Janssen COVID-19 Vaccine authorised for use in EU
Posted: 12 March 2021 | Hannah Balfour (European Pharmaceutical Review) | 1 comment
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
The European Commission (EC) has granted conditional marketing authorisation (CMA) to the single-dose Janssen COVID-19 Vaccine to prevent COVID-19 in people from 18 years of age.
The CMA follows a positive opinion from the European Medicines Agency (EMA)’s committee for human medicinal products (CHMP), which concluded that the data on the vaccine was robust and met the criteria for efficacy, safety and quality.
Data included in the evaluation included that of the Phase III ENSEMBLE study, which showed that the vaccine was well tolerated and reduced cases of symptomatic disease by 67 percent in vaccinated individuals, compared to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied and protected against COVID-19 related hospitalisation and death 28 days after vaccination.
In the trial, the side effects of the Janssen COVID-19 Vaccine were usually mild or moderate and cleared within a couple of days after vaccination. The most common included pain at the injection site, headache, tiredness, muscle pain and nausea.
The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
Johnson & Johnson (Janssen Pharmaceutical’s parent company) revealed it is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company added that it aims to begin delivery of its COVID-19 vaccine to the EU in the second half of April and to supply 200 million doses to the EU Big Three (France, Germany and Italy) plus Norway and Iceland in 2021.
“This vaccine is the result of more than a decade of investment in research and development and deep commitment by our scientists. We appreciate the collaboration and the support of the European Commission in this monumental effort,” said Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “With this Conditional Marketing Authorisation, we are proud to bring our single-shot vaccine to help protect millions of people across EU member states.”
In addition to the EU approval, the Janssen COVID-19 Vaccine has Emergency Use Authorization (EUA) in the US and Interim Order authorisation in Canada. It has also been filed for an Emergency Use Listing (EUL) with the World Health Organization. Rolling submissions for the vaccine candidate have also been initiated in several countries worldwide.
Big Pharma, Biologics, Clinical Trials, Regulation & Legislation, Vaccines, Viruses
EMA's Committee for Medicinal Products for Human Use (CHMP), Janssen Pharmaceuticals, Johnson & Johnson (J&J), The European Commission (EC), The European Medicines Agency (EMA)
Ik wil heel graag de bijsluiter van het Jansen vaccin lezen.
Kunt u me daarmee aub helpen?