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With vaccinations already started in the UK and USA. waiting his turn until your vaccine Pfizer / BionTech to gain approval and there, a number of critical questions arise about any side effects of the vaccine, if those who suffer it must allergy and, most importantly, what exactly happened to the two people who They lost their lives participating in vaccine trials in the US
Because the Margaret Keenan, 90, became the world’s first person on Monday who received their vaccine Pfizer / BioNtech against COVID-19, and gave hope to millions more, however a vaccine is not … laughed at the game, especially when we are talking about a pandemic situation.
Somehow, the first “cold” came from the NHS (British NSS), which warned that people with a history of allergic reactions you should not receive the Pfizer / BioNTech vaccine against it coronavirus “. The warning comes a day after two NHS workers showed symptoms.
Both NHS employees carry adrenaline injectors, the best known of which is the EpiPen, suggesting that they have reacted to them in the past.
These autojectors provide a quick adrenaline boost to treat allergic reactions that occur when certain people, for example, eat nuts. The Pfizer / BioNTech Patient Information Leaflet advises “not for use in allergy sufferers.”
“Signs of an allergic reaction can include itchy skin, shortness of breath, and swelling of the face or tongue,” says the package insert.
Both NHS workers appeared to have symptoms of “anaphylactoid reaction” shortly after receiving the vaccine and both recovered after appropriate treatment.
The identities of the NHS staff and the hospitals where they were vaccinated have not been released.
The NHS confirmed the two incidents, saying that all units have now been advised not to vaccinate people with a history of allergic reactions.
“As is customary with new vaccines, the regulatory authority (MHRA) has been cautiously advised that people with a history of significant allergic reactions should not receive this vaccine, as there have been side effects in two people with a similar history.” he told The Guardian. Professor Stephen Powys, Medical Director of the NHS in England.
The MHRA advice also states that “anyone with a history of significant allergic reaction to a vaccine, drug, or food (such as a prior history of anaphylactoid reaction or those who have been recommended to inject adrenaline) should not receive the Pfchte vaccine. / Bio “. Resuscitation facilities must be available at all times for all vaccinations. “Vaccination should only be carried out in facilities where resuscitation measures are available,” he concluded in his announcement.
The mysterious death of two (+ 4 other) people
Back in the US, Questions About Him Increase death of two other people who volunteered in the Pfizer / BioNTech vaccine clinical trials from April to today.
The two deaths – both over 55 years of age – join the other four who ended up among the first 38,000 volunteers (out of a total of almost 44,000 expected to be announced in the coming days) who were vaccinated.
One of the two volunteers, who received both doses of the vaccine, suffered a heart attack two months after receiving the second dose of the vaccine and lost the battle for his life three days later.
The second volunteer was obese and had pre-existing atherosclerosis, and died of atherosclerosis three days after receiving the first dose of the vaccine.
The other four deaths received the placebo vaccine, according to a report confirmed by the United States Food and Drug Administration (FDA):
“A total of six volunteers (2 who received the vaccine and 4 who received the placebo) out of 43 438 registered (0.01%) died during the reporting period from April 29, 2020 to November 14, 2020,” he said. the FDA in a statement. documents released prior to the scheduled Advisory Committee meeting on Thursday morning [απόγευμα Πέμπτης, ώρα Ελλάδος] where the granting of an emergency permit for the use of the vaccine in the country will be approved.
According to an FDA document that refers to the deaths in question, the investigator did not evaluate anyone as relevant to the study.
In contrast, according to the FDA report, clinical trial data for the vaccine indicate “a favorable safety profile, without identifying a specific safety concern that would prevent” authorization.
The Seven Most Common Side Effects of the Pfizer Vaccine
At the same time, there is another cause for concern: any side effects, even in healthy people.
The FDA, for its part, says that most of the side effects are the “classic short-term side effects of vaccines that generally last between 1 and 2 days.”
“The Pfizer vaccine for protection against Covid-19 coronavirus infection is safe, as its side effects are manageable and not life-threatening,” the statement said.
This is the first time such detailed information about the vaccine has been made public.
The figures correspond to the first 38,000 volunteers out of a total of 44,000 in phase III clinical trials in the United States, Brazil, Argentina, Germany and Turkey.
Almost half of the volunteers received the vaccine, which protects against coronavirus infection. The rest received a placebo vaccine to compare.
All the volunteers received two doses of the vaccine, 21 days apart, and for seven days after each dose of the vaccine, the volunteers recorded any symptoms.
Also, doctors will monitor them until 2 years have passed since the last dose to consider any long-term side effects. The published data refer to the first two months after vaccination.
According to documents published by the US Food and Drug Administration (FDA), the vaccine primarily causes seven local (injection site) and systemic side effects.
Local reactions include:
- Pain
- Redness
- Swelling (swelling)
Systemic reactions include fatigue, headache, myalgia (chills), chills, joint pain, and fever. There may be some more serious side effects (such as lymphadenopathy), but they are very rare.
How common are they?
According to the documents, the side effects appear within seven days of the vaccine, mainly after the second dose.
Particularly:
- 84% of the volunteers who received the vaccine had local reactions (at the injection site)
- 63% developed fatigue
- 55% had a headache
- 38% had myalgia
- 32% had chills
- 24% had joint pain
- 14.2% developed fever
The fever can be high (even above 39oC).
Younger volunteers (18 to 55 years old) were more likely to have a high fever than older volunteers. However, both the fever and the other side effects mentioned above were transient. Its duration was approximately 1-2 days.
More serious side effects were reported in very few volunteers (frequency less than 0.5%) and again most reports were made after the second dose and in younger patients (under 55 years).
What may be related to the vaccine is lymphadenopathy. Reported by 64 volunteers, mainly from 18 to 55 years old. Its average duration was 10 days.
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