Saturday, July 31, 2021

July 30: 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 NOTE: The Situation Report’s esteemed epidemiologist is on vacation this week, so we will be back next week with a deeper-dive look at trends. Here are the latest numbers:

The WHO COVID-19 Dashboard reports 196.6 million cumulative cases and 4.2 million deaths worldwide as of 12:30 EDT on July 30.

Global Vaccination

The WHO reported 3.8 billion doses of SARS-CoV-2 vaccines administered globally as of July 29. The WHO reports a total of 1.48 billion individuals have received at least 1 dose, and 735 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered continues to rise, now at 37 million doses per day, driven by increases in Asia. Our World in Data estimates that there are 2.17 billion vaccinated individuals worldwide (1+ dose; 27.68% of the global population) and 1.12 billion who are fully vaccinated (14.4% of the global population).

UNITED STATES

The US CDC reported 34.7 million cumulative COVID-19 cases and 609,853 deaths. Daily incidence continues to increase, now up to 66,606 new cases per day, which is nearly 6 times the most recent low on June 19 (11,469) and is still increasing steadily. Daily mortality also continues to increase, up to 296 deaths per day, which is 78% higher than the most recent low on July 10 (166)*.

*In an effort to provide a more accurate analysis of the current epidemiology, we are largely focusing on longer-term trends, as the most recent data are more likely to be affected by changes in the frequency of state-level reporting, particularly over the weekend.

US Vaccination

The US has administered 344 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations are increasing slowly, now up to 513,685 doses per day*. A total of 189.9 million individuals in the US have received at least 1 dose, equivalent to 57.2% of the entire US population. Among adults, 69.4% have received at least 1 dose, as well as 10.5 million adolescents aged 12-17 years. A total of 163.9 million individuals are fully vaccinated, which corresponds to 49.4% of the total population. Approximately 60.3% of adults are fully vaccinated, as well as 8.1 million adolescents aged 12-17 years.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current value provided here corresponds to 5 days ago.

US CDC MASK GUIDANCE Amid a national surge in COVID-19 cases, hospitalizations, and deaths attributed to the highly transmissible Delta variant, the US CDC this week issued updated guidance recommending indoor mask use in areas with high or substantial transmission rates, regardless of individual vaccination status. The agency also called for universal mask use by teachers, staff, and students returning to K-12 schools this fall, regardless of their vaccination status. According to CDC Director Dr. Rochelle Walensky, the agency reinstated its indoor mask use recommendations based on new research showing that vaccinated people infected with the Delta variant carry viral loads similar to those of people who are unvaccinated. The data comes from a new CDC report released today. Dr. Walensky reiterated that the vaccines remain highly effective at preventing severe disease, that breakthrough infections among vaccinated individuals remain uncommon, and that most of the new COVID-19 cases are among unvaccinated people. US health officials continue to urge those who are not yet vaccinated or partially vaccinated to undergo the shots to help slow the spread.

US FEDERAL WORKER VACCINE RULES US President Joe Biden on July 29 announced sweeping new COVID-19-related requirements for more than 4 million federal employees and hundreds of thousands of contractors who work at federal facilities worldwide, with the goal of increasing vaccination rates among the nation’s workforce and influencing other employers. Though not considered a vaccine mandate, all federal workers will be required to sign forms attesting they are fully vaccinated for SARS-CoV-2 or face inconveniences in their daily work lives. Unvaccinated workers “will be required to wear a mask on the job no matter their geographic location, physically distance from all other employees and visitors, comply with a weekly or twice weekly screening testing requirement, and be subject to restrictions on official travel," according to information released by the White House. In his speech, President Biden also called on states and local governments to use federal funding they have received, including from the American Rescue Plan, to give US$100 to anyone who gets fully vaccinated, and he said the federal government would reimburse small- and medium-sized businesses for providing paid leave so their employees and their families could get vaccinated. He also urged the US Department of Defense to quickly implement a mask mandate for members of the military, many of whom are reluctant to undergo vaccination. The plan received mixed reactions from labor unions and other groups, some of which said giving employees options was a tactic aimed at preventing harsh resistance from some people. Questions about the plan remain, and it will be interesting to see how quickly federal agencies implement the requirements.

ADDITIONAL DOSES/”BOOSTERS” Executives from Pfizer-BioNTech, Moderna, and J&J-Janssen, which manufacture the 3 SARS-CoV-2 vaccines authorized for use in the US, have all said fully vaccinated individuals can expect to eventually need additional doses of the vaccines, or “boosters.” However, there is not enough evidence-based data yet to provide a recommendation, according to a WHO official and the CDC’s Advisory Council on Immunization Practices (ACIP), which met last week to discuss the possibility of additional doses among immunocompromised individuals. Several US government health officials, including National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci, have signaled that some Americans who are older or have weakened immune systems might need an additional vaccine dose.

Pharmaceutical companies, officials, and healthcare workers cannot technically recommended additional doses for any of the vaccines in the US, which are being administered under US FDA emergency use authorizations (EUAs) that set specific standards for each regimen: 2 doses given 3 or 4 weeks apart for the Pfizer-BioNTech and Moderna vaccines, respectively, and 1 dose for the J&J-Janssen vaccine. In order to provide additional doses, the FDA would need to change a vaccine’s EUA or fully license the vaccine, which would provide greater leeway for providers to recommend additional doses. But last week, Dr. Amanda Cohn, Chief Medical Officer for the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), indicated the US government is actively looking into ways to provide access to additional doses prior to regulatory decisions, such as a compassionate use program. Some people are taking it upon themselves to seek out third doses, sometimes traveling to other states or even other countries to obtain shots.

