IMPORTANT VACCINE UPDATE

THE FDA has not signed off yet, but the panel has recommended it be approved.  They expect the approval to follow.  Once there is approval they expect to have the vaccine across the country within 48 hours.

I will post an update as soon as I learn it has received the go ahead.

FDA panel considers emergency approval of Pfizer-BioNTech coronavirus vaccine
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A U.S. advisory panel meets to decide whether to recommend that the Food and Drug Administration approve the Pfizer-BioNTech coronavirus vaccine. (The Washington Post)
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The day after the United States reported more than 3,100 daily deaths, a new record, federal advisers endorsed the Pfizer-BioNTech coronavirus vaccine, making it all but certain the Food and Drug Administration will authorize the vaccine on an emergency basis within hours or days, kicking off an unprecedented effort to inoculate enough Americans to stop a rampaging pandemic.

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Michigan to receive estimated 84K doses of Pfizer vaccine in first shipment, once approved

Pfizer
Posted at 1:34 PM, Dec 10, 2020
and last updated 4:34 PM, Dec 10, 2020

(WXYZ) — Michigan will receive approximately 84,000 doses of the Pfizer vaccine in first shipment, once approved by the FDA, state officials said Thursday.

RELATED: Michigan could get COVID-19 vaccine to general public by late spring, officials say

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is currently holding a meeting to consider Pfizer’s coronavirus vaccine, which has already gotten authorization from officials in Canada and the UK.

The committee will weigh the vaccine’s efficacy, and could issue an emergency use authorization of the vaccine by early next week.

An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.

Michigan Department of Health and Human Services Director Dr. Joneigh Khaldun has said that there are 48 hospitals and 12 local health departments that have the freezer capabilities to be able to receive and administer the Pfizer vaccine.

Additionally, Dr. Khaldun said that once the Moderna vaccine is approved, expected later this month, Michigan will receive an estimated 173,000 doses in its first shipment.

The state’s first priority, she said, will be to keep healthcare systems operating. That means the first vaccines will likely go to frontline healthcare workers, EMS workers, and other workers in ICUS and emergency departments. They will also likely go to those living and working in long-term care facilities.

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How will Texas roll out the Pfizer COVID-19 vaccine?

CORONAVIRUS
FILE – This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. Pfizer’s COVID-19 vaccine is entering the final phase of review by U.S. government regulators. The Food and Drug Administration on Tuesday, Dec. 8 released a positive review of the vaccine. (Courtesy of University of Maryland School of Medicine via AP, File)

AUSTIN (KXAN) — With federal regulators in a meeting Thursday slated to vote on whether to grant Emergency Use Authorization to the Pfizer-BioNTech COVID-19 vaccine, the possibility of a rollout of the first COVID-19 vaccines in the U.S. feels more tangible than ever.

If the vaccine is approved by the U.S. Food and Drug Administration Thursday, state health leaders have said the first week’s allocation of 224,250 doses of the Pfizer vaccine could be shipped to 109 hospitals in 304 counties as early as next week.

Local and state governments have already been planning for the expected approval of the Pfizer and other vaccines, so we already know quite a bit about how the vaccine will be distributed in Texas once it is available.

How soon could doses reach Texas?

Chris Van Deusen, the Director of Media Relations for the Texas Department of State Health Services (DSHS), said he believes it’s likely the FDA will issue an Emergency Use Authorization for the Pfizer vaccine in the next few days. Whenever that authorization is issued, he said “vaccines could start rolling” 24 hours after that point.

Van Deusen expects within several days, certainly within the week, of the Pfizer vaccine’s approval that it will arrive at Texas healthcare facilities. But he noted in addition to the FDA’s authorization, a Centers for Disease Control and Prevention committee will also have to approve Pfizer’s vaccine before Texas healthcare facilities can start administering it.

Where will the first doses go?

Texas leaders have already made it clear that key healthcare workers will be the first to receive this vaccine.

“I wish we had enough for everyone who wanted to be vaccinated in this first week to be vaccinated, but it’s just not possible,” Van Deusen said.

