden maintains national lead over Trump

WASHINGTON — After a month of political conventions, fresh controversies, more protests and additional deaths from the coronavirus, the 2020 presidential race remains where’s it’s been for months — with Joe Biden leading President Trump nationally by nearly double digits, and with a majority of voters opposing the president. Those are the results of a new national NBC News/Wall Street Journal poll, which finds Biden ahead by 8 points among registered voters, 51 percent to 43 percent, with more than 50 percent of voters disapproving of Trump’s job performance and with Trump holding the advantage on the economy and Biden holding the edge on the coronavirus.

What’s more, the poll shows that close to 90 percent of voters have firmly made up their minds, and that seven-in-10 believe the upcoming debates aren’t that important in deciding their vote.

“So far, despite major upheavals in the country, little has changed,” said Democratic pollster Jeff Horwitt, whose firm conducted this survey with Republican pollster Bill McInturff. “In 2020, the fundamentals of our country have been shaken to our core, while the fundamentals of the election have not,” Horwitt added. Still, the poll finds that 11 percent of all voters are up for grabs, which is greater than Biden’s ballot advantage over Trump. And Trump’s numbers have inched up in the poll since the summer, while Biden’s favorability rating has also improved in the past month. “Trump’s summer swoon is over,” said McInturff, the GOP pollster. The NBC News/WSJ poll — conducted Sept. 13-16 — comes after a turbulent and eventful month of news, including the Democratic and Republican conventions, the police shooting of Jacob Blake in Wisconsin, some 30,000 more deaths from the coronavirus, the Atlantic report alleging the president disparaged fallen military service members and the coverage of Bob Woodward’s new book on Trump. But the poll was conducted before the passing of Supreme Court Justice Ruth Bader Ginsburg on Sept. 18. According to the survey, Biden leads Trump, 51 percent to 43 percent, among registered voters — essentially unchanged from Biden’s 9-point lead last month, 50 percent to 41 percent. Six percent in the current poll say they’re undecided or supporting another candidate. Biden’s biggest advantages in the poll are among Black voters (he gets support from 90 percent of them to 5 percent for Trump), voters ages 18-34 (60 percent to 31 percent), women (57 percent to 37 percent), whites with college degrees (54 percent to 41 percent), independents (45 percent to 39 percent) and seniors (50 percent to 46 percent). Trump, meanwhile, has the edge among all white voters (52 percent to 43 percent), men (50 percent to 45 percent) and whites without college degrees (59 percent to 36 percent). (A separate NBC News/Wall Street Journal/Telemundo oversample of Latino voters will be released on Sunday at 6:30 p.m. ET to gauge where the Latino vote stands in the presidential race.) And in the combined 12 swing states — Arizona, Florida, Georgia, Iowa, Maine, Michigan, Minnesota, Nevada, New Hampshire, North Carolina, Pennsylvania and Wisconsin — Biden is ahead of Trump by 6 points, 51 percent to 45 percent.

Continue reading “Biden maintains national lead over Trump”

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Virus Infections grow As do lock down Protests

HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK

— Virus measures targeted by protesters despite case spikes

— The director of the University of Colorado’s football operations cited for violating coronavirus health orders after a team practice involved 108 people on a mountain hike.

— Police in London clashed with protesters at a rally against coronavirus restrictions, even as the mayor warned that it was “increasingly likely” that the British capital would soon need to introduce tighter rules to curb a sharp rise in infections.

— The official Oktoberfest is canceled in Munich, so 50 of the German city’s beer halls are hosting their own, smaller parties conforming to coronavirus guidelines.

MADRID — Spaniards are protesting in Madrid against the handling of the coronavirus pandemic by the city’s regional head, who has placed new restrictions on neighborhoods with the highest contagion rates.

Wearing face masks and trying to maintain social distancing, protestors clapped in unison while shouting for regional President Isabel Díaz Ayuso to step down. The protesters gathered at noon Sunday around the city, making it difficult to estimate the size of the protest.

In the Vallecas neighborhood, protesters chanted “For everyone or no one!” in a criticism of the restrictions Díaz Ayuso announced Friday for some of the poorest areas of Madrid where local authorities say the virus is spreading the fastest.

The restrictions affect around 860,000 people who won’t be able to leave their neighborhoods except for work, study or a medical appointment. Parks in the area are closed and shops and restaurants have to limit occupancy to 50%,

Spain is struggling to contain a second wave of the virus, which has killed at least 30,400 people according to the Spanish Health Ministry. Madrid’s rate of transmission is more than double the national average, which already leads European contagion charts.

