Americans have placed great trust that the arrival of a vaccine against COVID-19 will finally end our long national pandemic nightmare. The Trump administration has claimed that 100 million doses of a vaccine could be available by the end of the year and that they will begin to ship within 24 hours of getting the regulatory go-ahead. But there are good reasons to be skeptical of those claims, most of all that developing and manufacturing the vaccine is just the beginning. We also need to distribute and administer it, and that's where the administration's optimistic timeline starts to fall apart.
As a physician who's helped make biopharma products for more than 35 years, I can attest to the extensive planning, patience, and precision that these stages require. Rapidly distributing a safe and effective vaccine across the nation is likely to be one of the most significant logistical challenges ever undertaken by the government within our borders. President Donald Trump's handling of the pandemic — disorganized, hasty and erratic — suggests that neither he nor his administration are up to the task. To the contrary, an administration that has eliminated nonpartisan careerists throughout government in favor of professionally inexperienced opportunists is unlikely to pull off the monumental task they've set for themselves.
For the sake of discussion, let's imagine that on December 31, 2020, one or more vaccines have been approved by FDA, and hundreds of millions of doses of each are ready to ship. First, the supply chain needs to be filled and the drug delivered to the professionals who will administer it. Pfizer's product may require ultracold storage at -94ºF. This type of specialized storage is not available in your doctor's office: it is found in universities and research centers. If the first vaccine to be approved requires this kind of storage, the logistics of distribution will be daunting.
One solution might be to mobilize the military to distribute the vaccine, but even then there will be substantial hurdles. The Defense Department's mission is to get troops and military supplies to specific areas as quickly as possible. While those capacities are formidable, they do not include maintaining large quantities of vaccine at ultralow temperatures with mandatory recording of temperatures needed to meet regulatory requirements that assure the vaccine remains potent. Nor does the military routinely deliver troops and supplies to thousands of communities at once.
These difficulties would only be multiplied if a second vaccine is approved rapidly. Keep in mind that, like many other vaccinations, those that are ultimately approved for COVID-19 may require two doses. Since the vaccines are not interchangeable: you need to have the same vaccine for both shots, so if there are two distinct versions being shipped around the country, those handling distribution would need to make sure that the correct formulations made it to the correct communities in the correct quantities. Does the military have the existing, FDA-compliant systems to assure this?
Then there's the question of how many people will need to be vaccinated. The most optimistic model says 43% will need to have potent antibodies to achieve herd immunity, which would mean 142 million people. The administration claims that they reach that benchmark in one year. Of course, some millions will already have been infected, but they are only part of the number needed. We can barely get that many people to wear a mask, despite the proven risk reduction. And a Kaiser Family Foundation poll shows more than half of Americans are still wary of a COVID-19 vaccine. Even those who take a vaccine may not be permanently protected. Recent data suggest mutations are increasing the contagiousness of the virus. So far there is no word that any of these mutations will allow the virus to avoid the vaccine, but if they do, we may see further slowdowns in vaccine development.
Even if there are no snafus and each of the approximately 7,000 U.S. hospitals has an ultracold freezer, they will need to vaccinate 142 million Americans two times, one for each dose. That means an average of 40,000 visits or nearly 800 per week at each hospital. All the while, those facilities will also need to continue to provide routine care, including to patients who have already been infected with the coronavirus.
The supply chain issues are, in short, of an unprecedented magnitude. While all Americans hope that everything will go well, it is really too much to hope for. Every involved party is pitching in wholeheartedly: the pharma industry, the people who volunteer for the trials, the FDA, the military, the health care professionals and ancillary services and the hospitals. However, the lack of a focus on planning, absence of transparency from the Defense Department, and unrealistic statements and dearth of leadership by the president is setting us up for a monumental failure.
Gorelick is a board-certified internal medicine and pulmonary disease specialist and a member of the Committee to Protect Medicare. He has more than 35 years of experience in the development of drugs, biologics, and medical devices in the health care sector. This piece was written by The Washington Post.
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