Category: Corona Virus Vaccine

Three years after being shelved, a human trial of a Queensland COVID-19 vaccine has shown it is safe and effective but it's unlikely to be used to tackle the coronavirus any time soon.

Rather, researchers from the University of Queensland (UQ) hope a re-engineered version will pave the way for the vaccine technology to be further developed for potential use against other life-threatening respiratory viruses, such as respiratory syncytial virus (RSV).

The preliminary results of UQ's second-generation COVID vaccine come three years after its original COVID shot was abandoned after patients falsely tested positive to HIV.

The trial for the updated vaccine, which involved 70 volunteers, compared UQ's re-engineered molecular clamp technology with the approved Novavax jab, which began rolling out in Australia in February last year.

UQ molecular virologist Keith Chappell, who co-invented the technology that underpins the vaccine, said the trial of the updated version dubbed Clamp2 showed it to be "functionally equivalent" with Novavax.

"There was no difference at all in safety," Dr Chappell said.

"And in terms of the neutralising immune response, it was comparable."

He said UQ's commercialisation company UniQuest had licensed the technology to start-up biopharmaceutical company ViceBio.

ViceBio, which was founded to develop UQ's patented molecular clamp, is expected to launch human trials next year of a combined vaccine against RSV and human metapneumovirus (HMPV).

"We're very excited," Dr Chappell said.

"They're taking the technology forward for pathogens that are of great concern. It's looking great."

The Coalition for Epidemic Preparedness Innovation (CEPI) last year committed up to $8.5 million to continue the development of Clamp2 for use in the global response to future pandemics.

CEPI strives towards vaccines being developed within 100 days of a new virus emerging a goal known as the 100 Days Mission.

"There's going to be more pandemics, that's a given," Dr Chappell said.

"Our goal over the next few years is to pressure test ourselves and hopefully get everything in place so that we can respond as quickly as possible."

UQ scientists are in discussions with CEPI about future research involving the molecular clamp.

"Our hope is that we'll be given a novel virus, one that's not a disease threat, and we'll run through the process in real time and see whether we can produce a vaccine at the end of that," Dr Chappell said.

"There are thousands and thousands of different viruses out there. There's a wealth of novel viruses we could use to put ourselves to the test."

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At this stage, ViceBio has no plans to turn Clamp2 into a COVID vaccine, despite the promising results of the proof-of-concept trial.

"Our view is that the COVID vaccines that are out there and available are effective and it's not the biggest priority to bring a new one to the market at this stage," Dr Chappell said.

In line with CEPI's equitable access policy, UQ has agreed that vaccine candidates produced in outbreak situations using the molecular clamp technology will be available to at-risk populations, including low and middle-income countries.

Participants in the proof-of-concept COVID vaccine trial will be monitored regularly for six months after receiving the jab.

The original UQ clamp technology contained two fragments of a protein found in HIV.

The fragments acted like a chemical bulldog clip, holding together an engineered version of the spike protein found on the surface of SARS-CoV-2, the virus that causes COVID-19.

That worked by allowing the immune system to recognise and attack the spike protein, producing protective antibodies.

Dr Chappell said Clamp2 used a different molecule in place of the HIV fragments, with none of the diagnostic interference of the abandoned COVID vaccine.

"The second-generation molecular clamp has taken us the last three years to develop but it's looking great," he said.

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Second-generation COVID-19 vaccine is safe and effective and could help pave the way to tackle RSV and HMPV - ABC News

WASHINGTONToday, the Financial Crimes Enforcement Network (FinCEN), in close coordination with the Internal Revenue Service Criminal Investigation (CI), issued an alert to financial institutions on fraud schemes related to the COVID-19 Employee Retention Credit (ERC). The alert provides an overview of typologies associated with ERC fraud and scams, highlights select red flags to assist financial institutions in identifying and reporting suspicious activity and reminds financial institutions of their reporting requirements under the Bank Secrecy Act (BSA).

It is unfortunate that while the COVID-19 pandemic is behind us, fraud related to COVID-19 relief programs, like the ERC, continues to occur at a concerning scale, said FinCEN Director Andrea Gacki. We are issuing this alert in partnership with CI to remind financial institutions that it is critical that they remain vigilant in identifying and reporting related suspicious activity and to protect businesses from being taken advantage of by fraudsters.

Tax credits like employee retention credits were meant to provide assistance to struggling business owners during the COVID-19 pandemic, but fraudsters, unfortunately, used the credits to line their own pockets, said CI Chief Jim Lee. We hope this alert will help financial institutions recognize financial patterns that indicate fraud and help us recover funds stolen from U.S. taxpayers.

The ERC was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act as a tax credit to encourage businesses to keep employees on payroll during the COVID-19 pandemic. CI has identified ongoing fraud and scams related to the ERC that, to date, have resulted in 323 investigations involving more than $2.8 billion of potentially fraudulent ERC claims throughout tax years 2020, 2021, 2022, and 2023. In response to the scope of the ERC fraud, in September 2023, the IRS announced an immediate moratorium through at least December 31, 2023, on processing new ERC claims in an effort to protect honest small business owners from scams.

