There was a big increase in antivaccine activity on social media last week. I know this because other people mentioned it and there was a talking point about the Pfizer clinical trial not having tested for the ability of its COVID-19 vaccine to prevent transmission of the disease. The whole thing seems to have bubbled up after a member of the European Parliament started talking about vaccine mandates.
BREAKING:
In COVID hearing, #Pfizer director admits: #vaccine was never tested on preventing transmission.
"Get vaccinated for others" was always a lie.
The only purpose of the #COVID passport: forcing people to get vaccinated.
The world needs to know. Share this video!
pic.twitter.com/su1WqgB4dO
— Rob Roos MEP
(@Rob_Roos) October 11, 2022
Tucker Carlson was one of the first to run with this.
After this trumpeting of the "revelation" that Pfizer never tested its vaccine to determine if it prevented transmission in its phase 3 clinical trials, antivaxers were off to the races.
I thought I would give some examples of how it was being spun other than the one above. The antivax and COVID-19 conspiracy site The Epoch Times is where I will begin.
A Pfizer executive said Monday that neither she nor other Pfizer officials knew whether its COVID-19 vaccine would stop transmission before entering the market last year.
Member of the European Parliament, Rob Roos, asked during a session:
Was the Pfizer COVID vaccine tested on stopping the transmission of the virus before it entered the market? Did we know about stopping immunization before it entered the market?
The president of international developed markets for Pfizer was identified.
No … You know, we had to … really move at the speed of science to know what is taking place in the market.
Millions of people around the world were deceived by pharmaceutical companies and governments following Small's comments to him.
“Millions of people worldwide felt forced to get vaccinated because of the myth that ‘you do it for others,’” Roos said. “Now, this turned out to be a cheap lie” and “should be exposed,” he added.
The usual suspects were posting apocalyptic Substacks, for instance Paul Alexander, who was an advisor to Health and Human Services assistant secretary for public affairs. Alexander uses both his full and middle names. Who is that person? Regular readers will remember that in March of 2021, a vaccine scare was made by a vet named Geert Vanden Bossche, who claimed that imperfect vaccines would cause the emergence of "escape Mutants" that could evade immunity.
Alexander used that "failure" to start "just asking questions" The UNHOLIST of alliances, corrupted to the very core, didn't test if the vaccine stopped transmission. They didn't test for other things. Dr. Koops weighed in.
Pfizer and Moderna also:
-did not test whether there were any serious drug interactions with other commonly used medicines/vaccines.
-did not test whether there were genetic mutations in the host
-did not test whether the “vaccine” became systemic or stayed restricted to the injection site
-did not test whether “boosters” were actually beneficial (they simply stated that as the initial protocol as a two dose protocol without any data to support it)
-did not test whether the “non-active” ingredients caused any problems (these were not normal excipients-some of the placebo arm data suggests that these were also causing problems)
-did not test whether the “vaccine” was transmissible from the recipient
-did not test as to metabolic elimination of the vaccine from the host, i.e. how long does it remain active in the host
-proposed a product specification that would essentially allow for almost anything to pass
-did not account (i.e. screen) for a rather pronounced natural immunity already in the population
-conducted most of their studies outside of the US in countries that have been known for questionable clinical studies (Brazil in particular)
-had virtually no stability data
One notes that we have addressed a number of these claims before and so I will not address them again. The Pfizer vaccine was tested in the summer and fall of 2020 before a lot of people became sick. Alexander claims that the vaccines produced by Pfizer and Moderna do not permanently alter your genetic makeup.
We tried to warn you, but James Lyons-Weiler said that knowledge about lack of protection against transmission is old, not new. It is not shocking and we will show it. Lyons-Weiler tries to make it sound like it is.
The admission by a Pfizer exec has set social media ablaze with shock. That’s what you get when you suppress inconvenient truths. Now the flawed policies must be reversed or rescinded.
That is correct. Lyons-Weiler tries to say that the reason they're doing this is because there was a conspiracy to cover up this "inconvenient truth" Is there anything else? You know the answer to that.
