Friday, June 25, 2021

President “Hoax” and his “minor” virus

Inside the extraordinary effort to save Trump from covid-19

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Inside the extraordinary effort to save Trump from covid-19

Damian Paletta and Yasmeen Abutaleb

Thu, June 24, 2021, 12:30 PM

(EDITORS: This article is adapted from "Nightmare Scenario: Inside the Trump Administration's Response to the Pandemic That Changed History," which will be published June 29 by HarperCollins.)

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Health and Human Services Secretary Alex Azar's phone rang with an urgent request: Could he help someone at the White House obtain an experimental coronavirus treatment, known as a monoclonal antibody?

If Azar could get the drug, what would the White House need to do to make that happen? Azar thought for a moment. It was Oct. 1, 2020, and the drug was still in clinical trials. The Food and Drug Administration would have to make a "compassionate use" exception for its use since it was not yet available to the public. Only about 10 people so far had used it outside of those trials. Azar said of course he would help.

Azar wasn't told who the drug was for but would later connect the dots. The patient was one of President Donald Trump's closest advisers: Hope Hicks.

A short time later, FDA Commissioner Stephen Hahn received a request from a top White House official for a separate case, this time with even greater urgency: Could he get the FDA to sign off on a compassionate-use authorization for a monoclonal antibody right away? There is a standard process that doctors use to apply to the FDA for unapproved drugs on behalf of patients dealing with life-threatening illnesses who have exhausted all other options, and agency scientists review it. The difference was that most people don't call the commissioner directly.

The White House wanted Hahn to say yes within hours. Hahn, who still did not know who the application was for, consulted career officials. The FDA needs to go by the book, the officials insisted. Hahn relayed the message back to the White House. They kept pressing him to effectively cut corners. No, we can't do that, Hahn told them several times. We're talking about someone's life. We have to actually examine the application to make sure we're doing it safely.

Video: How Trump maintains his power over the Republican Party

How Trump maintains his power over the Republican Party

Former president Donald Trump has remained the main driver of the Republican Party priorities, despite losing his reelection bid in 2020.

When Hahn later learned the effort was on behalf of the president, he was stunned. For God's sake, he thought, it's the president who's sick, and you want us to bend the rules? Trump was in the highest-risk category for severe disease from covid-19 - at 74, he rarely exercised and was considered medically obese. He was the type of patient with whom you would want to take every possible precaution. As it did with all compassionate-use applications, the FDA made a decision within 24 hours. Agency officials scrambled to figure out which company's monoclonal antibody would be most appropriate given the clinical information they had, and selected the one from Regeneron, known simply as Regen-Cov.

A five-day stretch in October 2020 - from the moment White House officials began an extraordinary effort to get Trump lifesaving drugs to the day the president returned to the White House from the hospital - marked a dramatic turning point in the nation's flailing coronavirus response. Trump's brush with severe illness and the prospect of death caught the White House so unprepared that they had not even briefed Vice President Mike Pence's team on a plan to swear him in if Trump became incapacitated.

For months, the president had taunted and dodged the virus, flouting safety protocols by holding big rallies and packing the White House with maskless guests. But just one month before the election, the virus that had already killed more than 200,000 Americans had sickened the most powerful person on the planet.

Trump's medical advisers hoped his bout with the coronavirus, which was far more serious than acknowledged at the time, would inspire him to take the virus seriously. Perhaps now, they thought, he would encourage Americans to wear masks and put his health and medical officials front and center in the response. Instead, Trump emerged from the experience triumphant and ever more defiant. He urged people not to be afraid of the virus or let it dominate their lives, disregarding that he had had access to health care and treatments unavailable to other Americans.

It was, several advisers said, the last chance to turn the response around. And once the opportunity passed, it was the point of no return.

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The week leading up to Trump's infection was frenzied, even by his standards. On Saturday, Sept. 26, he had hosted a party with scores of maskless attendees to announce Amy Coney Barrett as his pick for Supreme Court justice. The celebrations had continued indoors, where most people remained maskless. By that time, the virus was surging again, but Trump's contempt for face coverings had turned into unofficial White House policy. He actually asked aides who wore them in his presence to take them off. If someone was going to do a news conference with him, he made clear that he or she was not to wear a mask by his side.

The day after the Supreme Court celebration, Trump had also hosted military families at the White House. At Trump's insistence, few were wearing masks, but they were packed in a little too tight for his comfort. He wasn't worried about others getting sick, but he did fret about his own vulnerability and complained to his staff afterward. Why were they letting people get so close to him? Meeting with the Gold Star families was sad and moving, he said, but added, "If these guys had covid, I'm going to get it because they were all over me." He told his staff that they needed to do a better job of protecting him.

Two days after that, he flew to Cleveland for the first presidential debate against his Democratic challenger, Joe Biden. Trump was erratic that whole evening, and he seemed to deteriorate as the night went on. The pundits' verdicts were brutal.

Almost 48 hours later, Trump became terribly ill. Hours after his tweet announcing he and first lady Melania Trump had coronavirus infections, the president began a rapid spiral downward. His fever spiked, and his blood oxygen level fell below 94 percent, at one point dipping into the 80s. Sean Conley, the White House physician, attended the president at his bedside. Trump was given oxygen in an effort to stabilize him.

The doctors gave Trump an eight-gram dose of two monoclonal antibodies through an intravenous tube. That experimental treatment was what had required the FDA's sign-off. He was also given a first dose of the antiviral drug remdesivir, also by IV. That drug was authorized for use but still hard to get for many patients because it was in short supply.

Typically, doctors space out treatments to measure a patient's response. Some drugs, such as monoclonal antibodies, are most effective if they're administered early in the course of an infection. Others, such as remdesivir, are most effective when they're given later, after a patient has become critically ill. But Trump's doctors threw everything they could at the virus all at once. His condition appeared to stabilize somewhat as the day wore on, but his doctors, still fearing he might need to go on a ventilator, decided to move him to the hospital. It was too risky at that point to stay at the White House.

Many White House officials and even his closest aides were kept in the dark about his condition. But after they woke up to the news - many of them were asleep when Trump tweeted at nearly 1 a.m. on Friday that he had the virus - Cabinet officials and aides lined up at the White House to get tested. A large number had met with him the previous week to brief him about various issues or had traveled with him to the debate.

It was unclear even to Trump's closest aides just how sick he was. Was he mildly ill, as he and Conley were saying, or was he sicker than they all knew? Trump was supposed to join a call with nursing home representatives later that day as part of his official calendar. Officials had been scheduled to do it in person from the White House, but that morning they were informed the call would be done remotely. Trump's aides insisted that he would still be on it.

