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Biden to reopen ACA marketplaces, lower barriers for joining Medicaid

Health & BeautyJan 26. 2021President Joe Biden speaks during a signing ceremony on Friday, Jan 22, 2021. MUST CREDIT: Washington Post photo by Jabin Botsford

By The Washington Post · Amy Goldstein

WASHINGTON – President Joe Biden is scheduled to take executive actions as early as Thursday to reopen federal marketplaces selling Affordable Care Act health plans and to lower recently imposed barriers to joining Medicaid.

The orders will be Biden’s first steps since taking office to help Americans gain health insurance, a prominent campaign goal that has assumed escalating significance as the pandemic has highlighted desire for affordable health care – and deprived millions of Americans coverage as they have lost jobs in the economic fallout.

Under one order, HealthCare.gov, the online insurance marketplace for Americans who cannot get affordable coverage through their jobs, will swiftly reopen for at least a few months, according to several individuals inside and outside the administration familiar with the plans. Ordinarily, signing up for such coverage is tightly restricted outside a six-week period late each year.

Another part of Biden’s scheduled actions, the individuals said, is intended to reverse Trump-era changes to Medicaid that critics say damaged Americans’ access to the safety-net insurance. It is unclear whether Biden’s order will undo a Trump-era rule allowing states to impose work requirements, or simply direct federal health officials to review rules to make sure they expand coverage to the program that insures about 70 million low-income people in the United States.

The actions are part of a series of rapid executive orders the president is issuing in his initial days in office to demonstrate he intends to steer the machinery of government in a direction far different from that of his predecessor.

Biden has been saying for months that helping people get insurance is a crucial federal responsibility. Until the actions planned for this week, he had not focused on this broader objective, shining a spotlight instead on trying to expand vaccinations and other federal responses to the pandemic.

The most ambitious parts of Biden’s campaign health-care platform would require Congress to provide consent and money. Those include creating a government insurance option alongside the Affordable Care Act (ACA) health plans sold by private insurers, and helping poor residents afford ACA coverage if they live in about a dozen states that have not expanded their Medicaid programs under the decade-old health law.

A White House spokesman declined to discuss the plans. Two Department of Health and Human Services officials, speaking on the condition of anonymity about an event the White House has not announced, said Monday they were anticipating that the event would be held Thursday.

According to a document obtained by The Washington Post, the president also intends to sign an order rescinding a rule compels nonprofits in other countries that receive federal family planning aid to promise not to perform or encourage abortions. Biden advisers last week previewed an end to this rule, which for decades has reappeared when Republicans occupied the White House and vanished under Democratic presidents.

The document also says Biden will disavow a multinational antiabortion declaration that the Trump administration approved three months ago.

The actions to expand insurance through the ACA and Medicaid come as the Supreme Court is considering two cases that could shape the outcome. One case is an effort to overturn rulings by lower federal courts, which have held that state rules, requiring some residents to work or prepare for jobs to qualify for Medicaid, are illegal. The other case involves an attempt to overturn the entire ACA.

According to the individuals inside and outside the administration, the order to reopen the federal insurance marketplaces will be framed in the context of the pandemic, essentially saying that anyone eligible for ACA coverage who has been harmed by the coronavirus will be allowed to sign up.

“This is absolutely in the covid age and the recession caused by covid,” said a health-care policy leader who has been in discussions with the administration. “There is financial displacement we need to address,” said this person, who spoke on the condition of anonymity to describe plans the White House has not announced.

The reopening of HealthCare.gov will be accompanied by an infusion of federal support to draw attention to the opportunity through advertising and other outreach efforts. This, too, reverses the Trump administration’s stance that supporting such outreach was wasteful. During its first two years, it slashed money for advertising and for community groups known as navigators that helped people enroll.

It is not clear whether restoring outreach will be part of Biden’s order or will be done within federal health-care agencies.

Federal rules already allow people to qualify for a special enrollment period to buy ACA health plans if their circumstances change in important ways, including losing a job. But such exceptions require people to seek permission individually, and many are unaware they can do so. Trump health officials also tightened the rules for qualifying for special enrollment.

Biden is expected to open enrollment without anyone needing to seek permission, said Eliot Fishman, senior director of health policy for Families USA, a consumer health-advocacy group.

In the early days of the pandemic, the health insurance industry and congressional Democrats urged the Trump administration to reopen HealthCare.gov, the online federal ACA enrollment system on which three dozen states rely, to give more people the opportunity to sign up. At the end of March, Trump health officials decided against that.

During the most recent enrollment period, ending the middle of last month, nearly 8.3 million people signed up for health plans in the states using HealthCare.gov. The figure is about the same as the previous year, even though it includes two fewer states, which began operating their own marketplaces.

Leaders of groups helping with enrollment around the country said they were approached for help this last time by many people who had lost jobs or income because of the pandemic.

The order involving Medicaid is designed to alter course on experiments – known as “waivers” – that allow states to get federal permission to run their Medicaid programs in nontraditional ways. The work requirements, blocked so far by federal courts, are one of those experiments. Another was an announcement a year ago by Seema Verma, the Trump administration’s leader of the Centers for Medicare and Medicaid Services, that states could apply for a fundamental change to the program, favored by conservatives, that would cap its funding, rather than operating as an entitlement program with federal money rising and falling with the number of people covered.

“You could think about it as announcing a war against the war on Medicaid,” said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.

Dan Mendelson, founder of Avalere Health, a consulting firm, said Biden’s initial steps to broaden insurance match his campaign position that the United States does not need to switch to a system of single-payer insurance favored by more-liberal Democrats.

The orders the president will sign “are going to do it through the existing programs,” Mendelson said.

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Vaccines may not work as well on virus variants, U.K.’s Hancock says

Health & BeautyJan 25. 2021

By Syndication Washington Post, Bloomberg · Joe Mayes

The U.K.’s health minister warned that coronavirus vaccines may be less effective against new variants of the disease, such as those found in South Africa and Brazil, and that stricter border controls are justified.