According to media reports, Israel’s Ministry of Health on July 29 became the first country to approve third doses of the Pfizer-BioNTech vaccine for people ages 60 and older who are at least 5 months post-second dose. The country already offers third doses to immunocompromised individuals. In a decision made late on July 28, a health ministry panel concluded offering a third dose to elderly residents might help stem the country’s 6-week surge in COVID-19 cases, driven by the Delta variant. In a televised address, Israel Prime Minister Naftali Bennett, noting the Pfizer-BioNTech vaccine is safe and effective, encouraged those eligible to begin registering for third doses as of August 1. Since the emergence of the Delta variant, the Israel Ministry of Health has twice announced a drop in effectiveness of the Pfizer-BioNTech vaccine in preventing symptomatic infection, although some experts say the data could be skewed because most testing occurred in transmission hotspots and among elderly populations.

PFIZER-BIONTECH EFFICACY/THIRD DOSE On July 28, medRxiv published preprint data from Pfizer-BioNTech showing the efficacy of its vaccine to prevent COVID-19 declined about 6% every 2 months over a period of 6 months. The data were collected from more than 40,000 clinical trial participants in Europe and the Americas. From 7 days to <2 months post-dose 2, vaccine efficacy was 96.2% (95% confidence interval [CI] 93.3-98.1); from 2 months to <4 months, efficacy was 90.1% (95% CI 86.6-92.9); and from 4 months to 6 months, efficacy was 83.7% (95% CI 74.7-89.9). Overall, vaccine efficacy was 91.1% (95% CI 88.8-93.0) for preventing symptomatic COVID-19, and 96.7% (95% CI 80.3-99.9) against severe disease. The companies said the data show the vaccine to be safe and highly efficacious in preventing COVID-19 through 6 months post-second dose in diverse populations but further data are needed to know whether efficacy continues to wane or whether “booster” doses will be necessary, and, if so, the timing of such doses.

Many experts said the not-yet-peer-reviewed data are reassuring, showing that people who are fully vaccinated likely are adequately protected. However, if the observed decline in efficacy steadily continues over time, it would fall below the internationally accepted threshold of 50% within 18 months of vaccination. This would bolster Pfizer-BioNTech’s claim that an additional shot of its vaccine will be needed to maintain long-term protection. The data also do not address the vaccine’s efficacy against the now widespread Delta variant. On July 28, Pfizer officials presented unpublished data in a quarterly earnings report to investors showing a third dose of the Pfizer-BioNTech vaccine could boost neutralizing antibody titers against the Delta variant in a small sample of individuals. The data show a more than 5-fold increase in post-second dose titers among vaccinees aged 18 to 55 and a more than 11-fold increase among those ages 65 to 85. The officials said they plan to seek authorization with the US FDA for a third dose by mid-August and indicated clinical studies of an experimental Delta variant vaccine are awaiting regulatory approval but also are expected to begin in August.

BREAKTHROUGH CASES A study published in the New England Journal of Medicine on July 28 examines breakthrough COVID-19 cases among healthcare workers who received 2 doses of the Pfizer-BioNTech vaccine. From January 20 to April 28, 2021, researchers identified breakthrough cases at Sheba Medical Center in Israel by monitoring healthcare workers for COVID-19 symptoms and testing those with known COVID-19 exposures. Following the identification of a breakthrough case, the research team matched the individual with 4 or 5 uninfected controls using generalized estimating equations. Of 39 breakthrough cases among 1,497 fully vaccinated healthcare workers, the researchers found the infected individuals had lower levels of neutralizing antibody titers than their uninfected controls. Additionally, most of the breakthrough cases were asymptomatic or mildly symptomatic, although 19% of the individuals reported symptoms that lasted longer than 6 weeks. The majority of the breakthrough cases (85%) were caused by the Alpha variant (B.1.1.7), and the research team observed no secondary cases stemming from breakthrough cases.

IMF GLOBAL FORECAST In an updated “World Economic Outlook,” the International Monetary Fund (IMF) on July 27 warned that the gap in economic recovery is widening between higher- and lower-income nations due to the COVID-19 pandemic and uneven access to SARS-CoV-2 vaccines. Overall, the global economy is expected to grow 6% in 2021 and 4.9% in 2022. The IMF upgraded its 2022 estimate, with a 0.5 percentage point increase over its projection made earlier this year, driven by growth in the US and UK markets. However, for emerging and developing markets, the IMF downgraded projections for 2021 by 0.4 percentage points from its previous projection, to 6.3%, noting the biggest risks include low vaccination rates and growing numbers of COVID-19 cases. The IMF called on wealthier nations to take urgent action to share vaccine doses with low- and middle-income countries (LMICs), warning that a worsening pandemic could severely hit those markets as well as impact growth projections for richer nations.

