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Thursday, March 4, 2021

Obesity a driving factor in COVID-19 deaths: global report

 The majority of global COVID-19 deaths have been in countries where many people are obese, with coronavirus fatality rates 10 times higher in nations where at least 50% of adults are overweight, a global study found on Thursday.

The report, which described a “dramatic” correlation between countries’ COVID-19 death and obesity rates, found that 90% or 2.2 million of the 2.5 million deaths from the pandemic disease so far were in countries with high levels of obesity.

The study analysed the COVID-19 death figures from Johns Hopkins University in the United States and the World Health Organization’s Global Health Observatory data on obesity.

Strikingly, the authors said, there is no example of a country where people are generally not overweight or obese having high COVID-19 death rates.

“Look at countries like Japan and South Korea, where they have very low levels of COVID-19 deaths as well as very low levels of adult obesity,” said Tim Lobstein, an expert advisor to the World Obesity Federation and visiting professor at Australia’s Sydney University who co-led the report.

“They have prioritised public health across a range of measures, including population weight, and it has paid off in the pandemic.”

By contrast, the report found that in the United States and Britain, for example, both COVID-19 death rates and obesity levels were among the highest.

The United Kingdom has the world’s third-highest coronavirus death rate and the fourth-highest obesity rate - 184 COVID-19 deaths per 100,000 and 63.7% of adults overweight, according to WHO data - followed by the United States, with 152.49 COVID-19 deaths per 100,000 and 67.9% of adults overweight.

John Wilding, a professor of medicine at Britain’s University of Liverpool and president of the World Obesity Federation, said obesity should be recognised as a key COVID-19 health risk and taken into account in vaccination plans.

“It’s really important that we recognise that obesity ... increases the risk,” he said in a statement about the report’s findings. “Therefore, like other diseases such as diabetes and cardiovascular disease, people with obesity should be considered for early priority in vaccination programmes across the world.”

https://www.reuters.com/article/us-health-coronavirus-obesity/obesity-a-driving-factor-in-covid-19-deaths-global-report-finds-idUSKBN2AW1X0

Fulcrum ends covid med trial

 After careful consideration, Fulcrum is discontinuing LOSVID, a Phase 3 trial with losmapimod for hospitalized subjects with COVID-19, due to significant changes in the COVID-19 treatment paradigm, including new therapeutic options and emerging vaccines.

  • The company has decided to redeploy its resources to other clinical programs and discovery efforts, with a continued focus on rare diseases.
  • Losmapimod was generally well tolerated in LOSVID, and an independent data safety monitoring board did not identify any safety concerns related to losmapimod.

Breast Cancer Mortality in Under 40s Resparks Screening Debate

 In the United States, breast cancer mortality rates dropped every year for women across all age groups between 1989 and 2010, but after that, the trend stalled for those younger than 40 years.

"It's clear that mortality rates in women under 40 are no longer decreasing," lead author R. Edward Hendrick, PhD, clinical professor from the Department of Radiology at the University of Colorado School of Medicine, in Aurora, Colorado, stated in a press release. "I estimate that in two to three years, the mortality rate will be increasing significantly in these women."

The findings were published online February 9 in Radiology.

The authors speculate that the findings may be related to recommendations for mammography screening.

For their study, the authors analyzed National Center for Health Statistics data for 1969–2017 and delay-adjusted invasive breast cancer incidence rates from the Surveillance, Epidemiology, and End Results program.

They found that breast cancer mortality rates decreased significantly by 1.5% to 3.4% per year for all age groups from 1989–2010, and by 1.2% to 2.2% per year after 2010 for those aged 40–79 years.

However, the rates increased after 2010 by a nonsignificant 2.8% per year for women aged 20–29 years and 0.3% per year for those aged 30–39 years.

Distant-stage breast cancer incidence rates increased by more than 4% per year after the year 2000 in women aged 20–39 years.

"Our hope is that these findings focus more attention and research on breast cancer in younger women and what is behind this rapid increase in late-stage cancers," Hendrick stated in the press release.

He and his colleagues speculate that the contrast between the upward trend in women younger than 40 and the downward trend in older women highlights the value of mammography and may reflect the benefits of regular screening, which is not currently recommended for women younger than 40 who are not at high risk for breast cancer.

However, other groups, including the American College of Radiology and the Society for Breast Imaging, support starting annual mammograms at age 40 years.