“We don’t know the degree of that,” Matt Hancock said in an interview on Sky News on Sunday, commenting on the extent of any potential reduced efficacy of the vaccines. “In the meantime, we’ve got to have a precautionary principle that says let’s not bring these new variants back to the U.K.”

Hancock’s warning came as the U.K. reported it had vaccinated more than 5 million people, including three-quarters of those over 80. Hancock said the government is conducting a vaccine trial on the South African variant to study its response to the inoculation, and that he’s concerned about new variants developing elsewhere.

“The new variant I really worry about is the one that’s out there but hasn’t been spotted,” he said, adding that the U.K. is offering its genome-sequencing capability to other countries to help them identify new strains. There are 77 known cases of the South African variant in Britain, and at least 9 cases of the Brazilian variant, Hancock said on the BBC’s “The Andrew Marr Show.”

The U.K. has already banned flights from South Africa and neighboring countries, plus all of South America, in a bid to stop the spread of the new variants. Hancock said the government didn’t rule out introducing even stricter international travel measures in the days ahead.

Britain is grappling with the highest death toll in Europe from the disease and battling to recover from its deepest recession in more than 300 years. The latest data published Sunday reported another 610 deaths, taking the U.K.’s total to 97,939. The government is also on alert over signs that a local variant of the virus, which is as much as 70% more transmissible, may be more deadly than the original strain.

The supply of vaccines – not distribution by the National Health Service – is the rate-limiting factor in the U.K.’s vaccination effort, Hancock said. Some 6.35 million people have now received their first dose, the latest figures showed, with Britain well ahead of other European countries.

Hancock couldn’t confirm that schools would be open again by Easter, saying that the government would have to look at the data around the pandemic at the time. While the government also wants to lift social restrictions as soon as possible, Hancock added that it’s too early to give any more details on potential easing.

“There is early evidence that the lockdown is starting to bring cases down but we are a long, long, long way from being low enough,” Hancock said on Sky. “You can see the pressure on the NHS, you can see it every day.”

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U.S. largely avoided Christmas coronavirus surge, but experts warn the threat could intensify

Health & BeautyJan 24. 2021Ambulances outside Emanate Health Queen of the Valley Hospital in West Covina, Calif., on Jan. 12. MUST CREDIT: photo for The Washington Post by Philip Cheung.

By The Washington Post · Fenit Nirappil

The United States appears to have avoided the worst-case coronavirus scenarios that officials feared would overwhelm hospitals in the aftermath of Christmas and New Year’s gatherings. But experts caution that the threat from the virus has not diminished and could intensify with the emergence of new variants.

Even as hospitalizations begin to stabilize, they do so from record heights. The country’s hospitals averaged more than 130,000 covid-19 patients a day over seven days this month, far exceeding summer and spring surges. The death toll from cases contracted before and after the holidays will stretch into February. Authorities reported nearly 4,500 deaths Wednesday, a new single-day record.

Cases skyrocketed at the start of 2021, approaching a seven-day daily average of 250,000 around Jan. 10 before declining. But the toll on the health-care system was softer than expected.

Hospitals had braced for enormous spikes in patients that could have forced rationing care, exhausted already limited beds and sparked a nationwide shortage of health-care workers. But officials across the country said those dire predictions – a wave of severe Christmas cases weeks after a rapid increase from Thanksgiving – did not materialize in most places.

“The surge on top of a surge that could have happened didn’t really happen,” said Erin Bromage, a biology professor at the University of Massachusetts at Dartmouth. “We dodged a bullet, and we’ve done better than we could have, but we are still in a pretty terrible spot.”

Anthony Fauci, the nation’s top infectious-disease expert, said at a White House briefing Thursday that cases appeared to be plateauing, but he warned it could be a temporary slowdown.

Hospital leaders and experts are still on edge. Variants of the coronavirus, including the B.1.1.7 strain that originated in Great Britain and is believed to be 50 to 70% more contagious, could result in further case spikes in cold weather months when people are more likely to be indoors. And the availability of the vaccine, while offering lifesaving protection to millions, could also lead to a false sense of complacency, particularly as it can be difficult to obtain.

“It’s like a pot of boiling water, so the temperature may have been turned down some, but it’s still dangerously hot,” said Carmela Coyle, chief executive of the California Hospital Association. “Plateauing is not a good thing.”

Travelers at Reagan National Airport in Arlington, Va., on Dec. 23. MUST CREDIT: Washington Post photo by Ricky Carioti.

Infections soared in the aftermath of Thanksgiving, leading some to fear an even greater surge after back-to-back Christmas and New Year’s celebrations where people would gather with family and friends and then travel back home, potentially spreading the virus with each step. The Transportation Security Administration recorded its highest number of airline travelers since the pandemic began around Christmas, exceeding 1 million daily.

Experts have floated several theories for why the holiday season dealt less damage than expected. Some people may have changed their behavior after seeing the Thanksgiving spike, such as by celebrating outdoors, limiting gatherings to immediate family or quarantining before Christmas. More people who have contracted the virus could be receiving treatment at home while the sickest patients are hospitalized.

Robert Kaplan, a medical professor at Stanford University who was among those raising alarms about a holiday surge, said hospitalizations appear to be dipping in states that already had high caseloads and rising in those that had lower caseloads.

“There may be some places in the country where there are fewer people eligible to get sick because they’ve already been infected,” Kaplan said.

Los Angeles County faces one of the worst crises, with officials taking steps to conserve oxygen needed to treat covid-19 patients struggling to breathe and 11% of intensive care beds still available.

Researchers and county health officials released new projections Wednesday offering some good news: Hospitalizations have leveled off with enough ventilators to treat patients, and declines in admissions are projected, even under conservative estimates.

