Louisiana Prepares For Distribution And Storage Challenges As Coronavirus Vaccines Near FDA Approval
On the heels of the United Kingdom approving the Pfizer/BioNTech COVID-19 vaccine, the United States is anticipating doing the same — and Louisiana officials are preparing for distribution.
The Food and Drug Administration (FDA) will meet with the Advisory Committee on Immunization Practices (ACIP) on Dec. 10, U.S. Assistant Secretary of Health Admiral Brett Giroir told a group of Louisiana reporters during Gov. John Bel Edwards’ weekly press conference on Wednesday.
Giroir said the first batch of vaccine will include 6.5 million doses to be spread across the country. Gov. Edwards said that Louisiana will receive a pro-rata share (based on the population over 18) of 1.6 percent of the vaccine or 40 thousand in the first week that it is distributed.
“This is extremely good news. The light is at the end of the tunnel and it’s a very positive, bright light.” Giroir said.
Giroir said the FDA could approve the vaccine as early as 24 hours after the ACIP meeting.
Shortly after the Pfizer meeting, the FDA has planned another ACIP meeting to discuss the Moderna vaccine. Just like Pfizer, it uses synthetic mRNA to deliver information about the COVID-19 spike proteins to the patient being injected, and that creates an immune response. They will be the first mRNA vaccines approved to be used in humans.
“It’s extraordinary that we have a vaccine in this period of time that is this safe with a new mechanism,” former Secretary of Health and CEO of Health Care Services for LSU Health Dr. Rebekah Gee said when asked about the news that a vaccine could be available very soon.
In an interview with New Orleans Public Radio, Gee expressed concerns over the challenges that both vaccines pose, given that they must be stored in very cold temperatures, particularly the Pfizer vaccine, that requires storage at -94 degrees Fahrenheit (-70 degrees Celsius) and would call for the use of dry ice in portable storage facilities.
“That’s a temperature met with the coldest deep freezers,” Gee said. “We’ve never thought about how much dry ice is in this whole state of Louisiana and where to get it and how to supply it. These are all unprecedented challenges. There’s a certain supply chain that has to happen in a way that it hasn’t happened before.”
Susan Hassig, Associate Professor of Epidemiology at the Tulane University School of Public Health, shares Gee’s concerns.
“It’s resource-intensive and problematic for places that are small, underfunded and under-resourced, whether that’s rural North and South Dakota, rural Louisiana, or a country in Central America or Sub-Saharan Africa,” Hassig told New Orleans Public Radio.
Giroir assured reporters at Wednesday’s press conference that the federal government has set up a reliable supply chain.
“We know every single freezer in the country and we have all the dry ice done. We’re down to the micro-planning level.” Giroir said, admitting that while the cold chain is challenging, “it’s not like delivering this to sub-Saharan Africa.”
The Moderna vaccine requires a temperature of -20 degrees Celsius, which is easier to manage than Pfizer’s -70 Celsius requirement. Both vaccines are most effective when patients receive two injections. Hassig said administering that second shot could be logistically complicated.
“The way they’ve tested it out in terms of determining their efficacy results is a very specific timing,” Hassig said. The second dose must be administered almost exactly 21 days after the first.
Giroir mentioned that the government has offered financial incentives to vaccine distributors who deliver the second shot successfully, in an effort to ensure that patients receive both injections.
“I think it’s well suited to an institutionally based kind of distribution environment, like a hospital, like a nursing home, where you’ve got hundreds of residents or staff that are going to be eligible and be able to be vaccinated,” Hassig said.
On Tuesday the Center for Disease Control and ASIP voted to distribute the first batch vaccines to healthcare workers and elderly residents of nursing homes and other long-term care facilities.
“Once you get to the next level, I just want to prepare you guys, there’s going to be a lot of controversy,” Giroir warned, explaining that decisions over whether essential workers or people with co-morbid conditions get the next tier of vaccine could pit groups against each other.
Giroir said the general public is not likely to be immunized until the spring of 2021. Hassig is hopeful that other vaccines with less-limiting temperature restrictions and that require only one shot, like the drug that Johnson & Johnson subsidiary Janssen is developing, will become available by then.
“I certainly would hope that the one-shot vaccine would have good, solid, scientifically acquired results by the time we’re at the point to do general population vaccine,” Hassig said. “It would make things so much easier.”
Given that one-shot vaccines are not currently up for FDA review, Giroir made no mention of them during the press conference. Gee said it’s less probable that people being immunized will have a choice of vaccines.
“The U.S. government has pre-paid for lots of vaccines. What will likely happen is you’ll just get whatever vaccine is available during that wave of time the vaccination is happening in. If you wanted a particular mechanism, you’d have to wait,” she said.
Giroir praised the efficacy of both the Pfizer and Moderna vaccines, particularly that they seem to be nearly 100 percent effective in preventing severe illness from COVID-19 infection and that they work in all ages.
Hassig pointed out that efficacy can be measured in more than one way and that she is unclear on whether the vaccine keeps people from getting infected at all or whether it keeps people who do get the virus from becoming seriously ill.
“Is it like having the wall that keeps the virus from getting in or is it a barrier that keeps most of the virus from getting in but once it gets in it also keeps you from having a bad outcome?” Hassig asked.
Either way, Hassig said, the vaccine is a positive development.
“Hospitals are full, healthcare workers are totally stressed out, and hundreds of people are dying. Changing that dynamic, cutting that back to 10 percent of what is currently occurring, would be an extraordinary benefit,” Hassig said. “The hospitals would no longer be packed with coronavirus patients. Those coronavirus patients, if they happen to need hospitalization, wouldn’t be dying anywhere near as much as they are”
Were it offered to her today, Hassig said she would take the Pfizer vaccine and is confident in the systematic way that the clinical trials were implemented.
“Sign me up for the vaccine!” said Gee, who as an obstetrician and gynecologist who regularly sees patients is eligible for one of the first batches of vaccines. She expressed confidence in the science behind the drug and the methodology used during trials.
Gee explained that instead of completing each step in the vaccine clinical trials independently, “steps were stacked.”
“There were no corners cut,” she said.
The most challenging effort, Gee believes, is getting people to trust in the vaccine.
“I saw patients this week and I would say about half my patients are not going to be the first in line to get the vaccine. They’re concerned. They wanna wait and see what happens. And the other half are gung-ho,” Gee said. “It’s hard to undo the damage that the Trump administration has done.”
Edwards, Giroir and Gee urged Louisianans to keep wearing masks, washing their hands, and socially distancing themselves from others as we enter what will hopefully be the final months of battling the COVID-19 vaccine.
“We just have to hold out for a couple more months,” Gee said. “Once we get the vaccine there’s a good chance that we’ll be able to do the things that we were able to do before in the ways that we did them before.”
Correction: An earlier version of this story gave an incorrect job title for Dr. Rebekah Gee.