Category: Corona Virus Vaccine

A man in Germany went above and beyond to make sure he wouldnt get COVID-19, prompting scientists to study the effects of hyper-vaccination.

The 62-year-old man who allegedly received the COVID-19 vaccine 217 times within 29 months was the subject of a new study published by The Lancet Infectious Diseases journal. Researchers wanted to see how hyper-vaccination affected the body.

We learned about his case via newspaper articles, Dr. Kilian Schober from the Institute of Microbiology Clinical Microbiology shared in a news release. We then contacted him and invited him to undergo various tests in Erlangen. He was very interested in doing so.

Researchers from the University of Erlangen-Nuremberg in Germany, who conducted the study, said that vaccines contain parts of the virus pathogen in order to teach a persons cells how to protect themselves and recognize the virus in the future. However, they also noted that if the cells are exposed many times, that can also weaken the immune system and make it unable to combat the virus effectively.

Scott Olson/Getty

That may be the case in a chronic infection such as HIV or Hepatitis B, that has regular flare-ups, explains Schober. There is an indication that certain types of immune cells, known as T-cells, then become fatigued, leading to them releasing fewer pro-inflammatory messenger substances.

The researchers analyzed his blood test results taken over several years and also got their own fresh blood and saliva samples taken to determine exactly how the immune system reacts to the vaccination.

They found that the man had a larger number of T-effector cells, which fight against the virus, than people who have gotten the vaccine three times. The fighting cells were also found to be just as effective as those who received three vaccinations. The same went for the Memory T cells, which recall the virus.

The number of memory cells was just as high in our test case as in the control group, said Katharina Kocher, one of the leading authors of the study. Over all, we did not find any indication for a weaker immune response, rather the contrary.

Never miss a story sign up forPEOPLE's free daily newsletterto stay up-to-date on the best of what PEOPLE has to offer, from juicy celebrity news to compelling human interest stories.

Their further tests found that the hyper-vaccination also didnt affect his immune systems response to other pathogens, leading them to determine that his immune system hasnt been damaged by all the vaccines.

However, researchers noted that this was just one case studied and that people who undergo the same thing may have different immune system responses, which is why they are keeping their recommendation to the general public of three COVID-19 vaccines.

Current research indicates that a three dose vaccination, coupled with regular top-up vaccines for vulnerable groups, remains the favored approach, they said in the release. There is no indication that more vaccines are required.

More:

Man Who Allegedly Received Over 200 COVID-19 Vaccinations Is Okay - PEOPLE

5 March 2024

A 62-year-old man from Germany has, against medical advice, been vaccinated 217 times against Covid, doctors report.

The shots were bought and given privately within the space of 29 months.

The man appears to have suffered no ill effects, researchers from the University of Erlangen-Nuremberg say.

"We learned about his case via newspaper articles," Dr Kilian Schober, from the university's microbiology department, said.

"We then contacted him and invited him to undergo various tests in Erlangen. He was very interested in doing so."

The man provided fresh blood and saliva samples.

The researchers also tested some frozen blood samples of his that had been stored in recent years.

Dr Schober said: "We were able to take blood samples ourselves when the man received a further vaccination during the study at his own insistence.

"We were able to use these samples to determine exactly how the immune system reacts to the vaccination."

Evidence for 130 of the jabs was collected by the public prosecutor of the city of Magdeburg, who opened an investigation with the allegation of fraud, but no criminal charges were brought.

Covid vaccines cannot cause infection but can teach the body how to fight the disease.

Messenger ribonucleic acid (mRNA) vaccines work by showing the body's cells a bit of genetic code from the virus.

The immune system should then recognise and know how to fight Covid should they encounter it for real.

Dr Schober worried hyper-stimulating the immune system with repeated doses might have fatigued certain cells.

But the researchers found no evidence of this in the 62-year-old.

And there was no sign that he had ever been infected with Covid.

The researchers said: "Importantly, we do not endorse hyper-vaccination as a strategy to enhance adaptive immunity."

And the results of their tests on the 62-year-old were insufficient for making far-reaching conclusions, let alone recommendations for the general public.

"Current research indicates that a three-dose vaccination, coupled with regular top-up vaccines for vulnerable groups, remains the favoured approach," they say on the university's website.

"There is no indication that more vaccines are required."

The NHS says Covid vaccines are normally given seasonally but some people with a severely weakened immune system may need additional protection at other times - and it will contact those whose NHS record suggests may be eligible.

Covid vaccines can have side effects. A common one is a sore arm from the injection.

Link:

German patient vaccinated against Covid 217 times - BBC.com

This is the first report of real-world effectiveness of BNT162b2 against COVID-19 hospitalization in children ages 611 during a period of almost one year predominated by the BA.4/BA.5 and X.B.B sub-lineages in a low-to-middle income country (LMIC). Completion of a primary series of the BNT162b2 vaccine was estimated to be 38% effective against COVID-19-related hospitalizations in children. This protection persisted over the study period of almost one year, with moderate, non-diminishing effectiveness over time. Our findings also suggest that a recent infection within 6 months does not significantlymodify the impact of vaccination on the risk of hospitalization.

Based on our findings, the incidence of COVID-19 hospitalization among children during the Omicron period is observed to be inversely related with the number of vaccine doses received. The incidence rate (IR) among fully vaccinated individuals was 1.5 times lower than that of the unvaccinated group (9.6 vs. 6 per 10,000,000 person-days). Previous studies evaluating the effectiveness of the BNT162b2 vaccine (VE) in the pediatric population against hospitalization predominantly during the BA.1/BA.2 Omicron waves have reported varying results. In the U.S., Price et al.8 found a VE of 68% against COVID-19-related hospitalizations, while Shi et al.14 estimated the VE to be around 50%. Similarly, in Italy, Sacco et al. reported a 41% VE against severe COVID-1913. In Singapore, Tan et al. estimated a very high VE of 85% over a two-month observation period11. Nonetheless, a casecontrol study in Hong Kong estimated the VE of the BNT162b2 vaccine against COVID-19 hospitalizations in children from January to August 2022 to be 44.7% (95% CI 3.4, 68.4%)15. While there is a paucity of research focusing on pediatric primary vaccination for the BA.4/BA.5 and X.B.B sub-lineages, our findings and study duration align with those from the latter study in Hong Kong. The comparatively lower VE observed in this study likely stems from heightened community immunity, attributable to multiple infection waves and potential undetected cases, alongside reduced severity in pediatric populations due to physiological differences, such as lower ACE2 expression in nasal pathways16,17,18. Vaccine effectiveness (VE) against hospitalization with the BNT162b2 vaccine without a booster more than 150 days after the last dose in older age groups, was lower than 50%. Similarly, higher VE was observed after administering a booster dose, as indicated by COVID-19 VE pooled data from the I-MOVE-COVID-19 VE network in Europe19. Determining superior immunity in children compared to older age groups, or vice versa, poses challenges due to variations in the primary dose timeframe. Additionally, individual risk of exposure to SARS-CoV2 may differ, contributing furhterto this complexity.

