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Compulsory Jabs vs the Nuremberg Code

Contribution Part 115 – 2021 # 08)

Have our authorities overstepped their bounds by moving towards compulsory vaccinations? (What does the post-WWII Nuremberg Code have to say?)

BRADES, Montserrat, July 7, 2021 –  A recent Government of Montserrat Human Resources circular of June 30th entitled “Updated Guidance on Discretionary Leave Provisions” has come to our attention here at TMR. In key parts, it reads:

“Public officers who apply for and are awarded Government Scholarships to study at institutions  abroad  will,  from the academic  year  2021/2022  be  required  to  be vaccinated before traveling to take up these awards . . . . It will also be a requirement for public officers attending training courses abroad to be fully vaccinated.”

Of course, given the third jab proposed for Autumn this year and reports of a train of onward booster shots every year or even every six months (as TMR has already reported[1]), “fully vaccinated” is a meaningless, dead term.  No, given what officials and even BBC[2] have said, it’s not “two jabs plus two weeks and you’re good to go.” BBC: “[p]lans for a Covid booster jab programme in the autumn will be set out in the next few weeks, [now former UK Health Secretary] Matt Hancock has said.”

Now, given utterly unnecessary sharp polarisation and accusations such as “incitement,” a point of clarification: there is evidence that vaccines can be effective and fairly safe. However, as risk is not evenly distributed in the population, if one has a significant medical history, consult a physician before any serious medical intervention. Where, too, if a train of treatments is in view, overall risks obviously can rise with such repeated exposure.

However, the bigger question raised by the circular is compulsory treatment – “required,” “a requirement” –  in the context of rushed experimental vaccines that to date only have emergency or contingent authorisation, not full approval. Tests for long-term effects and risks cannot be rushed.

Where, this obviously means – never mind objections by officialdom – they are still experimental and of course, there are significant concerns about risks.  Also, after the horrific Nazi medical experiments,[3] the Nuremberg Courts that judged war criminals issued a code for experimental medical treatments, which was then embedded in international and national law as well as in ethical standards for medical and research practice. This Nuremberg Code reads, in key parts[4]:

“[C]ertain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally . . . certain basic principles must be observed in order to satisfy moral, ethical and legal concepts . . . The voluntary consent of the human subject is absolutely essential. This means that the person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior[5] form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.”


A statement by Frontline Doctors group on Ivermectin

This is already decisive.

For, this means, sing- off- the- same- hymn- sheet PR talking points that suppress or stigmatise significant alternative views held by qualified people or simple concerns raised by the public are unethical and create liability. This includes marginalising concerns on risks of treatments,[6] the manifest fact that we are dealing with an unprecedented rushed global vaccination experiment, and issues regarding unduly sidelined evidence[7] that treatments such as Ivermectin-based cocktails can be effective. 

In short, it is arguable that we have not been given a balanced briefing that includes a true and fair view of reasonable alternatives, concerns, and risks.

Even if one could argue that we are increasingly or already beyond “experimental” treatment, a fortiori logic applies.

That is, if coercion, manipulation, hidden motives, and suppression of reasonable alternatives and/or concerns are improper for medical experiments, for cause – “how much more”  or “just like that” – they are also equally unacceptable for treatments in general. So, denial of the experimental status of the rushed vaccines does not allow one to wriggle off the hook.

The Nuremberg Code continues:

“[B]efore the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment . . .”

With a third jab and onward train of booster shots already being on the table, with emerging issues and concerns on risks (think, blood clots and heart issues for young men) and more,  it is simple fair comment to note that such informed consent has long since been undermined. Obviously, informed consent applies “just as much” to more or less established treatments.

Then, we see:


“The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature . . .”

Dr. John Campbell of the UK summarises how the degree of use of Ivermectin across Peru’s 25 states [33 million population] is linked to a reduction in Covid-19 deaths, there are similar results in Mexico and India

So, if there is reasonable access to and evidence of plausibly effective, less risky treatments (such as Ivermectin), then that should be fairly investigated and frankly disclosed.

Similarly, naturally acquired immunity is known to be highly effective. Some even suggest that it can be superior to that from many vaccines. So, why aren’t we testing for natural immunity before vaccinations and insisting on vaccinating people who have had and recovered from Covid-19?

The other methods or means test is also significant.

For, why are we using “gold standard” criteria for “evidence” that block the voice of otherwise valid “real-world evidence” and rule out otherwise plausibly credible treatments?

This lends added force to our next snippet from the Nuremberg Code:

“Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death . . .”

That speaks for itself, especially when we see:

“During the course of the experiment, the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.”

Resort to compulsion cannot be justified. The circular above is ill-advised and the precedent it may set is dangerous.

Accordingly, we find a final duty of those in charge of medical interventions:

“During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. “

Where, for cause, the attempted defence: “We were following the orders of legitimate authorities” was rejected by the Courts at Nuremberg.

This you will find does have some bearing to the United Nations “International Covenant on Civil and Political Rights (ICCPR)”


[1] TMR, June 25, 2021:  https://www.themontserratreporter.com/the-emerging-covid-vax-booster-shot-train/

[2] See BBC: https://www.bbc.com/news/health-57570377  and  https://www.bbc.com/news/uk-57548796.amp

[3] See https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments

[4] See, http://www.cirp.org/library/ethics/nuremberg/

[5] That is, hidden.

