Another Trump Administration Crime?

House committee refers former Trump Interior Secretary David Bernhardt for criminal prosecution

Ben Adler

·Senior Editor

Wed, May 11, 2022, 2:29 PM

The House Natural Resources Committee announced its first-ever criminal referral to the Department of Justice on Wednesday, asking it to investigate whether Mike Ingram, an Arizona real estate developer and a campaign donor to Donald Trump, bribed public officials during Trump’s tenure as president, including then-Deputy Secretary of the Interior David Bernhardt.

Since 2019, the House committee has investigated a decision by the U.S. Fish and Wildlife Service (FWS) in October 2017 to reverse its previous opposition to a proposed housing development in Benson, Ariz., called Villages at Vigneto. That decision was reversed again in July 2021, after Joe Biden took office as president.

Interior Secretary David Bernhardt and President Donald Trump in the White House on July 8, 2019. (Carlos Barria/Reuters)

According to a committee report in August 2017, Steve Spangle, who was then an FWS field supervisor, received a phone call during which an attorney from the Interior Department’s Office of the Solicitor asked Spangle to reverse his decision that the Army Corps of Engineers must consult with FWS before reinstating the then-suspended Clean Water Act permit for the Villages at Vigneto. The report said the phone call “was directed by Dep. Sec. Bernhardt” after he met with Ingram. Bernhardt went on to serve as secretary of the interior from 2019 to 2021.

“Evidence strongly suggests the decision was the result of a quid pro quo between Vigneto’s developer, Michael Ingram, and senior level officials in the Trump administration, potentially including then-DOI Deputy Secretary David Bernhardt,” the committee report concluded.

“The findings of this investigation show us yet again that the previous administration cast career staff expertise aside while they handed out federal agency decisions to Trump’s buddies and big donors on a pay-to-play basis,” Natural Resources Committee Chair Raúl Grijalva, D-Ariz., said in a statement released Wednesday.

House Natural Resources Committee Chair Raúl Grijalva, D-Ariz., at a hearing in 2020. (Michael Reynolds/Pool via Reuters)

The Vigneto development is in an ecologically sensitive area, according to the committee. “The land on which Vigneto would be developed is located approximately two miles upland from the San Pedro River, the last major free-flowing river in the desert Southwest,” the committee's report states. “The surrounding ecosystem is a fragile, yet critically important habitat for many unique species of wildlife and is considered a critical corridor for millions of migratory songbirds.”

As a result, the Army Corps was legally obligated to consult with FWS under the Endangered Species Act, but withdrew its request for consultation after Trump took office. The committee also documents that Ingram and a dozen other donors in Arizona, some of whom have business ties to Ingram, donated a total of $241,600 to the Republican National Committee, Donald Trump for President and state GOP committees in 2017.

Rep. Katie Porter, D-Calif., who chairs the Subcommittee on Oversight and Investigations of the Natural Resources Committee, issued a statement explicitly alleging corruption in the Trump administration.

“An exchange of money for a specific government action is the clearest form of corruption there is, and Americans — Democrats, Republicans, and Independents — share an understanding that this kind of quid pro quo erodes our democracy,” Porter said. “In this case, our oversight uncovered that the Trump administration’s Department of the Interior overruled local career professionals and reversed a long-standing position on environmental review requirements, just weeks after politically connected donors made nearly a quarter of a million dollars’ worth of contributions benefiting the Trump campaign. This concerning fact pattern demands additional fact finding, at a minimum, so the American people have answers on whether the Trump administration was acting in the public’s interest or the interests of the highest bidder.”

Rep. Katie Porter, D-Calif., chair of the House Natural Resources Committee's Subcommittee on Oversight and Investigations, in 2019. (Erin Scott/Reuters)

Bernhardt did not respond to Yahoo News’ request for comment before publication, nor did a spokesperson for Trump. Ingram’s real estate firm, El Dorado Holdings, sent a statement by its attorney Lanny Davis, a Washington, D.C., lawyer famous for his many high-profile political clients.

“The referral sent by Chairman Grijalva and Subcommittee Chairwoman Porter is false, misleading, unfair, and strikes me as reminiscent of McCarthyism’s use of innuendo as a surrogate for fact,” Davis said. “El Dorado participated in multiple meetings with this Committee, acted in full transparency, and gave full cooperation without a subpoena. Despite this, we were denied the basic and fundamental opportunity to rebut the allegations in this referral and denied a chance to even speak to the chairman. Unfortunately, the American people have been numbed and accustomed to political attacks that have little to do with the truth, and there needs to be bipartisan outrage when this occurs. It doesn’t matter if it’s a Democratic or Republican committee or a Democratic or Republican administration. I intend to spend every minute I can visiting with the Democratic and Republican members of this Committee to persuade them that what was done by the Chairman and Subcommittee Chairwoman was unjust and utterly failed to report the facts of no wrongdoing by Mr. Ingram or El Dorado. I still believe the final decision was made based on the law and the facts.”