Additionally, upon stratification of time intervals, we observed that vaccine effectiveness did not exhibit a distinct decline over time. Our study provides a unique perspective, underscoring the consistent and moderate protection offered by the BNT162b2 vaccine against severe disease, with an effectiveness of around 40% over a year. Our findings are consistent with findings from Hong Kong but with a greater degree of precision, further suggesting moderate non-diminishing effectiveness against COVID-19-related hospitalization in the BA.4/BA.5 and X.B.B Omicron period15.

The comparative protection provided by immunity from prior SARS-CoV-2 infection, vaccination and a hybrid of infection and vaccination has been extensively studied in the general population20,21. In children, a two-dose BNT162b2 vaccination regimen plus a prior infection (hybrid immunity) has demonstrated protection rates of 74% against Omicron BA.4/BA.5 and 62% against X.B.B. reinfections22. In adults, prior infection also provides protection against severe COVID-19 disease. However, no prior studies have explored the impact of hybrid immunity on the risk of COVID-19 hospitalization in children. Our study suggests two findings: a recent infection within 6 months appears to provide some level of protection against hospitalization, aligning with findings from other studies23. However, this effect is not statistically significant, possibly due to the small sample with prior infection of approximately 4%, indicating potential under-ascertainment during the Omicron waves or limitations in capturing infections only within the last 6 months. Interestingly, this factor also contributes to our observation that the effects of vaccination on the risk of hospitalization do not appear to be modified by a childs 6-month history of infection. While there is a possibility that the severity of COVID-19 infection following vaccination remains unchanged in those with a history of previous COVID-19 infection, this notion contradicts other research findings which suggests that hybrid immunity may confer protection against severe COVID-19, particularly in adults from high-income countries13. This limitation could have contributed to the lack of statistical significance, necessitating a cautious interpretation of our results. It is worth noting that measuring hospitalization as an outcome in children is different from assessing infection. It is important to consider that various factors can affect hospitalization rates, which may vary by location. Additionally, factors such as hospitalization criteria, bed capacity, and resource limitations must be considered, especially in low- and middle-income countries (LMICs).

Recent studies have indicated that booster doses increased VE to 58.9% in preventing hospitalizations during the BA.4/BA.5 Omicron period15. In Malaysia, the Ministry of Healths PICKids program provides the primary series to all children. It delivers booster doses after 6 to 12 months, prioritizing high-risk groups, including children with significant co-morbidities and those with immunocompromising conditions. In adolescents and older adults, vaccination rates are comparatively high; however, within the pediatric demographic, uptake is less robust, evidenced by approximately 43% receiving primary immunization series and only 0.2% having received booster doses. This disparity could be attributed to a shift in the balance of perceived risks and benefits, including concerns regarding vaccine safety. The approach has shifted from the Delta variant period's more forceful policy of mandatory vaccinations for access to public spaces and events, to the current strategy that relies on appealing to parental responsibility within the PICKids program. This change may reflect growing vaccine hesitancy24,25.However, local safety data is reassuring, with 525 reported adverse events following immunization (AEFI) among the targeted age group, equating to 158 reports per million doses, where 94% were non-serious. Of these, 34 reports were of serious AEFIs, including asthma exacerbation and Bells palsy, among children aged 5 to 11 years26.

Our results pave the way for subsequent investigative efforts. Prolonged surveillance could illuminate the enduring effectiveness of these vaccines, especially in the context of emerging viral variants. As the virus mutates and potentially presents challenges to existing vaccine formulations, there may be a demand for new vaccine compositions specifically targeting these variants. Moreover, the durability of both natural and vaccine-induced immunity may necessitate the exploration of regular booster doses, especially in populations that are more susceptible or exposed to frequent viral challenges. It is a research imperative to continue evaluating the effectiveness, safety, and optimal timing of such boosters. It is essential to delve into the broader implications of these findings on public health policies and vaccination strategies, addressing questions of effectiveness, safety, and optimal timing for booster doses in the Malaysian context.

Our approach used a large dataset with COVID-19 hospitalization as the primary measure. Our study, the largest conducted in low- and middle-income countries (LMICs) to evaluate vaccine effectiveness in children, provides greater precision than previous research. Moreover, as public health worldwide transitions to an endemic phase of COVID-19, our study examines the benefits of vaccination amidst a period of economic and social recovery and the relaxation of public health measures. We applied robust methods to address gaps in our knowledge of vaccination programs for younger children, including survival analysis, which allows participants to move between different comparison groups, thereby reducing potential biases related to unmeasured risk behaviours. Our longitudinal data also enabled us to assess how vaccine effectiveness against infection changed over time with a longer follow-up period than any previous study. While our study offers significant insights, it is not without limitations. The observational nature inherently brings potential biases. There could also be inadvertent misclassification of incidental COVID-19 cases during hospitalizations. Such situations might involve cases where patients admitted for unrelated indications with an incidentally positive test misclassified as a COVID-19 hospitalization. This misclassification could result in an underestimation of effectiveness, resembling the estimate for infection rather than accurately reflecting the effectiveness for severe outcome. Data linkage could miss matches, which could influence the reliability of estimates. Nevertheless, utilizing high-quality variables like national identification numbers is reinforced by rigorous verification and auditing at the field level, ensuring accuracy and completeness. Accounting for antecedent infections is a critical methodological consideration; however, in the context of the assessment phase and the prevalence of asymptomatic or mildly symptomatic infections, there exists a non-negligible risk of misclassification of prior infection status, a factor of heightened relevance during the Omicron phase. Furthermore, the failure to adjust for pre-existing comorbid conditions may result in the introduction of selection bias into the study results. Ultimately, the dynamics of SARS-CoV-2 epidemiology changes rapidly; hence, the applicability of these findings might be limited to the specific context captured in this study.