[6] TMR https://www.themontserratreporter.com/facebook-fact-check-fallacies-and-pandemic-panics-2/

[7] TMR, https://www.themontserratreporter.com/ivermectin-and-the-vaccine-debate/

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St. Lucia Times News

“Don’t Share the Video. It is Wrong!”

https://stluciatimes.com/dont-share-the-video-it-is-wrong/
St. Lucia Times News

June 11, 2021

https://stluciatimes.com/wp-content/uploads/2021/06/social-media-mobile-telephone.jpg

The President of Raise Your Voice Saint Lucia has expressed disgust at the continued sharing of graphic and at times embarrassing videos on social media.

Catherine Sealys is also concerned about the sharing of ‘intimate videos’ without the consent of the subject.

“Don’t share the video. It is wrong!” Sealys advises.

Sealys recalls that in the past several videos have appeared on social media, featuring among other things, mothers beating children and a man taking advantage of a naked woman who appeared to be intoxicated.

And most recently this week, the Raise Your Voice Saint Lucia President noted that a video had appeared on social media of a female accident victim in Vieux Fort.

Someone records the woman as she lies in pain on the ground with her skirt lifted.

“Your first duty is to save someone’s life, not to record them,” Sealys told St Lucia Times.

“For a woman to be in an accident and to be injured and to be on the ground suffering and somebody is videotaping her and then circulating that video, speaks to our tendency to absorb trauma, to be unempathetic,” she explained.

“Because if you are looking at this woman suffering, your first duty is to see how can you help her,” Sealys stated.

“I do not know what has happened to Saint Lucia, but everybody seems to feel anything that happens just take out my phone and start to video,” she lamented.

Sealys expressed concern over the national threshold for doing things that are unacceptable.

But she also condemned the hypocrisy of people who condemn the viral videos but share them anyway.

According to the Raise Your Voice Saint Lucia President, the relatives of victims continue to suffer.

“The persons in the video – they’re all over the place, not in the most dignified manner. We need to check ourselves in this country,” Sealys declared.

“This has to stop,” she asserted.

The Computer Misuse Act of Saint Lucia states:

  1. Malicious communications

(15. — (1) A person shall not use a computer to send a message, letter, electronic communication or article of any description that —

(a) is indecent or obscene;

(b) constitutes a threat; or

(c) is menacing in character,

with the intention to cause or being reckless as to whether he or she causes annoyance, inconvenience, distress or anxiety to the recipient or to any other person to whom he or she intends it or its contents to be communicated.

(2) A person who contravenes subsection (1) commits an offence and is liable on summary conviction to a fine not exceeding ten thousand dollars or to imprisonment for a term not exceeding three months or both and in the case of a subsequent conviction, to a fine not exceeding twenty thousand dollars or to imprisonment for a term not exceeding six months or both.

According to the law,  “computer” means a device that accepts information, in the form of digitalized data, and manipulates the information for some result based on a program or sequence of instructions on how the data is to be processed.

TMR: Below is an article that is a clear example for social media and less responsible media… and for more – visit: https://www.facebook.com/themontserratreporter

BBC apologises for coverage of Christian Eriksen’s on-field treatment (msn.com)

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CXC Headquarters - Executive Search

CXC Headquarters – Executive Search

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vaccine-graph-dod-112

Ivermectin and the vaccine debate

Is “Follow the [Official] Science” the last word on the Covid-19 vaccine debate?

Part 112/2021 (Contribution)

Mrs. Judith Smentkiewicz,

BRADES, Montserrat, May 31, 2021 –  Freedom is always “noisy,” sometimes “complicated” and often “messy.” So, while there is generally good evidence of vaccine efficacy and safety, vaccines are not the whole reasonable, responsible story on the pandemic. Especially, for people with medical histories who should consult their doctors before taking any serious medical action.

That’s why we need to hear other sides of the story. 

Accordingly, let us pay close attention to the Judith Smentkiewicz story. For, at age eighty years, she was on a ventilator at Millard Fillmore Suburban Hospital in Buffalo, New York; due to Covid-19 complications, and her family was desperately seeking treatment options. 

As The Buffalo News reports[1]:

The patient’s son, Michael Smentkiewicz, said hospital officials had told him and his sister, Michelle Kulbacki, on Dec. 31 that their mother’s chance of survival – as an 80-year-old Covid-19 patient on a ventilator – was about 20% . . . .  “We did a lot of our own research, we read about Ivermectin  . . . The results sounded very promising, and we decided we had to try something different”[2] . . . On Jan. 2, Smentkiewicz was given her first dose of Ivermectin, and . . . “In less than 48 hours, my mother was taken off the ventilator, transferred out of the Intensive Care Unit, sitting up on her own and communicating” . . . But after [being] transferred to another hospital wing away from the ICU, doctors in that unit refused to give her any more doses of the drug, and her condition quickly declined . . .

Understandably, having seen what a single dose of treatment often dismissed as a mere worm medicine did, the family took the hospital to court. New York State Supreme Court Judge Henry J. Nowak then sided with them, and “ordered the hospital to ‘immediately administer the drug Ivermectin’ ” He also told the family that the “family doctor would have to write a prescription for Ivermectin,” which he did. The result was again successful. That’s significant, let’s summarise the case:

PHASE 1: in ICU on a ventilator for CV-19, 80-year-old, 20% chance of survival
PHASE 2: One dose of Ivermectin, in 48 hours, out of ICU
PHASE 3: New doctors refuse further Ivermectin, deterioration, back to ICU
PHASE 4: After a lawsuit, Ivermectin again, and recovery.

So, is this a mere isolated anecdotal account, or is it yet another case of accumulating “real-world evidence” that we need to listen to? 

A key step is to see that her family members say that they “did a lot of [their] own research . . . read about Ivermectin.” So, if that is so, why is it we have repeatedly, overwhelmingly heard dismissive remarks about it from various officials and experts, as though yes it might fix some cases of worms but is all but utterly dubious conspiracist speculation when it comes to Covid-19?