The full notice is available online atFIN-2023-Alert007

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FinCEN Alert on COVID-19 Employee Retention Credit Fraud - FinCEN

Thanksgiving Holiday may further fuel the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) throughout the U.S. (Photo by Mario Tama/Getty Images) Getty Images

Once again the hashtag #CovidIsntOver is trending on social media like X (formerly known as Twitter) because, you know, Covid-19 is certainly not over. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread throughout much of the U.S. since thats what tends to happen when a country doesnt do a whole lot to prevent a virus from spreading. And over the week from November 4 through 11, Covid-19-related hospitalizations increased by 8.6%, according the latest data from the Centers for Disease Control and Prevention (CDC).

During that week, there were 16,239 such reported hospitalizations. If you look at the following map of the U.S. from the CDC, a number of counties are in orange, which means that they experienced a 20% or greater increase in hospitalizations during that week:

In that same time period, the numbers of Covid-19-related emergency room visits increased by 7.1% and Covid-19 related deaths by 9.1%. In addition, the percentage of Covid-19 that were positive bumped up by 0.1%. All of these number went in the wrong direction during that week and do not bode well for the Holiday season thats now upon us, assuming that you arent shaped like a ball and have spikes all over you.

Unfortunately, without any real national system in place for tracking new Covid-19 cases, the U.S. is sort of flying blind when it comes to SARS-CoV-2 activity. Since emergency room visits and hospitalizations tend to come at least a week or two after people have been infected, rises in such numbers mean that rises in SARS-CoV-2 activity probably occurred two or maybe even three or four weeks prior. And its a whole lot harder to prevent an upswing that has already been occurring after the fact, assuming that you dont have a DeLorean car that serves as a time machine. Basing Covid-19 prevention policies on hospitalizations and deaths alone would be sort of like showing people a burnt down house and saying, Do you think that we need to install some fire extinguishers in this house?

All of these numbers shouldnt be super-surprising since the past three Novembers since 2020 had all seen rises in Covid-19 cases. The arrival of colder and drier weather in the late Fall and Winter could further facilitate SARS-CoV-2 transmission. Moreover, with more and more activities moving indoors, more and more people could be interacting in closer and closer quarters, sharing their small talk, respiratory droplets and viruses. Plus, all the travel occurring from the Thanksgiving Holidays through New Years Day could be giving viruses free tickets to travel all over the country.

Now, its not as if the U.S. cant do anything to reduce the spread and impact of the SARS-CoV-2. Scientific studies have shown that wearing face masks while in crowded indoor settings can reduce the transmission of SARS-CoV-2, as Ive covered for Forbes. Yet, posts on social media with the #CovidIsntOver hashtag have been pointing out how those wearing face masks have been feeling more and more like lone maskers:

The CDC has pointed out how improving air purification and ventilation can reduce the risk of COVID-19 as well:

Yet, its not clear how many businesses and other organizations are currently taking such steps to clear the air.

Then theres been the problems with the roll-out of the updated Covid-19 vaccine this Fall, the one that is targeted towards the more recent XBB Omicron subvariant. Only about 14.8% of all adults in the U.S. have gotten this updated Covid-19 vaccine so far, as I covered for Forbes last week. Therefore, many people may be running around with fairly low or even absent protections against Covid-19.

Therefore, if you want to reduce your risk of getting Covid-19 and long Covid or passing the virus along to others, you may be kind of on your own. Thats because the answer to the question, What is the U.S. collectively doing to prevent yet another Covid-19 surge this November and December is probably not a whole lot.

I am a writer, journalist, professor, systems modeler, computational, AI, and digital health expert, medical doctor, avocado-eater, and entrepreneur, not always in that order. Currently, I am a Professor of Health Policy and Management at the City University of New York (CUNY) School of Public Health, Executive Director of PHICOR (@PHICORteam) and Center for Advanced Technology and Communication in Health (CATCH), and founder and CEO of Symsilico. My previous positions include serving as Professor By Courtesy at the Johns Hopkins Carey Business School, Executive Director of the Global Obesity Prevention Center (GOPC) at Johns Hopkins University, Associate Professor of International Health at the Johns Hopkins Bloomberg School of Public Health, Associate Professor of Medicine and Biomedical Informatics at the University of Pittsburgh, and Senior Manager at Quintiles Transnational, working in biotechnology equity research at Montgomery Securities, and co-founding a biotechnology/bioinformatics company. My work has included developing computer approaches, models, and tools to help health and healthcare decision makers in all continents (except for Antarctica). This has included serving as the Principal Investigator of over $60 million in research grants from a wide variety of sponsors such as the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), National Science Foundation (NSF), the Centers for Disease Control and Prevention (CDC), UNICEF, USAID, the Bill and Melinda Gates Foundation, and the Global Fund. I have authored over 250 scientific publications and three books. In addition to covering health, healthcare, and science for Forbes, I maintain a blog "A Funny Bone to Pick" for Psychology Today, a Substack entitled "Minded by Science"and have written articles forThe New York Times, Time, The Guardian, The HuffPost, STAT, the MIT Technology Review and others. My work and expertise have appeared in leading media outlets such as The New York Times, ABC, USA Today, Good Morning America, Tamron Hall Show, BBC, The Los Angeles Times, Newsweek, CBS News, Businessweek, U.S. News and World Report, Bloomberg News, Reuters, National Public Radio (NPR), National Geographic, MSN, and PBS. Follow me on Twitter (@bruce_y_lee) but dont ask me if I know martial arts.

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#CovidIsntOver Trends As Covid-19 Hospitalizations Rise By 8.6% - Forbes

Yin, Z. et al. Invasive pneumococcal disease among HIV-positive individuals, 20002009. AIDS Lond. Engl. 26, 8794 (2012).

