Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean?
Operation Warp Speed – the White House-led partnership for COVID-19 answers – is pushing its partners to be ready to begin distributing a coronavirus vaccine by Nov. 1.
The date is the first concrete goal set for companies working with Operation Warp Speed be prepared to deliver vaccines to doctors and hospitals, said Wes Wheeler of the delivery giant United Parcel Service.
Wheeler said UPS and other partners will be conducting test delivery runs in September. “We’ll be ready. We have to be ready,” he said. “The world is watching. We can’t fail.”
Operation Warp Speed is comprised of federal agencies such as the CDC, the FDA and the Department of Agriculture. The initiative aims to expedite the rapid production of COVID-19 tests, treatments and vaccines. Its goal is to produce and deliver 300 million doses of vaccine by January.
UPS is working as a consultant to Operation Warp Speed, Wheeler said. As the process moves forward, it expects to be involved with the government and private drug manufacturers in the logistics of vaccine distribution and storage in some capacity.
The Nov. 1 distributiondate is significant because President Donald Trump has repeatedly said he expects a vaccine to be released “very soon.” There has been speculation he might launch an “October Surprise,” counting on the release of a coronavirus vaccine to buoy his chances at the ballot box on Nov. 3.
The Food and Drug Administration and other top government scientists have said only science and data will be taken into account when deciding if a vaccine is accepted. On Thursday, Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, told Reuters he has faced no political pressure to release a vaccine without sufficient data on safety and effectiveness and he would resign if that happened.
The FDA has said it might consider releasing at least the first vaccine under what’s known as an Emergency Use Authorization rather than the full licensing process, if it has sufficient data on safety and efficacy.
“We have to balance the need to see a biologics license application … (it has) thousands of pages with a lot of different analyses many of which will not be directly relevant for a decision of whether or not to make the vaccine available,” Marks told a group of journalists attending a National Press Foundation training on Aug. 13.
No one can say with certainty when a SARS-CoV-2 vaccine will be approved for use by the FDA because it’s not known when the results of the large Phase 3 clinical trials will be available, or whether those results will meet the agency’s requirements for safety and effectiveness, said Dr. Kelly Moore, associate director of immunization education and the Immunization Action Coalition.
“Nonetheless, those preparing to distribute a SARS-CoV-2 vaccine are aiming to be ready to begin distribution as soon as a vaccine is approved,” said Moore, who also is a professor of health policy at the Vanderbilt School of Medicine in Nashville, Tennessee.
The logistics are daunting. The U.S. government is currently investing in at least seven potential vaccines. At least one of themneeds to be stored and transported at -80° Celsius or -112° Fahrenheit , a temperature at which antifreeze freezes and rubber shatters. Three others have to be stored at -20° Celsius or -4° Fahrenheit, the temperature ice cream is shipped at.
The candidate vaccines already are being produced and stored at manufacturing sites across the country. If they prove safe and effective, and are approved by the FDA, they will be released for use. Any candidate vaccines that don’t will be destroyed.
Two waves of vaccine delivery
Delivery of the vaccine to sites where it can be administered will happen in two waves, an early one, when supplies are limited and the military will be involved in logistics, and a later one, when the vaccine is plentiful and can be distributed through the regular vaccination channels.
“That plan is that in phase 1 we will have 10 million doses distributed in November and 20 million doses in December,” said Wheeler, president of UPS Healthcare and Life Sciences.
Because the initial doses will be in limited supply, the focus is expected to be on getting high priority recipients — likely front line health workers — fully vaccinated first, said Moore.
“I get the sense the Centers for Disease Control, the Department of Defense and the states will target a limited number of locations where they can easily reach people determined to be top priority,” she said.
Once more vaccine becomes available, likely within several months, the second wave of distribution would go through the routine vaccine distribution program, probably using the existing national Vaccines for Children program as a backbone, she said.
That’s also when vaccinations would likely become available at major pharmaceutical chains such as Walgreens and CVS. Both companies are already planning for that, they told USA TODAY.
Complexity upon complexity
The logistical situation is remarkably complex because there are multiple items involved.
Experts presume more than one vaccine may be ready early on, meaning there could be one, two or as many as seven different vaccines being administered nationally at the same time, each with a different temperature storage requirement.
It’s also thought some vaccines might work better for one group and others for another. That’s an enormous transportation complication, said Wheeler.
“They’re going to try to match effect with patient population,” he said. “So if one of the vaccines looks as if it will work best with young, healthy people then you divert to that population, if another works better with the elderly then it would go to that population specifically.”
Operation Warp Speed also wants the doses shipped with a matching vaccination kit containing personal protective equipment for the person giving the shot and leaflets about that particular vaccine, Wheeler said.
“In 30 years in the drug business, I’ve never seen anything like this. The logistics are amazing,” he said.
The vaccine, when it comes, will be more precious than gold. UPS already is involved in distributing doses of several of the candidate vaccines now being tested in Phase 3 clinical trials, in which 30,000 volunteers are given either a candidate vaccine or a placebo shot.
“There is not one single vial to spare, not one. We have 24/7 GPS tracking on every shipment,” he said.
Keeping vaccine cold
As it gears up for the work, UPS is already building a “freezer farm” at its Louisville, Kentucky, air operations headquarters, as well as a COVID-specific operations center there. The freezer farm building will be filled with hundreds of ultra-low temperature freezers, each about the size of a large home refrigerator but which can hold materials as low as -85° Celsius.
“About half the freezers are already in place and they’re being validated now,” he said.
The company has similar freezer farms in the Netherlands at its international air transit hub.
Vaccine that must be kept at -80° Celsius will be transported in boxes topped off with dry ice, which can be replenished as the dry ice boils away, Wheeler said.
Air transportation requires another level of planning at these temperatures because there are limits on the amount of dry ice that can be loaded onto planes under FAA regulations. As it sublimates to gaseous carbon dioxide there is a danger the oxygen content of the air would fall too low, incapacitating the crew.
Keeping vaccines at their proper temperature is crucial to keeping them effective, said Jaap Venema, chief science officer for U.S. Pharmacopeia, a public standard-setting organization for drugs.
As much of 25% of vaccine globally is lost because of cold chain issues. As the world works to create enough coronavirus vaccine for everyone, such loses are unimaginable, he said.
“That’s keeping me up at night,” he said.
Vaccine developer Pfizer said it has detailed logistical plans and tools to support transportation of its candidate vaccine, which must be kept frozen at -80° Celsius.
“We have specially designed, temperature-controlled containers that would allow the maintenance of storage conditions up to 10 days,” said Pfizer’s director of media relations Steve Danehy. “We are confident of our capability to deliver and store doses to the destinations governments designate, according to requirements at -80.”
Contributing: Karen Weintraub
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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