Something does not add up.

For example, it is commonly reported that up to a fifth of prescriptions in the leading medical country, the USA, are for “off-label use” of drugs.

That is, once a drug has been certified as safe and effective for one condition, it may be found to have other credible medical benefits. Accordingly, qualified medical doctors often responsibly use their own personal knowledge of such useful side effects to prescribe the drug for other complaints; even without going through the multiplied millions or even billions required to get an additional on-label certification. That is how low dose aspirin came to be prescribed for heart or circulation conditions and it is how another “controversial” drug, Hydroxychloroquine, was found to be effective for arthritis and lupus. 

In addition, it is clear that real-world experience or even traditional lore can and do provide useful evidence that various substances have good medicinal effects. Hence, the rising global market for natural remedies, supplements, “superfoods” – including mangoes, pomegranates, the sweet potato – and nutraceuticals, etc.

So, perhaps we should hear out what Dr. Joel Hischhorn of the Frontline Doctors group (which includes the Cameronian-Texan Dr. Stella Immanuel) has to say about Ivermectin (IVM) in his recently released book, Pandemic Blunder:

 “IVM is a medication used to treat many types of parasite infestations and came into medical use in 1981. It has been used about 3.8 billion times worldwide, and its success resulted in a 2015 Nobel Prize in medicine. It is also considered an antibiotic and antiviral drug. Like HCL [Hydroxychloroquine] it is a cheap generic requiring a prescription. It is believed that it prevents the coronavirus from entering host cells to stop replication . . . .  In recent years IVM has been found effective for a number of RNA viruses, including Zika, yellow fever, West Nile, and avian influenza A. COVID-19 is also an RNA virus. So, the repurposing of IVM for the current pandemic makes much sense. But it has not precipitated media attention, thus allowing some doctors at the forefront of the early home/outpatient movement to use IVM effectively.”

So, the last word has yet to be spoken on Ivermectin, etc., or even on the full story on vaccines.  For, full development and testing require four to seven years, typically, including giving time for long term side effects to emerge[3]:

Perhaps, then, it is time for a more balanced, open discussion on public health, treatment options, and onward possibilities for the ongoing pandemic?


[1] See https://buffalonews.com/news/local/after-judge-orders-hospital-to-use-experimental-covid-19-treatment-woman-recovers/article_a9eb315c-5694-11eb-aac5-53b541448755.html

[2] E.g., see references linked here https://covid19criticalcare.com/videos-and-press/flccc-lecture-for-ypo-gold-on-ivermectin/

[3] See https://www.uh.edu/engines/epi3044.htm

Posted in Columns, COVID-19, De Ole Dawg, Education, Health, International, Local, News, Regional, Science/Technology0 Comments

The vaccination centre at Twickenham

Covid-19: Job not done despite vaccination success, scientist warns

TMR: More than 50% have been vaccinated in the UK, reports say; but the scare tactics are in operation… Rather than promising additional prevention and proven treatment methods… Why not also offer the ‘proven’ alternatives or simply tell those already strong, and avoiding the ‘scare’? If this is so!

The vaccination centre at Twickenham
Twickenham Stadium was turned into a vaccine walk-in centre on Monday, including for over-18s

By Katie Wright
BBC News

https://www.bbc.co.uk/news/uk-57313399

TMR: · Considering one of the excuses (rather than reason) is that for the decades, Ivermectin has been used ‘successfully’, that it was used or tried only on animals! This pales. Isn’t it that all or most other drugs are used in trials on animals before approval for humans? Crude observation perhaps. Crisis time and what? See here just one more of undisputed efforts to convince. Touting vaccine success after millions dead??? Not the end of the stor…ies.

Dr. Pierre Kory Presentation in Phil. Congress about Iver_m_ctin – May 1, 2021: House Hearings on PH’s COVID-19 RESPONSE

House Hearings on PH’s COVID-19 RESPONSE

High Vitamin D Levels May Help Prevent COVID-19, Especially in Black Patients

High Vitamin D Levels May Help Prevent COVID-19, Especially in Black Patients
NEWSMAX.COM

TMR: If COVID-19 leaves nothing but torment, we can at least take away from it, the drive it has given that we have passed the time to take stock of our own life, healthily. See we present yet another on the case of “building immunity” naturally, to stave off future COVID attack.

Read Newsmax: High Vitamin D Levels May Help Prevent COVID-19, Especially in Black Patients | Newsmax.com

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Illustration of a dollar bill being pinned to a darts board by a vaccination syringe.

Ohio’s $1 million Covid vaccine lottery is bribery at its best Going without a mask isn’t enough incentive? How about $1 million?

Illustration of a dollar bill being pinned to a darts board by a vaccination syringe.
Shots for scratch! Medicine for moolah! Covid immunity for prizes and money! Chelsea Stahl / MSNBC

– May 14, 2021, By Hayes Brown, MSNBC Opinion Columnist

The best reason to get Covid-19 vaccine shots is, of course, to not have yourself, your loved ones, or your neighbors get infected and potentially die from a virus that has killed almost 600,000 people in the U.S. But $1 million is a pretty good runner-up, I have to say.

Ohio Gov. Mike DeWine on Wednesday announced the “Vax-a-Million” program. Starting May 26, a random Ohioan will be drawn weekly from the Ohio secretary of state’s voter registration database to get $1 million — so long as they’re vaccinated. Another five 12- to 17 year-olds will get the chance to sign up for a possible full-ride scholarship to a state college or university, again provided they’re vaccinated.