Article Google Scholar

Thio, C. L. et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort study (MACS). Lancet Lond. Engl. 360, 19211926 (2002).

Article Google Scholar

Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: Recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2022. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf

Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Interim Clin. Consid. Use COVID-19 Vaccines Curr. Approv. Auth. U. S. 2023. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html

Jensen, C. P. R., Warshawsky, B., Krishnan, R., Wong, E., Zafack, J., Salvadori, M. I., Forbes, N., Abrams, E., Young, K., Tunis, M. C., Wilson, S., Harrison, R., Deeks, S. & On behalf of the National Advisory Committee on Immunization (NACI). COVID-19 vaccines: Canadian Immunization Guide 2023. (accessed Nov 1 2023) https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#a6.4

Coburn, S. B. et al. Analysis of post-vaccination breakthrough COVID-19 infections among adults with HIV in the United States. JAMA Netw Open. 5, e2215934 (2022).

Article PubMed PubMed Central Google Scholar

Jones, D. L. et al. Severe acute respiratory syndrome Coronavirus 2: Vaccine hesitancy among underrepresented racial and ethnic groups with HIV in Miami, Florida. Open Forum Infect Dis. 8, 154 (2021).

Article Google Scholar

Jaiswal, J. et al. SARS-CoV-2 vaccination hesitancy and behaviors in a national sample of people living with HIV. AIDS Patient Care STDs 36, 3444 (2022).

Article PubMed Google Scholar

Costiniuk, C. T. et al. Understanding COVID-19 vaccine confidence in people living with HIV: A pan-Canadian Survey. AIDS Behav. https://doi.org/10.1007/s10461-023-03991-8 (2023).

Article PubMed PubMed Central Google Scholar

Callender, D. Vaccine hesitancy: More than a movement. Hum. Vaccines Immunother. 12, 24642468 (2016).

Article Google Scholar

MacDonald, N. E. Vaccine hesitancy: Definition, scope and determinants. Vaccine 33, 41614164 (2015).

Article PubMed Google Scholar

Gagneux-Brunon, A., Fresard, A., Lucht, F. & Botelho-Nevers, E. Vaccine coverage in PLWH: Disparities and potential impact of vaccine hesitancy. Hum Vaccines Immunother. 15, 305306 (2019).

Article Google Scholar

Rodriguez, V. J. et al. Psychometric properties of a vaccine hesitancy scale adapted for COVID-19 vaccination among people with HIV. AIDS Behav. https://doi.org/10.1007/s10461-021-03350-5 (2021).

Article PubMed PubMed Central Google Scholar

Czajka, H. et al. Who or what influences the individuals decision-making process regarding vaccinations?. Int. J .Environ. Res. Public Health 17, E4461 (2020).

Article Google Scholar

Salmon, D. A., Dudley, M. Z., Glanz, J. M. & Omer, S. B. Vaccine hesitancy. Am. J .Prev. Med. 49, S391S398 (2015).

Article PubMed Google Scholar

McKee, C. & Bohannon, K. Exploring the reasons behind parental refusal of vaccines. J. Pediatr. Pharmacol. Ther. 21, 104109 (2016).

PubMed PubMed Central Google Scholar

Gallagher, K. M., Juhasz, M., Harris, N. S. & Teshale, E. H. Predictors of influenza vaccination in HIV-infected patients in the United States, 19902002. J. Infect Dis. 196, 339346 (2007).

Article PubMed Google Scholar

Boey, L. et al. Vaccination coverage of recommended vaccines and determinants of vaccination in at-risk groups. Hum. Vaccines Immunother. 16, 21362143 (2020).

Article Google Scholar

Valour, F. et al. Vaccination coverage against hepatitis A and B viruses, Streptococcus pneumoniae, seasonal flu, and A(H1N1)2009 pandemic influenza in HIV-infected patients. Vaccine 32, 45584564 (2014).

Article PubMed Google Scholar

Harrison, N. et al. Predictors for and coverage of influenza vaccination among HIV-positive patients: a cross-sectional survey. HIV Med. 18, 500506 (2017).

Article CAS PubMed Google Scholar

Cotte, L. et al. Factors associated with pandemic influenza A/H1N1 vaccine coverage in a French cohort of HIV-infected patients. Vaccine 29, 56385644 (2011).

Article CAS PubMed Google Scholar

Menza, T. W., Capizzi, J., Zlot, A. I., Barber, M. & Bush, L. COVID-19 vaccine uptake among people living with HIV. AIDS Behav. 26, 2224228 (2022).

Article PubMed PubMed Central Google Scholar

Biswas, N., Mustapha, T., Khubchandani, J. & Price, J. H. The nature and extent of COVID-19 vaccination hesitancy in healthcare workers. J. Community Health 46, 12441251 (2021).

Article PubMed PubMed Central Google Scholar

Hudson, A. & Montelpare, W. J. Predictors of vaccine hesitancy: Implications for COVID-19 public health messaging. Int. J. Environ. Res. Public Health 18, 8054 (2021).

Article CAS PubMed PubMed Central Google Scholar

Martins, S. et al. Vaccination coverage and immunity against hepatitis B among HIV-infected patients in South Brazil. Braz. J. Infect. Dis. 19, 181186 (2015).

Article PubMed PubMed Central Google Scholar

Kim, C., Aminawung, J. A., Brinkley-Rubinstein, L., Wang, E. A. & Puglisi, L. B. COVID-19 vaccine deliberation in individuals directly impacted by incarceration. Vaccine 41, 34753480 (2023).