An expert who was approached for comment noted that the incidence of breast cancer increases with age.

It is more common in women as they age, so screening recommendations do not include women younger than 40 unless they are at very high risk for breast cancer, noted Joann G. Elmore, MD, MPH, professor of medicine at the David Geffen School of Medicine, the University of California, Los Angeles.

"The majority of deaths due to breast cancer are in women over age 40. The breast cancer mortality rates per 100,000 as shown [in this study] are ~3 patients/100,000 for the under 40 age group, ~30/100,000 in the 40–69 age group, and ~80/100,000 in the 70 and above age group," she pointed out.

Elmore was a coauthor of an editorial regarding the 2019 evidence-based guidance statement from the American College of Physicians (ACP). That guidance, which was endorsed by the United States Preventive Services Task Force, recommended screening every other year for average-risk women aged 50–74 years, as reported by Medscape Medical News at the time.

In their editorial, Elmore and coauthor Christoph Lee, MD, of the University of Washington, Seattle, applauded the ACP's approach but stressed that the guidance is not a perfect product and does not "clearly illuminate the full path ahead for every woman."

Breast cancer screening guidelines continue to evolve, they said. They concluded that "[p]hysicians are left to use their best judgment based on available research and expert recommendations."

Radiology. Published online February 9, 2021. Full text

https://www.medscape.com/viewarticle/946863

Lilly's tirzepatide beats Novo's semaglutide in diabetes phase 3

 Another phase 3 clinical trial of Eli Lilly’s tirzepatide in Type 2 diabetics has met its primary endpoint. The dual GIP/GLP-1 agonist beat Novo Nordisk’s semaglutide against multiple measures, although recent data on another dose of the rival drug suggest Lilly has a fight on its hands.

In recent months, Lilly has released data from a series of late-phase trials that have linked tirzepatide to significant reductions in participants’ blood sugar and body weight. The latest readout, from the 1,879-subject, 40-week SURPASS-2 clinical trial, provides evidence that tirzepatide is more effective than the 1-mg dose of Novo’s semaglutide.

Across three tirzepatide doses, Lilly saw reductions in A1C, a measure of blood sugar, ranging from 2.09% to 2.46%. A1C at baseline was 8.28%. Participants on 1 mg of semaglutide experienced a drop of 1.86% in A1C.

The pattern of dose-dependent tirzepatide results, all of which beat semaglutide, was seen across the other endpoints. The proportion of patients with A1C of 5.7% or below, the threshold of normal, in the tirzepatide arms ranged from 29.3% to 50.9%, compared to 19.7% in the semaglutide cohort.

Analysts praised the data. The team at Evercore said the data look very good, while analysts at Jefferies said the competitive pressure on Novo is set to rise.

Lilly also linked tirzepatide to significant reductions in body weight. Participants on the highest, 15-mg dose of tirzepatide lost 12.4 kg, which works out to a 13.1% decline from baseline. Subjects on semaglutide lost 6.2 kg.

The weight endpoint is a clear win for tirzepatide over 1 mg of semaglutide. However, Novo recently linked once-weekly dosing with 2.4 mg of semaglutide to a 14.9% reduction in body weight by Week 68. The Novo trial tracked patients for longer, and cross-trial comparisons can be unreliable, but the available data suggest the higher dose of semaglutide may provide a tougher test for tirzepatide.

Semaglutide appears to have a tolerability edge over tirzepatide, too. In the tirzepatide arms, 5.1% to 7.9% of participants stopped treatment due to adverse events. The dropout rate in the semaglutide cohort was 3.8%. Lilly sees value in all three doses of tirzepatide. Some patients could stick to a lower dose to sacrifice some efficacy to manage tolerability while others escalate to 10 mg and 15 mg. 

More data on tirzepatide are coming. Lilly has delivered top-line results from four of its seven phase 3 tirzepatide trials in recent months. The ongoing studies include a mammoth study Lilly initiated last year to assess the effect of tirzepatide on cardiovascular outcomes in patients with Type 2 diabetes. 

https://www.fiercebiotech.com/biotech/lilly-s-tirzepatide-beats-novo-s-semaglutide-diabetes-phase-3-but-another-study-muddies

What does it take to supply COVID-19 vaccines across the globe?

 As COVID-19 gained steam worldwide last spring, little was known about the disease and the havoc it would wreak on the world. A year later, vaccines offer hope in the global fight against the virus, but it will be a monumental task to produce them and deliver them around the planet.

