Operation Warp Speed - the partnership led by the White House for COVID-19 responses – urged its partners to be ready to begin distributing coronavirus vaccine by Nov. 1.
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FOLLOWING
The date is the first concrete goal set for companies working with Operation Warp Speed to be ready to deliver faxes to doctors and hospitals, said Wes Wheeler of supply giant United Parcel Service.
Wheeler said UPS and other partners will conduct test delivery runs in September.
‘We’ll be ready. We have to be ready, “he said. The world sees. We can not miss. “
Operation Warp Speed consists of federal agencies such as the CDC, the FDA, and the Department of Agriculture. The initiative aims to accelerate the rapid production of COVID-19 tests, treatments and vaccines. The goal is to produce and deliver 300 million doses of vaccine by January.
UPS is working as a consultant for Operation Warp Speed, Wheeler said. As the process progresses, it is expected to be involved with government and private medicine manufacturers in the logistics of distribution and storage of faxes in some capacity.
The November 1 release date is important because President Donald Trump has repeatedly said he expects a fax to be released “very soon”. There has been speculation that he would launch an “October surprise”, and is counting on the release of a coronavirus vaccine to boost his chances at the polls on November 3.
The Food and Drug Administration and other top government scientists have said that only science and data will be taken into account when deciding if a vaccine will be accepted. On Thursday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters that he had no political pressure for a vaccine release without sufficient data on safety and efficacy and he would resign if that happened.
The FDA has said it could consider releasing at least the first vaccine under what is known as an emergency use authorization instead of the full licensing process, if it has sufficient data on safety and effectiveness.
“We need to balance between the need to view an application for biological licenses … (it has) thousands of pages with many different analyzes, many of which will not be directly relevant to a decision on whether or not the vaccine is available,” he said. marked told a group of journalists who attended a training session of the National Press Foundation on August 13.
No one can say with certainty when a SARS-CoV-2 vaccine will be approved for use by the FDA, because it is not known when the results of the large Phase 3 clinical trials will be available, or whether those results will meet the requirements of the Agency for Safety and Efficiency, said Dr. Kelly Moore, associate director of immunization education and the Coalition for Immunization Action.
“Nevertheless, those preparing to distribute a SARS-CoV-2 vaccine aim to be ready to start distributing as soon as a vaccine is approved,” said Moore, who is also a professor of health policy. is at the Vanderbilt School of Medicine in Nashville, Tennessee.
The logistics are daunting. The US government is currently investing in at least seven potential fax machines. At least one of these must be stored and transported at -80 ° C or -112 ° Fahrenheit, a temperature at which antifreeze freezes and rubber breaks. Three others should be stored at -20 ° C or -4 ° Fahrenheit, the temperature ice is sent around.
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MOSCOW, RUSSIA – 14 AUGUST 2020: A laboratory of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Ministry of Health producing a COVID-19 vaccine. The vaccine is produced at the institute and other Russian pharmaceutical plants. It will be available to the public on January 1, 2021. Vyacheslav Prokofyev / TASS (Photo by Vyacheslav Prokofyev TASS via Getty Images)
The candidate faxes are already being produced and stored at manufacturers in the country. If they prove safe and effective, and are approved by the FDA, they will be released for use. All candidate faxes that do not will be destroyed.
Two waves of fax delivery
Delivery of the fax to sites where it can be administered will occur in two waves, an early one, if deliveries are limited and the army will be involved in logistics, and a later one, if the fax is a lot and can be distributed through the regular vaccination channels.
“That plan is that in Phase 1 we will distribute 10 million doses 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 high-priority recipients – likely health care workers – vaccinated first, Moore said.
“I get the feeling that 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 who are determined to be top priority,” she said.
Once more vaccines are available, probably within a few months, the second wave of distribution would go through the routine vaccine distribution program, likely using the existing national Vaccines for Children program as a backbone, she said.
This is also when vaccinations are likely to be available at major pharmaceutical chains such as Walgreens and CVS. Both companies are already planning for it, they told USA TODAY.
Complexity upon complexity
The logistical situation is remarkably complex, as multiple items are involved.
Experts think that more than one vaccine may be ready early, which means that one, two or as many as seven different vaccines can be administered nationwide at a time, each with a different temperature assignment for temperature.
It is also thought that some vaccines may work better for one group and others for another. That’s a huge complication for transportation, Wheeler said.
“They will try to fit effect with patient population,” he said. “So if one of the vaccines seems to work best with young, healthy people, then turn to that population, if another works better with the older ones then it would specifically go to that population.”
Operation Warp Speed also wants the doses to be sent with a matching vaccination kit with personal protective equipment for the person giving the shot and pamphlets about that particular vaccine, Wheeler said.
“In 30 years in the drug business I have never seen such a thing. The logistics are great, ”he said.
The fax, when it comes, will be more expensive than gold. UPS has already been involved in distributing doses of several of the candidate vaccines currently being tested in clinical phase 3 trials, in which 30,000 volunteers are given a candidate vaccine as a placebo shot.
“There is not a single bottle to be saved, not one. We have 24/7 GPS tracking on every shipment, ”he said.
Keep vaccines cold
While the work is underway, UPS is already building a “freezer farm” in its Louisville, Kentucky headquarters for air operations, 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 refrigerator at home, but which can hold materials up to -85 ° Celsius.
“About half of the freezers are already in place and they are now being validated,” he said.
The company has similar freezer farms in the Netherlands on its international air transport hub.
Vaccine that needs to be kept at -80 ° Celsius will be transported in boxes covered with dry ice, which can be replenished as the dry ice boils away, Wheeler said.
Air transport requires a different level of planning at these temperatures, as there are limits to the amount of dry ice that can be loaded on aircraft under FAA regulations. While it sublimes to gaseous carbon dioxide, there is a danger that the oxygen content of the air would fall too low, making the crew impossible.
Keeping faxes at the right temperature is crucial to keeping them effective, said Jaap Venema, chief scientific officer for US Pharmacopeia, a public organization for standard setting for drugs.
Like 25% of the vaccine worldwide is lost due to cold chain problems. While the world is working to create enough coronavirus vaccine for everyone, such losses are unimaginable, he said.
“That keeps me up at night,” he said.
Vaccine developer Pfizer said it has detailed logistics plans and tools to support transportation of its candidate fax, which should be kept frozen at -80 ° Celsius.
“We have specially designed, temperature-controlled containers that can allow storage conditions to last up to 10 days,” said Steve Danehy, Pfizer’s director of media relations. “We are confident of our ability to deliver and save doses to the destinations designated by governments, according to requirements at -80.”
Participants: Karen Weintraub
Coverage for health and patient safety 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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