Covid-19 News

Dutch Study Tracks Vaccine Effectiveness to Stop COVID-19 Household Contact Transmission

Dutch Study Tracks Vaccine Effectiveness to Stop COVID-19 Household Contact Transmission

A recent study in the Netherlands, led by scientists from the Center for Infectious Disease Control and the National Institute for Public Health and the

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A recent study in the Netherlands, led by scientists from the Center for Infectious Disease Control and the National Institute for Public Health and the Environment (RIVM), sought to estimate vaccine effectiveness against onward viral transmission by comparing secondary attack rates among household members between vaccinated and unvaccinated index cases. Capitalizing on contact tracing data as well as direct source material, the investigators conducted the study during the height of the Delta variant in Holland. The study team published yet-to-be peer-reviewed data suggesting that vaccine effectiveness in preventing viral transmission (from fully vaccinated to fully vaccinated) equals 40% (95% CI 20-54%). The effectiveness of full vaccination against transmission to unvaccinated household contacts equaled 63% (95% CI 46-75%). The study team reminded the reader that a previous study indicated that regarding the Alpha variant the effectiveness was 73% (95% CI 65-79%) against transmission to unvaccinated household contacts. The study was made possible by data accumulated by personnel at 25 Municipal Health Services agencies.

This Dutch observational population study, led by a team known as “RIVM COVID-19 surveillance and epidemiology team,” amounts to an estimation and includes limitations. Led by Brechije de Gier, the Netherlands-based study team used data from the national contact tracing system to estimate the transmissibility of SARS-CoV-2 in the Netherlands. Leveraging contact tracing system data, they sought to better understand the “secondary attack rate,” that is the percentage of SARS-CoV-2-infected cases lowered by vaccination.

The study investigators wrote in medRxiv that the results of their population-based study indicate that those who are COVID-19 vaccinated have protection against transmission from “vaccinated index cases.” Finding that these results are stronger in Alpha than the more virulent and transmissible Delta, they conclude “Vaccine effectiveness against transmission to unvaccinated household contacts is stronger than to vaccinated household contacts.” They emphasize that the vaccinated enjoy greater protection subject to variation based on factors such as individual behavior.

Importantly, the study results acknowledge the real-world observations involving vaccine durability challenges. The waning of vaccine effectiveness against infection and transmission of others, of course, can result in an increase in SARS-CoV-2 circulation in various populations. Based on the premise that full vaccination remains “highly effective in preventing severe disease” the authors argue vaccination remains front and center as input for the war on COVID-19.

Relevant Data

The data depicted in the table above was downloaded from the supplementary materials associated with the study. Based on data collected by personnel at 25 Municipal Health Services agencies during the late summer, the Delta variant was the dominant strain of the virus.

Note, the drop in SAR from 22% to 13% is associated with vaccinated index cases. Noteworthy, under “fully vaccinated households” SAR increases from 11% to 12%. The authors suggest that vaccinated index cases associated with reduced SAR demonstrate less transmissibility. However, questions have arisen. Note, greater transmissibility is associated with the 50-74 cohort.

Study Funding

Dutch Ministry of Health, Welfare, and Sports.

Lead Research/Investigator

Brechije de Gier, Center for Infectious Disease Control, National Institute for Public Health and Environment (RIVM)

National Israel Population Study Finds Pfizer Vaccine Effectiveness Wanes Rapidly: Durability of Vaccine in Question

National Israel Population Study Finds Pfizer Vaccine Effectiveness Wanes Rapidly: Durability of Vaccine in Question

With the Delta variant surge in Israel starting mid-June 2021 came reduced vaccine effectiveness and waning immunity. However, the extent of waning

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With the Delta variant surge in Israel starting mid-June 2021 came reduced vaccine effectiveness and waning immunity. However, the extent of waning immunity of the vaccine against the variant in this Eastern Mediterranean nation hasn’t been clear. Led by Haifa’s Technion-Israel Institute of Technology Dr. Yari Goldberg, Ph.D., the research team capitalized on a national Israeli database for the period of July 11 to 31, 2021 for all the nation’s residents that were fully vaccinated prior to June 2021. Using a Poisson regression model, the study team analyzed the comparisons between rates of confirmed SARS-CoV-2 cases and severe COVID-19 among the vaccinated population over different points in time, based on age group stratification with consideration of possible confounding factors. The data showed that the Pfizer-BioNTech vaccine (known as BNT162b2) effectiveness wanes after only a few months. The researchers found that in July, the 60 years and up age cohort that were vaccinated in January 2021 faced more breakthrough infection than those vaccinated in March 2021 (ratio rate 1.6, 95% CI 1.3-2.0).

Study Results

With results published in the New England Journal of Medicine (NEMJ), the study team included authors affiliated with Hebrew University of Jerusalem, Israeli Ministry of Health, Weizmann Institute of Science, Gertner Institute of Epidemiology, Sheba Medical Center Tel Hashomer, Tel Aviv University, and Ben Gurion University.

They found clear evidence for waning immunity. Those individuals aged 60 and up, who were vaccinated in January, were infected more than people two months later in March (rate ratio 1.6; 95% CI, 1.3 to 2.0). For those people aged 40 to 59, the rate ratio for infection among the fully vaccinated group in February changed as compared to the group that was inoculated a couple of months later (95% CI, 1.4 to 2.1).

Even people aged 16 to 39 years of age experienced differences depending on when they were vaccinated. First eligible in March 2021 when compared to those vaccinated two months later, the rate equaled 1.6 (95% CI, 1.3 to 2.0).

Similarly, the rate ratio for severe disease among those fully vaccinated depended on whether they were vaccinated sooner rather than later. The findings suggest that individual immunity in response to the delta variant of SARS-CoV-2 “waned in all groups a few months after receipt of the second dose of the vaccine.”

The rate ratio for severe disease among persons fully vaccinated in the month when they were first eligible, as compared with those fully vaccinated in March, was 1.8 (95% CI, 1.1 to 2.9) among persons 60 years of age or older and 2.2 (95% CI, 0.6 to 7.7) among those 40 to 59 years of age; due to small numbers, the rate ratio could not be calculated among persons 16 to 39 years of age.

Implications

The more precipitous the decline in effectiveness rates, the less durable the vaccine product is. If a vaccine product requires a booster every six months indefinitely, the value of such a product comes into question.

Lead Research/Investigator

Dr. Yari Goldberg, Ph.D., Technion-Israel Institute of Technology

https://www.nejm.org/doi/full/10.1056/NEJMoa2114228?query=featured_home

Quote from Wyttenbach

Facts:

1) Vaccinated now get up to 6.6x more often CoV-19 than unvaccinated.