View original post here:

Effectiveness of COVID-19 vaccines among children 611 years against hospitalization during Omicron predominance ... - Nature.com

A 62-year-old man in Germany intentionally got 217 doses ofCOVID-19 vaccines within 29 months. The vaccinations occurred outside of a clinical study, and after hearing about the "hypervaccinated" man, medical researchers in Germany reached out to him to run tests.

The researchers first learned about the man, who they say got the vaccines "deliberately and for private reasons," when a public prosecutor in Magdeburg, Germany, opened a fraud investigation, according to a paperpublished in The Lancet Infectious Diseasesmedical journal on Monday. The prosecutor confirmed 130 of the vaccinations and ultimately did not file criminal charges against the man.

The researchers sent a proposal to the man and the prosecutor saying they wanted to investigate the potential impact on his immune system from getting so many of the shots.

click to expand

The man voluntarily gave them blood and saliva samples and the researchers compared his antibody levels to a control group of 29 people who had three doses of mRNA COVID-19 vaccines, according to the study.

They were able to measure the man's antibody levels after his 214th vaccination and found them highest on that day and again three days after his 215th vaccination. His contraction kinetics the cell response to the antibodies mirrored those of the control group. His 217th vaccination showed just a modest increase in antibodies.

They checked the levels of a variety of types of cells involved in immune system responses, and while some were boosted as his vaccinations increased, many levels were in line with the control group.

The researchers say the man appeared to suffer no significant side effects despite the extreme number of doses.

"In summary, our case report shows that SARS-CoV-2 hypervaccination did not lead to adverse events and increased the quantity of spike-specific antibodies and T cells without having a strong positive or negative effect on the intrinsic quality of adaptive immune responses," the study reads. "While we found no signs of SARS-CoV-2 breakthrough infections in [the man] to date, it cannot be clarified whether this is causally related to the hypervaccination regimen."

"Importantly, we do not endorse hypervaccination as a strategy to enhance adaptive immunity," they note.

Staying up to date withCOVID-19 vaccinationsis recommended for everyone ages 6 months and older in the U.S. There are three types of COVID-19 vaccines available in the U.S. two mRNA vaccines from Moderna and Pfizer, and a protein subunit vaccine from Novavax and there is no preferential recommendation of one over the other, according to the CDC.The CDC has a table with informationon the number of recommended doses based on your past vaccinations.

The CDC recently amended its COVID-19 guidelines, shortening the 5-day isolation period and updating its guidance on masks and testing. The new recommendations offer a "unified, practical approach to addressing risk" from COVID as well as other infections like the flu and RSV, the agency said.

Caitlin O'Kane is a New York City journalist who works on the CBS News social media team as a senior manager of content and production. She writes about a variety of topics and produces "The Uplift," CBS News' streaming show that focuses on good news.

Read the original:

A man got 217 COVID-19 vaccinations. Here's what happened. - CBS News

Study population and data

We defined the study population as persons residing in the United States, age 18 years or older, and fully vaccinated (defined as completion of their primary series and 1 or more monovalent booster doses). The epidemiologic data used in the model reflects the timeframe up until approximately September 2022, coinciding with introduction of bivalent COVID-19 vaccines in the United States. Applying publicly available data from the US Centers for Disease Control and Prevention (CDC) COVID-19 surveillance program, we generated age-specific monthly risk estimates of severe COVID-19 (defined as related hospitalization or death)25,26. Age-specific seroprevalence estimates were obtained from the CDC based on the nucleocapsid antibody, suggesting prior infection, and updated to account for cases since the last survey27 (see Appendix, Prior infection and serosurveillance data).

We developed a stochastic, person-level simulation model (microsimulation) of severe COVID-19 cases in the United States. We created hypothetical cohorts of one million persons in each risk group who were fully vaccinated, defined as having completed their primary series and received at least one monovalent mRNA booster dose. The population size (1 million) for each risk group was chosen to broadly represent the geographic scale of a county in the United States (Table2). We modeled the population in 12 key risk groups defined by: i) age: 1849 years, 5064 years, 6574 years, 75+ years; and ii) immune status: immunocompetent, mild immunocompromised status (e.g., low-dose corticosteroids, mild immunosuppressive medications), and moderate/severe immunocompromised status (e.g., hematologic malignancy with active treatment or poor response to vaccines, solid organ or bone marrow transplant, high-dose corticosteroids or other moderate/severely immunosuppressive medications)16 (see Appendix, Model calibration). Upon entry into the simulation, each person was assigned an age, immune status, vaccine status (1 or 2 monovalent mRNA booster doses)28, and prior infection status27. For the age-specific cohorts and the immunocompromised risk group, prior infection status was informed by estimates of seroprevalence (nucleocapsid antibody consistent with prior infection; see Appendix for full methodologic approach)27,29. Prior infection status was necessary to define whether an individual had protection from hybrid immunity (vaccine and prior documented infection) or vaccination alone, given that hybrid immunity has been suggested to provide more robust and durable protection compared to vaccination alone1 (Supplementary TableS1). Each person was assigned a time since their last COVID-19 vaccine or infection (measured in number of months), to account for waning of protection over time. This timing was determined from sampling of publicly available data on time series data of vaccine administration and COVID-19 cases and then tracked over the simulation period (Supplementary Fig.S4).

We simulated a two-year time horizon, which was chosen to allow adequate time for comparison of vaccine strategies (i.e., one year time horizon would not allow estimation of differences from one-time and annual strategies). We assumed a hypothetical fixed population with no aging or demography. The start of the simulation (time 0) coincided with approximately September 2022, alongside introduction of the bivalent vaccine in the United States.

