Category: Covid-19 Vaccine

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Analysis of Dutch cities mortality doesnt show that COVID-19 vaccines increase the risk of death, contrary to Berensons interpretation – Health…

August 18, 2022

CLAIM

New paper suggests Covid mRNA vaccination rates are linked to increases in overall deaths

DETAILS

Misrepresents source: The preprint used to support the claim investigated the correlation between the distribution of mortality across Dutch cities and COVID-19 vaccination coverage. However, Berenson presented some numerical results as if it were an increase in overall mortality. Furthermore, this numerical result wasnt adjusted for possible bias. Inadequate support: The preprint used to support the claim used city-level data and not individual-level data which precludes drawing conclusions on the impact of vaccination on the risk of dying. Furthermore, all possible confounding factors arent accounted for, which may bias the final results.

KEY TAKE AWAY

COVID-19 vaccines have been tested in several large clinical trials. Their effectiveness largely outweigh the risk of rare side effects. A study comparing vaccination coverage and all-cause mortality in Dutch cities doesnt show that COVID-19 vaccines increase the risk of dying. The studys design is not appropriate to draw such a conclusion.

REVIEW More than 80% of the Dutch population over 12 has been vaccinated against COVID-19, as of August 2022. Large clinical trials and ongoing monitoring of the millions vaccinated worldwide show that COVID-19 vaccines effectiveness largely outweigh the risks of rare side effects and effectively protect against severe forms of the disease.

However, inaccurate claims that these vaccines are dangerous, increase the risk of death, or weaken the immune system frequently circulated on social media, and Health Feedback already debunked several of them.

Journalist Alex Berenson made such a claim in July 2022 when he stated on Substack that new results suggested Covid mRNA vaccination rates are linked to increases in overall deaths. Berenson had made multiple inaccurate and misleading claims about COVID-19 and vaccines that Health Feedback previously debunked.

In his article from 28 July 2022, Berenson reported on a preprint (a study not yet peer-reviewed or accepted by a journal) published by Andr Redert, who previously worked as a researcher in computing sciences but is not trained in virology, immunology, or epidemiology. In that preprint, Redert compared the all-cause mortality and vaccination coverage in Dutch cities.

Although Berenson acknowledged that the preprint doesnt demonstrate that vaccination caused an increase in all-cause mortality, this is implied by the Substack articles headline. Berenson also combined his take on Rederts preprint with observations of increased all-cause mortality in highly vaccinated countries. Regardless of whether this last statement is accurate, it is clear that Berensons subtext is that mRNA vaccination causes an increase in mortality. The readers comments section at the bottom of the article clearly shows that this is how his article is interpreted.

As we explain below, however, Berensons interpretation is incorrect and based on a flawed interpretation of the preprints results. Rederts preprint itself suffers from limitations that weaken the conclusions that can be made about vaccine safety.

In his paper, Redert looked at the distribution of mortality and vaccination coverage between Dutch cities. Some cities presented an all-cause mortality above average, and others, below. Similarly, some cities had vaccination coverage above the national average and other cities below. Redert then tried to determine if there was a correlation between the two and, if so, what proportion of the mortality was distributed across cities in the same way as vaccination coverage. In other words, Redert asked to what extent a city with an above average vaccination coverage would see its all-cause mortality also rise above average or, conversely, drop below average.

Redert observed that the weekly mortality partially correlated with vaccine coverage. In other words, cities with an all-cause mortality above average tended to also exhibit vaccination coverage above average.

However, it is important to stress that Rederts preprint only established correlations between vaccination coverage and mortality, and didnt demonstrate any causal association. Correlation by itself doesnt prove that one event is the cause of another. Rederts preprint also doesnt provide any biological explanation or medical evidence showing that vaccination increases the likelihood of dying.

Furthermore, Redert used city-level data: all-cause mortality and vaccination coverage in that same city. Drawing conclusions on the risk of individuals dying from average data obtained at the city level is known as an ecological fallacy. In our case, city-level data tell us nothing as to whether vaccinated people were overrepresented among those who died, for instance.

Therefore, data from Rederts preprint arent suitable to support Berensons suggestion that vaccination is linked to an increase in all-cause mortality.