How is it, that in all Germany currently ca. 6…8x more unvaccinated vs vaccinated show up in hospitals? Due to Brexit?

New Stem Cell Therapy Approaches Have Proven Effective in Treating COVID-19

New Stem Cell Therapy Approaches Have Proven Effective in Treating COVID-19

Despite many advances in the treatment of the COVID-19 virus, no specific treatment remains for patients with infectious diseases. This is especially true

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Despite many advances in the treatment of the COVID-19 virus, no specific treatment remains for patients with infectious diseases. This is especially true for patients admitted to the intensive care unit (ICU) who require mechanical ventilation support. However, Georgina Ellison Hughes, a member of the UNESCO International Society for Aging and Diseases (ISOAD), found mesenchymal stem cells (MSC) are effective in regulating multiple mechanisms and can restore immune system homeostasis in COVID-19 patients. MSC’s unique and strong immunomodulatory properties make it an excellent candidate cell type for the treatment of COVID-19.

In February 2020, an international team showed that injections of MSC into seven COVID19 pneumonia patients improved symptoms and recovery time compared to three placebo-treated patients.

Researchers are now advancing these findings showing that MSC is effective in regulating multiple mechanisms and can restore immune system homeostasis in patients with COVID-19.

King’s College London Study

In their latest study, the team completed a randomized, single-blind, placebo-controlled phase II clinical trial of MSC injections. The results of clinical trials showed the significant efficacy of MSC treatment, and MSC infusion rapidly and significantly improved the prognosis and alleviated symptoms in critically ill and critically ill patients. Follow-up chest images showed greater improvement in patients with severe illness in the MSC-treated group compared to the placebo group. Importantly, treatment was also associated with shorter hospital stays (11 vs. 15 days).

MSC treatment improved characteristic markers of the disease by showing reduced levels of C-reactive proteins, pro-inflammatory factors, and cytokines in treated patients. MSC treatment resulted in the long-term persistence of COVID-19 antibody. MSC injections also reduced the incidence of thrombosis indicated by plasma neutrophil extracellular traps or a decrease in “NET”.

Overall, patients in the MSC treatment group were highly tolerant and were discharged without side effects. Mortality was zero in the MSC group and 6.9% in the placebo group. Consistent with previous clinical studies, the findings show that MSC is a safe therapeutic approach for use in humans and is effective in treating COVID-19.

Lead Research/Investigator

Professor Georgina Ellison-Hughes, King’s College London

Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia - Research Portal, King's College, London

New stem cell therapy approaches have proven effective in treating COVID-19 - Florida News Times

Credit: PIXTA / CC0 public domain Despite many advances in the treatment of the COVID-19 virus, no specific treatment remains for patients with infectious…

floridanewstimes.com

Does Federal Vaccine Mandate Spell Holiday Logistics Woes?

Does Federal Vaccine Mandate Spell Holiday Logistics Woes?

According to an October 25 CNBC report, “Business groups ask White House to delay Biden Covid vaccine mandate until after the holidays.” The framing of

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According to an October 25 CNBC report, “Business groups ask White House to delay Biden Covid vaccine mandate until after the holidays.” The framing of this question shows us the delicate balance of health policy, economic realism, and the overall vagueness of the federal mandate in the context of developing science. Apparently, White House staffers at the Office of Management and Budget are now getting together with business lobbyists as OMB finishes its review of Biden’s mandate for employers with 100 or more employees. Business leadership groups are asking the White House to “wait until after the holiday shopping season to implement the rule.” These folks are concerned that premature implementation could worsen both labor supply and supply-chain problems. As to the former, there is concern about an “exodus” of workers once the mandates kick in.

37% of Truckers to Quit?

OMB and the White House Budget office have met extensively with representatives of workers, businesses, and others in the still-unfinished project of codifying President Biden’s plan for executive action on vaccines for 100+ worker employers. Per CNBC, this would cover about two-thirds of the private workforce. There are also meetings set with lobbyists for truckers, staffing firms, dentists, and realtors to discuss actions. The American Trucking Association noted that many drivers will quit in lieu of vaccination. They estimate that 37% of drivers may retire, quit, or move to a company with less than 100 employees. “Now, placing vaccination mandates on employers which in turn force employees to be vaccinated, will create a workforce crisis for our industry and the communities, families, and businesses we serve,” Chris Spear, president, and CEO at ATA, wrote to OMB recently.

Business Roundtable Wants More Time

Retailers are also particularly concerned the mandate could trigger a spike in resignations that would exacerbate staffing problems at businesses already short on people, said Evan Armstrong, a lobbyist at the Retail Industry Leaders Association. He also noted, “It has been a hectic holiday season already, as you know, with supply chain struggles—-This is a difficult policy to implement. It would be even more difficult during the holiday season.” Polling has shown that about 30 percent of unvaccinated workers would rather quit than take the jab. Industry lobbyists are asking that the mandate not go into effect until January or later. Per the lobbyist association the Business Roundtable, the White House, “should allow the time necessary for employers to comply, and that includes taking into account employee retention issues, supply chain challenges, and the upcoming holiday season.”

TSA Worker Shortage Looming?

Another take on how federal mandates might impact our holidays in the US is from Channel 12 News, Phoenix. They note that the current pre-Thanksgiving November 22 deadline is impractical as many TSA workers are yet to be vaccinated. TSA Administrator David Pekoske notes that “About 60% of our workforce has been vaccinated—-That number needs to go up quite a bit higher over the next few weeks.” Jovan Petkovic, who is secretary of the local TSA union for Pheonix says that while they have tried to educate their members, many in TSA are concerned due to “misinformation” and politicization of COVID-19. “They don’t understand what it is—-So they’re, of course, afraid of it, and they’re opposing it.” Travel advisor Janet Semenova notes that travel is way up. “Even as the world is opening up, and more people are vaccinated and feeling more comfortable and confident traveling, there’s still a lot of logistical things that you have to consider when booking a trip,” she said. Semenova added, “We’re seeing airlines canceling flights regularly, changing schedules at the last minute, bumping people at the last minute.”

Business groups ask White House to delay Biden Covid vaccine mandate until after the holidays

White House officials at the OMB are meeting with industry lobbyists this week as the administration conducts its final review of the mandate.

www.cnbc.com

Quote from Wyttenbach

Israel:: Now has one of the lowest vaccination rates. Just a tick above 60%. Every day still one booster 3x vaxx dies. This is down from 4/day booster deaths just in line with decreasing cases....So we may note that boosters do not really help.

Well I applaud this attempt at data analysis from W.

He has however omitted the fact that number of people with booster jab has been increasing. Nor has he done a comparison of the rate of death between booster / no booster / unvaccinated adjusting for age and comorbidities. The adjustment has a very big effect on the result.

