Deaths After Pfizer COVID Vaccines Not Linked to Shots, Says European Medicines Agency

No link has been found between the Pfizer-BioNTech vaccine and several fatalities in Europe involving people who died after receiving a COVID-19 shot, regulators said Friday.

The finding was reported in the European Medicines Agency's (EMA) first safety update on the vaccine, which was authorized for emergency use in the European Union in December.

In the update, the EMA said its safety committee had assessed deaths reported after vaccination with the Pfizer-BioNTech shot, including those in frail and elderly people.

The Pharmacovigilance Risk Assessment Committee (PRAC) took into account the presence of other medical conditions and the death rate for the corresponding age groups in the general population.

The committee concluded that the data "did not show a link" to vaccination with the Pfizer-BioNTech shot and "the cases do not raise a safety concern. Further reports will continue to be carefully monitored."

The EMA report mentioned the deaths of more than 30 frail, elderly individuals in Norway—who died after they had received vaccines—that have garnered international media attention. Some anti-vaccination proponents have pointed to the deaths as evidence that the shot is harmful.

"In many cases concerning individuals above 65 years of age, progression of (multiple) pre-existing diseases seemed to be a plausible explanation for death. In some individuals, palliative care had already been initiated before vaccination," the EMA update said.

According to the EMA update, the safety data collected from the vaccination rollout in Europe is consistent with the known safety profile of the vaccine and no new side effects were identified.

Clinical trials involving thousands of people have shown that the most common side effects will not be experienced by all people, and are usually mild or moderate, lasting only a few days. But a small percentage of people may experience more severe side effects.

"The confirmed rate of all serious side effects for the SARS-CoV-2 vaccines are about 1 in 500,000 people inoculated, which is far better than the death rate for COVID-19, which is around 1 in 500 people in some United States cities," Irving Coy Allen, associate professor of immunology at Virginia Tech, told Newsweek.

Among the known severe side effects of the of the Pfizer-BioNTech vaccine is anaphylaxis—a severe, potentially life-threatening allergic reaction. According to the U.S. Centers of Disease Control and Prevention, around 11 cases per million may suffer anaphylaxis. The majority of people who have experienced these allergic reactions have a history of allergies.

While the EMA said it had not yet determined its own frequency estimate for anaphylaxis following vaccinations with the Pfizer-BioNTech shot, the agency did not identify anything new regarding this issue in its safety update.

"Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect," the EMA said. "No specific safety concern has been identified for vaccine use in frail elderly individuals. The benefits of [the Pfizer-BioNTech vaccine] in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes regarding the use the vaccine."

The EMA said it will continue to monitor the safety and effectiveness of the vaccine as more people across the world receive the shot.

"These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health, if needed," the EMA said.

In the case of fatalities that occur shortly after immunization, experts say it is important to be aware that these can occur by chance and are not necessarily evidence of cause and effect.

Kent Woods, former chief executive of the U.K. Medicines and Healthcare products Regulatory Agency, told Newsweek: "Two factors will tend to increase these chance associations. Firstly, vaccines are being given to millions of people. Secondly, vaccines are being given preferentially to the elderly and most frail in whom 'background' mortality risk is higher than the average for the population.

"But even in young people, a close time relationship between vaccination and sudden death does not constitute sound evidence of a causal connection."

In the case of the deaths in Norway, the country's Medicines Agency said it had investigated 13 of them—involving people living in nursing homes—as of January 18, and had not found evidence that the vaccine caused the fatalities.

Camilla Stoltenberg, the head of the agency, told a news conference: "These are people who are very old, are frail and have serious diseases."

The Norwegian Medicines Agency (NMA) said that every day, an average of 45 people die in Norwegian nursing homes or other similar institutions, and that when vaccinating such a group, deaths will "inevitably occur."

"The reports on many of these deaths state that no link with vaccination is suspected and that the event was due to an underlying illness suffered by the patient, but that the death is being reported for the sake of completeness," the NMA said. "However, in the case of some of the frailest patients, the possibility that relatively mild side effects of the vaccine could have serious consequences cannot be ruled out."

"The vast majority of those who have been vaccinated appear not to have suffered any adverse reaction to the vaccine," the NMA said.

Norwegian health authorities are carrying out an in-depth analysis of the deaths, the country's Institute of Public Health said on January 19.

"So far, there are no statistical analyses that indicate that coronavirus vaccination has had an increased risk of death among those vaccinated," Dr. Sara Viksmoen Watle, Senior Physician at the institute, said in a statement.

On January 8, the institute emphasized that severely frail patients or patients with a short remaining life expectancy should undergo an individual assessment to see whether or not the benefit of vaccination outweighs the risk, and to ensure they are healthy enough to tolerate potential side effects.