Does Pfizer "admit" that people given its COVID-19 vaccine "shed" spike proteins and infect unvaccinated people? No, that's not true. The claim is based on the standard clinical study protocol used for a wide range of medicines. There is no publicly available evidence the mRNA COVID-19 vaccines cause vaccinated persons to cast off excess spike proteins. The mRNA vaccines teach the body to make the distinctinve spike proteins, which the immune system then attacks, preparing itself to ward off COVID-19 if the patient is exposed. The mRNA can only enter the body through a dose given by injection; it can't be passed between people. The shots are not infectious.
The claim appeared in an article (archived here) published on the anonymous VaccineSafety.Info website on October 27, 2021, with the title "Pfizer Confirms COVID-Vaccinated People Can 'Shed' Spike Proteins And Harm The Unvaccinated." It opened (emphasis theirs):
A new study has confirmed that people who have been vaccinated against COVID produce excessive spike proteins that are capable of passing the Blood Brain Barrier causing irreparable damage to the brain -- and Pfizer's own documents warn that vaccinated people actually shed these excessive spike proteins putting the unvaccinated at risk for harm:
In their latest issue brief, America's Frontline Doctors (AFLDS) warned how spike proteins resulting from experimental COVID-19 gene therapy vaccines have the capacity to 1.) pass through the "blood-brain barrier" causing neurological damage, 2.) be "shed" by the vaccinated, bringing about sickness in unvaccinated children and adults, and 3.) cause irregular vaginal bleeding in women.
This is what the post looked like on November 8, 2021:
(Source: VaccineSafety.Info screenshot taken on Mon Nov 08 16:54:59 UTC 2021)
To make its case the VaccineSafety.info page, which has no contact information, cites a 146-page Pfizer vaccine protocol pdf from November 2020. Pfizer, as it does with all new medicines, undertook a study to "evaluate the safety, tolerability, immunogenicity, and efficacy of [messenger] RNA vaccine candidates against COVID-19 in healthy individuals."
The VaccineSafety page also makes its case based on an April 26, 2021, issue brief from America's Frontline Doctors (AFLDS) -- an anti-vaccine activist organization that Lead Stories has written about in previous debunks. The issue brief is a statement of the activist organization's position on COVID vaccines.
Here is the "About" page for VaccineSafety.info. It provides no contact names or addresses and the contact form had not been built for VaccineSafety.info:
(Source: VaccineSafety.Info screenshot taken on Mon Nov 08 23:13:59 UTC 2021)
Lead Stories previously debunked a claim of COVID-19 vaccines threatening unvaccinated people through someone who's already received a vaccine.
According to the U.S. Centers for Disease Control and Prevention (CDC), people who get a COVID-19 shot cannot shed or release vaccine components. This is what the website says:
(Source: CDC website screenshot taken on Mon Nov 08 18:18:09 UTC 2021)
That point was echoed in a statement, emailed to Lead Stories on November 9, 2021, by a Pfizer spokesperson. It read (emphasis theirs):
The Pfizer-BioNTech COVID-19 vaccine is a synthetic mRNA vaccine and does not contain any virus particles. Because there is no virus produced in the body, no shedding occurs.
In a May email to Lead Stories, Pfizer's spokesperson wrote that the vaccine cannot be inhaled and can only enter the human body through an administered dose.
The VaccineSafety.Info web article recycles the shedding claim by cherry-picking standard study protocol language to make it sound like Pfizer is reporting on a risk specific to the COVID vaccine, writing:
So Pfizer's own internal report (on page 69) warns health care workers about being exposed to people who have been vaccinated -- which is rather ironic considering most health care workers are required to be vaccinated themselves.
Anyone walking in to a hospital or doctor's office will be exposed to the spike proteins being shed by virtually the entire staff of workers -- but the concentrations will be low compared to what is in the blood streams of the vaccinated.
That section of the study protocol is a definition of terms to be used by participants in a drug safety study. Here's what part of Page 69 of the Pfizer protocol says: (In the Pfizer study, an AE is an accidental exposure):
(Source: Pfizer pdf screenshot taken on Mon Nov 08 18:48:39 UTC 2021)
This sort of wording is standard study protocol language. It's part of something called the Common Protocol Template (CPT) Initiative. In 2017 some changes were made to standardized research documents. Because of this standardization effort, it's simple to find similar language in other non-COVID-19 studies.
One example is a final Pfizer protocol for a non-COVID-19 drug, dated February 22, 2019. This was a study for crisaborole ointment, an eczema treatment. On Page 46 of the document, the wording of section 8.3.5.3. is like the one for Pfizer's COVID vaccine and identical to the one for a final protocol amendment (Page 70), dated October 1, 2021, for PF-06826647, a treatment for severe plaque psoriasis.
(Source: Pfizer study screenshot taken on Tues Nov 09 22:46:09 UTC 2021)
That section of the study protocol does not mean people have been exposed. It gives participants the term to use for accidental needle-pokes, spillage or other accidents.
Since the CDC says the virus can't be spread through the vaccines approved for use in the United States, the type of exposure or direct contact the study is referring to is something else. It's more than just being in the same room with someone who's been vaccinated and breathing the same air.
The statement by America's Frontline Doctors highlights thousands of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-sponsored by the CDC and the Food and Drug Administration (FDA).
Lead Stories has debunked several claims that misuse VAERS.
Anyone with internet access can add a report to the VAERS list of reports. The public access link to it expressly warns against unwarranted conclusions based on VAERS material because the list only provides a tally of unverified notes about any health event people experience after they are vaccinated.
The list itself cannot be used to prove or quantify, since all it shows is a chronological correlation, not the causal link that would be more difficult to establish. It's the equivalent of a police precinct's running "blotter" reports that may serve as a starting point for police work, not an endpoint.
VAERS website warnings include:
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
This is how America's Frontline Doctors describes itself in its mission statement:
AFLDS believes that the American people have the right to accurate information using trusted data derived from decades of practical experience, not politicized science and Big Tech-filtered public health information.
And this is how the Vaccine Safety Info website describes itself:
The intent of this site is to curate news, research, perspectives and data on vaccines and their safety to support people being able to make informed decisions.
