Tuesday, September 7, 2021

It's mRNA or nothing

Yahoo Finance

'It's game over. It's mRNA or nothing:' Expert on future of vaccines

Anjalee Khemlani

Anjalee Khemlani

·Senior Reporter

Tue, September 7, 2021, 3:05 PM

Pfizer (PFE) and its partner BioNTech (BNTX) recently got FDA full approval for the most widely-approved and sought after COVID-19 vaccine in the world, to date.

It signals an important change in how vaccines of the future could look, according to Arnaud Bernaert, formerly head of Global Health and Healthcare at the World Economic Forum.

Bernaert, now head of Health Security Solutions at Swiss-based SICPA, told Yahoo Finance, "I think it's game over. I think it's mRNA or nothing. [Other technology] takes too long."

Pfizer, BioNTech and Moderna (MRNA) are invested in the tech, with announcements of pursuits of combination flu-covid shots as well as other diseases.

The potential for mRNA was recognized early. "mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration," according to a 2018 article in Nature.

Bernaert cited these reasons as well. "If success needs to be defined as a function of the agility of a manufacturer to be able to reposition the DNA template for combating the next variant, I don't think the U.S. and Europe will do anything else but buy mRNA vaccines" moving forward, he said.

"They [mRNA] will represent 60% or 70% of the market. The other guys will die," he added.

But the pandemic also arrived after early development hurdles had been overcome for the technology. That included the method of delivery, lipid nanoparticles. And within the timeframe of getting the vaccines authorized, Moderna was first to reduce the storage temperatures needed from ultra-cold to normal freezer temperatures.

Now, the next step to unlocking their potential as a dominant technology will be global manufacturing, Bernaert said.

"I think mRNA is going to be a highly decentralized manufacturing technology," he said.

Deals happening now could be viewed as early efforts. That includes the various manufacturing and fill/finish deals that Pfizer and Moderna have penned in the past year.

Moderna has forged relationships with Catalent (CTLT), Switzerland-based Lonza, Spain-based Rovi, and France-based Recipharm for manufacturing. The company also partnered with Takeda (TAK) in Japan, Magenta in the United Arab Emirates and Tabuk in Saudi Arabia for distribution. It has partnered with Thermo Fisher (TMO), Sanofi (SNY), Baxter BioPharma and Samsung Biologics, in South Korea, for fill/finish. In addition, Moderna is working with Canada to set up a new manufacturing facility for future products. That's all on top of investing in its Massachusetts plant to expand manufacturing.

By comparison, pharma giant Pfizer has largely relied on its own sites in the U.S. and Europe, along with BioNTech's capacity, but recently signed agreements for global efforts. That includes with the Biovac Institute in South Africa and Eurofarma in Brazil for manufacturing. It has also partnered with Sanofi for fill/finish.

But further in the future, Bernaert expects mRNA use will lead to a decrease in the need for large-scale manufacturing footprints, "with 20,000-liter bioreactors a story of the past."

Bernaert pointed to California-based Nutcracker Therapeutics, as an example.The company is working on a smaller instrument that could give doctors access to locally-produced mRNA doses.

Already, mRNA companies have achieved improving stability at warmer temperatures compared to ultra-cold temperatures for the first doses. For now, however, the process is "crude," Bernaert said.

"The cold chain challenges will reduce, I think, over time. There will be lots of investments in better encapsulation mechanism, better lipid nanoparticles. It was very crude in the first place. I mean, let's call a spade a spade. The template itself and the way you grow enzymes, I think it's fairly crude."

He foresees synthetic biology DNA templates on the front end and better encapsulation mechanisms (lipids) on the back end. Brought together, it leads to a much more stable manufacturing process, Bernaert said.

Whatever the future holds, mRNA is set to dominate. "Viral vector technologies are going to become obsolete," Bernaert said.

Above is from:  https://www.yahoo.com/news/its-game-over-its-m-rna-or-nothing-expert-on-future-of-vaccines-200508222.html

Friday, September 3, 2021

September 3: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

The COVID-19 Situation Report will not be published on Tuesday, September 7, 2021, in recognition of the Labor Day holiday in the US. The report will resume publication on Friday, September 10.

EPI UPDATE The WHO COVID-19 Dashboard reports 218.6 million cumulative cases and 4.53 million deaths worldwide as of September 3.

Global Vaccination

The WHO reported 5.29 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of September 1. A total of 2.01 billion individuals have received at least 1 dose, and 1.21 billion are fully vaccinated. Analysis from Our World in Data indicates that global daily vaccinations are holding relatively steady at approximately 41 million doses per day, which is the third highest peak to date*. The global trend continues to closely follow the trend in Asia. Our World in Data estimates that there are 3.16 billion vaccinated individuals worldwide (1+ dose; 40.1% of the global population) and 2.16 billion who are fully vaccinated (27.4% of the global population). *The average doses administered may exhibit a sharp decrease for the most recent data particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

UNITED STATES

The US CDC reported 39.5 million cumulative COVID-19 cases and 641,725 deaths. Daily incidence continues to increase, but the trend is tapering off toward a peak or plateau. On August 27, the US surpassed 150,000 new cases per day, and the current average of 153,245 is the highest since January 28. Daily mortality also continues to increase, and the mortality trend may be starting to taper off as well, although Florida’s new reporting scheme is impacting how we interpret the current trend (see below). The US surpassed 1,000 deaths per day on August 24, and the current average of 1,046 deaths per day is the highest since March 11*.

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

The Florida Department of Health updated its COVID-19 mortality reporting process, which affects how the official state and CDC data are interpreted. Previously, like other states, Florida assigned dates to COVID-19 deaths corresponding to the date they were reported; however, Florida now assigns dates that correspond to the date of death. While reporting mortality by the date of death is technically the most accurate approach, it makes it difficult to monitor current trends. Deaths can take days or weeks to be identified, confirmed, and reported, which results in a sharp artificial decline in daily mortality over the most recent several days, even though the actual trend could be increasing. As deaths are confirmed, they will be added to the correct date of death, so the data from recent days will fill in over time. These delays mean that it will take extra time to identify changing trends, including the peak during a surge or the start of a new surge. Based on recent trends, we believe Florida is averaging more than 200 deaths per day; however its most recent report includes only 11 deaths for September 1, bringing its average down all the way down to 64. Because Florida represents approximately 20% of the average national daily mortality, its new reporting scheme is affecting how we interpret the national-level trend as well. The US average could easily be 100-150 deaths per day higher than the current reported value.

