Biden signs $137M deal for COVID test factory to start producing 83.3M tests a month in late 2024 | Daily Mail Online

The Biden administration struck a $137 million deal to build a new factory in the U.S. to ramp up production of COVID-19 testing kits – but the new facility won't be completed until late 2024 at the earliest.

MilliporeSigma, a brand formed by Germany’s Merck KGaA, will build a new factory in Sheboygan, Wisconsin, the Defense Department announced as the U.S. hit a high record of 489,267 COVID cases on Wednesday 

While the contract gives the company three years to complete the facility, it is not immediately clear when it will ramp up to full production, which is expected to pump out 83.3 million tests per month.

'Construction is expected to begin the second half of 2022 and initial planning and preparatory work is already underway,' a MilliporeSigma spokesperson told 'We estimate that the facility will be capable of providing lateral flow membranes in the latter part of 2024.'

The individual said that the production of lateral flow membrane is 'critical for rapid diagnostic tests' that will not only help with COVID-19 detection, but also with 'any future public health emergencies.'

The deal has fueled speculation that the administration is predicting high rates of testing capabilities for coronavirus detection will still be needed several years down the line.

Others have pointed out that the deal does not fix any immediate issues rising from testing kit shortages in the U.S., which has led to massive wait times at testing locations across the country.

Hours-long lines continue to build up across the country as Americans scrambled to get tested for COVID-19 amid a massive surge in cases with spread of the Omciron variant and a nationwide shortage of tests

The Biden administration struck a deal, it announced Wednesday, with a German company to build a factory in Wisconsin that will increase capabilities to pump out 83.3 million tests per month – but the facility won't be completed until late 2024 at the earliest

'Worldwide market demand for lateral flow membrane exceeds supply, and there is limited production capacity in the United States,' the spokesperson said. 'The current lack of domestic supply of lateral flow membrane impacts the United States' ability to respond fully to the COVID-19 pandemic and any future public health emergencies.'

'MilliporeSigma's new lateral flow membrane facility will increase domestic supply, help alleviate shortage concerns, and add to the United States' pandemic preparedness and response.'

The Pentagon released a statement Wednesday stating: 'On Dec. 29, 2021, the Department of Defense (DoD), on behalf of and in coordination with the U.S. Department of Health and Human Services, awarded a $136.7 million contract to MilliporeSigma to establish nitrocellulose membrane production capacity in the United States.'

'Nitrocellulose membrane,' according to the statement, 'is a critical material used in manufacturing SARS-CoV-2 rapid point-of-care tests.'

The facility will expand MilliporeSigma's ability to manufacture nitrocellulose at the new facility that will support production of 83.3 million tests per month starting in 2025.

Money for the project is allocated through the $1.9 trillion American Rescue Plan passed by President Joe Biden early in his presidency. It falls under the need to 'support domestic industrial base expansion for critical medical resources.'

'It's probably the most constrained piece of technology in expanding capacity, in making more of these over-the-counter or point-of-care tests,' an official told Reuters. 'This amount they're going to produce is roughly equivalent to another billion over-the-counter tests being able to be made.'

The official said the government is invoking the Defense Production Act (DPA) to award the contract, claiming there are several similar contracts in the works.

Biden has already used the DPA to speed production of swabs and pipettes for COVID-19 test production.

DPA is a 1950s Korean war-era national defense law giving federal agencies the power to prioritize procurement orders in times of war or national emergency.

The MilliporeSigma deal comes as nations face more urgency to produce testing as the highly-contagious Omicron variant spreads throughout the world – leading to some of the biggest-ever spikes in cases in the near two-year pandemic. 

The United States has hit a record of nearly 500,000 daily coronavirus cases Wednesday – the most any country has ever reported – as experts say that the latest surge of infections will only get worse in the next month.

On Wednesday, 489,267 positive COVID cases were reported.

The Centers for Disease Control and Prevention (CDC) reports anywhere from 40 to 70 per cent of new cases in America are from the Omicron variant, which was first discovered last month by South African health officials.

Earlier this month, Biden unveiled a plan to distribute 500 million at-home coronavirus tests, building on a prior pledge to invest $3 billion in the kits.

There are concerns Biden won't be able to deliver on his promise for 500 million tests as it emerged Wednesday contracts for the order won't be finished until early January and the administration is still 'working to finalize' how to distribute the kits.