Article CAS PubMed PubMed Central Google Scholar

Tsachouridou, O. et al. Factors associated with poor adherence to vaccination against hepatitis viruses, streptococcus pneumoniae and seasonal influenza in HIV-infected adults. Hum. Vaccines Immunother. 15, 295304 (2019).

Article Google Scholar

Pinto Neto, L. F. D. S., Vieira, J. V. & Ronchi, N. R. Vaccination coverage in a cohort of HIV-infected patients receiving care at an AIDS outpatient clinic in Esprito Santo, Brazil. Braz. J. Infect. Dis. 21, 5159 (2017).

Article PubMed PubMed Central Google Scholar

Althoff, K. N. et al. Predictors of reported influenza vaccination in HIV-infected women in the United States, 20062007 and 20072008 seasons. Prev. Med. 50, 223229 (2010).

Article PubMed PubMed Central Google Scholar

Durham, M. D. et al. Rates and correlates of influenza vaccination among HIV-infected adults in the HIV outpatient study (HOPS), USA, 19992008. Prev. Med. 53, 8994 (2011).

Article PubMed Google Scholar

Drewes, J., Langer, P. C., Ebert, J., Kleiber, D. & Gusy, B. Sociodemographic, HIV-related characteristics, and health care factors as predictors of self-reported vaccination coverage in a nationwide sample of people aging with HIV in Germany. Int. J. Environ. Res. Public Health 18, 4901 (2021).

Article CAS PubMed PubMed Central Google Scholar

Hanhoff, N., Vu, Q., Lang, R. & Gill, M. J. Impact of three decades of antiretroviral therapy in a longitudinal population cohort study. Antivir. Ther. 24, 153165 (2019).

Article CAS PubMed Google Scholar

Chambers, C. et al. Coronavirus disease 2019 vaccine effectiveness among a population-based cohort of people living with HIV. AIDS 36, F17F26 (2022).

Article CAS PubMed Google Scholar

Lang, R. et al. Analysis of severe illness after postvaccination COVID-19 breakthrough among adults with and without HIV in the US. JAMA Netw Open 5, e2236397 (2022).

Article PubMed PubMed Central Google Scholar

Bogart, L. M. et al. COVID-19 related medical mistrust, health impacts, and potential vaccine hesitancy among black Americans living with HIV. JAIDS J. Acquir. Immune Defic. Syndr. 86, 200207 (2021).

Article CAS PubMed Google Scholar

Valle, A., Fourn, E., Majerholc, C., Touche, P. & Zucman, D. COVID-19 vaccine hesitancy among French people living with HIV. Vaccines 9, 302 (2021).

Article PubMed PubMed Central Google Scholar

Stephenson, R., Sullivan, S. P., Pitter, R. A., Hunter, A. S. & Chavanduka, T. M. COVID-19 pandemic optimism and vaccine willingness among an online sample of US gay, bisexual, and other men who have sex with men. Vaccines 9, 745 (2021).

Article CAS PubMed PubMed Central Google Scholar

Ulloa, A. C., Buchan, S. A., Daneman, N. & Brown, K. A. Estimates of SARS-CoV-2 omicron variant severity in Ontario, Canada. JAMA 327, 12861288 (2022).

Article CAS PubMed PubMed Central Google Scholar

COVID-19 Alberta statistics. COVID-19 Alta. Stat. 2023. https://www.alberta.ca/stats/covid-19-alberta-statistics.htm

Public Health Agency of Canada. COVID-19 vaccine uptake and intent: Canadian Community Health Survey (CCHS) insight. 2023. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/covid-19-vaccine-uptake-intent-canadian-community-health-survey.html#a7

Centers for Disease Control and Prevention. CDC HIV Prevention Progress Report. 2019. https://www.cdc.gov/hiv/pdf/policies/progressreports/cdc-hiv-preventionprogressreport.pdf

Benham, J. L. et al. COVID-19 vaccine-related attitudes and beliefs in Canada: National cross-sectional survey and cluster analysis. JMIR Public Health Surveill. 7, e30424 (2021).

Article PubMed PubMed Central Google Scholar

Skirrow, H. et al. Womens views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: A multi-methods study in the UK. BMC Pregnancy Childbirth 22, 33 (2022).

Article CAS PubMed PubMed Central Google Scholar

Aw, J., Seng, J. J. B., Seah, S. S. Y. & Low, L. L. COVID-19 vaccine hesitancyA scoping review of literature in high-income countries. Vaccines 9, 900 (2021).

Article CAS PubMed PubMed Central Google Scholar

AlShurman, B. A., Khan, A. F., Mac, C., Majeed, M. & Butt, Z. A. What demographic, social, and contextual factors influence the intention to use COVID-19 vaccines: A scoping review. Int. J. Environ. Res. Public Health 18, 9342 (2021).

Article CAS PubMed PubMed Central Google Scholar

Willis, D. E. et al. COVID-19 vaccine hesitancy: Race/ethnicity, trust, and fear. Clin. Transl. Sci. 14, 22002207 (2021).

Article CAS PubMed PubMed Central Google Scholar

Tram, K. H., Saeed, S., Bradley, C., Fox, B., Eshun-Wilson, I. & Mody, A. et al. Deliberation, dissent, and distrust: Understanding distinct drivers of COVID-19 vaccine hesitancy in the United States. Clin. Infect. Dis. 2021; ciab633.

