Covid-19 Vaccine: Important Points

Here are the source links for that claim. I will let you look at them an evaluate:
1. https://www.bmj.com/content/371/bmj.m4037
2. https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/?sh=444e90695247

IÃ¢ÂÂm getting the links directly from the website. Here is the link for thesource for that point: https://www.fda.gov/media/144245/download

HereÃ¢ÂÂs the link for the source: https://www.fda.gov/media/144245/download

I found this article intriguing and alarming, which is why I shared it. I did click the source links out of curiosity. Here are the links to sources used regarding vaccine trial definitions of Ã¢ÂÂeffectiveÃ¢ÂÂ:
1. https://www.bmj.com/content/371/bmj.m4037
2. https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/?sh=444e90695247

I just don’t see where this writer is pulling stats like that. I’ll leave the question open and unanswered. I speculate that between the two vaccines probably building antibodies thus the positive test for the virus. Possibly found the answer p42 on FDA pdf:

“It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.”

I like vaccines that prevent minor symptoms like death.

“Who wrote this crap.”

The British Medical Journal did

https://www.bmj.com/content/371/bmj.m4037

Article has a great chart that shows that NONE of the vaccine trials looked at whether their vaccine would result in:

1. Reduction in severe covid-19 (hospital admission, ICU, or death)

2. Interruption of transmission (person to person spread)

thanks for posting this. the citations in the original article are well worth reading.

here’s some bits i extracted from the citations:

MINOR IMPACT: Vaccine manufacturers claim that Covid-19 vaccines are 95 percent “effective,” but the FDA is allowing companies to define effectiveness as “prevention of mild symptoms.” The studies are not designed to detect a reduction in outcomes such as severe illness, hospitalization or death.1,2 For individuals who develop severe symptoms, the vaccine is not a remedy. Instead, nutritional and oxidative support can help keep the illness from going into “overdrive.”3

EXPECT ADVERSE REACTIONS: Participants in every Covid-19 vaccine trial have reported adverse reactions including high fever, chills, muscle pains and headaches.4-6 Some have even reported severe reactions that required hospitalization and invasive treatment. According to the FDA, potential long-term effects may include Guillain-Barré syndrome, brain swelling, muscle weakness and paralysis, convulsions and seizures, stroke, narcolepsy, shock, heart attack, autoimmune disease, arthritis and joint pain, multisystem inflammatory syndrome in children, and death.7 Some UK health workers have experienced anaphylactic shock after receiving one dose of the approved vaccine.8

WON’T PREVENT COVID-19: An FDA Pfizer briefing paper published December 10, 2020 revealed 43 percent more suspected cases of Covid-19 in the vaccinated group than in the placebo group within seven days of vaccination.9

NO LIABILITY: Covid-19 vaccine manufacturers will be protected from all liability—if you are injured, you cannot sue.10 Manufacturers will have complete indemnity even though all previous attempts at creating coronavirus vaccines caused harm and never advanced to regulatory approval.11

WILL NOT END RESTRICTIVE MEASURES: Dr. Anthony Fauci of the National Institutes of Health acknowledges that the vaccines may prevent symptoms but will not block spread of the virus, so vaccine recipients will still need to wear masks, practice social distancing and avoid crowds.12,13

NOT NECESSARY: According to the CDC’s current best estimate, the “infection fatality rate” (IFR) for Covid-19 is less than 1 percent for people age 69 and younger, including a .003 percent IFR for children and adolescents.14

COULD MAKE YOU STERILE: Two prominent doctors, including the ex-head of Pfizer’s respiratory research, warn that Covid-19 vaccines contain a spike protein called syncytin-1, vital for the formation of the placenta.15 If the vaccine triggers an immune response to this protein, then female infertility, miscarriage or birth defects could result.

Citations:

1. Doshi P. Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ. 2020;371:m4037. https://www.bmj.com/content/371/bmj.m4037.

2. Haseltine WA. Covid-19 vaccine protocols reveal that trials are designed to succeed. Forbes, September 23, 2020. https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/?sh=5da0663d5247.

