HOT OFF THE PRESS AND PERTINENT:

FROM THE NYT:

A guide to BA.5

”The Covid virus has a Darwinian quality. As variants emerge, they compete with one another to become dominant. The most contagious variants tend to win the competition because they can spread more quickly. It’s survival of the fittest...

That is why the virus has become more contagious over time. Today, the most contagious form of Covid yet — the BA.5 subvariant — is spreading around the globe. “It looks as if we are unable to control it,” Dr. Charles Chiu of the University of California, San Francisco, told The Times…In the U.S., cases have surged recently, as has the number of hospitalized patients with Covid (although some of them were admitted for other reasons and happened to test positive for the virus while in the hospital)…”

(J. Harris: And now President Biden has Covid.)

FROM HOPKINS COMPLETE REPORT:

COVID-19 Situation Repor [ AN UP TO DATE COVID SUMMARY]

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

”…CONCERN OVER BA.5 SUBVARIANT As the Omicron subvariant BA.5 drives increases in COVID-19 cases and hospitalizations in several regions and countries worldwide, health officials are, for the most part, holding back on sounding alarms. In the US, where the average number of cases and hospitalizations are at their highest levels since February, many state and local health authorities are characterizing the increase in cases as concerning but not disturbing, with many saying repeated warnings about COVID-19 surges are falling on pandemic-fatigued ears. However, US health officials are speaking out. White House COVID-19 Coordinator Dr. Ashish Jha has warned the BA.5 subvariant is the most immune evasive variant yet, urging US residents to stay up to date on their vaccines and expressing support for the reinstatement of mask mandates. Chief Medical Advisor to the US President Dr. Anthony Fauci called on eligible people to get vaccine boosters and said a decision about boosters for those under age 50 likely will soon be announced. In Europe, the WHO announced today that COVID-19 case numbers have tripled and hospitalizations have doubled across Europe over the past 6 weeks. WHO Europe Director Dr. Hans Kluge warned that people should not underestimate BA.5, calling on nations to bolster vaccine uptake and require mask wearing.

A dearth of data is complicating the true picture of how big BA.5-driven surges are, or will get, as publicly reported data has become less common due to the closing of testing sites and an increase in at-home test use. Some experts estimate that for every 1 reported case, there are 7-10 unreported cases. Additionally, BA.5 has several spike protein mutations that make it better at infecting human cells and evading immunity from vaccination or previous SARS-CoV-2 infection. These capabilities allowed the subvariant to gain predominance in the US in just over 2 months, and it is now causing 3 of every 4 new COVID-19 cases in the nation. BA.5 is so adept at skirting immune defenses that many people who were recently infected with a different Omicron variant are becoming reinfected. Some studies suggest that reinfections could cause lasting symptoms. And as the virus continues to circulate, there is a real risk of further mutations, meaning we likely will be living with some form of the virus for the foreseeable future.

VACCINE BOOSTERS The administration of US President Joe Biden is pressing the need for US residents aged 50 years and older and immunocompromised individuals to get their second COVID-19 vaccine booster as soon as possible due to the immune-evasive nature of the Omicron subvariant BA.5, as well as said a decision is expected soon about additional booster doses for all adults. According to US CDC estimates, BA.5 is now responsible for 78% of all new COVID-19 cases. Officials have stressed that booster doses provide additional protection against earlier Omicron subvariants and potentially later subvariants as well. However, current boosters have not yet been updated to more specifically target Omicron and its subvariants, leaving a dilemma for eligible individuals about whether to get a booster now or wait for updated versions. Additionally, some experts wonder and worry whether BA.5 will even be the predominant variant in the fall, potentially making new boosters less effective than expected.

Only 34% of the US population aged 5 years or older has received their first booster dose, COVID-19 pandemic response funding is dwindling, and public appetite for continued vaccinations is diminishing. All of these uncertainties create a perfect storm for risk communication difficulties for experts and officials alike, uncertain of the best course to recommend and how to inform the public about their choices. Some experts hope that next-generation vaccines, such as nasal vaccines—which may have a higher chance of preventing not just severe disease outcomes but also infection—or pan-coronavirus vaccines—which may work better against future variants as well as current variants—may help to boost vaccination rates. Additionally, the CDC is expected to make an announcement about its recommendations for the newly authorized Novavax vaccine later today. Some hope the protein-based vaccine also will help boost vaccination rates among unvaccinated individuals.

