The European Medicines Agency (EMA) has recommended the approval of the Janssen (Johnson & Johnson) single-dose vaccine for COVID-19, providing a significant boost to vaccination efforts across the European Union. This decision arrives as the company informed EU legislators of potential delivery delays until mid-April. The Janssen vaccine is the fourth to be approved by the EU regulator, following those from Pfizer/BioNTech, AstraZeneca/Oxford University, and Moderna.
The EMA's human medicines committee (CHMP) concluded that the vaccine's data were robust, meeting the criteria for efficacy, safety, and quality. EMA Executive Director Emer Cooke stated that this approval provides authorities across the European Union with another crucial tool to combat the pandemic and protect public health.
A clinical trial involving over 44,000 participants across the US, South Africa, and Latin American countries demonstrated an efficacy rate of 67 percent. The trial assessed the vaccine's ability to prevent moderate to severe COVID-19, showing a significant reduction in symptomatic disease among vaccinated individuals.
The EMA reported that side effects were generally mild or moderate and resolved within two days post-vaccination. The most common side effects included pain at the injection site, headache, fatigue, and muscle pain. These findings align with safety data from other approved COVID-19 vaccines, reinforcing the overall favorable safety profile.
The EU's contract with Janssen, signed in October 2020, enables member countries to purchase 200 million doses, with an option to acquire an additional 200 million doses. This agreement is poised to significantly enhance the EU's vaccine supply and accelerate immunization campaigns across the continent.