In his account of Rederts preprint, Berenson misinterpreted some of the results and used them to draw ill-founded conclusions.

Redert provided the example of a given week where 5% of the total 4,000 deaths from all causes of that weekthat is, 200 deathswere distributed between cities in the same way the vaccination coverage was. The remaining 3,800 deaths were distributed across cities in a manner uncorrelated with vaccination coverage.

Berenson apparently interpreted this 5% of vaccination-correlated mortality as an increase in the total number of deaths, because he also claimed that his 5% figure was consistent with other data reporting a 5% excess mortality in several countries. He then went on to comment that a 5% increase would actually represent many more dead people in the long run.

However, Berensons interpretation of this piece of data is erroneous. This 5% figure from Rederts preprint is not related to the number of all-cause deaths that Berenson cited. Rederts analysis focused on the distribution of deaths across all cities, not on the total number of deaths. In fact, Redert warned: These [5% deaths] are not 200 additional deaths related to vaccination, it means that 200 out of 4k deaths were distributed over municipalities in the same pattern as vaccination coverage.

Also, this 5% figure is the result of Rederts analysis for one weekweek 50 of 2021used as an example and isnt necessarily representative of the entire pandemic, contrary to what Berenson suggested.

Third, many confounding factors bias the direct comparison of all-cause mortality and vaccination coverage. Confounding factors are variables that affect the outcome of an experiment, but arent the variables being studied. If scientists dont factor in the influence of confounding factors in their study, they may draw erroneous conclusions about causality. For example, older people are more likely to get vaccinated against COVID-19 and to die from any cause. Therefore, one would expect that cities with an older population will exhibit a higher than average vaccination coverage and a higher all-cause mortality without any causal association between the two.

Redert was well aware of these confounding factors and proposed a way to take them into account by normalizing his results to pre-pandemic mortality data. However, this 5% figure Berenson extracted from the preprint comes from the raw data and not from the normalized data adjusted for confounding factors. Considering all the above, it is clear that Berensons take on Rederts paper is thus flawed and his conclusions are inaccurate.

Even when considering the adjustments for confounding factors proposed by Redert, the studys design limits what can be concluded from it.

First, Redert used weekly mortality data, but these data were compared with the final vaccination coverage of November 2021. In order to really compare if the mortality correlated with the vaccination coverage, at least partially, it would be better to use mortality and vaccination coverage data from the same week. Given that the study aimed to investigate whether vaccination impacted all-cause mortality, one could even imagine comparing the mortality of a given week with the vaccination coverage of an earlier time period, but not with the final vaccine coverage.

Second, Redert took into account some important confounding factors by normalizing his results by the mortality in 2019, before the COVID-19 pandemic. While this can correct confounding factors due to demographic, such as age or wealth, it would not correct for any other possible confounding factors that would affect both all-cause mortality and vaccine coverage during the pandemic. For instance, we can hypothesize that cities heavily impacted by COVID-19 will tend to vaccinate more, resulting in higher vaccination coverage, but at the same time would suffer from greater disruption to vital elements such as transport and healthcare that could worsen all-cause mortality.

Berenson incorrectly suggests that COVID-19 vaccination can increase all-cause mortality based on the results from a non-peer-reviewed publication. However, Berensons interpretation of the publication is flawed. Furthermore, several limitations in the design of the study itself make it impossible to draw conclusions from the results. By contrast, large clinical trials, as well as the millions vaccinated against COVID-19 in real-world conditions show that COVID-19 vaccines benefits largely outweigh their risks.

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Analysis of Dutch cities mortality doesnt show that COVID-19 vaccines increase the risk of death, contrary to Berensons interpretation - Health...

The BCG vaccine against COVID-19 and other infectious diseases in type 1 diabetic adults – News-Medical.Net

August 18, 2022

A recent article published inCell Reports Medicine demonstrated that Bacillus Calmette-Guerin (BCG) vaccinations might offer a platform for protection against emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogenic infections in type 1 diabetics.