Schmid, P., Rauber, D., Betsch, C., Lidolt, G. & Denker, M.-L. Barriers of influenza vaccination intention and behaviour: A systematic review of influenza vaccine hesitancy, 20052016. PLOS ONE 12, e0170550 (2017).

Article PubMed PubMed Central Google Scholar

Paudel, Y. R., Du, C. & MacDonald, S. E. The influence of place on COVID-19 vaccine coverage in Alberta: A multilevel analysis. PLOS ONE. 17, e0276160 (2022).

Article CAS PubMed PubMed Central Google Scholar

MacDonald, S. E., Paudel, Y. R. & Du, C. COVID-19 vaccine coverage among immigrants and refugees in Alberta: A population-based cross-sectional study. J. Glob. Health 12, 05053 (2022).

Article PubMed PubMed Central Google Scholar

Green-McKenzie, J. et al. Factors associated with COVID-19 vaccine receipt by health care personnel at a major academic hospital during the first months of vaccine availability. JAMA Netw. Open 4, e2136582 (2021).

Article PubMed PubMed Central Google Scholar

Nguyen, L. H. et al. Self-reported COVID-19 vaccine hesitancy and uptake among participants from different racial and ethnic groups in the United States and United Kingdom. Nat. Commun. 13, 636 (2022).

Article ADS CAS PubMed PubMed Central Google Scholar

Barry, V. et al. Patterns in COVID-19 vaccination coverage, by social vulnerability and urbanicityUnited States, December 14, 2020May 1, 2021. MMWR Morb. Mortal Wkly. Rep. 70, 818824 (2021).

Article CAS PubMed PubMed Central Google Scholar

Javanbakht, M. et al. Substance use and other factors associated with COVID-19 vaccine uptake among people at risk for or living with HIV: Findings from the C3PNO consortium. Prev. Med. Rep. 35, 102300 (2023).

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COVID-19 vaccine uptake among people with HIV: identifying ... - Nature.com

In a recent study published in npj Vaccines, researchers reported that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BA.5 bivalent booster dose enhanced neutralization of Omicron XBB (sub)variants in non-small cell lung cancer (NSCLC) patients.

Study:BA.5 bivalent booster vaccination enhances neutralization of XBB.1.5, XBB.1.16 and XBB.1.9 variants in patients with lung cancer. Image Credit:Steve Heap/Shutterstock.com

Monovalent vaccines based on the wild-type SARS-CoV-2 spike messenger ribonucleic acid (mRNA) have been safe and effective against severe disease in most patients with solid tumors.

Nevertheless, SARS-CoV-2 Omicron variants have acquired mutations in the spike proteins receptor-binding domain, which enable evasion from neutralizing antibodies (nAbs) elicited by vaccines based on the wild-type strain.

Some studies suggest NSCLC patients have poor immune responses to monovalent vaccines and do not develop nAbs against SARS-CoV-2 variants of concern (VOCs).

In the present study, researchers evaluated nAb responses against the wild-type SARS-CoV-2 strain and Omicron variants in NSCLC patients. They obtained plasma samples from 34 NSCLC patients and 12 healthy controls to determine nAb titers against the wild-type strain and BA.5, XBB.1.16, XBB.1.5, BQ.1.1, and XBB.1.9 variants.

Patients in the monovalent booster cohort were double-vaccinated and received the monovalent booster (third dose) six to eight months after the last dose.

NSCLC patients and healthy subjects in the bivalent booster cohort previously received three (monovalent) vaccines and the bivalent booster (fourth dose) 1012 months after the last dose.

Individuals in the monovalent booster cohort had detectable nAb titers against wild-type SARS-CoV-2, whereas the response was significantly reduced against Omicron variants 40 days after receiving the booster. Specifically, 9% and 18% of the monovalent booster cohort had nAb responses against Omicron XBB.1.9 and XBB.1.16 variants, respectively.

Notably, NSCLC patients receiving the bivalent booster developed a significantly elevated nAb response. All patients in the bivalent booster cohort elicited nAb responses against the wild-type strain and the BA.5 variant.

Further, 65% of patients in the bivalent booster cohort had detectable nAbs to XBB.1.9 and XBB.1.16, and 80% showed responses against XBB.1.5 and BQ.1.1 variants.

Nevertheless, nAb titers against XBB.1.9, XBB.1.5, and BQ.1.1 variants were significantly lower than against the wild-type strain. All healthy individuals in the bivalent booster cohort showed nAb titers against wild-type SARS-CoV-2 and the BA.5 variant.

Moreover, 92% of healthy individuals had nAbs against XBB.1.5 and BQ.1.1 variants, while 83% induced nAbs against XBB.1.9 and XBB.1.16.

Like NSCLC patients, healthy individuals had a significantly reduced nAb response against currently dominant XBB (sub)variants relative to the wild-type virus. Notably, there were no significant differences in nAb titers between healthy participants and NSCLC patients after receiving the bivalent booster.

The team observed a decline in nAb titers against the wild-type strain and Omicron variants among healthy subjects four to six months after bivalent booster vaccination.

Specifically, only 42% of healthy subjects had nAbs against XBB.1.9 and XBB.1.16 variants, and 55% induced nAbs against XBB.1.5. Further, the decline in nAb titers was more prominent in NSCLC patients.

Although nAb titers between NSCLC patients and healthy individuals were not significantly different 40 days post-bivalent booster vaccination, nAb titers to XBB.1.9 and BQ.1.1 variants were reduced among patients four to six months post-boost.

