Category: Covid-19 Vaccine

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Pentagon Complied with COVID-19 Waiver Rules According to Watchdog But Services Moved Slowly – Military.com

March 16, 2024

A Pentagon watchdog review of the military's COVID-19 vaccine exemption process found that each of the branches largely complied with policies and, in some cases, even went beyond what was required to consider service members' requests for religious accommodation.

While rejecting a number of accusations that the services hadn't properly reviewed waiver requests, the Pentagon's inspector general did fault the Army and Air Force for taking too long to process the requests and wrote in a report released Thursday that discharges were inconsistent, leaving some service members with full benefits while others were left with partial benefits.

The exemption process became the subject of political and legal scrutiny amid the height of the pandemic after some service members filed legal challenges that ultimately made their way to the U.S. Supreme Court.

READ NEXT: Navy Fires Commander of USS Ohio -- 3rd Submarine Skipper Relieved in 7 Months

The investigation was kicked off in February 2022 after the inspector general "received complaints through the DoD Hotline between August 2021 and June 2022 alleging that the Military Services were improperly processing COVID-19 vaccination exemption requests," the report said. "We continued to receive complaints and, on June 2, 2022, the Acting DoD Inspector General issued a memorandum ... to the Secretary of Defense."

That memo told Defense Secretary Lloyd Austin that the watchdog "found a trend of generalized assessments" and "denial memorandums we reviewed generally did not reflect an individualized analysis."

It was an allegation that was key to the arguments of several court cases filed by service members that were largely successful in halting discharges over a refusal to comply with the policy.

However, the inspector general ultimately found no evidence that the services were "rubber stamping" denials, declaring that investigators "found no evidence of a lack of individual review by the decision authorities."

Investigators said that the officials that they interviewed discussed the cases "in detail," but they created approval and denial letter templates to both streamline the process and make sure all the required information was being conveyed to service members.

The allegations of "rubber stamping" even made it to at least one of the offices and prompted discussions among staffers about whether the wording should be altered. Ultimately, the unnamed office kept the templates out of a desire to provide consistency for the denials and out of a fear that more customized letters would suggest service members weren't all being reviewed under the same standard.

The report also noted at one point that some requests were considered by the services, even though they didn't need to be. The report cited four requests by Army soldiers whose chaplains "determined that four Service members did not have sincerely held religious beliefs to support a religious accommodation, as required by DoD policy."

"In each case, the Army decision authority stated that they considered the Service member's request regardless of the chaplain's assessment," the report said.

The Army and Air Force's delays in meeting their 90- and 30-day processing deadlines, respectively, were chalked up to the large volume of requests -- more than 16,000, as of January 2023.

Out of the requests reviewed by the inspector general, the Army's cases averaged 192 days to receive a decision while the Air Force's requests averaged 168 days.

Staffers in the offices that typically handle exemption requests told investigators that they normally handled just a few requests per year and on simpler topics such as grooming or clothing -- not something as complex as vaccinations.

Investigators also faulted the services for discharging service members under varying discharge types or reentry codes. While the report explained that "this occurred because the DoD did not have department-level guidance requiring uniformity," they nevertheless pointed out that "service members experienced different impacts to their educational benefits and eligibility to reenlist in military service after discharge."

The report recommended that the Pentagon review its exemption process to try to increase its efficiency "during periods of high-volume requests" and create a better policy to standardize reentry codes. It also noted that both recommendations were accepted by the Defense Department, which has already begun making changes.

Related: Military Services Will Amend COVID Vaccine Refuser Records So They Aren't Passed Over for Promotions

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Pentagon Complied with COVID-19 Waiver Rules According to Watchdog But Services Moved Slowly - Military.com

Canada National Advisory Committee Publishes Recommendation for Use of Novavax’s Nuvaxovid XBB.1.5 COVID … – Novavax Investor Relations

March 16, 2024

Canadas National Advisory Committee on Immunization has published guidance on the use of Nuvaxovid XBB.1.5, a recombinant protein subunit COVID-19 vaccine, in Canada. The recommendations state that Nuvaxovid XBB.1.5 can be used in unvaccinated or previously vaccinated individuals aged 12 years and older.

This recommendation supports efforts to provide greater access to a non-mRNA protein-based COVID-19 vaccine option and could help achieve improved immunization rates. The vaccine has been distributed by the Public Health Agency of Canada across the regions, and provincial public health programs can advise on specific availabilities.

Data from clinical trials continue to show broad neutralization responses to currently circulating forward-drift variants including JN.1 and JN.4 for our protein-based non-mRNA COVID-19 vaccine, while maintaining a favorable side effect profile. Peer-reviewed real-world effectiveness data is being published that shows the immune responses seen in our trials translates into COVID-19 prevention in the real world.1

References:

1. Link-Gelles R, et al. Early Estimates of Updated 20232024 (Monovalent XBB.1.5) COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Attributable to Co-Circulating Omicron Variants Among Immunocompetent Adults Increasing Community Access to Testing Program, United States, September 2023January 2024. MMWR. 2024; accessed online February 28, 2024, at https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a2.htm?s_cid=mm7304a2_w

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Canada National Advisory Committee Publishes Recommendation for Use of Novavax's Nuvaxovid XBB.1.5 COVID ... - Novavax Investor Relations

A bug in an Irish government website that exposed COVID-19 vaccination records took 2 years to publicly disclose – TechCrunch

March 16, 2024

Image Credits: Brian Lawless / PA Images / Getty Images

Two years ago, the Irish government fixed a vulnerability in its national COVID-19 vaccination portal that exposed the vaccination records of around a million residents. But details of the vulnerability werent revealed until this week after attempts to coordinate public disclosure with the government agency stalled and ended.