The IMF also cautioned that if inequality worsens, nations risk experiencing political instability and discontent, which is happening already in some countries. The pandemic is sowing a “summer of anger,” with political protests documented in Tunisia, Iraq, South Africa, Thailand, Colombia, Brazil, and Haiti, to name a few. Even some wealthier nations—including France and Australia—recently have witnessed large protests against vaccination mandates and lockdown tactics centered on slowing the number of new COVID-19 cases. Experts from the Council on Foreign Relations (CFR) and Columbia University write that “COVID-19 has acted like lighter fluid for countries where embers of discontent were already smoldering.” In a closed briefing this week, Ramesh Rajasingham, UN Acting Assistant Secretary-General for Humanitarian Affairs and Deputy Emergency Relief Coordinator, warned UN Security Council members that three-quarters of the countries needing humanitarian aid have already recorded more COVID-19 cases and related deaths than in all of 2020. Calling the response so far “inadequate,” Rajasingham urged the international community to not only increase vaccine shipments to fragile and conflict-affected countries but also bolster delivery systems by providing logistical and security support. The need for effective and efficient vaccine delivery to LMICs is an issue that cannot be ignored by the developed nations and the private sector.

US POVERTY REDUCTION The number of poor Americans is expected to decline nearly 45% this year from 2018 levels—a record drop in record time—but pieces of the enormous temporary safety net created amid the COVID-19 pandemic that helped to achieve this reduction have ended or are scheduled to soon revert to their pre-pandemic size. In a report released on July 28, the Urban Institute estimated the American Rescue Plan Act, enacted in March 2021, will reduce the 2021 annual poverty rate to 7.7%, well below the 13.9% rate estimated for 2018. The projected poverty rate is expected to be lowest among children (5.6%), but rise for adults ages 18 to 64 (8.1%) and again for older Americans (9.2%). The rates are higher for Hispanic people (11.8%), Asian American and Pacific Islanders (AAPI; 10.8%), and Black people (9.2%) than for white people (5.8%). The federal stimulus checks have had a larger impact on poverty reduction than any other program, according to the report.

One of these programs, the US CDC’s extended federal eviction moratorium, which has prevented eviction for an estimated 10 million people over the past year, is set to expire on July 31. Some advocates, researchers, and US lawmakers are calling for another extension of the program, citing an analysis showing many of these evictions would occur in communities with low vaccination rates and increasing numbers of COVID-19 cases attributed to the Delta variant. A study published this week in the American Journal of Epidemiology supports calls for extending the moratorium, showing that between March and September 2020, eviction moratorium expirations were associated with increased COVID-19 incidence and deaths and backing up the notion that eviction prevention constitutes an important public health measure to mitigate the pandemic’s impacts.

“MEDICAL FREEDOM” LAW New Hampshire (US) Governor Chris Sununu last week signed into law a so-called “medical freedom” bill that prohibits “any public facility, any public benefit, or any public service” from requiring state residents be vaccinated against SARS-CoV-2 to receive or access such services or facilities. The law states that “every person has the natural, essential, and inherent right to bodily integrity, free from any threat or compulsion by government to accept an immunization.” Notably, the law sets out several exceptions, including vaccination requirements for schools, childcare, county nursing homes, and the state’s mental health system. Additionally, the New Hampshire Department of Corrections may mandate certain medical treatments or immunizations “when a direct threat exists.” The law does not address private businesses. Governor Sununu continues to voice support for SARS-CoV-2 vaccines. According to state data, nearly 54% of the state’s residents are fully vaccinated, above the national average.

TENNESSEE VACCINE OUTREACH The Tennessee (US) state government last week resumed its adolescent vaccine education and outreach activities after earlier this month halting most advocacy in the face of pressure from conservative state lawmakers who accused the department of pressuring teenagers to receive a SARS-CoV-2 vaccine. Tennessee Health Commissioner Dr. Lisa Piercey on July 23 said the state’s health department will restart outreach efforts recommending vaccines for children, except for social media posts specifically targeting teenagers. The department once again will include its logo on public-facing vaccine material and hold vaccination events on school property, including for COVID-19. Dr. Piercey stressed the department never ceased vaccinations among children but only paused its communications and marketing efforts surrounding vaccines. Now that those efforts are restarting, messaging will be targeted toward parents, she noted. Dr. Piercey declared the state will provide vaccines to minors without parental permission in “fringed and nuanced” circumstances. Tennessee is in the bottom 10 states in terms of vaccination coverage, with 39% of its population fully vaccinated.

TANZANIA Tanzania President Samia Suluhu Hassan on July 28 kicked off the country’s SARS-CoV-2 vaccination campaign, publicly receiving the J&J-Janssen vaccine in an effort to bolster confidence in the shots and quell fear stemming from disinformation spread under her predecessor’s administration. Former President John Magufuli, who died in March of heart complications, downplayed the COVID-19 pandemic, endorsed home remedies and prayer as treatments, and called vaccinations “dangerous.” After Magufuli’s death, President Hassan established a COVID-19 expert committee to evaluate the safety and effectiveness of vaccines, as well as make public health recommendations including physical distancing and mask wearing. Tanzania joined COVAX in June, despite having been eligible since the facility’s establishment. The country received more than 1 million doses of the J&J-Janssen vaccine over the weekend from a US donation delivered through COVAX, and President Hassan on July 27 placed an order with the African Union's African Vaccine Acquisition Task Team (AVATT) for an undisclosed number of additional vaccines. The Tanzania government faces challenges to reversing skepticism about vaccines, but President Hassan assured residents the country will obtain enough supplies to reach its goal of vaccinating 60% of the population. Only 2 other African nations—Burundi and Eritrea—have yet to begin national vaccination campaigns.