US Vaccination

The US has administered 372 million cumulative doses of SARS-CoV-2 vaccines, and daily vaccinations have leveled off over the past several days, hovering at slightly more than 800,000 doses per day since August 23*. We have not observed a marked increase in daily vaccinations since the US FDA issued full approval for the Pfizer-BioNTech vaccine. There are 205.9 million individuals who have received at least 1 dose, equivalent to 62.0% of the entire US population. Among adults, 74.5% have received at least 1 dose, as well as 13.5 million adolescents aged 12-17 years. A total of 175.0 million individuals are fully vaccinated, which corresponds to 52.7% of the total population. Approximately 63.7% of adults are fully vaccinated, as well as 10.4 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 average provided here corresponds to 5 days ago.

As we have covered previously, there are considerable disparities in terms of both vaccination coverage and the impact of the ongoing US surge at the state and regional levels. This week, we will look more closely at COVID-19 mortality since July 1 (ie, during the current surge) and any potential associations with state-level full vaccination coverage. It is well documented that full vaccination provides good protection against severe COVID-19 disease and death, including from the Delta variant. In this analysis, we will compare the raw increase in per capita cumulative mortality from July 1-September 1. Comparing the per capita values will allow us to more directly compare states to each other, and using the raw increase—ie, as opposed to the relative increase—we can mitigate the effects of the baseline cumulative incidence, which varies widely by state. By July 1, all states had removed eligibility restrictions and opened vaccination up to the general public. Daily vaccination progress slowed, so we can reasonably assume that coverage—or at least the relative differences in coverage—remained relatively consistent over that period.

The median state-level increase in per capita cumulative mortality over this period was 8 deaths per 100,000 population, and the mean was 11. This indicates that most states reported lower increases, while a small number of states reported much higher totals. In total, 32 states reported increases of 10 or fewer, and 12 states* reported increases of 15 or more, including 4 states with increases of more than 30: Louisiana (40), Florida (36), Arkansas (35), and Mississippi (34). Of the 12 states reporting increases of more than 15, 10 are in HHS Regions 4 (Southeast), 6 (South Central), and 7 (Central). Among the 16 states reporting increases of 5 deaths per 100k or fewer, the top 5 are all in Region 1 (Northeast)**, 4 states are in Region 3 (Midwest), and 3 are in Region 5 (Mid-Atlantic).

Among the 12 states reporting increases of 15 deaths per 100k or more, all but Florida (#21; 53.4%) are in the bottom half of states in terms of full vaccination coverage. Florida is also the only one of these states with full vaccination coverage greater than 50%. Eight (8) of these states are in the bottom 12 in terms of vaccination coverage, including #48 Wyoming (39.1%), #49 Alabama (38.6%), and #50 Mississippi (38.5%). Among the top 10 states in terms of full vaccination coverage, 6 are also in the top 10 in terms of the increased per capita mortality. Only 1 of the top 28 states in terms of vaccination coverage reported an increase in mortality greater than 10 deaths per 100k: Florida (+49).

Several states reported notably lower or higher increases in per capita mortality than would be expected based solely on their vaccination coverage. As noted above, Florida reported the second-largest increase in mortality, but it ranks #21 in terms of full vaccination coverage. While vaccination is a key tool in terms of mitigating the impact of COVID-19, it needs to be combined with non-pharmaceutical interventions (NPIs), such as physical distancing and mask use, to slow transmission, and Florida officials have exhibited an unwillingness to implement those types of measures during the current surge. Increased transmission and incidence will inevitably lead to increased mortality. New Jersey, Oregon, and Washington also rank considerably lower in terms of increased mortality than they do for vaccination coverage—18, 19, and 20 positions lower, respectively—but it is not immediately clear why these states, in particular, faced elevated COVID-19 mortality compared to their vaccination coverage.

Conversely, North and South Dakota rank much better in terms of increased COVID-19 mortality than their vaccination coverage would suggest. North Dakota is #44 in terms of vaccination coverage (41.8%), but it is #4 in terms of the increase in mortality (4 deaths/100k), a difference of 40 positions. South Dakota also ranks #4 in terms of increased mortality**, but it ranks #26 in terms of vaccination coverage (49.4%), a difference of 22 positions. Similarly, Nebraska and Ohio each rank 18 positions higher in terms of increased mortality than they do for vaccination coverage. Notably, these and other similar states—including Idaho, Michigan, Minnesota, and West Virginia—appear to still be in the early stages of their respective surges, so it is possible that we could observe larger increases in mortality as they move closer to their respective peaks. In contrast, most of the Region 1 states appear to already be peaking in terms of COVID-19 mortality, and their lower mortality during this surge suggests that higher vaccination coverage provided protection against severe disease and death at the state level.

With some notable exceptions, there appears to be an association between higher vaccination coverage and lower COVID-19 mortality during the current surge. The surge first emerged in Missouri, before moving south and east, into Arkansas, Louisiana, Mississippi, Alabama, and Florida, so it has been present there longer than in other parts of the country. The lower vaccination coverage in these states, however, appears to be contributing to elevated hospitalizations and mortality—in some instances, equal to or worse than their previous records. The timing of the geographic spread of the surge could also potentially factor into the lower mortality reported in states that are still in the early stages of their respective surges, particularly those with lower vaccination coverage. Additional analysis, including after more states pass their peaks and on case-fatality ratios over this period, could provide further insight into the association between state-level vaccination coverage and COVID-19 mortality during this surge.

*Delaware reported an overall increase of 20 deaths/100k, but this included a jump of 13 on August 1 due to a bolus of 130 newly reported deaths, most of which were previously unreported. Without this reporting anomaly, Delaware would have had an estimated increase of 7.

**Including ties; 6 states reported increases of 4 deaths per 100k, all tying for the #4 rank.

VARIANT OF INTEREST: MU In its August 31 COVID-19 Epidemiological Update, the WHO announced the addition of another SARS-CoV-2 variant to its list of variants of interest (VOIs), B.1.621 or “Mu.” The Mu variant, which also includes the descendent Pango lineage B.1.621.1, includes several mutations that show the potential for immune escape in both people previously infected with SARS-CoV-2 and those who are vaccinated; however, more research is necessary to confirm the theory. As of August 29, more than 4,500 sequences of the lineage were recorded in 39 countries. The Mu variant was first identified in Colombia in January 2021. Since then, the variant has spread worldwide, with cases reported in the UK, US, Europe, and Hong Kong. While the global prevalence of the Mu variant among sequenced cases is below 0.1% globally and declining, the variant accounts for at least 39% of cases in Colombia and 11% in Ecuador, with prevalence in both countries continuing to increase. But WHO warned that reports on the variant’s prevalence should be “interpreted with due consideration” because of variations in countries’ sequencing capacities. Mu is the fifth variant of interest named by the WHO since March 2021. In August, Public Health England (PHE) released a risk assessment for the variant, which it calls VUI-21JUL-01, highlighting that laboratory findings show it is similar to the Beta variant first detected in South Africa and raising concerns over its potential for immune escape. The WHO said it will continue to monitor and study the variant’s epidemiological evolution.