The bad news: Even with declining caseloads, the stress on hospitals will be so high that bed shortages will continue. Those who have been admitted are coming in with more severe cases of covid-19 and are more likely to die.

About one in eight covid patients in Los Angeles died from September to November – a figure that doubled to one in four after Nov. 3.

Roger Lewis, who leads the Los Angeles County Department of Health Services modeling team, said the figures suggest hospitals are being more selective in whom they admit.

“With that level of hospital demand, clinicians are forced to be very careful to reserve hospital resources for patients who clearly need it to ensure that resource is available to those whose life depends on it,” Lewis said. “Decisions are being made now to send people home with instructions to come back rather than admitting as a precaution.”

Dr. Brad Butcher chats with a nurse regarding the condition of a patient while doing rounds at UPMC Mercy Hospital in Pittsburgh on Jan. 11. MUST CREDIT: Washington Post photo by Michael S. Williamson.

Nicholas Testa, chief medical officer of Dignity Health, which operates four hospitals in Los Angeles County and two in neighboring San Bernardino County, said the hospitals experienced a Christmas surge with admissions peaking 15 days after the holiday. He said the health system managed the increase in part because length of stays have been shorter and county and state officials have offered additional resources. Still, hospitals teetered on the brink of rationing care.

“We got as close to the edge of care as I ever want to be,” Testa said. “When you get to what’s called crisis care is when you have to start making decisions about (who gets) ICU beds and ventilators. We did not get to that point thank God. It came pretty darn close.”

The American Hospital Association says others reported similar experiences.

“No one should be fooled that we are in an easy period right now,” said Nancy Foster, the group’s vice president for quality and patient safety policy. “The cold hard data says we were on the brink in many places, many communities across the country.”

California appears to be in a stronger position statewide as Northern California avoids the brunt of crisis. Mark Ghaly, the state’s top health official, on Tuesday hailed a 8.5% decline in hospitalizations and 2.8% decline in ICU admissions over two weeks as a sign that the post-holiday surge was “not as bad” as projected.

Arizona has been another major coronavirus hotspot, reporting the nation’s highest per capita rates of new cases, hospitalizations and deaths through January. The hospitalization rate now stands at 65 per 100,000 residents, a slight decline from the start of the month.

Marjorie Bessel, chief clinical officer for Banner health, Arizona’s largest health system, said the Jan. 11 peak, even if lower than expected, left hospital workers toiling in crowded conditions under enormous stress. Hospitals forced patients to share their rooms and repurposed labs and other areas, while corporate office staff were redeployed to the front lines.

“Yes it could have been worse and yes it could have been better if there was more mitigation and more enforcement of mitigation,” said Bessel, who has criticized Republican Gov. Doug Ducey for declining to implement new restrictions to slow the virus’ spread. “Let’s just hope the worst is truly behind us, and we can continue to spend the next many, many months recovering from what we just went through.”

Parts of the country that weren’t as hard hit as the southwest heading into Christmas season avoided a new crisis.

“We’re past the surge that could have come from Christmas and New Year’s,” Illinois Democratic Gov. J.B. Pritzker said last week after lifting restrictions. “I say that with some trepidation, because you know, there’s always the possibility that we’ll see an upsurge from that. But I think with one incubation period past New Year’s Day, New Year’s Eve, our numbers look like good news.”

Louisville Democratic Mayor Greg Fischer told residents at a town hall last week that hospitals avoided “extreme stress” in the holiday aftermath. In an interview, he said weekly cases hit 4,100 last week, a slight increase from a previous high, but the newly infected were disproportionately young and less likely to be hospitalized.

“We are seeing case counts spike, but we are not seeing a massive run to the hospitals,” Fischer said.

In Pennsylvania, the University of Pittsburgh Medical Center system prepared for hospitalizations across all its facilities to approach 3,000 in January, more than twice the 1,200 mid-December peak. Instead, they have been declining to about 600 this week – a potential sign that residents learned lessons after a Thanksgiving spike.

“We prepared for the worst, but we deal with what exactly the realities are today,” said Donald Yealy, senior medical director at the system. “I would not be surprised if there was one final increase left. I don’t expect covid-19 infection and illness to just evaporate.”

Nearly 3,900 deaths were reported Friday, suggesting Wednesday’s peak may not be an anomaly. The seven-day average of deaths in the weeks after Thanksgiving hovered around 2,500.

“We are getting in some way numb to the numbers,” said John Brownstein, chief innovation officer at Boston Children’s Hospital. “The numbers of hospitalizations, cases and death are still incredibly high. Even if we see a pullback, those numbers are still incredibly scary.”

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100 million doses in 100 days: How Biden’s coronavirus vaccine push compares with those of other countries

Health & BeautyJan 24. 2021

By The Washington Post · Emily Rauhala, Adam Taylor

A key part of President Joe Biden’s new coronavirus strategy is a push to administer 100 million doses in 100 days, or a lofty sounding 1 million immunizations a day.

That goal, part of a comprehensive national plan launched this week, has raised questions about how quickly the United States can, and should aim to, deliver vaccines to its population.

The strategy document calls the 1 million shots per day pace “aggressive,” an effort that will “take every American doing their part.” But critics have pointed out that it does not constitute a major leap from the current rate, which has already neared or even surpassed the target. Many wonder why the country cannot move more swiftly.

It remains possible that the United States could pick up its pace as vaccine supply increases and logistics improve. But in international context 1 million doses a day does not seem slow.

Though differences in population, logistical capacity and data transparency, along with different levels of vaccine vetting and effectiveness between vaccine types, make it hard to compare vaccination campaigns across countries, the United States is near the top of the pack, behind some of the fastest countries to vaccinate, including Israel and Britain, but ahead of most of the rest of the world.

The biggest factor shaping the rate of vaccination is global supply.