During the simulation, we applied an individual-specific, time-varying probability of SARS-CoV-2 infection and severe COVID-19 for each month time step, informed by the model calibration using COVID-19 surveillance datasets (see Calibration and Validation section). This probability combined a fixed group-specific force of infection term by age and immune status and an individual, time-varying level of protection against SARS-CoV-2 infection and severe COVID-19. An individuals risk of SARS-CoV-2 infection and severe disease changed over time as protection waned. The primary analysis used a static model of infection, meaning we did not account for indirect effects due to vaccination (i.e., reduced transmission due to vaccine-induced protection), although we did test a dynamic transmission model in an alternative analysis (see Scenario Analysis). Each persons level of protection was based on vaccine status (time since last vaccine) and prior infection history (time since last infection, if applicable). This model explicitly accounted for waning of protection against SARS-CoV-2 infection and severe COVID-19 independently based on timing of last vaccination and prior infection, which was estimated from literature1,2,3,5,20,30 (Supplementary TablesS1-S2). We separately modeled individuals as either having vaccine-induced (without prior infection) or hybrid immunity (defined as vaccination with documented prior infection) since literature suggests far higher and more durable protection for hybrid immunity1,20 (Supplementary Fig.S1).

We simulated severe COVID-19 cases, defined as a composite outcome of COVID-19 related hospitalization or COVID-19 related death. The study focused primarily on severe COVID-19 based on a public health priority to reduce hospitalizations and deaths, although we did simulate non-severe COVID-19 cases and subsequent effects on protection and immunity (Supplementary TableS9). All COVID-19 cases (severe and non-severe) reset the time since last COVID-19 case or vaccine. While acknowledging that a certain fraction of COVID-19 cases will result in long COVID, we did not account for long COVID given limited data to inform these estimates. We assumed no reinfections occurred within 90 days of a SARS-CoV-2 infection. Analysis was conducted in R (version 4.2.1).

We simulated three distinct vaccination strategies with booster vaccines for COVID-19, including: i) one-time booster at the start of the simulation (base case); ii) single booster followed by annual boosters (total of 2 doses); and iii) single booster followed by boosters every 6 months (semiannual; total of 4 doses). In September 2022, the available COVID-19 booster vaccine in the United States was the bivalent vaccine (ancestral strain and Omicron subvariants BA.4/5), followed later by a monovalent formulation against Omicron XBB.1.5. Each round of vaccination was administered in the population over a 3-month period. We calibrated the protection and waning of a mRNA booster dose to published data on vaccine effectiveness over time using data from both monovalent and bivalent COVID-19 booster vaccine literature (Supplementary TableS1)1,2,3,5. We modeled the benefit of a booster dose to restore maximal protection against severe COVID-19 prior to waning (Supplementary Fig.S1). Therefore, the impact of additional vaccination conservatively did not increase the absolute protective effectiveness previously achieved, but only restored the lost protection due to waning. This approach to vaccine modeling resulted in estimates of relative vaccine effectiveness similar to published estimates on the bivalent mRNA booster (Supplementary Fig.S3)3. We estimated the waning protective effectiveness of a booster dose by age group and prior infection status over a 24-month period using a linear mixed effects model. We modeled the outcome of protection against severe COVID-19 and infection as the log of 1 minus protective effectiveness, with predictor variables of the log of months since last vaccine dose or COVID-19 illness (whichever was more recent), age group (1849 years, 5064 years, 65+ years), and prior infection status, based on available literature. We modeled two immunocompromised groups, generating age-specific estimates for a mild immunocompromised group (13% lower protection) and moderate or severe immunocompromised group (25% lower protection, incorporating faster waning)2,16,31,32. We assumed that each repeated booster dose would achieve the same level of effectiveness without immune exhaustion, immune imprinting phenomenon, or reduced vaccine effectiveness due to new variants33,34, although we explored this in sensitivity analyses.

The primary study outcome wassevere COVID-19, measured as the annual absolute risk of severe COVID-19 over a 2-year simulation period in each risk group. Each of the boosting strategies was compared to the base case of a one-time booster at the start of the simulation. For each strategy, we estimated the total number of severe COVID-19 cases, absolute annual risk reduction of severe COVID-19 (cases per 100,000 persons), relative risk reduction, and NNT with a specified vaccination frequency to avert one severe COVID-19 case (calculated per person, not vaccine dose).

We calibrated the model to age-specific estimates of severe COVID-19 risk generated from an average over the 6-month period preceding model initialization (March 2022August 2022). For the two immunocompromised populations, we used literature estimates for their age distribution, assuming the same age-specific risk of infection but 2.8-fold higher risk of severe disease given infection25,29,32 (see Appendix Model calibration; see Table2 for severe COVID-19 risk estimates). This calibration yielded a per month, force of infection coefficient specific to each age and immune status on their risk of severe COVID-19, which was multiplied against 1 minus an individuals current level of protection to obtain individual per month probability of severe COVID-19. The probability of SARS-CoV-2 infection (non-severe) was modeled with an additional multiplier and separate estimates on level of protection (see Appendix, Model calibration). For model validation, we performed a comparison of model-predicted outcomes over the first 3 months of the simulation (September 2022- November 2022).

We repeated the primary analysis under different scenarios for emergence of novel variants with immune evasion (Fig.1A), including one scenario with a variant targeted vaccine. Upon circulation of a novel variant, we modeled two different immune evasion scenarios: i) absolute protection from vaccine or hybrid protection against non-severe and severe COVID-19 is reduced by 10%, due to immune evasion; and ii) absolute protection is reduced by 10%, and rate of waning increases by 5%. We did not simulate variants with higher infectiousness or severity. In the scenario with a variant targeted vaccine, we assumed the vaccine restored the protection lost due to the new variant in vaccine-induced immunity and partially restored protection for hybrid immunity. Novel variants were introduced over a 3-month period. A full description of the analysis is available in the Appendix (see Scenario analysis: Novel variants).