This isn't all the antivax content, not by a long shot, seemingly coordinated to amplify the message that the Pfizer vaccine was illegitimate because it never tested for the ability of the vaccine to prevent transmission. There were many videos because there are always antivax videos. Alexander interviewed Vanden Bossche about the same thing. John Campbell thinks that this is a new story that had been hidden for nearly two years.
He went on about how around 1:45.
…at the time I remember representatives of the UK government who’ve now been made into Dames and Knights and all sorts of things emphatically telling us that everything that was normally done in any clinical trial was done during these trials. They gave us their word about this, and let’s hope that this doesn’t turn out to be less than accurate.
My purpose in writing this post is not so much to point out why this whole "shocked" line of hysteria is nothing new, as Susan Oliver did a nice job of deconstructing Campbell's misinformation, but I will discuss some of it with my spin.
Let's start digging. There is a seemingly simple but poorly understood question about the purpose of a vaccine.
What is the purpose of a vaccine? Vaccines don't have only one purpose. The main purpose of a vaccine is to prevent people from getting sick from a disease caused by a virus or bacterium. In the middle of a Pandemic that had killed over a quarter of a million people in the US alone, a vaccine doesn't do that very well. The second purpose of a vaccine is to prevent the disease from getting established in a vaccine-vaccinated person in the first place and to prevent the person from spreading the disease to other people. This phenomenon is called "sterilizing immunity" and means that the immunity produced by a vaccine is so effective that the virus can't replicate in the person who got it and cause them to get sick.
Most vaccines that prevent severe disease also prevent transmission to at least some extent, even if far from being able to produce sterilizing immunity, and vaccines that aren't very good at preventing infections and transmission, are referred to as "leak." I talked about this concept in a lot of detail when I talked about Vanden Bossche's claim that because COVID-19 vaccines areleaky, they choose for nasty variant in the presence of mild or asymptomatic disease in the vaccine. The example of antivaccine activist and scientific fraudster Andrew Wakefield, who made the same claim for the Measles vaccine, is a good example of how this claim is not new.
The Pfizer and Moderna COVID-19 vaccines were starting to roll out to populations other than healthcare workers and very high risk individuals when the Scientific American article was published. I will revisit it one more time before discussing the Pfizer trial.
The main point is here.
Although many vaccines widely used today (against measles, for example) produce very effective sterilizing immunity, others, such as the hepatitis B vaccine, do not. With these vaccines, an individual’s immune system is trained to prevent illness, yet the pathogen can persist in that person’s body, potentially allowing them to infect others. A lack of sterilizing immunity means that the pathogen can continue to circulate in a population, where it may cause illness in unvaccinated and vulnerable people or evolve to evade our immune responses, Bowdish explains.
Another example is also included.
The case of rotavirus—which causes severe vomiting and watery diarrhea and is especially dangerous to infants and young children—is fairly straightforward. Vaccination limits, but does not stop, the pathogen from replicating. As such, it does not protect against mild disease. By reducing an infected person’s viral load, however, it decreases transmission, providing substantial indirect protection. According to the Centers for Disease Control, four to 10 years after the 2006 introduction of a rotavirus vaccine in the U.S., the number of positive tests for the disease fell by as much as 74 to 90 percent.
The vaccine that doesn't produce sterilizing immunity is one of the favorites cited by antivaxers.
For example, vaccines against Bordetella pertussis, the primary bacterium that causes whooping cough, or pertussis, do a great job of preventing illness but do not entirely clear the pathogen. Rather, as B. pertussis replicates in the upper respiratory tract, vaccine-induced antibodies apply pressure via natural selection to weed out bacteria whose disease-causing genes are turned on. Because these same genes are responsible for the parts of the microorganisms that are targeted by antibodies, bacteria that keep them turned off evade the immune response and hang out undetected in the upper respiratory tract, Bowdish explains. This becomes a problem when someone with a naive immune system, such as an infant, contracts the pathogen. In the absence of antibodies, B. pertussis‘s disease-causing genes become activated again, causing illness. Nevertheless, the introduction of pertussis vaccines in the 1940s cut annual U.S. cases from more than 100,000 to fewer than 10,000 by 1965. In the 1980s cases began slowly climbing again as parents increasingly refused to vaccinate their children. Today there is renewed focus on reducing the chance of exposure and getting antibodies to infants by immunizing pregnant women and new mothers.