He is also noting the fact that the booster campaign is now reaching enough of the population to e reducing transmission...

To be fair it is difficult to get real numbers from this data - you need a proper analysis and not an anti-vaxer report raw figures thing. And if you are an antivaxxer you think all the proper analyses are done by some alphabet mafia and not to be trusted. In that case you are stuck.

Pay attention boys!

X1 solar flare with a major CME

StackPath

Quote from Fm1

A recent study in the Netherlands, led by scientists from the Center for Infectious Disease Control and the National Institute for Public Health and the Environment (RIVM)

Fully vaccinated infect more fully vaccinated household contacts than unvaccinated...?! So no difference between vaxx/unvaxx. The 50% higher protection of vax versus unvax is just selection bias from natural immunity.

Quote from zorud

How is it, that in all Germany currently ca. 6…8x

For the children:: Infection and serious illness are different. Infection prevention was the base for vaccine passports. So there is no more base for vaccine passports. In fact 2 G should be recovered & tested no longer vaccinated!

Quote from Fm1

King’s College London Study

In their latest study, the team completed a randomized, single-blind, placebo-controlled phase II clinical trial of MSC injections.

One more $$$$$$$$$$$$$$$$$$$$$$ cure instead of early ziverdo 2$ treatment....

Double standards? Dr. Mobeen Syed reviews the hurdles faced by ivermectin and molnupiravir in the COVID pandemic

Double standards? Dr. Mobeen Syed reviews the hurdles faced by ivermectin and molnupiravir in the COVID pandemic

Dr. Mobeen Syed aka “Dr. Been” has become a sensation on YouTube educating millions on various medical topics during this difficult pandemic including

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Dr. Mobeen Syed aka “Dr. Been” has become a sensation on YouTube educating millions on various medical topics during this difficult pandemic including refreshingly sincere lessons on topics such as ivermectin. Most recently the online doc raised concern over the inconsistent criteria applied in ivermectin and molnupiravir trials in the quest to get authorization for the treatment of COVID-19. TrialSite has covered Dr. Been’s previous examinations of potential COVID treatments, including how his YouTube channel was censored for discussing information related to hydroxychloroquine, remdesivir, and ivermectin.

In a YouTube video streamed on October 7, 2021, Dr. Been contrasts the methods used by the FDA and CDC for approval of COVID treatments. Dr. Been emphasizes the lack of impartiality, and preferential treatment in the recommendation guidelines by the FDA and CDC.

He claims that there are clear signs of preferential allowances in the molnupiravir trial and in other recommended drugs (remdesivir, bamlanivimab) when applying for emergency use authorization (EUA). Meanwhile, ivermectin clinical trials are repeatedly disqualified.

Recap of Molnupiravir Timeline

Previously, TrialSite news reported on researchers at Emory University who discovered molnupiravir in 2014. With time, it demonstrated efficacy against several viruses including coronaviruses.

In-vitro studies for molnupiravir on human cells against SARS-CoV-2 were done in 2020. After combining Phase II & III study in their clinical trials, Merck halted clinical trial expansion in October 2021. The pharmaceutical company declared efficacy had been demonstrated, and they were now ready for an EUA.

Double standards? A closer look at Acceptable Study Trials

Dr. Been’s YouTube video clarifies several questions by a comparison with study trials from other drugs.

Is one study trial sufficient for an EUA?

The fact that a single trial is being considered to grant molnupiravir an EUA is sending signals of preferential treatment. But, this is not a precedent: bamlanivimab was also granted EUA on the basis of a single trial in November 2020.

But Dr. Been raises another concern related to an amendment of the EUA granted for bamlanivimab in September 2021. The BLAZE-1 trial researched bamlanivimab and etesevimab used together in treatment of early or mild infection with COVID-19; the BLAZE-2 trial investigated bamlanivimab alone as post-exposure prophylaxis.

From there, the FDA concluded that “it is reasonable to expect that bamlanivimab and etesevimab together may be safe and effective for post-exposure prophylaxis,” despite no data supporting this specific drug combination used for this indication. The FDA granted approval for combining two drugs bamlanivimab plus etesevimab for post-exposure prophylaxis of COVID-19.

Dr. Been also draws attention to the fact that authorizing bodies criticize poor studies for lack of balance in participants. The Blaze-2 study used by FDA had this particular fault-number of participants testing negative in treatment group far outnumbered participants testing positive 966:209 respectively.

Quality of Evidence

Dr. Been suggests that the FDA’s position on quality of evidence is inconsistent when it comes to COVID-19.

For example, open label trials allow the investigator and participants to know who is receiving treatment or placebo. The use of open-trials leaves room for bias and is criticized as low-quality evidence, but these trials were accepted in support of remdesivir’s EUA. Remdesivir also drew criticism from meta-analyses and a WHO study for its lack of effectiveness, specifically in patient survival. Nevertheless, remdesivir is still approved for COVID-19, while ivermectin fails to get the nod, despite numerous double-blinded trials – a higher standard than open trials.

Dr. Been points to the ubiquitous problem of low quality of evidence, using a study analyzing Infectious Diseases Society of America (IDSA) clinical practice guidelines. The study contends that the IDSA failed to comply with adequate standards for recommendation using high-quality evidence. For instance, low-quality evidence from non-randomized studies and expert opinions was used to support 50% of recommendations. Observational studies were used in 31%, while only 16% of recommendations were based on one or more randomized controlled trials.

It should be noted, however, that the study presented by Dr. Been on this point was published in 2010 and may not accurately represent current conditions.

Another question raised was the use of pre-print data in assessing drug efficacy and safety. A pre-print dated September 30, 2021 was referenced in a CDC article on the effectiveness of the AstraZeneca-Oxford vaccine (ChAdOx1) against SARS-CoV-2. At the time of reference, it was not peer-reviewed, a disqualifier that has continually been used against other orphan drug studies.

Do We Use Drugs Proven Ineffective in Other Studies?

Typically, if a reliable study proves that a drug is ineffective against a particular indication, the drug is precluded from use against that indication. TrialSite reminds the World Health Organization (WHO) rejected the use of remdesivir due to the results of the Solidarity trial indicating no clinical benefit in October 2020.

Nevertheless, the drug was still granted an EUA by the FDA later that month. Additionally, a July 2021 Bayesian re-analysis showed three comparable studies of remdesivir having “statistically non-significant results”. The results of these studies have not precluded the use of remdesivir in treatment of patients with COVID-19.