Security researcher Aaron Costello said he discovered the vulnerability in the COVID-19 vaccination portal run by the Irish Health Service Executive (HSE) in December 2021, a year after mass vaccinations against COVID-19 began in Ireland.

Costello, who has deep expertise in securing Salesforce systems, now works as a principal security engineer at AppOmni, a security startup with a commercial interest in securing cloud systems.

In a blog post shared with TechCrunch ahead of its publication, Costello said the vulnerability in the vaccination portal built on Salesforces health cloud meant that any member of the public registering with the HSE vaccination portal could have accessed the health information of another registered user.

Costello said the vaccine administration records of over a million Irish residents were accessible to anyone else, including full names, vaccination details (including reasons for administering or refusals to take vaccines), and the type of vaccination, among other types of data. He also found internal HSE documents were accessible to any user through the portal.

Thankfully, the ability to see everyones vaccination administration details was not immediately obvious to regular users who were using the portal as intended, Costello wrote.

The good news is that nobody other than Costello discovered the bug, and the HSE kept detailed access logs that show there was no unauthorised accessing or viewing of this data, per a statement given to TechCrunch.

We remediated the misconfiguration on the day we were alerted to it, said HSE spokesperson Elizabeth Fraser in a statement to TechCrunch when asked about the vulnerability.

The data accessed by this individual was insufficient to identify any person without additional data fields being exposed and, in these circumstances, it was determined that a Personal Data Breach report to the Data Protection Commission was not required, said the HSE spokesperson.

Ireland is subject to strict data protection laws under the European Unions GDPR regulation, which governs data protection and privacy rights across the EU.

Costellos public disclosure marks more than two years since first reporting the vulnerability. His blog post included a multi-year timeline revealing a back-and-forth between various government departments that were unwilling to take claim to public disclosure. He was ultimately told that the government would not publicly disclose the bug as though it never existed.

Organizations are not obligated, even under GDPR, to disclose vulnerabilities that have not resulted in a mass theft or access of sensitive data and that fall outside of the legal requirements of an actual data breach. That said, security is often built off the knowledge of others, especially those who have experienced security incidents themselves. Sharing that knowledge could help prevent similar exposures at other organizations that might otherwise go unaware. This is why security researchers tend to lean toward public disclosure to prevent a repeat of mistakes from yesteryear.

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A bug in an Irish government website that exposed COVID-19 vaccination records took 2 years to publicly disclose - TechCrunch

Epilepsy Linked to Higher COVID Hospitalization, Death Rates – Medscape

March 16, 2024

Epilepsy was linked to a significantly increased the risk for hospitalization and death from COVID-19 early in the pandemic, while healthcare utilization rates in this patient population declined, data from two linked studies showed.

Results showed that individuals with epilepsy had a 60% higher risk for hospitalization and a 33% higher risk of dying from COVID-19 than those without the disorder. However, during the pandemic, the number of hospitalizations and ER visits by people with epilepsy dropped by as much as 30%.

"The neurotropic effects of Sars-CoV-2 might explain some of this increased risk for people with epilepsy, or epilepsy might be associated with alterations in the immune system, predisposing to more severe COVID-19," the investigators, led by Owen Pickrell, MBBChirm, PhD, Swansea University, United Kingdom, wrote.

The findings were published online on March 5, 2024, in Epilepsia.

Epilepsy is one of the most common neurological conditions and affects approximately 50 million people worldwide, with significant comorbidity and an increased risk for early death.

During the pandemic, clinicians treating people with epilepsy and other conditions shifted their skills to treat an ever-increasing number of patients with COVID-19, which may have hindered epilepsy-specific services for a time.

To further explore how the COVID-19 pandemic may have affected the health of this patient population, researchers analyzed health records from a large database with information about hospital admissions, primary care visits, COVID-19 vaccination status, and demographics of 90% of Welsh residents.

Those living with epilepsy before or during the study period (March 1, 2020, to June 31, 2021) were identified and compared with controls without epilepsy.

The analysis included approximately 27,280 people with epilepsy and 136,400 matched controls. Among those with epilepsy, there were 158 deaths (0.58%) and 933 hospitalizations (3.4%). In comparison, there were 370 deaths (0.27%) and 1871 hospitalizations (1.4%) in the control group.

Unadjusted analyses showed the risk of dying from COVID-19 for those with epilepsy vs controls was more than twofold higher (hazard ratio [HR], 2.15; 95% CI; 1.78-2.59) and the increase in the risk for hospitalization was similar (HR, 2.15; 95% CI; 1.94-2.37).

After adjusting for 40 comorbidities, including serious mental illness, asthma, and diabetes, those with epilepsy had a 60% increased risk for hospitalization (adjusted HR [aHR], 1.60) and a 33% increased risk for death (aHR, 1.33) than those without epilepsy (all P < .0001).

The findings "may have implications for prioritizing future COVID-19 treatments and vaccinations for people with epilepsy," the investigators wrote.

Study limitations included the inability to account for the effect of vaccinations or prior infections with SARS-CoV-2. Moreover, the study did not account for geographical or temporal variations in prevalence and COVID-19 variants.