Antivaccine thinking about vaccines is usually black and white. Either the vaccine is 100% effective, or it is useless, or it is deadly enough to cause a vaccine holocaust. In medicine, nothing is certain except that each and every one of us will die one day, and the efficacy of any intervention is on a spectrum. Nonsterilizing vaccine can be very useful. In December 2020, a completely nonsterilizing vaccine that was effective at preventing severe disease would have helped to prevent a lot of deaths.
The main point of this particular conspiracy theory about Pfizer not having tested its vaccine for it's ability to prevent transmission is not to claim that it doesn't prevent severe disease. I will get to that in a second, but first I want to look at the trial.
The results of the phase 3 clinical trial of the Pfizer BNT162b2 vaccine were published in the New England Journal of Medicine. There is a method in the paper.
The first primary end point 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 end point 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, 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 end points 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.
The primary endpoint for efficacy was confirmed by laboratory testing, and the secondary endpoints were efficacy against severe disease and not transmission. It's all right in the methods.
It was included in the FDA press release.
At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
RFK Jr cited an article from The Epoch Times.
The U.S. Food and Drug Administration wrote in late 2020 that there was no data available to determine whether the vaccine would prevent transmission and for how long it would protect against transmission of the SARS-CoV-2 virus that causes COVID-19.
“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person,” the agency specifically noted.
Meanwhile, Pfizer CEO Albert Bourla, around the same time, said his firm was “not certain” if those who receive its mRNA vaccine will be able to transmit COVID-19 to other people.
”I think this is something that needs to be examined. We are not certain about that right now,” Bourla told NBC News in December 2020 in response to a question about transmissibility.
Thanks to Dr. Oliver, I was able to find this guidance document in the UK.
Clinical trial evidence demonstrates that the vaccine reduces clinically severe infection and severe disease. The impact of the vaccine on preventing transmission remains unknown and individuals who have been vaccinated may still carry and be able to transmit the virus. We advise anyone who has been vaccinated to continue to observe national lockdown restrictions and engage with asymptomatic LFD and PCR testing if appropriate
Scientists noted in January 2021.
Current estimates of the level of effective population immunity for interruption of transmission is ~60–70%, but vaccination coverage required by a partially effective vaccine to interrupt transmission might be higher. With 8 billion people to vaccinate with a two-dose regimen, we might need 10–11 billion doses to interrupt transmission.
The vaccine was not being marketed as a panacea by the scientific community.
Wait, but? This was buried in clinical trial methods, FDA press releases, and government guidance documents, according to antivaxxers. They covered it up. There are examples of press reporting that didn't do anything. The Washington Post article stated that the trial didn't look at the vaccine's ability to prevent transmission.
Major questions that remain unanswered about the vaccine include how long the protection will last and whether the vaccines prevent people who are infected despite vaccination from spreading the disease.
The trial showed no evidence that immunity subsided during the two months after the second dose, but more data will need to be gathered to assess whether protection tapers off. The reviewers called for further study of whether people, particularly those with asymptomatic infections, spread the disease. Epidemiologists have worried about a worst-case scenario in which people who are vaccinated stop wearing masks but may become asymptomatically infected and spread the disease.
“It is possible that if efficacy against asymptomatic infection were lower than efficacy against symptomatic infection, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission,” the review states.
In December 2020 we didn't know how well the Pfizer vaccine could prevent transmission of the disease because it wasn't designed to do that. Contrary toCampbell's claims, most phase 3 trials for vaccines look at transmission as an endpoint to be used for licensure, as Susan Oliver explains in her video. One of the vaccine trials that I will include is the one in which the prevention of transmission was not an outcome.
Campbell was hoisted on his petard by Dr. Oliver because he showed that he knew why the Pfizer trial didn't assess the ability of its drug.
Best part of @DrSusanOliver1's new video is she found a clip from May 2021 of John Campbell from before he was an antivaxxer demonstrating he knows exactly why the current talking point he's pretending to be outraged about is stupid.