That these vaccines were invented, put through clinical testing and either have been rolled out or are nearing distribution is an accomplishment in itself, but the work is really just starting. The companies leading the charge aim to produce billions of doses to vaccinate the world's population, and encouraging real-world data from the ongoing rollouts are showing why it's such an important effort.

Meanwhile, as variants spread and experts weigh the need for boosters, more production capacity will be all the more important in 2021 and beyond.

Here, we outline the supply chains established by the five leading vaccine players and their partners over the last year.

Pfizer 

Pfizer became the first vaccine maker to earn an FDA emergency use authorization in late 2020, and, now, its BioNTech-partnered shot is in the early stages of a worldwide rollout.

Pfizer and BioNTech aim to produce 2 billion doses of the vaccine in 2021, most of which will come from facilities owned by those companies. Aside from their own efforts to set up manufacturing capacity, Pfizer and BioNTech have partnered with at least 10 other companies that are helping the company scale up, including global pharma giants Novartis and Sanofi.  

For the U.S. supply chain, Pfizer’s manufacturing process starts in St. Louis, where the company makes raw materials for the vaccine antigen. There, the company produces plasmid DNA, or the template required to produce mRNA vaccines, by using a cell culture process.  

Pfizer uses its site in Andover, Massachusetts, to produce the mRNA drug substance. The substance is purified before being shipped to Kalamazoo, Michigan, where Pfizer completes the manufacturing process for stateside distribution. At the Michigan facility, the company combines mRNA drug substance and other materials to create bulk vaccine, which is then transferred to a filling line to be put into vials and capped. The vials are then inspected, labeled and packaged for shipping.

In Europe, Pfizer’s site in Puurs, Belgium, receives ingredients for the formulation process from BioNTech and other manufacturing partners. Through numerous steps, the team there creates formulated bulk vaccine and then transports it to the filling area to fill vials. Those vials are packaged into boxes that each fit around 200 units, which are then moved into the facility’s “freezer farm.”  

To prepare for shipping, the company adds dry ice and a GPS temperature monitor to the crates. 

Pfizer's partner BioNTech is handling the drug substance production for Europe and the rest of the country at a site in Mainz, Germany. It has also hired a contract manufacturer to purify the substance at another site in Rentschler, Germany. Two BioNTech contract manufacturers, DermaPharm in Germany and Polymun in Austria, are chipping in by manufacturing formulated lipid nanoparticle bulk.

As it was preparing for the scale-up, BioNTech purchased a former Novartis site in Marburg, Germany. The company has started production at the plant, where annual capacity is expected to be 750 million doses at peak.  

Meanwhile, after Sanofi suffered a setback with its vaccine program, it teamed up with Pfizer and BioNTech to produce 100 million doses of that mRNA vaccine for the European market in 2021. The first batches will be delivered from Sanofi’s site in Frankfurt, Germany, by August. Sanofi still aims to advance its own vaccine candidates. 

Novartis, which isn’t involved in COVID-19 vaccine research, has also offered to assist Pfizer and BioNTech with fill and finishing work. The Swiss pharma giant plans to receive bulk mRNA active ingredient from BioNTech at its site in Stein, Switzerland. Novartis will then fill vials and prepare them for shipment back to BioNTech for worldwide distribution. The work will begin in the second quarter, and deliveries from the site are slated to start in the third quarter. 

AstraZeneca

British Big Pharma AstraZeneca has set the hefty goal of delivering up to 3 billion doses of its University of Oxford-partnered adenovirus shot globally by year-end. To see that quest through, it has locked up production capacity across 15 countries spanning 25 separate manufacturing sites.

Vaccine produced from AZ’s supply chains is typically country- or region-specific, with the drugmaker prioritizing local manufacturing “wherever possible,” Ruud Dobber, Ph.D., executive vice president and president of AZ’s biopharmaceuticals business, said (PDF) in a testimony planned for a recent hearing before the House Energy and Commerce Committee's oversight arm.

In the U.S., CDMO Emergent BioSolutions has snared a total of $261 million from AZ to crank out drug substance for the vaccine at its Baltimore Bayview facility, while Catalent produces viral vectors at its gene therapy facility in Harmans, Maryland. Catalent is also handling fill-finish services at the Anagni, Italy, facility it picked up from Bristol Myers Squibb early last year.

