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Two health professionals from the US state of Alaska developed a severe allergic reaction within minutes of receiving the Pfizer / BioNTech coronavirus vaccine. One remains under observation and another was released shortly after an hour.
The episodes are very similar to the two cases of allergic reaction reported last week in the UK. But an intriguing difference: one of the American professionals did not have a history of severe allergies, like the other three.
Following the cases, regulatory bodies in the US and UK warned that people with a history of a severe allergic reaction to drugs and foods should not get the vaccine. But there was no veto for the rest of the population, including those with a history of moderate allergy.
So, what do these episodes indicate about the safety of the new vaccine manufactured by Pfizer / BioNTech, companies that have requested authorization from Anvisa (National Health Surveillance Agency) for applications in Brazil?
What happened in the United States and the United Kingdom?
The two healthcare professionals who had a severe allergic reaction were immunized at the same Alaska hospital.
The first, a middle-aged woman, began to develop a rash, shortness of breath and a rapid heart rate about ten minutes after being vaccinated at Bartlett Regional Hospital in Juneau.
He immediately received an injection of epinephrine, a traditional treatment for allergic reactions. Patients with a history of severe allergy even have injection pens in case of emergency.
But Lindy Jones, director of the hospital’s emergency department, said the health worker had no history of severe allergies. She had her first seizure and her symptoms subsided with epinephrine, but then they came back and she received steroids and epinephrine and was referred to the intensive care unit (ICU), the newspaper reports. The New York Times. Its state is stable and remains under observation.
The second patient had a history of severe allergy but had an anaphylactoid reaction, not anaphylaxis, the medical team said, representing a much less serious condition. The symptoms (swelling in the eye, itchy throat and dizziness) appeared about ten minutes after the application and subsided as soon as she received epinephrine. The patient was discharged one hour later.
The two cases of allergic reaction in the UK also involved healthcare professionals, both with a history of severe allergy – one to eggs and the other to various medications. The Pfizer / BioNTech vaccine does not contain part of the egg.
For the Food and Drug Administration (FDA), most Americans with allergies can safely receive the vaccine and only people who have had severe allergic reactions to the vaccines or the ingredients in this particular vaccine should avoid taking the injection. . The list of ingredients can be consulted in English at this link from the Government of Canada.
According to FDA guidelines, healthcare professionals who vaccinate patients should monitor everyone for 15 minutes and, in the case of those with a history of severe allergic reaction, for 30 minutes. Furthermore, health facilities must be prepared to adopt immediate treatment.
The British regulatory agency MHRA said that anyone with a history of anaphylaxis or severe allergic reactions to a drug or food should not receive the Pfizer / BioNTech vaccine.
What does this mean for vaccine safety?
“If you want absolutely no adverse effects, then no vaccine or medication will be ‘safe’ in that sense. Every effective drug has unwanted effects. So when we say it is ‘safe’, we are talking about the weight of unwanted effects in Compared to benefit, it is very clearly in favor of benefit, ”explains Stephen Evans, professor at the London School of Hygiene and Tropical Medicine.
“The concept of ‘safe’ is not absolute, it’s ‘safe’ in the context of each use,” explains Evans.
Regulators in the United Kingdom and the United States have made the decision to authorize the distribution of the covid-19 vaccine based on much more information than has been made public, usually in the form of press releases.
The Pfizer / BioNTech vaccine reduces COVID cases in approximately 95% of immunized people, but has very common side effects, such as injection site pain, headache, chills, and muscle pain. This can affect more than 1 in 10 people.
These are all signs that the immune system is activating and can be controlled with paracetamol, for example.
According to FDA data, studies with the Pfizer / BioNTech vaccine indicated that in the group of people who developed any side effects, arm pain (84%), fatigue (63%), headache (55%) were recorded , pain. muscle (38%), chills (32%) and fever (14%).
“The RNA vaccine (such as the one from Pfizer / BioNTech) for covid has already been tested in more than 70,000 people in phase 3 clinical trials. There may be a rare adverse effect (eg 1 in 1 million) that? Was it detected in phase 3? Yes. But monitoring of those vaccinated for adverse effects continues after approval. It will be phase 4, “said epidemiologist Denise Garrett, vice president of the Sabin Vaccine Institute.
“Bottom line: So far, there is no indication that mRNA vaccines are unsafe. I would take this vaccine and give it to my son, my most precious asset.”
The danger surrounding the side effect debate is that people mistakenly assume that the health problems that happen to be coincidental were caused by the vaccine.
It is easy to predict that there will be scary stories in the coming months: whether in the press or on social media, with the wrong origins or simply malicious.
There will be cases where one day someone will receive the vaccine, shortly after, they will have a serious health problem that would have occurred even if they had not been immunized.
That’s why the safety of the vaccine is monitored long after one is approved to see if there are any unknown health problems. The British regulator, for example, has a program to record patient problems and monitors anonymous data from doctors’ offices for any vaccine-related warning signs.
