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.

Wednesday, June 16, 2021

People hospitalized with COVID-19 now have one overwhelming thing in common. They're not vaccinated.

USA TODAY

People hospitalized with COVID-19 now have one overwhelming thing in common. They're not vaccinated.

Elizabeth Weise and Aleszu Bajak, USA TODAY

Wed, June 16, 2021, 5:38 AM

In Minnesota, the HealthPartners system has seen a “precipitous decline” in COVID-19 hospitalizations, says Dr. Mark Sannes, an infectious disease physician and senior medical director for the system, which operates nine hospitals and more than 55 clinics. But now, nearly every admitted patient he does see is unvaccinated.

“Less than 1% of our hospitalized COVID patients are vaccinated," he said.

In Ohio, at University Hospitals Cleveland Medical Center, only 2% of the COVID-19 patients admitted in the last month were vaccinated, said Dr. Robert Salata, the hospital's physician-in-chief.

And at Sanford Health, which runs 44 medical centers and more than 200 clinics across the Dakotas, Minnesota and Iowa, less than 5% of the 1,456 patients admitted with COVID-19 so far this year were fully vaccinated, said spokesperson Angela Dejene.

Falling rates of COVID-19 across the United States mask a harsh reality – the overwhelming majority of those getting sick and being hospitalized today are unvaccinated, while vaccinated people are vanishingly rare.

Hospitals in states with the lowest vaccination rates tend to have more COVID-19 patients in intensive care units, according to hospital data collected in the past week by the Department of Health and Human Services and vaccination rates published by the Centers for Disease Control and Prevention.

Wyoming, Missouri, Arkansas and Idaho currently have the highest percentage of COVID-19 patients on average in their ICUs; those states all have vaccinated less than 40% of their population.

Medical centers say there's also an obvious change in the age of their sickest patients, as older people are much more likely to be vaccinated than younger.

"We're all seeing the same thing – when someone does get sick and comes to the hospital, they're much more likely to be young and unvaccinated," said Dr. Robert Wachter, professor and chair of the Department of Medicine at the University of California, San Francisco.

Cathy Bennett, president and CEO of the New Jersey Hospital Association, said the picture is the same in her state.

"As COVID vaccinations rolled out across New Jersey, there’s been a major shift in the ages of patients admitted to the hospital," said Bennett. "Unlike last spring, when those 65 and older accounted for the majority of hospitalizations, we’re now seeing more young people hospitalized with COVID."

In Ohio, Salata said the shift should be reassuring, showing the vaccines work.

"It sends a very strong message to the hesitancy people out there because the data speaks for itself," he said.

'It's not all about you'

Doctors say there are multiple reasons people aren't yet vaccinated. There are the hesitant, who still have questions and sometimes fall prey to misinformation, and the opposed, who often harbor anti-government or anti-science sentiments.

"We've had a little success when we've spoken to them on a one-to-one basis. We can give them the information that they need to make their decision," said Dr. Gerald Maloney, chief medical officer for hospital services at Geisinger health network, which runs nine hospitals in Pennsylvania.

Some still can't easily access vaccine, either because it's not available nearby or because they can't get time off work.

And while the U.S. government paid for all vaccines and vaccinations so no one should be charged, others remain fearful they will be on the financial hook for a shot, Maloney said.

Eleanor Leisenring speaks with Cheryl McHale, RN, after receiving the COVID-19 vaccine at a Geisinger community vaccine center in Danville, Pa.

Eleanor Leisenring speaks with Cheryl McHale, RN, after receiving the COVID-19 vaccine at a Geisinger community vaccine center in Danville, Pa.

Last week, Health and Human Services secretary Secretary Xavier Becerra clarified in a letter that providers may not bill patients for COVID-19 vaccines.

There's still a lot of work to be done to create the trust necessary for these groups to embrace vaccination, Maloney said.

"The people who say, 'It's my body, my choice?' Well, it's not all about you," he said. "It's also about the people that you're around."

