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Saturday, March 13, 2021

Chinese inflammatory disease biotech Connect Biopharma sets terms for $150M US IPO

 Connect Biopharma Holdings, a Chinese Phase 2 biotech developing therapies for T cell-driven inflammatory diseases, announced terms for its IPO on Friday.


The Taicang, China-based company plans to raise $150 million by offering 9.4 million ADSs at a price range of $15 to $17. At the midpoint of the proposed range, Connect Biopharma Holdings would command a market value of $863 million.

Connect's lead candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha, a validated target for the treatment of inflammatory diseases such as atopic dermatitis (AD) and asthma. The company has initiated a Phase 2b trial of CBP-201 moderate-to-severe AD in the US, Australia, and New Zealand, with top-line results expected in the 2H21. Connect also plans to initiate additional trials in asthma and chronic rhinosinusitis with nasal polyps in the 1H21 and in AD patients in China in the 2H21.

Connect Biopharma Holdings was founded in 2012 and plans to list on the Nasdaq under the symbol CNTB. Jefferies, SVB Leerink, Piper Sandler, and CICC are the joint bookrunners on the deal.

Mexico gets shipment of million vaccine doses from China's Sinovac

 Mexico received a shipment of a million doses of the COVID-19 vaccine by China’s Sinovac Biotech Ltd, the foreign ministry said on Twitter on Saturday.

Foreign Minister Marcelo Ebrard said earlier in the week that Mexico was upping its orders from China to make up for a vaccine shortfall and would request 22 million more doses.

Mexico ordered an additional 10 million doses of Sinovac, in addition to the previously ordered 10 million doses, which are due to arrive between March and May. The new order will get to Mexico between May and July, Ebrard said.

Mexico will also order 12 million vaccine doses made by the state-backed China National Pharmaceutical Group (Sinopharm) once it has been approved by its health regulator, Ebrard said.

https://www.reuters.com/article/us-health-coronavirus-mexico-vaccines/mexico-gets-shipment-of-million-vaccine-doses-from-chinas-sinovac-idUSKBN2B50F9

Fraud 'Rampant' in Medicare Advantage

Can a patient have and not have diabetes at the same time? According to private insurers participating in the Medicare Advantage program, the answer is yes. The data architecture of Medicare Advantage is vulnerable to fraud perpetrated by the Medicare Advantage Organizations (MAOs) who administer Medicare Advantage plans. These MAOs stand to collect inflated profits if they determine that their beneficiaries have complicating diagnoses for certain purposes but not for others.

Why does it matter?

The stakes for the new administration – and the country as a whole – are enormous. Over 23 million Medicare beneficiaries are enrolled in Medicare Advantage plans, for whom the federal government paid out $264 billion in 2019 alone. It is increasingly clear that these public funds are vulnerable to fraud. The HHS Office of Inspector General recently reported that in just one year $2.6 billion was paid to MAOs based on their reports of patient diagnoses that lacked supporting data from providers. It is widely anticipated that investigations and prosecutions of corporate fraud will increase under the Biden administration, and given the dollars at issue and the critical importance of our national healthcare system, fraud in the Medicare Advantage program should be a particular focus of this renewed enforcement effort.

Why is the program so vulnerable to fraud?

To illustrate Medicare Advantage's vulnerability to fraud, consider how it relies upon two independent data systems to pay for a beneficiary's inpatient hospital care.

The first system determines the amounts MAOs pay hospitals. This system uses the same MS-DRG prospective payment methodology as traditional Medicare, under which payment for each episode of care is a fixed fee. This fee is based on the procedures performed and the patient's current diagnoses as reported by the hospital to the MAO.

The second system determines the capitated amount the government pays the MAO for insuring all of a beneficiary's covered care during the relevant period. The government estimates the cost of this care by calculating a Risk Adjustment Factor (RAF) for each beneficiary. The RAF is based on information regarding each beneficiary's demographic information and current diagnoses as reported to the government by the patient's MAO. The higher the RAF, the greater the payment the MAO will receive for that beneficiary.