3. Brownstein D, Ng R, Rowen R et al. A novel approach to treating COVID-19 using nutritional and oxidative therapies. Science, Public Health Policy, and the Law. 2020;2:4-22. https://ozonewithoutborders.ngo/wp-content/uploads/2020/07/Novel-Approach-to-Covid-19.pdf.

4. Jackson LA, Anderson EJ, Rouphael NG et al. An mRNA vaccine against SARS-CoV-2 – preliminary report. New England Journal of Medicine. 2020;383(20):1920-1931. https://www.nejm.org/doi/full/10.1056/NEJMoa2022483.
5. Allen A, Szabo L. NIH “very concerned” about serious side effect in coronavirus vaccine trial. Scientific American, September 15, 2020. https://www.scientificamerican.com/article/nih-very-concerned-about-serious-side-effect-in-coronavirus-vaccine-trial/.

6. Mayer A. Leading COVID vaccine candidates plagued by safety concerns. The Defender, November 13, 2020. https://childrenshealthdefense.org/defender/covid-vaccine-candidates-safety-concerns/?itm_term=home.

7. U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee, October 22, 2020 Meeting Presentation, slide #16. https://www.greenmedinfo.com/blog/covid-19-vaccine-bombshell-fda-documents-reveal-death-21-serious-conditions-possi1.

8. Reals T. U.K. warns against giving Pfizer vaccine to people prone to severe allergic reactions. CBS News, December 9, 2020. https://www.cbsnews.com/amp/news/covid-vaccine-pfizer-shot-uk-warning-people-with-history-of-significant-allergic-reactions/#app.

9. https://www.fda.gov/media/144245/download, page 42.

10. Public Readiness and Emergency Preparedness Act. COVID-19 PREP Act Declarations. https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.

11. Lyons-Weiler J. Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity. Journal of Translational Autoimmunity. 2020;3:100051. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7142689/.

12. Khemlani A. Fauci: Early COVID-19 vaccines will only prevent symptoms, not block the virus. Yahoo! Finance, October 26, 2020. https://finance.yahoo.com/news/fauci-vaccines-will-only-prevent-symptoms-not-block-the-virus-195051568.html.

13. Scipioni J. Dr. Fauci says masks, social distancing will still be needed after a Covid-19 vaccine—here’s why. CNBC, November 16, 2020. https://www.cnbc.com/2020/11/16/fauci-why-still-need-masks-social-distancing-after-covid-19-vaccine.html.

14. Centers for Disease Control and Prevention. COVID-19 pandemic planning scenarios. Updated September 10, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html.

15. Petition/motion for administrative/regulatory action regarding confirmation of efficacy end points and use of data in connection with the following clinical trials. Dr. Wolfgang Wodarg and Dr. Michael Yeadon, petitioners. Filed with European Medicines Agency, December 1, 2020. https://healthimpactnews.com/wp-content/uploads/sites/2/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf.

Doshi P. “Will covid-19 vaccines save lives? Current trials aren’t designed to tell us.” BMJ. 2020;371:m4037:

https://www.bmj.com/content/371/bmj.m4037

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

https://www.cnbc.com/2020/11/16/fauci-why-still-need-masks-social-distancing-after-covid-19-vaccine.html

Dr. Fauci says masks, social distancing will still be needed after a Covid-19 vaccine—here’s why

