Danish cohort study finds negative effectiveness of mRNA vaccines against Omicron 90 days after 2 injections

20 dec 2021

The UK is reporting a similar “negative effectiveness” with the AstraZenaca vaccine.

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Christian Holm Hansen, Astrid Blicher Schelde, Ida Rask Moustsen-Helm, Hanne-Dorthe Emborg, Tyra Grove Krause, Kåre Mølbak, Palle Valentiner-Branth doi:

https://doi.org/10.1101/2021.12.20.21267966

This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

ABSTRACT

In this brief communication we are showing original research results with early estimates from Danish nationwide databases of vaccine effectiveness (VE) against the novel SARS-CoV-2 Omicron variant (B.1.1.529) up to five months after a primary vaccination series with the BNT162b2 or mRNA-1273 vaccines.

Our study provides evidence of protection against infection with the Omicron variant after completion of a primary vaccination series with the BNT162b2 or mRNA-1273 vaccines; in particular, we found a VE against the Omicron variant of 55.2% (95% confidence interval (CI): 23.5 to 73.7%) and 36.7% (95% CI: 69.9 to 76.4%) for the BNT162b2 and mRNA-1273 vaccines, respectively, in the first month after primary vaccination. However, the VE is significantly lower than that against Delta infection and declines rapidly over just a few months. The VE is re-established upon revaccination with the BNT162b2 vaccine (54.6%, 95% CI: 30.4 to 70.4%).

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

We used only administrative register data for the study. According to Danish law, ethics approval is exempt for such research, and the Danish Data Protection Agency, which is a dedicated ethics and legal oversight body, thus waives ethical approval for our study of administrative register data, when no individual contact of participants is necessary and only aggregate results are included as findings. The study is therefore fully compliant with all legal and ethical requirements and there are no further processes available regarding such studies.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv

https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v2

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