In the first system, the data flow is between the hospital and the MAO. In the second, it is between the MAO and the government. The problem arises because the government does not have real-time access to hospital claims data in the first system, and hospitals do not have access to the MAO's reports to the government in the second system.

Our diabetes example demonstrates the consequences of this lack of integration and transparency, particularly in the context of secondary diagnoses. For instance, suppose that a Medicare Advantage member with type 2 diabetes is admitted for surgery, and the hospital later codes this secondary diagnosis on its bill to the MAO. This diagnosis may move the episode of care into a more heavily weighted DRG, which can increase by thousands of dollars the amount the MAO must pay the hospital. These increased payments incentivize MAOs to challenge the propriety of such secondary diagnoses by contending that they are inactive conditions or otherwise irrelevant to the episode of care. Some MAOs have initiated programs to routinely delete certain diagnoses in order to downgrade DRGs and reduce payments to hospitals.

Whether a patient has type 2 diabetes is also an important datum in the Medicare Advantage risk adjustment system. A beneficiary with a current diabetes diagnosis will receive a higher RAF score, and the government will pay the MAO more to insure that beneficiary. While the MAO has an incentive to delete this secondary diagnosis to reduce its payment to the hospital, it can increase its own payments from the government by including this diagnosis in the risk adjustment reports it transmits to the government. If the MAO does not synchronize its provider payment determinations with its risk adjustment reports, our patient will both have and not have diabetes at once. The MAO will improperly profit by being paid to insure a diabetic patient while not paying a hospital to care for one.

How can we prevent this fraud?

It is unfortunate that the current Medicare Advantage data reporting systems are vulnerable to this type of fraud and do not have real-time policing mechanisms. MAOs are likely to continue to take advantage of a system that lets them act as though a patient is less sick when paying for their care, and more sick when seeking money from the government to cover that same patient. The most effective tool to deter and remedy this type of fraud is the federal False Claims Act, which imposes treble damages and significant monetary penalties on companies that defraud the government. Prosecuting those who engage in this fraud under the False Claims Act, including through cases brought by whistleblowers, is the most effective remedy and deterrent.

David Engel, JD, is a healthcare attorney admitted to the New York Bar. Gary Azorsky, JDJeanne Markey, JD, and Ray Sarola, JD, are members of the Whistleblower/False Claims Act practice group at Cohen Milstein Sellers & Toll.

https://www.medpagetoday.com/publichealthpolicy/medicare/91616

BioNTech Recruits Rivals to Boost Covid-19 Vaccine Production

 The maker of the West's first Covid-19 vaccine is building a new manufacturing alliance that could throw Europe and the rest of the world a lifeline amid a painful shortage of shots and a rebound in infections.

BioNTech SE, a German company that joined with Pfizer Inc. to manufacture and distribute its vaccine, has marshaled an alliance of 13 companies, including Novartis AG, Merck KGaA and Sanofi SA, in an effort to meet -- and perhaps exceed -- an ambitious target of making two billion doses of vaccine this year.

The European Union has been struggling with a shortage of vaccines as manufacturers, including British-Swedish pharmaceutical firm AstraZeneca PLC, have fallen behind on their delivery pledges to the bloc.

The shortage has largely been limited to the EU, which was slower than its Western allies in ordering and approving the vaccines, and it has raised tensions between the bloc and the U.K. and the U.S.

This could pose a challenge to BioNTech's alliance. Its vaccine uses sophisticated new techniques that require scarce ingredients and expertise. This makes for a delicate supply chain that is vulnerable to the type of export controls the EU, the U.K. and the U.S. have imposed in recent months, company officials have warned.

Pfizer and BioNTech developed the first Covid-19 vaccine authorized in the West in record time, but its complex manufacturing has left the U.S. giant struggling to meet production targets.