We repeated the primary analysis using a dynamic transmission model, which accounted for the indirect effects of vaccination on transmission. This analysis was designed to test the importance of considering transmission dynamics in the analysis. This model departed from the primary microsimulation model based on the following modifications. First, the force of infection term was formulated to be directly related to the number of SARS-CoV-2 infections in the population in the prior time step (week) with age-specific contact matrices35,36. Second, the simulated population included all age groups and unvaccinated individuals. Third, vaccine strategies were applied with imperfect uptake coverage by age- and immune status to reflect current uptake (Supplementary TableS7). Fourth, the model was only calibrated to match observed severe COVID-19 cases at time 0 (Supplementary TableS8). We compared booster vaccination strategies in the following groups to determine the impact of indirect effects of vaccination: i) 75+ years and moderate/severe immunocompromised; ii) 65+ years and mild and moderate/severe immunocompromised; and iii) all groups 18+ years. In all strategies, we applied one-time booster vaccination as the base case intervention to those 18+ years based on expected uptake. Study outcomes were computed among persons assigned to the booster vaccination strategies (i.e., excluding unvaccinated persons, or those who did not receive additional vaccination), to improve comparability to the primary model. A full description of the model specifications is available in the Appendix (see Scenario analysis: Dynamic transmission model).

We conducted sensitivity analyses on the main microsimulation analysis to evaluate the robustness of our findings. First, we repeated the analysis under optimistic or pessimistic assumptions on level of protection (10% lower or higher) from vaccine-induced and hybrid immunity, as well as differential waning of protection (10% lower or higher) (Supplementary TablesS13S16). Second, we repeated the analysis for a lower (0.5x) and higher (2x) incidence of severe COVID-19(Supplementary Tables S17, S18). Third, we performed analyses under the assumption that additional boosters would have lower vaccine effectiveness (i.e., immune exhaustion)(Supplementary Table S25). Fourth, we performed the analysis with higher or lower seroprevalence and an additional analysis with a population of only previously infected persons (i.e., 100% seroprevalence)(Supplementary Tables S19S21). Fifth, we repeated the analysis assuming higher proportion of sub-clinical infections(Supplementary Table S24). Additional details on sensitivity analyses can be found in the Appendix (see Sensitivity analysis).

We generated uncertainty intervals for the primary analysis based on parameter uncertainty in vaccine effectiveness and waning over time, baseline seroprevalence levels, and non-severe infection multipliers (Supplementary TableS5). This interval is generated by simulating the full range of model inputs at baseline, which define the bounds of the interval; the reported point estimate uses the base case assumption of model inputs, so the bounds are expected to be asymmetric relative to the point estimate. Uncertainty intervals are designed to demonstrate uncertainty within a single vaccine strategy under a range of baseline conditions; vaccine strategies should be compared against one another using the same set of assumed baseline model inputs.

This study was not human subjects research given use of publicly available secondary datasets with aggregated estimates that are not identifiable.

Further information on research design is available in theNature Portfolio Reporting Summary linked to this article.

Read more from the original source:

Comparing frequency of booster vaccination to prevent severe COVID-19 by risk group in the United States - Nature.com

The new guidance for COVID-19 which is combined with other respiratory illnesses no longer suggests 5-day isolation periods. (Photo by Luis Alvarez via Getty)

by Alexa Spencer

The Centers for Disease Control and Prevention (CDC) announced new COVID-19 recommendations on March 1. The list of guidelines includes an end to five-day at-home isolation periods for people who test positive for the virus.

The updated guidelines calledRespiratory Virus Guidance offer a unified approach to addressing respiratory illnesses, rather than a COVID-19-specific guidance. All recommendations now apply to COVID-19, RSV, and the flu.

The question remains: Could the relaxed guidelines have a negative impact on frontline workers and communities of color? These groups are historically vulnerable to COVID-19 exposure and poor health outcomes if the virus is contracted.

If we continue to make sure that we have the levels of vaccine coverage that weve had before, we will be in good standing, says Dr. Reed Tuckson, the former commissioner of public health for the District of Columbia. Tuckson is a co-founder and board member of the Black Coalition Against COVID.

He says Black people and professionals were able to close major vaccine disparity gaps when the primary series was released. During that time, vaccines were administered at no-cost. Today, COVID-19 shots are available for free under insurance plans when the provider is in-network. For uninsured people, the federal governmentsBridge Access Programcovers the cost, but the program is set to end on December 31.

Tuckson also says combining recommendations may be helpful.

They decided to simplify things so that it just makes more sense for people to actually be able to implement the guidance. The context is that the flu season and the RSV season have now all become one with the COVID season, he told Word In Black in a phone interview.

The CDCs core respiratory illness prevention steps include:

Regarding isolation time, the Respiratory Virus Guidance recommends that people with symptoms of a virus isolate at home until theyre fever-free without the use of medicine for 24 hours. Similarly, they recommend one isolate until any other symptoms improve within the same time period.

Some people find it concerning that the CDC is ending the official five-day isolation period for COVID-19 and allowing people to leave home before all of their symptoms are completely cleared up. Tuckson says the CDC still wants infected people to isolate if theyre sick.

You still want to be cautious. And I would recommend personally that if youre still feeling unwell, dont go to work, dont be around others, he says.

Mandy Cohen, director at the CDC, shared similar sentiments.

We still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory virusesthis includes vaccination, treatment, and staying home when we get sick, Cohen said in a statement.

But The Peoples CDC, a coalition of public health practitioners, scientists, healthcare workers, educators, advocates and people from all walks of life working to reduce the harmful impacts of COVID-19, disagrees. In a March 4 op-ed published onReckon, the group wrote that the CDCs rollback of the 5-day isolation protocol ignores the dangers of long COVID, and that intra-office transmission of COVID-19, a result of already insufficient workplace protections, leads to repeated episodes of short staffing levels.

The coalition wrote that instead, we need mandated universal paid sick leave and funding for long COVID-19 prevention and treatments, among other population interventions. We do not need more people spreading COVID-19 at work.

According to the CDC, the updated guidelines are in response to a drop in hospitalizations and deaths associated with COVID-19. Compared to January 2022, weekly hospital admissions have decreased by more than 75% and deaths by more than 90%, the agency reported.

In the first week of 2024, 35,097 people were hospitalized, the CDC COVID-19 tracker shows. Limited federal data is available on the number of people who die from the virus-19. According to data collection by BNO News, 1,652 Americans died in the week between February 25 and March 3.

In addition to rates of poor health outcomes related to COVID-19, the CDCs new guidance considered the cost of extended isolation, which included the fact that people with limited sick time may experience a financial loss.

The bottom line is that when people follow these actionable recommendations to avoid getting sick, and to protect themselves and others if they do get sick, it will help limit the spread of respiratory viruses, and that will mean fewer people who experience severe illness, Dr. Demetre Daskalakis, director at the National Center for Immunization and Respiratory Diseases, said in a statement.

