Covid-19 Updates & Info

[ti-amie]

[ti-amie]

[dryrunguy]

Here's the latest Situation Report. Haven't read it yet. But the section on pandemic-related fraud caught my eye.

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EPI UPDATE The WHO COVID-19 Dashboard reports 592 million cumulative cases and 6.45 million deaths worldwide as of August 18. According to the WHO weekly epidemiological update for August 17, the number of new weekly cases decreased by 24% during the week of August 8-14, compared to the previous week. The number of new weekly deaths decreased by 6%, compared to the previous week.

At the regional level, the number of new weekly cases decreased across all six regions: African (-38%), European (-38%), Eastern Mediterranean (-30%), Western Pacific (-18%), Americas (-17%), and South-East Asia (-11%). The number of new weekly deaths increased in the Western Pacific (+31%) and South-East Asia (+12%) regions and decreased or remained stable in the African (-33%), European (-25%), Eastern Mediterranean (-7%), and Americas (-4%) regions.

UNITED STATES
The US CDC is reporting 93 million cumulative cases of COVID-19 and 1,033,332 deaths. The current 7-day moving average of new daily cases is down over last week, dropping to 98,940 on August 16 from 107,899 on August 9. The average daily mortality remains relatively stable, at 398 on August 16. Daily mortality has remained above or around 400 since July 12.** New national ensemble forecasts of new and total deaths predict that the number of newly reported COVID-19 deaths will remain stable or have an uncertain trend over the next 4 weeks, with 1,800 to 5,000 new deaths likely reported in the week ending September 10, 2022, and a total of 1,046,000 to 1,055,000 COVID-19 deaths predicted to be reported by this date.

Both new hospital admissions (-3.5% over the past week) and current hospitalizations (-5.3%) decreased over the previous week, potentially reflecting a downward trend to the latest surge driven by the Omicron BA.5 subvariant. New national ensemble forecasts predict that the number of new daily confirmed COVID-19 hospital admissions will remain stable or have an uncertain trend, with 2,600 to 9,700 new confirmed COVID-19 hospital admissions likely reported on September 9, 2022.

BA.5 is now projected to account for 88.8% of sequenced specimens in the US. The BA.4 sublineage accounts for about 5.3% of cases, while the BA.4.6 sublineage accounts for 5.1% of cases. Together, BA.2.12.1 accounts for only about 0.8% of cases. According to the estimate, Omicron variants represent all new cases in the US.
**Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US RESPONSE The US appears to have entered somewhat of a COVID-19 plateau. While there are signs that the latest surge caused by the Omicron BA.5 subvariant might be slowing—the average number of daily infections and hospitalizations are falling—an average of about 400 people have died of the disease every day for the past month. US officials have indicated that Omicron-adapted vaccine boosters could be available for everyone aged 12 and older within the next month, but the US FDA and CDC must act first to authorize and recommend a new vaccine booster. Experts have mixed opinions regarding an FDA plan to base its authorization decision on studies involving mice instead of humans. The UK this week approved a new bivalent booster from Moderna that targets both the original SARS-CoV-2 strain as well as the original Omicron variant, BA.1. The FDA rejected BA.1 bivalent booster versions earlier this year, instead calling on vaccine manufacturers to develop bivalent boosters targeting the Omicron BA.4 and/or BA.5 subvariants.

The federal government has already secured millions of doses of these not-yet-authorized bivalent vaccine boosters from Moderna and Pfizer-BioNTech, but the White House recently announced it is making plans to no longer buy vaccines, treatments, or diagnostic tests, as early as this fall. Without additional funding from the US Congress to purchase those products, availability will shift to the commercial market, raising questions about equitable access. However, the Biden administration is expected to extend the COVID-19 public health emergency for another 90 days in mid-October, which likely would ensure expanded Medicaid coverage, telehealth services, increased payments to hospitals, and other pandemic measures remain in place into early 2023. Meanwhile, the US CDC has loosened its COVID-19 guidance and public health agencies are adapting lessons learned during the pandemic to address other—possibly more pressing—public health and equity challenges, signaling what many see is an attempt to enter a “new normal.”

US CDC REORGANIZATION US CDC Director Dr. Rochelle Walensky on August 17 announced a large-scale reorganization and pivot for the agency, after receiving the results of an external review of the institution that she initiated in April. The review was led by James Macrae, a long-time senior official with the US Department of Health and Human Services, the parent agency of CDC, and was based on 120 interviews with key informants inside and outside the institution. Findings from the review are not yet public. Dr. Walensky announced that, according to the review, the future success of the CDC depends on pivoting from a slower, more academic institution to a swift emergency response agency, providing actionable information to the public and other health authorities in an appropriate and understandable fashion. Initial agency changes to institute this vision include revamping the website, creating a new equity office, creating a new executive council to oversee the overall new vision, hastening time to publication for data needed for response decisions, prioritizing budget allocation for the agency, and promoting staff according to public health impact. Additionally, officials responding to public health crises would now be required to stay in their positions for at least 6 months, and more staff would be trained for those roles as well. Dr. Walensky also is seeking greater authority for the CDC to collect data from states, more quickly finance external partners during health crises, and develop more competitive benefits for prospective staff recruitment. Outside experts have praised the proposed changes to the agency’s vision but some remain skeptical as to whether the proposed shifts are possible or will be enough to address the missteps of the agency during the COVID-19 pandemic.

