Operation Warp Speed, the White House-led association for COVID-19 responses, is pressuring its partners to be able to start distributing the coronavirus vaccine until November 1.
The November 1 target represents the first specific date the White House has set for an imaginable delivery of vaccines to doctors and hospitals. The November date is the purpose for corporations operating with Operation Warp Speed, said Wes Wheeler of United Parcel Service, the delivery giant that could eventually deliver vaccines to hospitals and clinics.
Wheeler said UPS and its partners would conduct delivery tests in September.
“We’ll be ready. We have to be ready,” he said. The global is watching. We can’t fail. “
Operation Warp Speed is composed of federal agencies such as the CDC, FDA and Department of Agriculture. The initiative aims to boost the immediate production of COVID-19 tests, remedies and vaccines. Its purpose is to produce and administer three hundred million doses of vaccine as of January.
UPS is acting as a representative of Operation Warp Speed, Wheeler said. As the procedure progresses, he hopes to be concerned about the government and drug brands in the vaccine distribution logistics and garage to some extent.
The November 1 distribution date is vital because President Donald Trump has said he expects a “very soon” vaccine to be released. It has been hypothesized that it could launch an “October surprise” depending on the launch of a coronavirus vaccine to increase its chances at the polls on November 3.
The Food and Drug Administration and other high-level government scientists have said that only science and knowledge will be taken into account when deciding whether to accept a vaccine. On Thursday, Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, told Reuters that he had been stressed about releasing a vaccine without sufficient protection and knowledge of efficacy and would resign if that happened.
The FDA said it would possibly publish at least the first vaccine under what is called an emergency use authorization instead of the full authorization process, if it has sufficient protection and efficacy data.
“We want to strike a balance between the desire to see a biological license application … (contains) thousands of pages with many other tests, many of which will not apply to decide whether the vaccine is available or not.” “he says. told an organization of hounds who participated in an education of the National Press Foundation on August 13.
No one can say with certainty when the use of a SARS-CoV-2 vaccine will be approved through the FDA because it is known when the effects of phase 3 primary clinical trials will be available, or whether those effects will meet the protection and efficacy of the agency. requirements, said Dr. Kelly Moore, associate director of immunization education and the Immunization Action Coalition.
“However, those preparing to distribute a SARS-CoV-2 vaccine are aiming to be able to begin distribution as soon as a vaccine is approved,” said Moore, who is also a professor of fitness policy at the Vanderbilt School of Medicine in Nashville. Tennessee.
Logistics is daunting. The U.S. government is recently investing in at least seven possible vaccines. At least one of them will have to be stored and transported at -80 degrees Celsius or -112 degrees Fahrenheit, temperature at which the antifreeze freezes and the rubber breaks. Three others should be kept at -20 degrees Celsius or -4 degrees Fahrenheit, the ice temperature is sent.
Candidate vaccines are already produced and stored at production sites across the country. If they are shown and effective and approved by the FDA, they will be released for use. All candidate vaccines that will not be destroyed.
The delivery of the vaccine to the sites where it can be administered will be in two waves, the first, when the materials are limited and the army is concerned about logistics, and the last, when the vaccine is abundant and can be distributed through the usual immunization channels. .
“This plan is that in Phase 1, we’ll have 10 million doses distributed in November and 20 million doses in December,” said Wheeler, president of UPS Healthcare and Life Sciences.
Since initial doses will be limited, attention will focus on full vaccination of high-priority recipients, probably front-line fitness staff, Moore said.
“My impression is that the Centers for Disease Control, the Department of Defense, and the states will point to a limited number of options where they can seamlessly succeed people with precedence,” he said.
Once a new vaccine is available, probably within a few months, the distribution wave of the moment will pass through the regimen’s vaccine distribution program, probably the existing national vaccine program for young people as a backbone, he said.
It is also at this time that vaccines are very likely to be available at primary pharmaceutical chains like Walgreens and CVS. Both corporations are already making plans for this, they told USA TODAY.
Logistics is remarkably complex because several elements are involved.
Experts assume that more than one vaccine may be in one position from the beginning, meaning there may be only one, two or up to seven other nationwide vaccines, each with a different temperature requirement.
It’s also possible that some vaccines work better for one organization and others for another. “It’s a massive transport complication,” Wheeler said.
“They’ll check to adjust the effect to the patient population,” he said. the elders, would pass to that specific population.
Operation Warp Speed will also be the doses to be sent with a corresponding vaccination kit containing non-public protective devices for the user who injected the vaccine and brochures on this specific vaccine, Wheeler said.
“In 30 years in drug trafficking, I’ve never noticed anything like it. The logistics are amazing,” he said.
The vaccine, when it arrives, will be more valuable than gold. UPS is already distributing doses of several of the candidate vaccines that are being tested lately in Phase 3 clinical trials, in which 30,000 volunteers get a candidate vaccine or a placebo vaccine.
“There is not a single bottle to resell, not one. We have 24/7 GPS tracking for shipping,” he said.
While preparing for work, UPS is already building a “freeze farm” at its Louisville, Kentucky air operations headquarters, as well as a COVID-specific operations center. The construction of the freezer farm will be filled with heaps of freezers at very low temperatures, the size of a giant domestic refrigerator, but capable of containing fabrics as low as -85 degrees Celsius.
“About part of the freezers are already in position and they’re being validated,” he said.
The company has freezing farms in the Netherlands in its foreign air traffic center.
The vaccine, which will be stored at -80 degrees Celsius, will be transported in dry ice boxes, which can be restored as dry ice evaporates, Wheeler said.
Air requires some other point to make plans at those temperatures, as there are limits on the amount of dry snow that can be loaded into aircraft according to FAA regulations. Because it is converted into carbon dioxide, the oxygen content of the air may drop too much, leaving the equipment unable to function.
Keeping vaccines at the right temperature is so that they remain effective, said Jaap Venema, U.S. Chief Scientific Officer. S. Pharmacopeia, a public drug standardization organization.
Up to 25% of vaccines worldwide are lost due to bloodless chain problems. “While the world strives to create enough coronavirus vaccines for everyone, such losses are unimaginable,” he said.
“It helps me stay awake at night,” he says.
Vaccine developer Pfizer said he had detailed plans and logistics equipment to transport his candidate vaccine, which should be kept frozen at -80 degrees Celsius.
“In particular, we designed temperature-controlled boxes that would save situations for up to 10 days,” said Steve Danehy, Pfizer’s media relations director. “We are confident of our ability to deliver and purchase doses at government-designated destinations, as required up to -80.
Contributor: Karen Weintraub
Usa TODAY’s patient protection and physical fitness policy is made imaginable in components through a grant from the Masimo Foundation for Ethics, Innovation and Competence in the Health Sector. The Masimo Foundation does not contribute any editorial contribution.