The EMA issued a positive opinion on the vaccine this morning, followed by ratification by the European Commission. The EU has ordered 200 million doses of the vaccine: enough for 200 million people.
While the vaccine has been authorized for people aged 18+, the EMA and Janssen are also working on plans to conduct trials ‘from birth to less than 18 years of age’. These studies will also explore a two dose regimen.
The vaccine received its first authorization last month in the US.
Fourth EU vaccine
The J&J vaccine will become the fourth COVID-19 vaccine to be authorized across the 27 Member States: following Pfizer in December, and Moderna and AstraZeneca in January. J&J’s vaccine, however, differs from other authorized vaccines in that it is a one-dose regimen.
“After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality,” says the EMA.
In the EU, a CMA is the fast-track authorisation procedure to speed up approval of treatments and vaccines for public health emergencies.
A CMA guarantees that the approved medicine or vaccine meets rigorous EU standards for efficacy, safety and quality and is manufactured in approved, certified facilities in line with high pharmaceutical standards for large-scale production.
Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.
The vaccine
The Ad26.COV2.S vaccine is manufactured using adenovirus type 26 (Ad26): which delivers a piece of the DNA used to make the “spike” protein of the SARS-CoV-2 virus.
It is based on Janssen’s Ad26 vector platform, which is already used with other vaccines (the Ad26.ZEBOV/MVA-BN-Filo Ebola vaccine was approved by the European Medicines Agency in July; while investigational vaccines are being developed against Zika, filovirus, HIV, HPV, malaria, and respiratory syncytial virus).
The vaccine was found to be 67% effective at reducing moderate to severe COVID-19 cases in a global Phase 3 trial. This included a cohort in South Africa, allowing the company to also determine the vaccine is 52% effective against the B.1.351 strain.
As a one-shot vaccine, it has the potential to offer a logistical advantage and help vaccinate more people more quickly.
The vaccine can be stored at refrigerated temperatures for up to 3 months.