At this point, every vaccination is a win, one more person who can't pass the virus along. That's especially true in families where children can't be vaccinated and are still at risk.

At Akron Children’s Hospital in Ohio, “we have not seen any kiddos who have been admitted to the hospital who have been vaccinated,” said Dr. Michael Bigham, a pediatric intensivist in the critical care unit.

Among children 11 and younger, who can’t yet get the vaccine, having vaccinated family members is keeping them out of the hospital, and protecting them against MIS-C, the multisystem inflammatory syndrome that can be a rare but dangerous aftereffect of a COVID-19 infection in children.

“Most of the kids we’re seeing in the hospital with COVID or MIS-C had COVID in their household, maybe a parent or a grandparent, and most of those individuals had not been vaccinated,” he said.

The message from health care workers is unanimous: They just aren't seeing many vaccinated people get sick.

In New Jersey, the percentage of COVID-19 hospitalizations among those ages 18 to 29 has increased 58% since the beginning of the year. By comparison, the percentage of COVID-19 hospitalizations among the 65 and older age group – with a statewide vaccination rate of more than 80% – declined by 31.2%.

The numbers are no coincidence, Bennett said.

"Vaccination," she said, "works in preventing severe COVID illness."

This article originally appeared on USA TODAY: Majority of COVID-19 hospital patients in US now unvaccinated, younger

Sunday, June 13, 2021

New COVID outbreak in China?

The New York Times

In China's Latest Outbreak, Doctors Say the Infected Get Sicker, Faster

A vaccination center in Wuhan, China, on Wednesday. Doctors in the country say patients with the Delta variant are becoming sicker and their conditions are worsening more quickly than they did with the initial version. (Getty Images)

Keith Bradsher

Sun, June 13, 2021, 10:43 AM

As the delta variant of the coronavirus spreads in southeastern China, doctors say they are finding that the symptoms are different and more dangerous than those they saw when the initial version of the virus started spreading in late 2019 in the central city of Wuhan.

Patients are becoming sicker, and their conditions are worsening much more quickly, doctors told state-run television Thursday and Friday. Four-fifths of symptomatic cases developed fevers, they said, although it was not clear how that compared with earlier cases. The virus concentrations that are detected in their bodies climb to levels higher than previously seen and then decline only slowly, the doctors said.

Up to 12% of patients become severely or critically ill within three to four days of the onset of symptoms, said Guan Xiangdong, director of critical care medicine at Sun Yat-sen University in the city of Guangzhou, where the outbreak has been centered. In the past, the proportion had been 2% or 3%, although occasionally up to 10%, he said.

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Doctors in Britain and Brazil have reported similar trends with the variants that circulated in those countries, but the severity of those variants has not yet been confirmed.

The testimonies from China are the latest indication of the dangers posed by delta, which the World Health Organization last month labeled a “variant of concern.” First identified this spring in India, where it was blamed for widespread suffering and death, delta has since become the dominant variant in Britain, where doctors suggest that it is more contagious and may infect some people who have received only one of two doses of a COVID-19 vaccine.

China has uniquely detailed data, however, because it has essentially universal testing in the vicinity of outbreaks, allowing officials to gather detailed information on the extent of cases.

Delta’s spread in southeastern China focuses more attention on the effectiveness of China’s self-made vaccines. Chinese authorities have not indicated how many of the new infections have occurred in people who had been vaccinated. In some other countries where Chinese-made vaccines are in wide use, including the Seychelles and Mongolia, infections among vaccinated people are rising, although few patients have reportedly developed serious illness.

Nearby Shenzhen had a handful of cases last week of the alpha variant, which first emerged in Britain.

As some other parts of the world still struggle to acquire and administer large numbers of coronavirus tests, southeastern China has used its local production of scarce chemicals to conduct testing on a remarkable scale. Authorities said that they had conducted 32 million tests in Guangzhou, which has 18 million people, and 10 million in the adjacent city of Foshan, which has 7 million.