Ohio governor: Get vaccinated, win a million dollars

MAY 13, 202101:46

As a former resident of Michigan, I’m loath to say anything positive about the state’s southern neighbor. But this is actually a pretty genius idea from the Ohio government, especially given that “the Ohio Lottery will conduct the drawings but the money will come from existing federal coronavirus relief funds,” as The Columbus Dispatch reported.

Absent a decent stick — aside from, you know, the risk of dying from a virus — we’ve been forced to find carrots to convince the masses.

Daily vaccination rates have plummeted even as more and more people have become eligible to get their shots. It’s entirely possible that news that people who are fully vaccinated can go about their lives sans masks may change that and get folks who’ve been waiting to go in to see the local stabmonger.

But we’ve been hoping that more education will bring down hesitancy for months now. And while that may be the case among some demographics, others still stubbornly refuse to get vaccinated — looking at you, white Republican men. The Biden administration has so far ruled out any sort of penalty for people who aren’t vaccinated; the Food and Drug Administration still hasn’t approved any of the vaccines yet — it has only authorized them for emergency use, which isn’t the same.

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Absent a decent stick — aside from, you know, the risk of dying from a virus — we’ve been forced to find carrots to convince the masses. That has included encouraging selfies to handing out stickers to what we’re seeing in Ohio now. So it may seem desperate at this point, but I can’t be mad at any and all efforts to get people vaccinated.

Fauci weighs in on CDC’s new mask guidance for fully vaccinated

MAY 14, 202103:05

It might not even take the full million bucks to sway people. Polling backs up the idea that offering smaller amounts of cold, hard cash could make a difference. UCLA’s Covid-19 Health and Politics Project asked over 7,000 people who had yet to be vaccinated whether they’d be more likely to do so if they were paid for it. Thirty-four percent of respondents said $100 would make them more likely to make appointments; 31 percent said 50 bucks would do the trick.

So while Ohio has the highest potential payout, other states have been reaching out to people through their wallets. After a wildly successful rollout, West Virginia’s lagging numbers prompted Gov. Jim Justice to propose giving $100 savings bonds to residents ages 16 to 35 who get vaccinated. (They’re still working on how to deliver those bonds to the newly vaccinated.) As in Ohio, that money would come from federal Covid-19 funds already sent to the state.

How West Virginia health officials are battling Covid vaccine hesitancy

https://www.nbcnews.com/now/video/how-west-virginia-health-officials-are-battling-covid-vaccine-hesitancy-111763013610

It’s not just money on offer. In Chicago, the city will have a series of free concerts that will be open only to people who can prove they’re fully vaccinated. A hospital group in Alaska is giving away prizes, including airline tickets and money toward the purchase of an ATV. Here in New York City, Shake Shack is offering free fries when you buy a sandwich and flash your vaccination card. Krispy Kreme’s decision to offer free donuts to the vaccinated set off a whole round of discourse about whether the company was encouraging obesity. (It wasn’t, and the fatphobia was rightly shouted down.)

My favorite bribery scheme so far? Beer. In New Jersey, participating breweries will provide a free beer if you show your proof of vaccination as part of the state government’s “Shot and a Beer” program. (Get it? It’s a pun.) It’s a better name than Erie County, New York’s “Shot and a Chaser” program — but the latter is the best anecdotal evidence we have so far that these programs can get results, especially if you offer the shots at the brewery, too.

Are there arguments against bribing the masses to go get their shots? Sure. Back in January, when the vaccines were first being rolled out, an article in the Journal of the American Medical Association argued that proposals to pay people up to $1,500 for getting vaccinated were a waste of funds and morally questionable and that they might even backfire.

In a climate characterized by widespread distrust of government and a propensity to endorse conspiracy theories, those who are already COVID-19 vaccine-hesitant might perceive that the government would not be willing to pay people to get vaccinated if the available vaccines were truly safe and effective. Incentive payments might also stoke new fears and, perversely, increase resistance to vaccination.

It’s a well-reasoned set of concerns. But the article ends by noting that a “policy of paying people for Covid-19 vaccination should be adopted only as a last resort if voluntary vaccine uptake proves insufficient to promote herd immunity within a reasonable period of time.”

That sounds a lot like, well, now. That means that if you’re reading this in Ohio, good luck getting a windfall for doing the right thing. I’m rooting for you. It may be the only time I root for someone from Ohio, so savor this moment.

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The-New-England-Journal-of-Medicine

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

TMR – This dates from December 2020. In the particular Montserrat context: Should not the relevant authorities be explaining the information that helps encourage persons access the vaccine, rather than reaching the point of wanting to shut those down who address the issues negatively, to making the vaccine mandatory?

List of authors.

  • Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Gonzalo Pérez Marc, M.D.,
  • Edson D. Moreira, M.D., Cristiano Zerbini, M.D., Ruth Bailey, B.Sc.,
  • Kena A. Swanson, Ph.D., Satrajit Roychoudhury, Ph.D., Kenneth Koury, Ph.D., Ping Li, Ph.D., Warren V. Kalina, Ph.D., David Cooper, Ph.D.,
  • Robert W. Frenck, Jr., M.D., Laura L. Hammitt, M.D., Özlem Türeci, M.D., Haylene Nell, M.D., Axel Schaefer, M.D., Serhat Ünal, M.D.,
  • Dina B. Tresnan, D.V.M., Ph.D., Susan Mather, M.D., Philip R. Dormitzer, M.D., Ph.D., Uğur Şahin, M.D., Kathrin U. Jansen, Ph.D.,
  • and William C. Gruber, M.D. for the C4591001 Clinical Trial Group*

Abstract

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.

Methods

In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary endpoints were the efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.