MASK-USE TRIAL A group of researchers from Stanford Medicine and Yale University this week released findings from the first randomized controlled trial (RCT) in a real-world setting designed to evaluate the effects of mask use on SARS-CoV-2 transmission. The researchers found that mask use, even when worn inconsistently in the community, can lead to a reduction in symptomatic COVID-19 cases. Additionally, relatively low-cost, targeted interventions promoting mask wearing can significantly increase the use of face coverings in rural, low-income countries, according to the results. Although the study is not yet published, the researchers have submitted the paper to the journal Science, whose editors encouraged its public release given the current public health policy relevance, as the pandemic worsens in many parts of the world.

The study included more than 340,000 adults in 600 villages in Bangladesh. In 300 villages, researchers implemented a mask distribution and promotion initiative, now called the “NORM” model, which stands for “No-cost mask distribution, Offering information, Reinforcement to wear masks, and Modeling by local leaders.” The researchers saw a 29 percentage-point increase in mask-wearing in the intervention villages (42%) versus the comparison villages (13%). Overall, the increased mask usage led to a 9% reduction in serologically confirmed symptomatic SARS-CoV-2 infection. Notably, 100 of the villages received cloth masks, resulting in a 5% reduction in symptoms, while 200 villages that received surgical masks saw a 12% reduction in symptoms. The use of surgical masks was especially effective for people aged 60 years or older, leading to a 35% reduction in symptomatic SARS-CoV-2 infections in that age group. The team plans to conduct further research evaluating how masks limit symptomatic cases, whether by reducing exposure to viral load or by preventing infections entirely. For now, the study provides a “gold standard” showing mask wearing is an effective way to limit symptomatic COVID-19, and the interventions are being rolled out in other parts of Bangladesh and in Pakistan, India, Nepal, and areas of Latin America.

LONG-TERM HEALTH EFFECTS The scientific community continues to investigate the long-term impacts of COVID-19 on individual health. Researchers from the University College of London announced earlier this week that their survey of children with positive COVID-19 diagnoses provided reassurance that post-acute sequelae of COVID-19 (PASC), or so-called “long COVID,” does not impact large numbers of adolescents. The research team conducted a survey of 11- to 17-year-olds in England who had positive SARS-CoV-2 tests between September 2020 and March 2021. The study, which is not yet peer-reviewed, suggests that 2-14% of children with a positive test reported having symptoms 15 weeks after their initial diagnosis. While the reported prevalence still presents a public health concern for children with COVID-19, it suggests that these issues may not be as prevalent among younger people as previously thought.

Research also continues into the scope of COVID-19's long-term impacts among adults. A recent article published in The Lancet describes 1-year outcomes of individuals who survived hospitalization due to COVID-19. The study included 1,276 survivors discharged from the Jin Yin-tan Hospital in Wuhan, China, between January 7 and May 29, 2020. The cohort was followed for 12 months, with follow-up visits at 6 and 12 months. The research team found that the proportion of patients with at least 1 residual symptom decreased from 68% to 49% between the 6-month and 12-month follow-up appointments. However, researchers noted a slight increase in the proportion of patients experiencing anxiety and depression symptoms between the 6-month check-in (23%) and the 12-month follow-up (26%). The findings show that while most individuals returned to good health 1 year following their hospitalization, the overall health status of the COVID-19 survivors remained lower than for those in a non-hospitalized control group.

Another study published in The Lancet Infectious Diseases analyzed the risk of PASC among vaccinated adults. The research team conducted a community-based, case-control study among UK-based adults who used the COVID Symptom Study mobile phone app. The study matched individuals who contracted SARS-CoV-2 after vaccination with individuals who contracted the virus before vaccination in an attempt to parse out differences in disease presentation. The research team found that the odds of COVID-19 symptoms persisting for 28 days or more among those who were fully vaccinated was approximately halved (OR 0.51) compared with unvaccinated controls. While this risk reduction provides additional reasons to support COVID-19 vaccination, there is still a low but present risk that vaccinated adults could develop long COVID.

There already are reports of individuals suffering long-term COVID symptoms who feel that the scientific community is leaving them behind. Understanding and minimizing the long-term impacts of COVID-19 disease is an essential part of response and recovery, and research endeavors such as the ones described above can help characterize what could be a long tail on the end of the pandemic.

US SCHOOLS As the school year begins for many in the US, COVID-19 cases among children are rising, with nearly 204,000 new cases added the week ending August 26, representing 22.4% of the total weekly reported cases. This marks the second week with child cases at the level of the winter surge of 2020-21 and a 5-fold increase from July 22 to August 26, according to the American Academy of Pediatrics (AAP). US CDC data show the number of COVID-19 cases and related emergency room visits and hospitalizations among children were 4 times higher in states with low vaccination rates than those with higher vaccination rates during the month of August. CDC Director Dr. Rochelle Walensky said last week that recently opened schools with COVID-19 outbreaks generally are not following federal guidelines for vaccination and universal masking among staff and students. In one Iowa school district where masking is optional, parents are being given the option to quarantine their children if they have a known exposure, as long as they remain symptom-free, increasing the risk of transmission among asymptomatic children. In schools already operating, some outbreaks have caused districts to return to virtual learning, including one Texas school district where 2 junior high teachers died of COVID-19 complications the same week.

The US Department of Education announced this week it has begun investigations into 5 states—Iowa, Oklahoma, South Carolina, Tennessee, and Utah—whose bans on mask mandates in schools might violate civil rights laws meant to protect students with disabilities. The department has not opened investigations in Florida, Texas, Arkansas, or Arizona because all of the bans in those states are not being enforced due to ongoing legal or other actions. On August 27, a Florida judge ruled that Governor Ron DeSantis and the Florida Department of Education had overstepped their authority when they banned mask mandates in the state’s school districts because the policy does not provide a parental opt out. Governor DeSantis’s lawyers on September 2 filed an appeal with the 1st District Court of Appeal in Tallahassee.