Meanwhile, AZ is also handling filling and packaging at its own facility in West Chester, Ohio, Dobber said in his testimony

In Europe, AstraZeneca has tapped Halix and Novasep for shot production in the Netherlands and Belgium, respectively, and has teamed up with CDMO IDT Biologika for fill-finish services in Germany. AstraZeneca and IDT recently said they were looking at ways to hustle delivery of finished doses to Europe by the second quarter of 2021. And the companies are plotting combined investments to upgrade capacity at IDT’s Dessau, Germany, plant. The project, expected to wrap by the end of next year, will boost capacity in Dessau to the tune of “tens of millions” of vaccine doses per month, the companies said.

AstraZeneca’s complex supply chain has cast a shadow over its vaccine rollout in Europe, which is now set to receive some 40 million doses in the first quarter, down from the 80 million it originally expected.

AstraZeneca tied that shortfall to reduced manufacturing yields at a former Novasep plant in Seneffe, Belgium, which Thermo Fisher recently took over in its $878.2 million buyout of the company’s viral vector manufacturing business. While production capacity there has “drastically” increased, according to EU industry commissioner Thierry Breton, AstraZeneca’s heated—and often public—beef with the EU has prompted the 27-member bloc to seek supplies beyond its own borders.

Early in the kerfuffle, the EU urged AstraZeneca to divert doses from the U.K., where vaccination efforts are running more smoothly. But CEO Pascal Soriot told the Italian newspaper la Repubblica it owed the U.K. first, since the country had placed its order three months before the EU. That extra time also gave the company a runway to work through potential manufacturing issues in that supply chain, Soriot added.

AstraZeneca recently offered to tap facilities outside the EU to supply doses there, with one EU official pegging its Indian partner, the Serum Institute of India, as a potential source, according to Reuters. But about a week later, Serum Institute CEO Adar Poonawalla said his company had been told to focus on domestic doses first.

Now AstraZeneca has flagged potential problems with its second-quarter deliveries to the EU, but it’s drawn up a plan to bring in doses from abroad. AZ will source about half of its 180-million-dose order from its European operations, “while the remainder would come from its international supply network,” a company spokesperson told Fierce Pharma.

Last June, AZ tapped Serum Institute to supply 1 billion doses for other countries. As with Novavax, WHO’s Covax facility is on the hook to distribute those doses outside of India.

Russian drugmaker R-Pharm is also producing the shot on license from AZ, which it will export to markets in the Commonwealth of Independent States—a nine-country economic group comprised of Russia and post-soviet Republics, the Middle East and the Balkans.

Meanwhile, AZ has penned licensing deals with the Oswaldo Cruz Foundation, also known as Fiocruz, in Brazil and BioKangtai in China, while Mexico and Argentina have pledged to make between 150 and 250 million doses of the vaccine for Latin American countries starting in the first half of 2021.

Moderna 

Like other companies involved in the COVID-19 race, Moderna—which had the second mRNA vaccine to win a U.S. authorization after Pfizer—spent nearly a year getting ready for its global rollout. The company has enlisted five partners so far in the global manufacturing and distribution push, aiming to deliver more than 2 billion doses over the next 2 years.

As Moderna's vaccine, mRNA-1273, progressed through early stages of testing last year, the company entered a worldwide, 10-year collaboration with Switzerland’s Lonza to help scale up the program and others that could follow. Soon after, the biotech entered a fill-finish partnership with Catalent to help deliver on the U.S.’ big supply order of 100 million doses. That pact sought to utilize a Catalent site in Indiana. And since that original U.S. order, government officials have tripled down on the shot, scooping up a total commitment of 300 million doses.

The "vast majority of the U.S. production will be done in Massachusetts," Moderna co-founder Noubar Afeyan told Boston-based GBH News. In 2018, the company opened a 200,000-square-foot site in Norwood, Massachusetts. Lonza sites in New Hampshire and Switzerland are also helping produce vaccines, Fast Company reported

In December, the shot scored its FDA authorization and the U.S. rollout got underway. So far, Moderna has shipped 60 million doses worldwide. Most of those have gone to the U.S. Overseas, the supply chain is "in the process of ramping up," Moderna said in late February.

A month after inking its Catalent deal in the U.S., Moderna brought on Spain’s Rovi to complete fill--finish tasks for doses destined to be shipped outside the U.S. That deal incorporates Rovi's site in Madrid.