Guangzhou has also isolated and quarantined tens of thousands of residents who had been anywhere near those infected. The testing and quarantine appear to have slowed but not stopped the outbreak. China’s National Health Commission announced Friday that nine new cases had been found in Guangzhou the previous day.

“The epidemic is not over yet, and the risk of virus transmission still exists,” said Chen Bin, deputy director of the Guangzhou Municipal Health Commission.

This article originally appeared in The New York Times.

© 2021 The New York Times Company

Friday, June 11, 2021

June 11: 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.

COVID-19 Testing Toolkit Webinar Series – June 21

Join us for a webinar on June 21 at 10:00am ET, Lessons from Lufthansa, COVID-19 Testing for the Airline Industry. Our speaker, Martin Knuchel, Senior Director, Head of Crisis, Emergency & Business Continuity Management Lufthansa Group Airlines, will discuss how Lufthansa has handled the challenges of the last year and how the experiences will be used for travel going forward. This webinar is part of a series hosted by the Center’s COVID-19 Testing Toolkit which provides essential information on COVID-19 testing for organizations. Please register here.

EPI UPDATE The WHO COVID-19 Dashboard reports 174.4 million cumulative cases and 3.8 million deaths worldwide as of 7:30am EDT on June 11.

Global Vaccination

The WHO reported 2.2 billion doses of SARS-CoV-2 vaccines administered globally as of June 11, and 874 million individuals have received at least 1 dose. Our World in Data reported 2.30 billion cumulative doses administered globally, an increase of 12% compared to this time last week. After a week-long decline, global daily doses administered rebounded slightly to 34.4 million doses per day, down from a record of 36.0 million doses per day on June 5. Our World in Data estimates there are 488 million people worldwide who are fully vaccinated, corresponding to approximately 6.3% of the global population, although reporting is less complete than for other data.

The recent decline in global average daily doses administered is driven largely by a sharp decline in Asia and, to a lesser degree, a steady decline in North America over the past several weeks. Asia’s recent decline is largely a result of the trend in China, where the average daily doses administered fell by more than 15% from June 5 to June 9 before rebounding slightly. After a steady 6-week decline from its April peak, India’s daily average began increasing again in late May. It appears that India could potentially surpass its previous peak if it continues on its current trajectory, but there is still a considerable gap to its current record. Similarly, the trend in North America is driven largely by the steady decline in the US, down by two-thirds compared to its peak on April 13. Longer-term increases in Canada, the Dominican Republic, Mexico, and other countries in the region are making up for some of the decline in the US.

With the exception of North America, all continents are reporting steadily increasing or accelerating trends in daily vaccinations. While Asia’s daily average decreased over the past week, it is still more than 5.5 times higher than it was in mid-March and double where it was in mid-May. Notably, Oceania is now reporting an average daily per capita vaccination rate that is nearly on par with North America and slightly below the global average. Daily vaccinations continue to increase slowly in Africa as well. As a whole, Africa remains well behind the other continents on a per capita basis, but it appears that its collective daily vaccination trend may be starting to accelerate. On a per capita basis, Europe is reporting the highest daily average, and its peak on June 7 was only 11% less than North America’s record high in mid-April.

At the national level, China is easily #1 globally in terms of total daily doses administered. Despite its decline over the past week, China’s 17.4 million doses per day is more than 5.5 times the average in #2 India (3.13 million). At #3, the US (1.14 million) is the only other country reporting more than 1 million doses per day. Among the top 10 countries, 4 countries are in Asia, 4 are in Europe, and 2 are in the Americas.