IMMUNITY AGAINST OMICRON Various studies have indicated that prior SARS-CoV-2 infection may provide some protection against or reduce severity of future infection. However, new studies suggest that prior infection with an Omicron variant may provide increased protection against BA.4 or BA.5 compared to prior infection with Alpha, Beta or Delta variants—although outside experts note the comparison may not be fair because immunity wanes over time. A new preprint study posted August 17 to medRxiv supports this criticism, as it documented rapid waning of protection from an earlier Omicron variant infection against BA.5, particularly 3-5 months post-infection. Furthermore, another study published in Nature Communications suggests that protection post-Omicron infection (BA.1) declines more quickly among unvaccinated individuals compared to their vaccinated counterparts. Altogether, this growing body of literature emphasizes the continued importance of COVID-19 vaccination and the widespread variations in protection based on disease history, and the findings should be taken into consideration for future response planning.

LONG COVID RESEARCH RESULTS People with post-COVID conditions, or long COVID, and their advocates continue to push for more research and clinical treatments for the mix of—and far from uniform—lasting symptoms that make up the condition. Recent developments include a preprint study, posted to medRxiv this month, evaluating the distinguishing symptoms of long COVID. Notably, the researchers found that those with the condition had lower levels of the stress hormone cortisol, in addition to the often-present cognitive deficits—sometimes known as “brain fog”—and fatigue. Similar results have been reported in previous studies, including one published in Cell, which also documented “exhausted T-cells” that result in chronic inflammation indicative of several long COVID symptoms. Impaired memory, fatigue, shortness of breath, and trouble concentrating were among key complaints of participants of a study published August 12 in Clinical Infectious Diseases that followed patients for 12-18 months after infection. Overall, 43% of participants experienced persistent symptoms after mild COVID-19. Researchers also noted that shortness of breath and the number of experienced symptoms at the 12 month mark were significantly linked to specific SARS-CoV-2 spike protein-specific immune responses.

In a 2-year study published August 17 in The Lancet Psychiatry, Oxford researchers retrospectively assessed the risks of 14 neurological and psychiatric diagnoses after SARS-CoV-2 infection among 1.25 million patient records, including children. The researchers matched the COVID-19 patients with patients who had different respiratory infections and found that while common mood disorders typically returned to baseline after 1-2 months in both groups, adults with COVID-19 had an increased risk of psychotic disorder, brain fog, dementia, and epilepsy or seizures by the end of the second year of the follow-up, compared with adults with other respiratory diseases. Children also were at an increased risk for brain fog, in addition to insomnia, intracranial hemorrhage, ischemic stroke, psychotic disorders, and seizures. Children, however, experienced a finite horizon of 75 days for brain fog, nor were they at an increased risk for mood or anxiety disorders in the 6 months following SARS-CoV-2 infection. The study also accounts for the rise of 3 viral variants. The emergence of the Delta variant increased risks of ischemic stroke, seizures, cognitive deficit, insomnia, and anxiety disorders, as well as an increased death rate. The death rate following Omicron emergence was lower than just before, but the risks of neurological and psychiatric symptoms remained similar. Risk profiles remained similar just before and after the emergence of the Alpha variant. The studies all point to the need for more attention to be given to the post-infection risks of SARS-CoV-2, as well as other viruses.

WASTEWATER SURVEILLANCE The COVID-19 pandemic helped bolster an existing surveillance system for infectious diseases: wastewater testing. The method is now being used to track not only older diseases such as norovirus, but also new and emerging viruses including SARS-CoV-2, monkeypox, and polio. Several US states and jurisdictions have taken steps to launch or expand wastewater surveillance programs to provide a better understanding of circulating SARS-CoV-2 levels and variants. The New York Times this week published an interactive exploration into how these systems work and the steps involved in extracting results.

MASKING & INFECTIOUS AEROSOLS Healthcare workers are at an increased risk of SARS-CoV-2 infection, with many required or choosing to wear personal protective equipment such as masks. Those who always wore respirator masks rather than surgical masks had a 40% lower likelihood of infection, irrespective of cumulative exposure, according to a study published August 15 in JAMA Network Open. Among 2,919 healthcare workers included in the study, 749 (26%) tested positive for SARS-CoV-2 between September 2020 and September 2021. Among those with patient exposure, test positivity was 21% among workers wearing respirators compared with 35% among those who used surgical masks or a mix of masks (OR, 0.49; 95% CI, 0.39-0.61). The study was conducted in Switzerland prior to the predominance of the Omicron variant, so the results might not be applicable to newer, more transmissible variants.

A July 29 preprint study posted to medRxiv shows that viral shedding (measured as RNA copies) in exhaled breath aerosol was significantly greater during infections with the more highly transmissible SARS-CoV-2 Alpha, Delta, and Omicron variants than with the ancestral strain and variants not associated with increased transmissibility, even among people who are up to date on vaccinations. The researchers documented the highest viral shedding from a person with Omicron infection. They said the findings provide additional evidence that inhalation of infectious aerosols is the dominant mode of SARS-CoV-2 transmission and support the importance of continued mitigation efforts such as improving indoor air hygiene through ventilation, filtration, and air disinfection, and wearing masks or respirators.

PANDEMIC-RELATED FRAUD The US government has appropriated US$5 trillion in relief programs aimed at helping businesses and individuals during shutdowns due to the COVID-19 pandemic. However, that funding came with minimal oversight leading to an unprecedented amount of fraud, with billions of dollars stolen by thousands of people, through unemployment payouts or business assistance. Now, federal investigators and prosecutors are trying to identify and charge people who committed such crimes, with 500 people working on pandemic-fraud cases across at least 21 government agencies, as well as the FBI, Secret Service, Postal Inspection Service, and the Internal Revenue Service. But with tens of thousands of ongoing investigations, officials are concerned some crimes may never be prosecuted. New laws extend the statute of limitations for some pandemic-era fraud from 5 years to 10 years, and officials hope the extensions will help them find and prosecute more offenders. The costs of loose rules and lax oversight should provide lessons for future pandemic preparedness responses to include planning and prevention efforts for fraud.