DSHS released a list of the major healthcare facilities across the state which will receive COVID-19 vaccine doses in the first week the vaccine is available.

DSHS said the vaccine will be shipped on dry ice in a thermal box and that the federal government will provide “one re-charge of dry ice” that should keep the vaccines stable for at least five days, if they are kept at the right temperature.

While initially, the ultra-cold storage requirements of the Pfizer vaccine stirred some concerns about distribution in Texas, Van Deusen said the greatest limiting factor with this vaccine has actually turned out to be the requirement for the size of the orders for the vaccine. He said Thursday the state decided not to restrict any region’s access to this Pfizer vaccine based on regional storage abilities.

Different Texas hospitals have been allocated different amounts of vaccine doses, and Van Deusen said that is all based on the number of healthcare workers each facility believes it can quickly vaccinate.

What happens next?

While Texas awaits the Pfizer vaccine’s approval from federal regulators, state leaders also expect the approval of the Moderna vaccine to follow soon after.

This initial group of doses, Van Deusen expects, will be “probably the smallest allocation” Texas gets during the vaccine rollout.

“We expect more vaccine will be available in week two [of vaccine distribution], and it will be going to more providers,” he said.

There is a larger list of providers in regions around the state, which will receive shipments of the vaccine after the initial group of major hospitals received theirs. But DSHS said they haven’t posted that list yet as the specifics are still being ironed out.

“The Week Two plan is to expand distribution to more facilities and more types of facilities, we don’t have a final list yet, we are working on that now,” he said.

“Looking at things overall, this is really good news,” Van Deusen said. “But this is just the first kind of step in a long process.”

“I think people still need to be patient, it’s going to take months to get the vaccine available for everyone who wants to get it,” he continued. “We need to take those public health steps that we’ve been talking about for so long: wear a mask, stay home where you can.”

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Parkand Hospital outlines COVID-19 vaccine distribution plan for its employees

Area hospitals are working on plans for the COVID-19 vaccine distribution next week.

The state released its distribution list Friday, anticipating the vaccines will be approved by the time they arrive.

Parkland will get one of the largest batches of COVID vaccine from the state. Officials are expecting to receive it by next Thursday.

The first COVID-19 vaccine rollout in Texas is just days away.

Twenty North Texas hospitals will receive more than 50,000 doses of the Pfizer vaccine, which could get emergency FDA approval this week.

“Right now, we have a tentative date of the 16th, might be the 17th, depending on when the vaccine is approved by the FDA,” explained Francesco Mainetti with Parkland.

Parkland Hospital in Dallas will get one of the largest deliveries with more than 5,800 doses.

Mainetti is leading the distribution team for the hospital. Parkland has more than 15,000 employees, so he says they have broken staff down to five priority groups of 3,000 people a group.

“First we are going to focus on the employees in the main hospital that have direct patient contact, nurses, physicians with high exposure to COVID and to patients,” he said. “Once that wave is completed, we will move into our outpatient settings: Family care clinic, special care clinic.”

Support staff like cafeteria workers and custodians who work in the same environment as doctors and nurses will be in the third group. Staffers who don’t have regular contact with clinicians are in the fourth and fifth groups.

Because the Pfizer vaccine has to be stored in freezers at 70 degrees zero, the vaccines will be given in the hospital.  Once the vaccine is given, employees will automatically be notified for an appointment for the required second dose of the vaccine three weeks later.

“We are not going to make it mandatory. At least for now, it’s voluntary,” Mainetti said. “So depending on how many employees decide to take the vaccine, we can do more or less.”

Dallas County hospitals will get more than 27,000 doses.

Tarrant County will get about 18,000, and Collin County will get nearly 4,000 doses.

Denton County is the largest in our area to not receive doses.

Parkland officials say they have not surveyed employees about interest in the vaccine but will be ready when the delivery is made.

“As soon as the vaccine gets here, we are ready to distribute it to our employees,” Mainetti said.

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