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Moderna, Pfizer seek emergency EU approval for COVID-19 vaccines

Moderna, Pfizer seek emergency EU approval for COVID-19 vaccines
Pfizer and BioNTech say their BNT162b2 vaccine candidate is 95% efficient. Photo by BioNTech SE/EPA-EFE

Dec. 1 (UPI) -- U.S.-based companies Moderna and Pfizer applied for emergency authorization in Tuesday to roll out their COVID-19 vaccines in Europe, the European Union said.

The two companies, which are awaiting emergency use authorization from the U.S. Food and Drug Administration, have now sought what's called conditional marketing authorization from the European Medicines Agency.

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The EMA said its assessments of the vaccines would be "accelerated."

"An opinion on the marketing authorization could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine," the agency said.

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The EMA said it would schedule a meeting on the Pfizer vaccine by Dec. 29 at the latest and for Moderna's no later than Jan. 12.

The applications come one day after Moderna applied for an EUA from the FDA and more than a week after Pfizer and its partner, BioNTech, sought the same approval.

The companies are attempting to begin delivering the vaccines before the end of the year. Moderna says its vaccine has 94% efficacy and Pfizer lists its candidate's efficacy at 95%.

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California Gov. Gavin Newsom announced Monday the state will receive 327,000 doses of Pfizer's vaccine by the middle of this month.

"Transparency, equity and safety will continue to be our top priorities as we begin the distribution process for Phase 1," he said in a tweet.

Pfizer said FDA authorization would enable the use of its vaccine in high-risk populations by mid-December.

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The Pfizer vaccine is to be administered in two doses, and Newsom said during a virtual news conference Monday that the second dose is anticipated to arrive three weeks after the initial delivery.

Guidelines have not yet been recommended for the first stage of distribution.

If nothing changes, Newsom said, hospitalizations in California could triple the current rate in a month and projections see intensive care unit beds at 112% capacity.

"We are now looking in real time at hospitalization numbers and ICU capacity in those regions," he said.

Pfizer said last month it expects to produce 50 million doses this year and more than a billion by the end of 2021.

Moderna has also applied for Emergency Use Authorization with the FDA.

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