During the past 17 years, randomized clinical studies and epidemiological investigations showed that the BCG vaccine against tuberculosis protected people from numerous infections, such as upper respiratory tract infections, malaria, leprosy, bacterial, and viral infections. Additionally, the BCG vaccine might safeguard humans from immunological disorders like multiple sclerosis and type 1 diabetes.

There is a demand for effective and safe platform vaccines to immunize against SARS-CoV-2 infection and other contagious pathogens. As the SARS-CoV-2 pandemic got underway, epidemiological studies started to find a link between neonatal BCG vaccination and lower coronavirus disease 2019 (COVID-19) mortality and morbidity, even in elderly adults decades following the standard newborn vaccinations on a nation-by-nation basis. On the contrary, several global groups with various neonatal exposures, BCG strains, and other communities did not exhibit these benefits.

Since adults or newborns have never received the BCG vaccine in the United States (US), a randomized study of BCG for potential COVID-19 protection provides a clear comparison in a vaccine-naive US adult population.

In the current placebo-controlled, double-blinded, randomized phase II/III research, the scientists assessed the efficacy and safety of the multi-dose BCG vaccinations for preventing COVID-19 and other infectious illnesses in a SARS-CoV-2-unvaccinated, high-risk-community-based group, over 15 months, from 1 January 2020 to April 2021.

The authors aimed to discover whether the BCG vaccine would provide a platform vaccine approach to safeguard against a wide range of infectious diseases, such as SARS-CoV-2 infection in the at-risk population.

Type 1 diabetic adults were considered the high-risk group in the study. The team recruited 144 participants and randomly assigned 48 to placebo and 96 to BCG arms. Further, no volunteers dropped out during the 15-month research.

The present parallel trial was derived from an ongoing randomized, double-blinded study of BCG for treating long-established adult type 1 diabetes. Therefore, all participants were fully immunized with three BCG or placebo vaccinations at the SARS-CoV-2 pandemic onset in the US on 1 January 2020.

The study results indicated that, contrary toantigen-specific COVID-19 vaccinations, no participants experienced any systemic side effects from BCG during the vaccination period. Localized skin reactions are a known side effect of the BCG vaccine and typically start between two and four weeks after vaccination. No excessive local responses were documented as adverse reactions. Notably, other SARS-CoV-2 vaccinations were not yet available during the timespan of the trial and had no impact on the research.

The BCG vaccine was 92% effective against SARS-CoV-2 infection, with a cumulative incidence of 1% of BCG-treated subjects and 12.5% of placebo-treated volunteers meeting the criteria for confirmed COVID-19 diagnosis based on symptoms and positive serologies. Besides, the team discovered no polymerase chain reaction (PCR)-positive symptomatic subjects in the BCG arm, i.e., 0%, compared to five symptomatic, PCR-positive participants in the placebo cohort, i.e., 10.4%.

If only the PCR data were regarded, these results demonstrated 100% efficacy for the BCG vaccine against SARS-CoV-2 infection at 0.99 posterior probability. In addition, there were no SARS-CoV-2-related deaths in either the placebo group or the BCG group.

The researchers noted that excluding the COVID-19 viral epitope II, practically all SARS-CoV-2 domains included in the heatmap comparisons exhibited anoticeably greater cumulation of antibody reactivity in the placebo cohort relative to the BCG arm. Besides, BCG vaccination decreased the duration and severity of all infectious illness symptoms versus the placebo group.

Moreover, the study data showed that all infectious illness symptoms of BCG recipients were similar to or less severe than those of their household members. On the other hand, relative to their household members, most placebo participants experienced a more severe illness. BCG recipients typically felt mildersymptoms than placebo recipients or non-diabetic householdcontrols.

In conclusion, the study illustrated that the BCG vaccine offers efficient protection against COVID-19 and comprehensive protection against other infectious diseases in type 1 diabetic adults in the US.

The study findings also depicted that the BCG vaccination was efficient, safe, cost-effective, and perhaps protective against the constantly evolving SARS-CoV-2 strain of the COVID-19 pandemic, given its extensive protection against other infections. The authors mentioned that although the efficacy of the BCG vaccine requires one to two years to manifest, the immunity might last decades.