TOKYO OLYMPICS The Olympics have entered the start of their second week as the COVID-19 situation in Tokyo and Japan continues to worsen. Both the city and the nation on July 29 reported record numbers of new COVID-19 cases, with the nation averaging 6,518 daily new cases. Tokyo, which remains under a state of emergency, recorded 3,865 new cases on July 29, after only the day before passing 3,000 new cases for the first time. The city’s health officials have asked for hospitals to prepare extra beds as the spread of the SARS-CoV-2 Delta variant continues, with more than 75% of new cases caused by the variant. So far, COVID-19 precautions appear to have minimized the spread of SARS-CoV-2 outside of the Olympic “bubble,” although the number of new daily cases reported among Olympic accreditation holders appears to have risen on July 29 and July 30.

COGNITIVE IMPACTS Scientists have long known that areas of the brain involved with smell and taste also are involved in memory, thinking, planning, and mood, and public health officials are increasingly concerned about the long-term impacts of COVID-19 on brain function, memory, and cognition, a phenomenon known as “brain fog.” Scientific evidence is emerging that the virus’s neurological impacts are multi-pronged and not necessarily related to “long COVID,” or post-acute sequelae of COVID-19 (PASC). In a study published in The Lancet journal EClinicalMedicine, researchers from Imperial College London and colleagues examined data from 81,337 people who took exams as part of the Great British Intelligence Test and completed questionnaires regarding self-reports of suspected or confirmed COVID-19. The team found that the 12,689 individuals who had recovered from COVID-19 exhibited significantly more cognitive deficits than their matched counterparts, even among people who said they were no longer experiencing symptoms. Cognitive deficits were found to be especially substantial among those who were hospitalized, those who were hospitalized and on a ventilator, and those who had more severe symptoms but recovered at home.

Researchers with the University of Texas Health Science Center at San Antonio, who recently presented data at the Alzheimer's Association International Conference, found that neurological changes seen after COVID-19 mirror those found in people with Alzheimer’s disease. Genetic studies are showing that the genes responsible for increasing the risk of more severe COVID-19 also increase the risk of Alzheimer’s. Additionally, anecdotal reports suggest Alzheimer’s diagnoses appear to be more common among people in their 60s and 70s who have had severe COVID-19. Further research is ongoing to determine COVID-19’s longer-term impacts on neurological function, including cognition, intelligence, and risk of Alzheimer’s disease.

MUCORMYCOSIS Following India’s most severe COVID-19 surge in the spring, the country has seen an increase in cases of mucormycosis, also called “black fungus,” and related deaths. Since late March, the nation has recorded more than 45,000 cases of the disease, a serious but rare fungal infection caused by the mucormycetes group of molds, and more than 4,300 people have died, with most having contracted COVID-19 prior to their fungal infection. Clinicians have noted that symptoms usually manifest 12-18 days after COVID-19 recovery. In a letter published July 29 in Drug Development Research, researchers warn that because uncontrolled diabetes and other immunosuppressive diseases, as well as corticosteroid treatment, are seen as risk factors for the fungal infection, they suggest avoiding steroids to treat COVID-19, as they might be a contributing factor to the disease. As the number of mucormycosis cases continue to rise, there are questions about unreliable supplies of the drug used to treat the infection, adding an additional challenge to India’s already complicated COVID-19 recovery.

Thursday, July 29, 2021

COVID 19 Variants

JULY 29, 2021

Variants and Vaccines

BY SEIJI YAMADA

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Photograph Source: Travis Wise – CC BY 2.0

In late 2020 the British noticed that coronavirus cases were spiraling upward in the region of Kent. The culprit turned out to be a variant of the COVID-19 virus identified in September, Mutations in the genetic make-up, the RNA, lead to variants. They are still COVID-19 viruses, but they can behave differently. The variant first identified in Kent, UK (scientific name B.1.1.7, WHO name Alpha) is more infectious than the original strain which emerged from Wuhan, China.

The number of other people that each infected person infects is called the basic reproduction number, or R0 (“R naught”), in epidemiological parlance. It’s a measure of the biological characteristics of an infectious agent, but it can be affected by social and environmental conditions and human behavior (e.g. crowding vs. social distancing, ventilation, facemasks). The R0 of seasonal influenza is 1.3. The R0 of measles is around 15. As it emerged in Wuhan, the R0 of the original COVID-19 strain was 2.4—2.6. The R0 of the Alpha variant is 4 to 5.

The Beta variant (scientific name B.1.351) arose in South Africa in October 2020. It was found that the AstraZeneca vaccine was ineffective against the Beta strain – leading to a pause in its use there in February 2021. (The AstraZeneca vaccine may make a comeback in South Africa, since it is effective against the Delta strain, which is poised to become dominant there.)

The Gamma variant (scientific name P.1) arose in Brazil in December 2020. Manaus, in the Amazon, had had a severe epidemic of COVID-19 during 2020, such that it was estimated that 50% of its residents had been infected by October 2020. In December, Manaus experienced a second wave, more severe than the first, during which the Gamma strain was detected. Of note, Gamma caused infections in individuals who had been previously infected – demonstrating that an infection with one strain of COVID-19 might not lead to immunity against a different strain.