In the related study, researchers analyzed healthcare utilization by people with epilepsy before and after the pandemic using the same database. Results showed hospital admissions, ER visits, and outpatient visits significantly decreased during the pandemic.

In the year before the pandemic, people with epilepsy had double the rate of ER visits (rate ratio [RR], 2.36), hospital admissions (RR, 2.08), and outpatient appointments (RR, 1.92) compared with matched controls.

However, during the pandemic there was a greater reduction in hospital admissions (RR, 0.70; 95% CI, 0.69-0.72) and ER visits (RR, 0.78; 95% CI, 0.77-0.70) in those with epilepsy vs matched controls (RR, 0.82; 95% CI, 0.81-0.83) as well as hospital visits and ER visits (RR, 0.87; 95% CI, 0.86-0.88; all P < .0001). New epilepsy diagnoses also decreased during the pandemic (RR, 0.73; P < .0001)

The redeployment of epileptologists during the pandemic also meant that epilepsy

consultations and investigations were canceled, making it harder for people with epilepsy to access specialty care, the researchers noted.

"Our research also showed that there were fewer new diagnoses of epilepsy and fewer contacts with health services by people with epilepsy, during the period we examined," Huw Strafford, lead data analyst for the studies, said in a release.

Both studies were funded by Health and Care Research Wales. Pickrell reported receiving speaker fees from UCB Pharma and Angelini Pharma, travel grants from Angelini Pharma, and an unrestricted grant from UCB Pharma.

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Epilepsy Linked to Higher COVID Hospitalization, Death Rates - Medscape

COVID better contained 4 years later, but long-haul cases still not well understood – Press Herald

March 13, 2024

Its been four years since Maine recorded its first case of COVID-19, and far more is known today about the coronavirus that causes the disease and how to contain it.

We have come a long way since that first case in Maine, said Dr. Puthiery Va, director of the Maine Center for Disease Control and Prevention. We had minimal understanding of what the virus did and how it spread. We didnt have vaccines or treatment.

But much is still not known about why some patients develop chronic symptoms and about how to treat them. And health experts continue to warn that vaccination is the best defense.

As the coronavirus spread into Maine in March 2020, much of the world was shutting down, with limits on gatherings and mask mandates among a suite of pandemic restrictions and closures that followed. Widespread immunization began in Maine in early 2021, and more than 80% of Maine people received at least one dose of the life-saving vaccine. Restrictions were lifted over time, with the federal government ending the public health emergency last May.

Over the four years, more than 9,000 Maine people have been hospitalized with COVID-19 and 3,356 have died.

Hospitalizations and deaths still occur, but with widespread vaccination and more overall immunity in the population, they happen at a much lower rate. There were typically 50-100 people hospitalized with COVID-19 in Maine during the past few months, compared to a peak of 436 patients hospitalized statewide on Jan. 13, 2022. There were 440 deaths in Maine in 2023, compared to 1,272 deaths in 2022, according to the Maine CDC.

We have effective vaccines and treatments, Va said. The shift happened because we now have the tools. Its made COVID-19 more on par with flu in terms of hospitalizations and death.

Everyone 5 years old or older should get the updated 2023-24 vaccine if they have not already, according to the U.S. Centers for Disease Control and Prevention.People 65 and older who have not had a dose in four months or longer are recommended to receive another dose of the updated vaccine. Children between 6 months and 5 years old are eligible for one or two doses depending on previous vaccine doses.

The reduced impact of the virus is part of what led the U.S. CDC last week to eliminate isolation guidelines for those who have tested positive for COVID-19.

The agency eliminated the recommended five days of isolation for those with COVID-19 symptoms and now urges that people stay home and away from others until at least 24 hours after both their symptoms are getting better overall, and they have not had a fever (and are not using fever-reducing medication).

We can now be a little bit more flexible with COVID-19, Va said. If you are not feeling well, you should still be staying home.

LONG COVID REMAINS A PROBLEM

But while the world is in a better place in responding to COVID-19, long COVID remains a persistent problem. For some, COVID-19 symptoms remain long after the initial infection.

Dr. Clifford Rosen, principal investigator for the MaineHealth RECOVER program, which is part of a national effort to research long COVID, said about 10% of people who were infected with COVID-19 before the 2022 omicron wave developed long COVID symptoms, while about 5% to 8% of those who got infected more recently are contracting long COVID.

Symptoms of long COVID includebrain fog, fatigue, post-exertional malaise, dizziness, heart palpitations, loss of smell or taste, and chest pain.

We are making progress, but its slow and people are impatient, Rosen said. But no one should doubt that this is a real condition.

Rosen said one of the most important ways people can protect themselves against long COVID is to remain updated with their COVID-19 vaccines.

Treatments are still being researched, and Rosen said his research group is currently examining whether Paxlovid is an effective treatment for long COVID. Primary care doctors should consider prescribing Paxlovid for those with long COVID, Rosen said.

Other medications undergoing study include metformin, which is used to treat diabetes, and Immulina, a supplement that boosts the immune system.

Rosen said a proposal by Sen. Susan Collins, R-Maine, if successful, could help improve access to treatment for long COVID patients, by spending at least $5 million to establish COVID-19 Centers for Excellence. If the funding is approved, Maine could be one of the Centers for Excellence.

