Category: Covid-19

Participants

A non-probability cluster sampling strategy was used to recruit Flemish secondary school teachers. In August and September 2019, all secondary schools in Flanders (Belgium) were contacted through e-mail and telephone. To increase the response and participation rate, the Flemish Department of Education (Vlaams Departement Onderwijs) as well as all education networks (i.e., Flemish community schools, subsidised public schools, subsidised free schools) were involved in the recruitment and were asked to promote the study among all school principals. To stimulate school involvement, a convenient selection of schools in Flanders were visited to promote our study face-to-face. Schools that were willing to participate in the study were asked to send an e-mail with a link to an online questionnaire to their entire teaching staff. Furthermore, the same link was spread through social media (e.g., Facebook, Twitter) and by posting advertisements via the Flemish Department of Education. Teachers being in sick leave or having a distorted physical activity/dietary pattern (by e.g., injuries, diseases, following a diet) were excluded from the final sample. As this study was part of a larger longitudinal follow-up study, in which we questioned distorted physical activity/dietary patterns by one question, we could not differentiate between the two. As a result, participants who reported being distorted in either category were excluded.

This prospective cohort study is part of a larger longitudinal study, including six measurements throughout the 20192020 school year, i.e., Sep/Oct, Nov/Dec, Jan/Feb, Mar/Apr, May/Jun, and Jul/Aug. For the purpose of the present study (i.e., measuring the impact of COVID-19 lockdown on secondary school teachers PA and SB), the Jan/Feb measurement (Jan 27 Feb 11, 2020) will serve as baseline (T0). The measurement performed in Mar/Apr (Mar 23 Apr 7, 2020), which is five days after the installation of the lockdown measures, will serve as measurement under lockdown-exposure (i.e., primary endpoint (T1)). The measurements prior to T0 (i.e., Sep/Oct (T-2) and Nov/Dec (T-1)) will serve as pre control measurements, whereas the measurement after T1 (i.e., May/Jun (T2)) will serve as post control measurement. The Jul/Aug measurement was omitted due to anticipated summer holiday bias. The timeline of the measurements is displayed in Fig.1.

Timing of the measurements

At each time point participants were asked to complete an online questionnaire, including sample characteristics and primary outcome measures. Sample characteristics include socio-demographics, work-related information, and other health-related variables. Primary outcomes in the present study are PA and SB. During each measurement period of two weeks, three reminders were sent to the non-responders, each on the fourth, eighth and eleventh day after activation of the online questionnaire.

Socio-demographics include sex, age, highest diploma (i.e., secondary school degree, post-secondary school degree or certificate, Bachelors degree, Masters degree, PhD degree), having an extra job (yes/no), marital status (i.e., single, married, unmarried, living together with partner, divorced, widowed), having children (yes/no) and ethnicity (i.e., White European, White other, North-African, Afro-American, Indian, Middle-Eastern, South-Asian, Southeast-Asian, other). Work-related factors include education network (i.e., Flemish community schools, subsidised free schools, subsidised public schools) and total working hours per week. Health-related variables include self-reported height and weight (from which body mass index (BMI; kg/m) was calculated) and smoking status (yes/no).

The validated International Physical Activity Questionnaire (IPAQ Dutch long version) was used to estimate PA domains and intensities during the last seven days [23]. This self-report questionnaire includes 31 items and assesses four contextual PA domains: [1] work-related [2], transport-related [3], domestic and garden, and [4] leisure-time PA. The participants were asked to fill in the number of days and the amount of time (hours and minutes) spent in three different PA intensity levels within each domain, namely [1] walking [2], moderate-intensity PA, such as carrying light loads, washing windows, cycling or swimming at a regular pace, and [3] vigorous-intensity PA, such as heavy lifting, aerobics, running and fast cycling or fast swimming (as specified by the IPAQ). The outcome measures are domain- and intensity-specific PA as well as total PA expressed in min/week. Multiple criteria from the IPAQ scoring protocol were applied [24]: [1] only values of ten or more minutes of activity were retained; [2] non-relevant observations were excluded (e.g., answering in step counts instead of minutes); [3] PA levels higher than 960min/day (i.e., 16h/day) were excluded, as this would be unrealistic. Total scores per domain were calculated by multiplying the frequency of each PA per week by its duration expressed in minutes. Next, the domains were combined into total walking, moderate-intensity PA, and vigorous-intensity PA. Lastly, total PA was calculated by summing all items. It should be mentioned that total light-intensity PA, in which walking is just one component, is not questioned in the IPAQ. Therefore, total PA in this study only represents walking and moderate-to-vigorous-intensity PA. Note that the IPAQ scoring protocol includes a section Truncation of Data Rules, which is not applied in the current study. The protocol states that this rule attempts to normalize the distribution of levels of activity which are usually skewed in national or large population data sets [24]. Instead of truncating and forcing data into a normal distribution, we opted to tailor the statistical analyses to the non-normal data distributions (see Statistical analysis section). The IPAQ has fair to good psychometric properties (reliability: =0.80 and validity: r=0.30) [25].