On a per capita basis, the Dominican Republic is #1 globally with 1.6 daily doses per 100 population, and Fiji is #2 with 1.4. Notably, China (1.2) is #3 globally, despite having the world’s largest population. In fact, China accounts for approximately 18.5% of the global population but more than half of the daily global vaccinations. South Korea also is in the top 10 for both total and per capita daily doses administered, and its daily average has increased by a factor of 7.5 since mid-May. Among the top 10 countries in terms of per capita daily doses administered, 5 are in Europe, 2 are in Asia, 2 are in the Americas, and Fiji represents Oceania. All countries in the top 10 are reporting more than 1 daily dose per 100 population, more than double the global average (0.44).

Among African countries, Morocco (189,216 doses per day) is reporting the highest total average, and Mauritius is reporting the highest per capita average (0.54 daily doses per 100 population). In Oceania, Australia is reporting the highest total daily doses administered, with 120,710 doses per day.

UNITED STATES

The US CDC reported 33.2 million cumulative cases and 596,059 deaths. After steady declines since mid-April, the United States’ daily incidence increased slightly on June 7-8. Notably, however, states have reported nearly 12,500 previously unreported cases over the past week—including more than 1,000 on June 3; more than 2,500 on June 8; and more than 7,500 on June 9—which is contributing to an artificially elevated average. Additionally, delayed reporting over the Memorial Day holiday weekend is likely contributing to elevated reports as states caught up. A similar effect can be observed in daily mortality. Daily mortality quickly climbed from a low of 321 deaths per day on June 4 to 366 on June 7—the first day that the Memorial Day holiday weekend moved outside the 7-day window—an increase of 14% over that period. We expect both daily incidence and mortality to continue decreasing once reporting fully returns to normal, but we will monitor these trends closely.

US Vaccination

The US has distributed 372.8 million doses of SARS-CoV-2 vaccines and administered 305.7 million. Similar to daily incidence and mortality, the average daily vaccine doses administered* increased slightly over the past several days, likely stemming from delayed reporting over the Memorial Day holiday weekend. The US is averaging 867,109 doses per day, and 535,221 people are achieving fully vaccinated status per day, down from a high of 1.8 million per day on April 12.

A total of 172 million individuals in the US have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 51.9% of the entire US population. Among adults, 64.0% have received at least 1 dose, and 7.3 million adolescents aged 12-17 years have received at least 1 dose. A total of 141.6 million people are fully vaccinated, which corresponds to 42.6% of the total population. Among adults, 53.4% are fully vaccinated, and 3.6 million adolescents aged 12-17 years are fully vaccinated. Progress has largely stalled among adults aged 65 years and older: 86.5% with at least 1 dose and 75.8% fully vaccinated. In terms of full vaccination, 73 million individuals have received the Pfizer-BioNTech vaccine, 57 million have received the Moderna vaccine, and 11 million have received the J&J-Janssen vaccine.

*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.

The Johns Hopkins Coronavirus Resource Center is reporting 33.4 million cumulative cases and 598,756 deaths in the US as of 10:30am EDT on June 11.

mRNA VACCINES & RISK REDUCTION US CDC researchers last week published a study in medRxiv (preprint) showing 2-dose mRNA vaccines, specifically those from Pfizer-BioNTech and Moderna, are highly effective among working-age adults in preventing SARS-CoV-2 infections when administered in real-world conditions. Additionally, the vaccines lessened viral load, febrile symptoms, and illness duration among those vaccinated participants who became ill with COVID-19. Initial findings from the study, called HEROES-RECOVER, were released in March, with the latest findings based on 3,975 healthcare personnel, first responders, and other essential and frontline workers who self-collected nasal swabs for 17 consecutive weeks from December 13, 2020 to April 10, 2021.

Once fully vaccinated, participants’ risk of SARS-CoV-2 infection was reduced by 91%, and the risk among those with partial vaccination was reduced by 81%. Only 16 of the 204 people who became infected had been vaccinated. Participants who were fully or partially vaccinated were more likely to have milder and shorter illness when compared with those who were unvaccinated, with some having asymptomatic infection. Those participants who were fully or partially vaccinated and experienced infections also had 40% less detectable viral load, were 66% less likely to test positive for the virus for more than 1 week, and experienced 6 fewer days of viral shedding when compared with those who were unvaccinated. The study adds to the growing body of real-world evidence that US FDA-authorized mRNA vaccines are effective at preventing SARS-CoV-2 infection, according to the CDC.

