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Health

Moderna says Covid vaccine exhibits promise in a lab setting towards variants, together with delta

A healthcare worker prepares a dose of Moderna Inc.’s Covid-19 vaccine on Tuesday February 9, 2021 at the Pacheco Vaccination Center in Brussels, Belgium.

Geert Vanden Wijngaert | Bloomberg | Getty Images

Moderna said Tuesday that its Covid-19 vaccine showed promise against coronavirus variants, including the highly contagious Delta variant, first identified in India in a laboratory setting.

The two-dose mRNA vaccine produced neutralizing antibodies against Delta as well as Beta and Eta, variants that Moderna said were first found in South Africa and Nigeria, respectively.

The company said the results were based on blood serum from eight participants one week after receiving the second dose of the vaccine. The data has not yet been reviewed by experts. The results, while promising, may not reflect how the vaccines actually perform against the variants in real-world scenarios.

Moderna shares rose more than 4% in intraday trading after the lab results were announced.

“We continue to strive to investigate new variants, generate data and share them as they become available,” said Stephane Bancel, CEO of Moderna, in a press release. “These new data are encouraging and reinforce our belief that the Moderna COVID-19 vaccine should continue to protect against newly discovered variants.”

Moderna’s update comes days after World Health Organization officials urged fully vaccinated people to continue wearing masks, maintain social distance, and practice other pandemic safety measures as the delta spreads rapidly across the world.

Delta, now present in at least 92 countries including the United States, is expected to become the predominant variant of the disease worldwide. In the US, the prevalence of the variant doubles about every two weeks.

WHO officials said Friday that they are urging fully vaccinated people to continue to “play it safe” as much of the world remains unvaccinated and highly contagious variants like Delta spread in many countries and cause outbreaks.

The comments were a departure from the Centers for Disease Control and Prevention, which said fully vaccinated Americans can be maskless in most environments.

“People can’t feel safe just because they got the two doses. They still need to protect themselves,” said Dr. Mariangela Simao, WHO Deputy Director General for Access to Medicines and Health Products, during a press conference.

Approved vaccines from Moderna, Pfizer-BioNTech, and Johnson & Johnson have been shown to be highly effective in preventing Covid, particularly against serious illness and death.

Some variants, including Delta, have shown the vaccines to be slightly less effective, and WHO officials said they fear people vaccinated could become part of the chains of transmission.

The Wall Street Journal reported Friday that about half of the adults infected in a Delta variant outbreak in Israel were fully vaccinated with the Pfizer vaccine, prompting the local government to reintroduce indoor masking and other measures.

In the United States, President Joe Biden warned that unvaccinated people are particularly at risk of contracting Delta.

He said the number of Covid deaths would continue to increase across the country due to the spread of the “dangerous” variant, calling this a “serious concern”.

“More than six hundred thousand Americans have died, and with this variant of the Delta, you know there will be others too. You know it will happen. We need to vaccinate young people,” Biden said Thursday at a community center in Raleigh, NC

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Business

Sanofi-GlaxoSmithKline Covid Vaccine Exhibits Promise, Agency Says

Sanofi, the French pharmaceutical company, announced Monday that it will move the experimental Covid-19 vaccine it is developing with GlaxoSmithKline to a late-stage study after the shot provoked strong immune responses in an interim study in volunteers.

The results are encouraging news for a vaccine that has fallen behind in development and so far has disappointed those who expect it to be vital in fighting the pandemic. If the vaccine can be available in the last three months of this year, as the developers hope, it could continue to play a pivotal role as a booster, as well as an initial vaccination, in developing countries where vaccination pace is lagging.

The vaccine suffered a major setback in December when its developers announced that it did not appear to work well in older adults and that they had plans to test it in a Phase 3 study, the pivotal test in assessing the vaccine’s effectiveness. would have to move.

However, the companies modified the vaccine and began testing it in February in a Phase 2 study that enrolled more than 700 volunteers in the US and Honduras between the ages of 18 and 95. Sanofi said the vaccine raised no safety concerns and produced a strong immune response across age groups, suggesting it was successfully optimized.

Sanofi announced the results in a statement, saying it plans to publish the results in a medical journal soon.

Sanofi and GSK have much more vaccine development experience than some of their previously approved competitors. The two companies took a more established approach than those used in other, more rapidly developed Covid vaccines. Their shot is based on viral proteins made with engineered viruses that grow in insect cells. GSK supplies the Sanofi vaccine with an adjuvant, a component used in many vaccines to boost the immune response.

The Sanofi and GSK vaccine was one of six vaccines selected for funding through Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. Last summer, the federal government agreed to give companies $ 2.1 billion to develop and manufacture the vaccine, against 100 million doses once the shot was done.

