Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

Sus­pect­ed Ad­verse Re­ac­tions Re­port­ed in the First Three Months since Start of Vac­ci­na­tion with Nu­vax­ovid

COVID-19 Vaccine Ampoules (Source: Thorsten Simon/Pixabay.com)

The protein vaccine Nuvaxovid from the manufacturer Novavax was authorised in the EU on 20 December 2021 for persons aged 18 years and over. It has been available in Germany since 25 February 2022. The vaccine consists of the recombinant spike protein of the original variant of SARS coronavirus 2 and the saponin-based adjuvant Matrix M. Nuvaxovid triggers both the production of neutralising antibodies and a T-cell response against the spike protein in the human organism. A complete primary vaccination course consists of two doses of vaccine administered intramuscularly three weeks apart.

The safety of Nuvaxovid was assessed for authorisation on the basis of an interim analysis of pooled data from five clinical trials (Australia, South Africa, United Kingdom, USA and Mexico). At the time of analysis, a total of 49,950 subjects aged 18 years and older had received at least one dose of Nuvaxovid (n= 30,058) or placebo (n=19,892). The median age was 48 years at time of vaccination (range 18–95 years). The median follow-up observation period was 70 days after the second dose.

In the pooled reactogenicity data that included participants aged 18 years and older who participated in the two phase III studies (United Kingdom and USA) and received a dose of Nuvaxovid (n=20,055) or placebo (n=10,561), the most common adverse reactions were sensitivity at the injection site (75%), pain at the injection site (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (15%).

The article "Nuvaxovid® – suspected adverse reactions reported in the first three months since the start of vaccination with this vaccine" (article in German only) summarises the current safety data from Germany.

Updated: 05.07.2022