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Health

Executives with Pfizer, Moderna say they’re ramping up vaccine supplies

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Executives with Pfizer and Moderna said the companies are ramping up their supply of coronavirus vaccines, with shipments expected to double and possibly triple in the coming weeks, according to congressional testimony released Monday.

In a prepared statement to be made before a House subcommittee Tuesday, John Young, Pfizer’s chief business officer, is expected to say the company plans to increase its delivery capacity of 4 million to 5 million doses a week to more than 13 million by mid-March.

Moderna expects to double its monthly delivery capacity to 40 million doses by April, according to Dr. Stephen Hoge, the company’s president. Moderna has so far delivered 45 million doses, Hoge’s testimony says.

Young attributed the increased supply to “significant investments” Pfizer made in several manufacturing sites and other improvements.

The U.S. surpassed 500,000 coronavirus deaths, and questions about equity in vaccine distribution persist. The Biden administration said this month that it was ramping up supplies to low-income communities and people of color who have been hit hard by the virus.

The Food and Drug Administration authorized emergency use of the vaccines, which use mRNA and are more than 90 percent effective after two doses, last year.

Tim Stelloh is a reporter for NBC News based in California.

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US

Dominion Sues MyPillow, CEO Mike Lindell Over Election Claims

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WASHINGTON—One of the largest makers of voting machines in the U.S. on Monday sued a prominent supporter of former President Donald Trump, alleging that the businessman had defamed the company with false accusations that it had rigged the 2020 election for Joe Biden.

Dominion Voting Systems sued Mike Lindell, chief executive of Minnesota-based MyPillow Inc., and his company in the U.S. District Court for the District of Columbia, seeking more than $1.3 billion in damages.

In its complaint, the company cites a number of statements made by Mr. Lindell, including in media appearances, social-media posts, and a two-hour film claiming to prove widespread election fraud. Mr. Lindell said he helped produce the film, which he released online in early February.

The complaint alleges that Mr. Lindell made false claims about the integrity of Dominion’s voting machines and that he knew no credible evidence supported his claims that the company had stolen the election from Mr. Trump—what Dominion has called the “Big Lie.”

“He is well aware of the independent audits and paper ballot recounts conclusively disproving the Big Lie,” the complaint states. “But Lindell…sells the lie to this day because the lie sells pillows.”

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US

‘Longest week of our lives’: Texas food banks in crisis as storm disrupts supplies | Texas

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Food banks in Texas have gone into disaster mode as they ramp up operations to tackle a surge in hunger after unprecedented freezing conditions disrupted almost every part of the food supply chain in the state.

Grocery stores are empty, school meal programs suspended, and deliveries disrupted by untreated treacherous roads that have left millions of Texans trapped in precarious living conditions with dwindling food supplies.

Even those who did stockpile before the Arctic conditions swept in have lost refrigerated groceries due to lengthy power cuts and cannot cook what food they do have without electricity or gas.

In the worst-affected areas, food banks and pantries were forced to close for several days this week as it was impossible for staff and vehicles to get to the distribution sites. Relief was limited to disaster boxes sent to people seeking refuge in warming shelters.

On Thursday, the disruption to energy and safe water supplies had food banks scrambling to procure large quantities of bottled water and ready meals and snacks that do not require cooking.

“This is a disaster. We are doing rapid needs assessments so we can get appropriate food to those people quickly. When everything thaws, we’re preparing for a massive spike in demand,” said Valerie Hawthorne, director of government relations at the North Texas Food Bank, based in Dallas. “This has been the longest week of all our lives.”

A woman carries bottled water she received from a warming center and shelter in Galveston. Photograph: Adrees Latif/Reuters

Before the big freeze, this food bank ran two drive-through food distribution sites every day, serving between 300 and 1,500 families at each pop-up location. This week they were all were cancelled, though one is planned for Saturday, leaving thousands of families without enough food or reliant on relatives, neighbors, and mutual aid groups.

In addition to the regulars, advocates expect a rise in low-paid service industry workers – who are often just one or two paychecks away from hunger and will not be paid this week as many restaurants and bars were forced to close.

