The European Union’s medicines regulator has recommended conditionally approving Johnson & Johnson’s (J&J) single-dose coronavirus vaccine, a move which paves the way for the bloc to use a fourth licensed vaccine to curb the pandemic.
The European Medicines Agency (EMA) said on Thursday it was recommending that the vaccine should be authorised “after a thorough evaluation” of J&J’s data found it met the criteria for efficacy, safety and quality.
The United States, Canada and Bahrain have also approved the US company’s shot. South Africa is carrying out an expedited review.
“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s executive director.
The EMA has already greenlighted vaccines produced by Pfizer-BioNTech, AstraZeneca-Oxford University and Moderna. Three other vaccines are also under “rolling review” by the Amsterdam-based body – Novavax, CureVac and Russia’s Sputnik.
In J&J’s 44,000-person global trial, the vaccine was found to be 67 percent effective two weeks after inoculation, the EMA said.
Though many rival shots have reported a higher protection rate, direct comparison between headline numbers is difficult because their trials had different goals, and J&J’s study was conducted while new, more contagious variants of the virus were circulating.
Its vaccine delivers immunity-building proteins through a weakened version of a common cold virus, similar to AstraZeneca’s shot.
J&J has also used the technology in its EU-approved Ebola vaccine.
EU conditional marketing authorisation allows a treatment to be sold for a year without full data on its efficacy and side-effects being available.
Final approval by the European Commission is expected soon.
J&J chief scientific officer Paul Stoffels described the EMA’s decision as a “landmark moment” as the world struggles to control the pandemic, which has crushed economies and killed more than 2.7 million globally.
The shot, called COVID Vaccine Janssen after the J&J unit that developed it, is hoped to support the EU, where delivery delays from Pfizer and AstraZeneca have harmed supply.
J&J has agreed to deliver at least 200 million doses to the EU this year, including 55 million in the second quarter, with the first shipments expected next month.
Europe is having difficulty taming the virus as a more contagious variant first identified in the United Kingdom rips through the continent.
Italy and France have imposed fresh lockdowns.
Europe ranks far behind countries including Israel, Britain, Chile and the United States in the race to roll out vaccines.
For the first time in six weeks, new cases rose across Europe last week – by 9 percent.
The World Health Organization’s European office blamed that surge partly on virus variants, including the one first recorded in the UK, which is believed to be about up to 70 percent more transmissible.