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Open Roads Forum  >  Around the Campfire  >  General Topics

 > 2019–2022 CORONAVIRUS PANDEMIC POSTINGS

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BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/03/21 10:40am Link  |  Quote  |  Print  |  Notify Moderator

This analysis of health data records from several locations around the world estimated the probability of severe, critical, and fatal disease outcomes (ISR, ICR, and IFR respectively) by age group.

Quote:

rate of severe infections (ISR), which we define as infections resulting in hospitalization or out-of-hospital death, and the rate of critical infections (ICR), which we define as infections resulting in critical care admission or out-of-ICU death


Preprint doi: https://doi.org/10.1101/2021.07.29.21261282

Quote:

In conclusion, we presented the first estimates of age-specific ISR and ICR of SARS-CoV-2 using multi-country serology data. Our estimates show that, as with other SARS-Cov-2 outcomes, the ISR and ICR increased exponentially with age; however, the rate of increase in the risk of severe and critical disease outcomes with age is less marked than the rate of increase in lethality due to SARS-Cov-2 infection.


Another outcome from this analysis was a comparison of the rates of myocarditis due to mRNA vaccination vs severe and critical covid infections in the 16-24 year old range

Vaccine induced myocarditis: 0.025%
Severe covid infections: 0.3%
Critical covid infections: 0.035%
Fatal covid infections: 0.0035%

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/03/21 10:48am Link  |  Quote  |  Print  |  Notify Moderator

Vaccinated and unvaccinated individuals have similar viral loads in communities with a high prevalence of the SARS-CoV-2 delta variant
Preprint

Quote:

SARS-CoV-2 variant B.1.617.2 (delta) is associated with higher viral loads 1 and increased transmissibility relative to other variants, as well as partial escape from polyclonal and monoclonal antibodies 2. The emergence of the delta variant has been associated with increasing case counts and test-positivity rates, indicative of rapid community spread. Since early July 2021, SARS-CoV-2 cases in the United States have increased coincident with delta SARS-CoV-2 becoming the predominant lineage nationwide 3. Understanding how and why the virus is spreading in settings where there is high vaccine coverage has important public health implications. It is particularly important to assess whether vaccinated individuals who become infected can transmit SARS-CoV-2 to others. In Wisconsin, a large local contract laboratory provides SARS-CoV-2 testing for multiple local health departments, providing a single standard source of data using the same assay to measure virus burdens in test-positive cases. This includes providing high-volume testing in Dane County, a county with extremely high vaccine coverage. These PCR-based tests provide semi-quantitative information about the viral load, or amount of SARS-CoV-2 RNA, in respiratory specimens. Here we use this viral load data to compare the amount of SARS-CoV-2 present in test-positive specimens from people who self-report their vaccine status and date of final immunization, during a period in which the delta variant became the predominant circulating variant in Wisconsin. We find no difference in viral loads when comparing unvaccinated individuals to those who have vaccine “breakthrough” infections. Furthermore, individuals with vaccine breakthrough infections frequently test positive with viral loads consistent with the ability to shed infectious viruses. Our results, while preliminary, suggest that if vaccinated individuals become infected with the delta variant, they may be sources of SARS-CoV-2 transmission to others.


The title summarizes the findings. This is one more study which explains why the CDC is altering masking recommendations.

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/03/21 06:45pm Link  |  Quote  |  Print  |  Notify Moderator

The cdc describes the math here:
Vaccine efficacy or vaccine effectiveness

Here is the preprint of the ongoing phase 3 clinical trial at 6 months of the Pfizer vaccine.

Quote:

Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine
Preprint doi: https://doi.org/10.1101/2021.07.28.21261159


Abstract
Background BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2 months post-vaccination were unavailable.

Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy study, 44,165 =16-year-old participants and 2,264 12-15-year-old participants were randomized to receive 2 doses, 21 days apart, of 30 µg BNT162b2 or placebo. Study endpoints reported here are vaccine efficacy (VE) against laboratory-confirmed COVID-19 and safety data, both up to 6 months post-vaccination.

Results BNT162b2 continued to be safe and well tolerated. Few participants had adverse events leading to study withdrawal. VE against COVID-19 was 91% (95% CI 89.0-93.2) through up to 6 months of follow-up, among evaluable participants and irrespective of previous SARS-CoV-2 infection. VE of 86%-100% was seen across countries and in populations with diverse characteristics of age, sex, race/ethnicity, and COVID-19 risk factors in participants without evidence of previous SARS-CoV-2 infection. VE against severe disease was 97% (95% CI 80.3-99.9). In South Africa, where the SARS-CoV-2 variant of concern, B.1.351 (beta), was predominant, 100% (95% CI 53.5, 100.0) VE was observed.

Conclusion With up to 6 months of follow-up and despite a gradually declining trend in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing COVID-19. (ClinicalTrials.gov number, NCT04368728)



This quote is from the safety section of the study report where the authors are assessing for vaccine induced deaths. This quote is not from the efficacy section where the ability of the vaccine to prevent covid is assessed.
Quote:

During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died. None of these deaths were considered related to BNT162b2 by investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4).

