Paul-Ehrlich-Institut

Coronavirus and COVID-19

Safety of COVID-19 Vaccines

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 continuously all suspected cases reported in Germany on adverse effects or vaccination complications in a temporal relationship with the COVID-19 vaccination.

Safety Report 27 December 2020 to 31 May 2021

The Paul-Ehrlich-Institut (PEI) reports on 79,106 suspected cases of side effects or vaccination complications reported from Germany in the temporal connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 vaccine Moderna (MODERNA BIOTECH SPAIN, SL ), the vector vaccines Vaxzevria (formerly: COVID-19 vaccine AstraZeneca; AstraZeneca AB) and COVID-19 vaccine Janssen to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 31 May 2021. According to the Robert Koch Institute, 50,541,084 vaccinations were carried out by May 31, 2021, of which 36,865,276 vaccinations with Comirnaty, 3,972,764 vaccinations with the COVID-19 vaccine Moderna, 9,230,103 vaccinations with Vaxzevria and 472,941 vaccinations with the COVID-19 vaccine Janssen. 34,735 suspected cases of vaccination with Comirnaty were reported, 8,319 suspected cases of the COVID-19 vaccine Moderna, 34,870 suspected cases of Vaxzevria and 733 reports of the COVID-19 vaccine Janssen. In 449 reported suspected cases, the COVID-19 vaccine was unspecified. The reporting rate for all vaccines together was 1.6 per 1,000 vaccine doses, for reports of serious reactions 0.2 per 1,000 vaccine doses in total.

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 31 May 2021) (German only)

Safety Report 27 December 2020 to 30 April 2021

The Paul-Ehrlich-Institut (PEI) reports 49,961 suspected cases of adverse reactions or vaccine complications reported from Germany in temporal association with vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 vaccine Moderna (MODERNA BIOTECH SPAIN, S. L.) and the vector vaccine Vaxzevria (formerly COVID-19 vaccine AstraZeneca; AstraZeneca AB) for protection against COVID-19 from the start of the vaccination campaign on 27 December 2020 through 30 April 2021. As of 29 April 2021, 28,774,580 vaccinations have been administered, including 21,329,667 vaccinations with Comirnaty, 1,667,261 vaccinations with COVID-19 Vaccine Moderna, 5,775,546 vaccinations with Vaxzevria, and 2,106 vaccinations with COVID-19 Vaccine Janssen, according to the Robert Koch Institute. 20,160 suspected cases were reported for vaccination with Comirnaty, 3,073 suspected cases were reported for COVID-19 Vaccine Moderna, 26,206 suspected cases were reported for Vaxzevria, and three reports were reported for COVID-19.Vaccine Janssen. In 519 reported suspected cases, the COVID-19 vaccine was not specified. The reporting rate was 1.7 per 1,000 vaccine doses for all vaccines combined and 0.2 per 1,000 vaccine doses total for reports of serious reactions.

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 30 April 2021) (German only)

Safety Report 27 December 2020 to 2 April 2021

The Paul-Ehrlich-Institut (PEI) reports on 31,149 suspected cases of side effects or vaccination complications reported from Germany in connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 vaccine Moderna (MODERNA BIOTECH SPAIN, SL ) and the vector vaccine Vaxzevria (formerly: COVID-19 vaccine AstraZeneca; AstraZeneca AB) to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 2 April 2021. According to the Robert Koch Institute, 14,381,068 vaccinations were carried out by 2 April 2021, of which 10,722,876 vaccinations with Comirnaty, 713,067 vaccinations with the COVID-19 vaccine Moderna and 2,945,125 vaccinations with Vaxzevria. 12,409 suspected cases of vaccination with Comirnaty were reported, 1,139 suspected cases of the COVID-19 vaccine Moderna, 17,170 suspected cases of Vaxzevria and in 431 reported suspected cases the COVID-19 vaccine was unspecified. The reporting rate for the three vaccines together was 2.2 per 1,000 vaccine doses, and for reports of serious reactions 0.2 per 1,000 vaccine doses in total.

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 2 April 2021) (German only)

Safety Report 27 December 2020 to 12 March 2021

The Paul-Ehrlich-Institut (PEI) reports on 19,194 suspected cases of side effects or vaccination complications reported from Germany in connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 Vaccine Moderna (MODERNA BIOTECH SPAIN, SL) and the vector vaccine COVID-19 Vaccine AstraZeneca (AstraZeneca AB) to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 12 March 2021. According to the Robert Koch Institute, 8,863,270 vaccinations had been carried out by 12 March 2021, of which 7,093,082 vaccinations with Comirnaty, 298,788 vaccinations with the COVID-19 vaccine Moderna and 1,471,400 vaccinations with the COVID-19 vaccine AstraZeneca . 10,498 cases were reported for vaccination with Comirnaty, 736 cases for the COVID-19 vaccine Moderna, 7,663 cases for the COVID-19 vaccine AstraZeneca and in 297 cases the COVID-19 vaccine was unspecified. The reporting rate for the three vaccines together was 2.2 per 1,000 vaccine doses, and for reports of serious reactions 0.3 per 1,000 vaccine doses in total.

Due to current events, reports of sinus vein thrombosis up to 19 March 2021 were included in this safety report.

