We bring this article to you in the public interest and by courtesy of The Lancet's open distribtion policy. See end for information on reuse. (Source: The Lancet, UK;s top medical magazine)
It's a long artiicle and quite techmical but iot has to be in order to explain properly how the oublic have been misled by government and corporate propaganda.
If you are not into long reads and heavy medical; detail we suggest you scroll to the paragraph beginning Vaccine efficiency is generally reported ... immediately below the first graphic.
For inormation on reusing this article see the lines on copyright details at the bottom of the article and references and above the LINKS section of our page.
*******
Approximately 96 COVID-19 vaccines are at various stages of clinical development.
At present, we have the interim results of four studies published in
scientific journals (on the Pfizer–BioNTech BNT162b2 mRNA vaccine, the Moderna–US National Institutes of Health [NIH] mRNA-1273 vaccine, the AstraZeneca–Oxford ChAdOx1 nCov-19 vaccine, and the Gamaleya GamCovidVac [Sputnik V] vaccine) and three studies through the US Food and Drug Administration (FDA) briefing documents (on the Pfizer–BioNTech, Moderna–NIH, and Johnson & Johnson [J&J] Ad26.COV2.S vaccines).
Furthermore, excerpts of these results have been widely communicated
and debated through press releases and media, sometimes in misleading
ways.
Although attention has focused on vaccine efficacy and comparing the
reduction of the number of symptomatic cases, fully understanding the
efficacy and effectiveness of vaccines is less straightforward than it
might seem. Depending on how the effect size is expressed, a quite
different picture might emerge (figure; appendix).
FigureRRR and NNV with 95% CI ranked by attack rate in the unvaccinated (placebo) group for five COVID-19 vaccines
Vaccine
efficacy is generally reported as a relative risk reduction (RRR). It
uses the relative risk (RR)—ie, the ratio of attack rates with and
without a vaccine—which is expressed as 1–RR. Ranking by reported
efficacy gives relative risk reductions of 95% for the Pfizer–BioNTech,
94% for the Moderna–NIH, 90% for the Gamaleya, 67% for the J&J, and
67% for the AstraZeneca–Oxford vaccines. However, RRR should be seen
against the background risk of being infected and becoming ill with
COVID-19, which varies between populations and over time. Although the
RRR considers only participants who could benefit from the vaccine, the
absolute risk reduction (ARR), which is the difference between attack
rates with and without a vaccine, considers the whole population. ARRs
tend to be ignored because they give a much less impressive effect size
than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH,
1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the
Pfizer–BioNTech vaccines.
ARR
is also used to derive an estimate of vaccine effectiveness, which is
the number needed to vaccinate (NNV) to prevent one more case of
COVID-19 as 1/ARR. NNVs bring a different perspective: 76 for the
Moderna–NIH, 78 for the AstraZeneca–Oxford, 80 for the Gamaleya, 84 for
the J&J, and 117 for the Pfizer–BioNTech vaccines. The explanation
lies in the combination of vaccine efficacy and different background
risks of COVID-19 across studies: 0·9% for the Pfizer–BioNTech, 1% for
the Gamaleya, 1·4% for the Moderna–NIH, 1·8% for the J&J, and 1·9%
for the AstraZeneca–Oxford vaccines.
ARR
(and NNV) are sensitive to background risk—the higher the risk, the
higher the effectiveness—as exemplified by the analyses of the J&J's
vaccine on centrally confirmed cases compared with all cases:
both the numerator and denominator change, RRR does not change
(66–67%), but the one-third increase in attack rates in the unvaccinated
group (from 1·8% to 2·4%) translates in a one-fourth decrease in NNV
(from 84 to 64).
There are many
lessons to learn from the way studies are conducted and results are
presented. With the use of only RRRs, and omitting ARRs, reporting bias
is introduced, which affects the interpretation of vaccine efficacy.
When communicating about vaccine efficacy, especially for public health
decisions such as choosing the type of vaccines to purchase and deploy,
having a full picture of what the data actually show is important, and
ensuring comparisons are based on the combined evidence that puts
vaccine trial results in context and not just looking at one summary
measure, is also important. Such decisions should be properly informed
by detailed understanding of study results, requiring access to full
datasets and independent scrutiny and analyses.