Hunger was a serious problem in Texas even before the pandemic and the latest weather disaster, with about 4.3 million Texans struggling with hunger in 2019, including one in every five children.

Covid triggered an economic crisis that led to a demand for food aid doubling in many parts of Texas amid record unemployment and underemployment levels.

The extraordinary freeze has once again exposed existing deep inequalities that will make it much harder for low-income households to recover, according to Brian Greene, CEO of the Houston Food Bank. “The aftermath of every disaster is much harder on low-income families, who are going to be in more trouble even after the power and water comes back on,” he said.

Almost two-fifths of Americans do not have enough cash or savings to cope with an unexpected $400 expense such as burst pipes or a collapsed roof, according to research by the Federal Reserve,

Empty shelves are seen at a store in Austin. Photograph: Kolby Lee/Reuters

In rural Brazoria county, south of Houston, the pantry reopened on Thursday and served 140 families in just two hours – compared with 170 families usually seen over the course of an ordinary week. About 75% were first-timers desperate for food and water and were given enough for three days, as that’s all the pantry had available.

“It’s crazy. People are out of options. They’ve gone into survival mode to get what they can,” said Terri Willis, executive director of the Brazoria County Dream Center, which operates the pantry. “We are all in disaster mode.”

Long lines extend outside grocery stores with empty shelves, and water supplies have been disrupted by boil advisories and burst pipes; electricity is needed for those in rural areas with private wells.

Willis is particularly concerned about the district’s vulnerable children, as her organization usually provides a backpack of weekend meals for 620 kids who would otherwise go hungry. The schools are closed, so those children will go without. “It’s heart-wrenching. I’ve been one of those kids who goes hungry over the weekend. I’m praying that their parents can get here,” Willis said.

In Dallas, youngsters are also a huge concern: citywide, 87% of school children live in low-income households. Thousands depend on free school meals, with some receiving four meals a day – breakfast, lunch, a snack and dinner – but many schools were unable to offer any this week due to power cuts, burst pipes, water advisories and shortages.

Advocates are also worried about the city’s senior residents who rely on food aid to get enough to eat and may have been cut off from all services for several days. “It’s the elderly that have kept most of us up this week. They truly are the most vulnerable population, and we just don’t know how many have been unable to ask for help,” said Hawthorne.

At the other end of the food chain, fruit and vegetable crops in the Rio Grande Valley have been ruined by the extreme cold, while dairy farmers across the state are pouring millions of dollars of milk down the drain because they cannot get it to dairies. The drop in production could have short- and medium-term consequences on availability and prices.

Scientists have long warned that global heating is causing extreme weather events to become more frequent and intense – and to strike in places unaccustomed to and ill-equipped to deal with extreme heat or freezing temperatures.

The disruption to food supplies in Texas shows how poorly prepared the US is to deal with the climate crisis, according to Molly Anderson, director of the food studies program at Middlebury College in Vermont.

“What we see in Texas demonstrates a lack of planning for resilience and a failure to recognize that climate weirding is here and that it’s already impacting the food chain,” she said.

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Business

Why it’s hard to make vaccines and boost supplies

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With demand for COVID-19 vaccines outpacing the world’s supplies, a frustrated public and policymakers want to know: How can we get more? A lot more. Right away.

The problem: “It’s not like adding more water to the soup,” said vaccine specialist Maria Elena Bottazzi of Baylor College of Medicine.

Makers of COVID-19 vaccines need everything to go right as they scale up production to hundreds of millions of doses — and any little hiccup could cause a delay. Some of their ingredients have never before been produced at the sheer volume needed.

And seemingly simple suggestions that other factories switch to brewing new kinds of vaccines can’t happen overnight. Just this week, French drugmaker Sanofi took the unusual step of announcing it would help bottle and package some vaccine produced by competitor Pfizer and its German partner BioNTech. But those doses won’t start arriving until summer — and Sanofi has the space in a factory in Germany only because its own vaccine is delayed, bad news for the world’s overall supply.

“We think, well, OK, it’s like men’s shirts, right, I’ll just have another place to make it,” said Dr. Paul Offit of Children’s Hospital of Philadelphia, a vaccine adviser to the U.S. government. “It’s just not that easy.”