After this story was published, Davis sent an additional statement, which reads, in part: “The authors of the Committee referral to DOJ conveniently misled when they failed to quote from an independent review by local U.S. Fish & Wildlife Service officials to address the charge that the permit for the Vigneto project was continued because of political influence." Davis argues that the internal FWS review absolved Ingram of improper influencing FWS employees.

Environmental advocacy groups critical of DOI’s record during the Trump era saw the referral as vindication.

“We said all along that David Bernhardt was too compromised and too corrupt to be a Cabinet secretary,” said Jennifer Rokala, executive director of the Center for Western Priorities, in a statement. “This is damning evidence of a straight up pay-for-play favor. Mike Ingram got a secret meeting with David Bernhardt early in the Trump administration. Then the very same day that Bernhardt flipped the career officials under him, the cash flowed into the Trump campaign.”

Above is from:  https://www.yahoo.com/news/house-committee-refers-former-trump-interior-secretary-david-bernhardt-for-criminal-prosecution-192909087.html

May 1o, 2o22: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

VISUALIZING 1 MILLION DEATHS In the coming days, the official number of US residents who have died of COVID-19 will pass 1 million, although some estimate that threshold has already been exceeded. Globally, the WHO estimates about 15 million people have died due to causes directly or indirectly related to the pandemic. News reporting is applying different lenses to this immense loss, at levels difficult for humans to comprehend. Axios presents a timeline of the pandemic, comparing the numbers of deaths to historical events. Forbes published a series of photos accompanied by various pandemic-related facts. STAT breaks down the death toll into “5 different pandemics,” based on when and where you lived and who you were. The Washington Post notes that at least 9 million people nationwide lost a spouse, parent, grandparent, child, sibling, or friend to COVID-19 and tells the stories of several of those people. On May 9, the Washington National Cathedral rang its largest bell 1,000 times, one toll for every 1,000 US residents who have died of COVID-19. An additional toll rang out to acknowledge the ongoing threats of the virus, the final time the bell will ring to memorialize the pandemic. The White House is expected to commemorate the moment when the nation officially passes 1 million deaths.

US FALL/WINTER SURGE PREDICTIONS The US government has begun to prepare the public for and warn the US Congress of a potential surge in COVID-19 cases this coming fall and winter. Some experts predict as many as 100 million new COVID-19 cases will occur during the colder months. The estimate is based on several variables, including waning immunity, a growing sense of relaxation about the pandemic, and the potential for new variants. On May 8, White House COVID-19 Response Coordinator Dr. Ashish Jha called on Congress to authorize US$22.5 billion for vaccines, treatments, and diagnostics. The White House’s original request of US$30 billion dollars was pared down to US$10 billion in what appeared to be a compromise before negotiations hit a wall over US-Mexico border public health policies. Without additional funding, the administration has said it likely will run out of SARS-CoV-2 vaccines if the nation moves forward with authorizations for a second booster dose for all adults. White House documents suggest the country would need an additional 87 million vaccine doses for adult boosters and an additional 5 million for boosters for children, if authorized. The administration is discussing contingency plans if vaccine supplies run short, with some reporting that boosters could be limited to high-risk groups in the fall if additional funding is not secured.

BOOSTER DOSE EFFECTIVENESS A fourth dose of SARS-CoV-2 vaccine significantly boosts immune protection, according to data from the COV-BOOST subtrial published in The Lancet Infectious Diseases. The study evaluated antibody and cellular immune responses of a fourth dose of either Pfizer-BioNTech or Moderna, administered to participants who previously received 3 doses of Pfizer-BioNTech or 2 doses of AstraZeneca-Oxford and 1 dose of Pfizer-BioNTech. Participants who received the Moderna booster saw a 16-fold increase in anti-spike IgG titers, the metric used in the study for immunogenicity, while Pfizer-BioNTech recipients’ levels increased 12-fold. Compared to 28 days after the third dose, the Moderna booster more than doubled antibody levels and the Pfizer-BioNTech booster increased levels more than 1.5 times. Participants who received 3 doses of Pfizer-BioNTech and a Moderna booster exhibited significantly higher T-cell responses 14 days after the fourth dose compared to 28 days after the third dose, whereas participants who received other vaccine combinations all exhibited similar T-cell responses at the same time point. The researchers suggested there may be a ceiling for antibody levels with mRNA boosters.