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COVID better contained 4 years later, but long-haul cases still not well understood - Press Herald

Academy Affirms CDC COVID Booster Recommendation | Patient Care – AAFP News

March 13, 2024

The CDCs Advisory Committee on Immunization Practices made the recommendation at a February meeting that also included discussion of the chikungunya vaccine for people who work in or travel to certain environments; diphtheria, tetanus and pertussis vaccines for children; and other issues.

The AAFP has updated its Immunizations & Vaccines and COVID-19 Vaccine webpages with the latest information.

The new recommendation says people 65 or older who have already had a 2023-2024 COVID-19 vaccine should get an additional dose of an updated vaccine this spring, at least four months after the earlier immunization.

Data show that the COVID-19 virus circulates year-round, and not only in seasonal patterns like influenza and respiratory syncytial virus, though seasonal peaks in COVID-19 cases also occur along with influenza and RSV, said Pamela Rockwell, D.O., of Ann Arbor, Mich., the Academys liaison to the ACIP. It is important that older adults receive a second updated COVID-19 booster four months from their last booster since older adults show waning immunity to vaccines more quickly than younger adults and children.

An ACIP recommendation approved last fall already allows people who are moderately or severely immunocompromised to receive more than one COVID-19 booster in a given year. People who are immunocompromised must wait two months between doses, with additional doses given following a discussion with a health care professional.

The CDC also recommended chikungunya vaccination for laboratory workers with potential for exposure to chikungunya virus, and for adults who are traveling to a country or territory with a chikungunya outbreak.

In addition, chikungunya vaccination may be considered for either of the following groups of people traveling to an area that does not have an outbreak, but where there is evidence of chikungunya virus transmission among humans within the last five years:

The CDC also approved tetanus-diphtheria vaccine for children younger than age 7 for whom receipt of the pertussis component is contraindicated and updated language regarding administration of the Tdap booster in individuals ages 11 to 18 years.

The Vaccines for Children Program Information for Providers webpage has the latest information on each vaccine offered through the VFC program.

The ACIP also received updates on vaccines for influenza, polio, RSV, meningococcal disease and pneumococcal disease, and reviewed a presentation on Vaxelis, a vaccine for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

Officials with the National Center for Immunization & Respiratory Diseases also gave a presentation that suggested moving up the timeline for the annual COVID-19 vaccine schedule to relieve many lead time and planning issues, and to give vaccine manufacturers more time to determine vaccine strain composition.

Rockwell agreed with the suggestion, telling AAFP News,noting that the change would increase opportunity for children to be vaccinated prior to the school year starting in the fall before they enter their classrooms, resulting in more protection for children, their families and our communities from the effects of COVID-19 communicable disease.

ACIP is expected to vote on the 2024-2025 COVID-19 vaccine recommendations in June.

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Academy Affirms CDC COVID Booster Recommendation | Patient Care - AAFP News

Impact of vaccination on the association of COVID-19 with cardiovascular diseases: An OpenSAFELY cohort study – Nature.com

March 13, 2024

Characteristics of study cohorts

Among 18,210,937 people in the pre-vaccination cohort, 1,150,299 had a COVID-19 diagnosis during follow-up of whom 75,667 (6.6%) were hospitalised. There were 844,235 COVID-19 diagnoses (15,342 (1.8%) hospitalised) among 13,572,399 people in the vaccinated cohort and 162,103 (9,250 (5.7%) hospitalised) among 3,161,485 people in the unvaccinated cohort (Table1). Among 75,667 people in the pre-vaccination cohort who were hospitalised because of COVID-19 37,881 (50.1%) were hospitalised on the day of diagnosis and 6,278 (8.3%) were hospitalised the day after diagnosis: the remainder were hospitalised 228 days after diagnosis (TableS1). In the pre-vaccination cohort, the median age was 49 years (interquartile range (IQR) 3464), a slight majority (50.2%) were female, and 78.0%, 6.4% and 2.2% were recorded as being White, South Asian and Black ethnicities respectively. Differences between the vaccinated and unvaccinated cohorts reflected predictors of COVID-19 vaccine uptake20. The median (IQR) age was 54 (IQR 3968) years in the vaccinated cohort, compared with 36 (IQR 2847) years in the unvaccinated cohort. The proportions of females were 52.1% and 42.0% in the vaccinated and unvaccinated cohorts respectively, while the proportions recorded as of White ethnicity were 82.1% and 61.6% respectively, and the proportions living in the most deprived areas were 16.4% and 29.8% respectively. Compared with the vaccinated cohort, people in the unvaccinated cohort were more likely to be smokers, less likely to consult their GPs and less likely to have prior medical problems recorded (TableS2).

The numbersof events, person-years, and incidence rates per 100,000 person-years of vascular events before any COVID-19 diagnosis, after hospitalised COVID-19 and after non-hospitalised COVID-19, are presented, for each cohort and outcome, in Table2. There was a total of 212,557, 57,425 and 3,316 ATE in the pre-vaccination, vaccinated and unvaccinated cohorts respectively. The corresponding total numbers of VTE were 117,730, 29,107 and 3,178 respectively. In each cohort, the incidence of each arterial thrombotic and venous thrombotic event was higher after COVID-19 than before or without COVID-19. For each outcome and cohort, the highest incidence rates were after hospitalised COVID-19. Incidence rates were generally lower in the unvaccinated cohort than in the vaccinated cohort, as expected given that the median age of the unvaccinated cohort (36 years) was much lower than that of the vaccinated cohort (54 years).