Only 13% and 27% of bivalent vaccine-boosted NSCLC patients had nAb titers against XBB.1.16 and XBB.1.5 variants, respectively, and none of the patients induced nAbs against XBB.1.9.

Finally, the team assessed whether patient demographics and cancer treatment modalities influenced the findings. Age, sex, cancer stage, vaccine type, and race were not statistically different between cohorts.

Patients were categorized based on cancer therapy (immunotherapy, targeted therapy, chemotherapy, and combined therapy). The type of cancer treatment did not influence nAb responses to vaccination.

The study evaluated antibody responses against wild-type SARS-CoV-2 and Omicron variants in NSCLC patients relative to healthy participants after booster vaccination. The researchers observed that only 9% to 27% of patients had nAb titers against XBB (sub)variants following monovalent booster vaccination.

This raises concerns about higher risk of infection among monovalent booster recipients, given that XBB (sub)variants are currently predominant in the United States.

On the other hand, nAb responses against XBB (sub)variants among bivalent vaccine-boosted NSCLC patients were significantly higher and comparable to those in healthy individuals.

Nevertheless, nAb titers declined significantly four to six months post-bivalent vaccination. Cancer treatment type did not appear to influence nAb responses.

The studys limitations include the relatively small cohort size and single-center recruitment. Also, bivalent cohort subjects received an additional vaccine dose relative to monovalent booster recipients.

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New study shows bivalent COVID-19 booster increases antibody ... - News-Medical.Net

In this large register based cohort study including 589722 residents from the two largest regions of Sweden, we found a strong association between vaccination before first registered covid-19 and a reduced risk of receiving a diagnosis of PCC. In the study population, unvaccinated individuals had an almost fourfold higher proportion of PCC diagnoses compared with those who were vaccinated before infection (1.4% v 0.4%). We found a vaccine effectiveness against PCC of 58% for any dose within the primary vaccination series (ie, the first two doses and the first booster dose administered within the recommended schedule) given before a first registered infection. Vaccine effectiveness increased with each dose in the series: 21% for one dose, 59% for two doses, and 73% for three or more doses.

The few earlier studies on vaccine effectiveness against the long term effects of covid-19 have mostly shown protective effects, with a wide range of effect estimates,2627 but some failed to show an overall protective effect.2829 The methodology and data included in the earlier studies were heterogeneous and had limitations. Study populations have rarely been population based and often have included a small number of participants.3031 Analyses of different effects for different numbers of vaccine doses before covid-19 have not always been performed.2732 Because vaccination during follow-up has often not been a criterion for censoring, both vaccinated and unvaccinated individuals have been included in the unvaccinated group. In the present study, we used population based survival data of 589722 individuals, censoring at both vaccination and reinfection, and report vaccine effectiveness separately for any dose, one dose, two doses, and three or more doses. Earlier studies have generally lacked a clear definition of PCC, and symptoms have often been self-reported,29303133 whereas we used register based clinical diagnoses of PCC as the outcome. Furthermore, in earlier studies follow-up duration has often been short,29 whereas in our study the median follow-up was 129 days from 28 days after a first registered infection. A recent systematic review concluded that being vaccinated against covid-19 before infection had a protective effect on PCC in 10 of the 12 included studies, with effect estimates ranging from 0.48 to 0.87 for any vaccine dose given before infection.11 Owing to high heterogeneity between studies and the low certainty of evidence, no meta-analysis was performed. In other systematic reviews, meta-analyses have, however, included several of these studies, but the results should be interpreted with caution.3435 One of these meta-analyses concluded that receiving two doses of vaccine before covid-19 was associated with a lower risk of PCC compared with no vaccination, with an odds ratio of 0.64,34 and that the odds ratio was 0.71 with at least one dose before infection.35

Using register data from the whole adult population in the two largest regions of Sweden, we showed that vaccination against covid-19 before infection was associated with a decreased risk of receiving a diagnosis of PCC. When stratifying by the median time between last vaccination and infection (126 days) to assess the potential different effects of recent versus earlier vaccination, we found that receiving the last vaccine dose more than 126 days before covid-19 was still associated with a relatively high vaccine effectiveness against PCC, and only slightly lower than in the main analysis. In addition, to ensure sufficient time between vaccination and the acute infection, in a sensitivity analysis we restricted the vaccinated population to those who received their last vaccine dose more than 14 days before covid-19, and the estimated vaccine effect did not markedly change from the main analysis. Furthermore, in the main analyses we only considered the first PCC diagnosis at least 28 days from infection, but in sensitivity analyses we required at least 90 days from infection, with similar results.

Studies have shown that women may develop greater immune responses to vaccination than men,36 although this does not necessarily translate to better protection against the disease. In our study, men showed a higher vaccine effectiveness against PCC than women. It has not yet been fully established whether PCC is more likely to occur with particular variants. Available data suggest, however, that individuals infected with the omicron variant are at lower risk of developing long term effects of covid-19 than individuals infected with the other variants.373839 Nonetheless, it is difficult to determine if this lower risk is associated with the specific variant or is the result of immunity from previous infections or vaccinations, or as a result of shorter follow-up durations. A small study evaluating the protective effect of covid-19 vaccines against PCC, which included individuals with infections during the omicron period as well as the earlier periods, did not show significantly different results between the variants.30 In the present study, the study population included individuals with infections at the time when the alpha and delta variants predominated, and also during part of the pre-alpha and omicron periods. Although vaccination coverage was not evenly distributed during these periods, stratifying on the period of dominant variant at the time of infection showed only a slightly lower vaccine effectiveness against PCC in the omicron period than in the pre-alpha and alpha periods. As we did not have access to virus sequencing data in our analysis, we used the time of infection as a proxy for variant. Consequently, the variant causing acute infection in some of the study individuals might have been misclassified.