In an effort to further bolster its ex-U.S. supply chain, Moderna in late 2020 enlisted Swedish CDMO Recipharm for a separate fill-finish partnership on doses destined for ex-U.S. markets. That work will take place at a Recipharm site in France. 

Lastly, in early 2021, Moderna partnered with global logistics company Kuehne+Nagel to support deliveries to countries in Europe, Asia, Middle East and Africa, and parts of the Americas. The doses will come from Moderna’s international supply chain, which Kuehne+Nagel said is based in Europe. 

During its most recent supply update, Moderna bumped up its “base case” for 2021 production to 700 million doses, up from an initial estimate of 500 million doses. The company aims to make up to 1 billion doses of its mRNA-1273 in 2021 and 1.4 billion doses in 2022. Already, Moderna has booked $18 billion in supply orders for 2021, and it’s in the process of negotiating more deals for this year and next. 

Moderna's 1.4 billion-dose estimate for 2022 is based on the assumption that boosters will require a 100-μg dose. The company is testing various booster doses, and if boosters require less than 100-μg, the company could potentially turn out more than 2 billion doses next year, CEO Stephane Bancel said in a statement.

Johnson & Johnson 

Johnson & Johnson’s vaccine just scored an FDA authorization, its first worldwide, and now officials in the U.S. and elsewhere are eager to get it into distribution. The company aims to produce 1 billion doses in 2021 and has brought on numerous partners to help with the scale-up. Just this week, the company enlisted global vaccine player Merck in its ambitious supply push.

J&J’s vaccine is made in several stages, starting with the creation of drug substance by growing cells in a controlled environment. The material is then taken to production sites that convert the raw substance into large batches of vaccines. Lastly, fill-finish sites fill and package vials for final distribution. 

Johnson & Johnson has enlisted several partners in its global vaccine supply chain. (J&J)

In addition to using its relatively new vaccine production site in Leiden, the Netherlands, J&J has brought on partners for to help in various stages of the process, both in the U.S. and around the world. 

In the U.S., the company has partnered with Emergent BioSolutions to produce the initial substance, as well as Catalent and Grand River Aseptic Manufacturing to assist with vaccine production and fill-finish services. Emergent has also partnered with AstraZeneca in the U.S.

In Europe, the company is working with Catalent and Reig Jofre on vaccine production and fill-finish services. Catalent will use a site in Italy, while Reig Jofre's facility is located in Spain. J&J’s Leiden site is handling the initial step of making drug substance in Europe.

Global vaccine players are also getting involved to help boost supply of the one-dose shot. In February, J&J inked a vaccine manufacturing deal with fellow biopharma giant Sanofi. Under that agreement, Sanofi will provide J&J access to its vaccine production site in Marcy l’Etoile, France, where workers will formulate vaccines and fill vials. The work is expected to start in the third quarter of this year, and Sanofi's facility will turn out around 12 million doses per month.

In March, J&J unveiled the Merck collaboration after that company bowed out of the vaccine race.

Elsewhere, in India, J&J has partnered with Biological E on all three phases of the manufacturing process. Biological E plans to make 600 million doses of the J&J shot, Reuters reported in February. And in South Africa, J&J has enlisted Aspen Pharmacare to tackle drug product and fill-finish services. 

“Due to the global interconnectivity of our production and supply chain processes, one batch of the J&J COVID-19 vaccine will likely visit multiple countries through the course of various manufacturing stages in its journey from drug substance to a finished vial for injection,” the company says. 

At a Congressional hearing in late February, a J&J exec said the company is in good shape to deliver 20 million doses of its vaccine to the U.S. by the end of March, and 100 million in total by the end of June. With help from its partners, J&J is aiming to produce 1 billion doses this year. 

J&J is still looking to boost available supplies, though. In a Bloomberg interview after the FDA authorization, CEO Alex Gorsky said the company was "leaving no stone unturned" in its push to deliver more doses.

Novavax

Novavax, which expects to hit annual capacity of at least 2 billion doses this year, cranks out its phase 3 candidate NVX-CoV2373 at its own facilities in Maryland, Sweden and the Czech Republic. For now, product made in the U.S. will remain stateside, while the company’s ex-U.S. operations will fill the rest of the world’s orders, a Novavax spokesperson said via email.

