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

The EMA Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use Rec­om­mends the Au­tho­ri­sa­tion of No­vavax’s COVID-19 Vac­cine Nu­vax­ovid for Ado­les­cents Aged 12 to 17 Years

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended on 23 June 2022 that the indication for the protein-based COVID-19 vaccine Nuvaxovid be extended to adolescents aged 12 to 17 years. The current authorisation covers adults aged 18 and over.

Vaccination (Source: Gustavo/pixabay.com)

Authorisation Study Follows the Paediatric Investigation Plan (PIP)

Participants in the main study evaluating the efficacy of the vaccine Nuvaxovid in adults included young adults aged 18 to 25 years. The study in adolescents aged 12 to 17 years showed that the immune response to Nuvaxovid (immunogenicity) was comparable to that of young adults aged 18 to 25 years. The immune response was measured by the formation of antibodies against SARS-CoV-2.

The study was conducted at a time when the SARS-CoV-2 Delta variant was predominant. The study showed an efficacy of almost 80% in terms of protection against COVID-19 disease: six of the 1,205 adolescents who received full primary vaccination with Nuvaxovid developed COVID-19 compared to 14 of the 594 adolescents who received a placebo (sham injection). The CHMP is of the opinion that these results are consistent with those in adults.

Most Common Side Effects Are Similar to Those Seen in Adults

The most common typical and generally transient side effects of the vaccine in adolescents were largely comparable to those seen in people over 18 years of age. These include sensitivity, pain, redness and swelling at the injection site, headache, muscle and joint pain, fatigue, general discomfort, nausea or vomiting, and fever.

Fever occurred more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days of vaccination.

The CHMP decided that Nuvaxovid's benefits are greater than its risks in adolescents aged 12 to 17 years.

How does Nuvaxovid work?

Nuvaxovid is called a protein-based vaccine because it contains a version of the genetically engineered surface protein of SARS-CoV-2, the spike protein. Nuvaxovid contains an adjuvant (matrix M) in order to maximise its effect and it is given as two injections three weeks apart, usually into the upper arm muscle.

Updated: 24.06.2022