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LONDON — Britain’s government will fine people who refuse an order to self-isolate up to 10,000 pounds ($13,000) as the country sees a sharp surge in coronavirus infections.

The new rule obliges people to self-isolate if they test positive for the coronavirus or are traced as a close contact. The rule comes into effect on Sept. 28.

The government will help those on lower incomes who face a loss of earnings as a result of self-isolating with a one-time support payment of 500 pounds ($633).

The latest figures show that new daily coronavirus cases for Britain have risen to 4,422, the highest since early May. An official estimate also shows that new infections and hospital admissions are doubling every seven to eight days in the U.K.

The Conservative government is widely expected to impose further restrictions after Prime Minister Boris Johnson confirmed that Britain is seeing a second wave of infections, following the trend elsewhere in Europe. London’s mayor has also said tighter restrictions could be needed soon in the British capital.

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NEW DELHI — India has registered 92,605 new coronavirus cases in the past 24 hours and is expected to surpass the United States as the pandemic’s worst-hit country within weeks.

The Health Ministry on Sunday also reported 1,133 additional deaths for a total of 86,752.

Sunday’s surge raised the country’s virus tally to over 5.4 million. India, however, also has the highest number of recovered patients in the world, according to Johns Hopkins University. Its recovery rate stands at about 80%.

Over 60% of the active cases are concentrated in five of India’s 28 states — Maharashtra, Karnataka, Andhra Pradesh, Tamil Nadu and Uttar Pradesh.

Prime Minister Narendra Modi’s government has faced scathing criticism for its handling of the pandemic amid a contracting economy that left millions jobless.

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MELBOURNE, Australia — Australia’s second-largest city, Melbourne, has moved close to easing severe lockdown restrictions after recording only 14 new COVID-19 cases on Sunday.

It was the second day in a row new infections fell below 30. There were also five deaths recorded Sunday.

Melbourne’s lockdown restrictions are due to be eased next weekend when child care centers will be allowed to reopen and gatherings of up to five people from two different households will be permitted. But that depends on the rolling 14-day average of new cases being below 50. It now stands at 36.2.

Victoria state Health Minister Jenny Mikakos praised residents for adhering to lockdown rules, saying, “The huge sacrifices made by Victorians are saving many lives.”

Meanwhile, Australian Prime Minister Scott Morrison described an unexpected fall in Australia’s unemployment rate to 9.3% — down 14 percentage points from its peak during the pandemic — as “pleasant encouragement.”

The figures show about 400,000 Australians recently have returned to work.

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SEOUL, South Korea __ South Korea’s new coronavirus tally has fallen below 100 for the first time in more than a month.

The Korea Disease Control and Prevention Agency said Sunday that the newly counted 82 cases took the country’s total to 22,975 with 383 deaths.

The drop is likely partly driven by the fact that authorities conduct fewer tests on weekends. But even before Sunday, South Korea’s daily tally has held in the 100s for more than two weeks, down from 400 in late August.

Health officials say the downward trend is a result of stringent social distancing rules imposed on the densely populated Seoul metropolitan area. Those rules were recently relaxed.

The government is urging the public not to lower their guard as small-scale clusters are still being reported.

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TOKYO — Train stations and airports in Japan are filled with people traveling over the “Silver Week” holiday weekend, in a sign of recovery amid the coronavirus pandemic.

The surge in domestic travel is in contrast to previous holidays, when pressure was high for people living in urban congested areas to stay home and avoid areas with fewer infections.

The new daily cases in Tokyo have recently fluctuated around 200, but Japan does not have widespread testing and many cases are likely going undetected. Baseball games, stores and theaters are open again with social distancing, mask-wearing, hand sanitizers and temperature checks.

A study by mobile carrier NTT DoCoMo showed crowd size at a domestic terminal at Tokyo’s main Haneda airport, as well as train stations and shopping districts nationwide.

Japan, with about 1,500 deaths related to COVID-19, has banned almost all overseas visitors and requires quarantine and virus checks for returning Japanese. The Silver Week includes this weekend and two national holidays, Respect for the Aged Day and the Autumn Equinox.

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PARIS — Coronavirus infections tipped the scales again in France on Saturday with nearly 13,500 new infections in 24 hours. Economy Minister Bruno Le Maire is among them.

He announced Friday in a tweet that he had tested positive with no symptoms and was working during self-isolation. The high-profile Le Maire is the fourth French minister to test positive since March.