Several studies also have evaluated vaccine effectiveness of third dose boosters to Omicron. Researchers with Sweden’s Skane University Hospital conducted a vaccine-registry study across 3 periods of variant dominance: Omicron BA.1, transition period, and Omicron BA.2 beginning in the last week of 2021 through week 11 of 2022. Pfizer-BioNTech, Moderna, and AstraZeneca-Oxford vaccines were used in the vaccination program, but Pfizer-BioNTech represented 77% of all administered doses. A total of 593 severe cases were documented during the period, representing 65, 78, and 56 cases each week for the corresponding periods of BA.1, transition, and BA.2 dominance. Severe cases were older during the BA.2 period and had a more even sex distribution compared to those recorded during the BA.1 period. Following 3 doses, vaccine effectiveness remained above 80% through the study period, but decreased from 90% to 54% during BA.2 in participants who received 2 vaccine doses regardless of age, sex, or chronic conditions.

A second study, also published in Eurosurveillance, included a subset of 20 participants from a previous study comparing levels of plaque reduction neutralization test (PRNT) antibodies against the wild-type and BA.1 SARS-CoV-2 variants. Participants included previously infected and infection-naive individuals who were vaccinated with 3 doses of Pfizer-BioNTech or CoronaVac, or 2 doses of CoronaVac and 1 dose of Pfizer-BioNTech, as well as unvaccinated individuals who were previously infected. The researchers, who noted that there are no universally even a single dose of vaccine in participants previously infected elicited higher PRNT antibody responses than even 3 doses of the respective vaccine in infection naive individuals. Breakthrough infections with either BA.1 or BA.2 in previously vaccinated participants appeared to provide broad cross-neutralization against a range of variants of concern. Notably, BA.2 infection in unvaccinated participants produced low levels of PRNT antibody responses indicating they could remain susceptible to infection from other variants.

A third study, detailed in last week’s Morbidity and Mortality Weekly Report, analyzed surveillance and vaccination data during Omicron dominance from 15,000 nursing homes in the beginning of 2022 to estimate relative vaccine effectiveness against infection for any additional primary or booster dose compared to primary series vaccination, defined as 2 shots of Pfizer-BioNTech or 1 shot of J&J-Janssen. A relative vaccine effectiveness of an additional primary or booster dose was determined to be 46.9% against infection, suggesting that an additional or booster dose provides greater protection against Omicron infection than primary series vaccination alone. While weekly case rates decreased among all vaccination status groups during the study period, cases were consistently lower among residents with an additional primary or booster dose compared to those with primary series vaccination only or were unvaccinated, suggesting additional doses should be administered to all skilled nursing facility residents when they are eligible.

LONG COVID As many wealthy nations move into recovery phases of the COVID-19 pandemic, some are saying the next crisis will be addressing the millions of people worldwide who experience post-acute sequelae of COVID-19 (PASC), commonly known as long COVID. Researchers are continuing work to characterize the condition, attempting to answer questions including who might be more susceptible to long-term symptoms, how long symptoms might last, what treatments could provide some relief, and the impact long COVID symptoms have on long-term health. Globally, estimates range from 10% to 80% of COVID-19 survivors who experience at least 1 lasting symptom. Some estimate as many as 1 billion people worldwide could suffer from the poorly understood condition over the next few years. In the US, as many as 24 million people have experienced long-COVID symptoms since the start of the pandemic.

Growing evidence suggests that getting vaccinated against COVID-19 could reduce the risk of developing long COVID, although more research is needed to definitively assess the impact. And a recently reported case series posted to the preprint server Research Square shows some evidence that individuals experiencing long COVID symptoms might be able to use Pfizer’s antiviral treatment Paxlovid as a therapy for the condition. Because Paxlovid is authorized only for people who have recently tested positive for the virus, clinical trials are needed to more thoroughly assess its potential to treat long COVID.

J&J-JANSSEN VACCINE The US FDA on May 5 limited the authorized uses of J&J-Janssen’s single-dose SARS-CoV-2 vaccine to only certain adults who are unable or unwilling to get vaccinated with another approved or authorized vaccine. The agency made the decision based on an updated analysis on the risk of J&J-Janssen vaccine recipients experiencing thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition characterized by blood clots and low platelet counts that occurs 1-2 weeks post-vaccination. FDA officials determined that the known and potential benefits of the J&J-Janssen vaccine outweigh its risks for individuals aged 18 and older who cannot access other vaccines; for whom other authorized or approved vaccines are not clinically appropriate, like those who have had an allergic reaction to another SARS-CoV-2 vaccine; or who would not otherwise get vaccinated with an mRNA vaccine from Pfizer-BioNTech or Moderna. Out of about 18 million doses administered in the US, the FDA has identified 60 cases of TTS, including 9 deaths.