Adjusted hazard ratios were estimated using Cox-proportional hazards models to quantify the associations between COVID-19 diagnosis (time-varying exposure) and a first cardiovascular event including arterial thrombotic, venous thrombotic and other cardiovascular events. Minimally adjusted models accounted for age, sex and region and maximally adjusted models accounted additionally for ethnicity, area deprivation, smoking status, number of GP-patient interactions and history of comorbidities. In each cohort, maximally adjusted HRs (aHRs) comparing the incidence of each outcome after COVID-19 diagnosis with the incidence before or without COVID-19 diagnosis were attenuated compared with age-, sex- and region-adjusted HRs (Tables35, TableS3). For all outcomes, hazard ratios were extremely high on the day of COVID-19 diagnosis (day 0), particularly among individuals hospitalised with COVID-19 on the day of diagnosis. The incidence of each outcome in each cohort was also elevated during weeks 14 after COVID-19 diagnosis, compared with before or without COVID-19 diagnosis. aHRs were lower in subsequent time periods than during weeks 14 after COVID-19 diagnosis, though they were generally greater than 1 throughout follow-up in each cohort (Figs.2 and 3, Tables35). aHRs during weeks 1-4 after COVID-19 diagnosis were substantially lower in the vaccinated cohort than in the pre-vaccination and unvaccinated cohorts, and generally remained lower than in other cohorts during weeks 428 (Figs.2 and 3, Tables35). For each outcome and in each cohort, aHRs were substantially higher after hospitalised than non-hospitalised COVID-19 (Fig.2, Tables3 and 4, TableS3).

Upper panels: Maximally adjustedhazard ratios and 95% CIsfor arterial thrombotic events. Lower panels: Maximally adjustedhazard ratios and 95% CIsfor venous thrombotic events. Left panels: all COVID-19 diagnoses: Middle panels: hospitalised COVID-19. Right panels: non-hospitalised COVID-19. The numbers of people in the pre-vaccination, vaccinated and unvaccinated cohorts were 18,210,937; 13,572,399 and 3,161,485 respectively. The numbers of COVID-19 diagnoses were 1,150,299 (75,667 hospitalised) in the pre-vaccination cohort, 844,235 (15,342 hospitalised) in the vaccinated cohort and 162,103 (9250 hospitalised) in the unvaccinated cohort. Maximally adjustedhazard ratios and 95% CIsare plotted at the median time of the outcome event within each follow up period in each cohort. Events on the day of COVID-19 diagnosis (day 0) were excluded. The numerical values of hazard ratios and their95% CIs are displayed in Tables3 and 4.

Upper left panel: Acute myocardial infarction. Upper right panel: Ischaemic stroke. Second row left panel: Pulmonary embolism. Second-row right panel: Deep vein thrombosis. Third row left panel: Heart failure. Third row right panel: Angina. Lower left panel: Transient ischaemic attack. Lower right panel: Subarachnoid haemorrhage and haemorrhagic stroke. The numbers of people in the pre-vaccination, vaccinated and unvaccinated cohorts were 18,210,937; 13,572,399 and 3,161,485, respectively. The numbers of COVID-19 diagnoses was 1,150,299 in the pre-vaccination cohort, 844,235 in the vaccinated cohort and 162,103 in the unvaccinated cohort. Maximally adjustedhazard ratios and 95% CIsare plotted at the median time of the outcome event within each follow-up period in each cohort. Events on the day of COVID-19 diagnosis (day 0) were excluded. The numerical values of hazard ratios and 95% CIsare displayed in Tables3, 4 and 5.

The incidence of ATE during weeks 1-4 after COVID-19 diagnosis, compared with before or without COVID-19 diagnosis, was elevated in the pre-vaccination and unvaccinated cohorts (aHRs 4.40 (95% CI 4.164.65) and 8.53 (7.2010.1) respectively) but less markedly elevated in the vaccinated cohort (2.09 (1.922.28)) (Fig.2, Table3). The incidence of ATE remained elevated during weeks 5-28 in the unvaccinated cohort (1.54 (1.162.04)) and up to weeks 53102 in the pre-vaccination cohort (1.22 (1.141.30)). During weeks 14 the aHRs for ATE were substantially lower in the vaccinated cohort than in the unvaccinated or pre-vaccination cohorts (ratios of aHRs 0.28 (0.250.32) and 0.36 (0.330.38) respectively, TableS4). Although attenuated, aHRs remained lower in the vaccinated cohort than in the unvaccinated or pre-vaccination cohorts during weeks 528 (ratios of aHRs 0.70 (0.520.94) and 0.73 (0.660.82), respectively).

The aHRs for ATE were substantially higher during weeks 14 after hospitalised COVID-19, versus before or without COVID-19 diagnosis (pre-vaccination cohort 12.1 (11.213.1), unvaccinated cohort 19.6 (15.624.5)) than after non-hospitalised COVID-19 (pre-vaccination cohort 2.70 (2.502.92), unvaccinated cohort 4.35 (3.365.64)). In sensitivity analyses restricted to primary diagnoses of ATE, aHRs during weeks 14 after hospitalised COVID-19 (including both day 0 and the rest of that period) were attenuated compared with aHRs for all ATEs (FigureS1). Estimated hazard ratios were similar in sensitivity analyses removing censoring at first vaccination in the unvaccinated cohort (TableS5). In additional analyses splitting follow-up during weeks 1-4 into shorter time intervals, hazard ratios for ATE declined steadily from days 16 to days 2127 after COVID-19 diagnosis, in all cohorts (TableS6).