In related news, the British government on July 15 announced that individuals aged 50 or older, certain individuals in high-risk professions, and individuals over age 5 who are more likely to be at risk of severe disease outcomes will be eligible for a second booster dose in the fall. The announcement broadens eligibility beyond those who are aged 65 years and older.

YOUNG CHILD VACCINATIONS US medical experts and public health officials are expressing concern over low demand for COVID-19 vaccinations for the youngest children under age 5 and those ages 5-11. States were charged with ordering doses commensurate to expected demand, but some states’ orders only cover a small fraction of their child residents. For example, Mississippi has ordered enough vaccine doses to cover only 16% of its under-5 population with 1 dose. Florida did not preorder any doses for its under-5 population. Many parents there are struggling to find medical practitioners and health systems, which were able to independently order doses, that can provide the shots. The impacts are highest among families in underserved areas and those who rely on government-run health services. However, other experts caution that some states’ initial orders may not reflect future demands and childhood COVID-19 vaccination coverage. They say several factors may change over time, such as available vaccine storage, rampant misinformation, limited initial appointment slots, pushback from parents, reimbursement and logistical challenges, and some practitioners preferring to wait for full FDA approval prior to delivering vaccinations to younger populations.

Relatedly, Europe also may soon be administering vaccines to young children, as the European Medicines Agency (EMA) on July 18 began reviewing Pfizer-BioNTech’s vaccine for use in children aged 6 months to 4 years. Notably, increasing vaccination rates among young children at this point in the global response is paramount and could provide high impact. A recent study in JAMA Network Open found that antibody levels in previously infected individuals waned quickly over the first 200 days post-infection, with levels dropping most quickly in children under age 6.

WESTERN PACIFIC REGION A new wave of COVID-19 cases has hit the Western Pacific region, largely driven by the BA.4 and BA.5 Omicron subvariants. In Japan, cases are rising in every prefecture. The 7-day rolling average of new daily cases has surpassed February’s Omicron peak, and transmission does not seem to be slowing. The situation was further complicated by a 3-day weekend that saw high levels of activity at beaches and other tourist hotspots. The Japanese government is now trying to balance keeping the nation running with few restrictions while preventing hospitals from becoming overwhelmed. Cases also are rising in South Korea, where experts are predicting 200,000 daily cases by late-August, which would amount to half of the nation’s previous Omicron wave in March.

Hospitals in several Australian states are reaching capacity under the nation’s latest surge. Experts warn that while many emergency rooms are overwhelmed, most areas of the nation remain weeks away from their expected peak hospitalization rates. The situation is further complicated by a worse than average influenza season. According to data from the New York Times, New Zealand—a nation famous for early successes against COVID-19—now has the third highest daily confirmed rate of cases per 100,000 people of all nations, after Brunei and San Marino. Experts are concerned that the strain of new cases could lead to a collapse of the nation’s healthcare workforce. As a result, New Zealand officials are urging a renewed sense of urgency around COVID-19 precautions, including masking and testing.

In China, approximately 264 million people across 41 cities are under full or partial lockdown as part of the nation’s zero-COVID policy. Health experts are worried that the zero-COVID policy could become difficult to maintain given the increased transmissibility of the Omicron BA.4 and BA.5 subvariants. Some larger Chinese cities are rolling out new measures, such as mass testing and intense lockdowns, to try to curb the spread of the virus. There are growing concerns that increased COVID-19 prevention measures could further destabilize a struggling global economy.

ECONOMIC IMPACTS Fears of a global economic recession are on the rise. The global economic web was unsettled earlier this year when Russia invaded Ukraine, lowering the availability of energy, fertilizer, and food supplies. However, the largest disruptor of economic growth is the ongoing COVID-19 pandemic. The early phases of the pandemic disrupted the production of goods and the availability of services when governments implemented lockdowns to prevent transmission of the SARS-CoV-2 virus. However, the lockdowns prompted those stuck at home to begin ordering enormous volumes of goods over the internet. The combination of laborers stuck at home plus sky-high demand resulted in a global supply chain crisis. The supply chain crisis pushed prices for goods and services higher, and some industries have taken advantage of the global instability and their market dominance to secure record-breaking profits. Additional factors impacting inflation in the United States include an aggressive stimulus initiative and hesitancy by the Federal Reserve to increase interest rates.