The company has signed on Japanese contract development and manufacturing organization AGC Biologics to scale up and produce the Matrix-M adjuvant for its shot at facilities in the U.S. and Denmark, while Polypeptide Group is on deck to make two key intermediaries for the vaccine component at American and Swedish sites. Novavax also cranks out the adjuvant at its plant in Uppsala, Sweden.

Novavax has never scored a vaccine authorization in its three-decade history, but it appears poised to change that in 2021. CEO Stanley Erck told CNBC this week his company is eyeing a potential FDA authorization in May.

Another partner, Fujfilm Diosynth, is handling antigen production at sites in Texas, North Carolina and the U.K. Elsewhere, Biofabri is making the component in Spain, while Serum Institute of India is helping in India, SK Bioscience in Korea and Takeda in Japan. Novavax also does this work itself at its plant in the Czech Republic, which it snared in its $167 million buyout of local manufacturer Praha Vaccines last May.

Serum Institute of India and Takeda also have licenses to deploy Novavax’s shot in India and Japan, respectively, while Serum Institute has pledged to manufacture doses of NVX-CoV2373 for the World Health Organization’s equitable vaccine distribution effort Covax, which the facility itself will distribute outside India.

Novavax earlier this month revealed a memorandum of understanding with Gavi, the Vaccine Alliance, to supply 1.1 billion doses of its shot to Covax, which aims to distribute some 2 billion COVID-19 vaccine doses to low- and middle-income countries this year.

The final fill-finish step of Novavax’s production process will be managed by Par Pharma and Jubilant in the U.S., with Baxter and Siegfried wrapping up doses in Germany and Switzerland, respectively.

Novavax last summer bagged a massive $1.6 billion Operation Warp Speed deal to support late-stage vaccine testing and production, pledging a minimum of 100 million doses to the U.S. Earlier this month, Reuters, citing two unnamed EU officials, reported the company was homing in on a supply deal with the EU to provide an initial 100 million doses, with the option to sell 100 million more in the future.

https://www.fiercepharma.com/special-reports/vaccine-supply-chains-holding-line-against-covid-19

EU says no talks under way to buy Russia's COVID-19 vaccine

 The European Commission said on Thursday that there were no talks under way about buying Russia’s Sputnik V coronavirus vaccine, hours after the EU drugs regulator began reviewing the shot for possible approval.

The 27-nation bloc has so far signed supply contracts with six European and U.S. vaccine makers for a total of nearly 2.6 billion doses for its population of 450 million. It is also negotiating further supplies from two other Western companies.

“Currently no talks are ongoing to integrate the Sputnik vaccine in the portfolio,” a Commission spokesman told a news conference.

The European Medicines Agency (EMA) said it had begun a rolling review of Russia’s Sputnik V vaccine, which could lead to its approval for use in all 27 EU countries.

Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic - and EU officials have said Brussels could start negotiations with a vaccine maker if at least four member countries request it.

“Just because a vaccine is approved at European level, following positive assessment by the EMA, it does not mean there is any obligation for the Commission to include it in our portfolio,” a second spokesman for the Commission said.

EU officials have said that Sputnik’s manufacturing plants need to be assessed, and that it is not clear how many doses they can produce in the short term.

“At this stage there is still a very solid view (among EU member states) that we are not going to push inoculations of stuff that hasn’t been approved by EMA,” a senior member-state diplomat said.

“There are liability issues ... behind that, and there’s a degree of recklessness which the majority will not countenance.”

National emergency approvals are allowed under EU rules, but expose countries to liability risks if something goes wrong with a vaccine, whereas an EMA authorisation offers more legal protection.

One official said there had been preliminary discussions among EU members about whether to hold talks with the Russian vaccine’s developers, but nothing concrete had been put on the table.

EU countries are free to buy vaccines that have not been earmarked by the EU as a whole, but are advised to refrain from parallel talks and deals if the EU is negotiating a joint purchase.

https://www.reuters.com/article/us-health-coronavirus-eu-russia/eu-says-no-talks-under-way-to-buy-russias-covid-19-vaccine-idUSKBN2AW1B7

Obamacare would get a big (and quiet) overhaul in the Covid relief bill

 The $1.9 trillion coronavirus relief package that passed the House on Saturday would make one of the biggest changes to the Affordable Care Act in over a decade, and it could set the stage for a broader overhaul of the health care program — but don't be surprised if you haven't heard much about it.

