Vaccines

(Last update August 2022)

This page presents the current knowledge on COVID-19 vaccines, available evidence and epidemiological context as of August 2022. Due to the changing epidemiological situation in the EU/EEA, we recommend regularly checking ECDC’s homepage for any new information on variants of concern and COVID-19 vaccines.

Availability of COVID-19 vaccines in the EU/EEA

As of August 2022, six COVID-19 vaccines have received conditional marketing authorisation in the EU/EEA, following evaluation by the European Medicines Agency (EMA), and are part of the EU Coronavirus Vaccines Strategy Portfolio: Comirnaty (BNT162b2) by BioNTech and Pfizer, Spikevax (mRNA-1273) by Moderna, Vaxzevria (AZD1222) by AstraZeneca, Jcovden by Janssen (Ad26.COV 2.5), Nuvaxovid (NVX-CoV2373) by Novavax, and COVID-19 Vaccine (inactivated, adjuvanted) Valneva by Valneva Austria GmbH. There are marketing authorisation applications submitted by Vidprevtyn (Sanofi Pasteur). COVID-19 vaccine product-specific information can be found on EMA’s webpage COVID-19 Vaccines.

EMA has initiated rolling reviews for the following COVID‑19 vaccines: Sputnik V (Gam-COVID-Vac) by Gamaleya, COVID-19 Vaccine (Vero Cell) Inactivated by Sinovac Life Sciences, and COVID-19 Vaccine HIPRA (PHH-1V) by HIPRA Human Health S.L.U. [1]. Information on the vaccine roll-out, including information on the number of vaccine doses distributed to countries by the manufacturers and the number of doses administered to individuals by age group/other priority groups is displayed by the COVID-19 vaccine tracker on ECDC’s website.

Updated COVID-19 vaccines

Monovalent Omicron BA.1 vaccines and bivalent Omicron BA.1 and original strain vaccines from both Pfizer/BioNTech and Moderna are currently being assessed by EMA. Following a recent statement by the United States’ Food and Drug Administration, vaccines incorporating BA.4/5 are also expected to be developed [2]. On 15 June 2022, EMA started a rolling review of an Omicron-adapted Comirnaty COVID-19 vaccine, and on 17 June 2022 started a rolling review for a bivalent Spikevax COVID-19 vaccine adapted to provide better protection against two strains of SARS-CoV-2, the original strain and the BA.1 Omicron variant. Preliminary data indicate that adapted mRNA vaccines, which incorporate an Omicron variant strain, can increase and extend protection when used as a booster [3]. In addition, according to emerging data a bivalent mRNA vaccine targeting two strains of SARS-CoV-2, one of which should be an Omicron strain, may provide some advantages in widening the immune response [3].

Effectiveness and duration of protection by EU/EEA authorised COVID-19 vaccines against outcomes due to the Omicron variant

The body of evidence regarding vaccine effectiveness (VE) against different outcomes due to the dominant variant Omicron continues to grow. Data suggest that the studied vaccines do not perform as well against outcomes from Omicron compared to the Delta variant.

The available scientific evidence on VE by severity of disease (mild/moderate, severe, hospitalisation, death) and duration of protection due to the dominant Omicron variant has been recently reviewed and can be found in ECDC’s published technical reports:

In summary, studies conducted during the period when the Omicron subvariants BA.1 and BA.2 were dominant have found that VE against infection with the Omicron variant wanes over time, starting from around two to three months after completing the primary series. Similarly, the effectiveness against documented infection wanes after the administration of a first mRNA vaccine booster dose, from estimates within the range of 45−66% in the first three months to around 25−45% between three to six months after the booster dose. Studies suggest that booster doses in general have a modest effect and limited duration in preventing Omicron transmission in the population.

Published literature indicates that VE against severe outcomes caused by Omicron remains high, including among older age groups, with continued strong protection generally at around 80−90% around two to three months after receiving the first booster. Results of studies with a follow-up period of three to six months after the first booster dose are heterogenous, but generally show a gradual decrease in effectiveness against severe COVID-19 outcomes (VE estimates in the range of 53−100%). The available studies indicate that a first booster dose provides strong protection against severe disease in all the investigated age groups, and there are no clear signs of a more rapid waning in elderly groups. Studies have found that a second mRNA booster dose restores VE against severe disease, which remains stable for up to 10 weeks, but longer follow-up times are not yet available.

Duration of immunity is a complex issue and, to date, the correlation between measured immunity (e.g. levels of antibodies) and clinical protection from SARS-CoV-2 infection has yet to be established. The presence of memory T-cells could prevent severe disease in infected individuals for a long period of time, although the durability of these cells and role in protecting from infection (and onward transmission) remains unclear.

At present, only limited data are available on VE against different clinical outcomes for Omicron sub-lineages BA.4 and BA.5.A. Analysis from Portugal suggests that the VE may be reduced against infection with BA.5 as compared to infection with BA.2, but maintained for severe outcomes, similar to data from South Africa indicating that high VE against severe disease has been maintained during the BA.4/BA.5 dominant period [6,7].

Due to the changing epidemiological situation in the EU/EEA, we recommend regularly checking ECDC’s homepage for any new information relating to variants of concern and COVID-19 vaccines.

COVID-19 vaccine safety

The six EU/EEA-authorised COVID-19 vaccines all showed a very good safety profile in clinical trials before receiving recommendations of approval from EMA. Since licensing, EMA, other regulatory agencies and international bodies have been continuously monitoring the post-authorisation safety of COVID-19 vaccines.

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has reviewed several safety events and adapted product information accordingly. Despite the occurrence of rare adverse events, the overall benefits of authorised COVID-19 vaccines in preventing COVID-19 outweigh the risks of side effects [1].