A new survey from the National Parent Teacher Association, conducted with support from the CDC Foundation, shows fewer parents want their children attending in-person classes. Prior to July 27, when the CDC updated its health guidance for schools in light of the highly contagious Delta variant, 58% of 1,448 parents and guardians surveyed said they wanted their children back in classrooms, but that figure dropped to 43% by August 8. The proportions were lower for Black (41%) and Hispanic (37%) parents, who expressed a preference for online learning. These results likely reflect the fact that Black and Hispanic children, as well as adults, are disproportionately impacted by COVID-19. On August 31, the CDC released updated FAQs for parents with school-aged children. 

US PRISONS & JAILS Reducing the number of people detained in US prisons and jails could have prevented millions of COVID-19 cases and hundreds of thousands of related deaths, as the overcrowded, tight quarters fuel a constant risk of outbreaks among inmates and staff, according to a study published September 2 in JAMA Network Open. Researchers from Northwestern Medicine, the Toulouse School of Economics, and the French National Centre for Scientific Research analyzed data collected in 1,605 US counties from January to November 2020 and found that an 80% reduction in the U.S. jail population—a level achievable simply by finding alternatives to jail detention for people accused of non-violent offenses—was associated with a 2% drop in the growth rate of daily COVID-19 cases. The reduction was greater in counties with large urban areas and when jail turnover was taken into account. The US jail population has a 55% weekly turnover rate, the study notes. This turnover, in addition to staff returning home to their communities daily, has contributed immensely to the overall number of COVID-19 cases in the US, according to the researchers. For comparison, the study also looked at other anticontagion policies, finding that nursing home visitation bans were associated with a 7.3% reduction in COVID-19 case growth rates, followed by school closures (4.3%), mask mandates (2.5%), prison visitation bans (1.2%), and stay-at-home orders (0.8%). Besides mass decarceration efforts, some experts are calling for mandatory SARS-CoV-2 vaccinations for staff and detainees in jails and prisons to help reduce the risk of outbreaks.

US HOSPITAL BURDEN Across the US, hospitals are straining under the volume of COVID-19 patients, and several states are nearly out of ICU beds. Alabama, Arkansas, Florida, Georgia, and Texas have less than 10% of their ICU beds available. Georgia hospitals have topped their January highs on some days, and adult ventilator use has far outpaced the previous high. A US Department of Health and Human Services (HHS) dashboard paints a grim picture, where 42 states are reporting 70% or greater use of inpatient beds, and 7 of the remaining 8 are in the 60-69% use category. In several states, including Montana and Oregon, the National Guard is assisting to help ease staffing shortages. Children’s hospitals are no exception, with many at or near capacity. The CEO of the Children’s Hospital Association wrote a letter to US President Joe Biden requesting federal help to handle the surge. Adding to the stress, about US$44 billion in federal aid from the US$178 billion Provider Relief Fund created last year and $8.5 billion allotted by the US Congress for rural medical care has not been distributed. Healthcare institutions, advocates, and lawmakers are urging the Biden administration to quickly decide how the funds will be divided and when they will be released. HHS has said a plan is being developed.

VACCINE EFFECTIVENESS AMONG HEALTHCARE WORKERS Coincident with the end of California’s (US) mask mandates in June 2021 and the rise of the SARS-CoV-2 Delta variant, the University of San Diego Health (UCSDH) workforce experienced an increase in SARS-CoV-2 infections, despite high vaccination rates. According to correspondence published in the New England Journal of Medicine (NEJM), between March 1 and July 31, 2021, 227 UCSDH healthcare workers tested positive for SARS-CoV-2 by rt-PCR, of whom 57.3% were fully vaccinated. Researchers calculated vaccine effectiveness by month, saying effectiveness exceeded 90% March through June, but fell to 65.5% in July (95% confidence interval [CI], 48.9 to 76.9). Additionally, the July attack rate among vaccinated individuals increased as time from vaccination grew, with those who were fully vaccinated later in the year (March through May; 3.7 per 1,000 persons [95% CI, 2.5 to 5.7]) showing an attack rate nearly half that of those vaccinated earlier in the year (January or February; 6.7 per 1,000 persons [95% CI, 5.9 to 7.8]). For unvaccinated workers, the attack rate was much higher (16.4 per 1,000 persons [95% CI, 11.8 to 22.9]). The authors attribute the change in vaccine effectiveness to the rise of the Delta variant and waning immunity, in addition to the end of masking requirements that likely resulted in increased community exposure.

But some experts have questioned the study’s conclusions, saying the reduction in vaccine effectiveness could be due to several additional or separate factors, including a small sample size for the July data; a single, large outbreak of 70 cases among workers in July; and an increase in close contacts due to loosened preventive measures. As more studies are published showing a possible decrease in vaccine effectiveness over time, it is important to consider behavior changes that could contribute to outcomes, even if the data are not captured in studies.

LATIN AMERICA & CARIBBEAN The Pan-American Health Organization (PAHO) has called on countries with surplus SARS-CoV-2 vaccines to urgently donate them to Latin American and Caribbean nations, where only 1 in 4 people have been fully vaccinated. While vaccination coverage in some countries such as Uruguay and Chile have exceeded 60%, rates are much lower in other countries, including Guatemala and Nicaragua. At a news conference, PAHO Director Dr. Carissa F. Etienne said that while every country in the region has begun administering vaccines, “immunizations are following the fault lines of inequality” in the region. She also announced the launch of the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas, which hopes to ease vaccine shortages within the region. During a recent virtual meeting, Dr. Etienne invited public and private manufacturers to submit proposals for transferring technologies or producing raw materials for mRNA vaccines, some of which PAHO already is in the process of reviewing.

In a related development, Pfizer and BioNTech announced a deal in late August with Brazilian pharmaceutical company Eurofarma to manufacture at least 100 million doses of the companies’ vaccine annually for distribution within the region, beginning next year. An additional 540 million doses are needed to ensure every country in the region can vaccinate 60% of the population.

INDIA Since mid-July, India has dramatically increased its SARS-CoV-2 vaccination rates in rural areas, where the majority of the population lives, with 70% of the nearly 120 million shots delivered in the past 3 weeks going to individuals in villages. That is up from about half in the beginning of May, when the country opened up vaccine eligibility to all adults. About 11% of the country’s population is fully vaccinated, and 37% have received at least one dose as of September 1, according to Our World In Data. While a boost in acceptance of vaccines in rural areas is promising news, India reported the largest single-day increase in new COVID-19 cases in 2 months on September 2, recording 47,092 cases. The densely populated Kerala state, which recently ended its biggest festival involving family and social gatherings, accounted for 70% of the new cases. The Kerala health ministry warned the public to take “adequate steps” to prevent the virus’s spread into surrounding states, and the federal government has warned that, like Kerala, the rest of India could see an increase in COVID-19 incidence as festival season gets underway this month and runs through early November.