Though the development and emergency approval of coronavirus vaccines has unfolded at an unprecedented pace, drug companies are scrambling to make enough doses to meet demand. As some countries receive a high number of doses from among the limited total produced, others must wait their turn.

So far, a small number of relatively rich countries, including the United States, have snapped up the initial supply, relegating low- and middle-income countries to the back of the line – possibly for years. Some projections suggest poor countries will not have enough doses until 2023 or 2024.

Rich countries are set to fare better. The European Commission aims to vaccinate 70 percent of the adult population of the European Union by the summer, though details of that plan are not yet clear.

Anthony Fauci, adviser to Biden and director of the National Institute of Allergy and Infectious Diseases, said this week that the United States could potentially reach “herd immunity” by fall 2021.

Will other large countries move faster than the United States?

Possibly, but it is hard to say.

Questions about manufacturing capacity, the potential approval of additional vaccines and the impact of the new U.K. variant make predictions tough. However, India offers an interesting point of comparison.

On Jan. 16, India launched a plan to vaccinate 300 million people by August.

The roughly 200 day push to deliver 600 million doses is more ambitious than the U.S. plan. However, India’s population is more than three times larger than that of the United States.

China promised to vaccinate some 50 million people against the coronavirus before the Lunar New Year holiday next month – a seemingly rapid pace. But a report in a news outlet controlled by the ruling Communist Party said the country had administered 15 million doses by Jan. 20.

There are also questions about whether Chinese-made vaccines are as effective as the Moderna, Pfizer and AstraZeneca formulations used elsewhere.

Days after Brazilian officials announced that a vaccine made by Chinese company Sinovac was 78% effective protecting against moderate and severe covid-19 cases, for instance, they were forced to clarify that the shot’s efficacy rate among all cases was only 50.4%.

Ultimately, the biggest difference between the U.S. vaccination push and the Chinese effort is need.

Though there are doubts about China’s figures, the country reports just above 4,600 coronavirus deaths to date – comparable to the 4,409 U.S. deaths on Inauguration Day alone.

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Virus expert reveals why Thailand chose AstraZeneca’s viral vector vaccine

Health & BeautyJan 21. 2021Photo Credit: Bureau of Information office of Public Health ministry’s Permanent Secretary

By The Nation

Dr Yong Poovorawan, chief of the Centre of Excellence in Clinical Virology at Chulalongkorn University, appeared at a Public Health Ministry briefing on Wednesday in a bid to reassure the public after widespread concern over Thailand’s Covid-19 vaccine procurement.

“It is impossible for [every country] to get vaccines immediately even when they have enough money,” Dr Yong explained. “The global population is more than 7 billion. Just 50 per cent of population would need 8 billion vaccines since each person has to take two doses. So it will be impossible to vaccinate everybody within this year.”

How long before vaccine is approved – and will it be safe?

Vaccines usually take a long time to develop in animal and clinical (human) trials, which first need approval from the Food and Drug Administration (FDA), said Yong. Clinical trials have three steps: safety study, immunity test and effectiveness study. The final step usually takes more than a year or two for researchers to collect data from parallel trials where one group of volunteers is given the vaccine and a parallel “control” group is given a placebo.

However, that process has been accelerated as scientists around the world hurried to find a cure for the global pandemic. As a result, Covid-19 vaccines have been developed in just one year. They are now being screened for safety and efficacy by health authorities globally, including Thailand’s FDA.

Sinovac or AstraZeneca: Which is better?

We need to see which vaccines Western countries are using, said Dr Yong. The first available were mRNA vaccines – a new type of vaccine to protect against infectious diseases. These vaccines use strands of genetic material called mRNA inside a special coating called a nanoparticle. When injected, they instruct the human body to create a “spike protein” similar to the SARS-CoV-2 virus responsible for Covid-19. This immune response produces antibodies to protect our cells from getting infected if the virus enters our body. We could say it uses our body to create a vaccine, said Yong. The mRNA method is new for humans but draws on previous research on other diseases.

Another type is the viral vector vaccines produced by AstraZeneca and Russia’s Sputnik programme. These are similar to mRNA vaccines but use adenovirus as a vector instead of nanoparticles. This vaccine technology has a proven track record fighting the spread of Ebola in Africa. Moreover, viral vector vaccines will be cheaper in the future.

China’s Sinovac uses a third approach – the inactivated or killed vaccine method that has been in use for 70 years to combat viruses such as polio and rabies. The disadvantage of this vaccine is difficulty in manufacturing, increased cost per dose, and multiple immunisations required. Thailand has agreed to buy two million doses of SinoVac’s inactivated vaccine. As we know almost everything about traditional inactivated vaccines, it would be easier to handle, said Yong. But its relatively high cost of manufacturing makes it difficult to produce and purchase in high quantities.

Side effects of vaccine in Norway

Dr Yong also responded to news that 23 frail elderly patients had died soon after taking Pfizer BioNTec’s mRNA vaccine. The deaths might have been caused by side effects such as dizziness that triggered accidents, he said. Norwegian health authorities say common adverse reactions to mRNA vaccines that are not usually dangerous – such as fever, nausea and diarrhoea – may have played a role in the deaths. Dr Yong pointed out that death rates in general among the elderly had not risen after vaccination.

Will pregnant women and children get the jab?

Dr Yong said more research was needed on safety and dosage before pregnant women and children under 18 were given the vaccine in Thailand.

Addressing public calls to vaccinate people of working age first, he said there was no guarantee this move would prevent transmission. He explained that the vaccine may just prevent symptoms, meaning that even if they were inoculated, the working-age group could spread the virus to at-risk members of society.

People should understand that every disease can be prevented, Dr Yong said in conclusion. Vaccines were just one tool to help stop the virus from spreading. Meanwhile people should calmly continue using the tools in hand – keep their hands clean, wearing masks, and social distancing – to protect themselves. The results of vaccination would be seen soon, he predicted, since many wealthy countries had already rolled out inoculation programmes.