UNIVERSAL HEALTHCARE Countries with or close to achieving universal health coverage (UHC)—a system under which all individuals and communities receive needed health services without suffering financial hardship—saw smaller declines in routine childhood vaccinations during the COVID-19 pandemic, according to a study published August 16 in PLOS Medicine. Countries included in a “high UHC index” group had a 2.7% smaller reduction in childhood immunization coverage during 2020 when compared to countries with lower UHC Service Coverage Index rankings. Additionally, a study published August 17 in The Lancet Regional Health found that primary health care coverage in Brazil mitigated socioeconomic disparities in accessing SARS-CoV-2 vaccination. Taken together, these studies provide evidence that UHC guarantees more equitable access to vaccinations and suggest that policymakers should continue to advocate for working toward the goal of achieving access to safe, effective, quality, and affordable healthcare services for all.

https://covid19.who.int/

[ponchi101]

Very odd that the number of cases is dropping, but fatalities are not.
Simplest explanation: cases are the same, people are simply not getting tested as much.

[Deuce]

Well... the number of deaths always start increasing 2 or 3 weeks after the number of cases and hospitalisations begin increasing... so it would stand to reason that the number of deaths would start decreasing a couple of weeks after the number of cases start decreasing...

[Suliso]

People either don't test at all or do a self test and usually don't report even a positive test to any official authorities.

[Deuce]

People either don't test at all or do a self test and usually don't report even a positive test to any official authorities.

But that's been the case for about the past 6 months...

[Deuce]

.

This could turn out to be extremely important...

https://www.sciencedaily.com/releases/2 ... 091240.htm

..

[ti-amie]

[dryrunguy]

Here's the latest Situation Report. Am I the only one who has become completely lost by the "what vaccine should I be getting next?" debate? Especially given the fact we have no idea what variants will emerge down the road?

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OMICRON-ADAPTED BOOSTERS Previous COVID-19 Situation Reports have outlined the United States’ and other countries’ decisions to prioritize SARS-CoV-2 vaccines adapted to newer viral variants for future booster campaigns. New variants are differentiated from the original strain of the virus targeted by initial vaccines, showing significant mutations in portions of the spike protein. This differentiation reduces the effectiveness of current vaccines, as well as natural immunity gained through previous infection, and has contributed to surges in COVID-19 cases in many countries.

For many months, public health experts and scientists have discussed the promise of new vaccines, targeted for specific variants. Both Pfizer-BioNTech and Moderna are primed to offer versions of their COVID-19 vaccines specifically tailored to target various sublineages of the globally predominant Omicron variant. The UK became the first country to approve a bivalent COVID-19 vaccine for use as a booster among adults on August 15, authorizing the use of Moderna’s “Spikevax bivalent Original/Omicron,” which targets both the original SARS-CoV-2 strain and the Omicron BA.1 variant. Canada this week announced it has secured 12 million doses of an Omicron-adapted vaccine from Moderna, and the government is currently reviewing bivalent vaccine submissions from both Moderna and Pfizer-BioNTech, with decisions expected in about 2 weeks. Vaccines under review are targeting the original virus and earlier Omicron lineages.

In the US, the government has agreed to purchase 66 million doses of Omicron-adapted vaccines from Moderna and 105 million from Pfizer-BioNTech, but those vaccines are expected to target the original virus and the BA.4 and BA.5 subvariants instead of BA.1. Pfizer and BioNTech this week requested emergency use authorization (EUA) from the US FDA for the companies’ Omicron BA.4/BA.5-adapted vaccine for individuals aged 12 years or older, despite the lack of new clinical data on the shot. In the same announcement, the companies said a trial investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine is expected to start this month. The companies have provided the FDA with preclinical and manufacturing data on the vaccine, but they have not yet made that information public. Despite the later start researching and making a US supply, the companies say the mRNA platform is well-suited for quick adaptations and federal health officials remain steadfast that the newer bivalent vaccines will be available by mid-September.

Current projections suggest that any person aged 12 or older who has completed a primary COVID-19 vaccination series will be eligible to receive these booster doses when they become available. This projection could change as data come in and are considered, and eligibility could differ among any authorized vaccine boosters. Scientists agree that these new booster doses likely will help improve the nation’s immune protection, but some question how well they will work given that oftentimes, the version of a virus to which an individual has an initial immune response can impact responses to future variants and vaccines. Additionally, many public health experts are worried that the prevailing “COVID is over” sentiment in many countries will negatively impact uptake of vaccine boosters.

NOVAVAX VACCINE EUA On August 19, the US FDA expanded its emergency use authorization (EUA) of Novavax’s protein-based COVID-19 vaccine to include adolescents. The FDA initially authorized the 2-dose primary series vaccine for adults in July, demonstrating 90% efficacy, and the shots will now be available for individuals aged 12 to 17, among whom it showed 80% clinical efficacy. The 2 doses are given 3 weeks apart. The Novavax vaccine uses a more traditional, protein-based technology that teaches the immune system to recognize small, modified pieces of the coronavirus spike protein. This older technology is also used in vaccines for hepatitis B, HPV, and pertussis. The Novavax vaccine also contains the Matrix-M adjuvant, which helps to induce a broader immune response. In July, the company announced that the vaccine shows “broad” immune response to circulating variants, including Omicron BA.4 and BA.5. However, Novavax is also working on an updated version of the vaccine that specifically targets the Omicron variant and subvariants. The company intends to file for authorization for a bivalent vaccine later this year.