The COVID-19 pandemic also is responsible for economic downturns in other nations with a large impact on the global market, including China. China has adopted an aggressive and highly controversial zero-COVID policy that has led to forced lockdowns in many of the country’s large cities. The lockdowns have prevented normal industrial operations that supply a large portion of the world’s manufactured goods. The disruption in production and shipping of goods has significantly slowed growth for the Chinese economy, which shrank by 2.6% during the latest quarter. This slowdown, which denotes a growth of only 0.4% from the end of June last year, represents the lowest growth rate since early 2020, when the nation completely shut down to fight the pandemic. The latest economic reports have cast doubt on whether China can reach its 5.5% growth target for the year set by the ruling Communist party.

However, a couple of recent studies hint that aggressive COVID-19 responses might limit economic damage in the long-term. One study, an assessment of business closure policies in New York City published by the International Monetary Fund, set out to determine the impact of closures in specific industries on the spread of COVID-19. According to the results, reopening businesses early allowed New York City to recover functionality as an economic hub but at the cost of a large wave of infections in 2020. The study also found that an alternative policy that extended lockdowns made future travel safer and was ultimately more cost-effective. Another study, examining the impact of long COVID on the workforce of the UK, estimated that 80,000 people have left the UK workforce due to long COVID as of March 2022. According to the authors, continued pandemic waves will lead to more people missing work, losing jobs, or permanently leaving the workforce due to long COVID. While many experts agree that a zero-COVID policy is unrealistic, it is becoming rapidly apparent that pretending like the pandemic is over may also lead to long-term and impactful health and economic consequences.

GLOBAL VACCINE ACCESS Last month, the 12th World Trade Organization (WTO) Ministerial Conference agreed to a version of a proposal for a global intellectual property waiver to allow countries to more easily use patented technologies to develop COVID-19 vaccines. Originally proposed only a few months into the pandemic by India and South Africa, and endorsed by more than 100 other nations, the approved deal on a Trade-Related Aspects of Intellectual Property (TRIPS) waiver is much narrower in scope than the original proposal and likely comes too late to make a significant impact on vaccine access. The deal does not include intellectual property waivers for diagnostics, treatments, or other COVID-19-related medical tools, and it excludes countries with “existing” production capacity. The power imbalances in both the COVID-19 pandemic and the WTO negotiations are apparent, from vaccine nationalism to sluggish negotiations. But over the past 2 years, low- and middle-income countries (LMICs) from South America to Africa have worked to solidify plans to cooperate on mRNA technologies in order to develop and produce their own versions of vaccines for SARS-CoV-2 and other diseases. This effort to collaboratively develop an mRNA vaccine technology transfer hub, which is supported by the WHO and the US NIH, must overcome significant challenges but provides hope for a new model to enable more LMICs to overcome future disease outbreaks more effectively, without having to rely on high-income countries or corporations…”’

”CRUISE SHIPS The US CDC announced on July 18 that its COVID-19 Program for Cruise Ships is no longer in effect. Although the agency will continue to publish guidance to help cruise ships provide safer and healthier environments for crews and passengers, the color-coded chart and spreadsheet that detailed the level of spread on ships is no longer available. According to a statement in the webpage’s FAQ section, the CDC is ending the program because it depended on each cruise line having the same testing and screening guidelines, which now all differ among companies. However, cruise ships will continue to report COVID-19 cases to the CDC, and passengers have the option of directly contacting their cruise line for information on outbreaks aboard their ship.

*****

FROM LOCAL EPIDEMOLOGIST:

NORVAX: MIX AND MATCH DATA. PLUS SUMMARY OF THE NEW “OLD” VACCINE

1. 3.  Time-Release Microparticles Could Deliver “Self-Boosting” Vaccines (GEN) Most vaccines, from measles to COVID-19, require a series of multiple shots before the recipient is considered to be fully vaccinated. To make that easier to achieve, MIT researchers have developed microparticles that can be tuned to deliver their payload at different time points, and which could be used to create what the scientists describe as “self-boosting vaccines.” Using these particles, which resemble tiny coffee cups sealed with a lid, researchers could design vaccines that would need to be given just once, and would then “self-boost” at a specified point in the future. The particles can remain under the skin until the vaccine is released and then break down, just like resorbable sutures. The same strategy could also feasibly be used to deliver a range of other therapeutics, including cancer drugs, hormone therapy, and biologic drugs.