Bidne's coronavirus response coordinator Jeff Zients said during the Wednesday White House COVID briefing: 'Companies are already submitting information, and we expect the contract to be completed late next week.'

'That means that the first deliveries for manufacturers will start January,' he clarified. 'We'll set up a free and easy system, including a new website to get these tests out to Americans. We're actively working to finalize that distribution mechanism, which includes a website where people will be able to order tests for free. And we'll share more details in the weeks ahead — days and weeks ahead.'

Specific details have been scant about how the at-home test distribution will work and how long it will take for the tests to arrive once ordered. The questions come as long lines of Americans continue to form as people seek to get tested around the holidays. 

Many Americans are forced to wait several hours to be tested for COVID as the U.S. is now averaging 300,387 new COVID cases per day.  

The Omicron variant sweeps the nation, leading to record level of case rates. Every U.S. state is currently listed by the CDC as having a high level of community transmission of COVID, as seen in the above map

Americans are waiting in lines for hours in cities across the country to get their COVID test. Above is one of those lines of cars in Tropical Park in Miami, Florida on Wednesday

The country smashed its previously daily average record of 264,546 cases as the highly-infectious new Omicron variant continued to sweep the nation. 

The sudden spike has prompted warnings from experts that the virus will 'threaten critical infrastructure' in the US with workers at hospitals, grocery stores and gas stations forced into isolation.

Despite Omicron being milder than previous variants the sheer scale of the numbers means that 'there's a big hole' in terms of what the US can expect in terms of deaths, according to Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

'But what we do know and what is emerging here is that this country is going to be in the soup in just the next few weeks with so many cases and so many locations, that we're going to see critical infrastructure as well as health care challenged,' he told CNN

Despite test shortages, case spikes and reimposed restrictions, the travel nightmare will also continue into mid-January as airline staff call out sick with COVID.

At least 1,071 flights were canceled and 1,564 are delayed Thursday as travel chaos drags into a seventh day, according to tracking website FlightAware.

JetBlue announced it has already cut 1,280 flights between December 30 and January 13 because of the coronavirus pandemic.

Staffing shortages caused by COVID infections also led United Airlines to cancel 190 flights on Thursday, Delta said it canceled 86 and JetBlue reported 175 nixed flights.

Some passengers vented their fury on social media saying they were forced to wait on the tarmac for hours before being told to deplane. Others said the wait time at call centers was as long as 102 minutes as phone lines jammed.

Americans are also waiting in droves to be tested for COVID in cities across the country, demanding Biden fulfill his promise to have 500 million COVID at-home tests available  after announcing Wednesday that the contracts for the order won't be finished until 'late next week.'   

Aravindh Shankar, 24, flew to San Jose, California, on Christmas from West Lafayette, Indiana, to be with family. Though he felt fine, he decided to get tested Wednesday just to play it safe, since he had been on an airplane.

He and his family spent almost an entire day searching for a testing appointment for him before he went to a site in a parking lot next to the San Jose airport.

'It was actually surprisingly hard,' Shankar said about trying to find a test. 'Some people have it harder for sure.' 

More cars line up at the Indianapolis Motor Speedway in Indiana to get a COVID test on Wednesday, December 29

People line a street in Washington, D.C. to get a COVID-19 test on Wednesday

President Biden and his staff have pushed back against criticism of the lack of testing kits available during the holiday rush. With demand high and shelves emptying out of stock, some retailers have placed limits on how many at-home testing kits can be purchased at a time. CVS has a limit of six test kits per purchase both in stores and online while Walgreens limits it to four kits.

The administration bragged on Wednesday it has brought two more at-home tests on the market

'The Biden-Harris Administration has brought two new over-the-counter, at-home COVID-19 tests to the U.S. market. The tests, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, have received emergency use authorization (EUA) by the Food and Drug Administration (FDA),' the Department of Health and Human Services noted in a release.

'Combined, it is estimated the companies can produce tens of millions of tests per month for use in the U.S.,' the agency noted.

Again, it remains unclear when these tests will be in the hands of Americans.  

The White House has emphasized officials are working on the problem over the holidays and pushed out the numbers behind their work.

'There are now 20,000 free testing sites across the U.S., four times as many at-home tests available to Americans than were available this summer, and free at-home tests are already being made available at key community sites, such as community health centers and rural clinics,' HHS said.