The aHRs for VTE during weeks 1-4 after COVID-19 diagnosis, versus before or without COVID-19 diagnosis, were substantially higher than for ATE, particularly in the pre-vaccination and unvaccinated cohorts (aHRs 16.6 (95% CI 15.917.2) and 29.6 (26.732.9) respectively), but less markedly in the vaccinated cohort (4.87 (4.535.23)) (Fig.2, Table4). The incidence of VTE remained elevated, compared with before or without COVID-19 diagnosis, during weeks 528 in all cohorts and up to weeks 53102 in the pre-vaccination cohort (1.20 (1.091.32)). During weeks 14 the aHRs for VTE were substantially lower in the vaccinated cohort than in the unvaccinated or pre-vaccination cohorts (ratios of aHRs 0.17 (0.150.19) and 0.24 (0.230.26) respectively, TableS4). Although attenuated, aHRs remained lower in the vaccinated cohort than in the unvaccinated or pre-vaccination cohorts during weeks 528 (ratios of aHRs0 0.63 (0.490.80) and 0.61 (0.550.68), respectively).

The aHRs for VTE were substantially higher during weeks 14 after hospitalised COVID-19 (pre-vaccination cohort 88.5 (84.193.2), vaccinated cohort 46.7 (42.251.6), unvaccinated cohort 199.8 (174.7228.5)) than after non-hospitalised COVID-19 (pre-vaccination cohort 5.99 (5.616.40), vaccinated cohort 2.13 (1.912.38), unvaccinated cohort 7.64 (6.349.20)). The incidence of VTE was still markedly elevated during weeks 528 after hospitalised COVID-19 in the pre-vaccination, vaccinated and unvaccinated cohorts (aHRs 4.39 (4.014.80), 5.67 (4.636.94) and 7.50 (5.0711.1) respectively). In sensitivity analyses restricted to primary diagnosis of VTE, aHRs after COVID-19 diagnosis were attenuated compared with aHRs for all VTEs (FigureS2). This attenuation was particularly marked during weeks 14 (including both day 0 and the rest of that period) and after hospitalised COVID-19. In additional analyses splitting follow-up during weeks 14 into shorter time intervals, hazard ratios for VTE were generally similar during days 16 and days 713 after hospitalised COVID-19, then declined during days 1420 and days 2127 (TableS6). Hazard ratios after non-hospitalised COVID-19 did not markedly decline between days 1-6 and days 2127.

In each cohort, aHRs for acute MI during weeks 14 after COVID-19 diagnosis, versus before or without COVID-19 diagnosis, were similar to those for ischaemic stroke (Fig.3, Table3). In the pre-vaccination cohort, aHRs for acute MI remained elevated during weeks 2952 (1.16 (1.091.24)) and weeks 53102 (1.31 (1.191.45)), but the incidence of ischaemic stroke was only slightly elevated from 29 weeks onwards (aHR 1.16 (1.051.27) during weeks 53102). In all cohorts, aHRs during weeks 14 were markedly higher for PE (pre-vaccination 31.7 (30.333.1)), vaccinated cohort (9.10 (8.369.90), unvaccinated cohort 82.8 (72.794.3)) than for DVT, and aHRs for PE remained higher than for DVT during weeks 528 (Fig.3, Table4). By contrast, in the pre-vaccination cohort aHRs for DVT during weeks 29102 were higher than for PE.

The incidence of heart failure, angina, and subarachnoid haemorrhage and haemorrhagic stroke during weeks 14 after COVID-19 diagnosis was substantially elevated in each cohort, versus before or without COVID-19 diagnosis, although aHRs were lower in the vaccinated cohort than the pre-vaccination or unvaccinated cohorts (Fig.3, Table5). Compared with these outcomes, the incidence of transient ischaemic attack was less markedly elevated during weeks 14. Though greater than 1, aHRs for these four outcomes were markedly lower during weeks 528 than weeks 1-4 after COVID-19 diagnosis. In the pre-vaccination cohort, the incidence of heart failure during weeks 53102 was similar to the incidence before or without COVID-19 diagnosis (aHR 1.04 (0.981.11)). The incidence of angina and transient ischaemic attack was slightly elevated (aHRs between 1.10 and 1.16) and remained elevated during weeks 29102. aHRs for subarachnoid haemorrhage and haemorrhagic stroke were 1.32 (1.141.52) during weeks 2952 and 1.42 (1.151.76) during weeks 53102.

In subgroup analyses, aHRs for both ATE and VTE were generally lower in younger age groups, in females, and in those reporting white ethnicity (TablesS7, S8, FiguresS3, S4). Estimated excess risks of ATE 6 months post-COVID-19 diagnosis were 642, 229 and 718 per 100,000 people diagnosed with COVID-19 in the pre-vaccination, vaccinated and unvaccinated cohorts respectively (Fig.4, TableS9). Corresponding estimated excess risks of VTE were 797, 270, and 1094 per 100,000 people diagnosed with COVID-19, respectively.