Comparison of Molnupiravir and Ivermectin

Dr. Been went on to compare the evidence surrounding the use of molnupiravir and ivermectin in COVID-19 treatment. The results are summarized in the table below:

Criteria Molnupiravir Ivermectin

Supporting evidence One trial – Phase II & III combined 65 studies

Peer review No peer reviewed studies as it seeks EUA 45 peer-reviewed studies

Funding Federal funds Federal Funds ACTIV-6*

Disrupts viral replication Yes Yes

Interferes with viral binding to ACE2 No Yes

Enhances interferon (IFN) levels No Yes

Anti-inflammatory None indicated in available data Yes

Claims of efficacy Study recruitment halted with claims of efficacy Efficacy shown in numerous clinical trials

Mass production Not yet Yes

Cost $70/pill pennies/pill

EUA Moving towards EUA No EUA

Intent to use Conditional Govt. Placed orders before trial Not to be used for COVID-19 Physicians penalized

Mainstream media response Positive Attacked, use in COVID-19 barred.

Technical Information taken from Mahmud et al. study and Merck Ridgeback statement.

*TrialSite advisor Michael Goodkin as well as several others have declared that the NIH embrace of ivermectin in the ACTIV-6 trial is questionable—the dosage regimen appears too low for success, and we note the decision to include was late in the pandemic.

Impossible Expectations?

As previously reported on TrialSite, molnupiravir has received incredible perks compared to other trial drugs including conditional orders prior to clinical trial and governmental funding. Though both ivermectin and molnupiravir demonstrate anti-viral efficacy against SARS-CoV-2, ivermectin studies are repeatedly sidelined and disqualified.

TrialSite has previously reported on the tactics of disinformation at play, including manufacturing uncertainty about science that, under other circumstances, would be considered clear-cut.

National Swedish Study Finds COVID-19 Vaccines Not Effective After Six Months

National Swedish Study Finds COVID-19 Vaccines Not Effective After Six Months

Heavily funded by taxpayers, how durable are the COVID-19 vaccines? With unprecedented legal mandates in countries like America, investigators from

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Heavily funded by taxpayers, how durable are the COVID-19 vaccines? With unprecedented legal mandates in countries like America, investigators from Sweden’s Umeå University sought out to determine the actual durability of leading COVID-19 vaccine products. While initial efficacy appears high–helping to defend people from severe COVID-19–mounting breakthrough infections and waning immunity are known to have triggered ongoing booster programs. How durable are these young products? With limited evidence and a lack of specificity by vaccine product, a trio of researchers from the northern region of Sweden capitalized on Swedish national population data to determine if the vaccine’s effectiveness lasted even six months. Overall, this study determines any benefit beyond six months isn’t certain—and appears to dissipate. And what could be considered a bombshell of a story, is that the Umeå -based authors determine that the Pfizer-BioNTech vaccine known as BNT162b2 or “Comirnaty,” the only vaccine formally approved in the United States, shows notable waning efficacy, particularly among men, the elderly, and people with comorbidities. By month six, the data indicate little to no effectiveness, raising serious concerns about the strategy behind the mass vaccination program now underway.

Swedish law mandates that all healthcare providers in this Nordic nation must report health-related data, including vaccination, to two registries, including the Swedish Vaccination Register as well as the SmiNet register, both managed by the Public Health Agency of Sweden. The law requires 100% coverage of the entire population of approximately 10.2 million.

Designing a retrospective cohort study, the Umeå University study team included Peter Nordstrom, Marcel Ballin, and Anna Nordstrom. Dr. Peter Nordstrom is a geriatric physician at the university’s Department of Community Medicine and Rehabilitation, Unit of Geriatric Medicine. Marcel Ballin completed his doctorate in geriatric medicine in the Department of Public Health and Clinical Medicine while Ann Nordstrom teaches public health at the university. The team secured approval from the Swedish Ethical Review Authority.

The Study

Utilizing a retrospective study design, the investigators utilized Swedish nationwide registries including the Swedish Vaccination Register and SmiNet Register (both from the Public Health Agency of Sweden) as well as Statistics Sweden (the national agency for statistics) slicing and dicing the data based on observational study inclusion criteria which included all individuals (N=3,640,421) vaccinated with at least one dose of any COVID-19 vaccine up to May 26, 2021. The following vaccine products are included in the analysis:

Vaccine Product Maker

ChAdOx1 nCoV-19 AstraZeneca/Oxford

BNT162b2 Pfizer-BioNTech

mRNA-1273 Moderna

Looking at a total of 5,833,003 subjects, the population was selected based on vaccination status and COVID-19 infection up to October 4, 2021.

Vaccinated individuals were randomly sampled from the nation’s total population and matched on birth year, gender, and resident city/town/village. The Umeå University derived the study cohort from this broader population. They matched each inoculated person (equals two doses) 1:1 to one randomly sampled unvaccinated person based on year of birth, gender, as well as a baseline established with the date that the individual received their second COVID-19 vaccine dose in both vaccinated and unvaccinated populations.

Applying other exclusion criteria and repeating the matching procedure five times, the investigators narrowed the cohort to 842,974 matched pairs of vaccinated/unvaccinated subjects.

A second study cohort using less stringent matching criteria was formed for use in a “forthcoming sensitivity analysis.” The study authors matched each vaccinated person to the rest of the cohort based on age including a five-year buffer in age with each pair. Repeating this process ten times to support the matching of unvaccinated persons with several vaccinated persons leads to 1,983,315 per pair (N=3,966,630).

Analysis

The team employed proportional hazards models with 95% confidence intervals (CI), as well as restricted cubic splines (four knots in default positions) to produce time-to-event for the outcomes (symptomatic infection/severe disease) based on vaccination status (vaccinated/unvaccinated).

Leveraging registry data plus national data from Statistics Sweden, the team executed Cox regression analyses to calculate hazard ratios (HR). They adjusted for the matched samples based on 95% CIs based on “standard errors by the VCE procedure and ROBUST option in Stata.

Results

Results showed that the COVID-19 vaccines used in Sweden wane in effectiveness over time, corresponding with other observational study results. For example, the one approved vaccine in America, Pfizer’s BNT162b2 (“Comirnaty) starts off at 92% effectiveness yet by month number four (4) wanes in effectiveness to 47% (95% CI, 39-55, P<0·001). After month 6 the authors detected no effectiveness (23%; 95% CI, -2-41, P=0·07) and this obviously is a key rationale for booster programs in wealthy nations such as America, the UK, and Israel.

Following other studies, Moderna’s vaccine has shown to be a bit more durable as its mRNA-1273 vaccine effectiveness wanes less than the Pfizer-BioNTech vaccine does. For example, the team reports that the overall effectiveness waned slightly slower at 59% (95% CI, 18-79) by day 181 onwards. The Swedish study results aligned with others that AstraZeneca’s ChAd0x1 nCoV-19 afforded less protection while effectively waned faster with no effectiveness by month four (66%; 95% CI, 41-80). Overall vaccine effectiveness declined with males and the elderly.

