COVID-19 Vaccines New

Product information of the licensed COVID-19 vaccines New

Comirnaty (mRNA-Vaccine) - BioNTech Pfizer New

Marketing authorisation holder: BioNTech

Date of marketing authorisation: 21 December 2020

On 8 January 2021, the Summary of Product Characteristics (SmPC) was updated in order to allow to extract 6 (instead of previously 5) doses per container.

On 30 March 2021, short-term storage at -25 °C to -15 °C was approved (see SmPC item 6.3).

On May 28, 2021, the indication was extended for active immunization of individuals 12 years of age and older.

The product information is updated by adding  “vaccine stress-related responses” to 4.4.and "extensive swelling of the vaccinated limb” and “facial swelling” to 4.8.

The shelf life at -90 °C to -60 °C was extended from 6 to 9 months (see SmPC item 6.3 and BASG Direct Healthcare Professional Communication of 20 Sept. 2021).

Procedural steps taken and scientific information after the authorisation.

Inclusion of several mild and rare adverse reactions in the product information.

For Summary of Product characteristics (Fachinformation) and Package leaflet (Gebrauchsinformation) see  

EPAR - Product information on Comirnaty, last updated  06.10.2021.

Spikevax (mRNA-Vaccine) - formerly Moderna New

Marketing authorisation holder: Moderna

Date of marketing authorisation: 06 January 2021

On 22 June 2021, the name was changed from Moderna to Spikevax Injection Suspension.

Extension of indication to include use in adolescents from 12 years of age for Spikevax.

A third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised.

Procedural steps taken and scientific information after the authorisation.

For Summary of Product characteristics (Fachinformation) and Package leaflet (Gebrauchsinformation) see  

EPAR - Product information on Spikevax, last updated 12.10.2021, available in all EU/EEA languages.

Vaxzevria (Adenovirus-Vaccine) - formerly AstraZeneca New

Marketing authorisation holder: AstraZeneca
Date of marketing authorisation: 29 January 2021

On 29 March 2021, the name was changed from AstraZeneca to Vaxzevria Injection Suspension.

For Summary of Product characteristics (Fachinformation) and Package leaflet (Gebrauchsinformation) see  

Amendment dated 18.06.2021: Shelf life of unopened vials includes the following unanticipated temperature deviations from storage in refrigerator (2°C - 8°C) for a single period of:

  • 12 hours not above 30°C
  •  72 hours not below -3°C

Warning is added in 4.4 of the SmPC regarding the possibility of presenting a Guillain -Barré Syndrome (GBS).

Changes concern SmPC item 4.4 and 4.8.

Recent study results led to the addition of the following adverse drug reactions in the product information: facial paralysis (rare) and muscle spasms (uncommon). See SmPC 4.8.

Sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PL have been updated to implement signal recommendations on Immune Thrombocytopenia (ITP).

Procedural steps taken and scientific information after the authorisation.

EPAR - Product information on Vaxzevria, last updated 20.10.2021, available in all EU/EEA languages.

Janssen (Adenovirus-Vaccine) - Johnson and Johnson New

Marketing authorisation holder: Janssen-Cilag
Date of marketing authorisation: 11. March 2021

The manufacturer Janssen-Cilag is a subsidiary of the US company Johnson and Johnson (J&J). Therefore, the vaccine is also called "Johnson and Johnson vaccine".

Warning is added in 4.4 of the SmPC regarding the possibility of presenting a Guillain -Barré Syndrome (GBS).

Update of section 4.8 of the SmPC.

Shelf life extension from 3 to 4.5 months when stored at 2 to 8°C.

Topics of the two updates are additional side effects: Venous thromboembolism (VTE) , immune thrombocytopenia (ITP) and dizziness.

Procedural steps taken and scientific information after the authorisation.

For Summary of Product characteristics (Fachinformation) and Package leaflet (Gebrauchsinformation) see  

EPAR - Product information on Janssen, last updated 13.10.2021, available in all EU/EEA languages.

Further information

Immunization recommendations of the Austrian National Vaccination Committee (NIG) see "Fachinformationen"

Information about authorised Covid-19 vaccines and those under evaluation can be found on the website of the European Medicines Agency (EMA) and on the website of the WHO.

 

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