Results

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

Conclusions

A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)

QUICK TAKESafety and Efficacy of the BNT162b2 Covid-19 Vaccine 03:00

Digital Object Thumbnail

Coronavirus disease 2019 (Covid-19) has affected tens of millions of people globally1 since it was declared a pandemic by the World Health Organization on March 11, 2020.2 Older adults, persons with certain coexisting conditions, and front-line workers are at highest risk for Covid-19 and its complications. Recent data show increasing rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and Covid-19 in other populations, including younger adults.3 Safe and effective prophylactic vaccines are urgently needed to contain the pandemic, which has had devastating medical, economic, and social consequences.

We previously reported phase 1 safety and immunogenicity results from clinical trials of the vaccine candidate BNT162b2,4 a lipid nanoparticle–formulated,5 nucleoside-modified RNA (modRNA)6 encoding the SARS-CoV-2 full-length spike, modified by two proline mutations to lock it in the prefusion conformation.7 Findings from studies conducted in the United States and Germany among healthy men and women showed that two 30-μg doses of BNT162b2 elicited high SARS-CoV-2 neutralizing antibody titers and robust antigen-specific CD8+ and Th1-type CD4+ T-cell responses.8 The 50% neutralizing geometric mean titers elicited by 30 μg of BNT162b2 in older and younger adults exceeded the geometric mean titer measured in a human convalescent serum panel, despite a lower neutralizing response in older adults than in younger adults. In addition, the reactogenicity profile of BNT162b2 represented mainly short-term local (i.e., injection site) and systemic responses. These findings supported the progression of the BNT162b2 vaccine candidate into phase 3.

Here, we report safety and efficacy findings from the phase 2/3 part of a global phase 1/2/3 trial evaluating the safety, immunogenicity, and efficacy of 30 μg of BNT162b2 in preventing Covid-19 in persons 16 years of age or older. This data set and these trial results are the basis for an application for emergency use authorization.9 Collection of phase 2/3 data on vaccine immunogenicity and the durability of the immune response to immunization is ongoing, and those data are not reported here.

Methods

Trial Objectives, Participants, and Oversight

We assessed the safety and efficacy of two 30-μg doses of BNT162b2, administered intramuscularly 21 days apart, as compared with placebo. Adults 16 years of age or older who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection, were eligible for participation in the trial. Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition.

Pfizer was responsible for the design and conduct of the trial, data collection, data analysis, data interpretation, and the writing of the manuscript. BioNTech was the sponsor of the trial, manufactured the BNT162b2 clinical trial material, and contributed to the interpretation of the data and the writing of the manuscript. All the trial data were available to all the authors, who vouch for its accuracy and completeness and for adherence of the trial to the protocol, which is available with the full text of this article at NEJM.org. An independent data and safety monitoring board reviewed efficacy and unblinded safety data.

Trial Procedures

With the use of an interactive Web-based system, participants in the trial were randomly assigned in a 1:1 ratio to receive 30 μg of BNT162b2 (0.3 ml volume per dose) or saline placebo. Participants received two injections, 21 days apart, of either BNT162b2 or placebo, delivered in the deltoid muscle. Site staff who were responsible for safety evaluation and were unaware of group assignments observed participants for 30 minutes after vaccination for any acute reactions.

Safety

The primary endpoints of this trial were solicited, specific local or systemic adverse events, and use of antipyretic or pain medication within 7 days after the receipt of each dose of vaccine or placebo, as prompted by and recorded in an electronic diary in a subset of participants (the reactogenicity subset), and unsolicited adverse events (those reported by the participants without prompts from the electronic diary) through 1 month after the second dose and unsolicited serious adverse events through 6 months after the second dose. Adverse event data through approximately 14 weeks after the second dose are included in this report. In this report, safety data are reported for all participants who provided informed consent and received at least one dose of vaccine or placebo. Per protocol, safety results for participants infected with HIV (196 patients) will be analyzed separately and are not included here.

During the phase 2/3 portion of the study, a stopping rule for the theoretical concern of vaccine-enhanced disease was to be triggered if the one-sided probability of observing the same or a more unfavorable adverse severe case split (a split with a greater proportion of severe cases in vaccine recipients) was 5% or less, given the same true incidence for vaccine and placebo recipients. Alert criteria were to be triggered if this probability was less than 11%.

Efficacy

The first primary endpoint was the efficacy of BNT162b2 against confirmed Covid-19 with onset at least 7 days after the second dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the second dose; the second primary endpoint was efficacy in participants with and participants without evidence of prior infection. 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, the 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).

Major secondary endpoints included the efficacy of BNT162b2 against severe Covid-19. 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. Details are provided in the protocol.

An explanation of the various denominator values for use in assessing the results of the trial is provided in Table S1 in the Supplementary Appendix, available at NEJM.org. In brief, the safety population includes persons 16 years of age or older; a total of 43,448 participants constituted the population of enrolled persons injected with the vaccine or placebo. The main safety subset as defined by the FDA, with a median of two months of follow-up as of October 9, 2020, consisted of 37,706 persons, and the reactogenicity subset consisted of 8183 persons. The modified intention-to-treat (mITT) efficacy population includes all age groups 12 years of age or older (43,355 persons; 100 participants who were 12 to 15 years of age contributed to person-time years but included no cases). The number of persons who could be evaluated for efficacy 7 days after the second dose and who had no evidence of prior infection was 36,523, and the number of persons who could be evaluated 7 days after the second dose with or without evidence of prior infection was 40,137.

Statistical Analysis

The safety analyses included all participants who received at least one dose of BNT162b2 or placebo. The findings are descriptive in nature and not based on formal statistical hypothesis testing. Safety analyses are presented as counts, percentages, and associated Clopper–Pearson 95% confidence intervals for local reactions, systemic events, and any adverse events after vaccination, according to terms in the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1, for each vaccine group.