What about protection against severe COVID-19? The aggregate of all three vaccines in Sweden vaccine product performance waned from 89% (95% CI, 82-93, P<0·001) at day 15-30 to 42% ((95% CI, -35-75, P=0·21) from day 181 (month 4) and beyond. Again, sensitivity analysis demonstrated even worse performance with males, the elderly, and immunocompromised.

Limitations

Of course, the observational design includes inherent limitations. While the study team adjusted their approach to factor in cofounders the “possibility of residual and unmeasured confounding remains,” declared the authors. While certain exclusion criteria were applied (previously confirmed infection) probabilities are high that at least some individuals previously infected were included in this large national population analysis. It’s possible that if such individuals were part of the unvaccinated cohort, then natural immunity associated with previous SARS-CoV-2 infection could have weakened vaccine effectiveness estimates. Other limiting elements can be reviewed in the source.

Note, that this study hasn’t been peer-reviewed and should not be cited for medical evidence yet.

Final Thoughts

While the development of the COVID-19 vaccines marks a notable accomplishment in vaccine development history and undoubtedly contributes to protection against severe disease and death during the pandemic, actual durability isn’t well studied. While COVID-19 ushered a life sciences boom that can benefit humanity for decades to come, unfolding events necessitate a frank, systematic, and comprehensive investigation into the true benefits of these version 1.0 vaccine products.

Mounting evidence in the form of observational studies from Israel, the U.S., and the U.K. to now a national population study from Sweden suggests significant challenges in the actual durability of COVID-19 vaccines.

The product effectiveness wanes considerably within a few months. Vaccine performance depends on the actual underlying product as well as various demographic elements such as age, gender, comorbidities, and the like.

Accumulating data points amount to some challenges in the popular narrative about the overall effectiveness of mass vaccination as the only approach to eradicate SARS-CoV-2, the virus behind COVID-19.

TrialSite suggests an urgent need to better understand COVID-19 vaccine durability and overall effectiveness. With mandates and authoritarian leaning governing urges across multiple nations, an open and honest discussion about vaccine durability must be high on the list of national priorities.

Effectiveness of Covid-19 Vaccination Against Risk of Symptomatic Infection, Hospitalization, and Death Up to 9 Months: A Swedish Total-Population Cohort Study

Quote from Fm1

After month 6 the authors detected no effectiveness (23%; 95% CI, -2-41, P=0·07)

That's exactly what we see too, if proper= infection adjusted data is used! Pfizer/ASTRA is crap because a monoclonal cancer chemo therapy never will be a vaccine. Antibody production is not equal vaccine!!! Its just equal a vaccine effect!

This (Pfizer/ASTRA) is one of the biggest and still ongoing cheating in medical history. Moderna on the other side made one crucial step, in direction of a vaccine. They just need to add a few more different RNA strings and may be it will become real vaccine - but still using a very dangerous mechanism.

Quote from Fm1

Effectiveness of Covid-19 Vaccination Against Risk of Symptomatic Infection, Hospitalization, and Death Up to 9 Months: A Swedish Total-Population Cohort Study

Good to see that Sweden delivers the same depressing "vaccine" data as UK. After 210 day::best case 20% vaccine for infection protection for healthy people, when corrected for recovered then the protection is negative too!!

Overall (4 mio.) vaccine infection protection up to 77% negative!! After 210 days.

For serious disease bvaccine protection 52% for men 73% for woman. Infection corrected. No more protection for men...

Why do all this studies no corrections for recovered

Quote from Fm1

X1 solar flare with a major CME

A minor S1 solar radiation storm commenced and is currently in progress. Strong radio interference (R3) expected.

Not a Carrington event!

2021 COVID-19 Vaccine Rollouts are Associated with Worldwide Increases in COVID-19 Death Rates above 2020 Levels

2021 COVID-19 Vaccine Rollouts are Associated with Worldwide Increases in COVID-19 Death Rates above 2020 Levels

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. By Kathy Dopp, MS Mathematics

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By Kathy Dopp, MS Mathematics

Scatterplots contributed by Jessica Rose, PhD, MSc., BSc.

Abstract: COVID-19 vaccines are not preventing a rise in COVID-19 deaths. In fact, as of October 10th, 2021, COVID-19 death rates following vaccine rollouts are higher in 70% of the 178 countries for which we were able to obtain vaccination rollout dates and number of total vaccine doses administered. COVID-19 vaccine rollouts have not slowed the rate of serious COVID-19 disease or COVID-19 deaths caused by SARS-CoV-2 viral variants.

Background: In the United States, COVID-19 mRNA and vector-DNA Vaccines have the highest reported post vaccine death rate of any vaccine in history in the U.S. Center for Disease Control (CDC)’s vaccine adverse events reporting system (VAERS)1.

Table Description automatically generated with medium confidence

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41% Increase in US all-cause mortality in 2021 since COVID vaccine rollout Chart, waterfall chart Description automatically generated41% Increase in US all-cause mortality in 2021 since COVID vaccine rollout than in 2020

In the United States and in other countries around the world, there has been increased all-cause mortality in 2021 since COVID vaccine rollouts began than in 2020. COVID-19 mRNA and DNA-vector vaccines create antibodies surrounding internal organs by having the body create billions to trillions of spike proteins specific to the original SARS-CoV-2 variant. As shown in the Israeli and UK data, the current COVID-19 spike protein vaccines provide no protection against infectiousness, symptomatic illness, or being hospitalized with the current immune-escape Delta variant. Insufficient nasal and oral mucosal immunity against the Delta variant is created by current COVID-19 vaccine injections, so the vaccinated spread the Delta virus and carry viral loads 251 times higher than the previous Alpha variants in nasal and oral cavities.3,4

Vaccine Rollouts worldwide are followed immediately by increased COVID Deaths of the elderly & about 4 months later by the rise of an immune escape Delta variant

Delta variant prevalence (seen as a green line in charts below) is recorded to occur in vaccinated and unvaccinated hospitalized COVID-19 patients roughly four (4) months after initial COVID-19 vaccine roll-out dates due to vaccine-induced selective pressure.5 As seen in both Israel and the UK data, vaccination rollouts coincide with larger weekly rates of reported COVID-19 deaths per million than occurred during the 2020 COVID-9 pandemic period. During the beginning of vaccine rollouts there are all-cause mortality rises in deaths of the elderly. The larger rise in Israeli COVID-19 weekly death rates is than in the UK may have occurred because Israel gave the 2nd vaccine doses more quickly to the entire population, whereas the UK the adult population were all given the 1st dose and given more time before taking the 2nd dose. Israeli’s more numerous booster doses produced another larger COVID-19 death rate increase than the UK saw.