As one aide waited in line for a coronavirus test, she saw Conley sprint out of his office with a panicked look. That's strange, the aide thought. An hour or two later, officials were informed that Pence would be joining the nursing homes call. Trump couldn't make it.

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Trump's condition worsened early Saturday. His blood oxygen level dropped to 93 percent, and he was given the powerful steroid dexamethasone, which is usually administered if someone is extremely ill (the normal blood oxygen level is between 95 and 100 percent). The drug was believed to improve survival in coronavirus patients receiving supplemental oxygen. The president was on a dizzying array of emergency medicines by now - all at once.

Throughout Trump's time in the hospital, his doctors consulted with the medical experts on the White House coronavirus task force whom the president had long ago discarded. They talked to Hahn, National Institute of Allergy and Infectious Diseases Director Anthony Fauci and Centers for Disease Control and Prevention Director Robert Redfield, seeking input about his treatment.

Trump and his aides had ignored numerous warnings from the task force doctors that they were putting themselves and everyone in the West Wing at risk by their cavalier behavior. Over the past eight months, Trump had come dangerously close to the virus a number of times. Those repeated escapes had made the White House more careless, constantly tempting fate. Deborah Birx, the White House coronavirus task force coordinator, and Redfield wrote to top aides after every White House outbreak, warning them that 1600 Pennsylvania Avenue was not safe. Birx took her concerns to Pence directly. This is dangerous, she told him. If White House staff can't or won't wear masks, they need to be more than 10 feet away from one another. This is just too risky.

Their warnings had gone unheeded, and now some would pay a price. Trump hadn't wanted to go to the hospital, but his aides had spelled out the choice: He could go to the hospital Friday, while he could still walk on his own, or he could wait until later, when the cameras could capture him in a wheelchair or gurney. There would be no hiding his condition then.

At least two of those who were briefed on Trump's medical condition that weekend said he was gravely ill and feared that he wouldn't make it out of Walter Reed. People close to Trump's chief of staff, Mark Meadows, said he was consumed with fear that Trump might die.

It was unclear if one of the medications, or their combination, helped, but by Saturday afternoon Trump's condition began improving. One of the people familiar with Trump's medical information was convinced the monoclonal antibodies were responsible for the president's quick recovery.

Throughout the day Saturday, Oct. 3, the restless Trump made a series of phone calls to gauge how his hospitalization was being received by the public. In all likelihood, the steroid he was taking had given him a burst of energy, though no one knew how long it would last. Perhaps buoyed by that, Trump continued to post on Twitter from the hospital, anxious to convey that he was upright and busy. At one point Trump even called Fauci to discuss his condition and share his personal assessment of the monoclonal antibodies he had received. He said it was miraculous how quickly they made him feel much better.

"This is like a miracle," Trump told his campaign adviser Jason Miller in another one of his calls from the hospital. "I'm not going to lie. I wasn't feeling that great."

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Redfield spent the weekend Trump was sick praying. He prayed the president would recover. He prayed that he would emerge from the experience with a newfound appreciation for the seriousness of the threat. And he prayed that Trump would tell Americans they should listen to public health advisers before it was too late. The virus had begun a violent resurgence. Redfield, Fauci, Birx and others felt they had limited time to persuade people to behave differently if they were going to avoid a massive wave of death.

There were few signs that weekend that Trump would have a change of heart. It had already been a battle to get him to agree to go to Walter Reed in the first place. Now, he was badgering Conley and others to let him go home early. Redfield heard Trump was insisting on being discharged and called Conley on the phone. The president can't go home this early, Redfield advised the doctor. He was a high-risk patient, and there were no guarantees that he wouldn't backslide or experience some complication. (Many covid-19 patients seemed to be on an upswing and then quickly deteriorated.) Trump needed to stay in the hospital until that risk had passed. Conley agreed but said the president had made up his mind and couldn't be convinced otherwise.

If they couldn't keep him in the hospital, the advisers hoped that Trump would at least emerge from Walter Reed a changed man. Some even began mentally preparing to finally speak their minds. It would surely be the inflection point, they all thought. There's nothing like a near-death experience to serve as a wake-up call. It was, at the end of the day, a national security failure. The president had not been protected. If this fiasco wasn't the turning point, what would be?

Just as the country had been watching a few days before, many people tuned in again as Trump took Marine One back to the White House's South Lawn on Monday night. They saw him step out in a navy suit, white shirt and blue-striped tie, with a medical mask on his face. He walked along the grass before climbing the steps to the Truman Balcony.

But Trump didn't go inside. It was a moment of political theater too good to pass up - as suffused with triumph as his trip Friday had been humbling. He turned from the center of the balcony and looked back toward Marine One and the television cameras. It was clear that he was breathing heavily from the long walk and the climb up the flight of stairs.

Redfield was watching on television from home. He was praying as Trump went up the steps. Praying that he would reach the Truman Balcony and show some humility. That he would remind people that anyone could be susceptible to the coronavirus - even the president, the first lady and their son. That he would tell them how they could protect themselves and their loved ones.

But Trump didn't waver. Facing the cameras from the balcony, he used his right hand to unhook the mask loop from his right ear, then raised his left hand to pull the mask off his face. He was heavily made up, his face more orange tinted than in the photos from the hospital. The helicopter's rotors were still spinning. He put the mask into his right pocket, as if he was discarding it once and for all, then raised both hands in a thumbs-up. He was still probably contagious, standing there for all the world to see. He made a military salute as the helicopter departed the South Lawn, and then strode into the White House, passing staffers on his way and failing to protect them from the virus particles emitted from his nose and mouth.

Right then, Redfield knew it was over. Trump showed in that moment that he hadn't changed at all. The pandemic response wasn't going to change, either.

Above is from:  https://www.yahoo.com/news/inside-extraordinary-effort-save-trump-193026513.html

June 25: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

The Center also produces US Travel Industry and Retail Supply Chain Updates. You can access them here.

Starting next week, we will shift to 1 detailed epidemiological analysis each week. We will continue to publish 2 situation reports per week, including the high-level epi data, but the in-depth epi analysis will only be included on Fridays.

EPI UPDATE The WHO COVID-19 Dashboard reports 180 million cumulative cases and 3.9 million deaths worldwide as of 4:30am EDT on June 25.

While African countries have largely contained their respective COVID-19 epidemics, the continent as a whole has exhibited a substantial increase in daily incidence since mid-May. Africa’s daily incidence has more than tripled since its most recent low on May 17, increasing from 7,849 new cases per day to 26,250. If it continues on this trajectory, Africa could soon surpass its highest peak (32,750). On a per capita basis, the only continent reporting fewer daily cases is Oceania, but if it continues on this trajectory, Africa’s per capita daily incidence could potentially reach the same range as Asia, Europe, and North America. Previously, Africa has briefly exhibited higher per capita daily incidence than Asia, but it has not really been close to Europe or North America until now. In terms of total daily incidence, Africa surpassed North America on June 22. The last time Africa reported higher total daily incidence than any continent other than Oceania was July 2020, when the peak of Africa’s first wave briefly exceeded Europe’s low between its first and second waves.