SB was assessed by using the Dutch version of the validated context-specific sedentary behaviour questionnaire for adults developed by Busschaert and colleagues [26]. This self-report questionnaire assesses SB in three domains: [1] work-related [2], transport-related, and [3] leisure-time SB. Participants were asked to specify how much time they spent sitting/lying down during the last seven days (weekdays and weekend days separately) within each domain. The outcome measures are domain-specific SB as well as total SB expressed in min/week (i.e., sum score of minutes during the week and weekend). Participants were asked to fill in the number of days and the amount of time spent sitting/lying for several items/activities (e.g., TV watching, computer use, reading) within each of the three domains. For each item, a specific time interval could be chosen; e.g., 1 to 15min, 15 to 30min, 30 to 60min, 1 to 2h, etc. Midpoint values (e.g., 7.5min, 22.5min, 45min, 90min, etc.) of each test item interval were calculated. As it was not mentioned in the protocol how the upper limit time intervals more than seven hours a day and more than eight hours a day had to be interpreted, it was decided to consider these time intervals as 450min and 510min, respectively. Total sedentary time for an average day was estimated by summing all midpoint values of the specific SB contexts (weekdays and weekend days separately) and was estimated as follows: ((total sedentary time on a weekday * 5) + (total sedentary time on a weekend day * 2))/7. Although not explicitly mentioned in the paper of Busschaert and colleagues [26], but consistent with the IPAQ protocol, we decided to exclude participants with SB levels higher than 960min/day (i.e., 16h/day) from the analysis.

Patient and public involvement was not appropriate for this study.

Secondary school teachers from multiple geographical regions, urban and rural communities and different education networks were recruited for this study. Participants could report their sex, diploma and ethnicity. The author team included early, middle and late career researchers with balance from people who identify as male and female.

All data were analysed using R (R core Team, 2019; R Studio version 3.6.2) and SPSS (version 27). P-values<0.05 were considered statistically significant, whereas p-values between 0.05 and 0.10 were considered marginally significant. Representativeness of the sample at baseline (T0) was assessed by conducting two proportions z-tests. Drop-out analyses between baseline (T0) and the primary endpoint (T1) were conducted to assess possible selection bias of the retention group. In the first analysis, participants of whom we had data at T0 and T1 (i.e., retention group) were compared to participants of whom we only had data at T0 (i.e., drop-out group). As the generalized mixed models that we used typically include all available observation points, we decided to perform a second analysis in which we compared participants of whom we had data at T0 and T1 to participants of whom we only had data at T1. Independent samples t-tests, Mann-Whitney U tests and chi tests were conducted to detect possible differences between the drop-out group and retention group regarding total PA, total SB, sex, age, ethnicity, marital status, having children, smoking status, diploma, having an extra job, education network and BMI.

Multilevel models were used for data analysis. Preliminary analyses checked if a three level model was advised (repeated measures clustered within participants, participants clustered within schools) using graphical representations and by inspecting the amount of variance explained by each cluster. If necessary, one (or both) levels were dropped. Possible confounders, such as age and sex, were checked, but seemed to have no significant effects, and therefore no adjustments were made in the statistical models. The PA scale scores were non-normally distributed with continuous, positively skewed non-negative values. The SB scales also contained non-negative continuous values, but with less severe skewness. For both outcome variables, Gamma and Gaussian generalized linear mixed models were constructed using the R package lme4 [27]. To decide upon the model (i.e., Gamma or Gaussian) and link functions (i.e., log, inverse or identity), Bayesian Information Criterion (BIC) values were compared and a likelihood ratio test was performed (lrtest() function of the R package lmtest [28]). The model selection procedure of each outcome is explained in Additional file 1. For both PA and SB outcomes, the Gamma model with the log link function was selected. In total, five separate models (i.e., total PA, PA intensities, PA domains, total SB, SB domains) were analysed. In order to assess the effect of the lockdown on total PA and SB, a model with total PA and one with SB as outcome variable and time as predictor variable was fitted. To inspect the lockdown effect in the different domains (PA and SB) or intensities (PA), the same model was fitted but with the domains or intensities as a categorical predictor variable together with an interaction term between time and domains or intensities. Significance of main and interaction effects of the categorical variables consisting of more than two categories were checked using Wald Chi tests (Anova function from the R package car [29]). Contrasts were constructed (test Interactions function from the R package phia [30]) to inspect statistical differences between T0 and T-2, T-1, T1, T2 of each domain and intensity, respectively. Data visualisation was performed using the R packages ggplot2 [31] and sjPlot [32], based on the predicted values of the response variable. More detailed information on the statistical analysis procedure can be found in Additional file 2.

Continue reading here:

The impact of COVID-19 lockdown on physical activity and sedentary behaviour in secondary school teachers: a ... - BMC Public Health

WASHINGTON The Select Subcommittee on the Coronavirus Pandemic held a hearing titled A Hearing with Dr. Anthony Fauci. This hearing is the first time Dr. Fauci has testified publicly since retiring from public service. Earlier this year, Dr. Fauci appeared in front of the Select Subcommittee for a closed-door, two-day, 14-hour transcribed interview where he testified to serious failures in Americas public health system. During Dr. Faucis public hearing, he confirmed previous, concerning testimony and refused to take responsibility for the actions of his office. Members questioned Dr. Fauci about his facilitation and promotion of a singular COVID-19 narrative, his clearly misleading statements before Congress and the public, and his gross mismanagement of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Fauci reaffirmed shocking testimony that the six feet apart social distancing recommendation that he promoted was arbitrary, not based on science, and sort of just appeared. Conclusively, the Select Subcommittee held Dr. Fauci publicly accountable for pandemic-era failures.

Key Hearing Takeaways

Member Highlights

Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio), D.P.M, pushed Dr. Fauci to acknowledge that he agreed with every travel restriction issued by the Trump Administration at the height of the COVID-19 pandemic. Dr. Fauci testified during his transcribed interview that he unequivocally agreed with President Trumps decision to restrict travel from China, the EU, and the UK.

