Pfizer-BioNTech Vaccine Cleared by EU Agency

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Pfizer-BioNTech Vaccine Cleared by EU Agency

The headquarters of the European Medicines Agency in Amsterdam. The regulator recommended that Pfizer Inc.-BioNTech SE’s vaccine be authorized for use in the bloc.

Photo: remko de waal/Shutterstock

BRUSSELS—The Covid-19 vaccine from Pfizer Inc. and its German partner BioNTech SE was cleared for use by the European Union’s drug agency, a major step in efforts to tame the disease in a region that is fighting a deadly winter surge, as the bloc also tries to keep out a new mutation in the coronavirus found in Britain.

The European Medicines Agency said that the Pfizer-BioNTech vaccine—which was developed in Germany—is safe and effective against Covid-19, paving the way for EU authorities to formally authorize the use of the shot this week. Distribution could begin next week, following administrative procedures needed to coordinate a rollout across 27 member states.

The EU is also grappling with concerns over the spread of a new variant of the coronavirus in the U.K. that has prompted many countries to ban passenger flights from that country in an effort to prevent entry of the mutation, which the British government says is more infectious.

The decision to recommend authorization of the Pfizer-BioNTech vaccine comes after the U.K. and the U.S. approved it in early December. Some EU leaders expressed anger at the bloc’s slower pace, in light of the thousands of Europeans dying of the disease each day. The agency moved up the timing of its decision by a week.

U.S. regulators on Friday also permitted use of Moderna, Inc.’s Covid-19 vaccine, with the first immunizations expected Monday.

Even with the approval, a rollout to the EU’s 450-million strong population will take months, if not longer, with supplies of the vaccine constrained, say health officials.

“It will take time to roll out vaccines in sufficiently large numbers to enable all our citizens to be protected,” the EMA’s Executive Director Emer Cooke told reporters, Monday. “Vaccines alone will not be the silver bullet that will allow us to return to normal life, but 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.”

Europe was hit early on in the pandemic, with 300,000 people dying of the disease so far and 15 million sickened. After suppressing the coronavirus to very low levels in the summer, the pathogen has surged sharply this fall. Authorities across Europe have expressed alarm at stubbornly high levels of infection, hospitalizations and deaths, numbers that bode ill for the winter.

Before the rollout can commence, EMA’s decision must now be approved by the European Commission, which must first survey all 27 EU members. Authorities expect procedural and logistical issues mean some countries won’t start vaccinating until Dec. 29.

The EU has ordered 300 million doses of the Pfizer-BioNTech vaccine over the next year, enough to inoculate up to 150 million people with the two-shot inoculation. It lined up another 160 million doses of Moderna’s double-dose vaccine. On Jan. 6, the EMA is expected to decide whether to approve that vaccine.

If they do, European states only expect enough doses over the next several months to cover most—but not all—health-care workers and the very elderly.

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Germany, assuming both the Pfizer-BioNTech and Moderna shots are authorized and delivered on schedule, plans to vaccinate about 6.5 million people before April 1. The government’s priority list—those over aged 80, patients with serious health conditions and medical staff—totals eight million people. Some 18 million Germans are aged over 65.

Beyond those two vaccines, it might be months before the EU authorizes a third. AstraZeneca PLC and Oxford University developed a vaccine that is on average effective in 70% of people—but which suffered an error in clinical trials, when test subjects were given inconsistent doses.

This month, the EMA began a rolling review of a vaccine by Johnson & Johnson, which is still in large-scale clinical trials and won’t be authorized until February at the earliest. If that vaccine doesn’t win EMA approval, no other obvious contender is likely to arrive in Europe soon.

Meanwhile, the authorization of the Pfizer vaccine comes amid growing concerns over the risks of allowing the virus to spread, and mutate. A new variant in the U.K., which the government says is more infectious, has prompted a number of EU states to cut off travel to Britain.

The European Center for Disease Prevention and Control said Sunday that a few cases of the new strain had also been reported in Denmark, the Netherlands and possibly in Belgium. The mutated virus appears to cause it to spread more quickly, but doesn’t seem to make it more resistant to a vaccine, according to U.K. officials.

“At the moment we can say that there is no evidence to suggest that the vaccine will not work against the new variant of the coronavirus,” the EMA’s Ms. Cooke said. The vaccine, EMA officials added, wasn’t recommended for people under 16 years old. The shot has only been observed in a very small, single digit number of pregnant women, said agency officials, who recommended those women receive the vaccine after a case-by-case determination of whether the rate of spread in the community made not being vaccinated riskier than having the vaccine itself.

Monday’s recommendation by the EMA meanwhile sets off regulatory and logistical steps that would swiftly send the first doses across all of the EU’s 27 nations.

The European Commission, the EU’s executive arm, is coordinating the acquisition and distribution of vaccine doses to ensure a fair and rapid rollout across the bloc.

After Monday’s announcement, a new vaccine body is expected to issue its own guidance and then the Commission plans to authorize the vaccine for commercial use within 24 hours.

The Paul Ehrlich Institute, the federal institute for vaccines and biomedicines in Germany, must then issue certification papers for the vaccine. The EMA, which has limited technical staff, relies on national institutes for lab work, and it delegated the review of the Pfizer-BioNTech vaccine to the German institute, which has long worked with BioNTech.

The U.K. became the first Western nation to vaccinate patients against Covid-19. WSJ explains how the country is planning to roll out the BioNTech-Pfizer vaccine at record speed, making it a test case for the rest of the world. Photo: Jacob King/Bloomberg News

Approval paperwork must be translated into the EU’s 24 official languages. Each batch of vaccine must be validated before it can be shipped. Every member state in turn has its own procedures for domestic distribution and administration. That means rollout would likely begin on Dec. 26, with the first shots coming Dec. 27.

Europe’s population skews older, so it has more high-risk people to vaccinate compared with the U.S. Other countries, notably Canada, the U.S. and the U.K. pre-purchased more doses of forthcoming vaccines than the EU did. As a result, the bloc might not have enough to cover its entire population next year.

“Logistically this is going to be really challenging,” said Herman Goossens, a microbiologist at the University of Antwerp and a health adviser to the Belgian government. “I see politicians saying, ‘I hope the festivals will take place this summer, young people will be able to come to the festivals.’ No, I think that’s too optimistic. It will take the whole year 2021.”

Write to Drew Hinshaw at drew.hinshaw@wsj.com and Daniel Michaels at daniel.michaels@wsj.com

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