Some parents and health experts are concerned the reopening of schools for the first time in 18 months amid an uptick in new cases could increase the risk of COVID-19 outbreaks. However, others say that without the ability to provide online schooling for poorer children, in-person learning is essential to keep kids on track. In Delhi, only older children will return to schools and strict measures are in place to help limit transmission, including vaccinated staff, limited classroom capacity, mandatory temperature checks, staggered lunch breaks, and physical distancing within classrooms. Several large Indian medical organizations are backing the resumption of in-person classes, urging governments to take a “calculated risk.” A recent serological survey conducted in 70 districts across 21 states showed 57% of 6- to 9-year-olds had antibodies to SARS-CoV-2, and 62% of 10- to 17-year-olds had antibodies, possibly boosting confidence in reopening schools. Still, some parents will be keeping their children at home for fear that a third wave could be looming.

NORTH KOREA North Korea has refused a shipment of nearly 3 million doses of China’s Sinovac SARS-CoV-2 vaccine from the COVAX facility, saying the vaccines should instead be provided to more seriously affected countries due to a limited global supply. Although the country has applied for assistance through COVAX, the government has yet to receive any doses, after the most recent development and a delay in a planned shipment of about 2 million AstraZeneca-Oxford vaccines earlier this year. Reportedly, the government rejected the AstraZeneca-Oxford vaccine over concerns of side effects. North Korea’s state media have reported incidents of breakthrough infections among vaccinated individuals and expressed overall doubt in the vaccines’ effectiveness. North Korea has reported zero confirmed COVID-19 cases to the WHO, but many health experts doubt those claims and worry that a large outbreak could overwhelm the country’s outdated healthcare infrastructure. In June, Supreme Leader Kim Jong-Un said the country’s COVID-19 situation was grave, without specifying details, and publicly chastised several high-ranking officials for failing to implement long-term preventive measures. Both the US and South Korea have discussed possibly offering humanitarian assistance to the impoverished nation, and Russia earlier this year offered to provide its Sputnik V vaccine, although it is unclear whether North Korea accepted.

Wednesday, September 1, 2021

Meridian CUSD 223 closes Highland Elementary because of COVID 19

Meridian CUSD 223

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All,
After numerous conversations and true collaboration with the Health Department, I have accepted their strong recommendation to move Highland to an adaptive pause beginning Monday, August 30th. This means that there will be no in-person student attendance until September 13th and all Highland Elementary students will be in a remote learning environment.
While this decision pains me to make, I am confident that we did absolutely everything we could (including testing approximately 50 Kindergarten and 1st grade students on Thursday) in an attempt to ensure safety and stay open for in-person instruction.
This decision was not entered into lightly. Our current data throughout the district is alarming. The data from Highland is particularly eye-opening to say the least. We have 21 confirmed and probable COVID positive cases among our students, and our data indicate that up to 60 students have been quarantined this week. For context, we have 309 students between Kindergarten and Second Grade.
For comparison, we can look at our data compared to our neighboring communities. These are based on zip code comparison data publicly available on the Northwestern COVID dashboard.
The 7-day test positivity rate
Oregon/Mt. Morris/Chana - 7%
Byron - 7%
Rochelle - 4%
Forreston - 14%
Polo - 11%
MERIDIAN - 24%
New cases over the last 7 days per 100k people.
(This is used as a standard of measurement of COVID spread in a community. It simply takes a calculation of POSTIIVE CASES IN A GIVEN TIME FRAME / POPULATION X 100,000 to see the depth of spread.)
Oregon/Mt. Morris/Chana 88
Rochelle - 105
Byron - 123
Forreston - 278
Polo - 205
Meridian -545
HIGHLAND ELEMENTARY – 3,559 (based on current cases, may extend beyond 7 days)
HIGHLAND ELEMENTARY (If you include PROBABLE CASES) – 6,796 (based on current cases, may extend beyond 7 days)
Again, for context – our county has never gone over an 800 / 100k person weekly ratio throughout the Pandemic.
The adaptive pause will be for two weeks, and we will resume in-person instruction September 13th. I know that moving from in-person to remote instruction is terribly difficult and not ideal for student learning, family productivity, or parent's ability to work. In order to provide some consistency, all students will have consistent live meeting time with teachers.
· Kindergarten – 8:30 daily
· 1st Grade – 8:30 and 12:15
· 2nd Grade – 8:30 and 12:15
In addition, teachers will be accessible to parents throughout the school day. To ease this transition, students will practice logging on today and multiple packets of information and work will be sent home with students as we prepare for this transition. Additional scheduling information will also be provided in the packets sent home.
I would also like to publicly thank the health department for working with me for multiple days as we tried everything possible to remain open. I sincerely appreciate the patience that the Health Department provided as we tried everything possible to avoid receiving this recommendation. Please continue to put the health and wellness of our community at the forefront of your actions. Please continue to monitor for symptoms and report them to school. There is high transmission throughout our district and region, not just at Highland, and the more that we can get this under control the less likely there is further disruption to the learning environment.
There will be numerous logistical hurdles that this causes our families to jump over and through. For that, I do not have a good reply at this time other than I am sorry.
For any technological need or complications, please contact your teacher and nbelmonte@mail.meridian223.org.
If you have any questions, please feel free to reach out to me at your convenience.
Sincerely,

Tuesday, August 31, 2021

August 31: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

EPI UPDATE The WHO COVID-19 Dashboard reports 216.9 million cumulative cases and 4.5 million deaths worldwide as of August 31. Global weekly incidence decreased for the first time since mid-June, down 3.12% from the previous week. Weekly mortality also decreased, for the first time since late June*, falling 2.41% compared to the previous week.

*With the exception of the week of July 19, when Ecuador reported 8,786 deaths.