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Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots

Health & BeautyJan 20. 2021

By The Washington Post · Christopher Rowland

Long Island physician Benjamin Luft began receiving urgent calls from his elderly clinical trial subjects almost as soon as New York followed numerous other states last week and announced it would begin vaccinating anyone 65 or older with one of two authorized coronavirus vaccines, those made by Pfizer and Moderna.

The subjects wanted to get out of the clinical trial Luft is helping oversee of an experimental vaccine made by another company, Novavax.

They wanted to be “unblinded” and find out if they had received a placebo in the Novavax study, and, if so, try to get the Pfizer and Moderna vaccines, which have already been proved to be about 95% effective at preventing coronavirus infections.

“The number who have been calling me has been significant, and the numbers are increasing,” Luft, an infectious-disease expert at Stony Brook University Hospital, said in an interview. Fresh recruits also have begun to dry up, he said: “As we are doing our recruitment, all of a sudden the people over 65 became less interested.”

States have responded to the confusing, uneven and slow rollout of coronavirus vaccine by expanding eligibility for the shots ahead of schedule, quickly moving from the goal of immunizing front-line medical workers and long-term care residents into much broader populations of millions of elderly people.

But the moves have instantly made it more difficult to recruit and retain test subjects for clinical trials of vaccines that have yet to win emergency authorization.

The most immediately impacted vaccine trial in the United States involves Novavax, which on Dec. 28 set out to recruit 30,000 people for a major domestic trial, including 25% in the crucial over-65 category who are at the greatest risk for serious covid-19 disease.

Two-thirds of the test subjects in the Novavax study are getting the experimental vaccine, and one-third get the placebo, in the type of double-blind clinical trial that is considered the gold standard for testing whether drugs and vaccines work. But without recruiting and keeping a robust cohort of elderly subjects in the trial, the value of the data generated by the trial will be diminished.

“We hope Novavax vaccine will not be derailed by the fact that subjects in the trial would leave the trial to get access to a known vaccine,” Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, said last week at a JP Morgan conference. Novavax and the Food and Drug Administration, which oversees trials, say they remain hopeful the Novavax study can achieve full recruitment.

It is the latest in a series of challenges for Novavax, a Maryland biotechnology company that in July received $1.6 billion in federal taxpayer money via Operation Warp Speed development and manufacturing contracts. Earlier in the year it received nearly $400 million from the Coalition for Epidemic Preparedness Innovations (CEPI), a Norway-based nonprofit that supports global vaccine development.

The infusions of public and nonprofit money have dramatically boosted the prospects of a company that has never had a marketed product in its three-decade history. Its stock price began 2020 trading below $4 per share; it was worth $127.43 on Friday. But the company’s predictions last summer that it would produce 100 million doses by the end of 2020 and early 2021 proved overly optimistic.

The Novavax effort was crippled by manufacturing-related time lags that pushed its Phase 3 trial launch date from the fall into late December – a delay that has now put the company in its current bind over the trial.

Novavax did not have its own manufacturing facility, so it was forced to use contract manufacturers to make its vaccine for trials and eventually commercial operations.

The company said Operation Warp Speed last year kicked it out of its first contract manufacturer in Baltimore, Emergent, which made its early batches of vaccine for small-scale trials, and shifted it to a second manufacturer, Fujifilm, which is making the vaccine at plants in North Carolina and Texas.

The Novavax project was taken out of the Emergent facility to make way for manufacturing for Johnson & Johnson’s experimental vaccine, said Gregory Glenn, Novavax’s president of research and development. Slaoui also wanted Novavax to prove it could produce commercial-scale batches of 2,000 liters at a time in FujiFilm’s facilities, before it launched its Phase 3 trial, Glenn said.

The reason behind the switch and details about the delays have not been previously reported.

The changes pushed the pivotal trial so long into the competition among drug companies that the ability to recruit subjects is disappearing, Glenn said.

“The window is closing on the ability to conduct a randomized trial,” he said.

Asked to respond, Operation Warp Speed did not directly address the Novavax issues.

Novavax said it had 9,000 subjects as of last week toward its goal of 30,000 and intended to persevere. If it does not recruit enough people over 65 in the United States, it will ask the Food and Drug Administration to consider data from that age group from a smaller trial in the United Kingdom that is fully enrolled, Glenn said. Data from those trials is expected soon.

“If there is some reason we can’t complete the trial, we do have a large, 15,000-person placebo controlled trial from the U.K., and there is every reason to think the FDA would accept that,” Glenn said. He said 27% of the people in that trial were over 65 years old.

The FDA is hopeful there will still be a few months left to push through trials with full participation, but it is willing to look at foreign trial data, said a senior agency official who spoke on the condition of anonymity to discuss internal deliberations.

“We have no problem with accepting data from foreign trials, provided they are conducted under good clinical practices,” the official said. “We’re in a place here where we’re going to do our best with the data we have because we are in the middle of a pandemic.

“We’re not going to cut corners, but we’re not going to stand on ceremony. . . . It’s not like were going to sit there and make rules to make it difficult to use foreign data.”

Specialists in clinical trials said the case of Novavax highlights the dilemma in trying to develop a roster of multiple vaccines simultaneously to battle a global pandemic. In the United States and the world, multiple vaccines will need to be deployed to reach the immunization levels needed to reach herd immunity, which is estimated to be upward of 70% of the population.

The first two vaccines to win emergency authorization from the FDA, Pfizer and Moderna, were made with novel mRNA technology that allowed the shots to be engineered extremely rapidly. Their rapid development, testing and authorization in December make it difficult to recruit and complete trials by competitors later in the pipeline, according to experts in clinical trials.