VARIANTS OF CONCERN & VACCINATION The emergence of the SARS-CoV-2 Delta variant (B.1.617.2) has prompted health officials worldwide to encourage people to become fully vaccinated to help lower the risk of infection and severe disease. The Delta variant appears to be more transmissible than the wild type virus and other SARS-CoV-2 variants, shows some ability to escape immune detection in individuals after vaccination or initial infection, and could cause more severe disease, although more research is needed to confirm the latter. In the UK, the Delta variant is associated with more than 60% of infections and is causing surges of COVID-19 in some parts of England. In the US, the variant is responsible for more than 6% of infections sequenced by researchers. At a White House briefing on June 8, White House Chief Medical Advisor Dr. Anthony Fauci noted the variant has been detected in 60 countries and, in the UK, is impacting younger populations aged 12- to 20-years-old. Dr. Fauci also discussed vaccine effectiveness against the Delta variant, saying 2 doses of the Pfizer-BioNTech and AstraZeneca-Oxford vaccines appear to be significantly more effective than 1 dose in preventing infection or severe disease caused by the variant, and urged everyone to be vaccinated.

In a study published in Nature on June 9 as an accelerated article preview, researchers reported the J&J-Janssen vaccine offers “strong protection against symptomatic” cases of COVID-19 caused by the wild type SARS-CoV-2 virus, as well as the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Epsilon (B.1.427 and B.1.429) variants. The small study, which examined the immune responses of 20 volunteers between the ages of 18 and 55, found fewer neutralizing antibodies against the Beta and Gamma variants when compared to the original wild type virus. However, the non-neutralizing antibody and T-cell immune responses remained largely preserved in these individuals, making up for a lack of neutralizing antibodies when challenged by variants. These findings reiterate the importance of full vaccination in protecting against all known SARS-CoV-2 variants.

VACCINE PASSPORTS The use of vaccination “passports” continues to expand in Europe. This week, Germany unveiled CovPass, a digital vaccination card that individuals can save on their mobile phones. CovPass is compatible with the EU’s Digital COVID Certificate, which will document vaccination status, negative test results, or prior SARS-CoV-2 infection for individuals across the European bloc starting July 1, 2021. Jens Spahn, Germany’s Federal Minister of Health, indicated that CovPass is expected to be fully implemented by the end of June, which would support international travel during Europe’s summer tourism season. In addition to travel, the digital vaccination documentation can be used at businesses, museums, and other venues that require vaccination. Individuals can upload their vaccination status into the CovPass smartphone application by scanning a QR code provided after vaccination, and the app can then display the QR code wherever it is required. Vaccinated individuals will still be able to use the printed vaccination certificate, if they elect or are unable to use the digital version.

As vaccination coverage increases, many countries are allowing travelers to provide documentation of full vaccination status instead of negative SARS-CoV-2 test results upon arrival. The International Air Transport Association (IATA) already has documented instances of counterfeit vaccination documents in multiple countries, but it appears that the responsibility for verifying these documents is largely falling on airlines. Reportedly, airlines are calling for increased use of digital documentation, which is more difficult to counterfeit than paper copies, and it reduces the burden on airline personnel, who do not necessarily have the expertise necessary to identify fraudulent documentation.

US TRAVEL ADVISORIES On June 8, the US updated its COVID-19 travel advisories for several dozen countries. Notably, the Department of State lowered 58 countries from Level 4 (Do Not Travel) to Level 3 (Reconsider Travel) and lowered another 27 countries to either Level 1 (Exercise Normal Precautions) or Level 2 (Exercise Increased Caution). Additionally, the CDC issued updates for more than 120 countries and territories. The CDC’s Level 4 category (Very High COVID-19 Activity) fell from 140 countries and territories to 61, and the number of countries in the Level 1 category (Low COVID-19 Activity) jumped from 30 to 56. The changes reflect both a continuing decrease in COVID-19 burden in many countries around the world and growing evidence of the protection conferred by SARS-CoV-2 vaccines, in the US and elsewhere. The changes also aim to differentiate countries “with severe outbreak situations from countries with sustained, but controlled” transmission.