The global cumulative mortality surpassed 4.5 million deaths in today’s update:

1 death to 500k: 165 days

500k to 1 million: 86 days

1 to 1.5 million: 70 days

1.5 to 2 million: 44 days

2 to 2.5 million: 37 days

2.5 to 3 million: 52 days

3 to 3.5 million: 38 days

3.5 to 4 million: 51 days

4 to 4.5 million: 54 days

Global Vaccination

The WHO reported 5.02 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of August 30. A total of 1.93 billion individuals have received at least 1 dose, and 1.16 billion are fully vaccinated. Analysis from Our World in Data indicates that global daily vaccinations increased sharply over the past several days, up to 41 million doses per day, which would be the third highest peak to date*. The global trend continues to closely follow the trend in Asia. Our World in Data estimates that there are 3.11 billion vaccinated individuals worldwide (1+ dose; 39.45% of the global population) and 2.12 billion who are fully vaccinated (26.9% of the global population)**.

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

**China reported 448 million new vaccinated individuals (1+ dose) and 112 million fully vaccinated individuals on August 26, its first report since June 10.

UNITED STATES

The US CDC reported 38.9 million cumulative COVID-19 cases and 636,015 deaths. Daily incidence continues to increase, but the trend is tapering off toward a peak or plateau. The current average of 149,334 new cases per day is the highest since January 29. Daily mortality also continues to increase, and the mortality trend may be starting to taper off as well. The current average of 970 deaths per day is the highest since March 13*.

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

Data from HHS indicate that more than 100,000 COVID-19 patients are currently hospitalized nationwide. This represents the second highest peak to date, and is still increasing. The CDC reports more than 84,000 COVID-19 patients currently hospitalized, 32% below the highest peak.

US Vaccination

The US has administered 369.6 million cumulative doses of SARS-CoV-2 vaccines, and daily vaccinations appear to have peaked over the past several days. The average briefly exceeded 798,000 doses per day on August 23 before falling to 787,000 on August 25*. Notably, we have not observed a marked increase in daily vaccinations since the US FDA issued full approval for the Pfizer-BioNTech vaccine. There are 204.5 million individuals who have received at least 1 dose, equivalent to 61.7% of the entire US population. Among adults, 74.1% have received at least 1 dose, as well as 13.4 million adolescents aged 12-17 years. A total of 173.8 million individuals are fully vaccinated, which corresponds to 52.4% of the total population. Approximately 63.4% of adults are fully vaccinated, as well as 10.2 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 average provided here corresponds to 5 days ago.

US CDC ACIP MEETING At a meeting on August 30, the US CDC's Advisory Committee on Immunization Practices (ACIP) expressed initial support for third doses of SARS-CoV-2 mRNA vaccines for vulnerable populations, such as long-term care facility residents, and healthcare workers but said there is not enough data yet to recommend so-called booster shots for the general population. In a presentation to the committee, Dr. Sara Oliver, Co-Lead for the COVID-19 Vaccines ACIP Work Group, said data through July show the vaccines appear to provide strong protection against severe disease and hospitalization. Vaccine effectiveness (VE) against hospitalization remains high, between 75% to 95%, while VE against infection spans a much broader range, between 39% to 84%, since the predominance of the Delta variant. Dr. Oliver noted the reasons for lower VE “likely include both waning over time and the Delta variant.” Instead of focusing on booster doses, ACIP members emphasized that improving overall vaccination coverage is a “top priority,” as a high percentage of hospitalizations are occurring among unvaccinated individuals. They also said any booster dose recommendation should take into account equitable access to vaccines, both domestically and globally. The committee did not vote on booster doses, noting it intends to do so after the US FDA authorizes their use. The committee expects to meet in a few weeks to discuss data covering August, although a date was not announced. While the administration of US President Joe Biden has endorsed booster shots, saying they will be available by September 20, the FDA and CDC must first make recommendations based on scientific evidence.

At the meeting, the ACIP backed the US FDA’s full approval of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine, voting 14-0 to recommend the vaccine for individuals aged 16 and older. CDC Director Dr. Rochelle Walensky endorsed the recommendation, 9 months after the committee made an interim recommendation supporting the vaccine’s use. The committee reiterated that though there are rare reports of heart inflammation after mRNA vaccination, especially among males under age 30, the benefits of the vaccine outweigh the risks because the condition can occur at higher rates in COVID-19 patients than among those who received an mRNA vaccination.

DELTA HOSPITALIZATION RISK A study published August 27 in The Lancet Infectious Diseases adds evidence to what many experts already suspected: people infected with the highly contagious SARS-CoV-2 Delta variant are twice as likely to be hospitalized as those infected with the Alpha variant. To compare hospitalization rates, researchers from Public Health England (PHE) and Cambridge University examined data on 43,338 sequencing-confirmed COVID-19 cases between March 29 and May 23, 2021, during which time the Delta variant was becoming the predominant variant in the UK. The majority of the cases were among unvaccinated individuals (74%), while 2% were fully vaccinated and 24% had received one dose. Of 34,656 Alpha cases, 764 (2.2%) were admitted to the hospital within 14 days of a positive SARS-CoV-2 test, while 196 of 8,682 (2.3%) Delta cases were hospitalized. Although the percentages of hospitalized cases were similar between both variants, the risk of being hospitalized more than doubled (adjusted hazard ratio [HR] 2.26, 95% confidence interval [CI] 1.32-3.89) for Delta cases compared with Alpha cases when the researchers adjusted the data to account for certain factors, including age and sex. Delta cases also were more likely to seek emergency medical care or be hospitalized within 14 days versus Alpha cases (adjusted HR 1.45, 95% CI 1.08-1.95).

Although the researchers examined differences between vaccinated and unvaccinated groups for hospitalizations and emergency care or hospitalization, the results were non-significant due to low numbers of cases who were fully vaccinated. Therefore, the results only apply to people who are unvaccinated. In a statement, Dr. Anne Presanis, Senior Statistician at the University of Cambridge and a lead author of the study, emphasized the importance of getting fully vaccinated to reduce the risk of symptomatic infection with Delta, as well as reduce the risk of severe disease and hospitalization. The researchers noted that a previous study conducted in Scotland and published in The Lancet in June showed a similar increase in hospitalization risk among people infected with the Delta variant. While the UK study is the largest to date examining hospitalization risk for the Delta versus Alpha variants based on whole-genome sequenced cases, the researchers called for further assessments into how hospitalization risks differ for vaccinated individuals after infection with either variant.