“The future of large-scale trials [for coronavirus vaccines] is in doubt,” said Arthur Caplan, a medical ethicist and clinical trial specialist at the New York University Langone medical center. “The more vaccines appear with either emergency approval, expanded criteria or plain licensing, there’s no way that people are going to sign up for trials with placebo controls.”

Alternatives to placebo-controlled trials are “non-inferiority” trials, or comparative trials that pit an investigational vaccine or drug up against an existing product. With the high degree of efficacy of the Moderna and Pfizer vaccines, it could be difficult to prove other vaccines are equal or better at immunizing against the coronavirus. But because Moderna and Pfizer require ultracold handling, and there is such a shortage of vaccines generally, there is intense demand for a competing vaccine that can be more easily distributed.

“Given that we need more vaccines on the market, the number of doses and storage requirements all matter. It may not just be about efficacy, it may be about those things,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

The FDA official said a number of factors would have to be considered in non-inferiority trials.

“Obviously to do a non-inferiority trial with a vaccine that has 95% efficacy is very challenging and it really will depend on the specific vaccine,” the official said. Mitigating factors for a vaccine that is less effective could be a one-shot regimen, fewer side effects or easier shipping and handling, the official said.

Caplan said the problems with recruitment are bound to increase attention on the potential of “challenge trials,” in which subjects are given a vaccine then intentionally exposed to virus to see if the vaccines work.

Challenge trials are the subject of ethical controversy and would also be unlikely to be tried in elderly patients who are most at risk of developing severe disease or dying from covid.

Sanofi, which partnered with GlaxoSmithKline to develop a vaccine, also experienced significant setbacks in early stage clinical trials. It has opted to compare its vaccine candidate with another previously authorized vaccine (which has not been disclosed) in a mid-stage trial in February as well as a subsequent large Phase 3 trial in the second quarter.

Investigators are required to permit subjects to exit clinical trials once proven vaccines hit the market.

Johnson & Johnson said it had fully enrolled its Phase 3 placebo-controlled trial in December. It would not comment for this story.

AstraZeneca said it is nearing complete enrollment of its U.S. trial.

“Regarding unblinding, as vaccines receive emergency use authorization or approval, and participants in the AZD1222 trial are eligible to receive them, we have provided guidance to site investigators and trial participants so they can discuss the options that are available to them,” AstraZeneca spokesman Brendan McEvoy said in an email.

While Johnson & Johnson and AstraZeneca wrapped up enrollment of their placebo-controlled trials, and Sanofi’s delays are so severe it opted for its non-inferiority trial, Novavax appears to have been caught in the middle – with a placebo-controlled trial that risks falling short.

What Novavax really needs is more test subjects like Maureen Reininger, 65, a retired New York transit system supervisor and analyst who lives in the Long Island suburb of South Hempstead. Reininger was in charge of recovering cash and MetroCards from the booths in subway stations beneath Lower Manhattan after the 9/11 terrorist attacks, and she breathed toxic dust that she said has contributed to chronic sinus problems.

Yet despite New York’s moves last week that made her eligible for the proven vaccines, she said she wants to continue in the Novavax trial, not knowing if she received the vaccine candidate or the placebo. The reason she joined the trial in the first place was altruism, and a sense of contributing to the quest for vaccines, rather than her own possible early access to a shot, she said.

“I just wanted to be of assistance, to be helpful to our fellow humans,” she said. Reininger added that she is still taking precautions that will protect her if she received the placebo.

“I’m basically not going anywhere outside of my home, and when I do go out, when I go to the supermarket, and I’m in and out, and the mask is on, and I wear gloves,” she said. “When I do go into areas where there are other people, I physically will remove myself, even when I have my mask.”

Reininger acknowledged one factor that makes her different from other many people over 65 who want faster access to a vaccine: She does not have grandchildren.

“That would change things,” she said.

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CDC warns highly transmissible coronavirus variant to become dominant in U.S.

Health & BeautyJan 17. 2021

By The Washington Post · Joel Achenbach

The highly contagious variant of the coronavirus first seen in the United Kingdom will become the dominant strain in the United States within about two months, its rapid spread heightening the urgency of getting people vaccinated, the Centers for Disease Control and Prevention predicted Friday in its most sobering warning yet about mutations in the virus.

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In every scenario explored by the CDC, the U.K. strain, which British researchers estimate is roughly 50% more transmissible than the more common coronavirus strain, will account for a majority of cases in the United States by some point in March.

The CDC released modeling data to back up its forecast showing a rapid spike in infections linked to the U.K. strain. The agency said the emergence of these mutation-laden variants requires greater efforts to limit viral spread – immediately, even before the U.K. variant becomes commonplace.

So far, no variant is known to cause more severe illness, although more infections would inevitably mean a higher death toll overall, as the CDC made clear in an informational graphic released Friday: “MORE SPREAD – MORE CASES – MORE DEATHS,” it said.

The CDC report “speaks to the urgency of getting vaccines out. It’s now a race against the virus,” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

Scientists both in and out of government have stressed the need for the public to stick to proven methods of limiting viral spread, such as wearing a mask, social distancing, avoiding crowds and having good hand hygiene.

“We know what works and what to do,” Jay Butler, the CDC deputy director for infectious diseases, said Friday.

The emergence of highly contagious variants has grabbed the full attention of scientists, who in recent weeks have warned that these mutations require closer surveillance. The CDC and its partners in private and academic laboratories are ramping up genomic sequencing efforts to gain better awareness of what is already circulating. Experts think there could be many variants containing mutations worth a closer look.

“This is a situation of concern. We are increasing our surveillance of emerging variants. This virus sometimes surprises us,” Butler said.

Mutations could limit the efficacy of vaccines or therapeutic drugs such as monoclonal antibodies. Scientists believe vaccines will probably remain effective because they produce a robust immune system response, but such reassurances have been paired with cautionary notes about how much remains unknown.