BioNTech's response: An alliance designed to jolt production of the vaccine and speed up vaccinations in Europe and elsewhere. The negotiations for the new manufacturing alliance were coordinated with Pfizer, according to a BioNTech spokeswoman.

The cancer-research firm, based in the small German town of Mainz, came up with the vaccine based on the innovative messenger RNA technology in February 2020, and then teamed up with Pfizer to test, produce and market it around the globe.

The vaccine was authorized in Europe and the U.S. in December after trials showed it was highly effective at preventing infections in adults. On Thursday, a real-life study by Israel showed that the shot was also 94% successful in stopping asymptomatic transmission.

Yet despite their successes, Pfizer and BioNTech have struggled to make enough of the vaccine to satisfy demand, causing growing frustration around the world at the pace of delivery -- a bottleneck BioNTech's new manufacturing alliance now aims to alleviate.

After months of negotiations, the company has now assembled a web of companies, most of them in Europe and some key rivals to Pfizer. BioNTech said it was confident the alliance would allow it and Pfizer to meet their goal of producing two billion doses in 2021.

Under their original agreement, BioNTech, which owns the marketing rights for the vaccine, supplies Germany, China and Turkey, while Pfizer covers the rest of the world. So far, BioNTech and Pfizer have sold 500 million doses to the EU, 300 million to the U.S., 120 million to Japan, 110 million to China and its territories, 40 million to the U.K. and 20 million to Canada.

Millions of doses have also been sold in undisclosed contracts with Middle Eastern and other countries, and 40 million have been sold to Covax, an international initiative to provide vaccines to developing countries. Demand is set to keep growing.

Pfizer, a company going back nearly two centuries that employs around 100,000 people, currently makes 50% of the active ingredient for all doses, a spokeswoman said, with the other half produced by medium-size BioNTech. A BioNTech spokeswoman said the company was in fact producing 60% of the output.

BioNTech's co-founder and chief executive, Ugur Sahin, told The Wall Street Journal he realized last fall that his partnership with Pfizer wouldn't marshal enough capacity to meet global demand.

Pfizer, which had no mRNA production capacity before its deal with BioNTech, took longer than expected to set up plants at its sites in Kalamazoo, Mich., and Puurs, Belgium, according to the companies.

A Pfizer spokeswoman blamed the delays on the need to put together a supply chain for raw materials, adding that the company had since scaled up production at an unprecedented pace.

In October, Dr. Sahin and other BioNTech executives opened negotiations with other companies, weeks before Pfizer and BioNTech released the final data from their final-stage trials showing that the vaccine was more than 90% effective in preventing infections.

Days later, the companies quietly notified authorities in the U.S. and elsewhere that they would slash the delivery target for 2020 from 100 million to just 50 million. For the U.S., this meant that Pfizer would deliver only 20 million instead of 40 million doses by December.

The Kalamazoo factory was meant to supply the U.S. while the Puurs site would cater to the rest of the world. Still, some of the initial 20 million doses that the company supplied to the U.S. came from Europe, according to the companies.

In January, Pfizer launched a major upgrade of its Puurs facility. The upgrade paused production for two weeks, worsening Europe's vaccine shortage and prompting some governments to threaten Pfizer with legal action.

Sierk Poetting, BioNTech's chief operating officer, said the experience had demonstrated to BioNTech the urgency of launching a new manufacturing alliance, in order to live up to commitments in Europe and other markets.

BioNTech is increasing its own production. Its German factory, expected to come on line in April, should produce 750 million doses a year. The facility will mainly supply the EU, but its output won't be enough, so BioNTech had to enlist new partners across the supply chain, said Mr. Poetting.

The BioNTech-Pfizer vaccine uses mRNA packaged in a microscopic ball of fat to elicit an immune response. Such vaccines can be produced faster than conventional shots, but the process is sophisticated, with new partners now involved at each step of the process.

