Month: December 2020

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Ivermectin quickly replacing Hydroxychloroquine as best treatment for Covid-19

Allow me to be blunt, but at this point in time, anyone denying that HCQ-based protocols are effective is either a total ignorant or an evil liar. There’s just too much evidence. As Dr McCullough said, there’s only 1 in 17 billion chances that HCQ doesn’t work for Covid-19.

However, evidence for the even superior efficacy of Ivermectin is mounting quickly.

The video below and the accompanying post are worth your time.

HCQ in Spring cut mortality by 50% in 17 hospitals 2075 COVID cases

The association of treatment with hydroxychloroquine and hospital mortality in COVID-19 patients.

Peter Doshi on BMJ: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data

[A]ll eyes are on Pfizer and Moderna […] both companies to claim around 95% efficacy.

Let’s put this in perspective.

First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%.

Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown.

Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.


“Following administration of Ad26.COV2.S, fever, muscle aches and headache appear to be more common in younger adults and can be severe. For this reason, we recommend you take a fever reducer or pain reliever if symptoms appear after receiving the vaccination, or upon your study doctor’s recommendation.”

Seems a lot of unknowns and potential problems for a vaccine that, in the end, is completely unnecessary.

Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies | Nature Microbiology

Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials. Here, we describe key ADE mechanisms and discuss mitigation strategies for SARS-CoV-2 vaccines and therapies in development. We also outline recently published data to evaluate the risks and opportunities for antibody-based protection against SARS-CoV-2. Mechanisms of antibody-dependent enhancement of disease and mitigation strategies for SARS-CoV-2 vaccines and therapies are discussed.
— Read on

Antibody-dependent enhancement is a serious concern for #CovidVaccine — in fact, ADE is amongst the reasons why we never got a vaccine for coronavirus diseases in decades of research.