Analysis of the first primary efficacy endpoint included participants who received the vaccine or placebo as randomly assigned, had no evidence of infection within 7 days after the second dose, and had no major protocol deviations (the population that could be evaluated). Vaccine efficacy was estimated by 100×(1−IRR), where IRR is the calculated ratio of confirmed cases of Covid-19 illness per 1000 person-years of follow-up in the active vaccine group to the corresponding illness rate in the placebo group. The 95.0% credible interval for vaccine efficacy and the probability of vaccine efficacy greater than 30% were calculated with the use of a Bayesian beta-binomial model. The final analysis uses a success boundary of 98.6% for probability of vaccine efficacy greater than 30% to compensate for the interim analysis and to control the overall type 1 error rate at 2.5%. Moreover, primary and secondary efficacy endpoints are evaluated sequentially to control the familywise type 1 error rate at 2.5%. Descriptive analyses (estimates of vaccine efficacy and 95% confidence intervals) are provided for key subgroups.

Results

Participants

Figure 1.

Enrollment and Randomization.Table 1.
Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (the United States, 130 sites; Argentina, 1; Brazil, 2; South Africa, 4; Germany, 6; and Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections: 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2).

Safety

Local Reactogenicity

Figure 2.

Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group.

The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). The pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose; 66% after the second dose) than among younger participants (83% after the first dose; 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days.

Systemic Reactogenicity

Systemic events were reported more often by younger vaccine recipients (16 to 55 years of age) than by older vaccine recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger vaccine recipients; 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger vaccine recipients; 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of vaccine recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C. Younger vaccine recipients were more likely to use antipyretic or pain medication (28% after dose 1; 45% after dose 2) than older vaccine recipients (20% after dose 1; 38% after dose 2), and placebo recipients were less likely (10 to 14%) than vaccine recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group.

Adverse Events

Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by vaccine recipients than by placebo recipients. Sixty-four vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo. No Covid-19–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of the vaccine.

Efficacy

Table 2.

Vaccine Efficacy against Covid-19 at Least 7 days after the Second Dose.Table 3.

Efficacy of BNT162b2 against Covid-19 after the First Dose.
Vaccine Efficacy Overall and by Subgroup in Participants without Evidence of Infection before 7 Days after Dose 2.Figure 3.

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients. This case split corresponds to 95.0% vaccine efficacy (95% confidence interval [CI], 90.3 to 97.6; Table 2). Among participants with and those without evidence of prior SARS CoV-2 infection, 9 cases of Covid-19 at least 7 days after the second dose were observed among vaccine recipients and 169 among placebo recipients, corresponding to 94.6% vaccine efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that vaccine efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). Vaccine efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (vaccine efficacy, 94.6%; 95% CI, 68.7 to 99.9; case split: BNT162b2, 2 cases; placebo, 44 cases). Figure 3 shows cases of Covid-19 or severe Covid-19 with onset at any time after the first dose (mITT population) (additional data on severe Covid-19 are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a vaccine efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the vaccine, starting as soon as 12 days after the first dose.

Discussion

A two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95% effective against Covid-19. The vaccine met both primary efficacy endpoints, with more than a 99.99% probability of a true vaccine efficacy greater than 30%. These results met our prespecified success criteria, which were to establish a probability above 98.6% of true vaccine efficacy being greater than 30%, and greatly exceeded the minimum FDA criteria for authorization.9 Although the study was not powered to definitively assess efficacy by subgroup, the point estimates of efficacy for subgroups based on age, sex, race, ethnicity, body-mass index, or the presence of an underlying condition associated with a high risk of Covid-19 complications are also high. For all analyzed subgroups in which more than 10 cases of Covid-19 occurred, the lower limit of the 95% confidence interval for efficacy was more than 30%.

The cumulative incidence of Covid-19 cases over time among placebo and vaccine recipients begins to diverge by 12 days after the first dose, 7 days after the estimated median viral incubation period of 5 days,10 indicating the early onset of a partially protective effect of immunization. The study was not designed to assess the efficacy of a single-dose regimen. Nevertheless, in the interval between the first and second doses, the observed vaccine efficacy against Covid-19 was 52%, and in the first 7 days after dose 2, it was 91%, reaching full efficacy against disease with onset at least 7 days after dose 2. Of the 10 cases of severe Covid-19 that were observed after the first dose, only 1 occurred in the vaccine group. This finding is consistent with overall high efficacy against all Covid-19 cases. The severe case split provides preliminary evidence of vaccine-mediated protection against severe disease, alleviating many of the theoretical concerns over vaccine-mediated disease enhancement.11

The favorable safety profile observed during phase 1 testing of BNT162b24,8 was confirmed in the phase 2/3 portion of the trial. As in phase 1, reactogenicity was generally mild or moderate, and reactions were less common and milder in older adults than in younger adults. Systemic reactogenicity was more common and severe after the second dose than after the first dose, although local reactogenicity was similar after the two doses. Severe fatigue was observed in approximately 4% of BNT162b2 recipients, which is higher than that observed in recipients of some vaccines recommended for older adults.12 This rate of severe fatigue is also lower than that observed in recipients of another approved viral vaccine for older adults.13 Overall, reactogenicity events were transient and resolved within a couple of days after onset. Lymphadenopathy, which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. The incidence of serious adverse events was similar in the vaccine and placebo groups (0.6% and 0.5%, respectively).