Chairman Wenstrup: Science is always open to debate, and its a benefit. The science supported restricting travel from certain countries at the beginning of the pandemic. And after these orders went into effect, the president was called racist and xenophobic. Dr. Fauci, you said in your transcribed interview that you supported those orders. Dr. Fauci, were those orders racist and xenophobic?

Dr. Fauci: No, they were not.

Committee on Oversight and Accountability Chairman James Comer (R-Ky.) confirmed that Dr. Faucis Senior Advisor repeatedly violated NIH policies by forwarding official information to his private email account and backchanneling confidential information to disgraced grant recipient EcoHealth. Dr. Fauci was either incompetent as to what was happening directly under his nose at the NIH or he condoned the misconduct.

Chairman Comer: Theres a troubling pattern of behavior from your inner circle, not just Dr. Morens, but also your chief of staff, Mr. Folkers. Do you agree that it violates NIAID policy to use personal email for official purposes?

Dr. Fauci: The Dr. Morens issue that was discussed by this committee violates NIH policy. Yes.

Chairman Comer: Okay. On April 28, 2020, Dr. Morens edited an EcoHealth press release regarding the grant termination. Does that violate policy?

Dr. Fauci: That was inappropriate for him to be doing that for a grantee, as a conflict of interest, among other things.

Chairman Comer: So on March 29, 2021, Dr. Morens edited a letter that Dr. Daszak was sending to NIH. Does that violate policy?

Dr. Fauci: Yes, it does.

Chairman Comer: On October 25th, 2021, Dr. Morens provided Dr. Daszak with advice regarding how to mislead NIH on EcoHealths late progress report. Does that violate policy?

Dr. Fauci: That was wrong and inappropriate and violated policy.

Chairman Comer: On December 7th, 2021, Dr. Morens wrote to the Chair of EcoHealths Board of Directors to put in a word for Dr. Daszak. Does that violate policy?

Dr. Fauci: He should not have done that. That was wrong.

Rep. Rich McCormick (R-Ga.), M.D., held Dr. Fauci accountable for promoting unscientific vaccine mandates from his position of power at the White House. Contrary to what was promised, the COVID-19 vaccine did not stop the spread or transmission of the virus.

Rep. McCormick: You said in an interview that you gave us part of an audio book, written by Michael Specter, that you believed an institution should make it hard for people to live their lives so theyd feel pressured to get vaccinated. Can we run the audio clip on that, please?

Clip of Dr. Fauci, Summer 2021: I have to say that I dont see a big solution, other than some sort of mandatory vaccination. I know federal officials dont like to use that term. Once people feel empowered and protected legally, youre going to have schools, universities, and colleges are going to say, you want to come to this college buddy, youre going to get vaccinated. Lady, youre going to get vaccinated. Yeah, big corporations, like Amazon and Facebook and all of those others, are going to say you want to work for us, you get vaccinated. And its been proven that when you make it difficult for people in their lives, they lose their ideological bullshit and they get vaccinated.

Rep. McCormick: Thank you. Are all objections to COVID vaccinations ideological bullshit, Dr. Fauci?

Dr. Fauci: No, theyre not. And thats not what I was referring to.

Rep. McCormick: Well, in reference to making it hard for people to get education, traveling, working, Id say it very much was in context. And I take great offenseI think Americans take great offense to this. Thats exactly what you meant when you said making it hard for people to live without getting a vaccination. You affected peoples ability to work, travel, be educated, to actually flourish in America, to self-determine, as were all given God given rights. Shame on you. Dr. Fauci, you become Dr. Fear. Americans do not hate science. I dont hate science. The American people hate having their freedoms taken from them. You inspired and created fear through mask mandates, school closures, vaccine mandates that have destroyed the American peoples trust in our public health institutions. This fear you created will continue to have ripple effects over generations to come. You have already seen its effects in education, in the economy, and everything else. Quite frankly, you said if you disagree with me, you disagree with science. Dr. Fauci, I disagree with you because I disagree with fear.

Rep. John Joyce (R-Pa.), M.D., reaffirmed that the six feet apart social distancing guidance promoted by Dr. Fauci and his team was not based on science. Dr. Fauci attempted to evade accountability for his part in promoting this harmful narrative by blaming the Centers for Disease Control and Prevention (CDC).

Rep. Joyce: What was your relationship with the CDC when you saw a regulation, which was not based in the current science?

Dr. Fauci: Well, when I say was not based in science, I meant a prospective clinical trial to determine whether six foot was better than three, was better than 10.

Rep. Joyce: But once we realized that the virus was not spread by droplets, and was aerosolized, did you feel an indication to go back to the CDC and say, lets base this on science. Lets get rid of this six foot rule. This six foot rule crippled businesses, it allowed students to stay at home and not learn. Americans suffered, and that suffering continues because the fracture of trust in American scientists continues to this day.

Judiciary Committee Chairman Jim Jordan (R-Ohio) questioned Dr. Fauci on the Biden Administrations efforts to censor dissenting information on social media about the origins of COVID-19. Evidence uncovered by the Judiciary Committee suggests that Facebook felt pressure from the Biden Administration to downplay the lab leak theory.