The CDC continues to recommend that individuals are fully vaccinated before traveling to other countries. Additionally, all unvaccinated individuals should avoid travel to Level 3 (High COVID-19 Activity) countries, and unvaccinated individuals who are at elevated risk for severe COVID-19 disease should avoid nonessential travel to Level 2 (Moderate COVID-19 Activity) countries.

VACCINE DONATIONS TO TAIWAN Last week, Taiwan received a donation of 1.24 million doses of the AstraZeneca vaccine from Japan to aid in its vaccination campaign. Taiwan is facing challenges in acquiring vaccines, with Taiwan President Tsai Ing-wen repeatedly turning down offers from China after expressing concerns about the Chinese vaccines’ safety. Taiwan also has accused China of trying to block its vaccine purchases internationally. China regards Taiwan as part of its territory. On June 6, 3 US Senators stopped in Taiwan for a 3-hour visit, expressing bipartisan US support for the island and pledging the US government will donate 750,000 vaccine doses to reduce its severe vaccine shortage. Notably, the Senators’ visit could have implications of its own on US-China relations, as the delegation arrived in a US Air Force C-17 Globemaster III freighter, a primary strategic lift aircraft for the military. Some speculated that the optics of a military aircraft capable of transporting troops and tactical cargo on a Taiwanese runway could rouse a response from Chinese officials.

Approximately 3.25% of Taiwan’s 23.5 million people have received at least one dose of vaccine. Through COVAX, Taiwan has signed contracts for 4.76 million doses as well as 10 million doses of the AstraZeneca vaccine, and 5.05 million of the Moderna vaccine. Delivery delays are expected for the AstraZeneca vaccine produced in Thailand over distribution concerns in Southeast Asia. Taiwan also is pursuing development of its own vaccines; Medigen Vaccine Biologics said it will apply for Emergency Use Authorization locally following the release of phase 2 vaccine trial results and plans to apply to the European Medicines Agency (EMA) and other international health authorities to start large-scale phase 3 trials. Taiwan also is engaged in early stage discussions to produce vaccines for US companies. Additionally, Germany reportedly is assisting Taiwan in talks with Pfizer-BioNTech to supply the island with the company’s vaccine.

CHINA LOCKDOWN Officials in Guangzhou, the capital of the southern province of Guangdong, China, this week instituted strict lockdowns impacting more than 180,000 residents after a new SARS-CoV-2 outbreak, blamed on the Delta variant, was detected among people who ate at several restaurants in the city’s Liwan district. Officials said each infected person has passed the virus along to more people than in any other previous outbreak in the country. As of June 11, officials reported 2 imported COVID-19 cases and 9 indigenous cases in Guangdong, with nearly the city’s entire population of 18.7 million people undergoing testing earlier this week. China continues to rely on several core principles of prevention strategies, including tight lockdowns, widespread testing, limits on movement, and 2-week or longer government-supervised quarantines for people arriving from other countries. The strict travel restrictions are expected by many to remain in place through at least February, when Beijing will host the Winter Olympics.

Chinese leaders are urging people to get vaccinated, with an average of nearly 20 million people getting vaccinated daily. As of June 8, the nation has administered more than 794 million doses to its population of 1.4 billion, according to the government. The majority of the vaccinations are using 2 Chinese-produced vaccines, Sinovac’s Coronavac and the Sinopharm vaccine, both of which have received Emergency Use Listings (EUL) from the WHO. In clinical trials, the Sinovac vaccine showed it prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population. The Sinopharm vaccine’s efficacy for preventing symptomatic and hospitalized disease was estimated to be 79% for all age groups combined. However, with the spread of the Delta variant in Guangzhou, some are raising questions about the effectiveness of China’s vaccines, as that variant has proven capable of vaccine escape in other countries.