PAXLOVID REBOUND The US FDA has requested that Pfizer conduct a study examining an extended course of its antiviral Paxlovid among individuals who experience a rebound of COVID-19 after taking an initial 5-day course. The FDA wants to know if a second 5-day course of the antiviral would help prevent disease rebound, and has requested that Pfizer produce initial results of such a trial by September 30, 2023. While Pfizer claims that disease rebound following Paxlovid treatment remains rare, several high-profile cases have prompted the FDA’s request for further study into the phenomenon.

INCUBATION PERIOD According to a study published August 22 in JAMA Network Open, the incubation period of COVID-19 has decreased gradually as SARS-CoV-2 has continuously evolved and mutated, producing variants with different enhanced transmission and virulence. The incubation period is the interval between exposure and development of symptoms and is an important epidemiologic indicator for understanding transmission. Based on the authors’ meta-analysis, the initial “wild type” strain first detected in Wuhan, China, in 2019 had an incubation period of approximately 5.2 days. Later in 2020, the Alpha variant that quickly became dominant in the UK had an incubation period of about 5 days. The Beta variant was identified shortly after and showed a shortened incubation period of 4.5 days, followed by the Delta variant with 4.41 days. The incubation period for Omicron infection is currently 3.42 days. While a decrease in incubation period often is associated with more severe disease, the decrease with COVID-19 means it makes it much more difficult to control transmission, because the faster someone becomes contagious, the faster an outbreak spreads. Knowledge of this key epidemiological parameter is helpful not only in reducing local transmission but also in understanding presymptomatic transmission.

HOME ANTIBODY TESTS The advent of home antigen tests for SARS-CoV-2 were an important step in helping people gain real-time knowledge of their infection status so they could isolate at home and hopefully stop chains of transmission. Now scientists are working to develop at-home antibody tests to help people determine their level of protection from infection and whether they might need an additional vaccine booster. A new study published this week in Cell Reports Methods describes a finger-prick test to detect neutralizing antibodies against SARS-CoV-2. If the test holds up to large-scale testing, it could provide an inexpensive way for people to learn how well-protected they are against the virus, although they might still be susceptible to newer viral variants capable of evading certain immune system responses.

UK COVID-19 INQUIRY Officially launched in July, the UK COVID-19 Inquiry is an independent panel established to examine the UK’s response to and impact of the COVID-19 pandemic and provide lessons for future pandemic preparedness and responses. Now, a coalition of 9 health and development nongovernmental organizations (NGOs) are calling for the inquiry to expand beyond its focus on the domestic response to also consider in what ways the UK government’s response contributed to growing global inequities during the pandemic. The NGOs—including Oxfam GB, Save the Children UK, Médecins Sans Frontières UK, and Health Poverty Action—sent a letter on August 22 requesting an expansion of the investigation. Another signatory, RESULTS UK, released a report August 16 outlining and assessing various UK government actions in response to the pandemic and providing recommendations for the UK government, including the UK COVID-19 Inquiry be broadened. Inquiry representatives have not yet indicated whether they will expand their examination.

In related news, several US Republican lawmakers have vowed to investigate the role certain individuals played in the US COVID-19 pandemic response if they gain control of the House of Representatives or Senate next year. One figure is Chief Medical Advisor to the White House and NIAID Director Dr. Anthony Fauci, who formally announced his retirement from public service this week.

IRAN In an investigation, the Washington Post outlines how members of Iran’s government and the domestic pharmaceutical company Barkat pushed through the approval of a yet-unproven COVID-19 vaccine during the country’s worst SARS-CoV-2 surge. The company failed to deliver an agreed upon 50 million doses, and most Iranians were vaccinated with a Chinese-produced vaccine. Nevertheless, Barkat’s profits soared, and the company appears to have compensated government officials who sat on its board and pushed the vaccine’s approval.

[ponchi101]

Here's the latest Situation Report. Am I the only one who has become completely lost by the "what vaccine should I be getting next?" debate? Especially given the fact we have no idea what variants will emerge down the road?

::

...

You are not the only one. But I am not getting any more Bt/PF or Moderna boosters, unless they carry some new tech.
And I am not getting anything until Jan 2023.

[Deuce]

I've had the 2 initial vaccines, and 2 boosters. All Moderna.
My most recent booster was in June.
I will continue studying and reading up on the matter, and expect to get another booster in the late fall/beginning of winter, as that will be 5/6 months after my most recent booster.
What the next booster will be, I don't know - maybe the one targeting Omicron, maybe not.

One thing is certain: the boosters specifically targeting a particular variant will always lag behind - because these boosters cannot be created in a day, and so there will always be the potential of a new variant taking over just when the booster targeting the previous variant is being approved. It cannot be otherwise.

[dryrunguy]

Here's the latest Situation Report. Serious question: Would you take a booster that has not yet cleared human clinical trials to confirm safety and efficacy?

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EPI UPDATE The WHO COVID-19 Dashboard reports 595 million cumulative cases and 6.45 million deaths worldwide as of August 25. Global weekly incidence decreased for the second consecutive week, down 8% from the previous week. Global weekly mortality appears to have peaked as well, down 13.5% from the previous week.