2. Correlation Between Clinical and Wastewater SARS-CoV-2 Genomic Surveillance, Oregon, USA (CDC EID) SARS-CoV-2 variant proportions in a population can be estimated through genomic sequencing of clinical specimens or wastewater samples. We demonstrate strong pairwise correlation between statewide variant estimates in Oregon, USA, derived from both methods (correlation coefficient 0.97). Our results provide crucial evidence of the effectiveness of community-level genomic surveillance.

FROM JAMA:

Mix-and-Match COVID-19 Boosters After Inactivated Virus Vaccine

(J. Harris: It works)

FROM THE DMN:

Dallas County moved its internal COVID-19 risk level to “extreme caution” as case counts and hospitalization rise

”…BA.5 is most similar to BA.2, another omicron subvariant that picked up speed in Texas in March, although it has a few additional mutations on its spike protein,…A BA.5 infection seems to come with the same symptoms as the original omicron strain, including headache, a sore throat, a runny nose, fever and fatigue.

While the loss of taste and smell were tell-tale signs of COVID-19 infection with the alpha and delta variants, they’re much less likely with infections from omicron and its subvariants. A May study from researchers at Virginia Commonwealth University found that chances of smell and taste loss were just 17% for omicron, compared to 50% for the alpha variant….There’s also the risk of long COVID, which can lead to sometimes debilitating symptoms like fatigue and neurological issues for months after an initial infection. It’s estimated that anywhere from 10% to 30% of COVID-19 patients might experience long COVID, according to the American Medical Association…CDC and other federal health officials have repeatedly said that people should get boosted now… go ahead and get it and not wait until the new versions of the vaccine are released, especially if you’ve got anything of significance that you’re planning in the next two or three months like a trip or a wedding,” he said. “You don’t want COVID to mess those plans up.”

Recommendations for avoiding COVID-19 in the red risk level

Wear a mask indoors when in public.

Stay up to date with COVID-19 vaccines, including booster doses.

Get tested if you notice any COVID-19 symptoms.

Increase ventilation when indoors by turning on fans or opening windows to increase air circulation.)

(J. Harris: I think avoid crowds and gatherings is very important in our area. Marshall  counts are down only because nobody is counting. The majority of the clinics and doctors and hospitals are not in Marshall. Fortunately, we have plenty of funeral homes.)

FROM REUTERS:

Australians urged to work from home as winter Omicron wave swamps hospitals

LASTLY:

And I just couldn’t resist this current ”photo”:

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P.O. Box 721

Scottsville Texas

75688

 HELLO:  Take your time. 

You don’t have to read it all at once. Frequently, I find a need to include additional material for my physician readers. This is one of those editions. 

FROM BECKERS:

1. WHAT’S NEXT WITH COVID?

”…The dominance of the COVID-19 omicron variant continues to persist throughout the U.S., with subvariant BA.5 now accounting for 53.6 percent of the nation’s cases, but one expert says it could be hard to predict what will happen next….Right now, it’s all about which virus can outcompete the next one in terms of transmission. And in some cases, [the] ability to cause disease transmission is really a prime driver,…And that can be tied to its ability to evade immune protection to the host.”…’This is a stay-tuned moment’: Dr. Michael Osterholm on omicron uptick…”

2. Is it time to update the definition of ‘fully vaccinated’?

”…Based on the CDC’s definition, individuals are considered fully vaccinated against COVID-19 if they’ve received their primary series, which entails two doses of Pfizer or Moderna’s vaccine or one dose of Johnson & Johnson’s. …The CDC says people who receive recommended booster doses are “up to date” on their vaccines and best-protected, but …While research shows BA.5 can evade immunity from vaccination and past infection, vaccines are still effective at protecting against severe disease, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a July 12 White House briefing.

, I’d like being  “fully vaccinated” as well as “up to date” on boosters with two of them — for a total of 4 jabs.  Now, I’m anxious to hear about the new, slightly altered designed vaccines to cover more variants. I’m also intherested in “mix and match” vaccinations with some of the more old fachion vaccines that seem to work. Obviously, I believe in the vaccines usefulness.)