> Dr. Anthony Fauci warns “it’s not going to be a light switch” back to normalcy even when a Covid-19 vaccine becomes available to the public.
>
> In fact, Fauci recommends people still wear masks and practice social distancing even after getting the vaccine, he told CNN’s Jake Tapper on “State of the Union” on Sunday.
>
> On Monday, Moderna announced that preliminary data showed the Covid-19 vaccine it developed in collaboration with the National Institute of Allergy and Infectious Diseases is more than 94% effective. The news follows a similar announcement from Pfizer and BioNTech on Nov. 9, which showed their Covid-19 vaccine was above 90% effective.
>
> “Obviously, with a 90-plus percent effective vaccine, you could feel much more confident” about not getting the virus, Fauci told Tapper. “But I would recommend to people to not abandon all public health measures just because you have been vaccinated.” Those fundamentals include: universal wearing of masks, maintaining physical distance, avoiding large crowds, doing more outdoor activities and washing hands frequently.
>
> Because “even though, for the general population, it might be 90[%] to 95% effective,” said Fauci, “you don’t necessarily know, for you, how effective it is.” Even at those success rates, about 5% to 10% of people immunized may still get the virus.
>
> “In addition, the protective effect of a vaccine may take at least one month, if not slightly longer,” says Dr. David Ho, a virologist working on developing monoclonal antibody therapies for Covid-19 at Columbia University. (So far, Pfizer said early results showed its two-dose vaccine showed 90% effectiveness seven days after the second dose. Early data on Moderna’s two-dose vaccine showed 94.5% efficacy two weeks after the second dose.)
>
> “Therefore, for the foreseeable future, we will need to continue our mitigation measures, including wearing masks,” Ho says, noting that precautionary measures will likely last “for much of 2021.”
>
> Dr. Bruce Hirsch, an infectious disease specialist at Northwell Health, adds that many people have strong feelings about vaccines and may not take them, which “will impact the general population from being immune to Covid-19 and prolong the threat of the pandemic.”
>
> It is worth noting that as the trials for both vaccines progress, efficacy numbers could change, and it is also not yet clear how long any immunity would last.
>
> Fauci, 79, said when it is his turn to get vaccinated, he doesn’t plan on abandoning all the public health measures that he has been advocating during the pandemic.
>
> ″I could feel more relaxed, in essentially not having the stringency of it that we have right now, but I think abandoning it completely would not be a good idea,” Fauci told Tapper.
>
> Fauci predicted to Tapper that most of the country will get vaccinated in the second or third quarter of 2021. But “we are not going to turn [the pandemic] on and off, going from where we are to completely normal. It’s going to be a gradual accrual of more normality as the weeks and the months go by, as we get well into 2021,” he said.

Anti-vaxxer hysteria. The COVID-19 vaccines are extremely well tested using the same methods every other drug on the market is tested with. They go through Phase 1, Phase 2, and Phase 3 clinical trials. They’ve been tested with animals. They’ve been tested with over 100,000 humans. They work better than the smallpox vaccine.

Spreading fear and misinformation is the media’s job. Oh, and I guess Chinese intelligence agents too.

Yes, I agree with you. I think they are interpreting something in the suspected cases, but it is not clear to me either. It does seem like a lot of overall suspected cases, both in the vaccine group and the placebo group (~3000 out of ~40,000?), although less for vaccine. Why are they only saying suspected? They never actually did the PCR test on any of the participants?

I just can’t figure some of the convoluted wording.I’ve been trying to post on as much as I can in an objective non political, non skewed manner, just the facts but find few people read and a LOT of those will reply along political lines, not what is presented.

You’d think educating is a virtue but with this vaccine it’s a curse. Not that I have been able to get a complete handle on thi. I’m just trying to separate politics from medicine and then making an attempt at understanding the science.

The studies are not designed to detect a reduction in outcomes such as severe illness, hospitalization or death

The Moderna Phase 3 COVE study enrolled >30 000 subjects. The score for severe COVID illness or death = 30 in the placebo group, zero in the vaccine group.

The Pfizer Phase 2/3 studies enrolled 36 253 subjects. The score for severe COVID illness = 9 in the placebo group and 1 in the vaccine group.

Both of these results were highly statistically significant and form the basis for the Emergency Use Authorizations of 12/11 and 12/18.

I really appreciate you asking me about it. It has caused me to give it a closer look too. Thanks!

Thank you. WeÃ¢ÂÂve been looking at one of the sources in the article I posted. Source 9,the FDA pdf of study results. IÃ¢ÂÂm learning how to read it as a result of comments to this post. It is still confusing to me. It looks as though the study participants were tested after 7 days and then beyond that they are only listing suspected Covid, which makes me think they didnÃ¢ÂÂt retest them at later points. Otherwise why would it be called suspected Covid? (P. 42) Additionally I donÃ¢ÂÂt know what to make of the graph on p. 30 (figure 2). What is that showing? Cases or symptoms? And the third and final question, also from p. 30, were there only four severe cases out of the >30,000? Sorry, itÃ¢ÂÂs a lot, but you seem to have a good handle on this study. Thanks. HereÃ¢ÂÂs the link. https://www.fda.gov/media/144245/download