(at 6:55)https://t.co/ZGzT150Kka
— bat_stats
(@thebadstats) October 15, 2022
The purpose of clinical trials of vaccines is to determine if the vaccine is safe and effective at protecting the person against the disease. Why aren't vaccines tested for their ability to prevent transmission in trials? The answer is straightforward. The primary goal of a vaccine is to prevent disease. Prevention of transmission is gravy as well. The randomized controlled phase 3 trial for licensure is the best place to carry out study designs to identify interruption of pathogen transmission.
Conversely, RCTs might underestimate the protective effect of vaccines at the population level. This would occur if the COVID-19 vaccine, in addition to conferring direct protection to individuals, reduces transmission of COVID-19 between individuals, providing protection to unvaccinated individuals and enhanced protection of vaccinated individuals in contact with vaccinated individuals. Vaccine-induced herd protection, which might be crucial to the public health value of a vaccine, will be missed when trials are individually randomized and analyses fail to take account of the geographical distribution of individuals in the population58. Table 1 provides a summary of estimates of the basic reproduction number, herd immunity, efficacy and effectiveness for several vaccine-preventable diseases. The definition of effectiveness might vary by study.
The vaccine's ability to prevent infections is one of the factors considered ineffectiveness.
Collection of effectiveness data and understanding indirect protective effects of vaccination will allow countries to make rational plans for maintaining herd protection
When the vaccines were introduced, all of this was published.
Pfizer went from earlier stage clinical trials to its phase 3 trial and antivaccine messaging tries to impute sinister intent. Some of the misinformation appeared in the comments of my not-so-super- secret other blog.
Pfizer’s phase-1/2 trial did indeed study antibodies which is the best gauge for assessing transmission. Binding antibodies was reported for the 45 subjects but crucial neutralizing antibodies was only assesed for only seven subjects with Pfizer promising that data was forthcoming. I don’t believe it ever got reported before they eventually switched to assessing whether the vaccine prevented symptoms for the phase-3 trial.
https://pubmed.ncbi.nlm.nih.gov/32785213/
In the comments of my not-so- secret other blog.
Further to my comment above and speaking of shifting goalposts, the mother of all goalposts shifts occurred when Pfizer moved from studying efficacy of its vaccine by its immunogenicity profile in phase-1/2 to assessing symptoms in phase-3. This goalposts shift went largely unnoticed; drowned out by the thunderous fanfare and jubilation that proceeded the phase-3 trial news that the vaccine was 95% effective at preventing symptoms. And, perhaps the shift would’ve remained inconsequential if the vaccine hadn’t now proven to be ineffective at stopping shit.
Let it be known that it’s not just a case of Pfizer not assessing whether its vaccine is effective at stopping transmission, but them deliberately choosing this.
First, thic commenter didn't bother to scroll down and see the second article in which T-cell responses were reported Someone who doesn't know how clinical trials proceed from preliminary to phase 3 can't write. The purpose of phase 1 trials of vaccines is to assess gross safety, i.e., that the vaccine doesn't cause any obvious toxicity in a small group of patients. It is looking for obvious and serious safety signals before larger trials are done. Phase 2 trials look at a larger number of patients and are interested in signals of efficacy and safety. By the time you get to the phase 3 trial, the regulators want to know if the immunogenicity found in earlier phase trials translate into prevention of disease. That is where the rubber goes. The vaccine is useless if the immune response in the first and second trials doesn't translate into a significant prevention of disease. Pfizer probably chose not to assess the interruption of viral transmission because the FDA often advises companies on what they need to see in clinical trials to support the approval of an experimental drug or vaccine.
The antivax propaganda message that the clinical trials used as the basis for an EUA of Pfizer vaccine never examined whether the vaccine can prevent transmission reminds me of the original clinical trials used to license Pfizer. What is the way? This line of misinformation ignores what we have learned about the efficacy of the vaccine in preventing transmission since the publication of the results of the phase 3 trials two years ago. We didn't know much about how effective the Pfizer vaccine was in preventing onward transmission of the coronaviruses, but we have learned a lot since then. It's quite the opposite. There are many studies of the Pfizer vaccine alone for the primary course and for boosters for the original strain of SARS-CoV-2 and the Delta. Antivaxxers don't pay attention to these.