Rep. Jordan: In our study on the censorship of the Biden Administration working with big tech, I want to read you a WhatsApp message from Mark Zuckerberg: Can we include that the White House put pressure on us to censor the lab leak theory. So, this is a communication on July 16th, 2021, Nick Clegg, Joel Kaplan, Sheryl Sandberg, Mark Zuckerberg. Theyre certainly feeling the pressure to downplay any lab leak theory and go with the natural origin theory.

Dr. Fauci: Is there a question there?

Rep. Jordan: Theres one coming. Heres another email to Mark Zuckerberg. It says subject line COVID Misinformation Wuhan lab leak theory. In response to continued public pressure and tense conversations with the new Administration, we started removing five COVID claims, including the lab leak theory. Mr. Zuckerberg responds, This seems like a good reminder that when we compromise our standards due to pressure from an administration, in either direction, we often later regret it. Why was it so important the virus not have started in a lab?

Dr. Fauci: It wasnt so important that the virus, not, we dont know.

Rep. Jordan: Well it was important to someone in the Biden Administration. So much so that the top people at Meta, the top people at Facebook are asking, why are we getting all this pressure to downplay the lab leak theory? And we have an email from June of the same year, June 4th, 2021, saying the same thing. It was certainly important to somebodyIm asking you because youre the expert on the coronavirus. Im saying why was the Administration pushing not to have the lab leak theory as something that was viable?

Dr. Fauci: I cant answer that. Ive kept an open mind throughout the entire

Rep. Jordan: Youve kept an open mind, Dr. Fauci, open mind?

Rep. Michael Cloud (R-Texas) confirmed that Dr. Fauci sent taxpayer dollars to dangerous biolabs in Wuhan, China without reading or sufficiently reviewing the grant proposals. Dr. Fauci simply signed off on every grant that was placed on his desk.

Rep. Cloud: My understanding from your testimony to us, it says that the NIH process for awarding grants is that, basically a research proposal goes to a peer review committee to receive a priority score. Then it goes to an advisory council for NIH personnel. It receives a final vote. Basically, the group votes on it, and then eventually it ends up on your desk for signature. Right? Now, you said in that that sometimes, if I recall correctly, those grants are often approved in block, in mass, when theyre voted on. And then you sign off on them.

Dr. Fauci: Thats correct.

Rep. Cloud: This is one of the things thats really troubling to the American people, because they look at their lives being destroyed, and there is no one to hold accountable because these systems of accountability have become systems of plausible deniability. And so your name is on every single grant, but yet, you absolve yourself of any sort of responsibility by saying, well, you know, it goes to this committee thats you know, that has a number of people on it. And theyre approved in block. And so theres no accountability for anything, any of the taxpayer dollars that are going forth.

Dr. Fauci: I disagree with you, Congressman, because if you look at the number of grants, we fund thousands of grants. It would be physically impossible for me to go through every single grant in a detailed way to understand that. That is true, not only for me, but for virtually every institute at the NIH.

Rep. Cloud: Then why does your signature go on it?

Dr. Fauci: Because somebody has to sign off on it and you trust the expertise, and the competence, of the staff that go over it

###

Read the original here:

Hearing Wrap Up: Dr. Fauci Held Publicly Accountable by Select Subcommittee - United States House Committee on ... - House Committee on Oversight and...

Credit: Shutterstock/BaLL LunLa

A conservative physician group may amend its lawsuit alleging that several US medical boards abused their certification monopolies to censor doctors questioning the safety of covid-19 vaccines and abortions, a federal appellate court has ruled.

Register to receive our newsletter and gain limited access to subscriber content.

Get news, unique commentary, expert analysis and essential resources from the Global Competition Review experts.

Continued here:

Fifth Circuit revives covid-19 and abortion censorship claims - Global Competition Review

Families like mine deserve more from our state leaders than platitudes and delayed, toothless studies. We deserve truth, transparency and real accountability.

Adi Talwar

In 2022, Gov. Kathy Hochul promised to bring out the good, the bad, and ugly about New Yorks COVID-19 response.However, four years after such excruciating and heartbreaking deaths, we are still waiting for any significant action in our home state as members of Congress in Washington, D.C. get ready to question former Gov. Andrew Cuomo about the states handling of COVID.

My mother passed away in a nursing home during COVIDand as a leader of Voices for Seniors, Ive spent the past four years working with family members who also lost loved ones in nursing homes and are desperate for accountability. New York must do better and create a truly independent commission, free from political biasto bring out the good, bad, and ugly truths, as we were promised.

In the early days of COVID, over 15,000 New Yorkers died in nursing homes. New Yorkers lost parents, grandparents and loved ones in overcrowded facilities, unable to visit their relatives in their last days. The extended lockdowns in nursing homes in itself is something that needs an investigation, as both the impact of severe isolation and the true death toll from COVID is yet unknown.

In the weeks and months that followed, numerous legitimate questions were raised about whether these deaths were preventable, and what role then-Gov. Cuomos nursing home order played in contributing to this tragic death toll. Why were nursing homes forced to accept COVID-positive patients? Why were so many seniors exposed to this virus, leading to dangerous outbreaks among an already vulnerable population? Why was this policy created? Did elected officials understand how the virus was transmitted in these settings? And did contagious disease experts sign off on this order?

New York must answer these questions in order to better prepare for future health crisesand we deserve a nonpartisan investigation that avoids the specter of political theater. What appears clear to many of us who have spent the past four years advocating for the truth is that politics infiltrated every aspect of the states COVID response, and may have led to unnecessary tragedies. The only way to avoid more partisan posturing is to create a truly independent, apolitical commission staffed with health and policy experts.