Regional trends in weekly incidence and mortality also are declining. All regions, with the exception of the Western Pacific, reported decreases in weekly incidence, ranging from -13% to -23% from the previous week. Notably, the Western Pacific reported a slight increase (+1.6%), but the weekly total was still 17% lower than the most recent peak reported the week of August 1. Weekly mortality is declining in all regions except the Eastern Mediterranean and Western Pacific. The Eastern Mediterranean region does appear to be at or near a peak, so if it follows the global trends, we expect weekly mortality to begin decreasing in the next week or two. The Western Pacific region’s weekly mortality continues to increase substantially, up 7.7% over the previous week and 2.5 times the most recent low reported the week of July 11. In light of the region’s sharp peak in weekly incidence several weeks ago, we expect to observe a corresponding decline in mortality over the next week or two.*
*The WHO Dashboard notes that incidence and mortality data for the Africa Region are incomplete.

UNITED STATES
The US CDC is reporting 93.6 million cumulative cases of COVID-19 and 1,036,604 deaths. Average daily incidence continues to decline, down from the most recent high of 129,359 new cases per day on July 21 to 89,698 on August 23—the lowest average since May 12. Average daily mortality appears to have passed a peak, down from 466 deaths per day on August 12 to 390 on August 23. A lag in daily mortality of 2-4 weeks behind daily incidence is consistent with the trends we have observed over the course of the pandemic.**
**Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

Both new hospital admissions and current hospitalizations continue to decline, down 3.3% and 6.6%, respectively, over the past week. Both trends peaked around the last week of July, similar to trends in daily incidence.

The BA.5 sublineage is projected to account for 88.9% of sequenced specimens in the US. While BA.5 remains the overwhelmingly dominant variant—and continues to increase in prevalence—the prevalence of the BA.4.6 sublineage is increasing as well. Over the past 2 weeks, BA.4.6 became the #2 variant nationwide, now accounting 6.3% of sequenced cases, while BA.4 fell to #3 (4.3%). It remains unclear whether BA.4.6 is capable of usurping BA.5 in the US, but its increasing prevalence could potentially indicate that it is competing well against the dominant variant. Collectively, the remaining variants account for only 0.5% of cases nationally. All variants reported here are sublineages of the Omicron variant of concern (VOC).

US BOOSTER CAMPAIGN Following recent news regarding the authorization of variant-adapted SARS-CoV-2 vaccine boosters in the UK and applications for emergency use authorization (EUA) of BA.4/BA.5 boosters in the US (both Pfizer-BioNTech and Moderna), US government officials have signaled that variant-adapted booster doses could be available for individuals aged 12 years and older by early September. The bivalent vaccines will target both the original strain of SARS-CoV-2 and both the BA.4 and BA.5 sublineages (since they share common mutations to the spike protein).

While human clinical trials have not yet been conducted, the agency’s Director of the Center for Biologics Evaluation and Research (CBER), Dr. Peter Marks, indicated that he is “extremely confident” that the trials will demonstrate the candidate boosters to be safe and efficacious. In contrast to regulatory review of previous SARS-CoV-2 vaccine candidates, the FDA is not waiting on the completion of human clinical trials. Rather, the agency will base their assessment primarily on data from animal models and previous clinical trial data on BA.1-adapted bivalent candidate vaccines, a process similar to how the FDA reviews seasonal influenza vaccines. Clinical trials for the candidate boosters in humans are expected to begin this month. Reportedly, the FDA does not intend to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the candidate boosters; however, the CDC’s Advisory Committee on Immunization Practices (ACIP) has tentatively scheduled a meeting for September 1-2 in anticipation of a FDA decision.

Some experts have expressed doubt regarding the need for a BA.4/BA.5-specific booster, as it may provide little additional protection for the millions of people who have already been exposed to one of those variants. Similarly, antibodies generated to protect against BA.4/BA.5 may not provide sufficient protection against other emerging variants, such as BA.2.75. While some experts are concerned that the abbreviated regulatory review risks increasing vaccine hesitancy and mistrust among the public, others argue that it is critical to make variant-adapted boosters available quickly, to provide protection before the virus evolves further and new variants emerge.

PANDEMIC INVESTMENTS Much of the federal funding allocated to the US COVID-19 pandemic response—approximately US$3.9 trillion of US$4.5 trillion—has been spent, and the US Congress has not agreed to authorize additional funding. This leaves many wondering what is worth investing in at this point in the pandemic, when we have many tools to prevent and treat COVID-19 but also uncertainties about future SARS-CoV-2 variants. Many experts agree that funds should be directed toward developing next-generation vaccines—those that can prevent infection instead of only avoiding serious outcomes—and improving indoor air quality, which could help mitigate a host of airborne illnesses and allergens, as well as mitigate the health impacts of air pollution. Overall, they agree investments should be geared toward strategies that provide lasting benefits beyond the COVID-19 pandemic.

The world could be entering a new age of more frequent and intense infectious disease outbreaks, with some infectious disease experts calling attention to the fact that diseases can spread quickly as international travel ramps back up. This highlights the urgent need to improve other public health efforts, including upgrading disease surveillance, data collection, and analysis; rebuilding trust in science and public health systems; taking a holistic view of health to include human-driven environmental change and animal health; closing gaps in health inequities; and boosting funding for pandemic preparedness. With some modeling showing extreme disease events similar to COVID-19 could increase 3-fold in the coming decades, the US and the world must prepare now to mitigate future epidemic, and perhaps pandemic, impacts.

