In Germany, but also internationally, immunizations against the coronavirus with the vaccine of the companies Biontech and Pfizer have started. Among other things, the question of possible side effects arises.
The preparation – an mRNA vaccine – is based on a novel method. It has been tested and approved by the European Medicines Agency (EMA) in Amsterdam. The vaccine from Moderna, which has also already been approved in the EU, is based on the same principle.
Balance sheet of the Paul Ehrlich Institute
In the Corona pandemic, the federally owned Paul Ehrlich Institute (PEI) is the central information collection point for vaccine adverse events. As of January 10, the PEI had received 325 suspected cases with 913 adverse reactions, including 51 suspected cases with serious adverse reactions. This corresponds to 0.53 suspected cases per 1,000 vaccine doses and 0.08 suspected cases for serious adverse events per 1,000 vaccine doses, respectively. According to PEI, the values are consistent with data from the clinical registration studies and are also statistically unremarkable. PEI President Cichutek called the adverse events “mild to moderate.” PEI reports weekly on reported adverse events following Corona vaccination.
Deaths of critically ill: “coincidental association with vaccination”
In the 10 deaths reported so far shortly after a Corona vaccination, experts at the Paul Ehrlich Institute believe a connection with immunization is unlikely. In these cases, seriously ill people had died within four days of vaccination, the federal institute reported. It can be assumed that the patients died of their underlying disease, “in coincidental connection with the vaccination,” said Keller-Stanislawski, the department head responsible for the safety of drugs and medical devices. These were “very seriously ill patients with many underlying diseases”. Some had been treated palliatively. RKI president Wieler had already pointed out before the beginning of the vaccination campaign that due to the statistical probability “humans in the temporal connection with the vaccination will die” – for instance because first “the old and very old humans” are inoculated, which have due to their age generally a higher risk to die.
What should people expect immediately after vaccination?
In the Phase 3 clinical trials, numerous subjects experienced pain at the injection site. In concrete figures, this means: in 66 to 83 percent of the study participants. Many also complained of fatigue and headaches, chills or muscle aches. Eleven percent of the elderly and 16 percent of the younger ones also developed fever.
According to the Robert Koch Institute (RKI) and the Paul Ehrlich Institute, this is one of the usual vaccination side effects. Such reactions show that the body is processing the information about the pathogen against which the vaccination is supposed to work. The immune system reacts just right: it produces antibodies that protect against possible infection with Sars-CoV-2.
Individual cases of unusual reactions in the USA and Great Britain
Because those vaccinated are monitored very closely, deviations from “normal” vaccination reactions also quickly become public. In Great Britain, but also in the U.S. state of Alaska, a total of three cases have been reported in which freshly vaccinated persons showed a severe allergic reaction; this is referred to as anaphylactic shock. This is an acute situation, often with respiratory distress, which requires medical treatment as soon as possible. Both vaccinated persons in Great Britain were already known to be prone to such a reaction; they therefore carried a pre-filled adrenaline syringe. The person in Alaska was not known to have such a propensity.
The UK Medicines and Healthcare products Agency (MHRA) subsequently warned people with a history of anaphylaxis against vaccination. People with allergies of lesser severity, such as hay fever or the like, were not affected.
by Jeremy Abbott – American Correspondent – BN