Coronavirus: EMA says no specific safety concerns over Pfizer jab after Norway deaths

No specific safety concern has been identified for use of the Pfizer/BioNTech coronavirus vaccine in frail elderly individuals, the European Medicines Agency (EMA) said on Friday, days after reports of deaths in Norway.

Announcing the results of a Europe-wide review by its safety committee (Pharmacovigilance Risk Assessment Committee (PRAC), EMA said that there was no link between the jab and the deaths of elderly vaccinated people.

The review also found no new side effects as the vaccine has been rolled out.

EMA’s safety panel analysed deaths in light of other medical conditions the people had, as well as the fatality rate for corresponding age groups in the general population.

“Given concerns which arose from Norway about deaths reported in frail elderly individuals after vaccination with Comirnaty, PRAC reviewed the current reports of suspected side effects with fatal outcome in individuals of any age. This review did not suggest a safety concern,” it said.

Norwegian authorities had earlier also said there was no evidence of a causal link, and that Covid-19 is more dangerous to most patients than vaccination.

“No specific safety concern has been identified for vaccine use in frail elderly individuals.  The benefits of Comirnaty in preventing Covid-19 continue to outweigh any risks, and there are no recommended changes regarding the use the vaccine,” EMA said.

The safety updates provide the outcomes of the assessment of emerging data since marketing authorisation for Covid-19 vaccines.

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.

Meanwhile, EMA’s human medicines committee (CHMP) updated the product information for the Pfizer vaccine to clarify its position on the interval between the first and second dose.

The product information (section 4.2 and package leaflet) now recommends the administration of the second dose three weeks after the first dose. Previously, the product information stated that the interval should be “at least 21 days”.

The product information (section 5.1) already states that the participants whose data was used to calculate efficacy received their second dose within 19 to 42 days after their first dose. A sentence has been added with the information that 93.1% of these participants received the second dose 19 to 23 days after the first dose.

There are currently no clinical data on the efficacy of the vaccine when administered beyond intervals used in the clinical trial.

Amid a worldwide shortage of vaccines, some countries including the UK have opted to vaccinate more people with the first dose so as to give them some basic protection, rather than to hold back the second dose for a repeat jab in three weeks.

Cyprus has been holding back the second dose to administer three weeks after the first.