In April 2021, the FDA temporarily paused the use of the J&J-Janssen vaccine after the risk of TTS was identified, lowering vaccine confidence in and demand for the vaccine. Then in December 2021, the US CDC recommended individuals receive one of the mRNA shots instead of the J&J-Janssen vaccine. This most recent move could further diminish confidence in the vaccine, especially in low- and middle-income countries (LMICs) where the single-shot vaccine originally held promise. In response, J&J said the vaccine’s benefits outweigh its risks, especially when compared to being unvaccinated. Experts note that COVID-19 also carries a risk of serious or fatal blood clots, although a different type than those associated with the J&J-Janssen vaccine.

GLOBAL VACCINE & TREATMENT ACCESS COVAX has shipped nearly 1.5 billion SARS-CoV-2 vaccine doses to 145 countries worldwide and says it has access to enough doses to help all countries meet their national vaccination targets. While vaccine supplies have ramped up over the past few months, lower demand for the vaccines and complex logistics surrounding their delivery and administration pose ongoing challenges to getting vaccinations in arms. Global efforts have focused primarily on vaccines, but demand for COVID-19 antiviral treatments, diagnostics, and other medical supplies, such as oxygen, is rising in low- and middle-income countries (LMICs). Critically, COVID-19 treatments must be started within 5 days of initial symptoms, and infections must first be confirmed with testing. Notably, only about 20% of the 5.7 billion SARS-CoV-2 tests conducted globally have been in LMICs—and only 0.4% in low-income nations—according to the WHO-supported ACT Accelerator.

Many global health experts say the obstacles and inequities countries face today are highly—and tragically—reminiscent of those that prohibited the widespread use of HIV therapeutics in LMICs in the early 2000s. Some experts say the concentration of vaccine and medical supply manufacturers centered in only a few high-income countries continues to be a structural driver of inequity. Others are calling on pharmaceutical companies to provide more transparency, technology transfers, and prioritization of LMICs in distribution. Some say additional investments in global organizations such as Gavi, the Vaccine Alliance, would help build off lessons already learned in distributing and administering childhood vaccinations. And still others call for more innovation in the planning and delivery of all immunization services. Notably, an Africa CDC 27-country analysis shows those nations that acted quickly to establish and scale-up vaccination programs saw greater benefit than nations that lagged behind. Additionally, the paper calls on countries to focus on vaccinating the most vulnerable populations to achieve the greatest cost-benefit.

The upcoming second Global COVID-19 Summit is a reminder that even after more than 2 decades of lessons from the HIV epidemic, the global community has a long way to go to resolve inequities during the COVID-19 pandemic and prepare for the next global health emergency. On May 12, national leaders and representatives of private companies, philanthropies, and non-profit organizations will gather for the summit, co-hosted by the US, Belize, Germany, Indonesia and Senegal and aimed at increasing financing for the COVID-19 response in LMICs.

Ahead of the summit, US President Joe Biden called on upper-middle and high-income nations to pledge US$2 billion for COVID-19 therapeutics, such as the antivirals Paxlovid and molnupiravir, and US$1 billion for oxygen supplies. But President Biden—who is scheduled to deliver remarks, possibly virtually—likely will come to the table without additional US support, as the US Congress has yet to agree on additional COVID-19 aid. Administration officials say that without future financing, the US is at a disadvantage when asking other nations to step up their global response efforts and could face challenges in its domestic response. A group of former heads of state and Nobel laureates are calling on the US to immediately authorize US$5 billion for its global COVID-19 response, and activists are urging President Biden to take a stronger international leadership role. Congressional Democrats were working to pass new COVID-19 spending attached to a proposal for nearly US$40 billion in new Ukraine aid. But after continued disagreement over public health policies on the US-Mexico border, Democrats have uncoupled the proposal for an additional US$10 billion in new COVID-19 spending from the Ukraine aid and put it on a separate track. In a statement, President Biden conceded that new COVID-19 funding could wait but urged Congress to act quickly on the additional pandemic aid.