3. COVID-19 admissions to rise through July + 2 more forecasts

4. Don’t wait for an omicron-tailored booster, experts warn

FROM JAMA:

1. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US

Key Points:

Question  Are systemic reactions more common after simultaneous administration of COVID-19 mRNA booster and seasonal influenza vaccines than after COVID-19 mRNA booster alone?

Findings  In this cohort study of self-reported data from 981 099 persons aged 12 years or older, simultaneous administration of a COVID-19 mRNA booster dose and an influenza vaccine was associated with 8% to 11% increases, respectively, in systemic reaction compared with COVID-19 mRNA booster alone. These differences were statistically significant.

Meaning  Findings from this study suggest that simultaneous administration of COVID-19 mRNA booster and influenza vaccines may be associated with increased likelihood of systemic reactions.

(J. Harris: Reactions were mild. See the following Opinion piece. I plan to take the flu shot with my next Covid booster.)

2. Reactogenicity and Concomitant Administration of the COVID-19 Booster and Influenza

 Vaccine

”…Although emphasis on the benefits of vaccination and minimization of their adverse events might seem a reasonable approach to limiting nocebo effects, negative information about the COVID-19 vaccine is common, and from an ethics standpoint, individuals have the right to complete information so they can decide whether they want to receive the vaccine. Some argue that the best approach to gaining the public’s trust is to offer both the positive and negative scientific evidence, with refutational 2-sided risk and benefit messages.6 Thus, while messaging could include the fact that serious reactions are rare even when the vaccines are given concomitantly, in light of these data, clinicians can confidently inform patients that concurrent administration of the COVID-19 booster and seasonal influenza vaccine is both safe and associated with only a slight increase in adverse events compared with the COVID-19 booster alone……

Substantial efforts have been undertaken to increase rates of COVID-19 vaccination and boosting; however, less effort has focused on influenza vaccination. Nationally, during the 2020 to 2021 season, influenza vaccination coverage was only 50.2%.7 Significant disparities have also been noted by race and ethnicity. Influenza results in significant morbidity annually which could be averted by increased vaccination coverage. Despite the limitations detailed above… the data reported by Hause et al3 suggest that the development of public health campaigns to increase dual vaccination should be undertaken. Although logistical challenges may serve as barriers to the implementation of dual vaccination, organizing for provision of both influenza vaccination and COVID vaccination within clinical settings and at community-based nonclinical venues would be advantageous and may increase the likelihood of uptake. Given the small increase in rate of adverse events reported by Hause et al,3 health care systems should be encouraged to develop routine and streamlined processes for coadministration of these vaccinations.

2. Incidence and Relative Risk of COVID-19 in Adolescents and Youth Compared With Older Adults in 19 US States, Fall 2020

”…These results suggest that, contrary to reports from Europe and Asia, infection rates and relative risk among US adolescents and youth exceeded that in older adults from the start of the COVID-19 pandemic through fall 2020, before vaccines were available.”

3. Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge

”Findings of this study suggest that casirivimab-imdevimab [Regen-Cov] and sotrovimab[ Xevudy] were both associated with reduced risk of hospitalization or death and had similar effectiveness, although they did not meet the prespecified criteria for statistical inferiority or equivalence.

(J. Harris: These are injectable Monoclonal Antibodies)

4. Association Between COVID-19 Booster Vaccination and Omicron Infection in a Highly Vaccinated Cohort of Players and Staff in the National Basketball Association

Individuals who were fully boosted experienced 608 confirmed SARS-CoV-2 infections and were significantly less likely to be infected than fully vaccinated individuals who were booster eligible and had not received a booster, who had experienced 127 confirmed infections  The secondary analyses evaluating symptomatic infection showed a similar association… No hospitalizations or deaths occurred. Omicron was the dominant variant, representing 93% of 339 sequenced cases.

Discussion | This study found that in a young, healthy, highly vaccinated cohort frequently monitored for SARS-CoV-2, booster vaccination was associated with a significant reduction in incident infections during the Omicron wave.