VACCINES IN AFRICA WHO Director-General Dr. Tedros Adhanom Ghebreyesus said on June 7 he hopes that some SARS-CoV-2 vaccine manufacturing sites in Africa will be close to commencing production by the end of 2021. Senegal reportedly is among the potential sites, under an agreement with Belgian biotech group Univercells. Last month, the EU announced an investment of €1 billion (US$1.2 billion) for manufacturing and access to vaccines, medicines, and health technologies in Africa. The leading candidates for regional manufacturing hubs are Senegal, South Africa, Rwanda, Morocco, and Egypt. In South Africa, Aspen Pharmacare is already producing the J&J-Janssen vaccine locally, and the Biovac Institute is working with the French and German governments and pharmaceutical companies to establish production capacity of 30 million doses annually.

A report by The Wall Street Journal indicates that government officials in South Africa seized 2,400 doses of counterfeit SARS-CoV-2 vaccines. The problem of counterfeit vaccines is certainly not limited to African nations, but the limited supply available to most countries could drive increased demand, fueling a market for fraudulent products. Previously, fraudulent doses have been confiscated in Mexico, Poland, China, and other countries. Networks and markets for counterfeit medications already exist in many low- and middle-income countries (LMICs), which could facilitate the distribution of fake SARS-CoV-2 vaccines. In fact, the WHO estimates that 10% of all medical products in LMICs are “either substandard or falsified.” In response to an increased risk of counterfeit vaccines, Kenyan officials suspended the importation of SARS-CoV-2 vaccines by private companies in order to provide more control and oversight. To date, there are no known instances of fraudulent vaccines being administered at any government vaccination sites, and national governments are collaborating with Interpol to continue combating the threat.

INDIA VACCINATION POLICIES India’s federal government announced this week it would begin to play a larger role in the administration of SARS-CoV-2 vaccinations across the country. The change comes amid public backlash at the low rates of domestic vaccine administration, especially amid the country’s worst COVID-19 surge. As of June 10, more than 46 million people in India, or 3.4% of the population, are fully vaccinated. India has set an ambitious goal to vaccinate 900 million adults by the end of 2021 and provide cost structures that enable people from all economic backgrounds to receive a vaccine. The Indian government also reversed its original plan to have states and the private sector lead the charge to vaccinate those between the ages of 18 and 44, announcing the federal government will provide free vaccines to any adult starting later this month. Under the new directive, the federal government will send 75% of vaccines procured directly from manufacturers to states at no cost. The remaining 25% of vaccines will be available for sale to the private sector, which can resell the vaccines through private clinics or hospitals. This is a change from previous allocations, which sent 50% of vaccines to the federal government and the other 50% to states and the private sector. The hope is that the new policy, which will go into effect on June 21, will increase vaccine coverage across the country, aiding in the government’s response to the ongoing COVID-19 surge.

PEDIATRIC VACCINE CLINICAL TRIALS Pfizer announced this week it will expand its SARS-CoV-2 vaccine clinical trials to include children aged 5 to 11 years, with testing among younger age groups to begin in the coming weeks. The vaccine being used is the same as that authorized for use among adolescents and adults ages 12 and older, but it will be administered as lower doses based on age group. The phase 2/3 trial is expected to enroll as many as 4,500 participants across the US, Finland, Poland, and Spain. The company said it expects to have safety and immune response data for children aged 5-11 years in September, with data for children as young as 2 expected shortly after. Data for children aged 6 months to 2 years is expected to be available in October or November, according to company officials.