It was the second day in a row that new COVID-19 cases in France were above 13,000. The French health agency said Friday’s big jump was the result of one hospital in the Essonne region south of Paris belatedly reporting numerous cases. It wasn’t clear whether that kind of add-on effect was at play on Saturday.

For health authorities, it is clear that France needs to worry about the spread of the coronavirus, with over 1,000 clusters detected. There have been 31,274 deaths since the start of the pandemic — among the highest death tolls in Europe — and 26 deaths in the last 24 hours.

In Paris, the Prefecture de Police warned in a tweet that there will be no more tolerance for bars and restaurants where rules to counter the virus aren’t respected, like standing at counters or failing to respect social distancing. Police “are intensifying” checks that can lead to closing establishments, it said. In one Paris district, 13 establishments were formally notified that they risk being shut down and 16 others were fined, the prefecture tweeted.

Continue reading “Virus Infections grow As do lock down Protests”

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The Latest: German protesters decry virus restrictions

DUESSELDORF, Germany — Hundreds of people demonstrated in downtown Duesseldorf Sunday against government coronavirus restrictions and in support of a host of other causes. People waved signs with slogans like “end to panic, corona pandemic is a lie” and “corona rebels” as songs decrying coronavirus restrictions were played. They chanted “free Julian Assange” along with one speaker, and formed a “W” — symbolizing “we all” — with their hands, which they raised over their heads as the theme to Chariots of Fire played. No masks were to be seen, aside from on journalists covering the rally, and a few children mingled among the crowd. Before breaking away to walk along a route through the western city, the crowd swayed to Louis Armstrong’s “What a Wonderful World” and a man in a Superman costume sang along. Police reported no incidents.

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Threat of Lethal Autumn Looms in Europe After Covid Reprieve

  • French, German data show virus spreading in older people

  • Europe faces ‘very serious situation’ with resurgence: WHO As vacations and parties fed a late-summer surge of Covid-19 in Europe, there’s been one reassuring constant: a lower death toll. The latest numbers out of the continent’s hardest-hit countries show the relief may only be temporary. The virus has started spreading in older populations again, according to data from France, Italy, Germany, the Netherlands and the U.K. In France, its prevalence among those aged 75 or over more than doubled in the past three weeks.The shift could be a tipping point as Europe faces another wave of the virus. Rising cases among the elderly, more reports of nursing-home clusters and the number of deaths edging upward are “major warning signs,” France’s public health agency said in a report on Thursday.

    “We have a very serious situation unfolding,” said Hans Kluge, the World Health Organization’s regional director for Europe, said. For the first time, he wore a mask at the press conference on Thursday. “The September case numbers should serve as a wakeup call for all of us.” A 75-year-old is 220 times more likely to die of a coronavirus infection than her 27-year-old granddaughter, according to the U.S. Centers for Disease Control and Prevention. Data from Italy points the same way. The median age of diagnosed cases rose to 41 in the week ended Sept. 13, up from 30 a few weeks ago. The report noted that the virus is now circulating “even among people of a more advanced age.” Even in Germany, which has managed to hold its seven-day rate of infections to a low level of about 11.5 cases per 100,000 residents — about one-seventh the rate of France — outbreaks seeded by travelers have begun to spread to nursing homes.

Kaufbeuren, a small town in Bavaria, is a case in point. The virus first popped up only sporadically in people who had just returned from trips, Mayor Stefan Bosse said in a video statement earlier this month. “That has now unfortunately changed,” Bosse said. First a single worker at a local senior citizens’ home tested positive. By this week, the virus spread to some 30 residents and staff, according to the Robert Koch Institute. Authorities must find a way to protect old people without locking them away, French President Emmanuel Macron said on Friday. “We are reinforcing the rules,” Macron said, including making sure nursing home staff are tested. “We know that isolation and solitude are bad for old people.”

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French New Virus Cases Top 13,000 as Europe Lockdown Risk Rises

In France, Health Minister Olivier Veran pointed to what he called a worrying increase in the number of Covid-19 patients in intensive care. More infections among the oldest people means there will probably be even more hospitalizations and deaths in coming weeks, French authorities said. Because people who are sick usually take a few weeks to get worse, there’s a time lag before new infections begin to cause a shift in mortality rate. Veran appealed directly to French seniors, asking them to better protect themselves by cutting back on the number of people they see every day because they are “the most fragile in the face of Covid.”