Sanofi also has delivery agreements with the European Union and Canada. It was also agreed to ship 200 million doses to Covax, the program to deliver vaccines to middle and low income countries that is grappling with a shortage of expected doses. Sanofi also announced plans to help manufacture the approved vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson.

Sanofi said the Phase 3 trial of its vaccine will begin in the coming weeks and will enroll more than 35,000 adult volunteers around the world. Two formulations of the vaccine are being tested, one to prevent the original strain of the virus and the other for variant B.1.351, which was first observed in South Africa and against which some vaccines appear to be less effective.

Su-Peing Ng, Sanofi’s global medical director for vaccines, told journalists on Monday that the company believed it would be “operationally quite difficult” to enroll unvaccinated participants in the Phase 3 study because the vaccination rate was in many countries. Still, she said, vaccine doses are still scarce in many parts of the world, pointing to Latin America and Asia as places the company may want to enroll volunteers.

The company said that shortly after the Phase 3 trial begins, it will test whether its vaccine can boost immune responses in people who had been vaccinated with approved vaccines months earlier. These booster studies are expected to enroll volunteers in well-vaccinated parts of the world, including the US and Europe.

Sanofi and GSK said last year they are preparing to produce 1 billion cans a year. Thomas Triomphe, Sanofi’s global director of vaccines, said Monday that if the vaccine turns out to work, the company’s production would depend on the needs of the world this year.

The vaccine “has the potential to be a booster of choice for many nations and many different platforms”.

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Politics

Pandemic Aid Invoice Fulfills Biden’s Promise to Broaden Obamacare, for Two Years

WASHINGTON – President Biden’s $ 1.9 trillion coronavirus relief bill will deliver on one of his key election promises to fill the loopholes in affordable care law and make health insurance affordable for more than a million middle-class Americans who could not afford insurance under the original law.

The bill, which will most likely go to the House for a final vote on Wednesday, provides for a significant, if temporary, increase in health insurance subsidies earned under the law. Among the changes, the Obama administration’s domestic achievement will reach middle-income families who have been deterred from buying health plans on the federal market because they come with high premiums and little or no government help.

The changes will only take two years. For some, however, they will be sizeable: the Congressional Budget Bureau estimated that a 64-year-old earning $ 58,000 would cut monthly payments from $ 1,075 under current law to $ 412 under current law, as the federal government took one Would cover most of the cost. The bailout plan also includes bountiful new incentives to encourage the few holdout states – including Texas, Georgia, and Florida – to finally expand Medicaid to include those who have too much money to qualify for the federal health program for the poor, but too little to be able to afford private cover.

“For people who are eligible but not buying insurance, this is a financial problem, and increasing the subsidy will bring the price down,” said Ezekiel Emanuel, a health policy expert and professor at the University of Pennsylvania who advised Mr. Biden during his transition. The bill, he said, would “greatly reduce the number of uninsured”.

However, with those provisions only lasting two years, the Aid Act almost guarantees that health care will be the focus of the 2022 midterm elections when Republicans attack the measure as a lavish extension of a health bill they have long hated. In the meantime, some Liberal Democrats may complain that the changes only prove that a patchwork approach to health insurance will never work.

“Of course it’s an improvement, but I think it’s insufficient given the health crisis we are facing,” said Representative Ro Khanna, a progressive Democrat from California who prefers the government-run Medicare for All deposit system was greeted by Senator Bernie Sanders, independent from Vermont, and the Democratic Left.

“We are in a national health crisis,” said Khanna. “Fifteen million people have just lost their private health insurance. This would be the time for the government, at least for the 15 million, to say we should put them on Medicare. “

Mr Biden, when running for the White House, made it clear that he was not in favor of Medicare for All and instead wanted to strengthen and expand the Affordable Care Act. The bill, expected to arrive at his desk in time for an Oval Office prime-time address on Thursday evening, would do so. The health bill changes would cover 1.3 million more Americans and cost about $ 34 billion, according to the Congressional Budget Office.

New Jersey representative Frank Pallone Jr., who helped draft the Health Bill more than a decade ago and chairs the House’s Energy and Trade Committee, cited it as “the largest expansion we’ve had since the ACA was passed.” designated.

As a candidate, however, Mr. Biden made more promises, a “public option” – a government-led plan that Americans could choose from on the Health Act online marketplaces that now only include private insurance.

“Biden made a public option to voters, and it’s a promise he must keep,” said Waleed Shahid, a spokesman for the Justice Democrats, the liberal group that helped vote for Alexandria Ocasio-Cortez and other progressive Democrats . Of the stimulus bill, he said, “I don’t think anyone thinks this is Biden’s health plan.”