The pathogenesis of PCC has not yet been clarified, but several mechanisms have been proposed relating to the different symptom manifestations and it has become increasingly evident that patients with PCC are a heterogenous group. Potential mechanisms include organ damage, abnormal immune activation during acute infection, reactivation of other viruses, altered systemic immunity, autoimmunity, and sustained immune activation due to viral persistence.40 Determining the pathogenesis might suggest potential pathways for the protective effect of the vaccinesfor example, a reduced viral load during the acute infection after vaccination could reduce the viruss persistence with lasting immune activation. Different symptom clusters of PCC may have different pathogeneses and therefore different mechanisms for the vaccine effect. We have shown that almost 37% of patients with covid-19 treated in the ICU subsequently have a PCC diagnosis.16 Covid-19 vaccines have been shown to protect against hospital admission with covid-19,41 which could be one pathway for the vaccines to exert a protective effect against PCC. In our analysis, vaccine effectiveness against PCC seemed to be only partly explained by a decreased risk of hospital admission. In addition, analyses stratified on severity of acute disease as indicated by the need for hospital admission showed that vaccine effectiveness was similar in both the group admitted to hospital without ICU admission and the group with no hospital admission. Furthermore, a study showed that those who were vaccinated after covid-19 had a lower risk of developing PCC compared with those who were unvaccinated 12 weeks after covid-19.26 This, together with the findings in the present study, support the hypothesis of pathways beyond the protective effect against hospital admission that may contribute to the protective effect of covid-19 vaccines against PCC. It is also important to note that symptoms of PCC are frequently observed not only in patients with confirmed covid-19 but also in those without a positive SARS-CoV-2 PCR test result.42

The present study has several strengths. Firstly, we used register based data collected from high quality registers, resulting in essentially no loss to follow-up and a low risk of self-reporting bias. In Sweden, it is mandatory and regulated by law to register every administered covid-19 vaccine dose in the national vaccination register. Therefore the exposure data (vaccination) are particulary comprehensive and accurately measured. Secondly, we had access to individual level data from primary healthcare as well as inpatient and outpatient specialist healthcare. This is of importance when studying the diagnosis of PCC, since we have previously shown that most (>85%) patients with PCC in Sweden received their diagnosis in primary healthcare.16 In addition, to fully account for health seeking behaviour and the potential that the PCC group is a biased group of healthcare seekers, the number of healthcare contacts in 2019 was included as a confounder in the full model. Futhermore, the study was population based, covering the two largest regions of Sweden (Region Stockholm and Vstra Gtaland, 40% of the total Swedish population). Lastly, most previously published studies investigating the protective effect of vaccination before covid-19 against PCC have not been able to account for vaccinations given after infection. By not considering these vaccinations, the total protective effect against PCC will potentially be diminished as a result of the groups becoming more similar to each other. By using survival data in combination with data on vaccinations from the national vaccination register, we were able to censor individuals at vaccinations given after the acute infection.

The limitations of the present study include that both PCC and the ICD-10 diagnosis code, U09.9, are relatively new and the code has not yet been validated in a Swedish setting. It is possible that PCC might be overdiagnosed as well as underdiagnosed, which could affect both the sensitivity and the specificity of PCC as an outcome measure. If this affects both unvaccinated and vaccinated individuals fairly equally, this would lead to a non-differential misclassification of the outcome, which on average would result in some bias towards the null. However, we cannot fully rule out the possibility that vaccinated individuals are less likely than unvaccinated individuals to receive a PCC diagnosis owing to expectations from both patients and healthcare providers about the protective effect of vaccinationalthough it may be less likely that this bias would increase with increasing number of vaccine doses and show the strong dose-response association in our results. A recent paper from Sweden investigating healthcare use after covid-19 among patients with the PCC diagnosis code, in comparison with controls matched on age, sex, and number of healthcare contacts before infection, showed that the PCC group had significantly more healthcare contacts after covid-19.24 Therefore, we believe that the specificity of the PCC diagnosis code might be good, while its sensitivity remains less clear. In addition, it is possible that vaccine effectiveness differs in patients who experience a specific symptom compared with those who experience another symptom within the PCC spectrum. However, if the protective effect of the vaccines would be valid for a few specific symptoms within the PCC spectrum only, the relatively strong effect on the PCC diagnosis we see in the present study would be less likely to occur. A few studies have also investigated the impact of vaccination on existing PCC, showing both no effect as well as alleviation and aggravation of PCC symptoms.434445 The register based data used in the present study had limited data on symptoms and therefore it would be difficult to assess changes in symptoms of an already existing PCC. Furthermore, although PCC is diagnosed on a specific date, the condition and symptoms usually have been present before the date of diagnosis. Lastly, our results are based on first SARS-CoV-2 infections, whereas reinfections might represent most of the infections today. The potential impact of reinfections on the covid-19 vaccine effectiveness of PCC remains to be elucidated.

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Covid-19 vaccine effectiveness against post-covid-19 condition ... - The BMJ

In the United States, there is currently no federal law guaranteeing workers paid days off, and many are not entitled to unpaid time off.