WHO HEALTH EMERGENCIES PREPAREDNESS A working group formed to propose ways to strengthen the WHO’s preparedness and response to health emergencies last week released a draft report outlining its recommendations. The 56-page document will be considered by the 75th World Health Assembly convening later this month. The draft report proposes, among other suggestions, recommendations on strengthening the International Health Regulations (IHR); a timeline for the regulations’ possible amendment; an evaluation of the status and future of WHO-supported initiatives such as the Access to COVID-19 Tools Accelerator and vaccine technology transfer hub; and a reconsideration of the acronym for public health emergencies of international concern, PHEIC, which some pronounce as “fake.” Public health experts agree that now is the time to prepare for future pandemics. An editorial in The Lancet calls on individual countries to evaluate their responses to COVID-19, learn from their mistakes, and work to strengthen their health systems, and the editorial board of the Washington Post urges international cooperation to form a global and national early-warning system for new and emerging diseases.

May 5, 2022: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

EPI UPDATE The WHO COVID-19 Dashboard reports 513 million cumulative cases and 6.2 million deaths worldwide as of May 4. The global weekly incidence decreased for the sixth consecutive week—down 16% from the previous week—to the lowest weekly total since mid-November 2021. Most regions continued to report decreasing trends in weekly incidence. Africa’s weekly total continued to increase, up 32.5% over the previous week. The increase appears to be largely driven by a surge in South Africa, but analysis from Our World In Data shows a large increase in cases reported on the continent at the end of last week, representing either actual cases or a reporting anomaly. Weekly incidence also increased in the Americas, up 13% over the previous week. Increasing trends in Africa and the Americas are being driven by Omicron subvariants. The trend in reported global weekly mortality decreased for a fifth consecutive week, down 5% from the previous week, although the trend appears to be slowing.

Global Vaccination

As of May 4, WHO reported 11.6 billion cumulative vaccine doses administered globally, with 5.1 billion individuals receiving at least 1 dose, and 4.6 billion fully vaccinated*. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decline overall—down to 9.65 million per day on May 4 from nearly 40 million doses per day in late December 2021**. The trend continues to closely follow that in Asia. Our World in Data estimates that there are 5.15 billion vaccinated individuals worldwide (1+ dose; 65.4% of the global population) and 4.67 billion who are fully vaccinated (59.3% of the global population). A total of 1.88 billion booster doses have been administered globally.

*After a reporting anomaly last week, the WHO data for cumulative global vaccinated individuals are back to levels in line with those reported for April 18.

**The average daily doses administered may exhibit a sharp decrease for the most recent data, particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

UNITED STATES

The US CDC is reporting 81.4 million cumulative cases of COVID-19 and 993,341 deaths. The average daily incidence has more than doubled from the recent low of 24,843 new cases per day on March 29 to 61,712 on May 3. The daily mortality is beginning to increase, up to 325 deaths per day from a recent low of 306 deaths per day on April 29.* With a now increasing trend in deaths, we expect the official number of COVID-19 deaths to surpass 1 million within the next 2 weeks. Notably, new COVID-19 hospital admissions continue to trend upwards, with an increase of 20% over the past week. New cases are being driven by the BA.2 subvariant of Omicron, with an increasing proportion of cases due to BA.2.12.1 sublineage.

*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US Vaccination

The US has administered 577 million cumulative doses of SARS-CoV-2 vaccines. After a slight increase starting in late March, following US FDA authorization of a second booster dose, daily vaccinations are once again declining. A total of 258 million individuals have received at least 1 vaccine dose, which corresponds to 77.7% of the entire US population. Among adults, 89.1% have received at least 1 dose, as well as 27.7 million children under the age of 18. A total of 220 million individuals are fully vaccinated**, which corresponds to 66.2% of the total population. Approximately 76.2% of adults are fully vaccinated, as well as 23.2 million children under the age of 18. A total of 101 million individuals have received an additional or booster dose. This corresponds to 45.9% of fully vaccinated individuals, including 68.7% of fully vaccinated adults aged 65 years or older. Only 49.4% of individuals eligible for a first booster dose have received one.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent several days.

**Full original course of the vaccine, not including additional or booster doses.

15 MILLION DEATHS Global and national health agencies have been working to better understand the total numbers of lives lost during the COVID-19 pandemic. Earlier today, the WHO announced a revised measure of the estimated total excess deaths associated with COVID-19 during 2020 and 2021. The report estimates the full death toll associated directly or indirectly with the COVID-19 pandemic is 14.9 million, with a range of 13.3 million to 16.6 million. The staggering total represents the best estimate of individuals who passed away between January 1, 2020, and December 31, 2021, from COVID-19 who likely would not have died from a different cause over the same course of time, in addition to those who passed away due to a lack of healthcare accessibility caused by pandemic-associated lockdowns or overburdened healthcare systems. The number is nearly 3 times the 5.4 million COVID-19 deaths reported to the global health agency during that time period. The WHO acknowledges that 84% of the excess deaths were located in the Americas, Europe, and Southeast Asia, with 68% occurring in only 10 countries. Additionally, the estimate reflects a disparity of impact between men and women, with men accounting for 57% of the excess deaths.