Many countries in sub-Saharan Africa are reporting substantial increases in daily incidence. In fact, at least 14 countries are reporting relative biweekly changes of +100% or higher, mostly in Central, Eastern, and Southern Africa. Notably, the biweekly change is +1,363% in Lesotho; +791% in South Sudan; +694% in Rwanda; and +649% in Zimbabwe. In West Africa, Gambia, Liberia, and Sierra Leone are reporting biweekly increases of more than 300%. Namibia and South Africa are exhibiting the longest surges, starting in early May (or possibly mid-April for South Africa), with daily incidence increasing by a factor of 13 and 10, respectively, since that time. Zambia’s surge began closer to mid-May, and its daily incidence is now more than 50 times higher than it was at that time—up from fewer than 50 new cases per day to more than 2,500. The remaining countries’ surges began around early June. Fortunately, most of these countries are still reporting fewer than 100 new cases per day, and the large relative changes are principally a factor of very low daily incidence at the start of the surge—in some instances, fewer than 10 new cases per day. But Zambia’s surge illustrates the risk that even epidemics that were once largely contained can accelerate rapidly to substantial levels of community transmission.

South Africa, the most severely affected country in Africa, is combating its third wave and quickly approaching its highest peak. Namibia and Zambia have already set new records for daily incidence. Analysis from Reuters indicates that Sierra Leone, Rwanda, and Zambia are all reporting record-high daily incidence, and the Democratic Republic of the Congo and Namibia are currently reporting at least 90% of their highest peak.

Looking globally, Africa continues to stand out as having among the lowest vaccination coverage, illustrating the critical importance of providing international support and increasing access to vaccine doses. Only 10 countries in Africa are reporting 1+ dose coverage greater than 5%, and only Mauritius and Seychelles are reporting greater than 30%. In terms of full vaccination, only 13 countries are reporting greater than 1% coverage, but data are not available for many countries. As a whole, Africa’s 1+ dose vaccination coverage is 2.6%, 14 percentage points below Oceania and approximately one-tenth the global average (22.6%). Similar trends are evident with respect to full vaccination.

Most countries in Africa have limited genomic sequencing data available, which limits the ability to understand changes in prevalence for emerging SARS-CoV-2 variants. South Africa is one of the few countries with enough sequence data available to provide some indication of these changes. There, the Beta variant (B.1.351) became the dominant strain over the course of 2020 and has remained dominant through the first half 2021. The Delta variant began to emerge in late April, and its prevalence appears to be increasing rapidly. Alpha variant (B.1.1.7) prevalence began to increase around the same time, but the Gamma variant (P.1) does not represent a meaningful proportion of new cases. The extent to which the Delta variant is driving the ongoing surges in Africa remains uncertain, but similar associations have been observed in other parts of the world.

Global Vaccination

The WHO reported 2.6 billion doses of SARS-CoV-2 vaccines administered globally as of June 24, and 1.03 billion individuals have received at least 1 dose. After a period of steady increase, the global daily doses administered decreased slightly from the record high of 41.6 million doses per day on June 23 to 41.2 million yesterday. Our World in Data estimates there are 806 million people worldwide who are fully vaccinated, corresponding to 10.3% of the global population, although reporting is less complete than for other data.

UNITED STATES

The US CDC reported 33.4 million cumulative COVID-19 cases and 600,442 deaths. The US surpassed 600,000 cumulative deaths on June 22, the first country to do so:

1 death to 100k*- 84 days

100k to 200k- 113 days

200k to 300k- 86 days

300k to 400k- 33 days

400k to 500k- 33 days

500k to 600k- 130 days

*From February 29, 2020, the date of the first reported COVID-19 death in the US. Since then, health officials have identified more than 200 COVID-19 deaths that occurred prior to that date.

The CDC updated its SARS-CoV-2 genomic surveillance data, adding official data for May 23-June 5 and projections for June 6-19. Including the new projection period, the Delta variant (B.1.617.2) prevalence has increased from less than 1% to 20.6% over a period of 8 weeks, more than doubling in every 2-week period. Based on the current projection, the Delta variant is now the #2 variant nationwide. Gamma variant (P.1) prevalence also continues to increase steadily, now up to 16.4% of new cases. While still technically dominant based on the estimated prevalence, Alpha variant (B.1.1.7) prevalence has noticeably decreased over the past 2 reporting periods, down from a high of 70% to 52.2% in the June 6-19 projection. Combined, the Alpha, Gamma, and Delta variants account for more than 90% of all new cases in the US. These genomic data provide further evidence that the Delta variant is poised to become the dominant variant in the US over the coming weeks. In fact, the projection indicates that Delta is already the dominant variant in HHS Regions 7 (Central; 47.5%) and 8 (Mountain; 46.4%).

US Vaccination

The US has distributed 379 million doses of SARS-CoV-2 vaccines and administered 321 million. A total of 178 million individuals in the US have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 53.7% of the entire US population. Among adults, 65.7% have received at least 1 dose, and 8.5 million adolescents aged 12-17 years have received at least 1 dose. A total of 151 million individuals are fully vaccinated, which corresponds to 45.6% of the total population. Among adults, 56.2% are fully vaccinated, and 6.0 million adolescents aged 12-17 years are fully vaccinated.

mRNA VACCINES & MYOCARDITIS/PERICARDITIS The US CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting this week as part of ongoing evaluation of SARS-CoV-2 vaccine safety and efficacy data. A major portion of this week’s meeting addressed emerging data regarding the risk of myocarditis and pericarditis—inflammation of the heart muscle and lining around the heart, respectively—following vaccination. Researchers presented data collected from several systems the CDC uses to monitor for adverse events after vaccination.

The data indicate there is a “likely association” between the mRNA-based SARS-CoV-2 vaccines, from Pfizer-BioNTech and Moderna, and elevated risk of myocarditis and pericarditis in adolescents and younger adults, although the risk appears to be very low. The rates of myocarditis/pericarditis are higher in males than females, and the conditions are more common after the second dose of the vaccine. The analysis estimates the overall rate of myocarditis/pericarditis to be 12.6 cases per million second doses of the vaccines in individuals aged 12-39 years old. The conditions tend to present within approximately 5 days, and while most of the affected individuals were hospitalized, symptoms were generally mild and most recovered quickly. To our knowledge, neither condition has resulted in death among recently vaccinated individuals.

