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Pfizer calls for emergency use of its vaccine

Pfizer announced Friday that it has asked regulators in the United States to authorize emergency use of its COVID-19 vaccine, kicking off a process that could lead to limited initial application next month and help finally finish with the pandemic, but not before a long and harsh winter has passed.

This action comes days after Pfizer Inc. and its German partner BioNTech announced that their vaccine appears to be 95% effective in preventing mild and severe cases of COVID-19 in a large study under development.

The companies said protection and a good safety record should allow for emergency clearance, something the US Food and Drug Administration (FDA) can grant before final testing. In addition to the application on Friday, applications have already started in Europe and the United Kingdom and their intention is to present similar information soon.

“Our task of introducing a safe and effective vaccine has never been more urgent,” said Pfizer CEO Albert Bourla in a statement.

Given the peaks reached by the coronavirus in the United States and around the world, pressure is on regulators to make a decision quickly.

“Help is on the way,” said Dr. Anthony Fauci, America’s leading infectious disease expert, on the eve of the Pfizer announcement. He added that masks and other protective measures should not yet be abandoned. “We must actually multiply public health measures while we wait for that help to arrive.”

Friday’s filing sets off a series of events as the FDA and its independent advisers debate whether the vaccine is ready. In such a case, another government body will have to decide how initial doses are rationed in a country that is anxiously awaiting them.

Initial doses will be scarce and rationed. There will be about 25 million doses available in December, 30 million in January and 35 million more in February and March, according to information presented this week to the National Academy of Medicine. Recipients should receive two doses three weeks apart.

The COVID-19 vaccine from the pharmaceutical company Moderna Inc. is also on the way. Initial data indicates that it is as effective as Pfizer’s. Moderna plans to apply for its own emergency clearance in the coming weeks.

People will get their first chance to learn of the evidence for vaccines in early December at a public meeting of FDA scientific advisers.