The WHO report’s release was delayed over objections from India, whose government expressed concerns over its methodology. Earlier this week, the Indian government released new mortality data for 2020 ahead of the scheduled release of the WHO report. The data show India recorded 475,000 excess deaths in 2020 when compared with 2019. The government has not released data from 2021, when a wave of COVID-19 fueled by the Delta variant challenged the nation’s pandemic response. The WHO estimate for excess mortality in India is roughly 4 times that of the officially reported numbers, and the agency expects additional pushback.

WTO IP WAIVER NEGOTIATIONS After an 18-month-long impasse, the United States, European Union, India, and South Africa have negotiated an “outcome document” on temporary intellectual property (IP) waivers for COVID-19 medical tools to present to the World Trade Organization’s (WTO) 164 member states. WTO Director-General Ngozi Okonjo-Iweala, who has prioritized global vaccine equity since taking office in 2021, said the draft document will help to advance discussion and dialogue on temporary IP waivers, for this and future pandemics. Several of the plan’s details—including whether waivers would last 3 or 5 years—must be finalized before members can vote, a process expected to be completed by June. If approved by consensus, the proposal would allow certain lower-income countries to manufacture COVID-19-related vaccines and treatments without having to pay major pharmaceutical companies for licensing. Notably, China has indicated it is prepared to vote in favor of the plan. Critics of the proposal, including the pharmaceutical industry and Médecins Sans Frontières (MSF), say patent waivers will not solve vaccine inequity during the COVID-19 pandemic because issues with manufacturing, supply chains, and distribution will remain.

Pfizer, which has been under increasing criticism to voluntary waive patent protections for its SARS-CoV-2 vaccine Comirnaty and treatment Paxlovid, continues to face accusations of profiteering from the pandemic. In its 2022 first quarter earnings report, the company announced revenues of nearly US$26 billion, up 77% over the same period last year and driven primarily by sales of its COVID-19 products. Prescriptions for Paxlovid have increased nearly tenfold in the US since late February, and the company expects to make record sales of around US$100 billion this year. Throughout the pandemic, Pfizer has refused to waive patent rights or share any intellectual property related to its COVID-19 products, saying other companies would struggle to produce its mRNA vaccine, which involves 280 materials from 86 suppliers in 19 countries. Notably, Moderna reported its first quarter revenues were up more than threefold over the same period last year, rising from US$1.9 billion to US$6.1 billion and driven by its vaccine sales. Moderna has said it will not enforce patents on its SARS-CoV-2 vaccine during the pandemic. In a briefing, WHO Director-General Tedros Adhanom Ghebreyesus said pharmaceutical companies’ pricing schemes perpetuate inequality, calling the situation a “moral failing.” Other critics are calling for a reevaluation of how medical innovation is governed and financed to allow for a system that better supports public health instead of companies’ bottomlines.

SARS-COV-2 EVOLUTION The recent emergence of the SARS-CoV-2 Omicron sublineages BA.2.12.1, BA.4, and BA.5 has caused health officials to consider the virus’s evolution and what it might mean for the pandemic’s future. Experts believe the BA.2.12.1 subvariant is driving an increase in the daily hospitalization rate in the US after a lengthy transmission lull following the original Omicron variant surge at the start of 2022. The BA.4 and BA.5 subvariants are responsible for increasing cases in South Africa, and they have both been detected in more than a dozen other countries, including the US. A preprint study published on May 2 claims that all three Omicron subvariants may be spreading rapidly due to certain changes in the viral genome that can allow immune escape from antibodies generated by the original Omicron variant. The study found that fully vaccinated individuals who had an Omicron breakthrough infection may have a threefold drop in neutralizing antibodies, while unvaccinated individuals who had an Omicron infection may have a sevenfold drop. For reference, an eightfold drop in neutralizing antibodies is the typical signal used by the WHO to update seasonal influenza vaccines.