As of today, the only COVID review offered by Gov. Hochul is through a private consulting firm without subpoena power to interview policy makers or review critical documents. Additionally, this consulting firms study has been long-delayed. Rather than demonstrate a true commitment to finding the truth, this consulting firms overdue and inevitably incomplete study is merely another platitude offered to families in pain.

In Albany, legislators are pushing for a truly independent, bipartisan pandemic response commission, staffed with public health experts, and with full subpoena power to interview all relevant witnesses, gather documents, and access all relevant records. Additionally, this commission would have the power to hold public hearings, allowing COVID survivors and relatives to share their experiences and input.

The commission would use the information gathered to present concrete recommendations for state action to prevent similar tragedies and better prepare for future emergencies. And the commission would be working for the publicnot the governordelivering its findings and recommendations directly to New Yorkers.

Similar reviews have taken place after natural disasters and large-scale emergencies across the country, from the bipartisan 9/11 Commission to National Transportation Safety Board investigations. After 80,000 deaths in New York, one of the first epicenters of the COVID pandemic, there is no excuse for our state to drag its feet instead of taking immediate action.

After I lost my mother to COVID-19, I was desperate to know whether her death in a nursing home rehabilitation facility was avoidable. And after meeting so many families with stories like mine, I imagined the state leaders we elected would want to quickly find the truth for usno matter how ugly.

However, I never imagined four years later, I would still be calling for an honest and thorough investigation. Families like mine deserve more from our state leaders than platitudes and delayed, toothless studies. We deserve truth, transparency and real accountability.

Vivian Zayas is the co-founder of Voices for Seniors.

Follow this link:

Opinion: Pushing for Answers About New York's COVID Response - City Limits

An FDA advisory committee voted unanimously, 16-0, Wednesday to recommend that the COVID-19 vaccines for the 2024-2025 season target the JN.1 strain of the virus.

"From my review of the data, it appeared that the newer variants that are appearing -- KP.2, KP.3, and maybe some others that are coming up -- the potential for immunogenicity from a JN.1 vaccine to cover those variants seems to be pretty good," said Archana Chatterjee, MD, PhD, of Rosalind Franklin University of Medicine and Science in Chicago. "Antigenically they are close, and from the experience we had with [the] XBB [strain], it appears even with some variation, there's still reasonably good protection. So from that perspective, I would say that JN.1 is a reasonable strain to include."

Melinda Wharton, MD, MPH, of CDC's National Center for Immunization and Respiratory Diseases, agreed. "We can't predict which variants are going to emerge over the coming months," she said. "It may very well not be any of the ones that we're talking about today, but they're likely to be related to JN.1. So having a vaccine that's the trunk of the tree rather than the branches makes sense to me."

Chatterjee and Wharton were speaking during a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, where members were asked to specifically vote on whether they recommend a monovalent JN.1-lineage vaccine for the 2024-2025 formula. They were also asked to discuss considerations for the selection of a specific JN.1 lineage strain -- such as JN.1 or KP.2 -- for COVID-19 vaccines to be used in the U.S.

During the meeting, the committee heard presentations from representatives of three COVID-19 vaccine manufacturers: Moderna, Pfizer, and Novavax. Both Moderna and Pfizer representatives said they each had two mRNA vaccines in process -- one targeting the JN.1 variant and the other targeting the KP.2 variant. The Moderna spokesman said his company's vaccines would be ready for shipping in August, while the Pfizer representative said his firm's vaccines would be ready for shipping "immediately upon approval." All three company representatives said that their vaccines also were found to provide good coverage for other closely related subvariants.

The Novavax representative said his company had developed a single vaccine, for JN.1, on a protein-based platform, and that it would be ready for shipping in August. Several committee members said part of the reason they voted in favor of the JN.1 strain was to make sure that Novavax's vaccine was included so that patients could have a choice of vaccine type.

"Unless we have a compelling reason to do otherwise, given the limitations of Novavax, I think we do need to just recommend the JN.1 version," said Mark Sawyer, MD, professor of clinical pediatrics in the division of infectious diseases at the University of California San Diego. "Otherwise there are going to be equity issues or access issues to those who are reluctant to get an mRNA vaccine."

Adam Berger, PhD, division director of clinical and healthcare research policy at the NIH, said that although he agreed with recommending the JN.1 vaccine, he was uneasy about having any obligation to always include a protein-based option. "I'm concerned that it could end up putting us in a position in the future where, depending on what protein vaccines can be made from or made out of, that that will require us to go down this path," he said. "I'd like to make sure we don't get in that position in the future ... I think JN.1 is the right call, so that doesn't seem to be an issue, but I just want to point that out -- that could present some type of problem for us at some point."

The committee also heard from David Wentworth, PhD, chair of the WHO's Technical Advisory Group on COVID-19 Vaccine Composition, who reviewed his group's recommendation at its April meeting that future formulations of COVID-19 vaccines should aim to induce enhanced neutralizing antibody responses to JN.1 and its descendent lineages. That could include a monovalent JN.1 vaccine, although other formulations could be considered, he said.

An FDA briefing document released in advance of the meeting noted that "in prior years there appears to have been an inverse relationship between the time since vaccination and vaccine effectiveness, such that COVID-19 vaccine effectiveness against SARS-CoV-2 sublineages appears to wane over time and that better matching of the vaccine to circulating strains is associated with improved neutralizing antibody titers."