Unfortunately,
comparing vaccines on the basis of currently available trial (interim)
data is made even more difficult by disparate study protocols, including
primary endpoints (such as what is considered a COVID-19 case, and when
is this assessed), types of placebo, study populations, background
risks of COVID-19 during the study, duration of exposure, and different
definitions of populations for analyses both within and between studies,
as well as definitions of endpoints and statistical methods for
efficacy. Importantly, we are left with the unanswered question as to
whether a vaccine with a given efficacy in the study population will
have the same efficacy in another population with different levels of
background risk of COVID-19. This is not a trivial question because
transmission intensity varies between countries, affected by factors
such as public health interventions and virus variants. The only
reported indication of vaccine effectiveness is the Israeli mass
vaccination campaign using the Pfizer–BioNTech product. Although the
design and methodology are radically different from the randomised
trial, Dagan and colleagues
report an RRR of 94%, which is essentially the same as the RRR of the
phase 3 trial (95%) but with an ARR of 0·46%, which translates into an
NNV of 217 (when the ARR was 0·84% and the NNV was 119 in the phase 3
trial). This means in a real-life setting, 1·8 times more subjects might
need to be vaccinated to prevent one more case of COVID-19 than
predicted in the corresponding clinical trial.
Uncoordinated
phase 3 trials do not satisfy public health requirements; platform
trials designed to address public health relevant questions with a
common protocol will allow decisions to be made, informed by common
criteria and uniform assessment. These considerations on efficacy and
effectiveness are based on studies measuring prevention of mild to
moderate COVID-19 infection; they were not designed to conclude on
prevention of hospitalisation, severe disease, or death, or on
prevention of infection and transmission potential. Assessing the
suitability of vaccines must consider all indicators, and involve
safety, deployability, availability, and costs.
We declare no competing interests.
Supplementary Material
- Supplementary appendix
References
- 1.Covid-19 Vaccine Tracker.https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.htmlDate accessed: March 10, 2021
- 2.Safety and efficacy of the BNT162b2 mRNA COVID-19 Vaccine.N Engl J Med. 2020; 383: 2603-2615
- 3.Efficacy and safety of the mRNA-1273 SARS-CoV-2 Vaccine.N Engl J Med. 2021; 384: 403-416
- 4.Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.Lancet. 2021; 397: 99-111
- 5.Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia.Lancet. 2021; 397: 671-681
- 6.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcementDate: Dec 10, 2020Date accessed: March 10, 2021
- 7.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcementDate: Dec 17, 2020Date accessed: March 10, 2021
- 8.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcementDate: Feb 26, 2021Date accessed: March 10, 2021
- 9.What does 95% COVID-19 vaccine efficacy really mean?.Lancet Infect Dis. 2021; (published online Feb 17.)
- 10.Outcome reporting bias in COVID-19 mRNA vaccine clinical trials.Medicina (Kaunas). 2021; 57: 199
- 11.BNT162b2 mRNA COVID-19 vaccine in a nationwide mass vaccination setting.N Engl J Med. 2021; (published online Feb 24.)
Article Info
Publication History
Published: April 20, 2021
Identification
Copyright
© 2021 The Author(s). Published by Elsevier Ltd.
User License Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0) |
LINKS
Vaccine Adverse Reactions – Not Reported By Mainstream Media
The UK Government’s COVID-19 vaccination programme is now in full swing and the general public is being bombarded with the official line that to stop the COVID-19 pandemic and regain their freedom, people must be vaccinated. In fact they are told they must be vaccinated twice. …
Vaccine: More cases of rare blood clots, but regulator says benefits still outweigh risk
Reported cases of rare blood clots occuring in people soon after they received a shot of the AZ COVID-19 vaccine has risen to 168. The UK’s medicines regulator said the overall case fatality rate was 19%, with 32 deaths up to April 14. Note the dishonesty in the style of reporting again. Nowhere does the official press release make clear that the figures apply only to adverse reactions of blood clots, both non fatal and fatal. People are still suffering and dying from allergic reactions, heart attacks, organ failure and respiratory failure soon after being vaccinated.