When Mr Biden or the Democrats would come up with such a plan remains unclear, and passing it in an evenly divided Senate would be an uphill battle. White House officials said Mr Biden wants to overcome coronavirus relief law before setting a broader domestic agenda.

Affordable Care Act is dear to the heart of Mr. Biden, who as Vice President and President Barack Obama made it a big deal in 2010 with an expletive. It has expanded reach to more than 20 million Americans, cutting the uninsured rate from 17.8 percent in 2010 to 10.9 percent in 2019.

Updated

March 8, 2021, 8:08 p.m. ET

Even so, around 30 million Americans were uninsured between January and June 2020, according to the latest figures from the National Health Interview Survey. The problem only got worse during the coronavirus pandemic when thousands, if not millions, of Americans lost their insurance because they lost their jobs.

Mr Biden has already taken some steps to fix this. In January, he ordered the Affordable Care Act health insurance markets to reopen to give those throttled by the pandemic economy a new chance at insurance coverage. He also took steps to restore the cover mandates undermined by his predecessor, including protecting those with pre-existing medical conditions.

The stimulus plan would allow higher-middle-income Americans to get new financial assistance for purchasing plans in federal markets, and the rewards for those plans would cost no more than 8.5 percent of an individual’s modified adjusted gross income. It would also increase subsidies for those on lower incomes.

The White House and Democratic supporters of the bill say its health policy is the most significant addition to the Affordable Care Bill since it was passed, and possibly the only politically possible addition. They find that with an evenly divided Senate, there is little chance of more fundamental restructuring like Medicare for All.

“I understand the desire to really revise and simplify the system, but I think there is also the political reality of what can be enforced,” said Dr. Emanuel.

Healthcare remains a strong political selling point for Democrats with voters who consistently give Democrats an edge when asked which party they trust most to solve the problem. Republicans have tried for the past decade to undermine the Affordable Care Act and overturn it in Congress, to no avail.

“I think that argument was fought and lost,” said Whit Ayres, a Republican pollster, admitting that the repeal effort with the Democrats, who are in charge of the White House and both Houses of Congress, has ended, at least for now.

Republicans have always said their plan was to repeal and replace the health bill, but after 10 years they still haven’t found a replacement. Mr Ayres said his company is working to “develop an alternative health message” that is not about “just throwing everyone into a state health problem”.

However, polls show that the idea of ​​a government-led program is gaining traction among voters. In September, the Pew Research Center reported that the proportion of Americans who say health insurance should be provided through a single national government program has increased over the past year, particularly among Democrats.

The poll found that 36 percent of Americans and 54 percent of Democrats were in favor of a single national program. When asked whether the government was responsible for providing health insurance, either through a single national program or a mixture of public and private programs, 63 percent of Americans and 88 percent of Democrats agreed.

The Medicare for All debate marked a strong dividing line between progressive and more mainstream Democrats during the 2020 election. Massachusetts-based Mr. Sanders and Senator Elizabeth Warren put their candidacies on it only to lose the nomination to Mr. Biden.

In the hotly contested House primaries, support from Medicare for All gave a boost to candidates like Jamaal Bowman from New York, Marie Newman from Illinois and Cori Bush from Missouri. All ousted Democratic incumbents last year in primary races that focused on health care.

“I would argue that Medicare’s expansion has gained momentum given the pandemic and the experiences people are having,” said California Congressman Khanna. “You bought time, but I think at some point there will be a debate about a permanent solution.”

Categories
Entertainment

Sundance Diary, Half 2: The Promise of Music in a Highly effective Movie

AO Scott, our critic in general, keeps a journal while attending the virtual Sundance Film Festival, which runs through Wednesday. Read part 1 here.

Friday, 1am: It’s been almost exactly a year since I took a plane, almost as long since I’ve been to a movie theater, and many months since I got up after midnight. The Sundance premier screenings are held in three-hour windows, which makes the start time flexible. I was able to wash some dishes before deciding to go sightseeing in the evening. And of course the pause button is available for snack or bathroom breaks.

Normally I would skip an event like “Opening Night Welcome”, but I checked into this short program of zoom-in greetings and video montages to mark the line between everyday life and festival. I also wanted to take a look at Tabitha Jackson, the festival director, when she added a new entry to her list of premieres. She is the first woman to lead Sundance and the first person of color and person to be born outside the United States in this role. And now she’s also the first to run an online festival.

Over the past few years, I might have found her brief remarks a little cheesy, evoking the strength of community and the power of storytelling. Instead, I was moved and touched by the greetings from festival goers waving from their living rooms in Austin, Denver, New York, and elsewhere. Human connection cannot be taken for granted these days.

Then I saw two films, one of which blew me away. I will concentrate on emphasizing the positive in the usual festival spirit. Directed by Ahmir Thompson, better known to music fans as Questlove, this is a documentary entitled “Summer of Soul” about the 1969 Harlem Cultural Festival.