Biden told reporters on Tuesday he spent the day working the phones and said his administration had made 'a bit of progress' in getting more COVID testing kits distributed but he did not offer details. 

Meanwhile, White House press secretary Jen Psaki downplayed questions about the unsigned contracts to deliver the promised testing kits, calling it a 'part of the process.' 

'We have no concern about the contract being finalized. We're just working to finalize the contracts. We just announced this two days ago. But there's no — we don't see any issue or any halt to getting that done and to finalizing that. That's a natural part of the process,' she said at her press briefing on Thursday.

She also argued that the president has boosted testing capacity and pointed out it wasn't until October that five versions of at-home tests were available.

'The president knew that we needed to increase testing capacity. That's why he used the Defense Production Act to expand the supply of at-home tests. Without that, we wouldn't have the supply in the market,' she said. 

President Biden announced last Tuesday his plan to distribute 500 million at-home  COVID tests.

But he told ABC News the next day that 'I wish I had thought about ordering a half a billion [tests] two months ago, before COVID hit here.' 

The White House, however, has not be able to offer many details on how the tests will be distributed and how many kits households can order.

Psaki said Tuesday there would be a website people can use to order their testing kits.

'We will make the website available as soon as these tests are available. They will start to be available in January,' she said. 'And in terms of the numbers that different families can order: We are working through all those very important details right now.'

But when drilled on details - how long it would take to get a test after one was ordered, how would they be delivered - Psaki had no answers.

'Again, really good questions. And we, of course, want people to be able to rapidly receive the tests and people have certainty to know they can get a test, they can feel safe, go into their workplace, seeing their family members, sending their kids to school. That's our objective. The details of how it will be distributed and the mechanisms will all be coming soon,' she said. 

Despite the surge in people testing positive for the virus, it's highly unlikely that hospitalization numbers will ever rise to their previous peak, said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School Public Health. 

Vaccines and treatments developed since last year have made it easier to curb the spread of the virus and minimize serious effects among people with breakthrough infections.

'Its going to take some time for people to get attuned to the fact that cases don't matter the same way they did in the past,' Adalja said. 'We have a lot of defense against it.'

But even with fewer people hospitalized compared with past surges, the virus can wreak havoc on hospitals and health care workers, he added.

Cases are spiking at rates not ever seen since the start of the pandemic nearly two years ago

Deaths are not proportionally rising with the case rate as medical professionals claim the Omicron variant, while much more contagious, is not as deadly or serious a case of COVID as previous strains

'In a way, those hospitalizations are worse because they're all preventable,' he said.  

Meanwhile, on Tuesday, the Centers for Disease Control and Prevention admitted a serious error in calculating the prevalence of the variant, overblowing the figure recorded in mid-December by as much as 50 percentage points and sowing confusion as the nation breaks records for new cases. 

The agency released a revised chart on Tuesday showing that the new variant accounted for 23 percent of all COVID-19 cases for the week ending on December 18, as opposed to the 73 percent it originally reported.

The chart showed that the Omicron variant accounted for 59 percent of all new cases for the week ending on December 25, meaning the Delta variant has been accounting for far more infections than the agency initially thought, though Omicron is gaining ground quickly. 

Despite the CDC's astonishing error, data from the UK suggest that Omicron will soon account for nearly all new cases in the US.

Jeff Zients said on Wednesday the contracts for 500 million tests promised by Joe Biden will only be finalized 'late next week' - above Zients is seen with President Joe Biden at Monday's virtual meeting with governors

In England, which is several weeks ahead of the US in the Omicron wave, the new variant went from zero to 92 percent of all new cases in the four weeks leading up to December 27, according to data from the UK Health Security Agency.

The CDC corrected its error, to the confusion of many, on the same day that the nation broke its record for the most daily COVID-19 cases. On Monday, 512,553 new cases were reported in the US, marking the country's largest single-day tally since the beginning of the pandemic. The record-breaking figure was in part the product of a multi-day build up of unreported cases over the Christmas holiday on Saturday, which finally were logged to start the week.

Anthony Fauci again echoed on Wednesday that he 'strongly recommends' against going to large New Year's Eve gatherings this year as the highly contagious Omicron variant causes massive case surges nationwide.

'If your plans are to go to a 40 to 50-person New Year's Eve party with all the bells and whistles and everybody hugging and kissing,' Fauci said during the White House COVID-19 Response Team briefing, 'I would strongly recommend that this year, we do not do that.'