PAXLOVID Several high-profile cases of COVID-19 rebound following treatment with Paxlovid—including White House Science Advisor Dr. Anthony Fauci, US President Joe Biden, and, most recently, First Lady Dr. Jill Biden—raise questions about how often such cases occur. Initial studies of the antiviral suggest that between 1% and 6% of people who take the drug experience rebound, with or without symptoms, around days 10-14 after initially testing positive. But some physicians believe rebound cases are more common, estimating between 20% and 40% of patients who take Paxlovid experience the condition, based on anecdotal evidence. The US FDA has requested that Pfizer, the drug’s manufacturer, conduct clinical trials to better understand the condition and its frequency.

Nevertheless, Paxlovid remains highly effective at preventing serious COVID-19 among people at high-risk of disease progression, according to several studies. In a retrospective cohort study published August 24 in the New England Journal of Medicine, Israeli researchers report that the treatment reduced hospitalizations among people aged 65 years and older who were assessed as being at high risk for progression to severe disease by 73% and reduced the risk of death from complications by 81% when given shortly after infection during the Omicron surge, compared to patients who did not take the treatment. Those findings are consistent with earlier trial results. However, the researchers found Paxlovid showed no evidence of benefit among patients aged 40 to 64 years who were deemed at high risk for disease progression. Across both age groups, a lack of previous SARS-CoV-2 immunity and previous hospitalization were strongly associated with high rates of hospitalization due to COVID-19.

In another study published the same day in The Lancet Infectious Diseases, researchers report that during the Omicron BA.2 wave in Hong Kong, early Paxlovid use was associated with a 66% lower risk of death and early use of molnupiravir—another authorized antiviral, also known as Lagevrio and made by Merck—was associated with a 52% lower risk of death among hospitalized COVID-19 patients who did not need oxygen supplementation. Additionally, patients who took antivirals had a lower risk of disease progression and significantly shorter times reaching low viral burden than those who did not receive the treatments. Taken together, the studies support the continued use of antiviral therapeutics authorized to treat COVID-19 among certain populations, including older patients and those who are hospitalized but not requiring oxygen therapy upon admission, but raise questions for the use of the treatments among the general population. In the US, Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in certain adult and pediatric patients aged 12 years or older who are at high risk of disease progression, and Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in high-risk adults aged 18 or older who are at high risk of severe COVID-19 and for whom alternative treatment options are not accessible or clinically appropriate.

VACCINE EFFICACY AMONG YOUNG CHILDREN On August 23, Pfizer and BioNTech announced that their 3-dose primary series SARS-CoV-2 vaccine showed 73.2% efficacy among children younger than 5 years old without evidence of prior infection. The study was conducted during a time when the Omicron BA.2 subvariant was predominant. Among 794 children who were fully vaccinated, 13 were infected, compared with 21 of 351 children who received placebo doses. The vaccine was 75.8% effective among children younger than 23 months old and 71.8% effective among toddlers aged 2 to 4 years old. Sequencing of viral RNA from nasal swabs indicated that cases of COVID-19 among trial participants were primarily caused by Omicron BA.2. Given that the Omicron BA.4 and BA.5 subvariants emerged during the trial and now cause most infections among US adults, the companies indicated their intent to request US FDA emergency use authorization (EUA) of an Omicron BA.4/BA.5-adapted bivalent vaccine in children ages 6 months through 11 years. Though these results continue to illustrate that the Pfizer-BioNTech vaccine is safe, effective, and well-tolerated among children—and despite a national push to vaccinate more children—less than 5% of US children under age 5 have been vaccinated.

LONG COVID/PASC Many researchers are baffled by post-acute sequelae of SARS-CoV-2 infection (PASC) and post-COVID-19 conditions, often referred to as long COVID, a persisting condition affecting some people who have recovered from acute SARS-CoV-2 infection, for which symptoms are vaguely defined, vary in prevalence and severity, and are sometimes difficult to attribute to COVID-19. Despite centuries of evidence showing that viral infections can leave long-term, often debilitating, health complications in their wake, many suffering from long COVID and their advocates are urging more research and support to define and treat the condition. Earlier this month, the Biden administration released 2 reports that outline a national research action plan for the condition and describe federal services available to address the longer-term effects of the pandemic, including long COVID and related conditions.

But without a standardized definition or treatment protocols for long COVID, patients, healthcare workers, and insurers are left wondering how to proceed with care and recovery. Some are turning to unproven treatments and theories about potential underlying causes of the condition, including the hypothesis that tiny, persistent blood clots could be contributing to the wide array of symptoms. Additionally, without workplace protections, universal health care, and adequate medical support, adults with long COVID sometimes are forced to leave their jobs or incur enormous medical debt. In a new report, the Brookings Institution estimates that around 16 million US residents of working age (18 to 65 years old) have long COVID, and 2 million to 4 million of those are out of work due to the condition. The annual cost of those lost wages is estimated to be around US$170 billion annually, and as high as US$230 billion, according to the report, which warns that without sufficient policy actions, those impacts could worsen over time.

In related news, long COVID may be less common among pediatric COVID-19 patients than feared. A study published August 22 in JAMA Pediatrics reported a low burden of PASC among study participants, with only 3.7% of children with COVID-19 experiencing at least 1 systemic, syndromic, or medication feature of PASC when compared with children without COVID-19. The researchers noted that the risks of PASC were higher among participants who had more severe SARS-CoV-2 infection, were younger, or had comorbid complex underlying chronic diseases.