DIFFERENT VACCINES, DIFFERENT RECIPES

The multiple types of COVID-19 vaccines being used in different countries all train the body to recognize the new coronavirus, mostly the spike protein that coats it. But they require different technologies, raw materials, equipment and expertise to do so.

The two vaccines authorized in the U.S so far, from Pfizer and Moderna, are made by putting a piece of genetic code called mRNA — the instructions for that spike protein — inside a little ball of fat.

Making small amounts of mRNA in a research lab is easy but “prior to this, nobody made a billion doses or 100 million or even a million doses of mRNA,” said Dr. Drew Weissman of the University of Pennsylvania, who helped pioneer mRNA technology.

Scaling up doesn’t just mean multiplying ingredients to fit a bigger vat. Creating mRNA involves a chemical reaction between genetic building blocks and enzymes, and Weissman said the enzymes don’t work as efficiently in larger volumes.

AstraZeneca’s vaccine, already used in Britain and several other countries, and one expected soon from Johnson & Johnson, are made with a cold virus that sneaks the spike protein gene into the body. It’s a very different form of manufacturing: living cells in giant bioreactors grow that cold virus, which is extracted and purified.

“If the cells get old or tired or start changing, you might get less,” Weissman said. “There’s a lot more variability and a lot more things you have to check.”

An old-fashioned variety — “inactivated” vaccines like one made by China’s Sinovac — require even more steps and stiffer biosecurity because they’re made with killed coronavirus.

One thing all vaccines have in common: They must be made under strict rules that require specially inspected facilities and frequent testing of each step, a time-consuming necessity to be confident in the quality of each batch.

WHAT ABOUT THE SUPPLY CHAIN?

Production depends on enough raw materials. Pfizer and Moderna insist they have reliable suppliers.

Even so, a U.S. government spokesman said logistics experts are working directly with vaccine makers to anticipate and solve any bottlenecks that arise.

Moderna CEO Stephane Bancel acknowledges that challenges remain.

With shifts running 24/7, if on any given day “there’s one raw material missing, we cannot start making products and that capacity will be lost forever because we cannot make it up,” he recently told investors.

Pfizer has temporarily slowed deliveries in Europe for several weeks, so it could upgrade its factory in Belgium to handle more production.

And sometimes the batches fall short. AstraZeneca told an outraged European Union that it, too, will deliver fewer doses than originally promised right away. The reason cited: Lower than expected “yields,” or output, at some European manufacturing sites.

More than in other industries, when brewing with biological ingredients, “there are things that can go wrong and will go wrong,” said Norman Baylor, a former Food and Drug Administration vaccine chief who called yield variability common.

HOW MUCH IS ON THE WAY?

That varies by country. Moderna and Pfizer each are on track to deliver 100 million doses to the U.S. by the end of March and another 100 million in the second quarter of the year. Looking even further ahead, President Joe Biden has announced plans to buy still more over the summer, reaching enough to eventually vaccinate 300 million Americans.

Pfizer CEO Albert Bourla told a Bloomberg conference this week that his company will actually wind up providing 120 million doses by the end of March — not by speedier production but because health workers now are allowed to squeeze an extra dose out of every vial.

But getting six doses instead of five requires using specialized syringes, and there are questions about the global supply. A Health and Human Services spokesman said the U.S. is sending kits that include the special syringes with each Pfizer shipment.

Pfizer also said it’s factory upgrade in Belgium is short-term pain for longer-term gain, as the changes will help increase worldwide production to 2 billion doses this year instead of the originally anticipated 1.3 billion.

Moderna likewise recently announced it will be able to supply 600 million doses of vaccine in 2021, up from 500 million, and that it was expanding capacity in hopes of getting to 1 billion.

But possibly the easiest way to get more doses is if other vaccines in the pipeline are proven to work. U.S. data on whether Johnson & Johnson’s one-dose shot protects is expected soon, and another company, Novavax, also is in final-stage testing.

OTHER OPTIONS

For months, the chief vaccine companies lined up “contract manufacturers” in the U.S. and Europe to help them crank out doses and then undergo the final bottling steps. Moderna, for example, is working with Switzerland’s Lonza.