The mRNA is first produced, then purified, concentrated and filtered. BioNTech has brought in German company Rentschler Biopharma SE to help with these steps. Swiss company Novartis is also negotiating a contract to produce DNA molecules used in the first step.

In the next step, the mRNA is encased in its fatty envelope. The lipids are supplied by the German firms Merck and Evonik Industries AG, while Austria's Polymun Scientific Immunbiologische Forschung GmbH, Canada's Acuitas Therapeutics Inc., and Germany's Dermapharm Holding SE are helping with the formulation.

During the final step, the solution is filtered again and filled into vials, a process known as finish and fill. This will be done by Delpharm SAS, a French company; Siegfried AG; Baxter Oncology GmbH from Germany; Novartis, Dermapharm and Sanofi.

BioNTech's European alliance will produce about half of the global active ingredient supply for the Covid-19 vaccine, and it will cover around 20% of the finish and fill for each dose, Mr. Poetting said.

While BioNTech is confident the alliance will allow it to meet demand, the number of partners, the complexity of the process, and the raw materials required -- from DNA to enzymes, salts, sugars and various lipids -- make the supply chain delicate, with many opportunities for bottlenecks.

Right now, the scarcest ingredients are the lipids used to deliver the vaccine's RNA. These are produced by a handful of companies and the shortage is compounded by the fact that vaccine-makers use a similar technology and rely on the same suppliers.

"This is the ultimate bottleneck at the moment...the lipids are the hand-to-mouth issue," Mr. Poetting said.

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/BioNTech-Recruits-Rivals-to-Boost-Covid-19-Vaccine-Production-32676128/

Mitigating the Impact of Pandemic Influenza through Vaccine Innovation

 The Council of Economic Advisers 

September 2019

Executive Summary 

September 2019 

This report estimates the potentially large health and economic losses in the United States associated with influenza pandemics and discusses why the most commonly used vaccine production technologies are unlikely to mitigate these losses. We estimate the value of new vaccine technologies that would make vaccines available more quickly and likely improve their effectiveness in moderating the risks of pandemics. 

We discuss why private market incentives may be insufficient to develop new vaccine technologies or promote the uptake of existing, faster but more expensive technologies, despite their large expected value to society. And we argue that increased utilization of, and investment in, these new technologies—along with public-private partnerships, to spur innovation—may be valuable to decrease the impact of both pandemic and seasonal influenza.

 Every year, millions of Americans suffer from seasonal influenza, commonly known as “the flu,” which is caused by influenza viruses. 1 A new vaccine is formulated annually to decrease infections resulting from the small genetic changes that continually occur in the most prevalent viruses and make them less recognizable to the human immune system. 

There is, however, a 4 percent annual probability of pandemic influenza resulting from large and unpredictable genetic changes leading to an easily transmissible influenza virus for which much of the population would lack the residual immunity that results from prior virus exposures and vaccinations. The Council of Economic Advisors (CEA) finds that in a pandemic year, depending on the transmission efficiency and virulence of the particular pandemic virus, the economic damage would range from $413 billion to $3.79 trillion. Fatalities in the most serious scenario would exceed half a million people in the United States. Millions more would be sick, with between approximately 670,000 to 4.3 million requiring hospitalization. 

In a severe pandemic, healthy people might avoid work and normal social interactions in an attempt to avert illness by limiting contact with sick persons. By incapacitating a large fraction of the population, including individuals who work in critical infrastructure and defense sectors, pandemic influenza could threaten U.S. national security. 