The Delta variant (scientific name B.1.617.2) was responsible for the April-June 2021 second wave in India. At its peak, India was recording nearly 400,000 cases and over 4000 deaths per day, believed to be a severe undercount. The true cases may have been over a million per day, and true deaths may have been 10 to 15,000 per day. Between January and June 2021, 3 to 4.7 million excess deaths occurred in India. The Delta variant has a R0 of 5 to 8. Each case of Delta leads to 5 to 8 more cases. An infected individual is likely to infect everybody else in the household. This gives it an evolutionary advantage over even the Alpha variant. The WHO declared Delta a “variant of concern” on May 10. By mid-July Delta was the dominant variant in the U.S.

A study involving 4272 cases of Delta from Public Health England (published July 21 in the New England Journal of Medicine) concluded that two doses of the Pfizer-BioNTech vaccine was 88% effective and  that two doses of the AstraZeneca vaccine was 67% effective in preventing symptomatic COVID-19. (One dose of Pfizer was only 35.6% effective against Delta.) In contrast, according to Israeli data from mid-June to mid-July 2021, the Pfizer vaccine was only 39% effective in preventing COVID-19 infection, but this data has not been published in the peer-reviewed literature. Of note, however, vaccination was 91.4% effective in preventing severe COVID-19. On July 22, Los Angeles County Public Health Director Barbara Ferrer announced that 20% of the COVID-19 cases in LA County over the past month were breakthrough infections in individuals who had been fully vaccinated.

Parts of the world that have vaccinated their populations with the Sinopharm and Sinovac vaccines from China are experiencing outbreaks. Indonesia, which is currently experiencing a major Delta wave, has relied on vaccines from China.

While the currently available mRNA vaccines (Pfizer and Moderna) are not quite as effective against Delta as it was against the original COVID-19 virus, they nevertheless prevent hospitalization and death. Currently, in the U.S., 97% of those hospitalized with coronavirus and 99.5% of those dying from coronavirus are unvaccinated. Clearly, we must continue to promote vaccination.

Delta has put “herd immunity” nearly out of reach, however. The percentage of the population that needs to be immune [whether from vaccine immunity or from infection with the original virus (I hesitate to say “wild type”) or a prior variant] to achieve herd immunity is derived from R0. From the estimate that the original COVID-19 strain had an R0=2.5, the

% needed to achieve herd immunity = 1 – 1/R0 = 1 – 0.4 = 60%

which is close to (though a little less than) 70%. This is the basis for government officials telling us that we need to vaccinate 70% of the population. Since the R0 of Delta is estimated to be from 5 to 8, using R0=6,

% needed to achieve herd immunity = 1 – 1/R0 = 1 – 0.17 = 83%

The next variant of concern (or the one after, or the one after that . . . twenty letters left to go in the Greek alphabet) may not only be as contagious as Delta. It may also more easily escape vaccine immunity (like Beta with AstraZeneca) or natural immunity (like Gamma). It is entirely plausible that vaccines will need to be reformulated to match future variants.

As difficult as it may be to achieve, we must continue to try to achieve herd immunity. In the U.S., FDA approval will allow employers and schools to mandate vaccines. During the current Delta wave, because of breakthrough infections, even the vaccinated should maintain social distancing and wear masks indoors. With businesses pressuring government officials not to impose lockdowns, it will be up to the informed to take measures on their own.

The current Delta wave will also pass. Many will die, but because many of the elderly and infirm have been vaccinated, not as many as in the dark days of January. Since the beginning of COVID-19, the epidemic curves of the U.S. and the U.K. have been shaped similarly. Of course, the U.S. has five times the population of the U.K. (331.4 million vs 68.2 million), so its absolute numbers of cases has generally been approximately five times that of the U.K. – except since late June, when Delta, which hit the U.K. earlier, gave the U.K. an absolute number of daily cases higher than that of the U.S. During the Delta wave, the daily cases in the U.K. approached those of its worst days in early January. The U.K.’s Delta wave appears to have peaked, however. The U.S.’s Delta wave is still in its exponential climb.

Regardless of what the future may bring, the task at hand is to deliver life-saving vaccines to the world. To stave off more India-like disasters around the world, we must support an accelerating, global Covid immunization campaign. The Biden Administration’s decision to support the suspension of intellectual property rights for vaccine manufacturing was a step in the right direction. On June 9, the US announced that it will purchase and donate 500 million doses of the Pfizer vaccine. This is clearly inadequate when fewer than 5 doses per 100 people have been administered in Africa (total population 1.34 billion). U.S. taxpayers subsidized the development of the mRNA vaccines. It is a travesty that Pharma profits so handsomely from public investment. Life-saving vaccines are public goods that belong to the people.

Seiji Yamada, a native of Hiroshima, is a family physician practicing and teaching in Hawaii.

Above is from:  https://www.counterpunch.org/2021/07/29/variants-and-vaccines/

Tuesday, July 27, 2021

July 27: 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 194.1 million cumulative cases and 4.16 million deaths worldwide as of 12:28 EDT on July 26. Global weekly incidence increased for the fifth consecutive week, a 7.89% increase over the previous week. Global weekly mortality increased for the third consecutive week, a 20.77% increase compared to the previous week.

