Many of us happen to talk to someone who has been vaccinated against Covid.
And it is frequent to be told that after the first dose of Pfizer or Modern there were no problems while with AstraZeneca got worse: fever and aches, especially the next day. So much so that the idea of taking a sick day or two after the date set for vaccination with AstraZeneca is spreading. And unfortunately there are those who refuse short the AstraZeneca vaccine. Not only that: the common vulgate also wants mRna vaccines (Pfizer and Moderna) to cause adverse reactions (always mild and easily treatable) after second dose. As for AstraZeneca, in Italy probably no one knows what happens after the recall, as it must be done after 3 months.
How much truth is there in these rumors?
The premise – necessary and fundamental – that it is mostly about side effects common to all vaccines, to a lesser or greater extent, that don’t have to worry. In the overwhelming majority of cases it is sufficient to rest and take paracetamol.
The Aifa document
It helps us to clarify a report just published by the Italian Medicines Agency (Aifa), the second report on the surveillance of Covid-19 vaccines (data from 12/27/2020 to 2/26/2021), which confirms the high safety profile of vaccines currently used in Italy and Europe.
Therefore, from the end of December (administration of the first vaccines) to the end of February there have been 729 reports of adverse events per 100 thousand doses administered, regardless of the type of vaccine.
The reports mainly concern the vaccine Pfizer/BioNTech Comirnaty (96%), which was the most used, and only to a lesser extent the Moderna vaccine (1%) and the AstraZeneca vaccine (3%).
These are mostly non-serious adverse events: fever, headache, muscle / joint pain, injection site pain, chills and nausea.
Fever was reported more frequently after the second dose than the first, followed by headache and asthenia. The lower reporting rates of Moderna and AstraZeneca vaccines compared to Comirnaty are attributable to the lesser or more recent use, therefore – underlines Aifa in the report – they will need to be monitored over time.
Events (fever, headache, aches, chills, nausea) predominantly arise on the same day as vaccination or the day after.
In absolute terms, up to 26 February, they were included in the national pharmacovigilance network overall 30,015 reports, out of a total of 4,118,277 doses administered for all vaccines. The reporting rate was 907 / 100,000 doses for women and 424 / 100,000 for men. The average age of people who have experienced side effects of 46 years old.
The serious reports are 6.1% of the total, with a rate of 44 serious events per 100,000 doses administered. The evaluation of the causal role of vaccines in these ongoing reports requires specific investigation for each individual case.
Pfizer, Moderna and AstraZeneca
As for Comirnaty (Pfizer), most of the undesirable effects related to fever (especially after the second dose), injection site pain, asthenia / tiredness and chills, classified as non-serious in 95% of cases. They follow in order of frequency headache and paraesthesia, widespread muscle and joint pain, nausea and diarrhea. Altogether they are present 1,700 serious reports related to the Comirnaty vaccine: high fever, severe headache, widespread muscle / joint pain and asthenia, allergic-type reactions, lymphadenopathy, paraesthesia, tachycardia, hypertensive crisis and facial paralysis.
The reports relating to Moderna concern fever, asthenia / fatigue and pain at the injection site, 94% not serious. They follow widespread muscle and joint pain, headache, nausea and vomiting. In 32 reporting forms relating to the Moderna vaccine adverse events considered serious are reported: high fever, myalgia and diffuse arthralgia.
Does AstrZeneca cause fever?
Also for AstraZeneca most of the events concern fever, chills, asthenia / fatigue and pain at the injection site. 90% of these reports are classified as non-serious. They follow widespread muscle and joint pain, headache, nausea and vomiting. For the second doses of the AstraZeneca vaccine (expected 12 weeks after the first) it is not possible to make evaluations as they have not yet been administered. Most of the 79 reports of serious adverse events refers to high fever, tremor, dizziness, excessive sweating, drowsiness, difficulty in breathing, generalized pain.
Anaphylaxis and vaccination failure
As of February 26, 2021, they have been inserted 40 reports with death results. Case ratings indicate the absence of responsibility for the vaccine because they are people who had previous pathologies and who took several drugs at the same time. The average age of fatal cases was 86 years.
There are no cases of death following anaphylactic shock or major allergic reactions.
Very often death related to cardiovascular causes in patients who had underlying cardiovascular disease. Vaccine anaphylaxis is a serious, potentially life-threatening and rare event that occurs on average with a frequency of about 1 case per million, with symptoms that appear rapidly affecting the respiratory tract or the cardio-circulatory system, very often associated with symptoms affecting the skin and mucous membranes. With the introduction of the new vaccines against Covid, as expected, some cases of anaphylaxis. Currently, according to published US data, the reporting rate for vaccines at mRna is a result of 4.7 cases of anaphylaxis per million doses administered for Pfizer vaccine e 2.5 cases per million doses for the Moderna vaccine, most of which occurred after the first dose, within 30 minutes of administration, almost entirely in the female sex and in most cases, in people with a history of allergies or allergic reactions to other substances or a history of anaphylaxis. The main defendant was the polyetilenglicole (PEG), also called macrogol, one of the components present in the lipids that surround mRna.
All vaccinated persons should be observed for at least 15 minutes after vaccination, but in the presence of risk factors for severe allergic reactions they should be observed for a longer time (60 minutes). They were inserted from the end of December to the end of February 25 case reports of anaphylactic / anaphylactoid shock / reaction, all related to Comirnaty vaccine. At the moment there have been no reports of anaphylaxis / anaphylactic shock to the Moderna and AstraZeneca vaccines, probably in relation to the limited number of doses administered.
There are also 20 reports referable to a possible lack of efficacy of vaccination, all following the administration of two doses of the Comirnaty vaccine. Vaccination failure is referred to as a complete and appropriate vaccination it does not involve an adequate immune response (immunological vaccination failure) or it does not protect against the disease it intends to prevent (clinical vaccination failure).
Paracetamol and anti-inflammatories
As can be seen from the Aifa report, almost all of the adverse reactions reported for the three vaccines on the market are not serious and are resolved in a very short time – underlines Gianluca Trifir, full professor of Pharmacology at the University of Verona, member of the Covid-19 crisis unit of the Italian Society of Pharmacology and of the Advisory Board of the International Society of Pharmacovigilance -. In general, it can be recommended the use of paracetamol in case of fever and steroid anti-inflammatory drugs for the treatment of musculoskeletal pain. In case of high and persistent fever, despite the above treatments, or other disabling ailments necessary contact your doctor.
Report adverse effects
Also always good report any suspected adverse reactions vaccine via traditional channels (eg www.vigifarmaco.it) to allow Aifa to effectively update the report. In addition to this so-called “passive” surveillance, they have been promoted by national and international regulatory agencies several active pharmacovigilance studies. In particular, in Europe Ema financed an international project which, via web-app, will allow the benefit-risk profile to be effectively monitored of the different vaccines in fragile populations. This project will be coordinated for the Italian part by the University of Verona in collaboration with Aifa and different partners.
Bassetti: no to drugs before the vaccine
There are those who, before receiving the AstraZeneca vaccine, take drugs hoping to avoid getting sick. Indefensible behavior, second Matteo Bassetti, director of the Infectious Diseases Unit at the San Martino Hospital in Genoa: wrong to take a drug in prophylaxis to prevent an effect from happening, if this effect occurs in a small percentage of cases. It may make sense to use paracetamol, as well as ibuprofen, aspirin or whatever, when there are side effects, but what is the reason for taking it sooner? In this way we risk treating many more people than we really need.
March 10, 2021 (change March 11, 2021 | 20:22)