COVID vaccine update: US says Pfizer’s vaccine is expected to start arriving in states on Monday


WASHINGTON – The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has voted in favor of Pfizer and BioNTech’s coronavirus vaccine for people 16 years of age and older, bringing the United States closer to immunization from million people. Eleven committee members voted in favor of the recommendation and three were disqualified.
However, the vaccines cannot yet be administered in the United States.

First, the US Food and Drug Administration on Friday gave Pfizer and BioNTech permission to use the vaccines for emergency use, following a recommendation from its own vaccine advisers. ACIP met on Saturday and voted to recommend that the CDC approve the vaccine for use in the United States and add it to the immunization schedule.

The CDC must now decide whether or not to accept ACIP’s recommendation. Once this happens, the vaccines can be administered.

This is a last minute update. A previous version of this report can be found below.

The country’s first COVID-19 vaccine will begin arriving in the states on Monday morning, U.S. officials said on Saturday, after the government gave the green light to the vaccines needed to end an epidemic that has killed nearly 300,000 Americans.

The trucks will be deployed on Sunday morning as transport companies UPS and FedEx begin delivering Pfizer vaccine to nearly 150 distribution centers across the states, Army General Gustav Perna of Operation Warp Speed ​​said, the Trump administration’s vaccine development program. Another 425 sites will receive mailings on Tuesday and the other 66 on Wednesday.

Initially, around 3 million doses were to be shipped nationwide. It was not clear who would receive the first vaccines, although healthcare workers and nursing home residents were the priority. Perna said health officials would decide, and a similar number of shots will be withheld for the second dose of these recipients, which is necessary for full protection against COVID-19.

READ: Letter to use FDA emergency clearance to Pfizer

Saturday’s announcement kicks off a massive logistics operation involving federal and state governments, private companies and healthcare workers to quickly distribute scarce vaccine supplies across the United States. hospitals and raising fears that things will only get worse as people congregate over the holidays.

Perna compared the vaccine delivery effort to D-Day, the US-led military offensive that turned the tide of World War II.

“D-Day was the beginning of the end and that’s where we are today,” Perna said at a press conference. But he added that it would take months of work and “diligence, courage and strength to finally achieve victory.”

MaineHealth, a network of 12 Portland-based hospitals, plans to provide a scheduled first delivery of nearly 2,000 vaccines to doctors, nurses and others at risk while treating COVID-19 patients, said Dr Dora Mills, responsible for improving health.

“It’s almost hard for me to talk about it without ripping it up,” Mills said on Saturday. “This vaccine gives us a glimmer of light at the end of the tunnel. ”

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The first shipments will leave Pfizer’s manufacturing facility in Kalamazoo, Mich., By truck, and then be flown to regional centers across the country. Medical distributor McKesson and drugstore chains including CVS and Rite-Aid are also involved in the initial rollout and vaccinations in nursing homes and assisted living centers.

In a key distribution challenge, the vaccine, co-developed with BioNTech, must be stored and shipped at ultra-low temperatures – around 94 degrees below zero. Pfizer has developed shipping containers that use dry ice and GPS sensors will allow the company to track each shipment and make sure it stays cold.

The distribution sites are mainly large hospitals and other facilities capable of meeting these ultra-cold storage needs. Within three weeks, the vaccines should be delivered to all vaccination sites identified by states, such as local pharmacies, Perna said.

The vaccine was scheduled to arrive on Monday so that health workers could receive the vaccines and start administering them, Perna said.

Workers at the Mount Sinai Hospital System in New York City tested this week to prepare for their vaccines to be shipped. In a clean room, pharmacists practiced making separate doses of a training vaccine and making sure the freezer was kept cooler than in Antarctica.

“Few people have vaccinated against a large pandemic like this,” said Susan Mashni, vice president of pharmacy at Mount Sinai. “So we want to make sure we’re doing things right. There are a lot of different moving parts and parts. ”

The Food and Drug Administration authorized emergency use of the vaccine on Friday evening. He capped an unprecedented global race to speed up vaccines through testing and examinations, cutting years off the process of normal development.

The FDA found the vaccine to be highly protective and did not pose any major safety concerns. U.S. regulators worked for months to emphasize the thoroughness and independence of their review, but the Trump administration pressured the agency until the final announcement. A senior White House official has even threatened to impeach FDA chief Stephen Hahn if a decision doesn’t come by Saturday.

Fears that a vaccine was rushed could undermine vaccination efforts in a country with deep-seated skepticism about vaccines. Hahn again stressed his agency’s independence to reporters on Saturday.

“Science and data guided the FDA’s decision,” Hahn said. “We worked quickly because of the urgency of this pandemic, not because of any other outside pressure. ”

Although deemed safe, UK regulators are investigating several serious allergic reactions. The FDA instructions tell suppliers not to give it to those with a known history of serious allergic reactions to any of its ingredients.

FDA director of vaccines Dr Peter Marks said the agency would closely monitor any reports of allergic reactions in the United States.

“I think we still need to find out more, and that’s why we’ll be taking precautions,” Marks said.

The FDA will be reviewing a second vaccine from Moderna and the National Institutes of Health next week that looks about as protective as Pfizer’s shot. On Friday, the Trump administration announced that it had purchased an additional 100 million doses of the vaccine in addition to the 100 million previously ordered.

The announcement came after revelations last week that the White House chose not to block an additional 100 million doses of Pfizer vaccine for delivery in the second quarter of 2021. The Trump administration maintains that current orders as well as those in progress will be sufficient to accommodate any American who wishes to be vaccinated by the end of the second quarter of 2021.

CNN contributed to this report.

Copyright © 2020 by Associated Press. All rights reserved.


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