The coronavirus mutations are not unexpected, because all viruses mutate. There are now several “variants of concern” receiving scrutiny, including ones identified first in South Africa and Brazil, and U.S. officials have said genomic surveillance is still ramping up here and that there may be other variants in circulation, not yet identified, that are enhancing transmission.

“We’re going forward with the assumption that these three variants that we know about now are not going to be the only variants that emerge that are of concern to us,” Greg Armstrong, head of the CDC’s strain surveillance program, said Friday.

The CDC model suggests that the level of pain and suffering in late March, when the new variant is forecast to be dominant, depends on actions taken today to try to drive down infection rates.

The emergence in recent weeks of mutation-laden variants has alarmed the CDC and the scientific community. Because the threshold for herd immunity depends in part on how infectious a virus is, the emergence of a more transmissible strain can prolong efforts to crush a pandemic.

There has been particular scientific focus on the United Kingdom variant, known as B.1.1.7, which has been spreading with stunning speed in Britain, Denmark and Ireland and has been identified in dozens of countries. The United Kingdom conducts extensive genomic sequencing, and first detected the variant, which has 17 mutations, in September. But it was not flagged as a “variant of concern” until December, when it began circulating at explosive rates and quickly became dominant among the coronavirus infections in southern England.

Scientists say B.1.1.7 has mutations in the “receptor binding domain” of the virus, and this may be enhancing the ability of the virus to bind with cells in the human body. There is evidence it leads to higher viral loads, which in turn could boost the amount of virus that a person is shedding, or prolong the period in which someone can transmit the virus.

None of these mutations appears to change the basic mechanics of infection, and people should stick with common-sense measures to limit viral spread, said James Cutrell, an infectious-diseases physician at the University of Texas Southwestern Medical Center in Dallas.

“The same things that worked to protect you from this virus are going to work for these new variants as well,” Cutrell said.

The CDC did not call for new government restrictions to crush the pandemic but emphasized the need to drive down infection rates.

“Increased SARS-CoV-2 transmission might threaten strained healthcare resources, require extended and more rigorous implementation of public health strategies, and increase the percentage of population immunity required for pandemic control,” the CDC wrote. “Taking measures to reduce transmission now can lessen the potential impact of B.1.1.7 and allow critical time to increase vaccination coverage.”

It is unclear if the winter surge in the United States is at a peak, but the numbers are staggering, with more than 200,000 new infections confirmed every day on average.

This is not the first warning from the CDC about variants of the virus, but it is the first to offer a plausible timeline for when and to what degree the mutations seen recently could complicate efforts to end the pandemic.

It shows that vaccination, performed rapidly, is critical to crushing the curve of viral infections. Without vaccines, under one CDC scenario, the country could be dealing with even greater levels of infections in May than in January.

But if public health agencies can ramp up to 1 million vaccinations a day, the CDC model forecasts that daily new infections will decline in the next few months – even with the extra boost from the highly contagious U.K. variant. It has been identified in 12 states, the CDC said Friday, and the agency has informed officials nationwide that they should assume the variant is present in their state.

The CDC and unaffiliated scientists have said they see no evidence that this particular variant is driving the winter surge in cases. So far, it has been involved in fewer than 0.5% of infections nationwide, testing data suggests.

Friday’s sobering CDC forecast is based on simple models and has limitations, the agency acknowledged.

The model looks at just the B.1.1.7 variant and does not consider the impact of other variants already discovered or not yet identified. The variants in South Africa and Brazil could prove to be even more problematic, though they have not been spotted so far in the United States. Researchers have noted the disastrous spike in cases in Manaus, Brazil, in recent weeks, despite the high percentage of the population believed to have been previously infected – a situation that raises suspicions, not confirmed by data, that some people who had recovered are becoming reinfected by the new strain.

The CDC model treats the United States as a single unit even though the virus is spreading at different rates locally and regionally. No one knows, even at the national level, the current “R,” the reproduction number, of the common coronavirus variant. That’s the number of people an infected person will infect, on average.

The CDC model used plausible reproduction rates of 1.1 (faster spread right now) and 0.9 (slower). The CDC then used British data to project that the U.K. variant is 50 percent more transmissible than the common variant. The model assumes that between 10 and 30% of the population has been infected already and recovered and now has immunity.

“It would be foolish to say that this is never going to end, and we might as well stop trying,” the CDC’s Butler said. “But there is reason to be concerned. We’re not out of the woods on this pandemic yet. We need to continue to press ahead.”

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Coffee a big business in Thailand

Health & BeautyJan 15. 2021

By THE NATION

The coffee market in Thailand has been expanding significantly, with new cafes popping up in every city.

A report from Nestle (Thai) shows that the coffee market in the Kingdom has risen by 10.7 per cent or by Bt60 billion in 2020 alone, despite the Covid-19 outbreak.

Coffee is grown in several parts of the country, with Chumphon province being the largest producer. According to Spring News, Chumphon has devoted 104,326 rai to the bean and produces as much as 11,537 tonnes of Robusta per year.

After Chumphon, the other biggest producer of coffee is Ranong, where 44,080 rai has been devoted to the crop and 4,667 tonnes is produced on a yearly basis.

Other provinces where coffee is grown are Chiang Rai, Chiang Mai and Nan in the North, where 42,215 rai, 23,125 rai and 22,500 rai has been devoted to the crop, producing 3,402, 2,283 and 3,825 tonnes per year, respectively.

Coffee plantations in the North grow the Arabica variety of coffee.

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Insurance firm launches blood donation campaign amid new wave of infections

Health & BeautyJan 13. 2021Duangduen Kongkasawad

By The Nation

Thai Life Insurance has launched a blood-donation campaign to meet shortages amid the new wave of Covid-19 infections.

“To ensure blood supply meets demands in the country, Thai Life Insurance has launched a campaign encouraging people to donate blood every three months,” the company’s executive vice president Duangduen Kongkasawad said, adding that the aim is to procure 1.2 million cubic centimetres (cc) of blood this year.

