By: Greg Staley
The owner of Brothers Butcher Shoppe on 9001 Dufferin street in Vaughan took to Instagram three days ago to announce that they wouldn’t be accepting patrons who had been vaccinated with the Covid-19 vaccine for at least 28 days after vaccination.
The owner said, “I’ve decided to take a bit of a stand and I’m asking everybody who wants to take this stand with me to join me because I want this store to be the safest place there is around.”
“After reading the Pfizer documents that were submitted to the FDA especially section 8.3.5 which is labelled “exposure during pregnancy or breastfeeding and occupational exposure. We have decided that we believe in the health and safety of our customers beyond all else.” He continued “since the vaccine companies are openly studying the side-effects on women who are around those that are vaccinated – even if they aren’t themselves vaccinated. We ask that if you have received a Covid vaccine within the past 28 days to please order online through our website for curbside pickup and delivery.”
He isn’t the only business owner to refuse patrons who’ve been vaccinated over fears of shedding. Bling Lash lounge in Cambridge also posted that they wouldn’t be accepting vaccinated customers as well as the Flow Academy in B.C – although their days being open may be limited.
What document did the Brothers Butcher Shoppe owner refer to?
The document that was referred to by the owner of Brothers Butcher in Vaughan, Ontario was the document titled “A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and
Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals” and it has many concerned because of the uncertainty it seems to present.
The document under section 8.3.5 says that “exposure to the study intervention during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness.” Now to be clear this is the application that outlined the trials that were to take place – but why were they discussing this as a possibility?
The document appears to want to track any adverse events that are linked to EDP (exposure during pregnancy). The document says that “Details of the pregnancy will be collected after the start of study intervention and until 6 months after the last dose of study intervention.”
The document says that “a male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception” and “a male participant who is receiving or has discontinued study intervention who exposes a female partner prior to or around the time of conception” are considered examples of exposure during pregnancy or EDG.
So skin contact and inhalation are listed as an EDG – why? The document goes on to say “since the exposure information does not pertain to the participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed Vaccine SAE Report Form is maintained in the investigator site file.”
So let me get this straight – if an adverse event happens because someone was exposed by inhalation or skin contact to a vaccinated individual you don’t have to complete a case report form since they aren’t enrolled in the study? But it’s ok everyone – they’ll keep a complete report in their investigator file!
Section 18.104.22.168 Occupational Exposure
Under section 22.214.171.124 the document says that “an occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE.”
So this part mentions occupational exposure as direct contact with a study intervention or Covid vaccinated individual which “may or may not lead to the occurrence of an AE” or adverse event. Again, this could have never happened in all of those studied – but why look for a problem that doesn’t have a chance of occurring? Why aren’t AE’s from those with occupational exposure to a vaccinated individual recorded as part of the trial with a case report form?
Diverge Media will continue to keep an eye on this story and update it as new information becomes available to us.
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