Importantly, the available data indicate that the benefits of vaccination still far outweigh the risks of myocarditis/pericarditis. Even for males aged 12-17 years—the group with the lowest COVID-19 risk and highest myocarditis/pericarditis risk—risk and benefit calculations* estimate that 1 million second doses of the mRNA vaccines would prevent 5,700 COVID-19 cases, 215 hospitalizations, and 2 deaths, compared to 56-69 cases of myocarditis/pericarditis. A group of prominent public health and healthcare organizations—including HHS, CDC, and the American Academy of Pediatrics—issued a statement emphasizing the rarity of myocarditis/pericarditis following vaccination and encouraging all eligible individuals to get vaccinated. The US FDA is expected to update associated information for the mRNA vaccines, and the CDC continues to recommend SARS-CoV-2 vaccination to all eligible age groups.

*Calculated over a 120-day period.

US VACCINATION COVERAGE White House Coronavirus Response Coordinator Jeff Zients said the US will not reach US President Joe Biden’s goal of 70% of adults receiving at least 1 dose of SARS-CoV-2 vaccine by July 4. With the expectation now being that the US will fall slightly short of that benchmark, the White House issued a new goal of at least 1 dose of vaccine to 70% of adults aged 27 years and older by July 4. Currently, 150 million people are fully vaccinated, and Mr. Zients said that the US is expected to reach 160 million by mid-July.

As we have discussed previously, there are some regional disparities in terms of vaccination coverage in the US. In particular, several states in the South and West regions are lagging behind in their vaccination campaigns. Fewer than 40% of adults in Alabama, Mississippi, Louisiana, Idaho, and Wyoming have received at least 1 dose. Though Missouri is reporting 44% of adults receiving at least one dose, health officials are concerned about several counties in the south and north of the state reporting well below that rate, with one county reporting only 13% vaccination coverage. There is concern that lagging interest in vaccination among younger adults could provide a large enough unprotected population to continue fueling COVID-19 surges. At one hospital in Springfield, Missouri, nearly two-thirds of COVID-19 patients in the ICU last weekend were under 40 years old. In Missouri, Arkansas, and Utah, COVID-19 hospital admissions have increased more than 30% since the beginning of June. The Mayo Clinic’s ”hot spot” map shows Missouri as one of only 2 states reporting more than 10 daily cases per 100,000 population—the other being Nevada. The states reporting between 5 and 10 are largely located in the Southeast and Western portions of the country.

As the prevalence of variants of concern (VOCs) increases, including the Delta variant, vaccination remains a critical tool for containing community transmission and protecting against severe disease and death. Analysis from the Associated Press found that “breakthrough” infections accounted for only 0.1% of US COVID-19 cases in May, and only 0.8% of the 18,000 COVID-19 deaths were among fully vaccinated individuals. Previously, Dr. Andy Slavitt—former White House COVID-19 advisor—estimated that 98-99% of COVID-19 deaths are among unvaccinated individuals.

DELTA VARIANT The Delta variant (B.1.617.2) currently accounts for an estimated 20% of new COVID-19 cases in the US and likely will become the dominant strain in a matter of weeks, according to White House Chief Medical Advisor Dr. Anthony Fauci, who also noted the variant as the United States’ greatest threat in dealing with COVID-19. The European CDC (ECDC) Threat Assessment for the Delta variant projects that the variant will be responsible for 90% of cases by the end of August. Russia has already reached that threshold, where 90% of new cases in Moscow are being attributed to the Delta variant. This variant of concern (VOC) has been reported in 85 countries, is 40-60% more transmissible than Alpha (B.1.1.7), and may be associated with a higher risk of hospitalization.

According to a Public Health England study, a single dose of either the Pfizer or AstraZeneca vaccines reduced a person’s risk of developing COVID-19 symptoms caused by the Delta variant by 33%, compared to 50% for the Alpha variant. A second dose of AstraZeneca brought protection to 60% (66% for Alpha), and a second dose of Pfizer increased protection to 88% (90% for Alpha). A Scottish study found an increased likelihood of hospitalization among patients infected with the Delta variant, nearly double the risk for the Alpha variant. Additionally, that study showed that among fully vaccinated individuals, Pfizer’s vaccine provided 79% protection against the Delta variant, while it offered 92% against the Alpha variant. Vaccination with the AstraZeneca vaccine showed substantial but reduced results among those fully vaccinated, with 60% efficacy against the Delta variant and 73% protection against the Alpha variant. These studies underline the importance of vaccination as a tool to reduce hospitalizations and disease severity among COVID-19 patients.

CUBAN VACCINES Cuban health authorities on June 21 released new data on the nation’s home-grown Abdala SARS-CoV-2 vaccine, showing efficacy on par with several existing vaccines. As noted in previous updates, Cuba had foregone outside assistance when it came to vaccine imports, choosing to hold off and vaccinate its population with the 3-dose Abdala vaccine. The country began vaccinations in May, prior to the completion of studies examining the vaccine’s efficacy, in parts of the country where SARS-CoV-2 was spreading quickly. New results from the manufacturer’s Phase 3 trial suggest that this early vaccination initiative may have paid off. Abdala showed 92.28% efficacy among individuals who received all three doses. Following the announcement of these results, study organizers shared they would be opening the study codes of the Phase 3 clinical trial to vaccinate all participants who received the placebo.

Cuban health officials also announced that a second vaccine candidate, Sovereign 02, boasted 62% efficacy following its two-dose schedule. These are encouraging results, especially given the epidemiological backdrop of Cuba’s COVID-19 outbreak. Cuba is in the midst of a peak of COVID-19 cases, reporting a record-high 7-day average of new cases of about 1,625. The rate of people who have been vaccinated continues to increase alongside this change in the country’s epidemiological situation, with just over 20% of the population having received at least one dose of a COVID-19 vaccine. Hopefully, recent clinical trial results will spur vaccination rates to counter increased disease activity.

CHINESE VACCINE EFFECTIVENESS Several countries that mostly relied on the Chinese Sinopharma and Sinovac Biotech vaccines are currently facing large outbreaks. Despite high vaccination coverage, Seychelles, Bahrain, Chile, and Mongolia have all reported their highest daily incidence since mid-May*, all after reaching 50% coverage with at least 1 dose. In March, Seychelles was one of the world’s most vaccinated countries, with approximately 57% of its vaccinations using the Sinopharm vaccine. Between 50-68% of the population has been fully vaccinated in these countries, compared to 45% in the US, raising some questions regarding the effectiveness of the vaccines.

*Chile’s peak on June 8 was within 30 new cases per day (0.04%) of its highest peak.