PEDIATRIC LONG COVID/PASC The risk factors, clinical presentation, and recovery timeline for post-acute sequelae of COVID-19 (PASC), colloquially referred to as “long COVID,” largely remain a mystery, even 1.5 years into the COVID-19 pandemic. Most of the attention remains on adult PASC patients, and relatively little data are available for children who experience longer-term effects of SARS-CoV-2 infection. Estimates for the prevalence of PASC among adults who recover from acute SARS-CoV-2 infection range from 1-in-10 to 1-in-3 patients, but a dearth of data on pediatric PASC patients makes it more difficult to estimate the burden in that population. Several small studies suggest that approximately 7-20% of pediatric SARS-CoV-2 infections could result in longer-term physical and mental health effects.

There remains considerable uncertainty regarding the risk factors for PASC in both adults and children, and the focus on adults—in terms of both testing and clinical care—and relatively milder COVID-19 disease among children during the pandemic could make it difficult to identify children who are at risk of PASC. Additionally, pediatric PASC patients tend to have more normal test results, including blood tests, EKGs, and imagery (eg, CT scan), despite experiencing PASC symptoms. It may also be more difficult for children to explain symptoms such as “brain fog” to parents, guardians, or clinicians, and the longer-term impacts of PASC on physical and mental development may not be fully evident for years later. Similar long-term effects have been documented in children who recover from other diseases, such as Lyme disease or mononucleosis, but it likely will take dedicated research efforts over many years to fully characterize PASC in pediatric patients.

ROUTINE CHILDHOOD IMMUNIZATIONS A study published today in the US CDC’s Morbidity and Mortality Weekly Report (MMWR) examines the impact of the COVID-19 pandemic on the administration of certain routine childhood and adolescent vaccines. Researchers examined data from 10 US jurisdictions with robust vaccination reporting systems, comparing the number of vaccine doses administered between March-September 2020 with the same time period in both 2019 and 2018. The research team split the time frame into two distinct periods of March-May and June-September to account for areas implementing and then lifting stay-at-home orders. The researchers found that administration of routine pediatric and adolescent vaccines lagged significantly in the first time period (March-May) when compared to past years. Though the researchers noted a rebound in the second time period (June-September), it was not significant enough to make up for the lack of vaccine administration during the first period. The CDC expressed concern that this gap in vaccine coverage could lead to an increased risk of disease outbreaks in schools when many children return to in-person learning this fall, and the agency encouraged health care providers to consider providing missed vaccines at the same time as administering SARS-CoV-2 vaccines in an effort to catch up. The CDC previously advised a 2-week break between administering a SARS-CoV-2 vaccine and other vaccines but reversed that guidance late last month.

BAMLANIVIMAB Results from a phase 3 clinical trial published in JAMA found that the preventive administration of the monoclonal antibody (mAb) treatment bamlanivimab as a monotherapy reduced the incidence of SARS-CoV-2 infection among residents and staff at skilled nursing home facilities with at least 1 confirmed index case. The randomized, double-blind, single-dose trial enrolled residents and staff at 74 skilled nursing and assisted living facilities across 11 states with at least one confirmed COVID-19 case, for a total of 1,175 participants for the duration of the trial between August and November 2020. Within 7 days of a confirmed SARS-CoV-2 case at a facility, participants were screened for enrollment, tested for SARS-CoV-2 infection, and randomly assigned and dosed with 4,200 mg of intravenous bamlanivimab or placebo (saline) if eligible. Bamlanivimab significantly reduced the incidence of COVID-19 in the prevention population compared with placebo (8.5% vs 15.2%; odds ratio, 0.43 [95% CI, 0.28-0.68]; P < .001). Five (5) deaths attributed to COVID-19 occurred during the trial period, all of whom were in the placebo group. Notably, the US FDA in April 2021 rescinded its Emergency Use Authorization (EUA) for bamlanivimab as a monotherapy because of resistance of SARS-CoV-2 variants to the drug. However, the mAb treatment is still permitted to be used as a treatment in combination with another monoclonal antibody, etesevimab.