In Germany, the Paul-Ehrlich-Institut is the authority responsible for monitoring the safety of vaccines and biomedicines. For this purpose, the institute’s Division Pharmacovigilance collects and reviews reports on adverse drug effects and takes the necessary steps if required.
Reporting suspected cases of adverse effects is a central pillar for being able to judge the safety of medicines. Thus, new signals can be detected in a timely manner, and the risk/benefit profile of vaccines can be continuously monitored. In this context, it must be noted that even reactions with a timely relation to a vaccine do not necessarily have a causal relation.
Safety Reports
Open communication of risks, including potential ones, is a prerequisite for a high acceptance rate for vaccines among the population. The benefit of the COVID-19 vaccination for the health of individuals and the population as well as their effect in combating the pandemic essentially depends on the confidence in the vaccination.
To meet this requirement, the Paul-Ehrlich-Institut publishes all suspected cases reported in Germany on adverse effects or vaccination complications in a temporal relationship with the COVID-19 vaccination within the appropriate period of time.
Safety Report 27 December 2020 to 17 January 2021
According to the Robert Koch Institute, 1,139,297 people had been vaccinated by 17 January 2021. Of these, 1,136,573 people were vaccinated with Comirnaty (BioNTech) and 2,724 people with Moderna’s COVID-19 vaccine. Of the 1,139,297 people vaccinated, 6,581 people have already received the second vaccination (as of 18 January 2021).
The Paul-Ehrlich-Institut reports on 645 reported cases of suspected side effects or vaccination complications from Germany in connection with the vaccination with the mRNA vaccine Comirnaty (BioNTech Manufacturing GmbH) for protection against COVID-19 from the start of the vaccination campaign until 17 January 2021 in Germany. 2,629 adverse reactions were reported (an average of four reactions per report).
Serious reactions were reported in 145 cases. After receiving the COVID-19 vaccine from Moderna, eleven non-serious reactions were reported in two cases during the reporting period. The reporting rate for all individual reports was 0.57 per 1,000 vaccination doses, for serious cases 0.13 per 1,000 vaccination doses of Comirnaty.
Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 December 2020 to 17 January 2021) (German only)
Safety Report 27 December 2020 to 10 January 2021
The Paul-Ehrlich-Institut has reported on 325 recorded cases of suspected adverse effects or vaccination complications in connection with the vaccination with the mRNA vaccine Comirnaty (BioNTech Manufacturing GmbH) for protection against COVID-19, which it received from Germany from the start of the vaccination campaign until 10 January 2021.
913 adverse reactions were reported (on average 2.8 reactions per report). In 51 cases, serious reactions were reported. The reporting rate for all individual reports was 0.53 per 1,000 vaccinations, for serious cases 0.08 per 1,000 vaccinations.
Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 December 2020 to 10 January 2021) (German only)
Safety Report 27 to 31 December 2020
he Paul-Ehrlich-Institut has reported on 34 recorded cases of adverse effects or vaccination complications in a temporal connection with the vaccination with the mRNA vaccine Comirnaty Comirnaty (BioNTech Manufacturing GmbH) for the protection against COVID-19, which it received from Germany within the period from 27 December 2020 to 31 December 2020.
Ninety adverse reactions were described the mean figure was 2.7 reactions per report). In six cases, serious adverse reactions were reported. The reporting rate was 0.25 per 1,000 vaccinations for all reports of single cases and 0.046 per 1,0000 vaccinations for serious adverse events.
Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 to 31 December 2020) (German only)
Safety Studies
In addition to the observation of adverse effects on the basis of incoming reports of suspected cases – the so-called spontaneous recording process of adverse effects – the Paul-Ehrlich-Institut is committed to active pharmacovigilance studies for a high safety standard for vaccinations.
SafeVac 2.0
The Paul-Ehrlich-Institut has developed a smartphone app called SafeVac 2.0 to gain further insights into the tolerability of COVID-19 vaccines. All persons vaccinated are invited to use the ap to contribute actively to this observational study.
SafeVac 2.0 – Smartphone App to Survey Tolerability of COVID-19 VaccinesReporting Portal for Suspected Cases of Adverse Effects
The Paul-Ehrlich-Institut accepts reports of suspected cases of adverse effects after vaccinations from healthcare providers, the marketing authorisation holder, and persons vaccinated as well as their relatives.
Online-Reporting of Side Effects – www.nebenwirkungen.bund.de https://nebenwirkungen.bund.de/nw/EN/home/home_node.html
Corona Vaccination in Individuals Suffering from Allergies
https://www.pei.de/EN/newsroom/positions/covid-19-vaccines/positions-corona-vaccination-allergies.html;jsessionid=DDCAC779EE90243527EA44B9BFBAD632.intranet241?nn=164146
PEI – Updated: 21.01.2021 photo Source: CDC/Alissa Eckert, MS; Dan Higgins, MAMS