FROM HOPKINS SUGGESTIONS:

1. One Coronavirus Infection Wards Off Another — but Only If It’s a Similar Variant (Nature) Natural immunity induced by infection with SARS-CoV-2 provides a strong shield against reinfection by a pre-Omicron variant for 16 months or longer, according to a study1. This protection against catching the virus dwindles over time, but immunity triggered by previous infection also thwarts the development of severe COVID-19 symptoms — and this safeguard shows no signs of waning. The study… which analyses cases in the entire population of Qatar, suggests that although the world will continue to be hit by waves of SARS-CoV-2 infection, future surges will not leave hospitals overcrowded with people with COVID-19. The research was posted on the medRxiv preprint server on 7 July.

2. COVID-19 Pandemic Fuels Largest Continued Backslide in Vaccinations in Three Decades (WHO) The largest sustained decline in childhood vaccinations in approximately 30 years has been recorded in official data published today by WHO and UNICEF. The percentage of children who received three doses of the vaccine against diphtheria, tetanus and pertussis (DTP3) – a marker for immunization coverage within and across countries – fell 5 percentage points between 2019 and 2021 to 81 percent. As a result, 25 million children missed out on one or more doses of DTP through routine immunization services in 2021 alone. This is 2 million more than those who missed out in 2020 and 6 million more than in 2019, highlighting the growing number of children at risk from devastating but preventable diseases.

(J. Harris: Routine childhood and adult vaccinations and boosters must still be performed!)

3. FROM HOPKINS SUGGESTIONS TODAY:

The Durability of Natural Infection and Vaccine-induced Immunity Against Future Infection by SARS-CoV-2 (Proceedings of the National Academies) 

”…We estimated typical trajectories of waning and corresponding infection probabilities, providing the distribution of times to breakthrough infection for each vaccine under endemic conditions. Peak antibody levels elicited by messenger RNA (mRNA) vaccines mRNA-1273 [MODERNA] and BNT1262b2 [PFIZER] exceeded that of natural infection and are expected to typically yield more durable protection against breakthrough infections (median 29.6 mo; 5 to 95% quantiles 10.9 mo to 7.9 y) than natural infection (median 21.5 mo; 5 to 95% quantiles 3.5 mo to 7.1 y). Relative to mRNA-1273 and BNT1262b2, viral vector vaccines ChAdOx1[Oxford-AstraZeneca] and Ad26.COV2.S [Johnson & Johnson/Janssen] exhibit similar peak anti-S IgG antibody responses to that from natural infection and are projected to yield lower, shorter-term protection against breakthrough infection (median 22.4 mo and 5 to 95% quantiles 4.3 mo to 7.2 y; and median 20.5 mo and 5 to 95% quantiles 2.6 mo to 7.0 y; respectively)….’By quantifying the peak antibody levels for each vaccine relative to peak antibody levels following natural infection, we found that mean antibody response to the mRNA vaccines mRNA-1273 and BNT162b2 exceeded the mean antibody response to natural infection. In contrast, the mean antibody response to viral vector vaccines ChAdOx1 and Ad26.COV2.S was lower than the mean antibody response to these mRNA vaccines and similar to that of natural infection (Table 1)…These first estimates of the durability of immunity following vaccination provide essential knowledge to policy decision-making that can curb transmission long term, mitigating morbidity and mortality consequent to SARS-CoV-2 infection. Our quantitative estimates will be improved as data on long-term immunological responses to SARS-CoV-2 infection and vaccination are generated, providing increasingly precise knowledge that can refine our estimates not only for currently available vaccines, but for vaccines of the future as well….”

4. Investigating Trends in those who Experience Menstrual Bleeding Changes after SARS-CoV-2 Vaccination (Science Advances) Early in 2021, many people began sharing that they experienced unexpected menstrual bleeding after SARS-CoV-2 inoculation. We investigated this emerging phenomenon of changed menstrual bleeding patterns among a convenience sample of currently and formerly menstruating people using a web-based survey. In this sample, 42% of people with regular menstrual cycles bled more heavily than usual, while 44% reported no change after being vaccinated. Among respondents who typically do not menstruate, 71% of people on long-acting reversible contraceptives, 39% of people on gender-affirming hormones, and 66% of postmenopausal people reported breakthrough bleeding. We found that increased/breakthrough bleeding was significantly associated with age, systemic vaccine side effects (fever and/or fatigue), history of pregnancy or birth, and ethnicity. Generally, changes to menstrual bleeding are not uncommon or dangerous, yet attention to these experiences is necessary to build trust in medicine.