SCHOOL TRANSMISSION A case study published August 27 in the US CDC’s Morbidity and Mortality Weekly Report (MMWR) shows how quickly the highly contagious SARS-CoV-2 Delta variant can spread within a classroom of children too young to be vaccinated. The outbreak involved an unvaccinated Marin County, California (US), elementary school teacher who began showing COVID-19 symptoms on May 19, but who came to work the next 2 days, attributing the symptoms to allergies. During that time, the teacher read aloud to the class without wearing a mask, even though masks were required for staff and students while indoors. The teacher received a positive SARS-CoV-2 test on May 21 and informed the school on May 23. Several students became symptomatic on May 22, and the Marin County Department of Public Health (MCPH) initiated an investigation on May 26 to characterize the outbreak. Overall, 27 COVID-19 cases were identified, including the teacher. Among the teacher’s 24 students—all of whom were too young to be eligible for vaccination—12 of 22 who were tested received positive results between May 23-26. Notably, 8 out of 10 students who sat in the 2 front rows closest to the teacher became infected, representing an extremely high attack rate of 80%.

In another classroom, located across an outdoor courtyard from the source classroom, 6 of 18 students in a different grade—also too young for vaccine eligibility—tested positive between May 24 and June 1. Additionally, 8 other cases were identified among parents and siblings of the students in the 2 classes, 3 of whom were fully vaccinated. An additional infected adult was unvaccinated. Of the 18 cases sequenced, all were identified as the Delta variant. The report’s authors underlined the importance of vaccination and other preventive measures, “including masking, routine testing, facility ventilation, and staying home when symptomatic” to ensure safe in-person learning in schools. Notably, all of the children were seated 6 feet apart and the classrooms had portable high-efficiency particulate air filters with open doors and windows, raising a question about whether consistent masking could have helped contain transmission in this outbreak.

A separate MMWR report published the same day concluded that in Los Angeles County, California, schools with transmission mitigation and containment protocols in place, “case rates in children and adolescents were 3.4 times lower during the winter peak compared with rates in the community,” showing multi-pronged prevention strategies are critical in helping to prevent new cases as children return to classrooms. However, the authors cautioned the data were collected prior to the predominance of the Delta variant (September 1, 2020-March 31, 2021).

SARS-CoV-2 ORIGIN: US REPORT As expected, the US Office of the Director of National Intelligence on August 27 released an unclassified summary of a report stating that the US Intelligence Community “remains divided on the most likely origin of COVID-19. All agencies assess that two hypotheses are plausible: natural exposure to an infected animal and a laboratory-associated incident." Just over 3 months ago, US President Joe Biden ordered the Intelligence Community to undertake a systematic, detailed review of any evidence that could elucidate the origins of the COVID-19 pandemic. The only strong conclusion expressed in the summary is that SARS-CoV-2 was not developed as a biological weapon. Most agencies also agreed, with low confidence, that the virus probably was not genetically engineered, although 2 agencies believed there was insufficient evidence to make an assessment either way. In a statement following the summary’s release, President Biden said the US will continue to search for answers, adding, “I will not rest until we get them.” In order to do so, however, investigators will need cooperation from China, which continues to deflect blame and resist sharing information, according to the summary.

HURRICANE IDA Southern Louisiana (US) hospitals, already inundated with COVID-19 patients, are now dealing with damage from Hurricane Ida. The Category 4 storm made landfall in Lafourche Parish on August 29, battering the area for 16 hours with heavy rainfall and strong winds that caused widespread power outages, levee failures, flooding, collapsed buildings, and the need for rescues. At least 2 hospitals in Lafourche Parish reported significant damage, including extensive roof damage and partial generator failure. Residents of the parish were ordered to evacuate, but evacuating hospital patients was not an option because no other hospitals had the capacity to take additional patients due to an overwhelming number of COVID-19 patients and staff shortages.

Louisiana Governor John Bel Edwards said that with more than 2,400 COVID-19 patients hospitalized in the state, many in serious or critical condition, the focus is on ensuring there is enough generator power and clean water at hospitals to meet patients’ needs, including providing oxygen and ventilator support, both of which require electricity. Nearly 1 million people within the New Orleans power grid were without power due to the storm’s “catastrophic intensity,” with the Entergy Corporation working to get lines back in operation. Hurricane Ida hit on the 16th anniversary of Hurricane Katrina and, with sustained winds of 150 mph, tied a record for the most intense hurricane on record to hit Louisiana. Notably, lessons learned after Katrina, including the relocation of hospital generators to higher floors, likely helped save lives during this storm.

COURT-ORDERED VACCINATION As the rate of SARS-CoV-2 vaccination slowly creeps up in the US, a significant portion of the population continues to resist getting the shots. In what appears to be efforts to persuade the reluctant, several judges have ordered defendants to be vaccinated as part of their orders. In New York, a Bronx County criminal court judge ordered a man pleading guilty to drug possession and shoplifting to get a SARS-CoV-2 vaccine as part of his plea deal, an action that the judge said would be viewed as rehabilitative. In another case in New York, a federal judge in Manhattan granted bail for a defendant charged with conspiracy to distribute fentanyl on the condition that she be vaccinated so she posed less of a danger to the community. Neither defendant appeared to object.

In a similar case, a Cook County, Illinois, judge on August 10 revoked a woman’s right to visit her 11-year-old son until she is vaccinated for SARS-CoV-2. The 39-year-old woman shares custody of the boy with her divorced husband, who did not seek such an order. The woman’s lawyer said she believes the judge exceeded his authority and hopes an appellate court, which is expected to hear the case this week, reverses the decision. While some legal experts say these judges might have overstepped their authority, others argue that the orders fall within their jurisdiction, highlighting the legal and ethical questions surrounding the interpretation of the line between civil responsibility and civil liberty.

EU TRAVEL RESTRICTIONS The EU on August 30 recommended that member states halt all non-essential travel from the US due to the rising number of COVID-19 cases throughout the country. The EU also recommended the removal of Israel, Kosovo, Lebanon, Montenegro, and North Macedonia from the bloc’s “white list” of places whose tourists could be permitted entry without certain restrictions. In order to be included on the white list, countries have to have no more than 75 new daily COVID-19 cases per 100,000 residents over the last 14 days, and these 6 countries no longer meet that criterion. The decision is non-binding, as each EU member state is able to set its own tourism policies and restrictions. Possible restrictions include testing requirements, quarantine upon arrival, a ban on non-vaccinated travelers, and a ban on all non-essential travelers from the stated countries. The white list now includes 18 countries.

Removal of the US from the white list follows a previous decision in June that recommended lifting restrictions on non-essential travelers from the US and 14 other nations. A majority of countries in the EU lifted non-essential travel restrictions after the decision in hopes of retaining income from the summer tourism season. New travel restrictions are anticipated to cost billions in lost tourism income.