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The BCG vaccine against COVID-19 and other infectious diseases in type 1 diabetic adults - News-Medical.Net

Novavax shares plunge on weak demand for its COVID-19 vaccine – CBS News

August 11, 2022

Shares of COVID-19 vaccine maker Novavax cratered Tuesday as the U.S. biotech company slashed its sales forecast due to a slump in demand for its shots. The company's stock dived 31% after it cut its 2022 sales outlook in half.

Novavax's protein-based vaccine was a latecomer to the market. It was authorized by the Food and Drug Administration for use by adults in the U.S. onlylast month, long after a majority of adults had already been vaccinated with Pfizer, Moderna or Johnson & Johnson shots. Only 7,381 Novavax vaccine doses have been administered in the U.S., government data shows.

The company alluded to softening demand for the COVID-19 vaccine in its earnings call Monday. Novavax CEO Stanley Erck said that hurdles in getting approval to administer booster shots and first doses to younger Americans have also hurt sales, as these applications are the company's best bet for finding a market.

The Novavax COVID-19 vaccine has not been authorized by the FDA for use as a booster vaccination.

"Receiving booster and adolescent label expansions globally has taken longer than expected, and expanding our label is our core commercial priority. When coupled with global oversupply, this drove a shift in demand for our vaccine from the second quarter into the second half of the year and into 2023," Erck said in the call.

Novavax does not expect any additional revenue through Covax, an international alliance aimed at ensuring vaccine equity by delivering doses to low- and middle-income countries. The company had expected to sell 350 millions shots through the partnership.

Wall Street analyst Adam Crisafulli of Vital Knowledge highlighted Novavax's earnings miss. Revenue for the second quarter came in at $186 million, versus Wall Street forecasts of $975 million.

Novavax slashed its full-year earnings guidance to $2 billion to $2.3 billion, from a previous estimate of $4 billion to $5 billion.

"It's just an issue of earnings and guidance. The report last night was pretty disappointing and the guidance was slashed significantly. From a bigger-picture perspective, there's a sense that the COVID opportunity is diminishing overall while Novavax just came out of the gate too far behind the mRNA products," Crisafulli told CBS MoneyWatch.

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Novavax shares plunge on weak demand for its COVID-19 vaccine - CBS News

COVID-19 boosters this fall? Most older adults are ready to roll up their sleeves – Michigan Medicine

August 11, 2022

The new poll shows that only 19% of people age 50-64, and 44% of people over 65, have gotten two booster doses.

With officially reported cases surging in recent weeks, and many more cases going unreported because results of at-home tests arent tracked, the poll has some surprising findings about older adults experiences with the disease and testing.

In all, 50% of those aged 50 to 64, and 69% of those over age 65, said they had never had COVID-19 by late July 2022.

In the 50-to-64 age group, 29% said they had had COVID-19 once, 9% said they had had it more than once, and 12% said they may have had it but werent sure.

In the over-65 group, 24% said they had had it once, 2% had had it more than once and 5% said they may have had it.

At-home tests, which were scarce until early 2022 and have been made available for free through the federal government, health insurance companies and community locations, have been used by 44% of older adults. The percentage who had ever used an at-home test was highest among those aged 50 to 64, those with higher incomes and education levels, and those who are working.

Meanwhile, 57% of older adults had had PCR testing, which is what feeds the official reporting of COVID-19 rates, but has become less widely used in recent months given the ease and availability of at-home tests. The same groups that were more likely to have used at-home tests were also more likely to have had a PCR test.

SEE ALSO: Which older adults are getting their flu shots and COVID boosters?

But 28% of those over age 65, and 22% of those age 50 to 64, said they had never been tested for COVID-19. Those with high school educations or less, and those with incomes under $30,000, were most likely to say this.

Of those who said they had had COVID-19 at least once, 21% said they had never gotten a test but had had symptoms. Meanwhile, 53% of this group said they had tested positive on a home test and 43% said they had a positive PCR test; respondents could indicate that they had tested positive on both kinds of tests.

