German PEI greenlights Pfizer citing insufficient data after myocarditis reports

The PEI presented a new safety report in which it provided information about possible side effects and complications of Corona vaccines. In addition to the already known cases of thrombocytopenia (TTS), i.e. cerebral vein thrombosis with a simultaneous lack of blood platelets, the institute is now reporting on possible connections between Corona vaccinations and cases of myocardial inflammation, known as myocarditis.

Reports of myocarditis cases first appeared in Israel where the Pfizer/BioNTech vaccine was mainly used. A committee of the Israeli Ministry of Health maintains that there is a relationship between the heart muscle inflammation and the administration of this vaccine, and especially after the administration of the second dose the condition appeared “likely”.

In the US, too, there have recently been increasing reports of myocardial inflammation following administration of mRNA vaccines. Younger men and teenage boys were also particularly affected. In 16- to 24-year-olds, there had been “a higher number of observed cases than expected”. In this regard, the US Centers for Disease Control and Prevention announced that they would call an “emergency meeting” of their advisors on June 18 to address the unexpectedly high number.

In Germany, however, the PEI announced that there was “no clear picture” of the possible connection citing insufficient data. So far 92 cases have been reported to the institute in which recently vaccinated people suffered from myocarditis and/or pericarditis, an inflammation of the pericardium. The majority of the reports relate to the same vaccine as in Israel and the USA, where mainly young men between the ages of 16 and 29 were affected.

“Unfortunately, no current age- and gender-stratified vaccination rates for general practitioners are currently available, so it cannot be calculated whether the number of reported cases of (peri) myocarditis in younger age groups is higher than would be expected statistically by chance in their age group.”

According to the PEI, many heart muscle inflammations also run without symptoms or with nonspecific symptoms, so there could be a corresponding number of unreported cases.

The regulatory tasks of the PEI include the marketing authorisation of particular groups of medicinal products and the approval of clinical trials. The medicinal products in the responsibility of the PEI are: vaccines for humans and animals, medicinal products containing antibodies, allergens for therapy and products for diagnostic tests, blood and blood products and tissue and medicinal products for gene therapy.

The agency also reported that thromboses related to platelet deficiency following the administration of AstraZeneca and Johnson&Johnson vaccines posed no “specific risk”. Incidentally, in South Africa, two million doses of the Johnson & Johnson product had to be discarded last week because a core component of the vaccine had been contaminated in a US factory.

The World Health Organization (WHO) is meanwhile also studying data on cases of inflammation of the heart muscle (myocarditis) after vaccination with the Pfizer product.

“We are overseeing this through a strategic vaccine safety advisory group. We’re still collecting data, but it looks like they are from the United States and there is some data from Israel as well. We are in a phase in which we are investigating whether myocarditis is a signal and a sign of vaccine exposure or whether it is a normal distribution in the population,” said the deputy director general of the WHO, Mariangela Simao, at a briefing on Monday.

Meanwhile, an investigative parliamentary committee set up at the request of the AfD opposition had invited the Berlin virologist Christian Drosten as an expert witness on Friday.

The AfD chairman in the committee of inquiry, Lars Hünich, said in an interview with reitschuster.de that he found it particularly noteworthy that Drosten admitted that in the vast majority of cases, “it was a mild illness”. A few hours later, the Brandenburg Minister of Health Ursula Nonnenmacher (Greens) claimed exactly the opposite before the same committee, saying that it was a serious illness.

“What we heard was absolutely exciting. You have to be honest. Even he [Drosten] said that the focus on the CT values would be imprecise or far too coarse, and that it would be better to make the viral load the decisive factor. And then at some point you have to ask the question: Why was this not implemented? Just this statement by Drosten and this knowledge was worth summoning in my eyes,” according to Hünich. Using CT values as a marker has given a totally skewed picture of the pandemic.

The AfD committee chairman concluded: “The fact that you can find almost nothing about these statements in the media does not surprise me, but I find it very regrettable. This day has shown once again the importance of such parliamentary inquiries. It’s a shame that there is either no or only very one-sided reporting in the media.”