Global Vaccination

The WHO reported 3.7 billion doses of SARS-CoV-2 vaccines administered globally as of July 26. The WHO reports a total of 1.44 billion individuals have received at least 1 dose, and 672 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered is up, now at 33 million doses per day, driven by increases in Asia. Our World in Data estimates that there are 2.14 billion vaccinated individuals worldwide (1+ dose; 27.5% of the global population) and 1.08 billion who are fully vaccinated (13.9% of the global population).

UNITED STATES

The US CDC reported 34.4 million cumulative COVID-19 cases and 608,528 deaths. Daily incidence continues to increase, now up to 42,226 new cases per day, which is nearly 3.7 times the most recent low on June 19 (11,467) and is still increasing steadily. Daily mortality also continues to increase, up to 239 deaths per day, which is more than 45% higher than the most recent low on July 10 (164).

US Vaccination

The US has administered 342.2 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations are increasing slowly, now up to 471,948 doses per day*. A total of 188.7 million individuals in the US have received at least 1 dose, equivalent to 56.8% of the entire US population. Among adults, 69% have received at least 1 dose, as well as 10.5 million adolescents aged 12-17 years. A total of 163.2 million individuals are fully vaccinated, which corresponds to 49.1% of the total population. Approximately 60% of adults are fully vaccinated, as well as 8.1 million adolescents aged 12-17 years.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current value provided here corresponds to 5 days ago.

US HOSPITALIZATIONS The number of COVID-19-related hospitalizations is beginning to rise in most US states, following increasing numbers of COVID-19 cases driven by the spread of the more transmissible Delta variant. Nationally, hospitalization rates remain low overall, nowhere near the previous pandemic peaks. But the increases in hospitalizations are high and rising in parts of the country that have low vaccination rates, including Florida, Nevada, Arkansas, and Missouri. Some Florida hospitals are seeing the highest number of COVID-19 patients since the beginning of the pandemic, and the pace of this surge is accelerating rapidly. One hospital in Missouri said its increase in patients occurred nearly 5 times as fast as last fall’s surge. An estimated 97% of hospitalized patients are unvaccinated. Patients also are skewing younger, with 69% under the age of 65, according to CDC data as of July 17. Some hospitals are scrambling to find space for intensive care patients, trying to address personnel shortages, and attempting to maintain adequate supplies of medical equipment such as ventilators.

According to new projections released last week by the COVID-19 Scenario Modeling Hub—a consortium of researchers working with the US CDC to track the pandemic—the current US surge will continue throughout the summer and into the fall. In the most likely of 4 scenarios, there would be around 60,000 new cases and about 850 deaths per day, with 70% of eligible Americans vaccinated. Currently, the US is averaging around 42,000 new cases per day and about 250 deaths per day. Nationwide, 57.5% of eligible people are fully vaccinated. The researchers encouraged state and local leaders to take note of the projections, urging them to reimplement mask mandates and physical distancing requirements that could help lessen the surge’s impact.

US GOVERNMENT RESPONSE As the number of new COVID-19 cases continues to rise in the US, the US government is examining further tactics to contain the pandemic. Last week, the White House purchased an additional 200 million doses of the Pfizer-BioNTech vaccine. The purchase is in anticipation that additional doses will be recommended for certain populations and that the vaccine could “soon” be authorized for use in children ages 5-11. The US government also hinted at reinstated mask recommendations.

Overall, the US government is focused on improving national vaccination rates, particularly in communities with low coverage where most new COVID-19 cases are in unvaccinated individuals. On July 22, the government announced US$100 million for rural health clinics to develop vaccine confidence and outreach efforts. Additionally, the US Department of Health and Human Services will invest US$1.6 billion from the American Rescue Plan to support COVID-19 testing and mitigation activities in vulnerable communities. These funds will address the rise in cases among unvaccinated people by detecting, diagnosing, tracing, and mitigating the spread of SARS-CoV-2 in homeless shelters, correctional facilities, and other hard-hit and high-risk areas. In recognizing the 31st anniversary of the Americans with Disabilities Act, the government announced a package of guidance and resources to support individuals experiencing “long COVID,” also known as post-acute sequelae of COVID-19. According to the guidance, long COVID can be considered a disability under certain federal civil rights laws, thereby allowing federal protections and resources for adults and children impacted by long-lasting symptoms of COVID-19.

As the US government focuses on challenges to the nation’s domestic recovery from the pandemic, including rising consumer prices and turbulent financial markets, officials from the US Agency for International Development who are responsible for making the US an “arsenal of vaccines” are struggling to help other countries acquire resources and distribute SARS-CoV-2 vaccines, COVID-19 therapeutics, and personal protective equipment. At issue is more than US$1 billion the White House diverted from the agency in June to pay for the purchase of 500 million additional doses of the Pfizer-BioNTech vaccine, meant to supplement the 80 million vaccine doses the government has already allocated for donations abroad, according to unnamed officials. But the unexpected shift in funding, and the wait time for those doses to be delivered, has put pressure on the US government to maintain its status as a leading donor of COVID-19 assistance. USAID officials tasked with vaccine distribution abroad continue to advocate for increased resources from the White House and US Congress in order to assist countries in need.

