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Eu­ro­pean Com­mis­sion Grants Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion for No­vavax's COVID-19 Vac­cine Nu­vax­ovid

On 20 December 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the conditional marketing authorisation of the COVID-19 vaccine Nuvaxovid (NVX-CoV2373) from the US pharmaceutical company Novavax to the European Commission. The approval was granted by the European Commission on the same day. This is the approval of the first protein-based vaccine for the prevention of COVID-19 available in the European Union (EU) and the European Economic Area (EEA).

Novavax SARS-CoV-2 Vaccine (Source: Vladimkas production/shutterstock.com)

The CHMP experts at the EMA began their evaluation of the application for Conditional Marketing Authorisation (CMA) for the COVID-19 vaccine Nuvaxovid on 17 November 2021. A conditional marketing authorisation is a marketing authorisation that is subject to conditions. It is used to accelerate the use of therapeutic medicines and vaccines for unmet public health medical needs in the EU.

Novavax's COVID-19 vaccine, unlike previously licensed COVID-19 vaccines, is neither an mRNA nor a vector vaccine. Rather, it is a protein-based inactivated vaccine that contains the spike protein of the SARS-CoV-2 coronavirus and the active enhancer Matrix M, with which nanoparticles are formed.

Efficacy

The results of two large clinical trials involving more than 45,000 people show that Nuvaxovid effectively protects people aged 18 and older against COVID-19.

In the first trial, about two-thirds of the subjects received the vaccine, while the others received a placebo vaccine. It was shown that seven days after the second dose of Nuvaxovid there was a 90.4% reduction in the number of symptomatic COVID-19 cases (14 cases out of 17,312 people) compared to those given a placebo (63 out of 8,140 people).

In the second study, the groups of people receiving Nuvaxovid were equal to those receiving a placebo. This study also showed a reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared to people who received a placebo (96 out of 7,019 people). The efficacy of the COVID-19 vaccine in this study was 89.7%.

During the course of the trial, the original SARS-CoV-2 strain and variants of concern such as Alpha and Beta were the most common circulating viral strains. Currently, there is limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.

Safety

The most common side effects of Nuvaxovid experienced in the trials were generally mild or moderate. They improved within a few days after vaccination. The side effects included headache, nausea or vomiting, muscle and joint pain, tenderness and pain at the injection site, tiredness and malaise. More than 1 in 10 people were affected.

Redness and swelling at the injection site, fever, chills and aching limbs occurred in fewer than 1 in 10 people. Enlarged lymph nodes, high blood pressure, skin rash, skin redness, itching at the injection site and itchy skin rash were rare side effects (affecting fewer than 1 in 100 people).

Updated: 20.12.2021