This event is sometimes referred to as “Black Woodstock”, but the parallel is a bit misleading and describing “Summer of Soul” as a concert film doesn’t do it justice. I mean, it captures some absolutely fascinating musical performances – from Stevie Wonder, the Staples Singers, Max Roach, Nina Simone, Ray Barretto, and Sly and the Family Stone, among others – but it anchors them in a vibrant and intricate tableau of politics, Culture and city life.

Thompson uses archival footage and recent interviews wisely to contextualize long-lost footage of the festival itself, which ran over several summer weekends, including the day the moon landed. He contends that what happened in Harlem was at least as significant and should be remembered as a turning point in black history (as well as the history of New York, America and musicals).

More than 50 years later, when enthusiastic summer crowds and live performances are out of reach, it is a reminder of what is possible and the power and promise of popular art in troubled times.

Categories
Health

Eli Lilly’s Alzheimer’s Drug Reveals Promise in Small Trial

In a small clinical trial, an experimental Alzheimer’s drug slowed the rate at which patients lost the ability to think and care for themselves, drug maker Eli Lilly announced on Monday.

The results have not been published in any form and have not been fully reviewed by other researchers. If exactly, it will be the first time a positive result has been found in a so-called phase 2 study, said Dr. Lon S. Schneider, Professor of Psychiatry, Neurology, and Gerontology at the University of Southern California.

Other experimental drugs for Alzheimer’s disease were never tested in phase 2 studies, went straight to larger phase 3 studies, or did not produce positive results. The Phase 3 trials themselves repeatedly had disappointing results.

The two-year study included 272 patients with brain scans that suggest Alzheimer’s disease. Her symptoms ranged from mild to moderate.

The drug donanemab, a monoclonal antibody, attaches to a small portion of the hard plaques in the brain, which are made up of a protein, amyloid, that is characteristic of Alzheimer’s disease. The patients received the drug by infusion every four weeks.

Participants who received the drug had a 32 percent slowdown in the rate of decline compared to those who received a placebo. In six to twelve months, plaques were gone and stayed gone, said Dr. Daniel Skovronsky, scientific director of the company. At this point, the patients were no longer receiving any medication for the duration of the study – they were given a placebo instead.

The small study needs to be replicated, noted Dr. Michael Weiner, a leading Alzheimer’s researcher at the University of California at San Francisco. Even so, “this is big news,” he said. “This gives hope to patients and their families.”

Eli Lilly has not released the relevant data needed for a thorough analysis, said Dr. Cutter. For example, the company only provided percentages describing functional decline among participants, not the actual numbers.

The company will provide this data at a subsequent meeting and in an article in a medical journal, said Dr. Skovronsky. Eli Lilly received the results on Friday and had to report them immediately, he said, as the results may affect Lilly’s stock.

Dr. Schneider, who served on an independent data protection and monitoring body for the study, said he was not allowed to disclose more data than the company provided.

The experiment served as a test for the so-called amyloid hypothesis. The idea is that Alzheimer’s is closely related to amyloid buildup in the brain; If amyloid accumulation can be prevented or reversed, the disease can be prevented or cured.

Drug companies have spent billions of dollars testing anti-amyloid drugs to no avail, leading many experts to believe the hypothesis is wrong – or that the only way to treat Alzheimer’s is to start very early, before clinical ones There are signs of illness.

The Eli Lilly study recruited patients who were not based on symptoms but rather on scans that showed significant buildups of amyloid in their brain. The researchers also looked at a protein, tau, that forms spaghetti-like tangles in the brain after the disease begins.

“We needed mild to moderate entanglement pathology, but not so many entanglements that the disease may no longer be hoped for,” said Dr. Skovronsky.

The primary endpoint or aim of the study was a measurement that combined performance on mental reasoning and memory tests with ratings of participants’ performance in activities of daily living such as dressing and meal preparation.

The main side effect has been seen regularly in patients given experimental monoclonal antibodies to treat Alzheimer’s disease: an accumulation of fluid in the brain. It occurred in nearly 30 percent of patients, said Dr. Skovronsky, but most of them had no symptoms. The effect was seen on brain scans.

During the study, Eli Lilly started a second phase 2 study, Trailblazer 2, in the hope that the initial efforts would produce results. These results are expected in 2023.

Dr. Skovronsky said Eli Lilly will speak to the Food and Drug Administration and regulators in other countries about giving patients access to the drug.

“Sure, the dates are exciting,” he said. “But we have to see what the regulators say.”

For 25 years he has hoped for definitive evidence that the amyloid hypothesis is correct.

“This is what we’ve been waiting for,” said Dr. Skovronsky.