Large-scale, immediate immunization is the most effective way to control the spread of influenza, but the predominant, currently licensed, vaccine manufacturing technology would not provide sufficient doses rapidly enough to mitigate a pandemic. Current influenza vaccine production focuses on providing vaccines for the seasonal flu and primarily relies on growing viruses in chicken eggs. Egg-based production can take six months or more to deliver substantial amounts of vaccines after a pathogenic, influenza virus is identified—too slowly to stave off the rapid spread of infections if an unexpected and highly contagious pandemic virus emerges. Egg-based production can also diminish vaccines’ efficacy in protecting against influenza infection in both seasonal and pandemic years. Influenza viruses must be adapted to grow in chicken eggs, which can lead to modifications in their surface proteins (antigens) so that the vaccine prepared from them may not match the circulating influenza viruses well. 

In addition, the length of time needed for egg-based production may impair vaccine efficacy in two ways: the virus selected for vaccine manufacture may no longer be the predominant circulating virus six months later; or, even if the selected virus remains the predominant circulating virus, it may mutate between the time it is identified and the time the vaccine is available six months later, making the vaccine less effective. 

During the severe 2017–18 influenza season, the overall effectiveness of the vaccine against the circulating viruses was 38 percent. The vaccine created for the last pandemic, which occurred in 2009–10, was 62 percent effective in protecting people under age 65 years and 43 percent effective for those age 65 and older—the age group at highest risk of medical complications and death from influenza. And in 2014–15, when there was a mismatch between the virus used for the vaccine and the predominant circulating virus, the vaccine was only 19 percent effective. 2 Improving the speed of vaccine production and vaccine efficacy are both important goals to mitigate pandemic risks and may also decrease the costs of seasonal influenza. 

Our analysis shows that innovation to increase the speed of vaccine production is key. Improving vaccine efficacy alone will be of little value in a pandemic if, as is the case with current egg-based production, the vaccine only becomes available after a large number of infections have occurred. Improving efficacy only yields value after greater speed has been achieved. 

The CEA finds that technologies that could deliver sufficient doses of vaccine at the outset of an influenza pandemic could produce about a $730 billion benefit for Americans over the course of an average pandemic, primarily due to the prevention of loss of life and health. Combining this increase in production speed with a 30 percent increase over the vaccine effectiveness seen in the last pandemic (2009–10) would generate a larger benefit of about $953 billion— about one half the cost of an average pandemic. The benefits dissipate quickly, however, with each week of delay in the vaccine’s availability, as the number of unexposed people to protect diminishes. The cost of a 1-week delay at the baseline vaccine effectiveness from the last pandemic is $41 billion per week, on average, for the first 12 weeks; falls to $20 billion per week for the next 12 weeks; and disappears entirely if the vaccine’s availability is delayed by more than 39 weeks, because the outbreak would be over before the vaccine prevented new infections. 

Adding a 30 percent improvement to the vaccine effectiveness seen in the last pandemic makes the per-week cost of delay $53 billion over the first 12 weeks, on average, falling to $26 billion over the next 12 weeks. The expected value of having a vaccine available at the outset of a pandemic—that is, the savings discounted by the 4 percent annual probability of having a pandemic—is $29 billion, or $89.63 per American. Adding a 30 percent increase to the baseline pandemic vaccine’s effectiveness to the faster production increases the expected value to $38 billion, or $117.07 per American. The expected per capita value from increasing the production speed for pandemic vaccines is over four times the current per-dose cost for egg-based vaccines. Newer technologies, like cell-based or recombinant vaccines, have the potential to cut production times and improve efficacy compared with egg-based vaccines and are currently priced below the expected per capita value of improved production speeds for pandemic vaccines. 

But these existing technologies have not yet been adopted on a large scale. Besides improving pandemic preparedness, new vaccine technologies may have an additional benefit of potentially improving vaccine efficacy for seasonal influenza. We estimate the economic benefits that these new technologies could generate for each seasonal influenza vaccine recipient, and find that the benefits are particularly compelling for older adults (65+) who are at high risk of influenza complications and death. 