Upper panels: Estimated absolute increase in risk for arterial thrombotic events. Lower panels: Estimated absolute increase in risk for venous thrombotic events. Left panels: pre-vaccination cohort. Middle panels: vaccinated cohort. Right panels: unvaccinated cohort. The numbers of people in the pre-vaccination, vaccinated and unvaccinated cohorts were 18,210,937; 13,572,399 and 3,161,485 respectively. The number of COVID-19 diagnoses was 1,150,299 in the pre-vaccination cohort, 844,235 in the vaccinated cohort and 162,103 in the unvaccinated cohort. Increases in risks were estimated within sex and age groups, and the estimated overall increase in risk is the average of these(shown in black), weighted according to the proportions in each sex and age group in the pre-vaccination cohort. Estimated excess events at 28 weeks are displayed in TableS9.

Originally posted here:

Impact of vaccination on the association of COVID-19 with cardiovascular diseases: An OpenSAFELY cohort study - Nature.com

Lake County’s fourth ‘anni-misery’ of COVID-19 marked by memories of tragedy, triumphs and lessons learned – Chicago Tribune

March 13, 2024

It was not that long ago that collaboration between scientists, pharmaceutical manufacturers, academics, the government and others sped the creation of COVID-19 vaccines in less than a year, putting the world on a path to return to a new normalcy.

Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University, sits on the Federal Food and Drug Administrations Vaccines and Related Biological Products Advisory Committee which oversaw the development of the vaccine.

Chatterjee said the vaccines were developed in less than a year because some of the technology was already in place. Some shifting of methodology was necessary, but the cooperation between everyone involved helped get shots in arms in a relatively short period of time.

There were so many reasons it happened so quickly, said Chatterjee, who is also the vice president of medical affairs at Rosalind Franklin. Everyone pulled together to develop the vaccine. They worked together to secure a vaccine as soon as possible.

The development of safe, effective vaccines and (the) technology behind doing so was nothing short of a modern-day miracle, added Dr. Michael Bauer, the medical director at Northwestern Medicine Lake Forest Hospital.

The coronavirus pandemic was declared a national health emergency in the United States, and the first case was reported in Lake County four years ago this week, creating changes in the way Americans still live their lives today.

Lake County Health Department Executive Director Mark Pfister oversaw the countys effort to deal with the pandemic, protect against the disease and get people vaccinated. He spread the message of the three Ws wash your hands, watch your distance and wear a mask.

I call this the fourth anni-misery of the start of the pandemic, Pfister said. I cant call it an anniversary because Im not celebrating it. I am marking it.

Lessons learned from the pandemics three Ws continue to be practiced. Utilizing those habits makes a difference, which is one reason there were fewer cases of flu last year, he said. Pfister said those who do are, being good stewards of the community.

Many people are continuing to stay home when they are sick, wear masks, wash their hands or use hand sanitizer, he said. Thats one of the reasons we do not see that many cases. I have not had a cold in the last four years.

Though few places require wearing masks to enter, there are still signs on doors recommending people wear them or saying masks are optional. Medical facilities warn people to use a face covering if they have symptoms of a disease.

With 98% of the American population developing strong immunity to COVID-19, Pfister said it is because they received vaccinations, got the disease or both. That is why there are fewer hospitalizations and deaths.

Its not killing us anymore, he said.

Along with people developing natural immunity to COVID, Bauer said the virus has undergone mutations lowering the severity of the disease. Both Pfister and Bauer said people should continue taking the vaccine.

Fortunately, the virus has mutated and evolved into what we typically see with many other respiratory illnesses, including other coronaviruses, Bauer said. We encourage everyone to stay up to date with vaccines and other protective mechanisms, especially those at high risk.

While there were a lot of negatives during the pandemic, Pfister said there were also positives. Companies like AbbVie, Abbott and Baxter along with Rosalind Franklin, other schools, the health department and public officials banded together to get people vaccinated, he said.

Stockpiling personal protection equipment for the next time a pandemic occurs is crucial. Pfister said supply-chain issues and other situations caused critical shortages. That should be avoided. Some youngsters did not learn as much as normal through online schooling.

Some students got less education, and we need to do everything we can help them catch up, Pfister said.

Members of the medical profession had adjustments to make, Bauer said. Peoples habits changed, forcing doctors and nurses to modify what they were doing. People stopped coming to emergency rooms and medical offices for fear of getting the disease.

It literally turned the medical and hospital world upside down, Bauer said. Surgeries outside of emergency conditions were halted, and people lived in fear of dying from this new, awful disease.

Before March of 2020, Chatterjee said the medical community was aware of what was happening with the virus in China and the possibility of a spread. By spring, the FDA held discussions about a vaccine. They were virtual, no longer face-to-face. By June, they began dealing with ways to create it.

We talked about how to design the clinical testing, Chatterjee said. With the mRNA formula, there was a much faster platform. They ran clinical testing. The manufacturers got involved and started making it.

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Lake County's fourth 'anni-misery' of COVID-19 marked by memories of tragedy, triumphs and lessons learned - Chicago Tribune

4 years after the COVID emergency, what the coronavirus means today – WBUR News

March 13, 2024

Four years ago this week, as fears were growing about a novel coronavirus, then-Massachusetts Gov. Charlie Baker declared a state of emergency. The World Health Organization declared the threat a pandemic. Businesses and schools started to close, and a new disease called COVID-19 suddenly upended our lives.

The virus has now touched just about everyone and taken a tremendous toll, contributing to nearly 22,000 deaths and more than 118,000 hospitalizations in Massachusetts alone.

Today, the social distancing era is over, and millions have received COVID vaccines. The U.S. Centers for Disease Control and Prevention recently loosened precautions by droppinga five-day isolation rule, treating COVID much like other common respiratory illnesses.