LASTLY:

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EastTexasExposed.com

iExposed Us 

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75688

Note that Shreveport, Tyler, and Dallas are at a High Level of Covid danger. Follow “Daily /100,000 in the chart below.

CDC raises Dallas, Collin, Tarrant Counties’ COVID-19 risk level to red

5 things to know about the COVID-19 red risk level in North Texas

”…The CDC is at red…The CDC measures community spread level using a combination of three metrics: total new COVID-19 cases per 100,000 people, total new COVID-19 hospital admissions per 100,000 people, and percentage of inpatient beds occupied by COVID-19 patients…“Transmission is definitely increasing a lot, hospital numbers are going up, and people should be more cautious,” Huang said. “I wouldn’t say it’s an inconsistent message. I think they’ve got a different scoring system.

Mask up indoors

Under the red designation, which signifies high community spread, the CDC recommends everyone wear masks indoors when in public and on public transit. That a step up from the yellow designation, which recommends indoor masking only for people with a high risk of severe illness.

FROM THE NYT:

Novavax’s latecomer Covid-19 vaccine gets U.S. authorization.

”…The Food and Drug Administration on Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that received significant federal funding to produce the shot. The vaccine will be a new option for Americans as vaccination rates stagnate…..After two years of development, the vaccine has finally overcome manufacturing problems to become the fourth shot to earn clearance in the United States….The two-dose vaccine was authorized as a primary immunization series for adults, rather than a booster, which is likely to limit its market at first. …Novavax’s vaccine, given in [two] doses spread three weeks apart, works differently from mRNA vaccines. It provokes an immune response with nanoparticles made up of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been widely used around the world for decades….The authorization comes with a warning that Novavax’s vaccine is linked to an elevated but small risk of forms of heart inflammation known as myocarditis and pericarditis. In their review of Novavax’s data, F.D.A. scientists identified six cases of the side effect in about 40,000 trial volunteers…In a number of clinical trials, Novavax found that its vaccine was highly protective against symptomatic infection. But the original formulation is probably not as effective against the Omicron variant, which emerged in November and has evaded some of the protection afforded by authorized vaccines from other companies…..The company says it plans to accelerate its research on shots specifically tailored for two newer versions of Omicron, known as BA.4 and BA.5….Trials have also shown that Novavax’s shot works well as a booster, and the company is expected to seek authorization for boosters soon. The company may then be able to attract vaccinated people who want to switch to a new option to protect against new variants…Dr. Moore speculated that some people might switch to Novavax for a booster this fall because it produced relatively few cases of aches, fatigue and other passing side effects in clinical trials. ..”

FROM YOUR LOCAL EPIDEMOLOGIST:

BA.5 is here. Time to ride the wave

”…BA.5 has arrived. An estimated 10-15% of Americans will be infected. Unfortunately, hospitalizations and death will follow, albeit at lower rates than we’ve seen before…Do not use the CDC community levels for masking… This tells us when to take collective action so the hospitals don’t surge. ..This does not tell us when to wear a mask for individual protection. The old CDC transmission map is painted red (which doesn’t even take into account under-reporting) and shows 98% of Americans should wear a mask in crowded, indoor spaces if they don’t want to get sick. Transmission is high across the states and will get higher.

(J. Harris: This is a good, understandable read and goes stepwise through what you need to do if you get sick now.)

FROM WEBB MD

Coming Soon: More Breathable, More Comfortable Face Masks

FROM nature:

Wastewater sequencing reveals early cryptic SARS-CoV-2 variant transmission

(A PREPRINT: …”…We develop and deploy improved virus concentration protocols and deconvolution software that fully resolve multiple virus strains from wastewater. We detect emerging variants of concern up to 14 days earlier in wastewater samples, and identify multiple instances of virus spread not captured by clinical genomic surveillance. Our study provides a scalable solution for wastewater genomic surveillance that allows early detection of SARS-CoV-2 variants and identification of cryptic transmission…”

FROM HOUSTON CHRONICLE:

”…COVID-19 hospitalizations have nearly doubled in the Houston area over the last month, according to re-published Texas Medical Center data, which paints a clearer picture of the risk associated with newer, increasingly transmissible versions of the virus…

HOPKINS SUGGESTS:

1. Risk of Myocarditis and Pericarditis Following BNT162b2 and mRNA-1273 COVID-19 Vaccination (Vaccine) Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. From December 14, 2020 – January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. Both vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.