He claimed that smaller gatherings with everyone fully vaccinated and boosted against coronavirus is low risk, despite the massive number of breakthrough cases with the Omicron variant's emergence.

The nation's top infectious disease expert also had a sobering message on Wednesday – COVID likely isn't ever going away. 

'We're never going to stop counting, tests – but we're looking forward, as everyone I think feels is appropriate, that ultimately we're going to have to live with something that will not be eradicated and very likely would not be eliminated,' he said.

Meanwhile, CDC Director Rochelle Walensky, in a round of television interviews on Wednesday morning, said she was watching the nation's case load and its potential impact on health care providers.

Biden says he WILL issue domestic flight vaccine mandate IF his medical team advises it - one day after Fauci flip flopped on his support for one 

Joe Biden fueled confusion on Tuesday by saying he will issue a vaccine mandate for domestic flights if his medical team advises it - one day after Dr Anthony Fauci walked back his comments in support of such a measure.

Biden told reporters at Rehoboth Beach, Delaware - while walking his new German Shepherd puppy, Commander, with First Lady Jill Biden - that he will make a decision on domestic travel vaccine requirements 'when I get a recommendation from the medical team.'   

In November, Biden said he would wait for the scientific community to provide him a recommendation when asked if consideration has been given to requiring proof of vaccination for domestic flights.

The surge in COVID cases from the Omicron variant has made the White House reassess whether to impose it.

Fauci, Biden's top health adviser, seemingly called for a vaccine mandate for air travelers on Sunday but quickly retracted his remarks the next day. 

'Everything that comes up as a possibility, we put it on the able and we consider it, that does not mean that it is likely to happen,' Fauci clarified to CNN's Jim Acosta on Monday.

'I doubt if we're going to see something like that in the reasonably foreseeable future,' he added.  

The president also told reporters during his stroll on Tuesday evening that there has been 'a bit of progress' toward the administration's goal of producing and distributing at-home COVID testing kits amid nationwide shortages. 

The administration has pledged that all Americans will be able to acquire an at-home rapid test for coronavirus after previously ruling it out.  

While there was some data from other countries that showed less severe illness with Omicron, it was too early to say what the impact might be across the United States, particularly given its uneven vaccination rates, Walensky told MSNBC.

'We may have many, many more cases and so we may still very well see a lot of severe disease in the hospitals,' Walensky said.

'What I am focused on now is making sure that we can get through this Omicron surge, that we do so with minimal amount of hospitalization and severe disease,' she added, pointing to vaccines and booster shots as top tools to curb infections. 

'We are seeing and expecting even more cases of this Omicron variant,' even if many are mild, she said separately on CNN.

Walensky also defended the CDC's move to slash the quarantine period for asymptomatic cases in half, to five days from 10, without any negative testing requirement.

The CDC director said that PCR tests are too sensitive and could return a positive even after someone is no longer contagious, and that rapid antigen tests could be unreliable in later stages of infection.

'We know it performs really well during that period where you're initially infected, but the FDA has not at all looked at whether … your positive antigen really does correlate with whether you're transmissible or not,' she told CBS Mornings.

Walensky explained that even if someone tests negative with an antigen test after five days of isolation, the CDC would still urge them to wear a mask to prevent possible spread.

'Since it wasn't going to make a difference in our recommendations, we did not recommend an antigen at that period of time,' Walensky said.

'What we do know is about 85% to 90% of viral transmission happens in those first five days, which is why we really want people to stay home during that period of time,' Walensky said. 'And then mask for the rest of the time to capture that last 10% to 15%.'

States showing the highest daily infection numbers on Tuesday included New York, which reported as many as 40,780 cases, and California, which reported over 30,000. Texas reported more than 17,000 cases and Ohio over 15,000.

Global COVID-19 infections hit a record high over the past seven-day period, according to new data Wednesday.

Almost 900,000 cases were detected on average each day around the world between December 22 and 28, with myriad countries posting new all-time highs over the past 24 hours, including the United States, Australia and many European nations.

The simultaneous circulation of the Delta and Omicron variants of the coronavirus is creating a 'tsunami of cases', World Health Organization (WHO) director-general Tedros Adhanom Ghebreyesus told reporters.

'Delta and Omicron are now twin threats driving up cases to record numbers, leading to spikes in hospitalization and deaths,' said Tedros. 