"Consistent with this observation, a decrease in effectiveness of COVID-19 vaccines (2023-2024 Formula) against COVID-19 caused by JN.1 lineage viruses has been reported," the authors wrote. "Available data suggest that updating the current formula of COVID-19 vaccines to more closely match currently circulating JN.1 lineage viruses is warranted for the anticipated 2024-2025 respiratory virus season in the U.S."

FDA officials will take the advisory panel's recommendation into account when it considers which updated vaccines to approve and/or authorize. The agency does not have to follow its advisory panels' recommendations, but often does. The CDC's Advisory Committee on Immunization Practices (ACIP) will also weigh in with recommendations on use of the vaccines.

The FDA advisory committee meeting comes at a time when vaccine uptake is low. As of May 11 -- the latest date for which figures were available -- 22.5% of adults reported receiving an updated COVID vaccine since mid-September 2023, and 14.4% of children ages 6 months to 17 years were reportedly up to date on their COVID shots, according to the CDC.

Joyce Frieden oversees MedPage Todays Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow

See original here:

FDA Advisors Give a Hearty Thumbs Up to a COVID Vaccine Based on the JN.1 Strain - Medpage Today

(Precision Vaccinations News)

The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted today to recommend that COVID-19 vaccines be updated to a monovalent JN.1-lineage composition for 2024-2025 and expressed a preference for the JN.1 strain.

As of June 5, 2024, Novavax Inc. stated in a press release that, pending authorization, it expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September 2024.

Novavaxs JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for various JN.1 descendant viruses, including KP.2 and KP.3.

'We believe updating to the JN.1 lineage or JN.1, as recommended by theWorld Health Organizationand the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19,' wrote the company.

'Our most recent nonclinical data have demonstrated that our JN.1 vaccine candidate induces broad neutralization responses to JN.1 lineage viruses including those with theF456Lmutation (e.g., JN.1.16), theR346Tmutation (e.g., JN.1.13.1), to FLiRT variants that contain both mutations such as KP.2, currently the most common circulating variant in the U.S., and to FLuQE variants that are increasing in circulation (e.g., KP.3).'

'Our JN.1 vaccine candidate also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants, including those containing theF456L,R346T, andFLiRTmutations (e.g., KP.2).'

'These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including circulating forward drift variants.'

Based on data presented by vaccine manufacturers today, the VRBPACacknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains and the need to minimize confusion in making public health recommendations.

As of June 2024, Novavax's vaccine is the only protein-based, non-mRNA vaccine available in the U.S. Novavax vaccines have been offered by most pharmacies in the U.S.

Read the original post:

JN.1 Protein-based Non-mRNA COVID-19 Vaccine Prepares for September Delivery - Precision Vaccinations

People do not need to have tested positive for the coronavirus to be considered for a diagnosis of long COVID, a new report from the National Academies of Sciences, Engineering and Medicine concludes.

The report, produced by a committee of experts at the request of the U.S. Social Security Administration, aims to summarize what is known about long COVID, a complex condition that was estimated to affect more than 9 million people in the United States in 2022.

Among its conclusions: Because testing has not always been available to people with COVID-19 and because some who tested themselves at home never reported the results to healthcare systems many who were infected never received formal documentation of their illness.

Some long COVID cases have arisen from the early days of the epidemic, before testing was even generally available, said Dr. Paul Volberding, professor emeritus of medicine at the University of California San Francisco, who served as chair of the committee. As the pandemic has evolved, some people live in areas where they might not have easy access to tests.

The report concluded that sole reliance on a documented history of SARS-CoV-2 infection when diagnosing long COVID will miss these individuals, so symptoms and self-reported prior infection are generally sufficient to establish that someone has been infected. As it stands, no diagnostic test for long COVID is available.

See more here:

Report: Positive COVID test not needed for Long COVID diagnosis - Los Angeles Times

Specialty

Please choose I'm not a medical professional. Allergy and Immunology Anatomy Anesthesiology Biostatistics Cardiac/Thoracic/Vascular Surgery Cardiology Critical Care Dentistry Dermatology Diabetes and Endocrinology Emergency Medicine Epidemiology and Public Health Family Medicine Forensic Medicine Gastroenterology General Practice Genetics Geriatrics Health Policy Hematology HIV/AIDS Hospital-based Medicine I'm not a medical professional. Infectious Disease Integrative/Complementary Medicine Internal Medicine Internal Medicine-Pediatrics Medical Education and Simulation Medical Physics Medical Student Nephrology Neurological Surgery Neurology Nuclear Medicine Nutrition Obstetrics and Gynecology Occupational Health Oncology Ophthalmology Optometry Oral Medicine Orthopaedics Osteopathic Medicine Otolaryngology Pain Management Palliative Care Pathology Pediatrics Pediatric Surgery Pharmacology Physical Medicine and Rehabilitation Plastic Surgery Podiatry Preventive Medicine Psychiatry Psychology Pulmonology Radiation Oncology Radiology Rheumatology Substance Use and Addiction Surgery Therapeutics Trauma Urology Miscellaneous

Read more:

Effects of Viral Infections Like COVID-19 on Head and Neck Cancers: The Role of Neutrophil-Lymphocyte Counts and ... - Cureus

Todays hearing is Dr. Faucis first public testimony since retiring from federal service