We discuss why the private market has not embraced these newer vaccine production technologies and the lack of private incentives to develop and utilize improved vaccine production technologies that could better mitigate pandemic risk. First, there is a key misalignment between the social and private returns from medical research and development (R&D) and capital investment in pandemic vaccines. R&D and investment costs are only recouped by sales when the pandemic risk occurs. 

Part of the value of vaccines that can mitigate future pandemic risks, however, is their insurance value today that provides protection against possible damage. This insurance value accrues even if the pandemic does not occur in the future, and it implies that the social value of faster production and better vaccines is much larger than its private return to developers. This divergence leads to an underprovision in vaccine innovation because it does not get rewarded for its insurance value. Second, pandemics represent a risk with a small probability of occurring but with large and highly correlated losses across the population. The rarity of influenza pandemics and the fact that the last serious one in this country occurred a hundred years ago may lead consumers and insurers to underestimate the probability and potential impact of a future influenza pandemic. Moreover, the risk cannot be effectively pooled because everyone is at risk concurrently.

Although vaccine innovation is not currently rewarded for its insurance value, public-private partnerships created under a 2006 statute have been key in the development of the newer vaccine production technologies that offer the prospect of improved seasonal influenza vaccines and the accelerated timelines needed for improved pandemic preparedness. Push incentives like public-private partnerships combined with pull incentives—such as the government’s preferential purchase of vaccines produced domestically with newer, faster technologies—that may create more efficacious seasonal vaccines, especially for older people, can promote additional cost-effective innovation and lessen the impact of future pandemics.

https://trumpwhitehouse.archives.gov/wp-content/uploads/2019/09/Mitigating-the-Impact-of-Pandemic-Influenza-through-Vaccine-Innovation.pdf 

NYC lawmakers call for summer school to make up COVID losses

 A bipartisan band of City Council members is demanding Mayor de Blasio and Schools Chancellor Meisha Porter create an optional summer school program for New York City kids whose academic lives have been upended by pandemic-related school closures.

“We are concerned that the money the [Department of Education] receives from the three subsequent federal stimulus bills will be spent frivolously and nonsensically, rather than helping students return to a more optimal pace of learning,” reads a March 11 letter signed by Republicans Joe Borelli, Eric Ulrich and Steven Matteo, and Democrats Robert Holden, Inez Barron, Chaim Deutsch and Alicka Ampry-Samuel. “Total federal stimulus from 2021 and 2022 for K-12 adds up to $193 billion. Let’s not waste our share.”

The proposal calls for the DOE to institute a one-to-two-month optional half-day summer program to make up for shortfalls, particularly with math and reading.

Though it’s not specified in the text, Borelli said he wants live, in-school learning “with a human teacher.”

New York state is on track to receive $100 billion alone from the federal government as part of President Biden’s $1.9 trillion coronavirus stimulus package.

“If it’s poorly spent, what good is all the money in the world? The stimulus is worthless if it doesn’t go directly towards making up the year of lost reading and math instruction for students,” Borelli, of Staten Island, told The Post. “If the DOE doesn’t see that as a priority they are hopeless.”

Borelli said the cost would depend on how many students signed up for the program. There are currently 960,000 kids enrolled in city public schools. In October the DOE reported that 52% of students were enrolled in full-time remote learning, while 48% were in some form of “blended” learning. High Schools are reopening March 22.

The idea of make-up summer schooling is gaining momentum around the country.

“Canceling summer vacation may not be a popular idea, but it is a national imperative during a historic crisis,” former Mayor Bloomberg wrote in an editorial Wednesday. President Biden also spoke of possible summer school. Even Randi Weingarten, the powerful president of the American Federation of Teachers, has been willing to play ball, saying just weeks ago that summer school “a real opportunity for students to rebuild.”

In a press release last week the city’s United Federation of Teachers signaled they were open to the idea.

“Referrals for both remediation and enrichment programs should be made by teachers and principals, but we urge the DOE to plan for the number of students needing summer instruction to surpass the 188,000 who enrolled in the 2020 summer program,” the union said.

