While the U.S. release date of the BioNTech-Pfizer COVID-19 vaccine is still uncertain, healthcare workers began receiving it in England on Tuesday after having been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) last week. The day after its release, CNN reported U.K. health authorities advising:
People with a “significant history of allergic reactions” should not be given the Pfizer/BioNTech coronavirus vaccine … after two health care, workers experienced symptoms after receiving a shot the day before.
The National Health Service England told CNN Wednesday that the pair “responded adversely” after receiving their shots the previous day. Both workers had a history of allergic reactions and carried an adrenaline auto-injector and developed anaphylactoid reaction symptoms following their vaccination Tuesday.
CNN reported that Professor Stephen Powis, national medical director for the NHS in England, said:
As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.
CNN said that MHRA issued the following statements and advice to healthcare professionals:
Any person with a history of a significant allergic reaction to a vaccine, medicine, or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline auto-injector) should not receive the Pfizer BioNtech vaccine. Vaccines should only be carried out in facilities where resuscitation measures are available.
We are fully investigating the two reports that have been reported to us as a matter of priority. Once all the information has been reviewed, we will communicate updated advice.
CNN added that the MHRA advised people with a history of a significant allergic reaction to talk to a healthcare professional before receiving the Pfizer/BioNTech.
In May, the MHRA set up a website called the COVID-19 Yellow Card site, dedicated to reporting “side effects and incidents related to medicines and medical devices used in patients infected with SARS-CoV-2, the novel coronavirus that causes COVID-19.”
According to CNN, Pfizer responded to the incidents after being informed by the U.K. regulator of “two yellow card reports that may be associated with allergic reaction:”
As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.
In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.
Before hosting the live-streamed panel of independent scientists to consider the FDA’s initial review of the BioNTech-Pfizer COVID-19 vaccine this Thursday, the U.S. Food and Drug Administration (FDA) released a briefing document detailing Pfizer and BioNTech’s COVID-19 vaccine-candidate data. Those documents acknowledged the increased potential of allergic-like adverse responses among the vaccine group at 0.63 percent compared with the placebo group 0.51 percent.
Pfizer’s trial protocol states that people with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s)” were to be “excluded from the study.”
Several independent experts commented on the incident on the U.K.’s Science Media Centre website, including Stephen Evans, professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine:
Allergic reaction occurs with quite a number of vaccines, and perhaps even more frequently with drugs. So, it is not unexpected.
The Pfizer data showed that about 0.6% of people had some form of allergic reaction in the trial on the vaccine, but about 0.5% on placebo. So, there was a genuine excess of allergic reaction but this was small and the true rate is not known, and there is a lot of uncertainty around that estimate.
The only thing that is contraindicated with this vaccine (meaning you mustn’t have it) is hypersensitivity to the vaccine or any of the excipients (other things in the vaccine), but some people won’t know if they have hypersensitivity to some constituents of the vaccine.
The FDA document revealed:
There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals….
A total of six deaths occurred in the reporting period (2 deaths in the vaccine group, 4 in placebo). In the vaccine group, one participant with baseline obesity and pre-existing atherosclerosis died 3 days after Dose 1, and the other participant experienced cardiac arrest.
And to put things in perspective for us, Dr. Kelly Moore, associate director of the Immunization Action Coalition, was quoted by CNN telling us what we can expect once
the “neediest” begin to take the jab:
When shots begin to go into arms of residents, Moore said Americans need to understand that deaths may occur that won’t necessarily have anything to do with the vaccine.
“We would not at all be surprised to see, coincidentally, vaccination happening and then having someone pass away a short time after they receive a vaccine, not because it has anything to do with the vaccination but just because that’s the place where people at the end of their lives reside,” Moore said.
“One of the things we want to make sure people understand is that they should not be unnecessarily alarmed if there are reports, once we start vaccinating, of someone or multiple people dying within a day or two of their vaccination who are residents of a long-term care facility. That would be something we would expect, as a normal occurrence, because people frequently die in nursing homes.”
Another thing to note about releasing this drug is the complete burial of a recent petition to the European Medicine Agency (EMA) to stop its release. The motion, filed on December 2 by Dr. Michael Yeadon, an ex-Pfizer head of respiratory research, and Dr. Wolfgang Wodarg, a lung specialist and former director of the public health department, is for immediate suspension of the BioNtech/Pfizer study on BNT162b.
The 43-page document lists numerous reasons why the vaccine is not only unsafe but poses serious health risks to all who take it, according to a review of the report in this article:
The formation of so-called “non-neutralizing antibodies” can lead to an exaggerated immune reaction, especially when the test person is confronted with the real, “wild” virus after vaccination. This so-called antibody-dependent amplification, ADE, has long been known from experiments with corona vaccines in cats, for example. In the course of these studies all cats that initially tolerated the vaccination well died after catching the wild virus.
The vaccinations are expected to produce antibodies against spike proteins of SARS-CoV-2. However, spike proteins also contain syncytin-homologous proteins, which are essential for the formation of the placenta in mammals such as humans. It must be absolutely ruled out that a vaccine against SARS-CoV-2 could trigger an immune reaction against syncytin-1, as otherwise infertility of indefinite duration could result in vaccinated women.
The mRNA vaccines from BioNTech/Pfizer contain polyethylene glycol (PEG). 70% of people develop antibodies against this substance — this means that many people can develop allergic, potentially fatal reactions to the vaccination.
The much too short duration of the study does not allow a realistic estimation of the late effects. As in the narcolepsy cases after the swine flu vaccination, millions of healthy people would be exposed to an unacceptable risk if an emergency approval were to be granted and the possibility of observing the late effects of the vaccination were to follow. Nevertheless, BioNTech/Pfizer apparently submitted an application for emergency approval on Dec. 1, 2020.
This interview with Dr. Wodarg for the magazine L’Humanité should be required reading for anyone set to receive the jab. Another excellent source for information on the “Dark Side” on the vaccine is this interview with Robert F. Kennedy, Jr.:
Whether these incidents will affect Pfizer’s vaccine’s release in the United States remains to be seen, but to many, the decision to “Just Say No,” has already been made.
