FDA approves first COVID-19 vaccine as University officials prepare for distribution

Friday, December 11, 2020 - 9:13pm

The Food and Drug Administration gave emergency use authorization to the COVID-19 Pfizer/BioNTech vaccine Friday evening.

The Food and Drug Administration gave emergency use authorization to the COVID-19 Pfizer/BioNTech vaccine Friday evening. Buy this photo
Courtesy of Dominic Coletti

The Food and Drug Administration gave emergency use authorization to the COVID-19 Pfizer/BioNTech vaccine Friday, a major step in curbing a pandemic that has killed more than 290,000 Americans. Pfizer has said they are ready to distribute the vaccine within hours. 

The Pfizer mRNA vaccine has shown a 95 percent effectiveness in preventing COVID-19 in a study with over 43,000 participants. The vaccine itself requires two injections taken 21 days apart.

In a press release Friday, Gov. Gretchen Whitmer praised the vaccine's development, saying FDA authorization will finally help slow the spread the virus. 

“This is great news for our families, frontline workers, small businesses, and economy," Whitmer said. "In Michigan, a state built on hard work and innovation, a safe and effective COVID-19 vaccine will be manufactured by Michigan workers at a Michigan business."

The Michigan Department of Health and Human Services announced their priority groups for COVID-19 vaccination in a press release Friday. The first phases of distribution will administer vaccines first to health care personnel and residents of long-term care facilities, then to essential workers and finally to senior citizens or adults with high risk medical conditions. 

Dr. Joneigh Khaldun, the state’s chief medical executive, said Michigan’s distribution plan is based on recommendations by experts.  

“Because initial allocations of vaccine will be limited, we must prioritize how the vaccine will be distributed across the state and will use the guidance and principles outlined by the CDC and national experts,” Khaldun said. “We want every adult to be planning now for how they will get their vaccine once it becomes available to them.”

The University of Michigan is prepared to start administering Pfizer vaccines as early as Dec. 15 and will do so in three phases that match the state’s prioritization plan. 

In a COVID-19 vaccine briefing on Friday, Stan Kent, the chief pharmacy officer at Michigan Medicine, and Medical School professor Sandro Cinti addressed community members’ questions and highlighted the successes of the vaccine candidates. Cinti, who co-leads Michigan Medicine’s COVID-19 Vaccine and Therapeutics Task Force, explained who the first distribution phase applies to. 

“Health care personnel (is a main group)— and personnel doesn't mean doctors, nurses — it means everybody from the person who is helping to move the patient, clean the rooms, all those health care personnel who have direct or indirect contact with patients or with infectious material,” Cinti said. “And then the other group is long-term care facilities, so the people who live there and the people who work there.”

According to Cinti, Michigan Medicine plans to vaccinate about 60,000 to 80,000 people in the next few months and is developing a vaccine operations center to hire and train distributors. He expects the Moderna vaccine, another potential vaccine that uses similar mRNA technology, to receive FDA emergency use authorization in the coming weeks.  

MDHHS officials aim to vaccinate 70 percent of Michiganders who are 18 and older — nearly 5.4 million people. Michigan expects to receive 84,000 doses of Pfizer’s vaccine next week.  

A recent poll by the University Institute for Healthcare Policy and Innovation shows that more than half of 50 to 80 year olds worry about the safety and risks of a rapidly-developed vaccine.

Khaldun said the vaccine has some mild side effects but emphasized that the FDA always ensures medication is fit for distribution before authorizing it. 

“The process for approval of a COVID-19 vaccine is scientifically sound, and no steps have been skipped,” Khaldun said. “People should know what to expect when they get a vaccine — such as mild side effects like a sore arm or low-grade fever.” 

Kent addressed skeptics’ concerns about the vaccine and said while the final product labels are not yet available, the vaccine will contain no preservatives. He also touched on the speed of the vaccine’s development, a concern held by many commenters and members of the public at the briefing. Kent said new technology and additional resources played a large role in the rapid development of the vaccine. 

“We still went through all the steps,” Kent said. “It's just that we went through them much, much more quickly. So, I feel very confident that all of the right things were done, and people should be assured that (the vaccine) will be safe.”

Cinti made clear the Pfizer vaccine will not contain the SARS-CoV-2 virus that causes COVID-19. He acknowledged the mRNA technology is new and there isn’t much long-term data, but said the vaccine cannot interact with recipients’ DNA. 

“Some people think, ‘It's going to change my genetics, it's going to change something about me, and something bad is going to happen,’” Cinti said. “I can understand that that's a feeling, but this piece of mRNA, it doesn't get into the DNA, it doesn't get into the nucleus of the cell. The nucleus is where all the DNA problems occur, where all the genetic rearrangements occur.”

On Thursday, Whitmer announced the creation of the bipartisan Protect Michigan Commission, a group of state officials charged with educating Michiganders about the vaccine.

MDHHS officials said there will be no out-of-pocket costs to individuals for the vaccine, estimating that by late spring 2021 the vaccine supply will meet the demand of the general public.

Cinti said it’s too early to stop taking other precautions, like social distancing and mask wearing, even with a vaccine. But Cinti added that it is possible restrictions can be lifted as early as late next spring or early in the summer and said he and Kent believe it is high time to “vaccinate people” and “get this over with.”

“What they didn't look at was if you get the vaccine and you're protected, can you still get (some coronavirus) that then goes in your nose and then infect somebody else?” Cinti said. “So that isn't completely clear yet, so I don't think we can make the statement that, 'Oh you can rip your mask off, you're done.’”

Daily News Editor Hannah Mackay can be reached at mackayh@umich.edu. Daily Staff Reporter Dominic Coletti can be reached at dcoletti@umich.edu


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