The CDC also recommends that people get vaccinated and utilize testing. Shortly after the agency announced its new guidance, the White House announced an end to its free at-home COVID-19 test program. In the past, every household could order four tests by visiting COVIDtest.gov. As of Friday, March 8, that option will be suspended.

More:

What Do The New COVID-19 Guidelines Mean For Your Health? - Seattle Medium

In a recent study published in Frontiers, researchers investigated the transmission- and immunoglobulin G (IgG) viral neutralization potential of coronavirus disease 2019 (COVID-19) booster vaccine products (antibodies) passed from mother to offspring through breastmilk.

They evaluated the IgG concentrations of milk, plasma, and stool samples from 24 infants and 34 vaccinated mothers, 14 of whom received COVID-19 booster doses during the study.

Study:COVID-19 booster enhances IgG mediated viral neutralization by human milkin vitro. Image Credit:BaLL LunLa/Shutterstock.com

Study findings reveal that booster vaccination substantially increased IgG levels in mothers' milk and infants' stool samples compared to unvaccinated participants.

In vitro neutralization experiments using a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-like pseudovirus shows a 60% increase in the viral neutralization efficacy following the COVID-19 booster, highlighting the potential of booster dosed breastmilk to augment the otherwise poor immunity of infants against this terrible disease.

The coronavirus disease 2019 (COVID-19) pandemic is one of the most disease outbreaks in human history, claiming almost 7 million lives and leaving hundreds of millions more debilitated since its discovery in late 2019.

While the rapid global development and administration of anti-COVID-19 vaccines significantly reduced disease impacts, infants present a vulnerable cohort because they are too young for conventional vaccinations, compounded by their underdeveloped immune systems.

Maternal vaccination during breastfeeding has been shown to effectively confer their infants protection against a number of viral diseases, with the United States (US) Centers for Disease Control and Prevention (CDC) recommending the intervention against whooping cough, respiratory syncytial virus (RSV), influenza, and most recently, COVID-19 (albeit with hitherto limited to no evidence backing the latter).

Previous work by the present research group established the presence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Immunoglobulin G (IgG) and IgA antibodies in human breastmilk and infant fecal matter, with Halasa and colleagues validating the benefits of maternal COVID-19 vaccination in infant immunity shortly after in 2022.

Unfortunately, subsequent studies revealed this immunity to be short-lived, with evidence suggesting substantial antibody concentration declines six months following vaccination.

While mRNA booster vaccine doses have proved instrumental in maintaining adult immunity against the pandemic, the transmission and viral neutralization efficacy of booster-derived, breastmilk-transmitted anti-COVID-19 antibodies remains unknown.

The present study aims to evaluate SARS-CoV-2 antibody titers in the milk and plasma of mother (following booster vaccine reception) and the stools of their infants.

They further use in vitro viral neutralization assays to elucidate the efficacy of these antibodies in eradicating VSV-gfp-SARS-CoV-2-S-gp, a SARS-CoV-2-like pseudovirus. The study was conducted at the University of Florida between December 2020 and May 2022.

It comprised 39 breastfeeding mothers and 25 infants, 34 and 24 of whom were included in the final analyses (due to lack of complete data for missing participants).

Study data included maternal/infant demographics, family and medical histories, and vaccination side-effects, collected via participant-completed questionnaires.

Additionally, blood (for plasma), milk, and stool samples were collected during enrolment and at each of the seven follow-up sessions included in the study design.

Of the included cohort, 14 mothers received a mRNA booster dose and comprised the cases against which the non-booster vaccine-receiving controls were compared.

Enzyme-linked immunosorbent assays (ELISAs) were used to measure IgA and IgG titers in plasma, milk, and fecal samples.

A SARS-CoV-2 Spike glycoprotein-expressing Vesicular Stomatitis Virus (VSV-gfp-SARS-CoV-2-S-gp) alongside infection-competent human ACE2 receptor expressing Baby Hamster Kidney fibroblasts (BHK cells) were used for in vitro neutralization assays.

The MTT (3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide) assay was used to measure antibody neutralization efficacy. Modified plaque reduction assays were conducted to confirm MTT results.

Demographic data analyses revealed that most of the 34 mothers and 14 included infants were non-Hispanic White women (mean age mid-30s and 10 months, respectively).

Booster vaccine doses were observed to substantially increase IgG concentrations in milk, plasma, and blood samples.

While IgA levels were also shown to persist above pre-vaccination levels following booster administration, these increases were found to be more subdued. These findings were mirrored when evaluating infants' stool samples' immunoglobulin titers.

"Throughout the 12-month period, we observed a less dynamic response in IgA levels in both human milk and plasma. The booster primarily triggered a rise in IgG levels, indicating a shift in the immune response toward a stronger IgG-mediated protection against SARS-CoV-2."

Spearman correlations further present that the concentrations of IgG in milk and plasma are correlated, suggesting that one may be used as a proxy for the other in situations wherein specific blood or milk samples are unavailable for analysis.

These findings also highlight a time-dependent IgG titer response, with IgG concentrations progressively declining on advancing duration following booster reception.

Most notably, in vitro neutralization assays found significant increases in milk- and plasma-derived IgG neutralization efficacy, with estimated 60% and 90% improvements, respectively.

Validating these results using milk IgG depletion experiments showed that milk samples' viral neutralization efficacy significantly declined following IgG depletion.

" Our results, from both the plaque reduction assay and MTT, show that cell survival and cellular activity is protected and preserved in cells treated with boosted plasma or milk during in vitro VSV-gfp-SARS-CoV-2-S-gp infection."

The present study corroborates previous research highlighting the benefits of maternal vaccinations in reducing COVID-19 infection risk in breastfeeding infants.

Most notably, it highlights the potential of anti-COVID-19 booster doses to more than offset time-dependent IgG efficacy declines, evident through the boosters' impacts on plasma, milk, and infant stool IgG titers.

"Although future studies are necessary to fully elucidate the specific mechanisms whereby luminal IgG confers infant protection, these works highlight the protective role of maternal milk-derived IgG. Our current studies add to the existing body of literature, further underscoring the importance of human milk-derived IgA and IgG in promoting infant health."