VACCINATION MANDATES As the Delta SARS-CoV-2 variant sweeps across the US, more jurisdictions and companies are considering strengthening public health measures to mitigate the virus’s impact. This includes vaccination mandates for employees. On July 26, California, the country’s most populous state, became the first in the nation to announce that all state employees and on-site public and private workers in health care and high-risk congregate settings will be required to show proof of vaccination or submit to mandatory once-or-twice weekly testing. State employees are required to submit vaccination documentation by August 2, and health care and congregate-setting facilities must be in full compliance by August 23. Unvaccinated workers also will be required to wear appropriate PPE. A few hours earlier, New York City, the nation’s largest city, announced that all 340,000 municipal employees of the city, including police officers and teachers, will be required to be vaccinated or start weekly testing by September 13. As of August 2, any employee who is unvaccinated must wear a mask indoors at all times or risk termination. In their announcements, both California Governor Gavin Newsom and New York City Mayor Bill De Blasio encouraged other local governments and private sector employers to implement vaccination mandates.

The Department of Veterans Affairs on July 26 became the first federal agency to implement a vaccination mandate, requiring 115,000 of its frontline healthcare workers to show proof of full vaccination within the next 8 weeks. In its announcement, the VA referenced several organizations that support vaccine mandates. Many of those groups—including the American Medical Association, the American Nurses Association and 55 other groups representing millions of doctors, nurses, pharmacists, and other healthcare workers—issued a joint statement early on July 26 calling for all healthcare and long-term care employers to require their employees to be vaccinated for SARS-CoV-2. The statement cites highly contagious variants, including the Delta variant, and “significant numbers” of unvaccinated people as drivers for rising numbers of COVID-19 cases, hospitalizations, and deaths in the US. The groups also called on other employers across the country to implement policies to encourage vaccination. As we have previously reported, vaccination mandates for employees of a hospital system (Bridges et al v. Houston Methodist Hospital et al) and students of a university (Ryan Klaasen et al v. The Trustees of Indiana University) so far have been upheld in US federal district courts. An appeal from one of those cases is expected, and additional legal challenges likely will result from these, and future, vaccination mandates.

MODERNA VACCINE FOR ADOLESCENTS The European Medicines Agency’s Committee for Medicinal Products for Human Use on July 23 approved the Moderna SARS-CoV-2 vaccine (known as Spikevax in Europe) for use in children aged 12 to 17 years. The vaccine already is authorized for adults aged 18 and older, but it is the first time this vaccine has been authorized for people under age 18. According to the EMA, data from more than 3,700 children ages 12 to 17 showed the vaccine produced an antibody response comparable to the one seen in young adults aged 18 to 25 years. The younger group also experienced similar mild-to-moderate side effects. The agency noted that the trial was unable to detect new, uncommon side effects or evaluate the risk of known ones, including the inflammation of heart muscle and tissue, because of the relatively small number of study participants, but added that the “benefits of Spikevax in children aged 12 to 17 outweigh the risks.” Until now, the Pfizer-BioNTech was the only option for children aged 12 and older in Europe. The US FDA currently is considering whether to authorize the Moderna vaccine for the same age group.

VACCINE TRIALS FOR CHILDREN The US FDA reportedly has urged 2 SARS-CoV-2 vaccine makers, Pfizer-BioNTech and Moderna, to expand the size of their clinical trials among children aged 5 to 11 years in order to assess whether the rare side effects of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) that have been seen in young adults shortly following vaccination also appear in this younger age group. Federal regulators requested the companies include at least 3,000 children in their studies, reportedly about double the original number of participants. Moderna confirmed its plans to expand the size of its pediatric clinical trial and expects to have data on its vaccine’s use among children ready to submit to the FDA in winter 2021 or early 2022. Pfizer-BioNTech indicated it does not plan to alter its original timeline of submitting a request for the FDA to expand authorization to 5-to-11-year-old children by the end of September, and presenting data for younger children, aged 6 months to 2 years, in October or November. The FDA last month added warnings about the potential for myocarditis and pericarditis to patient and provider fact sheets for both the Moderna and Pfizer-BioNTech vaccines.

LONG COVID/PASC IN CHILDREN Children’s National Hospital (US), in collaboration with the US NIH’s National Institute of Allergy and Infectious Diseases, announced on July 25 they are launching a large, multi-year study to examine the long-term effects of COVID-19 and multisystem inflammatory syndrome in children (MIS-C) following recovery from acute SARS-CoV-2 infection. The study will enroll up to 1,000 children and young adults under age 21 who have recovered from confirmed infection with SARS-CoV-2, with or without symptoms, or MIS-C, as well as up to 1,000 household contacts who will serve as a control group, and 1 parent or guardian per participant to complete questionnaires. Surveys will gather information about quality of life, social impact, and any long-term physical impacts of the virus, and researchers also plan to detail the role of genetics; duration and quality of immune responses following infection; so-called “long COVID,” also called post-acute sequelae of COVID-19 (PASC); and MIS-C.