Breakthrough infections are certainly possible, as no vaccine is 100% effective, but lower efficacy for the 2 Chinese-made vaccines and the role of emerging variants could be driving the increases in daily incidence in these countries. The Sinopharm vaccine’s efficacy rate is estimated to be 78.1%, and the Sinovac vaccine’s is 51%. In comparison, the Pfizer-BioNTech and Moderna vaccines have over 90% efficacy, AstraZeneca-Oxford is at 63%, and J&J-Janssen has 85%. Bahrain has now begun offering booster shots of the Pfizer-BioNTech vaccine to those who originally received the Sinopharm vaccine, which accounts for about 60% of the doses administered there. More than 95 countries have received doses of the Chinese-produced vaccines.

AFRICA Africa is facing a rapidly increasing third surge, with the number of new COVID-19 cases rising for 5 consecutive weeks since the beginning of this wave on May 3. At the current rate of infection, the third surge will surpass the previous one by early July, with at least 12 nations experiencing case increases. Experts are citing the spread of the Delta variant (B.1.617.2) as one factor influencing this latest surge, with 14 nations across the continent reporting cases of the variant. In Kisumu, Kenya, health officials say Delta is driving an upswing in cases, particularly among young people, and have expressed fear that a wave of infections like that seen in India in April and May could be on the horizon. Weak adherence to public health measures, including an increase in social gatherings and movement, also is contributing to a rise in infections. Many hospitals are overwhelmed, and a shortage of oxygen on the continent is hindering patient care for those who do find beds.

Only about 1.1% of the continent’s population is fully vaccinated. According to WHO Regional Director for Africa Dr. Matshidiso Moeti, the continent needs an additional 215 million vaccine doses to fully vaccinate 10% of its population, and about 700 million doses to reach 30% of the population by the end of the year. Eighteen (18) countries have used 80% of their doses received through COVAX, with 8 of those having exhausted their supplies, and another 29 nations having used more than 50% of their doses. Just under 1.5% of the 2.7 billion vaccine doses administered globally have been administered in Africa. Many health experts were confused by how African countries initially kept COVID-19 at arm’s length, and if this surge proves as devastating as India’s latest, a collective failure of the international community to adequately support the continent could be to blame.

AUSTRALIA The Australian government has run a highly effective COVID-19 response, with efforts to close borders and enforce physical distancing rules limiting the cumulative number of COVID-19 cases to just over 30,300. The country has seen only two spikes of COVID-19 incidence, with the latter tapering off around the end of September 2020. Roughly 11% of Australia’s cumulative COVID-19 cases have come since the beginning of October 2020, representing a slow burn of new cases. These new cases have come in small outbreaks, forcing the Australian government to enact stricter public health measures intermittently. Notably, a recent outbreak in Queensland of nine cases is being attributed to the Delta SARS-CoV-2 variant. Health officials have expanded mandates on mask wearing, citing concerns of the Delta variant’s heightened transmissibility. A separate and larger COVID-19 outbreak of the Delta variant is ongoing in Sydney, leading the city to implement stricter public health measures to limit the spread of the virus. The Australian government has raised concerns over the longevity of its response measures in light of these recent clusters of new cases. Nearly 25% of the country’s adults have received one dose of vaccine, but less than 5% are fully vaccinated. The low vaccination rates have led some to question whether the nation is prioritizing contact tracing and testing over vaccination, while some experts blame shortfalls in expected vaccine shipments for lagging rates.

ISRAEL Israel reinstated its indoor mask mandate today, less than 2 weeks since the mandate was dropped on June 15. Public Health Director Dr. Sharon Alroy-Preis said the Ministry of Health previously determined the mask mandate should be reintroduced if Israel records a daily average of 100 new COVID-19 cases over one week. As of June 24, the rolling 7-day average of confirmed cases was 99.57, with daily incidence rising, according to Our World In Data. Israel’s coronavirus czar Dr. Nachman Ash announced the country recorded 227 new cases on June 24, though he said he does not feel the nation is entering a fourth surge. Dr. Alroy-Preis blamed a lack of adherence to mandatory quarantine rules for travelers from high-risk countries for the introduction of the Delta variant into the country, one of the causes of the latest outbreak, and she called on the government to more strongly enforce the rules. Israel is one of the world’s most vaccinated countries, but the Delta variant is driving new cases among unvaccinated children and vaccinated individuals, who account for as much as 50% of new cases. However, there is not yet enough data to conclude the vaccines’ effectiveness against the Delta variant, according to Dr. Alroy-Preis. Prime Minister Naftali Bennett, who took office last week, announced the government will reestablish its coronavirus cabinet to assist in future decisions related to the pandemic.

Belvidere Park District Pool to open June 30

William Grady Pool to open June 30 after new management agreement

June 25, 2021 11:33 amAndrew CarriganTOP STORIES

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William Grady Pool

BELVIDERE (WREX) — After delaying the start of the season, families in Belvidere will soon be able to return to William Grady Pool.

The Belvidere Park District announced on Friday a partnership with the Belvidere Family YMCA that will allow the pool to reopen on
Thursday, June 30.

Earlier this month, the park district announced they would be delaying their opening due to the national life guard shortage.

“This is a great example of two Belvidere institutions coming together for the overall benefit of the community,” said Rick Wulbecker, Superintendent of Recreation for the Belvidere Park District. “And while the situation (of staffing issues at pools around the country) is not exclusive to us, it put us in a tenuous position for opening the pool safely."

The park district says masks will not be required, but the concessions stand will be closed. Patrons will be allowed to bring their own food, however.

"We are proud to be part of such a strong collaboration, to swiftly come together to continue the community's long-standing tradition of summer at the William Grady Pool," said Jen Jacky, CEO of the Belvidere Family YMCA.

Here's the pool's opening weekend schedule:

  • Wednesday, June 30, soft open, hours Noon- 4 p.m.
  • Thursday, July 1, full open, Noon-6 p.m.
  • Friday, July 2, Noon-8 p.m.
  • Saturday-Monday, July 3-5, Noon-6 p.m.

Author Profile Photo

Andrew Carrigan

Andy Carrigan is the Social Media & Digital Content Manager at WREX. He joined the 13 WREX team as a photographer in 2016 after graduating from Northern Illinois University.

Wednesday, June 23, 2021

June 22: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

The Center also produces US Travel Industry and Retail Supply Chain Updates. You can access them here.

EPI UPDATE The WHO COVID-19 Dashboard reports 178 million cumulative cases and 3.9 million deaths worldwide as of 7:00am EDT on June 22. Global weekly incidence and mortality decreased for the seventh consecutive week. Global incidence fell by 5.5% compared to the previous week, and mortality decreased by 11.75%.