The reforms, which would include temporarily expanding subsidies to purchase insurance and making them available to people of all incomes for the first time, have gotten little attention from either party.

For Democrats, who spent last year debating whether to move to a single-payer system, the more minor changes are uncontroversial and are therefore discussed less than other features of the bill.

Republicans, who have increasingly downplayed their opposition to the ACA, otherwise known as Obamacare, have made little mention of them in messaging against the bill.

And industry groups, which spent tens of millions of dollars on ads and lobbying campaigns against previous Democratic health care proposals, are largely supportive this time.

"These ACA changes have really flown under the radar and not attracted major opposition from Republicans," said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, a nonprofit health policy research organization.

The biggest ACA-related item in the American Rescue Plan, which the House passed last week, would address one of the most persistent complaints about the law among customers and political opponents alike: sky-high premiums for people who don't qualify for federal tax credits to help pay them.

The tax credits can go a long way for those who qualify — in many cases, it's possible to find a plan with zero premiums. But everyone making more than 400 percent of the federal poverty line ($51,520 for an individual) falls off a "subsidy cliff" and has to pay full price. Premiums vary widely depending on local health care costs, and plans often are so expensive that customers forgo insurance.

For the next two years, the American Rescue Plan would expand the tax credits to higher earners and cap the maximum premium anyone is expected to pay at 8.5 percent of their income. It would boost tax credits at lower incomes, as well: People making less than 150 percent of the federal poverty line ($19,320 for an individual) would be expected to pay $0 in premiums for a benchmark plan, for example.

For those with lower incomes, the bill would boost incentives for states to expand Medicaid by having the federal government pick up the tab for new recipients. Twelvestates, including Florida, Georgia and Texas, have refused to accept Medicaid dollars through the ACA. It's unclear whether the bill would affect their calculations.

The changes, which would be temporary, closely mirror Joe Biden's health care agenda from the presidential campaign, and Democrats are expected to try to make them permanent down the line.

But they also are low-hanging fruit politically. Unlike with other health care reforms, there are few obvious "losers" beyond fiscal hawks worried about adding to the deficit. The U.S. Chamber of Commerce and top lobbying groups representing insurers, hospitals and doctors have all endorsed the measures, which would pump more money into the system without asking them to cut costs or pay new taxes.

"The industry has been generally supportive of the ACA coverage provisions in the covid relief bill," Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University, said in an email.

Brian Blase, a National Economic Council member in the Trump administration, described the overall Democratic approach as "talk about how evil health insurance companies are but continue to funnel them money."

The nonpartisan Congressional Budget Office estimates that the added subsidies would cost $34 billion and that they would insure 1.3 million more people by next year. Blase said that if the subsidies are extended permanently, they could cost the government significantly more by encouraging smaller businesses to offload their workers onto the ACA exchanges.

While some conservative policy thinkers like Blase have criticized the proposal over its cost, congressional Republicans seem less sure how to message against it. House Minority Leader Kevin McCarthy of California never brought it up in his floor speech opposing the relief legislation, focusing instead on other elements of the $1.9 trillion bill.

Many Republicans faced attack ads in 2018 and 2020 for their opposition to the ACA, and the party has largely pivoted to attacking "Medicare for All" instead, even as the Supreme Court considers a Republican-led lawsuit to overturn Obamacare.

But the detente among Democrats, Republicans and big business may not last long.

Democrats are already discussing creating a public insurance option that would compete with private insurers in a future bill. There's also a push to allow some older Americans to buy into traditional Medicare.


Past public option frameworks have called for reimbursing doctors and hospitals at rates tied to Medicare, which tend to be much lower than what private insurance pays. Proponents argue that that would pressure insurers and providers alike to lower prices. Polls have long found broad bipartisan support for the idea, and Biden has called for both a public option and lowering the Medicare age to 60.

But moving more Americans to government plans is likely to mean less money for doctors, hospitals and specialists. While some proposed versions would adjust rates upward somewhat to ease the transition, a coalition of health care industry groups spent big on ads opposing a public option last year and would be likely to do the same again. Republicans, who have shown little enthusiasm for the idea, would be sure to follow suit.

"The health care industry would fight a public option with everything they have," Levitt said.

https://www.nbcnews.com/politics/congress/obamacare-would-get-big-quiet-overhaul-covid-relief-bill-n1259343