EU on track for late Christmas present: A coronavirus vaccine

On the darkest day of the year, the EU provided some light amid the solstice gloom with a recommendation to start using BioNTech/Pfizer’s coronavirus vaccine.

By approving the rollout of the first vaccine against the virus that has killed more than 375,000 in the European Economic Area and ravaged the global economy, the European Commission paved the way for people over the age of 16 to receive the jab across the bloc two days after Christmas.

“The authorization of this first vaccine is definitely a major step in the right direction and an indication that 2021 can be brighter than 2020,” Emer Cooke, executive director of the European Medicines Agency (EMA), said. 

Despite the fanfare, the approval was nearly three weeks behind the U.K. regulator’s, which green-lit the vaccine on December 2. The country began its vaccination program six days later, prompting questions as to what the holdup was in Brussels. Cooke and her team said they had used a more robust mechanism to authorize the vaccine, which shifted liability for any potentially costly problems from taxpayers to the companies behind it. The scientists also used the delay to learn from valuable extra data from the U.K. and elsewhere.

The EMA walked a fine line between pressure to speed things up — initially from the Polish and Hungarian prime ministers, and later from the German and Italian health ministers — and fear that regulators were moving too quickly. The gift of a coronavirus vaccine, although weeks behind other Western countries and coming two days shy of Christmas, was a “historic scientific achievement,” Cooke said. 

The Commission, for their part, found a way to speed up the consultation process with member states and approve the vaccine just hours after the EMA’s positive recommendation. 

“This is a very good way to end this difficult year and finally start turning the page on COVID-19,” Commission President Ursula von der Leyen said, barely unable to stop smiling.  She also emphasized that the vaccine was developed in Germany, financed with €9 million in EU research funds over the past decade and backed by a €100 million loan from the European Investment Bank in June: “This is a true European success story.”

The Commission already signed a deal for 200 million doses of the mRNA vaccine, with the option of purchasing an additional 100 million. Von der Leyen repeated her promise that the doses would be available to all EU countries “at the same time, on the same conditions,” divided between each EU country based on their populations.

The exact day when vaccine shipments will leave Pfizer’s Belgian factories is unclear: The Commission had said this would happen on December 26, so European countries could start vaccinations simultaneously on von der Leyen’s declared Europe’s vaccinations days between December 27 and 29. A Commission official also said this timeline would not be affected by the Commission’s quicker approval, but von der Leyen said the shipments would leave factories “within days.” A Pfizer spokesperson did not immediately respond to a request for comment.

If the festive gifts do arrive earlier than December 26, some countries, like Denmark, said they would not wait for other countries but rather start to vaccinate as soon as the shipments arrive. Others, like the Netherlands, might have to wait until January due to technical issues, while others, like Hungary, have not yet made their vaccination plans public.

The late Christmas present may have come nearly three weeks after the U.K. — the first country in the world to approve the jab — but it was nonetheless a week ahead of the EU regulator’s latest target date. 

Cooke insisted the EMA couldn’t go quicker: Scientists in the agency and in each of the EU member states worked “around the clock,” receiving emails “at all hours of the day and night” to review the data and get more information from the drugmakers — even as recent as this past weekend. And crucially, the mechanism used to give the green light is more robust than the vaccine approvals in the handful of countries that have so far given the go-ahead. 

Rather than using emergency procedures that leave the state to pick up the tab if something goes wrong, the EU’s conditional market authorization, once it is rubber-stamped by the Commission, means that the companies, rather than EU taxpayers, accept liability for any unforeseen issues. The conditional marketing authorization (CMA) process also means that drugmakers agree to conduct further studies and submit frequent safety reports. 

Still, the agency brought forward the date for its extraordinary scientific review to December 21 after pressure from German Health Minister Jens Spahn and Italian Health Minister Roberto Speranza for an earlier approval date. Cooke said the original December 29 was just an estimate, and the agency moved the date after realizing they could conduct more work in parallel. 

“In the last few months, EMA has seen the intense debates taking place in the public arena, some calling for a speedier approval, while others were concerned that development was going too fast to ensure safety,” Cooke said. “We at EMA have kept our steer and we’ve been guided by the spread of the scientific evidence and nothing else.”

Harald Enzmann, chair of the EMA’s human medicines committee (CHMP), also refuted any suggestion that political influence prompted the agency to speed things up because the process includes representatives from every EU country. 

“The option to pressurize the EMA from one or other corner is extremely limited — up to nonexistent,” Enzmann said. “The focus was exclusively on science. There were too many involved … to allow any political whitewashing. Let me reassure you. [This] was a scientific assessment — full stop.”

The BioNTech/Pfizer vaccine was backed by trial data from more than 43,000 participants, which the companies said showed the vaccine was 95 percent effective in preventing severe COVID-19 cases. Regulators from the EMA pointed to how eight people who received the vaccine in the trial contracted COVID-19, compared to 162 in the placebo — “a rather clear result,” Enzmann said.

When speaking about the safety of the vaccine, Sabine Straus, the chair of EMA’s safety committee (PRAC), said that more than 10,000 participants have been tracked two months after the second dose, and the most common side effects are on par with most other vaccines, including pain at the injection site and headaches. 

“The safety profile based on the data from these large clinical trials is reassuring,” Straus said.

The agency also received reports from the U.K. and U.S. of people experiencing allergic reactions after receiving the vaccine, some of which have been severe. That prompted a recommendation for people to be kept under “close observation” for 15 minutes after being vaccinated. Still, the number of cases of allergic reaction are very low. 

For pregnant women receiving the vaccine, the EMA concluded there was not enough data to conclusively assess safety. Hence, decisions on whether to vaccinate pregnant women should proceed on a case-by-case basis, depending on the risks of infection and other factors.

Straus stressed that drugmakers will submit monthly safety reports, and the agency has a robust system for tracking side effects that occur. 

Referring to the new variant of the virus circulating in the U.K. — which has prompted several countries to introduce bans on travelers from the country — Cooke said there was “no evidence to suggest that the vaccine would not work on the new variant.”

Meanwhile, von der Leyen said Monday night that more authorizations would follow: The EMA is set to review Moderna’s vaccine on January 6, and the agency has rolling reviews of vaccines from Oxford/AstraZeneca and Johnson & Johnson. She also stressed that Europe is the largest contributor to the COVAX facility, a mechanism to ensure equal access to vaccines globally.

Still, the vaccine contracts have been intensely criticized in the past months for not making enough information — including the prices and the indemnity agreements — public. A Belgian politician accidentally tweeted the prices of the vaccines, which shows that EU countries will pay €12 per dose, not including the initial downpayment the Commission made.

CORRECTION: An earlier version of this article misstated the timeline of U.K. approval for the Pfizer vaccine. The British regulator green-lit the vaccine on December 2 and the country began its vaccination program six days later.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.