Beyond rich nations, the Serum Institute of India has a contract to manufacture a billion doses of AstraZeneca’s vaccine. It’s the world’s largest vaccine maker and is expected to be a key supplier for developing countries.

But some homegrown efforts to boost supplies appear hobbled. Two Brazilian research institutes plan to make millions of doses of the AstraZeneca and Sinovac vaccines but have been set back by unexplained delays in shipments of key ingredients from China.

And Bottazzi said the world simultaneously has to keep up production of vaccines against polio, measles, meningitis and other diseases that still threaten even in the midst of the pandemic.

Penn’s Weissman urged patience, saying that as each vaccine maker gets more experience, “I think every month they’re going to be making more vaccine than the prior month.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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World

AstraZeneca CEO Pascal Soriot interview on supplies to the EU

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Pascal Soriot, chief executive officer of AstraZeneca.

Simon Dawson | Bloomberg | Getty Images

AstraZeneca’s CEO Pascal Soriot has defended its delayed rollout of the coronavirus vaccine to the EU, saying the drugmaker is “working 24/7” to fix production issues. But he also noted that the EU had ordered three months later than the U.K., however, and this meant it was behind in dealing with supply issues.

The EU has reacted angrily to a delay in AstraZeneca’s supply of coronavirus vaccine, which is expected to be approved by the European medicines regulator by the end of the week, to the bloc.

The 27-member bloc was expecting around 80 million doses of the jab by the end of March, but now will reportedly receive only around 31 million doses. As member states struggle to access vaccine supplies and rollout jabs, the EU has said it could limit exports of Covid-19 vaccines made in the EU.

Speaking to the Italian newspaper La Repubblica, Soriot said that delays in the supply of its coronavirus vaccine were caused by a variety of production issues.

“We believe we’ve sorted out those issues, but we are basically two months behind where we wanted to be,” he said

The British-Swedish drugmaker had also experienced “teething issues like this in the U.K. supply chain,” Soriot noted, but as the U.K. contract was signed three months before the European vaccine deal, the company “had an extra three months to fix all the glitches we experienced.”

However, he said AstraZeneca still planned on delivering a good bulk of the vaccines promised to the EU in February. “But, you know, if we deliver in February what we are planning to deliver, it’s not a small volume. We are planning to deliver millions of doses to Europe, it is not small,” he told the newspaper.

A Brazilian doctor voluntarily receives an injection as part of phase 3 trials of a vaccine developed by the University of Oxford and British pharmaceutical company AstraZeneca, in July 2020.

Nelson Almeida | AFP | Getty Images

Asked what amount the EU could expect to receive, Soriot said that as soon as the vaccine is approved by the European Medicines Agency (EMA), “we will be shipping at least 3 million doses immediately to Europe, then we’ll have another shipment about a week later and then the third or fourth week of February. And the target is to deliver 17 million doses by February.”

“It’s not as good as we would like to, but it’s really it’s not so bad,” he said. Globally, Soriot said production capacity would be 100 million doses from February onward.

Anger in the EU

Talks between AstraZeneca and the EU were held on Monday, after which the EU’s Health Commissioner Stella Kyriakides said that discussions had “resulted in dissatisfaction with the lack of clarity and insufficient explanations.”

The EU has asked AstraZeneca to provide it with a detailed plan of vaccine deliveries and when distribution will take place, with further discussions set for Wednesday.

Some countries, including Italy, have threatened legal action against AstraZeneca for the delay. Others have asked why the U.K., which is heavily reliant on the AstraZeneca jab in its vaccination rollout, has sprinted ahead in its vaccination drive and had not experienced supply shortages, as yet. It has immunized more than 6.8 million people, with at least a first dose of the two-dose vaccine.

Soriot said that the U.K. production plant was more productive, and insisted there was no anti-EU context.

“First of all, we have different plants and they have different yields and different productivity. One of the plants with the highest yield is in the U.K. because it started earlier. It also had its own issues, but we solved them all, it has good productivity, but it’s the U.K. plant because it started earlier.”