Reps for Blaz punted to the DOE, which told The Post they were ” committed to providing a holistic summer school experience for as many students in-person as possible,”

https://nypost.com/2021/03/13/nyc-lawmakers-want-summer-school-to-make-up-for-lost-learning/

Crossing the Line

 The Centers for Disease Control and Prevention has issued ever-changing, sometimes contradictory guidance throughout the Covid-19 pandemic. But the disparity between the agency’s treatment of evictions and its approach to the immigration crisis at the southern border represents a new low.

Federal law and regulations give the CDC authority to act “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.” Regulations also “provide for the apprehension, detention, examination, or conditional release of individuals . . . reasonably believed to be infected with a communicable disease.”

The CDC’s imposition in September of a nationwide eviction moratorium stretched this authority. The moratorium made it a crime—subject to a penalty of up to one year of imprisonment and a fine of up to $250,000—to evict certain tenants for not paying rent. The dubious justification was that evicted people might move into close quarters where it would be difficult to observe social distancing or other infection-control measures: shared family housing, for instance, or congregated settings like shelters. Never mind that potential evictees could have been living in close settings already or that a controlled shelter setting may make distancing easier. Never mind, too, that unless those evictees were scrupulously sheltering-in-place, avoiding contact with anyone outside their home, moving would not necessarily increase their contacts with others.

Not only does the moratorium do little to reduce Covid-19’s spread, it may also violate the Constitution and the statute that the CDC relied on to issue the order. Two weeks ago, a federal court in Texas declared the eviction moratorium unconstitutional because it exceeds the limited powers granted the federal government in the Constitution’s Commerce Clause. The court found that property rights in buildings are “inherently local,” and regulation of local evictions does not have a substantial effect on interstate commerce. The CDC order did not limit enforcement to evictions that affect interstate commerce; just 15 percent of the millions of Americans who relocate each year cross state lines. And two days ago, a federal judge in Ohio found that the moratorium exceeded the CDC’s statutory authority. For the moment, both decisions apply only to the plaintiffs in the cases, since neither court imposed an injunction ordering the agency to stop enforcing the moratorium.

While the CDC was willing to stretch constitutional limits, statutory language, and common sense to regulate evictions, it has taken a hands-off approach to limiting the spread of Covid-19 from Mexico into Texas and beyond into other states—an area where it has clear constitutional and statutory authority. Amid a surge in migration, the CDC is not requiring Covid-19 testing of migrants, nor is it requiring those who test positive to isolate. That’s a job for local governments and NGOs, according to White House spokesperson Jen Psaki.

Local authorities in Brownsville, Texas have tested 1,553 migrants released at the bus station by the Border Patrol since January 25, finding that 185 were Covid-19 positive but lacking the authority to detain them. The Covid-positive migrants reportedly planned to travel on to other states, including Maryland and New Jersey. How many more are being released elsewhere?

Federal regulations direct the CDC to arrange for “appropriate accommodation” and “appropriate medical treatment . . . for individuals who are apprehended or held in quarantine or isolation under this part.” Yet the CDC is abandoning its own Covid-19 protocols, allowing shelters housing children crossing the Mexico–U.S. border to expand capacity above the 50 percent limit recommended to inhibit viral spread. After professing concern that evicted Americans might be endangered in shelters, the agency relaxed migrant-shelter standards in response to the Biden administration’s immigration policy. On average, 321 children per day are being referred to shelters, up from 47 per day in early January. A record 3,700 migrant children are currently in Border Patrol custody.

The CDC’s nationwide eviction moratorium had less to do with science than with political posturing. It exceeded the agency’s mandate while doing little to protect the public from illness. Yet, in an attempt to obscure the immigration crisis that the Biden administration currently faces, the agency has abdicated its duty to protect against communicable diseases that cross international and interstate borders. The CDC should focus on its core mission: protecting the nation from health threats both foreign and domestic.