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 12 March 2021) (German only)

Safety Report 27 December 2020 to 26 February 2021

The Paul-Ehrlich-Institut (PEI) reports on 11,915 suspected cases of side effects or vaccination complications reported from Germany in connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 Vaccine Moderna (MODERNA BIOTECH SPAIN, SL) and the vector vaccine COVID-19 Vaccine AstraZeneca (AstraZeneca AB) to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 26 February 2021. According to the Robert Koch Institute, 5,910,537 vaccinations had been carried out by 26 February 2021, of which 5,378,703 vaccinations with Comirnaty, 168,189 vaccinations with the COVID-19 vaccine Moderna and 363,645 vaccinations with the COVID-19 vaccine AstraZeneca. 8,368 cases were reported for vaccination with Comirnaty, 484 cases for the COVID-19 vaccine Moderna, 2,765 cases for the COVID-19 vaccine AstraZeneca and in 298 cases the COVID-19 vaccine was unspecified. 16.8% of the reports were classified as serious and 83.2% as non-serious. The reporting rate for the three vaccines combined was 2.0 per 1,000 vaccine doses.

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 26 February 2021) (German only)

Safety Report 27 December 2020 to 12 February 2021

The Paul-Ehrlich-Institut (PEI) reports on 7,690 suspected cases of side effects or vaccination complications reported from Germany in the temporal connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 Vaccine Moderna (MODERNA BIOTECH SPAIN, SL) and COVID-19 Vaccine AstraZeneca (AstraZeneca AB) to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 12 February 2021. According to the Robert Koch Institute, 3,967,246 vaccinations had been carried out by February 12, 2021, of which 3,848,994 vaccinations with Comirnaty, 86,967 vaccinations with the COVID-19 vaccine Moderna and 31,285 vaccinations with the COVID-19 vaccine AstraZeneca. 7,277 cases were reported for vaccination with Comirnaty, 258 cases for the COVID-19 vaccine Moderna, 20 cases for the COVID-19 vaccine AstraZeneca and in 135 cases the COVID-19 vaccine was unspecified. Serious reactions were reported in 1,178 cases, 1,072 cases after vaccination with Comirnaty, in 41 cases after vaccination with the COVID-19 vaccine Moderna and in 11 cases after vaccination with the COVID-19 vaccine AstraZeneca. In 63 cases with severe reactions, the name of the vaccine was not given. The reporting rate for the three vaccines together was 1.9 per 1,000 vaccine doses, and for reports of serious reactions 0.3 per 1,000 vaccine doses in total.

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 12 February 2021) (German only)

Safety Report 27 December 2020 to 31 January 2021

The Paul-Ehrlich-Institut (PEI) reports on 2,846 reported suspected cases of side effects or vaccination complications in connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH) and COVID-19 Vaccine Moderna (MODERNA BIOTECH SPAIN, SL) for protection before COVID-19 since the start of the vaccination campaign on 27 December 2020 until 31 January 2021 from Germany. According to the Robert Koch Institute, 2,467,918 vaccinations had been carried out by January 31, 2021, of which 2,432,766 were vaccinated with Comirnaty and 35,152 with the COVID-19 vaccine Moderna. 2,717 cases were reported for vaccination with Comirnaty, 80 cases for the COVID-19 vaccine Moderna and in 49 cases the COVID-19 vaccine was unspecified. Serious reactions were reported in 349 cases, in 337 cases after vaccination with Comirnaty and in one case after vaccination with the COVID-19 vaccine Moderna. In eleven cases with severe reactions, the name of the vaccine was not given. The reporting rate for all individual reports was 1.15 per 1,000 vaccine doses, for serious cases 0.14 per 1,000 vaccine doses in total. The reporting rates for reports after vaccination with Comirnaty were 1.12 per 1,000 vaccinations and for severe cases 0.14 per 1,000 vaccinations. The reporting rates for vaccination with the COVID-19 vaccine Moderna were 2.28 reports for 1,000 vaccinations, one of which was rated as serious.

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 31 January 2021) (German only)

Safety Report 27 December 2020 to 24 January 2021

The Paul-Ehrlich-Institut (PEI) reports on 1232 reported suspected cases of side effects or vaccination complications in connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH) and COVID-19 Vaccine Moderna (MODERNA BIOTECH SPAIN, SL) for protection before COVID-19 since the start of the vaccination campaign on 27 December 2020 until 24 January 2021 from Germany. According to the Robert Koch Institute, 1,783,118 vaccinations had been carried out by 24 January 2021. There were 3,404 adverse reactions described (on average 2.8 reactions per report). 1,211 cases were reported for vaccination with Comirnaty, 17 cases for Moderna's COVID-19 vaccine and in four cases the COVID-19 vaccine was unspecified. Serious reactions were reported in 182 cases, 181 cases after vaccination with Comirnaty and in one case after vaccination with Moderna's COVID-19 vaccine. The reporting rate for all individual reports was 0.7 per 1,000 vaccine doses, for serious cases 0.1 per 1,000 vaccine doses in total. The reporting rates for reports after vaccination with Comirnaty were 0.7 per 1,000 vaccinations and, for serious cases, 0.1 per 1,000 vaccinations. The reporting rates for vaccination with the COVID-19 vaccine from Moderna were 0.8 reports for 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 24 January 2021) (German only)

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

The 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 app to contribute actively to this observational study.

Reporting 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

Content

  1. Role of the Paul-Ehrlich-Institut
  2. COVID-19 Vaccines
  3. Proof of Vaccination as Defined in the COVID-19 Protective Measures Exemption Directive and the Directive on Coronavirus Entry Regulations
  4. FAQ Coronavirus
  5. Biomedicines
  6. Safety of COVID-19 Vaccines
  7. Research Work
  8. SARS-CoV-2 Test Systems