The first blood-donation event will be held on the first floor of Thai Life Insurance headquarters on Bangkok’s Ratchadapisek Road from January 13 to 15. Donations will also be collected via a mobile unit parked in front of the company’s Rattanathibet branch on January 13. Blood donations will be collected from 9am to 3pm.

“To ensure donors’ safety, the company has implemented strict measures to contain the spread of Covid-19, such as screening each donor’s body temperature, collecting information on their history and providing enough space to implement social distancing,” she said.

Members of the company’s Life Fit programme can collect points for up to 30 per cent discount on next year’s premium after submitting their blood donation reports via the Thai Life Insurance smartphone app.

“There are still many people who are sick and need blood for treatment, so we invite healthy people to donate blood every three months,” she said.

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EU-funded campaign urges consumers to beware of counterfeit cosmetics and beauty products

Health & BeautyJan 12. 2021

By The Nation

Southeast Asia is awash with counterfeit beauty, skincare, and cosmetic products, many of which pose a real threat to the health and well-being of the people who use them and the economies they are trafficked in, according to the IP Key Southeast Asia project.

Funded by the European Union (EU), the project has launched the second phase of the #YourHealthIsPriceless campaign in the region to directly connect with consumers and help raise their awareness about the risks and dangers associated with substandard products.

An OECD-EUIPO 2017 report identified China and India as major producers of counterfeit pharmaceuticals, and Singapore as well.

In terms of counterfeit perfumes and cosmetics, an OECD-EUIPO 2017 report states that generally, China is the key producer of these products, that are shipped worldwide, but these goods are also produced in countries such as Malaysia, Thailand, India, and Singapore. But, seeing as how counterfeiters use complex and constantly changing trade routes so as to avoid detection, it can be difficult to pinpoint the exact origins and manufacturing sources of some products, the project said.

Due to the surreptitious manner in which counterfeit goods are produced and trafficked from one country to another, the value of counterfeit cosmetics and beauty products in a specific country would be very difficult to estimate, the report said. Nevertheless, the value and volume of counterfeit goods seized by Thai IP enforcement authorities, as reported by the Department of Intellectual Property (DIP) Thailand, gives a good indication of the size and value of the counterfeiting industry in general. The IP Key SEA project is working with the DIP and Thai authorities in order to address the pressing issues of counterfeiting and piracy in the country.

According to the European Commission’s “Counterfeit and Piracy Watchlist 2018”, these physical marketplaces, including shopping venues and open-air markets, are still operating and selling counterfeit products of different brands, especially in this sector. These physical marketplaces are very well-known, open to the public, close to landmarks and tourist attractions, and easily accessible via public transportation.

The major venues include MBK Center in Bangkok, where allegedly more than 2,000 shops count 100-500 counterfeit items per shop, including a large number of fake cosmetics, personal care products, and beauty products. EU stakeholders have also reported the presence of huge quantities of counterfeit goods at Mike Shopping Mall in Pattaya, Phuket Night Market in Phuket, and Rong Kluea Market in Sa Kaeo province. Regarding other Southeast Asian countries, these fakes can be found for sale in Petaling Street Market in Kuala Lumpur, and Saigon Square Plaza in Vietnam, for instance.

But it’s not just the physical marketplaces that pose a problem; these fake goods are easily available across a number of online shops, which adds another level of complexity to stopping the incessant trade of these poor quality and health endangering-products. Only through heightened consumer awareness can this marketplace also be cut off as a contributor to the problem, the report said.

“The first phase of our #YourHealthIsPriceless campaign, launched last September, received a good reception and much interest from Thai media outlets and those in Southeast Asia and the EU, which is helping us communicate with the public and spread the message of just how important consumer vigilance is to help stop the trade of these dangerous products. On top of our social media efforts during the first phase, we also partnered with young Thai micro-influencers to connect with people of all ages, and communicate relevant information to them and make them aware of the importance of safeguarding their health and well-being by only purchasing genuine products,” said Tiago Guerreiro, IP Key SEA Project leader.

In this second phase of the #YourHealthIsPriceless IP Key SEA campaign, the focus will be on starting conversations in the community about the importance of intellectual property and trademarks and how they contribute to protecting them from poorly made pirated products. The campaign will share important insights such as helping people identify a counterfeit product. Local authorities are embracing the IP Key SEA project across Southeast Asia as they continue to make inroads to halt the import and sale of counterfeit cosmetics and beauty products, he said.

“We have been working closely with Southeast Asian IP authorities for three years now through the organisation of activities covering various areas of intellectual property, namely trademarks, copyright, and related rights, industrial designs, geographical indications, patents, plant variety protection/plant breeders’ rights, and IPR enforcement. We organise technical meetings, where we share best practices, and capacity building activities with our IP and law enforcement counterparts in order to assist them in addressing the challenges that arise in relation to the protection and enforcement of IP rights. It’s through these activities that the project promotes the adoption of international and EU best practices in the enforcement of IP rights, which would contribute to a more transparent IPR environment in the region,” Guerreiro added.

Combating the trade in counterfeit and pirated goods requires collaboration between countries and a united effort to cut off trade routes and implement more stringent systems and processes. One of the key missions of IP Key SEA is to help countries in the region to be better equipped to understand how they can bolster their law enforcement capabilities and work more effectively when it comes to cross-border IPR enforcement. By doing this they are not only protecting their citizens they are also protecting their economies, he said. For example, in the EU alone, the total revenue loss attributable to the legitimate sector averages annually at 17.9 billion euros and 3.5 billion euros total government revenue loss during 2013-17.

People can share their personal experiences alongside a description, photo, or video, including the hashtags #YourHealthIsPriceless #IPKeySEA #EUinThailand #EUForeignPolicy and tag the @IPKey_EU Twitter account or IP Key Facebook page.