On June 19, Brazil surpassed 500,000 cumulative COVID-19 deaths, the second country to do so after the US. If it continues on this trajectory, Brazil could surpass the US as #1 globally in terms of cumulative mortality, but it is still approximately 100,000 deaths behind. Brazil remains #3 globally in terms of cumulative incidence; however, the US and India are both reporting declining daily incidence, whereas Brazil’s epidemic continues to accelerate. Over the past several days, Brazil surpassed India as #1 globally in terms of both daily incidence (June 17) and daily mortality (June 20).

Global Vaccination

The WHO reported 2.4 billion doses of SARS-CoV-2 vaccines administered globally as of June 21, and 983 million individuals have received at least 1 dose. Our World in Data is reporting 2.66 billion cumulative doses administered globally, an increase of 11% compared to this time last week. The global daily doses administered is once again increasing, largely driven by trends in Asia, up to a new record high of 39.8 million doses per day. Our World in Data estimates there are 782 million people worldwide who are fully vaccinated, slightly more than 10% of the global population, although reporting is less complete than for other data.

UNITED STATES

The US CDC reported 33.4 million cumulative COVID-19 cases and 599,354 deaths. We expect the US to officially surpass 600,000 cumulative deaths in this afternoon’s or tomorrow’s update.

The rate of decline in the United States’ COVID-19 incidence is beginning to taper off. This was inevitable as the US appears to be entering the “long tail” of its COVID-19 epidemic, but there is some concern that the slowing progress could be a function of increasing prevalence of the Delta variant of concern (B.1.617.2; VOC). The US CDC publishes genomic sequencing data, both at the national and regional levels, and this week, we will analyze trends in VOCs, including Delta, that could potentially impact COVID-19 incidence. Official data are available through May 22 and are updated every 2 weeks; however, the CDC also displays its “Nowcast” projections for the next 2-week period, through June 5. The CDC’s SARS-CoV-2 genomic surveillance represents a relatively small fraction of reported cases, so the prevalence values are weighted estimates that account for “non-random sampling of sequencing data over time and across states.”

From February 28 through May 22, the proportion of sequences corresponding to the Alpha variant (B.1.1.7) increased significantly, from 26.6% to 69.5%, becoming the dominant variant over that period. The prevalence of the Gamma variant (P.1) also increased, from 0.5% to 8.4%, the #2 variant in the US as of May 22. The proportion of sequences corresponding to the Delta variant (B.1.617.2) increased slowly from February 27 through May 22 (0.0% to 2.7%); however, it jumps to 9.9% in the CDC’s Nowcast projection for May 23-June 5, which would make it the #3 variant nationwide. If this jump is indicative of a longer-term increasing trend, the Delta variant could quickly become the dominant variant in the US. The Nowcast projection also shows another, smaller jump for the Gamma variant, from 8.4% up to 11.6%. The projected prevalence of the Alpha variant fell slightly to 65.5%, and all other variants are projected to represent fewer than 5% of new cases nationwide.

At the regional level, the Alpha variant remains the dominant strain in all 10 HHS regions as of May 22, but the Nowcast projection potentially signals major changes in the coming weeks. For the period ending May 22, the Alpha variant prevalence ranges from 51.7% in Region 1 (New England) to 76.6% in Region 7 (Central), and it is more than 70% in most regions. Interestingly, Region 7 also represents the highest Delta variant prevalence, with 7.3%. Region 3 (Mid-Atlantic) has the lowest Delta variant prevalence, with only 1.4%. In the Nowcast projection for May 23-June 5, the Alpha variant still represents more than 50% sequences in all but 1 region, with only Region 2 (New Jersey/New York) projected to be 49.7%. The projected prevalence is 50.4% in Region 1 (New England), which could indicate that the Alpha variant prevalence could soon drop below 50% in a second region. The Gamma variant is #2 in Region 1 (17.5%), and the Delta variant is #2 in Region 2 (17.7%). The Gamma variant is also currently #2 in several other regions: 6 (South Central), 7 (Central), 8 (Mountain), and 9 (West Coast). The largest increases in the projected Delta variant prevalence are in Regions 7 (Central) and 8 (Mountain), with increases of 16.2 percentage points (pp) and 19.4pp, respectively. The Gamma variant is also projected to make substantial jumps in several regions, including Region 9 (+7.2pp), Region 1 (+6.3pp), and Region 10 (Pacific Northwest; +5.3pp).

In light of inconsistencies in reporting due to the Memorial Day holiday weekend (May 29-31), it is difficult to get a clear understanding of the current trends in daily incidence. The United States’ daily incidence is at its lowest point since early in the initial surge in March 2020, and while it has exhibited a relatively consistent overall decline since mid-April, it appears that the decline could be leveling off to some degree. Prior to the Memorial Day holiday weekend, the relative biweekly change was -35%, indicating a substantial decline. Reporting delays over the holiday contributed to further declines over the next 1.5-2 weeks, which brought the relative change down to a low of -44% on June 10. Since then, it increased to -24%, still indicating a decline, but to a lesser degree than before Memorial Day.

Notably, the new federal Juneteenth holiday weekend (June 18-20) could result in further disruptions to reporting, as will the upcoming Independence Day holiday weekend (July 3-5). Juneteenth (June 19) was only officially designated as a federal holiday last week, and with little advance notice, it is unclear to what extent state and local health departments across the country were closed on Friday, June 18, in observance of the holiday. With these 3 holidays in rapid succession, it could be difficult to identify longer-term trends in SARS-CoV-2 transmission, which could potentially mask impacts from VOCs, including the Delta variant, through the middle of July.

US Vaccination

The US surpassed 150 million fully vaccinated individuals on June 21. The US has distributed 379 million doses of SARS-CoV-2 vaccines and administered 319 million. The daily vaccine doses administered* continues to decline steadily, down from a high of 3.4 million doses per day on April 11 to 855,986 on June 16. The US is averaging 581,391 new fully vaccinated individuals per day.

*The US CDC does not provide a 7-day average for the most recent 5 days due to anticipated reporting delays for vaccine administration. This estimate is the most current value provided.

A total of 177 million individuals in the US have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 53.4% of the entire US population. Among adults, 65.4% have received at least 1 dose, and 8.4 million adolescents aged 12-17 years have received at least 1 dose. A total of 150 million individuals are fully vaccinated, which corresponds to 45.2% of the total population. Among adults, 55.9% are fully vaccinated, and 5.8 million adolescents aged 12-17 years are fully vaccinated. Progress has largely stalled among adults aged 65 years and older: 87.3% with at least 1 dose and 77.1% fully vaccinated. In terms of full vaccination, 79 million individuals have received the Pfizer-BioNTech vaccine, 59 million have received the Moderna vaccine, and 12 million have received the J&J-Janssen vaccine.