This trial and its preliminary report have several limitations. With approximately 19,000 participants per group in the subset of participants with a median follow-up time of 2 months after the second dose, the study has more than 83% probability of detecting at least one adverse event, if the true incidence is 0.01%, but it is not large enough to detect less common adverse events reliably. This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remains to be determined. Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose. These data do not address whether vaccination prevents asymptomatic infection; a serologic endpoint that can detect a history of infection regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported later. Furthermore, given the high vaccine efficacy and the low number of vaccine breakthrough cases, the potential establishment of a correlate of protection has not been feasible at the time of this report.

This report does not address the prevention of Covid-19 in other populations, such as younger adolescents, children, and pregnant women. Safety and immune response data from this trial after immunization of adolescents 12 to 15 years of age will be reported subsequently, and additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as immunocompromised persons. Although the vaccine can be stored for up to 5 days at standard refrigerator temperatures once ready for use, very cold temperatures are required for shipping and longer storage. The current cold storage requirement may be alleviated by ongoing stability studies and formulation optimization, which may also be described in subsequent reports.

The data presented in this report have significance beyond the performance of this vaccine candidate. The results demonstrate that Covid-19 can be prevented by immunization, provide proof of concept that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases, and demonstrate the speed with which an RNA-based vaccine can be developed with a sufficient investment of resources. The development of BNT162b2 was initiated on January 10, 2020, when the SARS-CoV-2 genetic sequence was released by the Chinese Center for Disease Control and Prevention and disseminated globally by the GISAID (Global Initiative on Sharing All Influenza Data) initiative. This rigorous demonstration of safety and efficacy less than 11 months later provides a practical demonstration that RNA-based vaccines, which require only viral genetic sequence information to initiate development, are a major new tool to combat pandemics and other infectious disease outbreaks. The continuous phase 1/2/3 trial design may provide a model to reduce the protracted development timelines that have delayed the availability of vaccines against other infectious diseases of medical importance. In the context of the current, still expanding pandemic, the BNT162b2 vaccine, if approved, can contribute, together with other public health measures, to reducing the devastating loss of health, life, and economic and social well-being that has resulted from the global spread of Covid-19.

Supported by BioNTech and Pfizer.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Drs. Polack and Thomas contributed equally to this article.

This article was published on December 10, 2020, and updated on December 16, 2020, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank all the participants who volunteered for this study; and the members of the C4591001 data and safety monitoring board for their dedication and their diligent review of the data. We also acknowledge the contributions of the C4591001 Clinical Trial Group (see the Supplementary Appendix); Tricia Newell and Emily Stackpole (ICON, North Wales, PA) for editorial support funded by Pfizer; and the following Pfizer staff: Greg Adams, Negar Aliabadi, Mohanish Anand, Fred Angulo, Ayman Ayoub, Melissa Bishop-Murphy, Mark Boaz, Christopher Bowen, Salim Bouguermouh, Donna Boyce, Sarah Burden, Andrea Cawein, Patrick Caubel, Darren Cowen, Kimberly Ann Cristall, Michael Cruz, Daniel Curcio, Gabriela Dávila, Carmel Devlin, Gokhan Duman, Niesha Foster, Maja Gacic, Luis Jodar, Stephen Kay, William Lam, Esther Ladipo, Joaquina Maria Lazaro, Marie-Pierre Hellio Le Graverand-Gastineau, Jacqueline Lowenberg, Rod MacKenzie, Robert Maroko, Jason McKinley, Tracey Mellelieu, Farheen Muzaffar, Brendan O’Neill, Jason Painter, Elizabeth Paulukonis, Allison Pfeffer, Katie Puig, Kimberly Rarrick, Balaji Prabu Raja, Christine Rainey, Kellie Lynn Richardson, Elizabeth Rogers, Melinda Rottas, Charulata Sabharwal, Vilas Satishchandran, Harpreet Seehra, Judy Sewards, Helen Smith, David Swerdlow, Elisa Harkins Tull, Sarah Tweedy, Erica Weaver, John Wegner, Jenah West, Christopher Webber, David C. Whritenour, Fae Wooding, Emily Worobetz, Xia Xu, Nita Zalavadia, Liping Zhang, the Vaccines Clinical Assay Team, the Vaccines Assay Development Team, and all the Pfizer colleagues not named here who contributed to the success of this trial. We also acknowledge the contributions of the following staff at BioNTech: Corinna Rosenbaum, Christian Miculka, Andreas Kuhn, Ferdia Bates, Paul Strecker, Ruben Rizzi, Martin Bexon, Eleni Lagkadinou, and Alexandra Kemmer-Brück; and the following staff at Polymun: Dietmar Katinger and Andreas Wagner.

Author Affiliations

From Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) — both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) — both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children’s Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) — both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).

Address reprint requests to Dr. Absalon at Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, or at judith.absalon@pfizer.com.

A complete list of investigators in the C4591001 Clinical Trial Group is provided in the Supplementary Appendix, available at NEJM.org.