(J. Harris: This study indicates virtually no significant risk for vaccine induced pericarditis or myocarditis due to vaccine and only mild cases if is shoud, rarely, occour.)

2.  PFIZER-BIONTECH VACCINE FOR ADOLESCENTS The US FDA last week expanded full approval of the Pfizer-BioNTech SARS-CoV-2 vaccine to adolescents aged 12 to 15 years. The vaccine, known as Comirnaty, has been available for this age group since the FDA provided emergency use authorization (EUA) in May 2021, and the agency originally approved the vaccine for individuals aged 16 years and older in August 2021. To date, more than 9 million 12-15-year-old children have received the 2-dose primary series. Pfizer and BioNTech indicated they have also filed clinical trial data for approval among this age group with the European Medicines Agency (EMA) and other regulatory agencies around the world.

3. Pandemic Fueled Surge in Superbug Infections and Deaths, CDC Says (Washington Post) The coronavirus pandemic caused a surge in superbug infections and deaths in U.S. hospitals, reversing years of progress fighting one of the gravest public health challenges in modern medicine, according to a new analysis released by the Centers for Disease Control and Prevention. In 2020, the first year of the pandemic, infections and deaths among several serious pathogens increased about 15 percent overall from 2019, the report said. In 2020, more than 29,400 people died of antimicrobial-resistant infections commonly associated with health care, the report found. Of these, nearly 40 percent acquired the infection while hospitalized. The remaining infections occurred outside the hospital, including in nursing homes and other community health-care facilities.

FROM JAMA:

Long-term Immune Response to SARS-CoV-2 Infection Among Children and Adults After Mild Infection

”…n this cohort study, we evaluated the dynamic changes of the SARS-CoV-2 binding antibody titers in 252 family clusters mostly affected by asymptomatic or mild COVID-19 up to 12 months after initial infection. The findings suggest that anti–SARS-CoV-2 S-RBD IgG may persist more than a year from infection in all age groups, with antibody titers that inversely correlate with age….randomly determined; having a random probability distribution or pattern that may be analyzed statistically but may not be predicted precisely….”

FROM BECKERS:

1. What BA.2.75 means for COVID-19 vaccines: 2 notes

”…A new COVID-19 omicron subvariant, BA.2.75, has appeared amid a rising case count spurred by other variants, and early data suggests it’s more transmissible than other strains. Here’s what that could mean for vaccines. … Before BA.2.75 entered the stage, on June 30 the FDA recommended vaccinemakers to prioritize omicron subvariants BA.4 and BA.5 as they test modified vaccine compositions for this fall. It may be too early to point to which subvariant to be most concerned for, but playing catch up is a slow process, experts warn….”The virus has almost been quicker than we are,” Stanford (Calif.) University Professor of Medicine Dean Winslow, MD, told CBS News. “We can’t really spool out vaccine production in just a couple of weeks. It takes quite a while to actually spool out vaccine production for some of these newer variants.”

2. Though health experts are wary to draw conclusions before more data is available for the subvariant, which has been spotted in only three U.S. cases as of July 8, Glenn Wortmann, MD, infectious diseases section chief at MedStar Washington (D.C.) Hospital Center, told radio station WTOP the current COVID-19 vaccine should be effective against any subvariants, including BA.2.75.”

3. Moderna’s omicron-targeted vaccine nearly twice as effective against BA.4, BA.5

”…As vaccine-makers race to show promising results for their updated, omicron-targeted vaccines set to debut this fall, Moderna forged ahead to prove its candidate is nearly twice as effective as its original vaccine…In a phase 3 trial, Moderna’s updated vaccine candidate increased neutralizing antibody titers 6.3-fold against omicron subvariants BA.4 and BA.5, while its original vaccine increased neutralizing antibody titers 3.5-fold, according to a July 11 press release….Moderna said it shared the data with regulators and is awaiting peer-review for publication..”

FROM NEJM JOURNAL WATCH:

Which Form of Immunity Fared Best Against Symptomatic Omicron Infection?”…Importantly, against severe COVID-19 outcomes, all forms of immunity[natural or either vaccine] were highly effective — the silver lining of successive pandemic waves…”

and LASTLY:

Why can’t a green chili pepper shoot an archery bow?

No habenero

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