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A large increase in all-cause mortality occurred in persons 65 years and older in Southern United States at the beginning of COVID-19 vaccine rollouts. In the United States, all-cause mortality for 24 to 64 year-olds is higher in 2021 than in 2020, concomitant with COVID-19 mRNA and vector-DNA vaccine rollouts.

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Worldwide Data Show COVID-19 Vaccines are Associated with Increased Risk of COVID-19 Deaths

We collected COVID-19 deaths per million data from Our World in Data6 and collected COVID-19 vaccine rollout dates and number of doses per 100 people from Covid vaccines: How fast is progress around the world? The Visual and Data Journalism Team BBC News7 and analyzed it using R programming language. We generated scatterplots comparing the COVID-19 death rates prior to and post COVID-19 vaccine roll-out dates in each country. Each country in the scatterplot is randomly assigned a color and the size of the text increases with the number of vaccine doses per hundred individuals. The regression line of the data set in addition to the line with slope 1 that passes through the origin (y=x) to make it easy to see that countries plotted above this 45 degree line have a higher COVID-19 death rates after COVID-19 vaccine rollouts; and countries plotted below this 45 degree line have lower COVID-19 death rates post COVID-19 vaccine rollouts .1

The plot below shows COVID-19 death rates per million persons both before and after COVID-19 vaccine roll-out dates for 17 different COVID-19 vaccines in 178 countries, as of October 10, 2021. It includes 10 months of data pre-rollouts and at most 9.5 months post-rollouts, depending on the begin date of country COVID-19 vaccine rollout. COVID-19 deaths per million were obtained from Our World in Data.8 COVID-19 vaccine rollout dates and number of doses per 100 people were collected from Covid vaccines: How fast is progress around the world?9 and plotted using the R programming language. Each country in the plot is represented by a dot, randomly assigned a color. The size of its country name increases with its number of vaccine doses per hundred persons. The regression line shows the overall relationship of COVID-19 Death rates pre and post vaccination rollouts for these countries. The line with slope one (1) passing through the origin (y=x) is shown to make it easy-to-see countries plotted above this 45-degree line have higher COVID-19 death rates after vaccination roll-outs; and countries plotted below the 45-degree line have lower COVID-19 death rates after vaccine roll-outs.1 Overall, it can be visually seen that COVID-19 vaccines do not lower COVID-19 death rates, and, in fact, are associated with increased COVID-19 death rates in 70% of the 178 countries plotted.

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Many countries having relatively small pre- and post-vaccination rollout COVID-19 death rates cannot be seen in this plot of 178 countries, so the next plot shows just the lower corner of the plot for countries having less than 50 COVID-19 deaths both before and after COVID-19 vaccination rollouts.

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Some of the countries having lower COVID-19 death rates post vaccine rollout as of October 10, 2021, have already moved up to the 45 degree line and have an equally large COVID-19 death rate today as before their vaccine rollouts. For example, on October 10th, the date of the data pictured above, Australia had a lower COVID-19 death rate of 21.4 per million post-COVID-19 vaccination rollout than its initial rate of 35.25 before. However, by October 28th, Australia’s post vaccine rollout reported COVID-19 death rate rose a rate of 30.26 COVID-19 deaths per million since its vaccine rollout began on February 21, 2021, almost equal to before it began COVID vaccinations with mRNA and vector DNA vaccines. Because Australia did not begin its vaccination rollouts until end of the 3rd week in February, the comparison is for a shorter time period post-vaccine-roll-out. Thus, Australia’s post-vaccine rollout COVID-19 deaths per million per month is actually higher now than its pre-vaccination period and has moved almost to the line.

There are many possible mathematical explanations or theories that could be tested statistically, for why some countries have been able to keep their COVID-19 death rates lower than the world’s average world’s rate of 635.6 per million as of October 28th. Perhaps countries having lower COVID-19 death rates post-vaccine rollouts have vaccinated fewer persons; or are using more traditional, less dangerous vaccines; or are making early, effective treatments available such as hydroxychloroquine and ivermectin that are being used in countries reporting very low COVID-19 death rates such as China, Nicaragua, and the Congo.

CONCLUSION: COVID-19 vaccinations are not associated with decreases in COVID-19 death rates and, thus, do not reduce serious hospitalized COVID-19 case rates. Overall, numerical data show COVID-19 vaccine rollouts are associated with increased COVID-19 illnesses and deaths.

Anyone can check the current death report numbers, by using this web site URL: https://medalerts.org/vaersdb/…S=ON&VAX=COVID19&DIED=Yes

CDC VAERS analysis submitted to FDA by Josh Guetkow PhD. David Wiseman PhD. Paul E. Alexander PhD. Herve Selegmann PhD.

Study: Fully Vaccinated Healthcare Workers Carry 251 Times Viral Load, Pose Threat to Unvaccinated Patients, Co-Workers. August 23, 2021. Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733

The Covid mRNA and DNA vaccines do not provide any mucosal immunity that would do more to prevent infections and spread of COVID disease. Mucosal Immunity in COVID-19: A Neglected but Critical Aspect of SARS-CoV-2 Infection Michael W. Russell, Department of Microbiology and Immunology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States

“Vaccine escape” variants are mentioned in the DOHERTY MODELLING report in table of contents and p. 8.

Coronavirus (COVID-19) Vaccinations - Statistics and Research

Our vaccination dataset uses the most recent official numbers from governments and health ministries worldwide. The population estimates we use to calculate…

ourworldindata.org

Covid vaccines: How fast is progress around the world?

Charts and maps tracking the progress of Covid vaccination programmes.

www.bbc.com

Coronavirus (COVID-19) Vaccinations - Statistics and Research

Our vaccination dataset uses the most recent official numbers from governments and health ministries worldwide. The population estimates we use to calculate…

ourworldindata.org

By the Visual and Data Journalism Team by BBC News https://www.bbc.com/news/world-56237778

References in addition to Footnotes:

10/19/21 81 Research Studies Confirm Natural Immunity to COVID ‘Equal’ or ‘Superior’ to Vaccine Immunity. The Brownstone Institute lists 81 of the highest-quality, complete, most robust scientific studies and evidence reports/position statements on natural immunity as compared to the COVID-19 vaccine-induced immunity. https://childrenshealthdefense…vid-brownstone-institute/

10/07/21 Fully Vaccinated Countries Had Highest Number of New COVID Cases, Study Shows. The authors of a study published Sept. 30, in the European Journal of Epidemiology Vaccines said the sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences “needs to be re-examined.”