WASHINGTON Today, Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio) delivered opening remarks at A Hearing with Dr. Anthony Fauci. Chairman Wenstrup explained how Dr. Faucis divisive rhetoric during the COVID-19 pandemic silenced dissenting opinions and shamed Americans into compliance with coercive mandates, unnecessary masking, and egregious vaccine requirements. Evidence uncovered during the Select Subcommittees two-day, 14-hour transcribed interview with Dr. Fauci proves that the six feet apart social distancing guidance sort of just appeared and was not sufficiently based on science. The results of this guidance were catastrophic and resulted in the closure of small business and schools across the United States. The Chairman noted that many of these pandemic-era policies forced on Americans by Dr. Fauci and his team were, in fact, not based on the science Dr. Fauci claimed to represent. Further, under Dr. Faucis leadership at the National Institute of Allergy and Infectious Diseases (NIAID), both his Senior Advisor and Chief of Staff likely attempted to break federal law. The Select Subcommittee is thoroughly investigating this misconduct and will hold Dr. Fauci accountable for any involvement. Chairman Wenstrup concluded his opening statement by noting that todays hearing with Dr. Fauci seeks to ensure that federal public health institutions and leaders once again become accountable to the American people.

Below are Select Subcommittee Chairman Wenstrups remarks as prepared for delivery:

Good morning, and welcome Dr. Fauci.

First, I want to thank you for decades of public service. You served your country through multiple epidemics, pandemics, and health crisis.

Regardless of any disagreements we may have, you chose to serve and I want to extend our appreciation and gratitude.

I also want to thank you for your willing cooperation with the Select Subcommittee.

You have voluntarily sat for more than 14 hours of testimony and are appearing voluntarily today. This is more than we can say about other witnesses we have called, and we appreciate it.

Dr. Fauci, we are here to investigate the COVID-19 pandemic and to explore lessons learned positive or negative and to better prepare for future pandemics.

Simply put, America cannot move forward without first looking back.

We must know what went right and what went wrong in order to best ingrain proficiencies and remedy deficiencies.

In 15 months, the Select Subcommittee has sent more than 115 investigative letters, conducted 30 transcribed interviewsresulting in hundreds of hours of testimony, heldincluding today27 hearings or briefings, and reviewed more than one and half million pages of documents.

We arent throwing the baby out with the bathwater, that is not the intent. We are following the facts and holding wrongdoers accountable.

Beginning early in 2020, you became the figurehead of public health.

There were drinks named after you, you got bobbleheads made in your likeness, were on the cover of Vogue, and threw out the first pitch at a Washington Nationals game.

Almost overnight, you became a celebrity and a household name, in addition to being a public health official.

Americans from coast to coast and beyond listened to your words. And this is where we could have done betterthis goes to both sides of the aisle.

We should have been more precise.

We should have used the words we meant.

We should have used words and phrases that are accurate and not misleading.

And we should have been honestespecially about what we didnt know.

Dr. Fauci, I am not a virologist. But I am a physician and like most physicians we are constantly learning. Which is why we do continuing medical education and we always seek new information.

We learn new things based on new data. And we want to give our patients the best possible care based on new findings and improvements in science.

At a time when you were prompting the Proximal Origin Paper whose focus was to disprove the lab leak theory, I was in lockdown researching with another physician to try to understand the pathology, the affected physiology and what treatments worked.

He even made a phone call to identify an infectious disease doctor in China.

As well, during that time, we discovered the Baric Shi 2015 article on creating a chimera using gain of function type technology.

While policy decisions should have been based on scientific data, some, frankly, were not.

The burdensome 6-foot social distancing rule, did not have sufficient scientific support.

In your words, it sort of just appeared.

Even Dr. Collins said he still hasnt seen any empirical evidence to support this rule.

A rule that shut down schools and businesses. A rule that will have negative ramifications for decades.

As the pandemic wore on, more mandates also just sort of appeared, but the American public didnt get to see the scientific data to support these mandates.

Americans were aggressively bullied, shamed and silenced for merely questioning or debating issues such as social distancing, masks, vaccines, or the origins of COVID.

Many Americans were willing to comply with 15 days to slow the spread, and understood the necessity of banning travel from certain countries in an attempt to slow the virus. But many Americans became very frustrated when components of those 15 days stretched into years.

And it should not have been the case that Americans were forced to comply with oppressive mandates, when those who chose to illegally cross over our southern border were not.

Or when Governor Newsome or Whitmer were throwing parties at lavash restaurants. Not a good look.

Americans do not hate science. But Americans know hypocrisy when they see it.

Under your leadership, the United States health agencies adopted specific policy aims as a single dogmatic truth, without the benefit of debate. Out of desire for a single narrative.

Dr. Fauci, you once said, If you disagree with me you disagree with science.

Science doesnt belong to any one person.

I was never taught that science turns a blind eye to hypotheses. They serve to be proven or disproven. And done so with irrefutable facts.

It was interesting that you chose not to pursue an aggressive and transparent scientific investigation of both natural spillover and lab leak. We have been investigating both hypotheses.

You testified before the Select Subcommittee in your transcribed interview that the lab leak theory was not a conspiracy theory.

You embraced the Proximal Origin letterit wasnt necessarily a full peer reviewed research paperand shared it with the public from the White House lawn. You stated during your transcribed interview that you did not review published articles that considered a potential lab leak of COVID-19.

This is especially concerning if the works in question were conducted at a more risky and less safe BSL-2 lab.

Nevertheless, any dissent from your chosen scientific position was immediately labelled as anti-science. Anything less than complete submission to the mandates could cost you your livelihood, your ability to go into public, your childs ability to attend school.

