The Pfizer/BioNTech coronavirus jab has no link to reported post-vaccination deaths and no new side effects, the EU's medicines regulator said Friday based on the first data from the vaccine's rollout.
The update by the Amsterdam-based European Medicines Agency followed reports that dozens of mainly elderly people had died in Norway and other European countries after receiving a first shot of the vaccine.
The EMA said it had looked at the deaths and "concluded that the data did not show a link to vaccination with Comirnaty (the vaccine) and the cases do not raise a safety concern."
In its first safety update since the EU started its vaccination campaign in December, the watchdog said that overall, data "is consistent with the known safety profile of the vaccine, and no new side effects were identified."
Reports of occasional severe allergic reactions did not go beyond what had already been found about this "known side effect", it added.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"The benefits of Comirnaty in preventing Covid-19 continue to outweigh any risks, and there are no recommended changes regarding the use of the vaccine," the EMA said.
The EU watchdog has so far approved two vaccines, by Pfizer/BioNTech and Moderna.
It is set to give its verdict on a third, by AstraZeneca, later Friday. Germany recommended on Thursday that the AstraZeneca vaccine should only be given to under-65s.
The frail and the elderly are first in line for vaccinations in many countries.
Norway in particular registered 33 deaths among some 20,000 retirement home residents who had received their first dose of the Pfizer-BioNTech vaccine.
Concern grew as a number of countries, including France and also Denmark, Finland, Iceland and Sweden, gave similar reports.
Oslo said earlier this month it had not established a link but recommended doctors consider the overall health of the most frail before giving them the jab.
The EMA said that "given concerns which arose from Norway" it had reviewed reports of deaths of people of any age after receiving the jab.
"In many cases concerning individuals above 65 years of age, progression of (multiple) pre-existing diseases seemed to be a plausible explanation for death," it said.
Some had already received palliative care, it said.
The EMA noted that clinical trials of the Pfizer vaccine had included people aged 75 and older.
But the watchdog said it had asked the company to keep "reviewing all reports of suspected side effects with fatal outcome thoroughly."Follow our full coverage of the coronavirus pandemic here.