Army physician warns about toxic ingredients in COVID shots. Sep 27, 2021 ‘Use of mRNA vaccines in our fighting force presents a risk of undetermined magnitude in a population in which less than 20 active-duty personnel, out of 1.4 million, died of the underlying SARs- CoV-2.’ Physician and Army Lieutenant Colonel Theresa Long. To try and steer the Department of Defense to policies that protect military personnel from dangerous COVID vaccines and defend our national defense. The AFFIDAVIT OF LTC. THERESA LONG M.D. IN SUPPORT OF A MOTION FOR A PRELIMINARY INJUNCTION ORDER. September 24, 2021

Dr. Joel Hirschhorn: Nearly Two Million Americans Dead from COVID Vaccines, Infections, and Collateral Impacts October 27, 2021

Medical Bombshell: Pfizer Vax Attacks Human Blood Creating Clots Under Microscope. Oct 26, 2021 Highly respected medical doctor and inventor, Richard Fleming, has released a 32-minute detailed presentation documenting his shocking findings. In late 2020, before the Pfizer shot had even been rolled out, top scientists and experts around the world warned the Pfizer and Moderna shots posed extreme risk of causing blood clots, myocarditis and other cardiovascular problems. One year later, Pfizer and Moderna have been forced to issue warnings confirming their controversial MRNA vaccines can indeed cause a long list of problems not just limited to the cardiovascular system. Now, research scientist, Dr. Richard Fleming, has tested the Covid-19 Pfizer vaccine on fresh human blood samples in-vitro and made a string of nightmare discoveries confirming the medical community’s findings. To find out more about this ground-breaking research, visit Fleming-Method.com

Israeli Mathematician Says Vaccination Causing Surge in Youth Deaths. October 20, 2021

22 Studies and Reports that Raise Profound Doubts about Vaccine Efficacy for the General Population By Paul Elias Alexander October 28, 2021

New Lancet Study From Sweden Shows Vaccine Effectiveness Against Infection Dropping to Zero and Sharp Decline Against Severe Disease As Well. October 28, 2021

Quote from Fm1

10/07/21 Fully Vaccinated Countries Had Highest Number of New COVID Cases, Study Shows.

You should dark red mark your calendar for October 2021! It's the starting point of the pandemic of the vaccinated now!

Also Germany today reports that 1/3 of all hospital patients are double vaxx. We already noted in Israel that double vaxx going to hospital had a 5x higher death rate that unvaxx going to hospital. Lets hope its just the vulnerable and not a general rule....

Quote from Wyttenbach

You should dark red mark your calendar for October 2021! It's the starting point of the pandemic of the vaccinated now!

Also Germany today reports that 1/3 of all hospital patients are double vaxx. We already noted in Israel that double vaxx going to hospital had a 5x higher death rate that unvaxx going to hospital. Lets hope its just the vulnerable and not a general rule....

That is you (singular) not we (plural).

Every serious person looking at the Israeli data sees vaccines effective at preventing serious disease and death, and the booster increasing that protective effect enormously.

Perhaps you are not aware of Simpson's effect?

Here is a non-mafia - amateur - transparent - data scientist looking at Israeli data

What do new Israeli data say about effect of vaccines & boosters vs. death/critical/severe disease?

Key Points: I downloaded and analyzed data containing daily COVID-19 deaths and critical infection numbers from the Israeli ministry of health dashboard from…

www.covid-datascience.com

I would recommend the citizen's reporting on covid-datascience to everyone here. Independent analysis of the data but by people who understand data enough to avoid (and explain) the obvious problems.

Here is a great post: one of a series where the previous three looked at vulnerable get vaccinated and other effects and how therefore age confounding makes vaccine efficacy look worse than it actually is. This one looks at time confounding and how that makes reported vaccine efficacy look better than it actually is...

How time confounding can bias vaccine effectiveness upwards via Simpson's paradox

OK -- one more Simpson's paradox themed post. There is one more major point I want to make sure people realize to avoid misinterpreting some of the commonly…

www.covid-datascience.com

OK -- one more Simpson's paradox themed post. There is one more major point I want to make sure people realize to avoid misinterpreting some of the commonly used simple summaries of infection, hospitalization and death rates with respect to vaccination that people look at to get a "common sense" indication of how well "vaccines are working"

Three previous examples show how age confounding can make vaccines look worse than they are, decreasing estimates of vaccine effective (VE) if computed overall, i.e. not stratifying by age or adjusting for age effects in the model in some other appropriate way. We showed this in 3 settings:

1. Effectiveness vs. serious disease computed from a snapshot of active serious infections on August 15, 2021 from the Israeli MoH dashboard
2. Effectiveness vs. serious, critical, or fatal disease for the time interval August 10 through September 8 from the Israeli MoH dashboard
3. Effectiveness vs. Delta variant COVID-19 deaths from Technical Briefing 20 from Public Health England on August 2, 2021.

All three examples had the same paradoxical results whereby overall VE estimates were MUCH lower than any of the age-specific VE estimates when broken down by age. These were all illustrations of Simpson's paradox, caused by the fact that the confounder (age) was strongly positively associated with the exposure (vaccination) and outcome (serious disease/death). However, Simpson's paradox works both ways -- it is also possible for an unadjusted confounder to make vaccines look better than they are. If the confounder is strongly positively associated with the exposure but strongly negatively associated with the outcome, then Simpson's paradox can make the overall VE appear much higher than if computed separately for different levels of the confounder, and thus provide a misleading account of vaccine effectiveness.

I have suspected this phenomenon is responsible for inflating some unusually high estimates of vaccine effectiveness in the USA in the spring and early summer, with numbers >96% reported, creating the misimpression that vaccines were preventing nearly all COVID-19 infections, hospitalizations and deaths, raising expectations unrealistically high for the ability of vaccines to completely protect vs. COVID-19. In this blog post, I will illustrate how, with the dynamics of vaccination, infections, and COVID-19 deaths over time, time confounding can create a Simpson's effect that artificially inflates VE estimates whenever they are computed over a very long time interval (e.g. all of 2021) and the analysis is not stratified by time or otherwise adjusted for time effects in the modeling.

The lesson of this is that we need to be wary of simple summaries from observational data reported in the media and other places as evidence for or against vaccine effectiveness, whether percent of cases/hospitalizations/deaths that are vaccinated, or simple "vaccine effectiveness" calculations computed from overall numbers, without stratifying or otherwise adjusting for key confounding factors such as age and time and other confounding factors.

With observational data, the presence of these confounding factors makes simple summaries sometimes grossly misleading, and that is why advanced statistical modeling is necessary to try to adjust for key confounding factors if one wants a reliable estimate of vaccine effectiveness.

THH

COVID data-science

Being keenly aware of political biases on both sides, my goal is to try to remain as apolitical as possible and try to filter out what I perceive as political biases and describe what I consider to be key insights gained from a particular report or resource. I acknowledge that it is not possible for me or anyone to completely separate their thinking from their own worldview and political views, but will do my best to provide a measured, balanced perspective focused on problem-solving and truth-seeking.