But COVID is still with us, even if it is not as dangerous as it once was, experts say, largely because so many people have built up immunity from vaccinations and prior infections.

The most recent data from Massachusetts health officials shows COVID-related emergency department visits are minimal and hospital admissions are low though hospitals remain crowded with patients suffering from other ailments.

On this fourth anniversary of the pandemic, WBUR reached out to several experts who have been on the front lines of studying and fighting COVID since its early days. Here are some of their thoughts about COVID then and now lightly edited and condensed:

Shira Doron, hospital epidemiologist, Tufts Medical Center: When I think back to what was happening four years ago, I think of it as a time when we were doing both too much and too little. We should not have allowed prolonged school closures, restrictions on the use of playgrounds and beaches, or extended delays on elective medical care to occur. At the same time, we should have had widespread testing much earlier, and we should have been more prepared to tackle supply chain and capacity shortages.

Bill Hanage, associate professor of epidemiology, Harvard T.H. Chan School of Public Health: Lots of very intense memories both professional and personal, given the far reaching impact of the pandemic on all our lives. And the truly ghastly memory of knowing the outline of what was coming at us and trying to convince people of it.

Sandeep Jubbal, infectious disease physician, UMass Memorial Medical Center: The outset of the pandemic was chaotic and stressful due to lack of treatment and vaccines, and the spread of misinformation. But the silver lining was the unprecedented global collaboration, knowledge sharing, and application of cutting-edge technology that allowed the rapid development of treatments and vaccines. Without these tools, our world would have been a very different place with mortality numbers beyond imagination.

Cassandra Pierre, infectious disease physician and associate hospital epidemiologist, Boston Medical Center: Over time, I've observed people tune out the ongoing impact of COVID for their own sanity and the need to move forward. The fact that the majority of these admissions and deaths occur among the elderly and the immunocompromised may have made COVID more predictable, tame and potentially ignorable. But the elderly and immunocompromised remain essential members of our community and our own families and even the young and healthy remain vulnerable to complications like long COVID. COVID is still impacting us, even if we're not acknowledging it.

Doron: It was anyones guess whether widespread immunity would ever bring us to the point we have reached today. I never imagined that we would have a vaccine in such a short time. So overall, I consider where we are today, after "only" four short years, to be better than I expected and a huge relief.

Hanage: On the one hand, I remain horrified at how much illness and death has been considered acceptable, here and elsewhere. On the other, Im astonished by the pace with which effective vaccines were developed and available and also the reluctance of some to make use of them leading to yet more preventable suffering and death.

Jubbal: Constant mutations are part of the natural viral evolution. The virus has had multiple variants, and may continue to evolve, but has gone "weaker." And at some point, it will die away, as we have seen historically with other coronaviruses.

Doron: Immunity is long-lasting, and it is working to protect us against severe disease. This has been the case despite the ongoing emergence of new variants. That gives me hope. What I am pessimistic about is trust in public health. We are seeing dangerously low levels of vaccination. Polls show that people dont want to listen to health authorities any more.

Hanage: I expect that bit by bit, the population immunity to COVID will continue to improve, and severe outcomes will dwindle although I dont know how long that will take. I am pessimistic that the reaction to the pandemic will be to withdraw resources from public health rather than renew them.

Pierre: I'm feeling optimistic and pessimistic about the same thing: vaccines. Optimistic because the pandemic did create the ideal conditions for the acceleration of vaccine development. That said, we have certainly seen an erosion in vaccine confidence and acceptance. I'm concerned that we'll see the resurgence of diseases we've previously eliminated and also worried that if another pandemic-level threat appears, low vaccine acceptance will negate the benefits of a rapid and safe vaccine development.

Originally posted here:

4 years after the COVID emergency, what the coronavirus means today - WBUR News

Allergies, COVID-19, and Listener Questions Unpacked with Dr. Fred Harvey – WMNF

March 13, 2024

Vaccine therapy and inflammation concerns have recently come into the spotlight, especially with the roll-out of the COVID-19 vaccine. The potential occurrence of brain inflammation in both children and adults post-vaccination has been a focal point of these discussions, underscoring the need for more extensive research into the inflammatory responses triggered by the vaccine. A key voice in this dialogue is Dr. Fred Harvey, who brings to the conversation his concerns about the COVID-19 vaccine potentially leading to an increase in inflammation and the onset of neurological issues such as ADHD and autism. Dr. Harvey stresses the importance of addressing both brain and vascular inflammation in long-haul COVID patients, proposing a therapeutic approach focused on reducing inflammation. His stance has been shaped by his experience and understanding of the potential risks presented by the new vaccine therapy and the imperative to safeguard the health and well-being of those receiving the COVID-19 vaccine.

(00:07:45) Brain Inflammation Risks in Vaccine Therapy

(00:12:56) Blocking Importin in Long COVID Treatment

(00:14:55) Mevacor Therapy for Long COVID Symptoms

(00:16:20) Inflammation Reduction with Curcumin for Hypertension

(00:26:57) Reversing Cognitive Decline Through Functional Medicine

(00:31:56) Inflammation Reduction with Hydroxychloroquine

(00:37:47) Reducing Infectivity Through Mask-Wearing Practices

(00:52:54) Holistic Approaches to Health and Wellness

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Allergies, COVID-19, and Listener Questions Unpacked with Dr. Fred Harvey - WMNF

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