UK COVID-19 MORTALITY The UK is reporting considerably higher COVID-19 mortality in summer 2022 than in 2021. From June 8 through August 12, the UK’s COVID-19 mortality was nearly twice the total from the same period last year. During that span, the UK reported more than 5,700 COVID-19 deaths in 2022, compared to 2,936 in 2021. Overall, the cumulative mortality for 2021 far exceeds the 2022 total to date—65,000 compared to 28,303—however, the data illustrate the severity of the UK’s summer Omicron surge, driven largely by the BA.5 subvariant. In June 2021, the UK had reached the end of its Alpha wave, and the Delta variant of concern (VOC) emerged as a major driver of transmission. In contrast, the BA.5 subvariant grew quickly to predominance in June in the UK and essentially spanned the entire summer. Consistent with the trends over the course of the pandemic, the vast majority of UK COVID-19 deaths in summer 2022 were among older adults. Notably, nearly half of the summer 2022 deaths were among adults aged 85 years and older, compared to 27% in 2021, and there were 77% more deaths among adults aged 75-84 years than the same period in 2021.

The UK also suffered a historic heatwave this summer, which may have contributed to the elevated COVID-19 mortality. During 3 “heat periods” in July, the UK reported overall increases in deaths nationwide—ie, all deaths, not only COVID-19. The average daily mortality during these periods (1,224 deaths per day) was 7% higher than the rest of the month. On July 19 alone, when temperatures in the UK exceeded 40°C/104°F for the first time in history, the UK reported 1,775 deaths, more than 50% higher than the average during non-heat periods. Beyond the overall mortality trends related to the heat, data from the UK’s Office of National Statistics (ONS) shows spikes in COVID-19 deaths corresponding to periods of unusually high temperatures. Specifically, daily COVID-19 deaths were nearly one-third higher during 3 “heat periods” in July, compared to other days that month. Older adults tend to be particularly vulnerable to the effects of heat waves, which could potentially account for some of the increased COVID-19 mortality on those days. Further study is required in order to determine any link between the record temperatures and COVID-19 mortality.

REGULATORY PRESSURE According to a new report from the US House Select Subcommittee on the Coronavirus Crisis, senior officials in the administration of former President Donald Trump, as well as outside allies, pressured the US FDA to authorize SARS-CoV-2 vaccines on an accelerated timeline, prior to the November 2020 election, and to authorize or reauthorize ineffective and potentially dangerous treatments for COVID-19, particularly the antimalarial drug hydroxychloroquine touted by Trump. The committee reviewed emails and texts and heard testimony from high-ranking officials to understand the extent of political interference with the federal public health response to COVID-19. Importantly, there is no evidence that administration or outside efforts changed FDA decisions on vaccines, hydroxychloroquine, or any other therapies.

https://covid19.who.int/

[ponchi101]

Answer to your question: after my two original boosters, no.

[dryrunguy]

Here's the latest Situation Report. It starts off with a grim milestone. It also summarizes the basis of the Moderna lawsuit against Pfizer, which is... curious.

::

1 MILLION DEATHS IN 2022 WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced during an August 25 briefing that 1 million people have died with COVID-19 in 2022 thus far. Expressing disappointment in the mortality toll, Dr. Tedros blamed lagging vaccination rates and urged all countries to step up and improve vaccination access worldwide, particularly among high-risk groups. "We cannot say we are learning to live with COVID-19 when 1 million people have died with COVID-19 this year alone, when we are 2 and a half years into the pandemic and have all the tools necessary to prevent these deaths,” he said. According to the WHO, 136 countries failed to reach the June target of vaccinating 70% of their populations. Among those countries, 66 have vaccination coverage below 40% and 10 are below 10%, leaving one-third of the world’s population unvaccinated.

GLOBAL VACCINATION CHALLENGES Global COVID-19 vaccination rates have stalled recently. While 67.6% of the world’s population has received at least one dose of a vaccine—close to the WHO’s recently missed goal of 70% by mid-2022—only 20.9% of people in low-income countries have received at least one dose. A new report by the health consultancy Matahari Global Solutions, with support from the International Treatment Preparedness Coalition and the People’s Vaccine Alliance, examines progress on uptake of and access to COVID-19 tools across 14 nations—Bangladesh, Democratic Republic of the Congo, Haiti, Jamaica, Liberia, Madagascar, Nepal, Nigeria, Perú, Senegal, Somalia (and Somaliland), Uganda, and Ukraine. According to the report, the reasons for slow vaccine uptake in these nations are multifaceted and cannot be blamed solely on skepticism about vaccines, or “vaccine hesitancy,” although it does cite influence from “historical memory of experimentation on Black bodies by white colonizers.” The countries also face a range of challenges that contribute to low uptake, including lack of cold chain storage and healthcare workers, unpredictable supply chains, transportation problems related to deliveries or accessing vaccination centers, and insecurity. The report also outlines inequities in access to other COVID-19 tools such as oxygen, diagnostic tests, and therapeutics and discusses actions still needed to address the current pandemic as well as future health emergencies. Notably, experts from the University of Washington's Institute for Health Metrics and Evaluation (IHME) estimate that thousands of lives could be saved if antivirals to treat COVID-19, such as Paxlovid, were more accessible in low- and middle-income countries.