Fall booster attitudes varied based on COVID-19 history. Two thirds (66%) of those who had not had COVID-19 by the time they took the survey, and had received a COVID-19 vaccine in the past, said they were very likely to get a fall booster, as did 56% of vaccinated people who had had COVID-19 once.

Meanwhile, 39% of those who had had COVID-19 more than once, and had received at least one dose of COVID-19 vaccine, said they were not likely to get a booster this fall.

The poll also asked older adults if they plan to get vaccinated against influenza this fall; the optimal time for this years flu shots is likely to coincide with the availability of new COVID-19 boosters. Vaccine experts have advised in the past that the two vaccines can be given at the same time.

The difference between the two age groups was striking:

74% of people over 65 said they were very likely to get a flu shot, compared with 46% of people age 50 to 64.

Another 13% of the younger group, and 6% of the older group, said they were somewhat likely to get a flu shot.

Education level made a big difference in flu shot likelihood, with 70% of those who have college degrees or higher saying they are very likely to get a flu shot, compared with 53% of those whose formal educations ended earlier.

Three quarters (75%) of those who said they were very likely to get a flu shot were also people who had gotten at least one dose of COVID-19 vaccine and said they were very likely to get a fall COVID-19 booster.

In contrast, 20% of those who have never gotten a dose of COVID vaccine said they were likely to get a flu shot.

We cant forget that flu can pose a threat to older and more medically vulnerable adults, and the same precautions that work against COVID-19 vaccination, masks, good ventilation and keeping sick people away from others until their symptoms are over work against flu, says Malani. Although we avoided a twindemic of both viruses at once last winter, its not clear well be so lucky again this winter. I encourage everyone to follow the CDC recommendations for their age and health status regarding vaccination and prevention.

The National Poll on Healthy Aging results are based on responses from a nationally representative sample of 1,024 adults aged over 50 from the Foresight 50+ Omnibus panel, which draws from the Foresight 50+ Panel by AARP and NORC at the University of Chicago who answered a wide range of questions online and by phone in late July, 2022. Questions were written, and data interpreted and compiled, by the IHPI team.Read past National Poll on Healthy Aging reports.

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COVID-19 boosters this fall? Most older adults are ready to roll up their sleeves - Michigan Medicine

64.7% of Wisconsinites have received one dose of the COVID-19 vaccine – WeAreGreenBay.com

August 11, 2022

WEDNESDAY 8/10/2022, 1:56 p.m.

(WFRV) The Wisconsin Department of Health Services has reported 1,584,203 total positive coronavirus test results in the state and 13,255 total COVID-19 deaths.

Unable to view the tables below?Click here.

The DHS announced an attempt to verify and ensure statistics are accurate, some numbers may be subject to change. The DHS is combing through current and past data to ensure accuracy.

Wisconsins hospitals are reporting, that the 7-day moving average of COVID-19 patients hospitalized was 534 patients. Of those,71 are in an ICU. ICU patients made up 13.5%of hospitalized COVID-19 patients.

The Wisconsin Department of Health Services reports that 10,040,933 vaccine doses and 2,613,637 booster doses have been administered in Wisconsin as of August 10.

Unable to view the tables below?Click here.

The Wisconsin Department of Health Services is using a new module to measure COVID-19 activity levels. They are now using the Center for Disease Control and Preventions (CDC) COVID-19 Community Levels. The map is measured by the impact of COVID-19 illness on health and health care systems in the communities.

The Center for Disease Control and Prevention (CDC) reports that 21 counties in Wisconsin are experiencing high COVID-19 community levels. Of those 21, three are in northeast Wisconsin: Brown, Door, and Marinette County.

36 counties in Wisconsin are experiencing medium COVID-19 community levels. Of those 30, thirteen are in northeast Wisconsin: Florence, Fond du Lac, Forest, Green Lake, Kewaunee, Langlade, Menominee, Oconto, Oneida, Sheboygan, Waupaca, Waushara, and Winnebago County.

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Every other county in Wisconsin is experiencing low COVID-19 community levels.

For more information on how the data is collected, visit theCDCs COVID-19 Community Levels data page.

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64.7% of Wisconsinites have received one dose of the COVID-19 vaccine - WeAreGreenBay.com

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