Amid rising cases and second-wave lockdowns, Europe might have a coronavirus vaccine authorized to use before the end of 2020.
Speaking during POLITICO’s Health Care Summit Wednesday, the head of the European Medicines Agency (EMA), Emer Cooke, said she’s “hopeful” that the agency will have an opinion about whether to authorize a coronavirus vaccine made by Pfizer and BioNTech by the end of the year.
Cooke’s comments followed breaking news that the companies found their vaccine to be 95 percent effective after completing a full review of their ongoing large-scale Phase 3 clinical trial.
The companies plan to submit this data to regulators — including the EMA and the U.S. Food and Drug Administration (FDA) — within days, a Pfizer spokesperson said.
Still, it will take time before Europeans can get the shot.
The companies have already begun producing the vaccine and expect to have 50 million doses made by the end of 2020. But they haven’t yet disclosed how many doses are coming from which manufacturing sites, which are located in three U.S. states, as well as Belgium and Germany.
They also haven’t disclosed which countries will get the first doses.
The European Commission has a contract to secure up to 300 million doses of the vaccine, but the U.S. also has a deal for up to 600 million doses, while the U.K. has another for up to 30 million.
Experts say they are encouraged by Wednesday’s trial results — but note that disputes over who should get the jab first are on the horizon.
“The achievements here have been supported by strong global collaborations,” wrote Trudie Lang, professor of global health research at the University of Oxford, in an emailed statement. “Now ensuring there is equitable distribution and implementation across the globe should be everyone’s focus.”
Data from different coronavirus vaccines has been piling in the past two weeks: Last week, BioNTech/Pfizer first reported that their vaccine was more than 90 percent effective based on a preliminary review of the phase 3 clinical trials. Two days later, Russia claimed its Sputnik vaccine was 92 percent effective. And on Monday, the U.S. drugmaker Moderna said its vaccine was 94 percent effective.
Wednesday’s fresh news from BioNTech and Pfizer left some asking why the vaccine jumped from 90 percent to 95 percent effective. The difference is that the companies saw more people in the placebo group — out of the nearly 44,000 participants — fall ill with COVID-19.
When the companies reported preliminary results, 86 people who had received the placebo and eight people who received the coronavirus vaccine became sick. In the week after, 162 people who had the placebo and the same eight people with the coronavirus vaccine fell ill. This created a higher efficacy rate of 95 percent.
At this point, the companies also have more safety and manufacturing data to submit to regulators, the Pfizer spokesperson said.
With the data expected imminently, regulators are waiting. They’ve only seen the interim result so far, but Cooke expressed optimism: “What we hear from the company is that the results are very promising — both from an efficacy and safety standpoint.”
But the agency’s job is to verify that expectation, she said, adding: “The devil is in the details.”
The agency has tried to speed things up as much as possible, launching a rolling review of the vaccine’s data in early October and checking their approval processes to ensure they are as “efficient and effective as possible,” she said.
Despite the pressure to get a vaccine out as quickly as possible, Cooke said the agency will uphold the science: “Our job is to serve the public; our job is not to serve the media,” she told POLITICO’s event.
So far, the companies have only released a press release — and not the underlying data — but their conclusions appear promising. They calculated efficacy in participants over the age of 65 at 94 percent. The 95 percent rate held across different ages and ethnicities. The most severe adverse reactions from the vaccine included fatigue and headaches after the second dose.
Stephen Evans, a professor at the London School of Hygiene & Tropical Medicine, said in a statement it’s promising that the vaccine appears to be effective in older populations, and effective at warding off severe and mild cases of COVID-19. Still, there is “statistical uncertainty in these data,” Evans added, so any suggestion that the 95 percent efficacy is “importantly different” from 90 percent “should be ignored.”
“We can expect both [the EMA and FDA] to conduct a very careful evaluation and we can rely on their conclusions,” Evans wrote. “Relying on a press release is not enough.”