AUSTRALIA Australian Prime Minister Scott Morrison announced that the country is moving past its “COVID zero” goal, arguing that the current level of restrictions “is not a sustainable way to live,” particularly in light of the emergence of the Delta variant. Throughout the pandemic, Australia has responded to local outbreaks with highly restrictive “lockdown” measures, while facing relatively few restrictions in the periods between outbreaks. This plan aimed to interrupt chains of transmission and prevent localized outbreaks from spreading to a regional- or national-level epidemic in order to reach and maintain essentially zero domestic transmission. The policy change appears to be tied to vaccination coverage, and the government could begin easing restrictions once national coverage reaches 70% among eligible individuals. Australia is currently reporting full vaccination coverage of 35% for individuals ages 16 and older, and officials reportedly believe Australia can double this rate by the end of 2021. Notably, Prime Minister Morrison also announced children aged 12-17 years are now be eligible for vaccination.

MEDIGEN VACCINE Taiwan on August 23 launched an island-wide rollout of its domestically produced Medigen SARS-CoV-2 vaccine, produced by Taipei-based Medigen Vaccine Biologics Corporation, with Taiwan President Tsai Ing-wen publicly receiving the first shot. But the rollout quickly hit speed bumps, with experts criticizing the launch of the vaccine without the completion of Phase 3 clinical trial and no efficacy data. Then, over the next 3 days, 4 people died after receiving the vaccine, raising questions about its safety among some experts. Taiwan’s Central Epidemic Command Center (CECC) said it does not plan to halt the campaign, as there is no indication that the deaths are associated with the vaccine. The CECC will continue to investigate whether there is a causal relationship, indicating the news has not affected vaccine uptake among the Taiwanese population. Throughout the pandemic, Taiwan has been successful at curbing dramatic surges in COVID-19 cases and reports fewer than 16,000 total confirmed cases to date.

SPUTNIK V Russia’s Sputnik V SARS-CoV-2 vaccine, officially known as Gam-COVID-Vac, appears to reduce the risk of hospitalization and prevent severe lung damage among COVID-19 patients, according to a preprint paper posted to medRxiv. The analysis, which has not yet been peer-reviewed, includes data from 13,894 patients, 9.3% of whom were fully vaccinated, having completed their second shot at least 2 weeks prior. Among those fully vaccinated, the adjusted vaccine effectiveness (VE) against hospital referral was 81% (95% confidence interval [CI], 68-88). The VE against hospital referral was slightly better among women (84%, 95% CI, 66-92) compared with men (76%, 95% CI, 51-88). The data also show that Sputnik V was 76% effective at protecting against severe lung injury, defined as more than 50% lung involvement. Although the data do not include genetic sequencing for viral variants, Russian health officials say 95% of new infections in July and August, when the study was conducted, were attributable to the Delta variant. The Sputnik V vaccine is authorized for use in 69 countries, but the European Medicines Agency (EMA) and the WHO continue to review the vaccine for authorization.

C.1.2 VARIANT A preprint article posted on medRxiv from a group of South African researchers describes a potential SARS-CoV-2 variant of interest assigned to the PANGO lineage C.1.2. According to the paper, which is not yet peer-reviewed, the variant was first identified in May 2021 and likely originated from the C.1 viral lineage, one of the lineages that dominated the first wave of SARS-CoV-2 infections in South Africa. The C.1.2 variant is believed to have between 44-59 mutations in regions such as the spike protein, receptor binding motif, and furin cleavage site, representing more mutations than previous variants of interest and variants of concern. The mutations described in the article are associated with increased neutralizing antibody evasion, increased transmissibility, and potentially increased viral reproduction.

By August 13, 2021, the variant had been detected in a majority of South African provinces, as well as in the Democratic Republic of the Congo, Mauritius, New Zealand, Portugal, and Switzerland. Despite the wide geographic spread, prevalence of C.1.2 in tested samples remains low. However, monthly increases in prevalence are similar to those seen in the early stages of the Beta and Delta variants. Researchers are currently assessing the effectiveness of vaccines against this lineage and more information is expected soon. Notably, though the researchers say they are “concerned” about C.1.2, it has not yet been named a variant of interest or concern, as more data are necessary to make that determination.

COMPARING mRNA VACCINE IMMUNE RESPONSE A research letter published in the Journal of the American Medical Association (JAMA) describes results from a prospective study comparing antibody responses to the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines among a cohort of Belgian healthcare workers. For the study, antibodies against the SARS-CoV-2 nucleocapsid protein were measured after vaccination. Among the 1,647 healthcare workers included in the evaluation, 2 doses of Moderna produced higher antibody titers than 2 doses of Pfizer-BioNTech; participants who were previously infected with SARS-CoV-2 had higher antibody titers than participants who were never infected; and higher antibody titers were correlated with younger age groups. The limitations of the study include a lack of information on cellular immunity and neutralizing antibody titers. Neutralizing antibodies can stop a virus from entering a cell and initiating infection while binding antibodies alert white blood cells to the presence of a pathogen and mark them for destruction. Neutralizing antibodies serve a different purpose from binding antibodies and they can result in long-term immunity to certain infections.

BLOOD CLOTTING RISKS The risk of blood clotting events after infection with SARS-CoV-2 is much higher than the risk posed by vaccination with either the Pfizer-BioNTech or AstraZeneca-Oxford vaccines, according to a large UK study published August 27 in the British Medical Journal (BMJ). A team led by researchers from the University of Oxford examined the health records of more than 29 million people who received a first dose of either vaccine between December 2020 and April 2021, as well as nearly 1.8 million who were infected with the virus, looking for complications up to 28 days post-vaccination or infection.

The researchers found that people who received the Pfizer-BioNTech vaccine had an increased risk of ischemic stroke and blood clots in arteries, while those who received the AstraZeneca-Oxford vaccine had an increased risk of low platelets (thrombocytopenia) and blood clots in veins. While the researchers said that people should be aware of the increased risk, they stressed that the risks of the same complications among people infected with SARS-CoV-2 are much higher. For example, the risk of thrombocytopenia is almost 9 times higher with infection than vaccination with the AstraZeneca-Oxford vaccine, and the risk of stroke is nearly 12 times higher after COVID-19 than with the Pfizer-BioNTech vaccine. The risk of blood clotting events also remained elevated for a longer period of time after infection compared with vaccination. Experts continue to stress that the short- and long-term complications of COVID-19 are much more severe than the risks associated with vaccination, and they urge those eligible to get vaccinated.