The federal agency for medicines and health products (FAMHP) has started an enquiry into the case of an 82-year-old man who died five days after receiving the first dose of vaccination against Covid-19.
The man, a care home resident who was among the first wave of people to receive the Pfizer-BioNTech vaccine, which requires two doses administered 21 days apart to be fully effective. The man had pre-existing medical problems.
According to the agency, an enquiry will now be carried out to discover if there was a direct link between the vaccination and the man’s death.
“In the vulnerable target group which is currently being vaccinated, we must take into account the appearance of serious health problems and death, regardless of vaccination,” the agency said in a statement. “Further analysis is essential to determine whether vaccination played a role in this death.”
During the period from 28 December and 12 January, a total of 34,979 doses of the Pfizer vaccine were administered in Belgium, according to the federal government’s coronavirus commission. During that period, there were ten reports of possible side-effects, one of which was described as ‘worrying’ as it included dizziness, raised blood pressure, muscular spasms and chest pain. The symptoms disappeared after several hours.
According to one expert, Pierre Van Damme of the university of Antwerp, the fatality is no cause for panic.
“We are talking about the most vulnerable part of the population now getting the vaccines. Then it is logical that someone dies during that period. The fact that there will be an investigation allows us to be absolutely certain that the vaccine itself was not the cause of death. Based on the facts, I also consider it very unlikely that would be the case. There is no need to panic about the vaccines.”
Nonetheless, a fatality so early in the vaccination campaign risks raising doubts over the safety of vaccines, particularly as they were developed at unprecedented speed.
“The speed is due to the high priority given to the vaccines,” Geert Leroux-Roels, professor emeritus in vaccinology at the university of Ghent told De Standaard.
“On a weekly basis, the findings on the safety of candidate vaccines are discussed with a team of doctors from the companies that commission the studies we conduct. Such a high intensity of follow-up in vaccine development is unprecedented,” he said.