VACCINE PATENT LAWSUIT Moderna on August 26 filed patent infringement lawsuits in the US and Germany alleging that Pfizer and BioNTech violated 3 patents Moderna filed between 2010 and 2016 on its mRNA technology, foundational in developing the company’s SARS-CoV-2 vaccine, Spikevax. Moderna claims that Pfizer and BioNTech copied that technology without permission to produce their vaccine, Comirnaty. Instead of seeking to remove the Pfizer-BioNTech vaccine from the market, Moderna is seeking monetary damages that could include royalties and lost profits incurred since March 2022, when the company began enforcing patents in wealthier nations after pledging not to do so during the emergency phase of the pandemic. Both Pfizer and BioNTech said the litigation was surprising and they remain confident in the intellectual property supporting their vaccine. Notably, some experts say at least one of the patented inventions Moderna included in the lawsuits was patented by two university scientists 6 years earlier than Moderna’s filing. While the earlier patent could weaken Moderna’s argument, the claim likely will not be completely invalidated. Analysts say the lawsuits point toward Moderna’s efforts to profit from the mRNA platform in future endeavors, including to treat and prevent other infectious diseases, cancers, rare diseases, and autoimmune disorders. The patent battle could drag on for years but is unlikely to impact production of the companies’ vaccines against COVID-19.

ACCESS TO COVID-19 TOOLS Most US residents have been able to access COVID-19 vaccines, treatments, tests, and other tools such as masks for low or no cost, largely because the federal government has purchased and allocated them to states and providers. However, because the US Congress has not moved to authorize additional funding for the pandemic response, the government can no longer buy the products for free or low-cost distribution. This week, the Biden administration announced it will pause its program to mail free at-home rapid COVID-19 tests to residents because “Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” according to a statement on the Covid.gov website.

In the face of dwindling supplies and funding-related tradeoffs, the Biden administration is aiming to preserve the existing supply of rapid antigen tests in anticipation of a fall surge in cases. If congressional funding becomes available, the program will quickly resume distribution, according to an unnamed administration official. Free tests will continue to be available to order as long as supplies last or through September 2, whichever comes first. After that, they will be available through 15,000 federally supported community sites, such as libraries and pharmacies, as well as community health clinics. Additionally, individuals can be reimbursed for the cost of tests through private and public health insurers.

With funds running low, the Biden administration is beginning to shift the cost of tests, vaccines, and therapeutics to health insurers and consumers. Experts caution that the impending commercialization of COVID-19 tools must account for systemic barriers that prevent equitable access to them, particularly among uninsured people. Already, programs meant to improve access to and uptake of vaccinations have folded, in some cases due to congressional resistance to authorize more pandemic response funds, just as the US prepares to launch a fall booster campaign with updated vaccines. However, due to a lack of funding, coupled with low demand for vaccination and increasingly relaxed federal guidance on preventive measures, many susceptible populations will continue to face barriers in accessing COVID-19 preventive measures and other healthcare.

VACCINE EFFECTIVENESS AGAINST OMICRON A new analysis in JAMA Network Open provides further support that Pfizer-BioNTech or Moderna booster dose administration following a 2-dose primary series provides protection against severe COVID-19 outcomes caused by the Omicron variant of concern. The cohort study of more than 2.4 million individuals estimated that mRNA booster dose effectiveness against severe COVID-19 during Omicron predominance was 87.4% with no waning up to 6 months after receiving the dose, compared to 69.6% effectiveness against severe COVID-19 following a 3-dose series of inactivated vaccine (ie, Sinovac CoronaVac or Sinopharm COVID-19 vaccines). Data from the US CDC, published August 26 in Morbidity and Mortality Weekly Report (MMWR), similarly emphasized the importance of vaccination, showing that while older Americans above the age of 65 faced greater hospitalization rates during the BA.2 predominant period, unvaccinated individuals had a 3 times greater risk of hospitalization compared to vaccinated individuals.

WASTEWATER SURVEILLANCE Wastewater surveillance is a proven method to track disease outbreaks and has provided an accurate and economical way to provide early detection of COVID-19 levels within communities—and even estimate the number of infected people in a specific area—helping to inform health authorities and policymakers throughout the pandemic. Sewage surveillance also is used to track other diseases, including monkeypox and polio, and experts say building and maintaining the infrastructure to expand wastewater-based disease surveillance should be a public health priority. However, funding for the relatively inexpensive systems is inconsistent, leading to pauses in the disease monitoring that, if continuously and thoroughly conducted, can help communities or entire countries save millions of dollars by quickly responding to disease outbreaks. But many governments, including the US Congress, are reluctant to allocate additional money for wastewater surveillance. In some cases, venture capitalists, nonprofit organizations, or academic institutions are stepping up to fill the gaps. But more funding will be needed to grow wastewater epidemiology to help provide warning signals of future potential disease outbreaks.

CHINA Several of China’s largest cities have imposed full or partial lockdowns amid new COVID-19 outbreaks. The measures impact at least 3 million people in the port city of Dalian and an undisclosed number in Chengde and Shijiazhuang in Hebei province. Though the province surrounds Beijing, the capital city is so far relatively unaffected. Partial lockdowns in other areas of the country are affecting millions more people. Measures include the need to show proof of negative test results within 24 hours to enter residential and public spaces, capacity reductions for public spaces, blanket closures of public entertainment and cultural venues, work-from-home mandates, and limits on the number of people that households may send to shop for daily needs. In many areas, the lockdowns will delay the start of the school year. Amid a heat wave, the workers responsible for enforcing the measures face significant occupational health and safety risks, such as heat stroke and exhaustion exacerbated by wearing bulky protective suits. The latest curbs reflect the government’s insistence of adhering to its “dynamic zero COVID” policy, often criticized for being unsustainable, disrupting the economy, and negatively impacting the mental health of residents, particularly teenagers and young adults.