The European Medicines Agency (EMA) on Monday recommended the conditional authorization of the coronavirus vaccine jointly produced by Pfizer and BioNTech.
This is the first vaccine the EMA has recommended for approval. Britain already authorized the jabs in early December.
The recommendation applies to those of at least 16 years of age, EMA director Emer Cooke said.
"It is a significant step forward in our fight against this pandemic, which is causing suffering and hardship for so many people, not just in Europe but all over the world," she said. "This is really a historic scientific achievement. Within less than a year, a vaccine will have been developed and authorized against a new disease."
Aside from age, limitations also apply to pregnant women. As only limited data is available for that group, it should be assessed on a case-by-case basis whether it would be safe to give a jab, said Harald Enzmann, Chair of EMA's Human Medicines Committee.
One major unknown factor is whether the vaccine prevents infections with the virus, or simply symptoms. This would mean that people who have been vaccinated could still be contagious.
"Wear masks, wash your hands and maintain distance. Vaccines alone will not be the silver bullet that will allow us to return to normal life," Cooke said.
The European Commission still needs to formally approve the vaccine. Commission President Ursula von der Leyen said she expected a decision by Monday evening.
"It's a decisive moment in our efforts to deliver safe and effective vaccines to Europeans!" she said on Twitter.
EU countries welcomed the move
Germany welcomed the agency's move to green light the vaccine, with Health Minister Jens Spahn calling it "a milestone in fighting pandemic." Germany hopes to begin vaccinating elderly people in care next weekend, he added. "Because we protect the most vulnerable first," said Spahn.
Meanwhile, Italian Health Minister Roberto Speranza called the EMA approval "the news we were waiting for."
"The battle against the virus is still very complicated, as shown by the latest news coming from London, but having an effective and safe vaccine at our disposal gives us more strength and hope," he added, referring to the discovery of a rapidly spreading new strain of the coronavirus.
A positive decision would pave the way for the EU countries to kick off mass vaccination campaigns before the start of 2021.
The agency said it was likely that the vaccine developed by Pfizer and BioNTech is also effective against the new coronavirus strain that caused dozens of countries to suspend their flights to and from Britain.
The EMA will decide on whether to authorize the Moderna vaccine on January 6.
