COVID-19 vaccine benefits exaggerated, say experts

Source: https://maryannedemasi.com/publications/f/covid-19-vaccine-benefits-exaggerated-say-experts

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK

Study: https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2932661-1

By Maryanne Demasi, PhD

In February, Federal Health Minister Greg Hunt boasted that AstraZeneca’s COVID-19 vaccine offered “100% protection” against death in the primary analysis of phase III trials. 

It was repeated by the CEO of AstraZeneca and uncritically reported by the mainstream media in what seemed to be an impressive achievement.

The published study in The Lancet, however, revealed a more nuanced picture. 

In the trial of 23,848 subjects across the UK, Brazil, and South Africa, there was one death in the placebo group and no deaths in the vaccinated group. 

One less death out of a total of one, indeed, was a relative reduction of 100% but the absolute reduction was 0.01%. (1/11,724 – 0/12,021)

Similarly, in February the CDC director Rochelle Walensky co-authored a publication in JAMA, which stated unequivocally:

“Clinical trials have shown that the vaccines authorized for use in the US are highly effective against COVID-19 infection, severe illness, and death.” 

However, there were too few deaths recorded in the controlled trials at the time to arrive at such a conclusion.  

The 6 month follow up data from the blinded Pfizer trial found there were 15 deaths in the vaccine group and 14 deaths in the placebo group. (see table S4)

Last week, at a roundtable meeting in the US Capitol, Prof Peter Doshi, associate editor of The BMJ raised concerns about the statements made by the CDC director.

CDC Admits It Has No Record of an Unvaccinated Person Spreading Covid After Recovering From Covid

By Cristina Laila

Source: https://www.thegatewaypundit.com/2021/11/cdc-admits-no-record-unvaccinated-person-spreading-covid-recovering-covid/

The CDC admitted it has no record of an unvaccinated person spreading Covid after recovering from Covid in response to an attorney’s FOIA request.

A New York attorney filed a FOIA request in September asking for “documents reflecting any documented case of an individual who (1) never received a Covid-19 vaccine; (2) was infected with Covid-19 once, recovered, and then later became infected again; and (3) transmitted SARS CoV-2 to another person when reinfected.”

The CDC responded: “A search of our records failed to reveal any documents pertaining to your request. The CDC Emergency Operation Center (EOC) conveyed that this information is not collected.”

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885937/pdf/nihpp-2021.02.11.21251585.pdf

Study: CD8+ T cell responses in COVID-19 convalescent individuals target conserved epitopes from multiple prominent SARS-CoV-2 circulating variants

Results:

As previously described, 60% of individuals included in the analysis were male and samples were collected a median of 42.5 days (interquartile range 37.5–48.0) from their initial diagnosis[8]. The group was selected evenly from tertiles (10 each) according to their overall anti-SARS-CoV-2 IgG titers[8,9]. Among the convalescent individuals, there were 132 SARS-CoV-2-specific CD8+ T cell responses corresponding to 52 unique epitope reactivities directed against several structural and non-structural target epitopes from the entire proteome.

Of all the mapped mutations, insertions, and deletions (n=45), only one mutation was found to fall within one of the 52 unique epitopes identified in the previous study (Fig 1S1). This mutation is the D80A mutation in the viral Spike protein, and occurs in the third residue of the RFDNPVLPF epitope. This is a HLA*A24:02-restricted epitope for which a CD8+ T cell response was detected in only one individual, and at a low frequency, indicating this is not a high-prevalence epitope within the studied cross-sectional sample.

ZeroHedge – Study Reveals ‘Dramatic’ Decline In All Three COVID-19 Vaccines’ Efficacy Over Time

Sars: https://www.science.org/doi/10.1126/science.abm0620

SARS-CoV-2 vaccine protection and deaths among US veterans during 2021

Abstract

We report SARS-CoV-2 vaccine effectiveness against infection (VE-I) and death (VE-D) by vaccine type (n = 780,225) in the Veterans Health Administration, covering 2.7% of the U.S. population. From February to October 2021, VE-I declined from 87.9% to 48.1%, and the decline was greatest for the Janssen vaccine resulting in a VE-I of 13.1%. Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge. From July to October 2021, VE-D for age 65 years was 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech; VE-D for age ≥65 years was 52.2% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer-BioNTech. Findings support continued efforts to increase vaccination, booster campaigns, and multiple, additional layers of protection against infection.

