The US drug agency is concerned about a possible increased risk of heart muscle inflammation that could emanate from the Corona vaccine Novavax.
The protein-based Novavax vaccine has already been approved in numerous European countries, including Germany. The authorities originally hoped to be able to convince people who were skeptical about vaccination. The US Food and Drug Administration (FDA) is now raising concerns about the possible risk of heart muscle inflammation with the Novavax vaccine. “The identification of multiple cases that may be associated with the vaccine is cause for concern,” the FDA said on Friday. Accordingly, the risk of so-called myocarditis could be higher with Novavax than with the mRNA vaccines from Biontech/Pfizer and Moderna.
The protein-based Novavax vaccine has already been approved in numerous European countries, including Germany. The authorities originally hoped to be able to convince people who were skeptical about vaccination. The FDA has now published an analysis of data from the clinical trials of the Novavax vaccine. According to this, six cases of heart muscle inflammation occurred in test persons who received the vaccine. In the group that received only a placebo, there was only one case. A total of 40,000 people took part in the studies.
Expert committee to assess risk of Novavax vaccine
The mRNA vaccines from Biontech/Pfizer and Moderna were also found to have a low risk of myocarditis, especially in young men – but not during the clinical trials before approval, but only afterwards, as the FDA emphasized. An independent FDA committee of experts is scheduled to meet Tuesday and assess the risk of the Novavax vaccine for approval. After Friday’s announcement, the US manufacturer’s shares fell by 20 percent. However, the company stated: “We believe that there is insufficient evidence to establish a causal relationship between the cases of myocarditis and the vaccine.”
The Novavax vaccine was approved in the EU in December, has been recommended in Germany by the Standing Vaccination Committee (Stiko) since February and is intended to expand the range of vaccines used. It is the first protein-based vaccine. The hope was that Novavax would encourage people who had reservations about the mRNA vaccines that had previously prevailed to be vaccinated. However, demand for the vaccine remained low.
Unlike the Corona vaccine from Biontech/Pfizer, for example, the Novavax vaccine can be stored at refrigerator temperature. This simplifies logistics and also makes the drug interesting for poorer countries. So far, five corona vaccines have been approved in the EU: the vaccines from Biontech/Pfizer and Moderna, which are based on the new mRNA technology, the vector vaccines from Johnson