A link to the supplemental data including table s4 has not yet been provided (the number of these deaths due to covid cannot be assigned without reviewing table s4).

For reference here is the previous report on the Pfizer vaccine.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
New England Journal of Medicine

* This post was last edited 08/04/21 08:19pm by BCSnob *   View edit history

JaxDad

Greater Toronto Area

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Joined: 08/02/2011

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Good Sam RV Club Member

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Posted: 08/04/21 06:40am Link  |  Quote  |  Print  |  Notify Moderator

Now here’s a potential game-changer, PCR tests in your home! Co-Diagnostics Inc’s Eikon PCR device.

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/05/21 06:47am Link  |  Quote  |  Print  |  Notify Moderator

On the effectiveness of Pfizer’s vaccine after 6 months we need to first review the FDAs definitions of a confirmed covid case and a severe case of Covid.
Quote:

Confirmed Covid-19 was defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms: fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting, combined with a respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification–based testing, either at the central laboratory or at a local testing facility (using a protocol-defined acceptable test).

Severe Covid-19 is defined by the FDA as confirmed Covid-19 with one of the following additional features: clinical signs at rest that are indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death.

Source: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine


Here are quotes from the 6 month summary on the efficacy of Pfizer’s vaccine.
Quote:

During the interval from the approximate start of observed protection at 11 days post-dose 1 to before dose 2, VE increased to 91.7% (95% CI 79.6-97.4). From its peak post-dose 2, observed VE declined. From 7 days to <2 months post-dose 2, VE was 96.2% (95% CI 93.3-98.1); from 2 months to <4 months, VE was 90.1% (95% CI 86.6-92.9); and from 4 months to the data cut-off, VE was 83.7% (95% CI 74.7-89.9).

Of 31 cases of severe, FDA-defined COVID-19,12 with onset post-dose 1, 30 occurred in placebo recipients, corresponding to 96.7% VE (95% CI 80.3-99.9) against severe COVID-19 (Fig. 2, Table S6).
The vaccine protected against covid infections but the protection appears the decrease after 4 months.

There was only 1 severe covid case in the vaccinated group and 30 severe cases in the placebo group; these cases only needed to fit the FDA definition above.

* This post was edited 08/05/21 06:58am by BCSnob *

Deb and Ed M

SW MI & Space Coast, FL USA

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Joined: 06/07/2004

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Posted: 08/05/21 08:01am Link  |  Quote  |  Print  |  Notify Moderator

I just read that in San Francisco, they are hinting that folks who got the J&J vax, might want to get a second "booster" shot of Moderna/Pfizer. And the study posted above bears the question: should those of us who got in early for vaccine (our 2nd shot was Mar 2) think about getting another shot to keep the ol' immune system "tweaked"??

Surely I'm not the only Snowbird who's watching Florida's all-time-high new case numbers with alarm, and pondering my own dwindling immunity??

Has anyone heard of a booster geared towards Delta??

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/05/21 09:16am Link  |  Quote  |  Print  |  Notify Moderator

Deb and Ed M wrote:

Has anyone heard of a booster geared towards Delta??


Yes!

Pfizer Press Release July 8, 2021 wrote:

While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant. The first batch of the mRNA for the trial has already been manufactured. The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals.

Link

I would not expect this booster to be available before the end of this year

This document from the FDA outlines the tests that will likely be required for submission for an EAU for boosters (see Appendix 2).
Emergency Use Authorization for Vaccines to Prevent COVID-19
The key test results will be
virus neutralization assays (using pseudovirus or wildtype virus)
Neutralizing antibody titers
From boosted previously vaccinated patients
From unvaccinated and not previously infected patients after full vaccination protocol

* This post was last edited 08/05/21 09:58am by BCSnob *   View edit history

steveh27

Grosse Pointe Woods, MI

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Joined: 08/21/2004

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Good Sam RV Club Member


Posted: 08/06/21 04:43am Link  |  Quote  |  Print  |  Notify Moderator

With a compromised immune system (due to chemo a stem cell transplant and a immuno suppressing drug) and no antibodies from the Pfizer vaccine I need a booster ASAP. I wonder why the FDA is taking so long to approve that?

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/06/21 04:51am Link  |  Quote  |  Print  |  Notify Moderator

Good question

First the FDA must finalize their requirements for testing boosters; the linked article has the FDA’s “current thinking” on what they might require. I suspect that with delta inducing breakthrough infections that are just as infectious as infections in unvaccinated people the FDA & CDC will shift their stance on the need for boosters.

BCSnob

Middletown, MD

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Joined: 02/23/2002

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Posted: 08/06/21 06:16am Link  |  Quote  |  Print  |  Notify Moderator

In this study (preprint Elapsed time since BNT162b2 vaccine and ........ SARS- CoV-2 infection in a large cohort) from Israel the authors found a ~2x increased risk of a Pfizer vaccine breakthrough infection beyond 146 days after 2nd dose than before 146 days after 2nd dose. These real world observational data are in agreement with Pfizer’s 6 month summary of their clinical trial.

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