Study Reveals mRNA COVID Vaccines Link To Prion Disease & Brain Degeneration
from Great Game India A shocking study has revealed the terrifying dangers of mRNA COVID-19 vaccines inducing prion-based disease causing your brain to degenerate progressively. The mRNA vaccine induced prions may cause neurodegenerative diseases because long-term memories are maintained by prion-like proteins. The study concluded that mRNA based vaccine may also cause ALS, front temporal …
Evidence of Problems With Covid Vaccine Grow And Te Real Agenda Becomes Clearer.
Mainstream media have been distracting us with stories of successful mass vaccination campaigns, but as ever things are not quite what they seem to be and though the claimed 999% take up of the vaccines is not verifiable, the deafening silence regarding the huge numbers of serious adverse reactions to all type of vaccine and the significant numbers of unexplained deaths which have occured soon after people reveived the jab suggest there will be worse news to come in the future ...
Backflipping Boris Says Vaccine Passports for Will Be ‘Feature of Our Life in the Future’
March 11, 2021 Contrary to what other ministers in his government have been saying recently, Prime Minister Boris Johnson admitted earlier this week it is highly probable that vaccine passports for international travel will be a feature of Britons’ lives in the future. Speaking at a Downing Street press event on Monday evening, the Prime Minister Johnson acknowledged … Continue readingTwitter Thought Police Will Ban Anyone Who Repeatedly Tells Truth About COVID Vaccine
In future anyone who “repeatedly posts misleading information” about SARS-COV2 (Covid-19) vaccines on Twitter will be put on a watch list and given five chances to chaine their opinion or self – censor their comments and opinions before being permanently banned from the social media platform, the company recently announced. A True to form however, … Continue reading
Council of Europe Decrees Vaccines Must Not be Mandatory and Non-Vaccinated Must Not be Discriminated Against
The Parliamentary Assembly of the Council of Europe – the international body of which Britain remains a member) – has passed a resolution that recommending that governments refrain from enacting laws that make any vaccines mandatory and stated that nobody should suffer discrimination on account of not having been vaccinated. The resolution obviously refers to … Continue readingWhy Is There A Correlation Between The Vaccine Rollout And Increased COVID–19 Mortality?
from UK Column Since the UK government began its rollout of the COVID vaccine regular reports of unusual death events occuring shortly after the deceased had received a shot of the vaccine have been reported in care homes and by doctors’ surgeries across the country. The Official line has been that the vaccine shot and … Continue readingPfizer COVID vaccine killed 40 times more old people than the virus itself would have – Report
March 4, 2021posted by The Defender The experimental Wuhan coronavirus (Covid-19) vaccines from Pfizer that were rushed into production and distribution via Donald Trump’s “Operation Warp Speed” program are killing far more elderly people than the so-called “virus” itself would have. A re-analysis of data provided by the Israeli Health Ministry concluded that Pfizer and BioNTech’s messenger … Continue reading Useless Drugs And Vaccines – Lying Science Whores. Told You SoUseless Drugs And Vaccines – Lying Science Whores. Told You So Dr. Offit, mandatory vaccine and conflicts of interest Do vaccines make you gay? Zika Virus Outbreak Centred On Area Where GM Mosquitos Were Released In 2015 – Why Are We Not Surprised The Left Scream About Their Opponents Intolerance But Who Is Really Intolerant Doctors, scientists greased by Big Pharma? Told you so. Weaponised Ebola Virus? The World Always Cathches Up Eventually? Meningitis B Vaccine - cost conundrum Flu Vaccines that don't work and healthy natural alternatives that work Fear and Painc! Mild Illness Suddenly Becomes A Killer Now Vaccine Is Available. Health Authorities Now Admit Severe Side Effects Of Vaccines Conflicts of interest in vaccine industry
Vaccines mask covert Eugenics?
Is it right to let Bill Gates, the man who made 'not fit for purpose' acceptable, manage vaccination programs?
Vaccines: First do no harm
Vaccines and the immune system
Vaccine paradox
California Infant Dies after 8 Vaccines, Family Gets Him Back from Hospital Cremated.
California: The Medical Police State
Fear And Panic Takes Hold As Zika Virus spreads Like Wildfire
Swine Flu Scam Exposed: Useless Drugs And Vaccines - Lying Science Whores
Mosquitos, Mad Scientists and Ethics
00069-0&id=gr1.jpg){kind=link}