The agreement with Pfizer and BioNTech will stipulate that the shots be produced in Europe, bringing home not just the finished product, but also most of the 280 components that go into making it, Ms. von der Leyen and Mr. Bourla of Pfizer said.

The contract will also allow for a range of different vaccine products.

An internal European Commission assessment of the bloc’s needs over the next two years, which is still being reviewed and was seen by The Times, lays out ballpark figures for how many doses might be necessary under different scenarios. According to the draft assessment, the bloc might require up to 510 million booster doses in 2022 and 2023.

Mr. Bourla said he expected a booster would be needed six to twelve months after people get their second shot, although some public health experts note that it is not clear yet whether that will be necessary. And the assessment includes a worst-case scenario for a new vaccine to target an “escape mutant,” a variant of the coronavirus that is too resistant to existing shots. The draft says the European Union would require 640 million doses of this type of vaccine for two doses per adult. And it puts the number of pediatric vaccines at 130 million for 2022 and 65 million for 2023.

The deal is not without risks, or critics. Countries and experts worry that the European Union may be becoming too dependent on Pfizer, and failing to hedge its bets in the event of problems with the vaccine or its production.

“I would caution against going for Pfizer/BioNTech only,” said Prof. Peter Piot, a microbiologist who advises Ms. von der Leyen. “That is too high risk for me, scientifically,” he said, though he noted that mRNA technology vaccines like Pfizer’s have so far been working well.

Of the new E.U. deal with Pfizer, Professor Piot said, “My interpretation is, what works is who can deliver.”

Ms. von der Leyen said the European Union could still procure doses from other companies.

She said the bloc was following the development of protein-based vaccines made by Novavax and Sanofi, as well as mRNA vaccines from Moderna, which are already being used in Europe, and CureVac, which is under review by the E.U. regulator. The Johnson & Johnson vaccine, which was rolled out in Europe this month, is also attractive because of its single-dose regimen and easy storage, she said.

The Pfizer shot is also expensive. While the financial details of the new agreement have not been disclosed, the previous contract priced the shot at approximately 15.5 euros, or about 19 dollars, making it the second-most expensive vaccine in the region after Moderna.

European Union members will each decide whether they want to use their full allocations of doses, or leave some for others to absorb, or to be resold or donated. They will also be free to make bilateral agreements with other pharmaceutical companies for vaccines in the future.

The new contract does little to address mounting global calls for the release of patents or for technology transfers to ensure that more of the world gets vaccinated soon. With India in the throes of a catastrophic wave of the virus, and the majority of the world’s population still far from getting access to a first dose of any vaccine, Europe’s talk of doses for children and boosters seems out of step with global needs, health experts say.

And while Ms. von der Leyen says the deal will enable the European Union to help poorer regions, it reinforces the fact that the rich are still coming first in the global scramble for vaccines.

Siddartha Sankar Datta, a senior official with the World Health Organization in Europe, said he worried about how the deal would affect global supply.

“I think the bottom line should be that the access to this vaccine should not be a prerogative of the purchasing power of the country,” he said. He said, “As countries make the effort to ensure their population base gets benefits, we have to still keep pushing ourselves to ensure more equitable access.”

Still, for Ms. von der Leyen, and for the European Union, the deal with Pfizer and BioNTech offers a chance to remedy past mistakes.

“Europe has decided to make sure that, under any circumstances, they will be prepared if there’s more need, and as a consequence of that political decision, they are now prepared to take much bigger risks,” said Moncef Slaoui, who led the U.S. vaccine effort Operation Warp Speed, and is in frequent contact with Ms. von der Leyen on E.U. strategy.

“Politics and science are intertwined here,” he said.

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