CUREVAC VACCINE CLINICAL TRIAL On June 16, CureVac announced preliminary efficacy results from a Phase 2b/3 clinical trial of its candidate SARS-CoV-2 vaccine. CureVac is based in Germany, but the studies included approximately 40,000 participants from across 10 countries in Europe and Latin America. The vaccine demonstrated an overall efficacy of 47% against any COVID-19 disease severity, falling short of the 50% threshold established early in the pandemic.

While the CureVac candidate vaccine uses an mRNA platform similar to those used in the Pfizer-BioNTech and Moderna vaccines, the estimated efficacy is much lower, approximately half of what was observed in those vaccines’ Phase 3 clinical trials. The exact cause for the lower efficacy is unclear; however, there are some potential factors that could contribute to the disparity. First, the CureVac clinical trials were conducted at a time when variants of concern (VOCs) are more prevalent around the world, and lower efficacy against these variants would impact the overall estimate. Additionally, the CureVac product uses a much smaller dose than other mRNA vaccines—12μg compared to 30μg or 100μg in the Pfizer-BioNTech and Moderna vaccines, respectively—which could potentially limit the magnitude of the immune response. One researcher who led one of the trials in Germany indicated that the lower efficacy is “very likely due to the dose.” The mRNA used in CureVac’s vaccine was slightly different from those in other vaccines, and it did not allow for higher doses due to increased risk of adverse events.

*125 of 134 total cases have genomic sequence data available for the interim analysis.

The CureVac press release indicates that final analysis is still underway, and the company will assess potential regulatory options once that is complete. While the vaccine’s performance may be viewed as disappointing compared to similar products already authorized for use, this example illustrates the extreme difficulties in developing novel vaccines, particularly on an accelerated timeline, and it should serve as a reminder of how fortunate we are that multiple of the early vaccine candidates successfully demonstrated such high efficacy.

DELTA VARIANT OF CONCERN Experts predict the highly transmissible Delta variant of concern, also known as B.1.617.2, will become the dominant strain in the US in the near future. As select states roll back pandemic guidelines and restrictions on social gatherings, the number of Delta variant cases has roughlydoubled every two weeks in the US, raising concerns among experts over the potential for breakthrough infections and localized outbreaks. US CDC Director Dr. Rochelle Walensky warned that transmission of the variant coupled with stagnating vaccination rates in some states could allow the variant to mutate enough to evade protection offered by the vaccines. Dr. Walensky and other experts continue to urge the public to get fully vaccinated, while others note an alarming trend in some states: people skipping their second dose. According to one study (preprint), 2-dose effectiveness of the Pfizer-BioNTech vaccine was 87.9% with the Delta variant, but only 33.5% after 1 dose.

According to data from the CDC and the US Department of Health and Human Services, 5 states—Alabama, Arkansas, Missouri, Oklahoma and Utah—have experienced increases of 37% or more in their 7-day daily case averages over the last two weeks. Notably, the vaccination rates in those 5 states are lower than the national average. Currently, 45.7% of the US population has been fully vaccinated. States with higher vaccination rates, including Vermont, Hawaii, and Massachusetts, have achieved levels of population immunity that could be more successful at keeping the Delta variant at bay.

Internationally, COVID-19 cases attributable to the Delta variant are rising sharply in parts ofIndonesia, including the capital Jakarta, which has seen an increase in the number of severe cases among younger adults. In Europe, experts are closely watching spikes in SARS-CoV-2 cases driven by the Delta variant. Officials in theUK and Portugal have reimplemented or held off on lifting lockdown measures due to an increasing number of cases, and experts in France, Germany, and Spain are monitoring clusters of Delta cases. The greater transmissibility and disease severity of the Delta variant could cause outbreaks to grow more serious more quickly than surges caused by previous variants.

GLOBAL COLLABORATION On June 21, the WHO and its COVAX partners announced they are working with a South African consortium to establish the African continent’s first COVID-19 mRNA vaccine technology transfer hub, aimed at scaling up SARS-CoV-2 vaccine production. Over the coming weeks, the partners—including Biovac, Afrigen Biologics and Vaccines, a network of universities, and the Africa CDC—will negotiate details with the government of South Africa and other stakeholders. The hub is expected to provide training and knowledge transfers on mRNA technologies that would allow manufacturers in low- and middle-income countries to produce the vaccines locally. However, the hub still needs to secure licensing agreements with vaccine manufacturers, notably Pfizer-BioNTech and Moderna, according to WHO officials, who noted those discussions are underway. Manufacturing at the South African hub is expected to begin in 9-12 months. South Africa President Cyril Ramaphosa praised the hub’s launch, calling it a historic step in the right direction, but he urged continued discussions on an intellectual property waiver under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS.

At the conclusion of this past weekend’s Summit for Vaccine Internationalism, led by countries from the global south, national health officials committed to openly collaborate on SARS-CoV-2 vaccine technologies, pool manufacturing capacity for vaccines and other medical supplies, and provide regulatory capacity support. Cuba and Mexico pledged to offer open licenses for their domestically developed vaccines, and Venezuela proposed creating a technology transfer platform similar to the WHO’s COVID-19 Technology Access Pool. While the COVID-10 pandemic has spurred remarkable and rapid collaboration among a variety of partners, some researchers are expressing concern that the benefits of collaboration could be hindered by geopolitical tensions and are not always shared equally. Additionally, global health experts continue to call for more robust efforts to increase access to and production of vaccines in low and middle income countries, underlining the mantra that the pandemic will not end until it’s under control in every country.

SOUTH AMERICA COVID-19 is surging across South America, which accounts for only 5% of the world’s population but 25% of the pandemic's death toll. Collectively, the region’s death rate per capita is 8 times the world’s rate. Nearly 1 million people have died of COVID-19 across 12 countries in South America, and the region holds 7 of the 10 countries worldwide with the highest daily death rates per capita.

In Brazil, tens of thousands of protestors took to the streets of cities nationwide on Saturday, with demonstrators blaming Brazil President Jair Bolsonaro for dismissing the seriousness of the pandemic. The Brazilian Senate is investigating President Bolsonaro’s handling of the nation’s pandemic response, including accusations he purposefully delayed vaccination efforts. Brazil passed 500,000 COVID-19-related deaths this past weekend, second only to the US and India, where the official death toll is 389,302 but is estimated to be up to 4.2 million. Nearly 18 million people have been infected with SARS-CoV-2 in Brazil, and the country is experiencing a daily average of nearly 73,500 new cases and around 2,000 deaths. Only 11.5% of residents are fully vaccinated. Notably, Brazil’s outbreak is being fueled by the Gamma variant, also known as P.1, which was first identified in the country’s Amazon region. The Oswaldo Cruz Foundation (Fiocruz), part of the nation’s Ministry of Health, warned the situation is “critical” and the onset of winter could result in even more infections.