According to a 2020 report from the U.S. Bureau of Labor Statistics, 78% of workers have access to paid sick time. This means that close to 1 in 4 workers may experience financial hardship when illness strikes.

COVID-19 can have significant effects on individuals wellbeing, causing a decline in their health-related quality of life. The infection symptoms, such as fever, cough, and fatigue often thwart productivity, making it harder to work and get daily tasks done.

COVID-19 vaccination, particularly the bivalent BNT162b2 formulation, has been shown to have very high efficacy against severe disease and moderate efficacy against symptomatic SARS-CoV-2 infection, according to the World Health Organization.

A study published in October and led by Manuela Di Fusco, senior director of Health Economics and Outcomes Research at Pfizer, analyzed the effects of Pfizers BA.4/5 BNT162b2 COVID-19 vaccine on symptoms, Health-Related Quality of Life (HRQoL), and work productivity.

The study enrolled 643 participants including 316 individuals who had been vaccinated and 327 who were unvaccinated. The unvaccinated cohort included individuals that never received any COVID-19 vaccine and those who were not up-to-date(if their last dose was over 12 months ago). The average age of the participants was 46.5 years old, with 25.7% having one or more comorbid condition. This study gathered patient-reported outcomes from individuals who were tested for SARS-CoV-2 at CVS Health test sites, targeting adults with a positive test result and at least one acute COVID-19 symptom.

The study utilized online surveys to collect baseline information on participants, including demographics, comorbidities, COVID-19 vaccination and infection history. Participants also provided information on COVID-19 antiviral treatment and changes in vaccination and infection status. The study measured outcomes such as symptoms, HRQoL, fatigue, work productivity, and activity impairment using validated measures at different time points over a four-week period.

The findings of the study revealed that the vaccinated group reported fewer acute symptoms, particularly systemic and respiratory symptoms commonly associated with COVID-19. Further, while all participants experienced some adverse effects on their overall HRQoL, the vaccinated group demonstrated a better work performance compared to the unvaccinated group. This was evidenced by lower rates of absenteeism and fewer work hours lost among those who had received the vaccine.

The researchers concluded that the vaccinated group experienced fewer and less persistent symptoms than the unvaccinated group. Moreover, their improved work performance highlights the positive impact of COVID-19 vaccination on individuals' ability to carry out their daily responsibilities effectively.

This study, funded by Pfizer, adds to the body of evidence supporting the role of COVID-19 vaccination in reducing the severity and frequency of symptoms experienced by those who receive it. Regarding their study on patient-reported outcomes, the authors wrote, it solidifies evidence indicating that the effectiveness of BA.4/5 BNT162b2 on COVID-19 disease could translate to extra benefits of reduction in the frequency and burden of symptoms, supporting faster recovery and return to work.

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COVID-19 Vaccination Reduces Symptoms and Improves Work ... - Managed Healthcare Executive

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Examining the Impact of the COVID-19 Vaccine on Smokers and ... - Cureus

Less than 10% of US interventional COVID-19 trials in the first 3 years of the pandemic included children, and only 1.6% enrolled them exclusively, despite this age-group accounting for 18% of infections, Harvard and Boston Children's Hospital researchers report today in JAMA Health Forum.

The team identified all COVID-19 trials registered on ClinicalTrials.gov from January 2020 to December 2022. They noted that children have been underrepresented in clinical research owing to ethical, logistical, and financial reasons.

"The emergence of the COVID-19 pandemic triggered a rapid investment in research activities to identify prevention measures and develop therapeutic interventions," they wrote. "While children were eventually determined to have a milder disease course compared with adults, studying children was critical to elucidate transmission patterns and identify treatments for pediatric patients with severe disease, including multisystem inflammatory syndrome."

Of 1,216 trials, 20 (1.6%) enrolled only children, while 120 (9.9%) included only children or both children and adults, and 1,096 (90.1%) enrolled only adults. The percentage of trials enrolling children rose from 45 (7.1%) in 2020 to 27 (15.7%) in 2022.

Relative to adult-only studies, those including children were less likely to focus on COVID-19 treatments (48.3% vs 69.8%) or on testing medications, biologics, or devices (48.3% vs 64.6%). Rather, they tended to focus on prevention (47.5% vs 23.0%), behavior (25.8% vs 16.8%), and vaccines (14.2% vs 5.8%).

Recent methodologic advancements in pediatric extrapolation, pharmacokinetic and pharmacodynamic modeling, and adaptive trial designs, can be applied to support earlier initiation.

Fewer drug studies enrolling children were phase 1 or 2 (42.0% vs 70.4%) or were randomized (69.2% vs 79.3%). Most studies including children (71 [59.2%]) focused on those older than 2 years, with only 49 (40.9%) open to younger kids.

The researchers said that low rates of inclusion of children probably reflect the tradition of delaying interventional trials in children until after adults have been studied.

But more attention is now being paid to the advantages of early pediatric trials. "Recent methodologic advancements in pediatric extrapolation, pharmacokinetic and pharmacodynamic modeling, and adaptive trial designs, can be applied to support earlier initiation," they wrote.

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Undiagnosed pneumonia outbreak in China puts pressure on ... - University of Minnesota Twin Cities

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Please choose I'm not a medical professional. Allergy and Immunology Anatomy Anesthesiology 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 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

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COVID-19 Vaccines and Axillary Nerve Dysfunction: A Case Report - Cureus