“We’re not doing it on purpose. I’m European, I have Europe at heart. Our chairman is Swedish, is European. Our CFO is European. Many people in the management are European. So we want to treat Europe as best we can.”

He noted that the drugmaker had a “best effort” type of agreement with the EU as it had wanted to be supplied at the same time as the U.K., even though it was later to request the vaccine. “We didn’t commit with the EU, by the way. It’s not a commitment we have to Europe: it’s a best effort.”

UK Prime Minister Boris Johnson poses for a photograph with a vial of the AstraZeneca/Oxford University Covid-19 candidate vaccine.

WPA Pool | Getty Images News | Getty Images

Scaling-up and production issues

With a coronavirus vaccine developed, clinically trialed and approved in less than a year, Soriot said it was natural to experience glitches in the scaling-up process.

“We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago, we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems,” he said, adding there were current problems with the production of the vaccine substance in two European plants.

“For Europe, the drug substance is essentially produced in two plants, one in the Netherlands, one in Belgium. The drug product is actually produced in Italy and Germany. So from a drug product viewpoint, we have full capacity. We have zero problem. The current problems have to do with manufacturing the drug’s substance,” he said.

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Business

China Overtakes U.S. as World’s Leading Destination for Foreign Direct Investment

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China overtook the U.S. as the world’s top destination for new foreign direct investment last year, as the Covid-19 pandemic amplifies an eastward shift in the center of gravity of the global economy.

New investments by overseas businesses into the U.S., which for decades held the No. 1 spot, fell 49% in 2020, according to U.N. figures released Sunday, as the country struggled to curb the spread of the new coronavirus and economic output slumped.

China, long ranked No. 2, saw direct investments by foreign companies climb 4%, the United Nations Conference on Trade and Development said. Beijing used strict lockdowns to largely contain Covid-19 after the disease first emerged in a central Chinese city, and China’s gross domestic product grew even as most other major economies contracted last year.

The 2020 investment numbers underline China’s move toward the center of a global economy long dominated by the U.S.—a shift accelerated during the pandemic as China has cemented its position as the world’s factory floor and expanded its share of global trade.

While China attracted more new inflows last year, the total stock of foreign investment in the U.S. remains much larger, reflecting the decades it has spent as the most attractive location for foreign businesses looking to expand outside their home markets.

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Health

Biden’s COVID testing push calls for more supplies and rapid tests

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At-home testing could transform the fight against the novel coronavirus.

USA TODAY

President Joe Biden seeks to reset the nation’s inconsistent coronavirus testing efforts with a $50 billion plan and more federal oversight.

Biden’s plan calls for a newly-created Pandemic Testing Board to coordinate a “clear, unified approach,” to testing for COVID-19, a marked difference from the Trump administration’s policy of states establishing their own plans with federal support.

Laboratories have ramped up production to more than 2 million tests each day, but stubborn problems persist. Some labs still struggle to complete timely tests – particularly when demand surges – due to shortages of critical supplies.

Public health labs largely are not equipped to detect new coronavirus variants such as ones first identified in the United Kingdom and South Africa. And there’s still debate among testing experts on whether wider use of cheaper but less sensitive rapid tests will be the smartest path out of the pandemic.

Biden on Thursday issued a flurry of executive orders, from mask mandates on federal property to reopening schools and accelerating vaccine shipments. Fixing the nation’s disparate testing system “will be the most challenging,” of all, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

Former Centers for Disease Control and Prevention Director Tom Frieden said Biden’s testing initiative fits with his broader, science-based plan to curb a pandemic that’s already killed more than 400,000 Americans.

“This is a really challenging pandemic to deal with,” said Frieden, president and CEO of Resolve to Save Lives, an initiative of Vital Strategies. “Important as executive orders are, they are only the start of a major effort.”

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Calling a national testing strategy the “cornerstone to reducing the spread of COVID,” the Biden’s plan calls for more rapid antigen tests, supplies, lab capacity and genomic sequencing to keep better track of hotspots and new variants.

There’s also tidbits for consumers. One executive order requires federal agencies clarify insurers’ obligation to cover testing, even for people who have no symptoms. For those without health insurance, testing will be free, the order states.