Original post:

COVID-19 booster enhances virus neutralizing antibodies in breast milk, new study reveals - News-Medical.Net

Researchers from the National Centre for Biological Sciences (NCBS) have in a study published in The Lancet Regional Health Southeast Asia on March 6, shared key insights into the effectiveness of Covishield and Covaxin the two most used COVID-19 vaccines in India, the Hindustan Times reported.

The study, titled 'Immunogenicity of SARS-CoV-2 vaccines BBV152 (COVAXIN) and ChAdOx1 nCoV-19 (COVISHIELD) in seronegative and seropositive individuals in India: a multicentre, non-randomized observational study', compared the immune responses in users for Covishield v Covaxin, it added.

The study involved collaboration between 11 institutes, including at least six from Pune. These six included the Indian Institute of Science Education and Research Pune (IISER), the National Chemical Laboratory (NCL), the National Centre for Cell Science (NCCS), and the Pune Knowledge Cluster.

Covishield was AstraZeneca's COVID-19 vaccine produced and branded locally by the Adar Poonawalla-led Serum Institute of India (SII) in Pune, while Covaxin was developed and produced by the Hyderabad-based Bharat Biotech.

1. Covishield's Robust Immune Responses: The comprehensive study, conducted from June 2021 to January 2022 and encompassing 691 participants aged 18 to 45 from Bangalore and Pune, found that Covishield, which employs a virus vector for spike protein delivery, consistently showed more robust immune responses than Covaxin, an inactivated virus vaccine.

2. Differential Immune Responses: The majority of participants exhibited a near-complete immune response to Covishield, while the response to Covaxin varied, particularly among those vaccinated before the emergence of the Omicron variant.

3. Antibody Levels and T Cells: Covishield induced higher antibody levels in both seronegative (individuals without prior exposure) and seropositive (individuals with prior exposure) subjects, suggesting a more potent and enduring immune response. Additionally, Covishield triggered a higher number of T cells compared to Covaxin, indicating a stronger overall immune response.

4. Protection Against Variants: Covishield consistently demonstrated higher antibody levels against various virus strains, suggesting its potential superior protection against variants such as Omicron.

Follow-up studies on vaccine immunology and the analysis of immune protection factors were lacking and theres a scarcity of comparative studies on these two vaccines. This is one of the very few studies that not only investigates the immune responses of participants after vaccination but also considers their immune history prior to vaccination," said Dr Mangaiarkarasi Asokan, former programme head, of VISION, and lead author of the study.

"While there was a whole lot of talk going on about which vaccine performed better against the COVID-19 virus, for us in India, only two vaccines were available and the majority of citizens were vaccinated in a phase-wise manner," said Vineeta Bal, emeritus professor, Biology, IISER Pune on the overall significance of this research.

She added that before this study, there was no comparison data available about the performance and effectiveness of these vaccines. "Some people only had data on Covaxin while others had data on Covishield. For the first time, this study has given us the comparative data for both vaccines," she added.

Bal also added that they pioneered technology to conduct this study, which will "now be helpful for immunology assessment in future".

Professor LS Shashidhara, centre director, NCBS, called it a "first-of-its-kind population-level immunological study on vaccines" and noted that it is significant as the virus is "still spreading and evolving".

"Such studies need serum samples from diverse subjects representing genetic, geoclimatic and nutritional diversity and innovative study design and rigorous statistical methods. No one single organisation can undertake such a study. We are grateful to all our partners and indebted to Hindustan Unilever for its generous funding. Results of this study so far and additional research that we are pursuing will have major inputs for future vaccine strategies as a public health programme," he added.

Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed it's all here, just a click away! Login Now!

See more here:

COVID-19 Vaccine: Covishield outperforms Covaxin in first-of-its-kind comparative study. Key things to know | Mint - Mint

A German man deliberately got 213 COVID-19 vaccine shots in less than a year, becoming a walking experiment for what happens to the immune system when it is vaccinated repeatedly against the same pathogen.

A correspondence published Monday in the journal Lancet Infectious Diseases outlined his case and concluded that while his hypervaccination did not result in any adverse health effects, it also did not significantly improve his immune response.

The 62-year-old man from Magdeburg is not named in the correspondence in compliance with German privacy rules. Of the shots, 134 were confirmed by a prosecutor and through vaccination center documentation; the rest were self-reported.

According to his immunization history, the man got his first COVID vaccine in June 2021, then went on to get 16 more that year.

He ramped up his efforts in 2022, getting 48 shots in January and 34 in February.

Around that time, German Red Cross staff members in Dresden became suspicious and issued a warning to other vaccination centers, encouraging them to call the police if they saw the man, CNN affiliate RTL reported.

In March 2022, he was detained in a vaccination center in Eilenburg by police who suspected him of selling vaccination cards to third parties, according to RTL. The public prosecutor in Magdeburg opened an investigation but did not end up filing criminal charges, according to the study.

The researchers read about the man in the news and reached out to him in May 2022. He agreed to provide medical information, blood and saliva samples. By that point, he was 213 shots in; he later got four more, against the researchers medical advice, said Kilian Schober, senior author of the new study and a researcher at the Friedrich-Alexander University Erlangen-Nrnberg

This is a really unusual case of someone receiving that many COVID vaccines, clearly not following any type of guidelines, said Dr. Emily Happy Miller, an assistant professor of medicine and of microbiology and immunology at Albert Einstein College of Medicine who did not participate in the research.

The man did not report any vaccine-related side effects and has not had a COVID infection to date, as evidenced by repeated antigen and PCR testing between May 2022 and November 2023. The researchers caution that its not clear that his COVID status is directly because of his hypervaccination regimen.

Perhaps he didnt get COVID because he was well-protected in the first three doses of the vaccine, Miller said. We also dont know anything about his behaviors.

Schober said it is important to remember that this is an individual case study, and the results are not generalizable.

The researchers also say they do not endorse hypervaccination as a strategy to enhance immunity.

The benefit is not much bigger if you get vaccinated three times or 200 times, Schober said.

The researchers analyzed his blood chemistry, which showed no abnormalities linked to his hypervaccination. They also looked at various markers to evaluate how his adaptive immune system was functioning, according to the study.

