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88-year-old Anneliese Spies receives the vaccine from Biontech / Pfizer in a Berlin vaccination center against the coronavirus.
Photo: Kay Nietfeld / dpa
The number of corona cases continues to rise, experts are calling for a tightened lockdown - there is no relaxation in sight.
The only hope is the prospect of a successful vaccination campaign.
It's been running for a few weeks.
By Sunday, more than 600,000 vaccinations had been administered in Germany.
An initial assessment is positive: "Both active ingredients approved in the EU have good safety and tolerability and excellent effectiveness," said Klaus Cichutek, President of the Paul Ehrlich Institute (PEI) on Thursday afternoon in Berlin.
By Sunday, the institute had reported 325 suspected cases of side effects after vaccinations, which corresponds to 0.53 suspected cases per 1000 vaccine doses.
51 cases are to be assessed as serious.
The values agreed with the data from the clinical approval studies and were statistically inconspicuous.
Ten people had died by Thursday morning.
"All deaths were seriously ill patients," explained Brigitte Keller-Stanislawski, an expert in clinical pharmacology.
"We assume that the patients died of their underlying disease." All were of an old age.
Relative safety after the first dose
For a week now, it has been possible to vaccinate against the virus in the European Union with the Corona vaccine from Moderna.
It is the second vaccine against the coronavirus that can be used in the EU.
The European Medicines Agency had previously recommended conditional marketing authorization for Ema.
In December, Ema had already approved the Covid-19 vaccine from Biontech and Pfizer.
The vaccines are very similar in terms of effectiveness and tolerability.
Both preparations are mRNA vaccines.
The protective effect against Covid 19 disease after the second vaccination dose at Moderna and at Biontech / Pfizer is around 95 percent, confirmed PEI President Cichutek.
With this, almost all people are protected with a vaccination, with a few exceptions.
So far, however, these are mainly "statistical uncertainties," and there are no concrete cases of ineffectiveness in Germany.
Protection already exists after the first vaccination dose.
The second dose could be given up to 42 days later.
Common symptoms: headache and fatigue
The experts at the Paul Ehrlich Institute consider the side effects to be manageable: most symptoms appear within one to three days.
The most commonly reported side effects are headache, fatigue, vaccination site pain, and muscle and joint pain, and a mild fever.
"The side effects occur a little more frequently in people over the age of 60 who have been vaccinated," says Keller-Stanislawski.
The consequences of the vaccination are somewhat stronger than with a flu vaccination.
The observations agree with the results of the manufacturers.
The institute's experts also give the all-clear for allergy sufferers.
Unlike their British counterparts.
They had advised caution.
"We do not assume that there is a higher risk for people with food allergies, for example," says the pharmacologist.
Nevertheless, to be on the safe side, the patients would have to stand under the supervision of a doctor for 15 minutes after the vaccination.
This is to rule out an anaphylactic shock, i.e. an allergic overreaction of the body.
Intolerance could occur in people with rare diseases.
Because here the data situation is quite thin.
There is a practical reason for this: the preliminary studies for the approval of the vaccines had to go through three phases.
In both cases, 30,000 participants took part in the testing of the vaccine - including people of all ages.
But even with this, not all cases could be covered - the people are simply too diverse, says Keller-Stanislawski.
"Among the 30,000 participants there were perhaps also people with multiple sclerosis, but the frequency is too low to make reliable statements." The rarer a previous illness, the more uncertain the data.
Protection against mutations
The Paul Ehrlich Institute (PEI) also assumes that the approved vaccines protect against the new virus mutations.
Should an adaptation of the construction plans of the vaccines become necessary due to mutations, which is in principle possible within six weeks, approval can be granted quickly, says PEI President Klaus Cichutek.
Initial tests by the US drug manufacturer Pfizer recently confirmed that the vaccine developed by the German company Biontech is effective against the new variants of the coronavirus discovered in Great Britain and South Africa.
However, after it appeared about a week ago, the study was not yet reviewed by external experts.
But now the PEI also confirms this view.
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