I used to cite an early study that showed that the vaccine was very effective in preventing both symptoms and infections among healthcare workers in England, and a more recent study that showed that the vaccine reduces transmission.
It's not surprising that vaccines are less effective at preventing transmission of the Delta and Omicron variant since they have evolved changes in the spike proteins that make the vaccine less effective. The Belgian study used contact tracing to estimate vaccine effectiveness against the original strains of the disease.
VET-estimates were higher for mRNA-vaccines, over 90%, compared to viral vector vaccines: 66% and 80% for Ad26COV2.S and ChAdOx1 respectively (Alpha, 0-50 days after vaccination). Delta was associated with a 40% increase in odds of transmission and a decrease of VEs (72-64%) and especially of VEi (71-46% for BNT162b2). Infection-acquired and hybrid immunity were less affected by Delta. Waning further reduced VET-estimates: from 81% to 63% for BNT162b2 (Delta, 150-200 days after vaccination). We observed lower initial VEi in the age group 65-84 years (32% vs 46% in the age group 45-64 years for BNT162b2) and faster waning. Hybrid immunity waned slower than vaccine-induced immunity.
Even in high-risk situations, such as among the residents of nursing homes and long term care facilities, there is good evidence that the vaccine can prevent transmission. The VET may have fallen for the Delta variant. There is less evidence published for the BA.4 and BA.5 variant due to the fact that they took off a year ago, but there is still a growing body of evidence. Black and white think that a vaccine that is only partially effective against preventing transmission is not preventing transmission at all. Updating vaccines will be important in the future due to the fact that Omicron has shown itself to be able to evade natural immunity due to a previous strain of the disease.
There isn't anything new here. I was led to a thread on the Counter Disinformation Project's website detailing how long antivaxxers have been hitting this particular fake criticism.
pic.twitter.com/Q5mkOwvRmW
— John Bye (@_johnbye) October 14, 2022
pic.twitter.com/ETXnX4lW4n
— John Bye (@_johnbye) October 14, 2022
pic.twitter.com/cFcwath7AG
— John Bye (@_johnbye) October 14, 2022
pic.twitter.com/e1E3mdJ2VB
— John Bye (@_johnbye) October 14, 2022
You can follow the entire thread for more information. This is one of the oldest COVID-19 antivax talking points because of some of the Tweets.
I wonder why antivaxxers are reviving this message now. It's the best reason I can think of. A Pfizer executive caught the attention of Tucker Carlson's producers and led to him appearing on Tucker Carlson's Fox News show last week. Add to that the human tendency towards black-and-white, either- or thinking in which, instead of existing on a continuum, people tend to conclude that a vaccine is either effective or not, safe or not, and you have a perfect storm of anti-vax propaganda. The Moderna phase 3 trial for its vaccine used a very similar design to Pfizer's phase 3 trial, but I'm not seeing this claim applied to that vaccine. This further supports the idea that this particular outbreak is opportunist.
She thinks politics is the reason.
That all the usual characters have jumped on this at the same time feels like an effort to build on the escalation in previous weeks. In the US this appears to be an effort to mobilise the anti-vax base in preparation for the mid-term elections next month when many disinformation doctors are standing for office.
We see far-right groups in Canada and Europe seeking to capitalise on this while in the UK Richard Tice’s Brexit Party has transformed into the sceptic Reform Party which is seeking to benefit from the chaos within the Conservative Party. Several other parties like the far-right English Democrats and Heritage Party which are working with disinformation groups are trying to do the same.
None of this is new, regardless of whether she is correct or not. Those of us who have followed antivaccine messaging for a long time have seen it all before, be it with the tetanus vaccine or the measles vaccine, for the latter of which is not good enough for antivaxers to accept that it works. Antivaxxers are promoting conspiracy theories thanks to the Pandemic. Pfizer and the FDA are accused of hiding the fact that the phase 3 clinical trials for the Pfizer vaccine didn't test for its ability to prevent transmission pops up, and then pops up again elsewhere, resulting in an endless and frustrating antivax narrative. The idea is that. When a piece of news makes it convenient for antivax peddlers to resurrect it, there is no doubt that this kerfuffle will go away. I am starting to think that prebunking the form of antivax disinformation will be more important than just trying to destroy it.
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