In addition to the specific evolutionary traits of the Omicron subvariants, there are some wider evolutionary trends that have been observed since the beginning of the pandemic. Some of these evolutionary trends include: a shift from superspreader events to more uniform transmission; a shift from more contagious variants to immunity-evading variants dominating globally; and the emergence of new variants through genetic drift. Each of these trends could be good for the future of pandemic planning. For example, a shift to more uniform transmission means that interventions such as germicidal ultraviolet irradiation may be capable of cutting back transmission in indoor public spaces. Even though past immunity-evading variants, such as Mu, have been outperformed by highly contagious variants, Mu-like variants could emerge again to become dominant in the future. This knowledge will help inform surveillance efforts to screen for emerging variants of concern. Additionally, knowing that newer variants are emerging through gradual genetic drift could help in the development of new vaccines and therapeutics. Understanding viral evolution will allow for better and more tailored responses to each emerging variant.

BOOSTER DOSES The debate over whether additional SARS-CoV-2 vaccine booster doses are needed continues to heat up as several Omicron subvariants are driving increasing transmission rates in the United States and abroad. A study from Israel published on May 5 provides evidence that a second booster dose for the Pfizer-BioNTech vaccine is capable of protecting against infection for 4 weeks and severe disease for 6 weeks. However, the WHO has yet to release an official recommendation for additional booster doses, and many health officials remain skeptical about the widespread administration of boosters since neutralizing antibodies tend to wane rapidly after the first and second booster in healthy populations. One point of agreement among experts is that elderly and immunocompromised individuals receive the most benefit from additional doses of vaccine, and the US FDA has authorized additional booster doses for adults aged 50 and older. Notably, 42% of COVID-19 deaths in the US at the beginning of 2022 were among vaccinated individuals, the majority of whom were not boosted. Additional countries such as Israel, Denmark, and Singapore also have authorized second booster doses for certain high-risk populations. US health officials appear confident they will have enough information to decide whether a second booster dose is necessary for the wider population at some point this summer. A major consideration for additional doses is whether the original vaccine formulation is sufficient or if Omicron-specific vaccine formulations are needed.

PARENTS ON YOUNG CHILD VACCINATIONS Children under age 5 in the US remain ineligible for vaccination against COVID-19, although a US FDA advisory committee is set to review data regarding the use of 2 different SARS-CoV-2 vaccines for this age group in June. However, most parents remain reluctant to vaccinate their young children, according to recent results from the Kaiser Family Foundation’s COVID-19 Vaccine Monitor survey. Only 18% of parents of children under age 5 said they are eager to get their child vaccinated as soon as a vaccine is authorized, and 38% said they will wait to see how the vaccine is working for others. Nearly 4 in 10 parents showed more reluctance to get their under-5s vaccinated, with 11% indicating they would do so only if required and 27% saying they will “definitely not” get their child vaccinated.

Notably, just over half of parents said they do not have sufficient information about SARS-CoV-2 vaccines’ safety and effectiveness in young children to make a decision, compared with 34% of parents with children aged 5-11 and 25% of parents with older children aged 12-17. The FDA’s seeming delay in reviewing vaccines for the youngest children made about 13% of parents less confident in vaccine safety, but 22% of parents said the slow pace made them more confident. Additionally, though 84% of parents feel their child is at least “somewhat safe” from COVID-19 at school, Black or Hispanic parents were less likely than White parents to feel their child is “very safe” at school (33% vs. 52%), and Black and Hispanic parents are nearly 3 times as likely as White parents to report their child usually wears a mask at school, regardless of the school’s masking policies.

The survey’s results highlight the need for culturally sensitive, targeted vaccine education campaigns to address parents’ concerns. Importantly, a study published May 3 in the journal Vaccine found that much of the informational material on SARS-CoV-2 vaccines in the US is written above a 10th grade reading level, meaning the texts are far too difficult for the average person to understand. The researchers, from the Mayo Clinic, concluded that more effort must be made to create materials that are more widely accessible.

MASKING & TRAVEL The US CDC this week reiterated its recommendation that everyone aged 2 or older wear a well-fitting mask or respirator while traveling, including while inside transit stations and on public transportation such as airplanes, trains, and vehicles. The agency also encouraged transportation operators to support mask wearing by all individuals, including employees. A federal judge last month struck down the federal transportation mask mandate that required everyone to wear masks while using public transportation, saying the requirement exceeded the CDC’s statutory authority. The US Department of Justice said it would appeal the decision, but the status of that appeal is unknown. Since the mandate was voided on April 18, the number of new COVID-19 cases have risen about 50% among Transportation Security Administration (TSA) employees, from 359 to 542 on May 2, according to an agency spokesperson. CDC’s masking reminder was issued the day the federal mandate was set to expire. The recommendation comes as all epidemiological indicators are showing a nationwide increase in new COVID-19 cases, hospitalizations, and deaths.