Families were thrown off planes and shamed when their two-year-olds struggled to wear a mask.

Children with disabilities lost access to therapy that they, and their families, depended on.

Students were out of the classroom and told to attend school remotely. Even when the science clearly demonstrated it was safe for them to be back in the classroom.

This harmed low-income students the most. And how were single parent households supposed to teach their own children and work at the same time?

Dr.Fauci, you oversaw one of the most invasive regimes of domestic policy the U.S. has ever seen, including mask mandates, school closures, coerced vaccination, social distancing, and more.

We have learned many lessons. Our early fear and confusion was understandable. COVID-19 was clearly novel.

Under your leadership, NIAID allowed disgraced characters like Dr. Peter Daszak to use millions in taxpayer dollars to conduct risky gain of function experiments in Wuhan, China.

The actions of EcoHealth and Dr. Daszak call into question the integrity of NIAIDs policies and procedures as a whole, as well as your role as NIAIDs Director. You did sign off on his research grant.

We need to know why Dr. David Morensyour direct report for more than two decadesassisted Dr. Daszak in avoiding oversight and scrutiny and said that you were involved.

Your senior advisor, and seemingly, your chief of staff, repeatedly attempted to evade transparency laws to shield information from public scrutiny.

We have senior officials from your office in their own writing, discussing breaking federal law, deleting official records, and sharing private government information with grant recipients.

The office you directed, and those serving under your leadership, chose to flout the law. And bragged about it. Why did you allow your office to be unaccountable to the American people?

You were the highest paid person in the government. This makes you more accountable to the people, not less.

Dr. Fauci, whether intentional or not, you became so powerful that any disagreements the public had with you were forbidden and censored on social and most legacy media.

This is why so many Americans were so angrybecause this was fundamentally un-American.

If I make a mistake, I answer to the people of Ohio and my own conscience. When you, or your agency, made mistakes, Dr. Fauci, what happened? We all need to be held accountable.

Sometimes, it is as simple as saying, We were wong.

You took the position that you presented the science; your words came across as final and as infallible in matters pertaining to the pandemic.

But such rigid demands of an ideologically diverse people shattered public trust in American health institutions.

Because I said so has never been good enough for Americans, and it never will be.

It is built into the American spirit we have a thirst for information. A drive for advancement.

Americans were first in flight. Weve landed on the moon. Weve cured diseases. And made innumerable discoveries and explorations that forever changed humanity.

Americans do not want to be indoctrinated. They do want to be educated. And they prefer to make their health decisions in conjunction with the doctor that they know and trust.

To be successful, our federal public health institutions must be accountable to the people again.

To be successful, our health organizations must do what they are supposed to do: protect Americans.

I look forward to a robust and on-topic discussion. Thank you.

###

Excerpt from:

Chairman Wenstrup Opens Hearing with Dr. Anthony Fauci - United States House Committee on Oversight and ... - House Committee on Oversight and Reform...

A first-of-its kind brain organoid grown at The University of Queensland has helped researchers identify therapies that reduce the impact of COVID-19 on people with Down syndrome.

Australian Institute for Bioengineering and Nanotechnology (AIBN) Senior Research Fellow Dr Mohammed Shaker and organoid expert Professor Ernst Wolvetang worked with a team to develop a synthetic organoid that mirrors the brain of a person with Down syndrome, to explore why people born with the genetic condition are more vulnerable to the coronavirus.

The risk of hospitalisation and death from coronavirus is much higher for people with Down syndrome, but until now there has been no clear data that explains why, Dr Shaker said.

Thankfully, our lab-grown organoids allow us to unlock this information and find ways to address the problem.

Organoids are tiny, synthetic organ replicas grown from human stem cells that researchers use to carry out experiments that would be ethically and practically difficult in live subjects.

The team grew Down syndrome brain models and encased them in a layer of specialised cells known as the choroid plexus, effectively creating an organoid with two functional brain domains for the first time.

Testing on the new organoid models revealed that certain components of the choroid plexus are underdeveloped in people born with Down syndrome.

The barrier function of the choroid plexus prevents coronavirus from infecting brain cells, and this barrier is compromised in people with Down syndrome, Professor Wolvetang said.

It means a crucial line of defence is missing and explains why patients in this cohort experience more severe COVID-19 symptoms.

The lab used the organoids to screen drug therapies that could compensate for this vulnerability, including the US Food and Drug Administration approved drugs Avoralstat, Camostat, Nafamostat, and Remdesivir.

Dr Shaker said it was clear that human brain organoid models could be important medical tools that offer unprecedented insights and potential drug screening for a range of conditions beyond Down syndrome and COVID-19.

"This work exemplifies how increasingly sophisticated human brain organoid models can be used to discover the cellular and molecular processes driving neurological diseases, he said.

It also shows that these organoids are crucial tools that allow us to evaluate the safety and efficacy of new therapeutics at scale."

Professor Wolvetang and Dr Shaker were assisted by AIBN colleagues Bahaa Al-mhanawi and Sean Morrison as well as Professor Alexander Khromykh, Dr Andrii Slonchak, and Julian Sng from the UQ School of Chemistry and Molecular Biosciences, and Professor Justin Cooper-White from the UQ School of Chemical Engineering.

The research was published in Science Advances.

AIBN Communications a.druce@uq.edu.au +61 447 305 979 communications@aibn.uq.edu.au

Read the original post:

Research to limit COVID-19 risk in people with Down syndrome - The University of Queensland