PHILIPPINES VACCINATION According to multiple news media reports, Philippines President Rodrigo Duterte recently indicated that he could begin arresting individuals who refuse SARS-CoV-2 vaccination. President Duterte is known for “brash rhetoric,” but he has demonstrated the willingness to take extreme measures to combat other threats, such as his “war” on drugs. The extent to which President Duterte can or will implement efforts to mandate vaccinations remains unclear. In comments earlier this week, he indicated that he would direct local government officials to compile lists of individuals who refuse vaccination. Mandatory vaccination policies pose a number of practical and ethical challenges, and many experts argue that they may not necessarily be the best option for increasing vaccination coverage, particularly from the perspective of establishing trust in the government and response. The Philippines has administered at least 1 dose of SARS-CoV-2 vaccine to approximately 5.7% of its population, and nearly 2% are fully vaccinated.

LONG COVID/PASC Studies are ongoing to improve our understanding of the longer-term physical and mental health effects of SARS-CoV-2 infection. Previous studies have documented cardiovascular, respiratory, and neurological symptoms that can persist for months after recovery from SARS-CoV-2 infection, including in individuals who experienced mild or asymptomatic COVID-19 disease. A study conducted by FAIR Health investigated private health insurance claims associated with “Long-Haul COVID.” The study included nearly 2 million COVID-19 patients and looked for the presence of COVID-19-related symptoms 30 days or longer after recovery from acute COVID-19 disease. The researchers found that 23.2% of COVID-19 patients reported at least 1 symptom 30 days or longer after recovery. The prevalence of persistent symptoms was higher among patients with severe COVID-19, but persistent symptoms also were present in patients who were asymptomatic or mildly symptomatic during the acute stage of their infection. Additionally, patients of all ages were affected by longer-term health effects, including children.

Researchers in the UK found that COVID-19 could be associated with the loss of brain tissue after recovery, even among individuals with mild COVID-19 disease. The study (preprint) utilized brain scans taken as part of an ongoing Biobank study. The researchers compared scans taken before infection and after recovery for 394 COVID-19 patients, and compared them with 388 healthy control participants. The study documented loss of grey matter brain tissue in recovered COVID-19 patients, compared to the controls. The effects were observable in multiple parts of the brain, including areas that could potentially increase the risk of Alzheimer’s disease or dementia later in life. The researchers also compared hospitalized and non-hospitalized COVID-19 patients. There was potential evidence of an association between disease severity and brain tissue loss, but it was not statistically significant. Notably, there were only 15 hospitalized patients included in the study, which limited the available data. The availability of brain imagery from before the pandemic provided the researchers with an opportunity to directly observe changes in brain tissue in individuals who were later infected with SARS-CoV-2.

MONOCLONAL ANTIBODY TREATMENT Regeneron’s monoclonal antibody (mAb) combination treatment appears to reduce deaths in COVID-19 patients who are unable to mount their own antibody response, according to RECOVERY trial preliminary results. In the clinical trial, 24% of patients given a combination of two monoclonal antibodies (casirivimab and imdevimab) died, compared with 30% of patients given standard care (rate ratio 0.80; 95% CI 0.70–0.91; p=0.001). The study also saw a reduction in the median length of hospital stays for those given the treatment compared to the control group. Patients receiving Regeneron’s treatment also were significantly less likely to require mechanical ventilation.

While mAbs have been available for use during the majority of the pandemic, their relative effectiveness in decreasing deaths or improving clinical markers has been debated. Previous studies have shown that some patients greatly improve following mAb infusion while others show no improvement at all. The US government had previously purchased 1.5 million doses of the combination therapy after it received emergency use authorization from the FDA, but those doses have widely gone unused. With the availability of antibody tests, hospitals can now test COVID-19 patients for evidence of an antibody response, or lack thereof. In those patients with no discernible antibody response, the REGEN-COV could be a potentially life saving intervention. However, the therapy’s high price (around $1,400 per treatment) likely will inhibit greater uptake in high-income countries and could be cost-prohibitive in developing countries.

MODERNA VACCINE The US government recently signed an agreement to purchase 200 million more doses of the Moderna vaccine, including an option to buy experimental doses in development. The US order brings the nation's total number of Moderna doses purchased to 500 million. Moderna thus far has provided 217 million doses to the US and is expanding its manufacturing capacity to fulfill this contract and others in the future. Moderna has added two new production lines to its plant in Boston, Massachusetts. These and other additions will increase its manufacturing capacity by 50% by the end of 2022. Moderna is currently developing booster shots and other experimental vaccines aimed at targeting newer SARS-CoV-2 variants.

US CDC CRUISE SHIP REGULATION A federal judge on June 18 ruled the US CDC cannot enforce its COVID-19 conditional sailing orders—under which cruise lines were required to implement a phased approach to testing and other safety measures before they could start sailing—that were intended to prevent the spread of SARS-CoV-2 on Florida-based cruise ships. Florida challenged the CDC rules in April, arguing they were obstructing the cruise industry’s operations and causing the state to lose hundreds of millions of dollars. In his ruling, US District Court Judge Steven D. Merryday sided with the state, issuing a preliminary injunction to begin on July 18, when the conditional sailing order will exist only as non-binding guidelines. Judge Merryday wrote in the 124-page decision, “In a word, never has CDC implemented measures as extensive, disabling, and exclusive as those under review in this action.” The ruling orders both parties to return to mediation to work out a final solution, efforts that have previously failed; however, the CDC could appeal the decision. On June 16, the CDC lowered its risk level guidance from Level 4 “Very High” to Level 3 “High” for cruise ship passengers who are not fully vaccinated. 

SUMMER OLYMPICS & WORLD CUP The 2020 Summer Olympic Games are slated to proceed in Tokyo despite rising concerns over Japanese vaccination rates and the nation’s current burden of COVID-19 cases. Olympic organizers announced some local fans will be allowed at events under strict rules, including mask wearing, no cheering, and returning directly home. Stadiums and other venues will be limited to50% capacity or up to 10,000 domestic fans, whichever is less. Spectators will be allowed only if no state of emergency is in effect, and the rules could change as vaccinations increase or if a surge is predicted. Japan is advancing efforts to improve national vaccination rates, with 33 million inoculations to date and 7.7% of the population fully vaccinated.

As the international community looks to future sporting events, Qatar has stated that only vaccinated fans will be allowed at the2022 World Cup, posing a substantial barrier for players and fans from many low- and middle-income countries who have yet to be vaccinated. Qatar is in the process of securing 1 million SARS-CoV-2 vaccine doses in case global efforts lag. FIFA President Gianni Infantino said the November 2022 matches are expected to be held in full stadiums. Qatar has fully vaccinated 45% of its population to date.