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Top Israel health official says renewed national lockdown still possible ‘if no choice’

The top official at the Health Ministry said Friday the potential reimposition of a nationwide lockdown was still on the table, after ministers agreed to tighten restrictions in area with high COVID-19 infection rates. “I don’t rule out the possibility that a full lockdown will be decided on, but again, a full lockdown is something that all of us want to avoid,” Health Ministry Director-General Chezy Levy told Kan public radio. “If there’s no choice, we’ll be there.” He cautioned, however, that while a total lockdown may be the quickest way to curb the coronavirus’s spread, there is “no magic wand” that can swiftly bring the infection rate down. “Therefore we’re trying to find a way in which we’ll do restrictions in a differential manner in cities that have the most extensive morbidity,” he said, pledging assistance to residents of these areas. Levy’s comments came as the Health Ministry reported 2,766 new coronavirus cases were confirmed on Thursday, a day after Israel recorded over 3,000 cases in a new single day record. According to the latest Health Ministry figures, there have been 125,755 infections since the pandemic began, with 25,277 active cases as of Friday morning. With six fatalities overnight, the death toll rose to 991. Of those currently infected, 416 people were in serious condition, with 123 Israelis on ventilators. Another 131 people were in moderate condition and the rest had mild or no symptoms. The Health Ministry said 34,586 tests for coronavirus were administered Thursday. In the interview, Levy was also asked about the ongoing mass protests against Prime Minister Benjamin Netanyahu over his indictment on corruption charges and handling of the pandemic.

Israelis protest against Prime Minister Benjamin Netanyahu outside his official residence in Jerusalem on August 29, 2020. (Yonatan Sindel/Flash90)

Some of Netanyahu’s political allies have said the demonstrations are a serious health risk and called for them to be restricted, but no data has signalled they are a major source of infection and US researchers have indicated protests outdoors may be relatively safe. “There is no data in the [epidemiological] investigations that someone was infected in the gathering itself because you are questioning people who have done a lot of activities, but the protests are a gathering that spurs infection,” Levy said. Levy’s boss, Health Minister Yuli Edelstein, signaled support Thursday for restricting the protests. “The coronavirus doesn’t have political views. When a religious person is restricted at prayer or at synagogues, which is a fundamental right, it wouldn’t hurt to restrict political gatherings,” he told Channel 12 news. Just because there is no law limiting protests, Edelstein said there’s no “obligation” for thousands of people to gather for demonstrations. Edelstein also said he fully backs coronavirus czar Ronni Gamzu, who has faced criticism from some members of Netanyahu’s Likud party and ultra-Orthodox lawmakers, including calls for his resignation. On Friday, Gamzu clarified that the sweeping new restrictions approved Thursday by the so-called coronavirus cabinet in “red” localities with high infection rates would not include full lockdown measures in all these areas. “The proposal yesterday in the cabinet was for the imposition of a lockdown in eight cities with particularly high morbidity and the imposition of restrictions on movement in the rest of the red cities,” he said in a statement quoted by Channel l2 news. However, he stressed the lockdown measures could be expanded to other areas and said a final decision would be made over the weekend and approved by ministers on Sunday. The new restrictions are set to take effect on Monday.

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UK nationwide lockdown still possible

LONDON (Reuters) – British Prime Minister Boris Johnson said he did not want another national lockdown but that new restrictions may be needed because the country was facing an “inevitable” second wave of COVID-19. Ministers were on Friday reported to be considering a second national lockdown, after new COVID-19 cases almost doubled to 6,000 per day, hospital admissions rose and infection rates soared across parts of northern England and London. That rise in cases was part of a second wave that was now unstoppable, the prime minister said. “We are now seeing a second wave coming in…It is absolutely, I’m afraid, inevitable, that we will see it in this country,” Johnson told UK media. Asked about whether the whole of the country should brace for a new lockdown, rather than just local restrictions, he said: “I don’t want to get into a second national lockdown at all.” But he did not rule out further national restrictions being brought in. “When you look at what is happening, you’ve got to wonder whether we need to go further than the rule of six that we brought in on Monday,” he said, referring to the ban on gatherings of more than six people. The United Kingdom has reported the fifth largest number of deaths from COVID-19 in the world, after the United States, Brazil, India and Mexico, according to data collected by Johns Hopkins University of Medicine. The UK’s official number of new positive cases shot up by nearly a thousand on Friday to 4,322, the highest since May 8, after a separate ONS model pointed to about 6,000 new cases a day in England in the week to Sept. 10.