Supplementary Material

ProtocolPDF4781KB
Supplementary AppendixPDF171KB
Disclosure FormsPDF559KB
Data Sharing StatementPDF71KB
Research SummaryPDF3161KB

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  5. 5. Pardi N, Tuyishime S, Muramatsu H, et al. Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes. J Control Release 2015;217:345-351.
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  8. 8. Sahin U, Muik A, Vogler I, et al. BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans. December 11, 2020 (https://www.medrxiv.org/content/10.1101/2020.12.09.20245175v1. opens in new tab). preprint.
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Citing Articles (954)

Letters
Figures/Media
  1. Download a PDF of the Research Summary.
  2. Figure 1. Enrollment and Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.
  3. Table 1. Demographic Characteristics of the Participants in the Main Safety Population.*
  4. Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale: mild, does not interfere with activity; moderate, interferes with activity; severe, prevents daily activity; and grade 4, emergency department visit or hospitalization. Redness and swelling were measured according to the following scale: mild, 2.0 to 5.0 cm in diameter; moderate, >5.0 to 10.0 cm in diameter; severe, >10.0 cm in diameter; and grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories are designated in the key; medication use was not graded. Additional scales were as follows: fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild: does not interfere with activity; moderate: some interference with activity; or severe: prevents daily activity), vomiting (mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; or severe: requires intravenous hydration), and diarrhea (mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; or severe: 6 or more loose stools in 24 hours); grade 4 for all events indicated an emergency department visit or hospitalization. 𝙸 bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.
  5. Table 2. Vaccine Efficacy against Covid-19 at Least 7 days after the Second Dose.*
  6. Table 3. Vaccine Efficacy Overall and by Subgroup in Participants without Evidence of Infection before 7 Days after Dose 2.
  7. Figure 3. Efficacy of BNT162b2 against Covid-19 after the First Dose. Shown is the cumulative incidence of Covid-19 after the first dose (modified intention-to-treat population). Each symbol represents Covid-19 cases starting on a given day; filled symbols represent severe Covid-19 cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for Covid-19 case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for vaccine efficacy (VE) is derived according to the Clopper–Pearson method.

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New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?

New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?

New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?

TMR is not suggesting to anyone not to access COVID-19 ‘vaccines’. Merely providing information to those who may be at risk, knowingly or otherwise, to be aware that there ARE varying life-threatening risks and to consider and consult, before becoming a ‘negative/positive statistic, all the theories, conspiratorial, truths taken on board. We encourage there is not an earlier time available for everyone to take stock of their health and immunise themselves against all poor health lifestyles.

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by Sue Hughes

April 09, 2021

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

In addition to the unusual blood clots linked to the AstraZeneca COVID-19 vaccine, which have received extensive attention in the past couple of weeks, other safety signals are also being investigated with this vaccine, and now with Johnson & Johnson’s Janssen vaccine as well, the European Medicines Agency (EMA) reports.

Highlights of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) meeting April 6-9 include that the agency has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

It also reports that PRAC has started a review of a safety signal to assess reports of thromboembolic events with low platelets in people who received the COVID-19 Vaccine Janssen.

Capillary Leak Syndrome with AZ Vaccine

An EMA press release issued today notes that five cases of capillary leak syndrome, characterized by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure in individuals receiving the AstraZeneca vaccine, were reported in the EudraVigilance database.

“At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a ‘safety signal’ — information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation,” the EMA states.

PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not, it adds.

Thromboembolic Events with J&J/Janssen Vaccine

Four serious cases of unusual blood clots with low blood platelets have been reported postvaccination with COVID-19 Vaccine Janssen, EMA reports. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the US. One of them was fatal.

COVID-19 Vaccine Janssen is currently only used in the US, under an emergency use authorization. COVID-19 Vaccine Janssen was authorized in the EU on March 11. The vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.

The Janssen vaccine uses an adenovirus vector, as does the AstraZeneca vaccine.

PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information, it adds.

For more news, follow Medscape on Facebook, Twitter, Instagram, YouTube, and LinkedIn

Additional ‘educational’ reading: https://www.medscape.org/viewarticle/948301

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4 Benefits Of Sleeping With a Garlic Clove Under Your Pillow

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It could be that you live in a time of vampires and werewolves. In this case, sleeping with a clove of garlic under your pillow should also be supported by a silver cross above your bed, holy water at the door, and a wooden stake at your right hand.

If you keep garlic under your pillow below things will happen.

1.Garlic Repels Mosquitoes & Other Bugs

Garlic makes a powerful natural toxic insect repellent. The natural repellent nature of garlic makes it a perfect tool for keeping pests off plants. Garlic water is simple to make and easy to administer. It can be used on vegetables or on flowering plants. keeping garlic under your pillow will avoid mosquitoes and spider bites. mosquitoes attract carbon dioxide when we exhale so eating garlic doesn’t seem to be as effective if u want to repel insects.

2.Garlic Cures Insomnia

Do you suffer from panic attacks or have trouble sleeping? Putting garlic under your pillow will definitely make you have better sleep. this remedy is been used since ancient times. The antioxidant and antimicrobial properties of garlic keep the body fluids and organs healthy and infection-free. It also aids in the healthy functioning of the heart and brain, thus regulating the sleep cycle. magnesium and potassium intake will be high if you eat garlic. it relaxes your muscles by producing a chemical called GABA. GABA is the body’s signal that it’s time to calm down, and it chills out your brain cells so that they can begin the restorative work that happens overnight.

3.Garlic An Anti-Bacteria

Fresh, raw garlic has proven itself since ancient times as an effective killer of bacteria and viruses. it is an anti-bacterial agent that can actually inhibits the growth of infectious agents and at the same time protect the body from pathogens. Once again, we can thank allicin. because it is able to block two groups of enzymes that allow infectious microbes to survive in a host body. Garlic can prevent infection inside or outside the body. so having garlic under your pillow at bedtime will make you sick less.

4.Garlic Makes You Breathe Better

Some compounds garlic can be responsible for bad breath and even body odor. These include Allicin. When the garlic is crushed, it turns into allicin, an antibiotic that fights against fungal and bacterial infection. Garlic can also help clear blocked nasal passages if you are suffering from a cold easing nocturnal breathing and reducing snoring, which in turn aids restful sleep, and also you can crush 3-4 garlic cloves into boiling water and inhale the steam. you will breathe easier than before.

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