To me, this process epitomizes the practice of data science, collecting data, filtering out biases, and aggregating information to try to extract knowledge and truth, which is what we are all trying to do in the case of this devastating virus.

Debunking Misinformation — and Critiquing Public Health Leadership: Jeffrey Morris, PhD, discusses how he dismantles false claims about vaccines — and he critiques some aspects of the Covid-19 public health response: “We don’t want to feed the anti-vaccine trolls, so we actively suppress clear scientific data.” Read the article in (link is external)MIT Technology Review(link is external).

Author Bio:

Jeffrey S. Morris is a statistical data scientist, professor and Director of Biostatistics at the Perelman School of Medicine at the University of Pennsylvania. He obtained his PhD in Statistics from Texas A&M University in 2000, and worked in the Department of Biostatistics at the University of Texas M.D. Anderson Cancer Center from 2000 to 2019, most recently as the Del and Dennis McCarthy Distinguished Professor of Gastrointestinal Cancer Research and Deputy Chair. He has done extensive NIH and NSF-funded research on statistical data science methods for biomedical research, with over 200 publications including top scientific, medical, and statistical journals and being chosen for numerous professional awards.

It looks like our clown does still not know that most vulnerable are age 70+. Among this age group vaccines perform worst. So its the exact contrary of what clowns claim.

I'm not interested how good vaccine work for age <50 as we here have < 10 CoV-19 deaths/year in this group. So faking figures with good performing age classes is a vaccine terrorist trick since the beginning.

Further clowns ignore that 6 out of 7 have natural immunity for delta where it was only 3 out 4 for alpha.

So vaccines over all show no real effect just systematic cheating of mixing immune with vaccinated and selling natural immunity for vaccine immunity.

This is exactly what we expect from a cancer monoclonal antibody chemo therapy. It (Pfizer/Oxford crap) is no vaccine at all.

Look at Moderna!

And Hilda, one of my fave internet bloggers on vaccine stuff because of her cartoons. Not authoritative or giving insight into the statistical modelling but always a good read.

This "Waning Immunity" Argument Against the FDA's Covid Vaccine Approval Is a Scientific Quagmire - Absolutely Maybe

I sure don’t envy the people under all that pressure at the U.S. Food and Drug Administration. They’ve been at the brunt…

absolutelymaybe.plos.org

I sure don’t envy the people under all that pressure at the U.S. Food and Drug Administration. They’ve been at the brunt of an extended media barrage to approve Covid vaccines more quickly. I didn’t agree they were moving too slowly – I wrote about why over at The Atlantic – but at least I could see a basis for taking that position. In the U.S., a lot of mandates were waiting for that green light, and the country is suffering a heavy toll, given extensive resistance to both vaccination and containment measures.

There’s been a much smaller push in the opposite direction, though, urging them to slow way down. Peter Doshi, from the BMJ, continued arguing that case last week. If there is a strong science-based case to make against the FDA approving the vaccines now, though, this wasn’t it.

Doshi added a “waning immunity” argument, and looped in others he’s made previously – in January, contesting the efficacy of the mRNA vaccines, and then in June, when he and a group of others petitioned the FDA against approving the vaccines until deep into 2022 or 2023 when follow-up for the phase 3 trials is completed. That’s a lot to untangle. I wrote a detailed analysis of the January blog post here. Doshi had relied on some very weird arguments. For example, he estimated vaccine efficacy based not on the people whose cough- and cold-like symptoms were diagnosed as Covid-19, but on everyone who got tested for those symptoms. It didn’t matter, he claimed, whether someone’s respiratory illness was not caused by SARS-CoV-2: as if a Covid vaccine can only be considered effective if it also prevents the common cold.

What about the petition to slow down FDA approval? That essentially boils down to this: since the vaccines can already be used with their emergency authorization, the bar for full approval should be raised far higher than usual. They don’t provide a solid justification for this, especially in a pandemic. The FDA put it this way when they denied the petition: it “does not contain facts demonstrating any reasonable grounds for the requested action”.

Doshi’s latest argument was mostly about waning immunity against non-severe Covid-19. According to the FDA report of the data underpinning their approval of the BNT-Pfizer vaccine, about 60% of the people in the big phase 3 trial were 4 to 6 months past their vaccination. Vaccine efficacy across the whole time was 91% (CI 89-93) against symptomatic disease, and 95% (CI 71-99.9) against severe disease (only 1 vaxed person severely ill versus 21 in the placebo group). This was before the Delta variant arrived in force.

In a preprint from BNT-Pfizer, the authors reported efficacy of 84% (CI 75-90) against symptomatic disease in the time period from 4 months. It’s likely that at some point, the approval will be amended to cover boosters or for a 3-dose regimen, at least for some people. However, the possibility that there could be a modification to how a vaccine is used in the future is not a reason to wait another year for approval. And not needing further doses down the line was never required for a Covid vaccine.

There are serious problems in the picture Doshi paints. He argues that because the people in the placebo group were pretty much all vaccinated by 6 months, we won’t have good long-term data for the BNT-Pfizer vaccine. That focus on the specifics of a single trial is fundamentally misleading, though. The original phase 3 trial is not the only way to track declining vaccine effectiveness. For example, they have a trial underway for 10,000 people randomized to a booster dose or placebo 6 months after being vaccinated. That’s just from the manufacturer. There’ll be a vast amount of data and analysis on this around the world now the vaccine is in wide use. Helen Branswell reports that the CDC’s vaccination committee was just told that in addition to the over 40,000 people in the phase 3 trial, they are looking at studies with a total of 680,000 people in them. On top of all that, there’s a vast amount of safety monitoring globally.

Quote from Wyttenbach

It looks like our clown does still not know that most vulnerable are age 70+. Among this age group vaccines perform worst. So its the exact contrary of what clowns claim.

No, it is not. The clowns all agree that vaccines perform less well for those who are older. Not surprising - they have less good immune systems.

But age confounding is particularly pernicious in the highest age-group where the stratification breaks down, e.g. > 70 years will contain a wide range of ages with varying (unvaccinated) death rates as well as vaccinated death rates.

I've noticed a key antivaxxer mathematical technique:

When proved wrong - subgroup the data

That works particularly well when there just is not enough contextual data at the subgroup level to deduces anything.

And an even more important and powerful technique: Don't give sources, precise data, and calculations - just hand-waving overall conclusions.

Thus here, you take a > 70 subgroup. I'd be happy for you to do a proper analysis of that data, why you think it proves your assertions. you could look at the covid-data-science posts on Simpson's paradox manifesting in many different ways to inspire your creativity doing this.

Enjoy!

THH