In total, the man got eight vaccine formulations, including mRNA vaccines from Pfizer/BioNTech and Moderna, a vector-based vaccine from Johnson & Johnson and a recombinant-protein vaccine from Sanofi. He got them in both arms.

Read the rest here:

A man deliberately got 213 COVID shots in less than a year. Here's what happened then. - OCRegister

EXCLUSIVE Florida Surgeon General Joseph Ladapo is standing firm behind his controversial decision not to force an isolation period for children not vaccinated against measles after an outbreak in his state in February, saying that erring on the side of individual choice should be a key lesson from the COVID-19 pandemic.

What honestly breaks my heart but I hope that people recognize is that, unfortunately, the same people who were ready to drive the car into the ground and take everyone down with them during COVID have learned no lessons, Ladapo said in an exclusive interview with the Washington Examiner.

Ladapo has drawn extensive public criticism after the outbreak of a cluster of six measles cases at Manatee Bay Elementary School in the Fort Lauderdale area.

On Feb. 20, Ladapo issued a statement to parents in the district, deferring to parents and guardians to make the decision about whether or not to send unvaccinated children to school.

Ladapos directive contradicts the general guidance from the Centers for Disease Control and Prevention for measles outbreaks, which recommends that unvaccinated people remain isolated for up to 21 days following potential contact with a measles patient due to the likelihood of transmission and the possibility of the unvaccinated patient developing symptoms. In this case, Ladapo said the generic guidance seemed completely excessive.

Ladapo said that, given that 97% of the students at the school had received at least one dose of the MMR vaccine, the decision to defer to parents was much more humane, much more practical, and much more sustainable.

In my judgment, thats a completely reasonable decision, considering the circumstances and considering what we know about the immunity rate in the community, the effectiveness of the vaccine, and the cost associated with isolation and keeping kids out of school for so long, Ladapo said.

Although the federal recommendation for isolation is 21 days, Ladapo noted that other countries have looser restrictions depending upon local conditions, including the inability of parents to provide child care for children other than public schools.

The World Health Organizations national-level guidance, which Ladapo cited in his interview with the Washington Examiner, says that pragmatic decisions often guide national policies, following a risk-benefit assessment.

Rep. Debbie Wasserman Schultz (D-FL), who represents the Fort Lauderdale region in Congress, called for the removal of Ladapo from his post over his handling of the incident, saying that his policies are a stark contrast to bipartisan public health success.

Ladapo instead politicizes public health and peddles risky freedom of choice rhetoric that fuels vaccine hesitancy and downplays the public and personal health necessity for vaccination, Wasserman Schultz said in a press conference last week.

George Washington University public health professor and former Planned Parenthood President Leana Wen called Ladapos policies outrageous and a preventable tragedy in a Washington Post op-ed, saying that lockdown measures are sometimes essential to control a public health crisis.

In contrast to Ladapos policy, Wen praised the 2019 decision of New York Commissioner of Health Oxiris Barbot to force unvaccinated people to take the MMR vaccine or pay $1,000 during a measles outbreak. As draconian as these steps might have seemed, they were taken only because it was necessary [to] stop an extremely contagious and highly devastating disease from resurging, Wen said.

Ladapo told the Washington Examiner that he did not make his policy decision lightly, saying that containing an outbreak must be weighed with other political and policy goals, such as learning loss from school isolation.

Its absolutely a fact that measles is very contagious, but the idea that the only thing that matters is reducing the risk of contagion to as low as you possibly can, even if that involves taking draconian measures, that, unfortunately, is what we saw during the pandemic, Ladapo said.

As of the beginning of March, 41 measles cases had been reported in 15 states and New York City. Other countries have struggled recently with measles outbreaks, including Canada and the United Kingdom.

Measles is one of the most contagious known infectious diseases, with 9 in 10 people who do not have either vaccine or natural immunity likely to become infected after exposure.

Children under 5 are most susceptible to serious cases of measles, which can result in lifelong neurological damage, including loss of vision or hearing. One in every 20 children infected with measles can develop pneumonia, which is the leading cause of death from the disease.

The vaccination against measles, mumps, and rubella, or MMR, is highly effective in preventing infection, with those who have at least one dose of the MMR vaccine obtaining 93% immunity, according to the CDC. Immunity against measles goes up to 97% with all three doses.

Following CDC and WHO recommendations, the Florida Department of Health provided information and literature to parents on the risks involved with measles infections and provided pop-up vaccination clinics in the school district to encourage vaccination.

Ladapo said that not many families chose to have their children vaccinated at the clinics, likely because they were more comfortable not receiving a measles vaccine, not changing their mind in terms of the decision they had already made about declining that particular vaccine.

According to the CDC, the American Medical Association, and the American Academy of Pediatrics, the MMR vaccine, which was first developed in 1971, has very small risks of complications.

We allow [vaccine refusal] in Florida, which is a good thing, Ladapo said. We allow parents to make that decision about what they put in their kids bodies.

When asked about the growing problem of vaccine hesitancy worldwide, Ladapo said reasonable skepticism of public health recommendations is very sane and rational and wise in light of a lack of transparency from public health leaders, particularly the CDC and the Food and Drug Administration.

Ladapo earned his joint MD/Ph.D. degree in health policy from Harvard University in 2008 with a research focus on behavioral economic strategies for cardiovascular disease prevention prior to being selected by Gov. Ron DeSantis (R-FL) for surgeon general in September 2021.

Ladapo has frequently generated significant controversy by contradicting the CDC and other public health agencies and professional groups on COVID-19 epidemiology and policy.

In November 2020, Ladapo wrote an op-ed for the Wall Street Journal advocating the use of ivermectin and hydroxychloroquine even without randomized studies demonstrating efficacy. As surgeon general, Ladapo has called for a pause in the use of mRNA vaccine technology due to concerns about genetic material contamination.

CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER

In Ladapos view, people who have grown skeptical of public health recommendations since the pandemic felt that they were being lied to or manipulated and that the information they were receiving and the recommendations they were receiving were not trustworthy.

Im sure [that] has contributed to more people questioning recommendations in general, including vaccination recommendations, Ladapo said.

More:

Florida surgeon general says controversial measles policy informed by lessons from COVID-19 - Washington Examiner