In the US, more than 4.1 million children have tested positive for SARS-CoV-2, and nearly 500 have died. In the week ending July 22, children accounted for 16.8% of reported weekly COVID-19 cases nationwide. Black, Hispanic/Latino, and Native American children have been hardest hit, accounting for 3 out of 4 deaths among patients under age 21. According to researchers, between 2% and 10% of recovered children have long-term symptoms, and about 2 out of 3 children who develop MIS-C are Black or Hispanic/Latino. The US$40 million study is one of many NIH is supporting to understand the range of SARS-CoV-2 effects on children. Little is known about why some children experience long-term symptoms following COVID-19 recovery, just as long COVID-19 is not well understood in adults. It is hoped that these controlled clinical trials will provide more answers about how these conditions can be more effectively treated and, possibly, prevented.

GLOBAL VACCINE ACCESS The World Bank and the COVAX facility on July 26 announced a new financing mechanism to help improve access to SARS-CoV-2 vaccines for low- and middle-income countries (LMICs), where vaccination rates are lagging. Countries that are seeking to purchase vaccines through the COVAX advance market commitment cost-sharing system via Gavi, the Vaccine Alliance, are facing hurdles in guaranteeing their own payments. Now, COVAX will be able to negotiate advance purchase agreements with vaccine makers based on aggregated demand across several of the 92 LMICs that participate in the advance market commitment, using financial backing from the World Bank and other multilateral development banks. The mechanism should enable more countries to receive bulk vaccine purchases at a lower cost, instead of relying solely on donations through COVAX, and countries would be able to select specific vaccines that align with their preferences. Additionally, it will allow for more transparency regarding vaccine availability, pricing, and delivery schedules, World Bank President David Malpass noted in a statement. Under the AMC cost-sharing arrangement, COVAX plans to provide up to 430 million additional vaccine doses for delivery between late 2021 and mid-2022. COVAX has already delivered nearly 153 million doses to 137 countries, but that number is far below its 2021 goal of 2 billion doses. The new financing mechanism comes amid growing concern over the widening gap in global vaccine access, with experts hoping the arrangement will facilitate vaccine deliveries to countries in need.

VIETNAM LOCKDOWN On July 23, Vietnam’s capital city of Hanoi began a 15-day lockdown amid a spike in new COVID-19 cases. The country’s health ministry reported 7,968 new cases on July 24, a record daily increase and up from the previous day’s count of 7,307. With the addition of Hanoi’s 8 million people, about one-third of Vietnam’s 100 million people are now on lockdown. Residents in larger cities, like Ho Chi Minh City and Hanoi, are no longer allowed to congregate in groups of more than 2 people and are only allowed to leave their homes for food, medication, or in the case of an emergency. According to Our World in Data, Vietnam has fully vaccinated only 0.4% of its population and is taking steps to procure more vaccine doses. On July 25, the country announced it received 3 million doses of the Moderna vaccine from the US through COVAX. Vietnamese officials are in talks with US officials about the domestic production of mRNA vaccines, which could begin late this year or in early 2022, with the goal of producing 100 to 200 million doses a year. The government also indicated it is considering authorizing the domestically produced Nanocovax vaccine. A phase 3 clinical trial testing the vaccine is ongoing, but results are not yet available.

FRANCE HEALTH PASS The French Parliament on July 26 approved a law mandating special health passes for entry to all restaurants, trains, planes, and some other public venues and requiring vaccinations for all healthcare workers and other essential workers such as firefighters beginning September 15. In order to obtain a health pass, people must show digital or paper proof of full vaccination, results of a recent negative SARS-CoV-2 test, or documentation of recent recovery from acute COVID-19. More than 160,000 people demonstrated around France over the weekend to protest the legislation requiring health passes. France President Emmanuel Macron welcomed peaceful demonstrations but added they will not make the pandemic disappear. “My message is simple: to get vaccinated,” he said. Nearly 60% of the French population has received at least 1 dose of vaccine, but the number of new daily COVID-19 cases has risen sharply since the beginning of the month. The Constitutional Council is expected to review the law next week to determine whether it complies with the country’s Constitution.

NFL COVID-19 RULES The US National Football League (NFL) sent a strong message to its 32 teams last week, encouraging clubs to convince players to get vaccinated for SARS-CoV-2 and alerting them that games having to be cancelled due to a COVID-19 outbreak among unvaccinated players would be forfeited and counted as a loss. According to a memo, the league intends to play its entire 272-game schedule over 18 weeks and would not add a “19th week” to accommodate games that cannot be rescheduled during the 18-week regular season. If a game is cancelled due to an outbreak and cannot be rescheduled, neither team’s players would receive their weekly salary and the responsible team would cover all financial losses. Additionally, vaccinated players or staff who test positive but are asymptomatic can return to the field after 2 negative tests 24 hours apart; however, unvaccinated individuals who test positive would be required to complete a 10-day isolation period. Unvaccinated players are required to undergo daily testing, physically distance, wear a mask indoors, and be prohibited from gathering with the team for media events or outside of official team activities, such as at nightclubs, bars, or house parties. If unvaccinated players violate the gathering rules, the NFL and clubs are permitted to issue fines of up to US$50,000 for a first offense, and more for further violations. For violating other COVID-19 protocols, such as not wearing a mask when required, players could be fined US$14,650 every time a transgression occurs. According to the memo, more than 75% of players are in the process of being vaccinated and more than half of the teams have vaccination rates of more than 80% of players. With the NFL placing the burden on teams and players to get vaccinated or else face significant economic consequences, it will be interesting to see if teams can reach near-100% vaccination rates.