Just as important as a national testing plan is the president’s call for better data reporting and a willingness to level with the American public, Frieden said.  

“President Biden has been very clear: We’re in it together,” he said.  “It’s going to get worse before it gets better. These are all hard truths and important facts that need to be shared and lived. And they have been ignored for a year.”

‘Make a big difference’

The plan calls for federal agencies to use a wartime Defense Production Act to fix persistent shortages of testing and vaccine supplies, as well as protective equipment like gowns, gloves and N95 masks. 

When labs run out of critical supplies such as chemical reagents, plastic tips or swabs, it delays or prevents a lab’s ability to complete a test, said Dr. Patrick Godbey, president of the College of American Pathologists.

Godbey said labs finish tests within hours when all supplies are on hand. But when labs can’t get supplies, some must ship samples to other labs to test, which delays results two days or more.

“I still can’t to do all the tests I’d like to do,” said Godbey,  laboratory director of Southeast Georgia Regional Medical Center in Brunswick. “If we can’t get the reagents necessary, we measure turnaround time in days.”

When testing demand surged this summer in Sunbelt states, labs in communities hard hit by COVID-19 were routinely taking one week or longer to complete results. Supply shortages snarled results at small and large labs alike. 

At home tests?:Companies attempt to make coronavirus tests widely available

Public health labs also have faced persistent shortages in testing materials since the beginning of the pandemic.

“Those are the kinds of situations where having the federal government step in can make a big difference,” said Plescia, of the Association of State and Territorial Health Officials.

Biden’s plans calls for federal agencies to use the Defense Production Act or other “appropriate authorities” to accelerate manufacturing of a dozen types of supplies: N95 masks, gowns, gloves, test swabs, reagents, plastic pipette tips, testing machines, swabs, needles and syringes, rapid test kits and material for rapid antigen tests. The federal government can use the act to compel private companies to make critical supplies for national defense or national emergencies.

“We still have supply-chain issues that we hope this (Biden’s plan) will address,” Godbey said. 

Biden pushes rapid testing

Biden’s push also calls for wider use of rapid tests to complement lab testing in settings such as schools.

Molecular PCR tests processed at labs remain the gold standard of accurate testing, but they are more expensive and results can take days to process. Rapid antigen tests can be performed outside labs and deliver results in 15 minutes.

Under the Trump administration, the U.S. Department of Health and Human Services purchased rapid testing machines for use in nursing homes nationwide. HHS also bought 150 million Abbott BinaxNow portable, rapid tests tests for states, nursing homes, Indian Health Services and Historically Black Colleges and Universities.

Only one rapid test, made by Australia-based Ellume, has gained U.S. Food and Drug Administration authorization for home use without a medical provider’s prescription. Several other companies are developing tests they hope to sell directly to consumers.

The Biden plan will establish a CDC support team to “fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available.”

The rapid tests are typically less sensitive than lab tests, which means they might not detect the virus in some cases. It’s a scenario that concerns lab experts like Godbey.

“I worry about inaccurate testing,” Godbey said. “Bad tests are worse than no tests at all.”

But others argue rapid testing makes sense when done frequently because they are likely to quickly detect when a person is infectious and prone to spread the virus to others.

“Even if the individual test lacks a certain sensitivity, you do that test on a frequent basis, that can really add a great deal of population security,” said Dr. William Schaffner, a Vanderbilt University School of Medicine professor of preventive medicine and an infectious disease doctor.

He said it makes sense to deploy such rapid tests in settings such as schools. If students, teachers and other school employees are tested frequently with rapid tests, parents can gain confidence the school is safe.

“All of the sudden the economy gets stimulated again because the parents can go to work,” Schaffner said. 

Michael Mina, a Harvard epidemiologist who has advocated for rapid antigen tests, said such testing can be quickly deployed. If the Biden administration authorizes the purchase and widespread use of these tests, they can be shipped directly to Americans homes and “we can start seeing cases plummet.”

“If we can do that, we can start to see cases come down dramatically across the country within weeks in a way that vaccines could never do in these first 100 days,” Mina said. 

Contributing: Karen Weintraub

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com

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