'I am highly concerned that Omicron, being highly transmissible and spreading at the same time as Delta, is leading to a tsunami of cases.'

Tedros repeated his call for countries to share vaccines more equity and warned that the emphasis on boosters in richer countries could leave poorer nations short of jabs.

He said the WHO was campaigning for every country to hit a target of 70% vaccine coverage by the middle of 2022, which would help end the acute phase of the pandemic.

New Year's Eve will mark the second anniversary of China alerting the WHO to 27 cases of 'viral pneumonia' of unknown origin in the city of Wuhan.

More than 281 million people have since been reported to be infected by the novel coronavirus globally and more than 5 million have died.

The CDC's new data on the prevalence of the Omicron variant shows that the Delta variant, which appears more severe but less contagious than Omicron, still has a hold on the country and is one driving factor behind the most current surge in cases.

It also raises the question of how the CDC could have recorded such a drastic difference in the strain's prevalence than what was the reality.

Jasmine Reed, a spokesperson for the CDC, recognized the 'wide predictive interval posted in last week's chart,' referring to the huge gap in the data for the week ending on December 18, and attributed it to the 'speed at which Omicron was increasing.'

'CDC's models have a range, and… we're still seeing steady increase in the proportion of Omicron,' she told Fox News. 

Fauci urges Americans to have a 'vaccinated, boosted' New Year's Eve and COVID will NEVER be eradicated 

Anthony Fauci said Wednesday that he 'strongly recommends' against going to large New Year's Eve gatherings this year as the highly contagious Omicron variant causes massive case surges nationwide.

'If your plans are to go to a 40 to 50-person New Year's Eve party with all the bells and whistles and everybody hugging and kissing,' Fauci said during the White House COVID-19 Response Team briefing, 'I would strongly recommend that this year, we do not do that.'

He claimed that smaller gatherings with everyone fully vaccinated and boosted against coronavirus is low risk, despite the massive number of breakthrough cases with the Omicron variant's emergence.

The nation's top infectious disease expert also had a sobering message about COVID on Wednesday – COVID likely isn't ever going away.

'We're never going to stop counting, tests – but we're looking forward, as everyone I think feels is appropriate, that ultimately we're going to have to live with something that will not be eradicated and very likely would not be eliminated,' he said. 

Even though Omicron is the most contagious variant yet, Fauci agrees with other medical professionals that it is a less severe case of COVID.

'All indications point to a lesser severity of Omicron versus Delta,' Fauci said, citing preliminary data.

He added: 'Final conclusion about the level of severity in children remains to be determined.'

The scant rate of testing in the US may be contributing to uncertainty in the data. The UK is performing 22.3 COVID tests per 1,000 people every day, five times more than the U.S. rate of 4.5, according to figures from Our World in Data. 

Moreover, only a tiny fraction of the positive tests are actually sequenced to determine the variant strain, leaving huge potential gaps in the surveillance effort.

Dr. Jerome Adams, the former surgeon general for the Trump Administration, also pointed to testing as a reason for the false Omicron numbers. He referred to something called the 'S gene dropout,' in which one of the three target genes is not detected – a signifier of the Omicron variant.

'A lot of people were seeing this S dropout on the tests even before they got the follow-up genetic testing, and so those samples were disproportionately more likely to be sent in for sequencing,' he told Fox News.

'It's also important for people to understand that in the grand scheme of things, they really were probably just a week or two ahead of what we're going to see anyway, because omicron is spreading so quickly that it is going to be 73 percent by the time you look at this week's or next week's numbers,' Dr. Adams told the news outlet.

While the CDC reported that the Delta variant accounted for 41 percent of cases in the week ending on December 25, that number could be as high as 58 percent given the agency's margin of error, NPR reported. 

The CDC's latest data will also put a burden on hospitals that will have to adjust their treatment methods to account for the vast different in Omicron and Delta cases, as different strains require different antibodies and medications. 

COVID-19 cases in the U.S. also doubled over the past two weeks. Over the past week, 235,269 Americans have been testing positive for the virus every day – a 98 percent increase from two weeks ago and approaching the prior record of 247,503 set last January, according to a analysis of Johns Hopkins data.

Though Omicron is thought to be less severe than Delta, hospitalizations have also been rising, up 6 percent nationwide over the past two weeks, to 71,381.