HEALTHCARE WORKFORCE Throughout the COVID-19 pandemic, the US healthcare workforce has faced excessive amounts of stress, exhaustion, trauma, and burnout, exacerbated by pre-pandemic worker shortages, uneven geographic distribution, and existing mental health challenges. In a new report, the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) describes workforce shortages among hospital and outpatient clinic staff both prior to and during the pandemic; impacts on the mental and physical health of healthcare workers; and an overview of federal healthcare workforce support, both programmatically and financially, during the pandemic. The 27-page report reviews literature and analyzes data from federal and other sources, as well as offers several lessons to inform future actions, including increasing policy attention for alleviating the maldistribution of workforce; ensuring a sufficient supply of personal protective equipment (PPE) and other necessary medical supplies; supporting diversity in the workforce; providing training and continuing medical education (CME); and researching the pandemic’s impacts on the healthcare workforce and how they can be addressed in the future.

POST-PAXLOVID VIRAL REBOUND As we previously reported, a very small percentage of people with confirmed COVID-19 who take Pfizer’s Paxlovid antiviral therapy experience a relapse of symptoms and viral load several days after completing the 5-day course of treatment, often testing positive again after a negative test. This week in an interview, Pfizer CEO Albert Bourla suggested those people can simply take another course of treatment, an idea the US FDA quickly rebuked. In a document posted on May 4, Dr. John Farley, Director of the FDA Office of Infectious Diseases, said there is “no evidence of benefit at this time for a longer course of treatment (eg, 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.” Additionally, the medication’s prescribing information specifically states, “Paxlovid is not authorized for use longer than 5 consecutive days.” Dr. Farley indicated the FDA is reviewing data from clinical trials and will provide additional information when it becomes available and reiterated that Paxlovid reduces the risk of hospitalization and death for patients with COVID-19 who are at high risk of disease progression.

RESEARCH ROUNDUP New to the Situation Report, this section will provide short synopses of new studies examining various aspects of COVID-19.

From JAMA, a surveillance study of more than 6,000 completed pregnancies between March 2020 and October 2021 in Canada. Findings reaffirm previous findings that SARS-CoV-2 infection during pregnancy is significantly associated with increased risk of adverse maternal outcomes and preterm birth.

From The Lancet eClinical Medicine, an assessment of cognitive function among 46 individuals hospitalized in the UK with severe cases of COVID-19. Findings suggest that acute illness can have long-lasting impacts on the cognitive abilities of those recovering from COVID-19, especially in tasks revolving around high cognition usage and processing speed. 

From JAMA Internal Medicine, results from a prospective cohort study assessing the performance of at-home diagnostics over the course of an individual’s SARS-CoV-2 infection. For the study, 225 individuals with RT-PCR-confirmed infections used antigen tests and sample comparisons throughout their infection. Findings show moderate sensitivity for at-home antigen tests when compared with RT-PCR and high sensitivity when comparing those same RT-PCR results to a viral culture. The authors also note that antigen test sensitivity peaked several days after symptom onset, suggesting people should continue to test if they initially test negative.

From eBio Medicine, an examination of hospital admission during separate waves of SARS-CoV-2 infection caused by the Delta and Omicron variants. This retrospective cohort study shows that individuals with Omicron SARS-CoV-2 infections were less likely to be admitted than those with Delta SARS-CoV-2 infections, but those who were admitted for either variant had similar risks of progressing to severe disease.

From Research Square, a new preprint examining the lethality of the Omicron variant, after accounting for vaccination status and community demographics. The analysis pulled data from electronic health records (EHRs) from a large US health system to conduct a weighted case-control study of 130,000 COVID-19 patients. The researchers found that the risks of hospitalization and death from the Omicron variant (B.1.1.529) were similar to the risk of hospitalization or death for past SARS-CoV-2 variants when controlling for comorbidities and vaccination status, suggesting the Omicron variant is not less severe than other variants as some previously reported.

From PLoS ONE, a study examining the clinical outcomes of cancer patients with COVID-19 infections. The research team examined EHRs of 271,639 COVID-19 patients, 10,426 of whom had received a cancer diagnosis at least 1 year prior to their infection. They found that those with cancer diagnoses had a higher risk of 30-day COVID-19 mortality and hospitalization than those without cancer diagnoses, and individuals with a recent diagnosis and or undergoing cancer treatment at the time of COVID-19 diagnosis had an even higher risk of worse outcomes.