As shown in Fig. 2, risk of infection accelerated in both unvaccinated and fully vaccinated Veterans beginning in July 2021 and through September 2021, consistent with the time dependence observed in the Cox proportional hazards models. This pattern was similar across age groups, and risk of infection was highest for unvaccinated Veterans. Veterans who were fully vaccinated with the Moderna vaccine had the lowest risk of infection, followed closely by those who received the Pfizer-BioNTech vaccine, then those who received the Janssen vaccine.

Fig. 2. Kaplan-Meier curves illustrating cumulative risk of SARS-CoV-2 infection by vaccination status and age.(A) All ages. (B) Age <50 years. (C) Age 50-64 years. (D) Age ≥65 years. The survival function estimates time to infection detected by most recent RT-PCR assay.

Risk of death after SARS-CoV-2 infection was highest in unvaccinated Veterans regardless of age and comorbidity (Fig. 3). However, breakthrough infections were not benign, as shown by the higher risk of death in fully vaccinated Veterans who became infected compared to vaccinated Veterans who remained infection-free.

Fig. 3. Kaplan-Meier curves illustrating cumulative risk of death due to any cause by vaccination status and RT-PCR assay.(A) Age <65 years. (B) Age ≥65 years. (C) Charlson Comorbidity Index score <3. (D) Charlson Comorbidity Index score ≥3.

We observed similar results when examining the time period corresponding to the dominance of the Delta variant (fig. S1). Specifically, among those with a positive PCR test on or after July 1, 2021, vaccination was protective against death, although with some differences by age and vaccine type. For age <65 years, vaccine effectiveness against death (VE-D) was 81.7% (95% CI: 75.7% to 86.2%) for any vaccine; 73.0% (95% CI: 52.0% to 84.8%) for Janssen; 81.5% (95% CI: 70.7% to 88.4%) for Moderna; and 84.3% (95% CI: 76.3% to 89.7%) for Pfizer-BioNTech. For age ≥65 years, VE-D was 71.6% (95% CI: 68.6% to 74.2%) for any vaccine; 52.2% (95% CI: 37.2% to 63.6%) for Janssen; 75.5% (95% CI: 71.8% to 78.7%) for Moderna; and 70.1% (95% CI: 66.1% to 73.6%) for Pfizer-BioNTech.

Source: https://www.zerohedge.com/covid-19/study-reveals-dramatic-decline-all-three-covid-19-vaccines-over-time

Study – SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines

Stars: https://pubmed.ncbi.nlm.nih.gov/33440640/

Abstract

The world is suffering from the coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 uses its spike protein to enter the host cells. Vaccines that introduce the spike protein into our body to elicit virus-neutralizing antibodies are currently being developed. In this article, we note that human host cells sensitively respond to the spike protein to elicit cell signaling. Thus, it is important to be aware that the spike protein produced by the new COVID-19 vaccines may also affect the host cells. We should monitor the long-term consequences of these vaccines carefully, especially when they are administered to otherwise healthy individuals. Further investigations on the effects of the SARS-CoV-2 spike protein on human cells and appropriate experimental animal models are warranted.

Study – The furin cleavage site in the SARS-CoV-2 spike protein is required for transmission in ferrets

Source: https://pubmed.ncbi.nlm.nih.gov/33907312/

Abstract

SARS-CoV-2 entry requires sequential cleavage of the spike glycoprotein at the S1/S2 and the S2′ cleavage sites to mediate membrane fusion. SARS-CoV-2 has a polybasic insertion (PRRAR) at the S1/S2 cleavage site that can be cleaved by furin. Using lentiviral pseudotypes and a cell-culture-adapted SARS-CoV-2 virus with an S1/S2 deletion, we show that the polybasic insertion endows SARS-CoV-2 with a selective advantage in lung cells and primary human airway epithelial cells, but impairs replication in Vero E6, a cell line used for passaging SARS-CoV-2. Using engineered spike variants and live virus competition assays and by measuring growth kinetics, we find that the selective advantage in lung and primary human airway epithelial cells depends on the expression of the cell surface protease TMPRSS2, which enables endosome-independent virus entry by a route that avoids antiviral IFITM proteins. SARS-CoV-2 virus lacking the S1/S2 furin cleavage site was shed to lower titres from infected ferrets and was not transmitted to cohoused sentinel animals, unlike wild-type virus. Analysis of 100,000 SARS-CoV-2 sequences derived from patients and 24 human postmortem tissues showed low frequencies of naturally occurring mutants that harbour deletions at the polybasic site. Taken together, our findings reveal that the furin cleavage site is an important determinant of SARS-CoV-2 transmission.