October 20, 2020

'There will be many, many problems': What to expect after a coronavirus vaccine is approved

Daily Briefing

    Federal health officials, public health experts, and drugmakers have said they believe FDA could issue an emergency use authorization (EUA) for a coronavirus vaccine candidate by the end of this year, meaning America could have just a few months to develop a plan to distribute the vaccine nationwide.

    A vaccine approval is coming. Get ready to ask these 8 questions.

    Currently, state, local, and federal officials are working on such plans, aiming to vaccinate as many Americans as possible against the novel coronavirus, which has infected nearly eight million people in the United States and has been linked to more than 215,000 deaths. But doing so won't be nearly as easy as it might seem—meaning that, even once the United States has a vaccine against the coronavirus, it could still be a while before life in America returns to "normal," experts say. Here's why.

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    Manufacturing enough doses of a vaccine could prove difficult

    According to the Center for American Progress (CAP), administering two doses of an authorized vaccine—which is the dosing currently being tested in many late-stage coronavirus vaccine trials—would require the manufacturing and distribution of a total of 660 million doses to vaccinate the entire U.S. population, or at least 462 million doses to vaccinate enough Americans to achieve herd immunity. But manufacturing that many doses of a vaccine may prove difficult, particularly in light of unique challenges posed by the coronavirus pandemic.

    For instance, the pandemic has caused disruptions in America's health care supply chain, which has become largely reliant on ingredients, materials, and products made in other countries. Labor and supply shortages throughout the world have resulted in the United States facing shortages of critical medical supplies, from ventilators and personal protective equipment (PPE) to ingredients needed to manufacture some prescription drugs and supplies that could be critical to the storage and distribution of coronavirus vaccines.

    According to the Wall Street Journal, pharmaceutical companies are working to build supply chains of both raw materials and factory capacity to manufacture billions of doses of coronavirus vaccines—a task that's no easy feat. According to CAP, one industry executive explained that the undertaking is especially difficult because the pandemic has caused a lack of visibility on all sides of the supply chain.

    And even if drugmakers can get the ingredients needed to make the vaccines, they may have a hard time finding the materials they need to store the doses. That's because medical glass has been in short supply since the start of the pandemic, which could prove to be an obstacle for vaccine manufacturers who will need millions of vials for vaccine storage, the Journal reports.

    As a result, even though pharmaceutical companies are working to ramp up production as quickly as they can, it's possible that there could be a gap of months between when the first doses of an authorized coronavirus vaccine are released and the point at which a company has manufactured enough doses to vaccinate the entire country, experts say. Neel Jones Shah, global head of air carrier relationships at Flexport, told CAP, "To a T, [manufacturers are] extremely nervous about being able to bring these to market as quickly as people might expect."

    Distributing a vaccine could prove even more difficult

    Even if companies can manufacture the needed number of doses of a coronavirus vaccine, the effort to distribute a vaccine would require the "largest" vaccination campaign "ever undertaken" in America, needing unprecedented planning and coordination, according to the Washington Post.

    The first obstacle the United States could encounter when distributing a new coronavirus vaccine is having the capacity and equipment needed to properly store and ship the vaccine doses, which also could be affected by the country's supply shortages, experts say. And the country could face a particular challenge when it comes to storing and shipping Pfizer's and BioNTech's coronavirus vaccine candidate, which could require a refrigeration temperature of minus 70 degrees Celsius, STAT News reports.

    "[V]accine supply chains are exponentially more complex than the PPE supply chain," Shah told CAP. "You can't ruin PPE by leaving it on the tarmac for a couple of days," but "[y]ou will destroy vaccines."

    And Joachim Kuhn—CEO of Va-Q-Tec, a manufacturer that is increasing its production of shipping containers by 50% this year—told STAT News, "We're seeing increased demand for containers that can store product at low temperatures and longer transport duration."

    Supply chain shortages also could affect health care providers' ability to administer the vaccines, the Journal reports, as syringes and needles are in high demand.

    Further, officials also must craft and implement a plan detailing who would receive and administer coronavirus vaccines—and determine which Americans, if any, would get priority for receiving a vaccine first.

    Last month, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a draft plan for distributing a coronavirus vaccine that prioritizes Americans based on their risk of infection, with health care workers among the first to receive the vaccine. NASEM created the plan at the request of CDC and NIH, and the proposal aims to serve as a guide for more detailed plans on how the United States should prioritize coronavirus vaccinations once a vaccine candidate is approved. For example, NASEM's proposal is intended to serve as a model for the Advisory Committee on Immunization Practices, which is an expert panel responsible for developing vaccination guidance for CDC and local, state, and tribal health authorities.

    CDC also called on and has been working with states to craft plans to distribute possible coronavirus vaccines, but federal and state governments haven't yet released official details on those plans. According to the National Governors Association (NGA), CDC in July developed a preliminary coronavirus vaccine distribution plan that expanded on public health infrastructure that was originally developed to distribute a H1N1 vaccine.

    Under the plan, manufacturers would deliver coronavirus vaccines to a central distributor that would then send weekly supplies of the vaccine to individual states and territories, the Post reports. The states and territories then would approve requests for vaccine doses from providers and clinics and distribute the doses to their facilities, where providers would administer the inoculation. In addition, NGA said additional supplies of the vaccine would be made available to "select private partners," such as CVS Health and Walgreens, to further "expand access."

    But senior Trump administration officials have implied that the federal government could take on a bigger role in distributing the vaccine, saying the effort would be a "joint venture" between CDC and the Department of Defense (DOD), the Post reports. One of the officials said DOD would be responsible for "getting the vaccines to the right place, at the right time, in the right conditions" and supplying needles and syringes, according to the Post.

    However the United States ends up distributing a coronavirus vaccine, the effort will be a major undertaking and will require a system to "track the supply, manage the allocation equitably around the country, deal with concerns with the vaccine that arise, track adverse events, and communicate clearly and transparently," Tom Inglesby, director of the Johns Hopkins Center for Health Security, said.

    And Bill Foege, a former CDC director and current co-chair of the NASEM panel that released the draft distribution plan, said Americans should expect snafus. "There will be many, many problems with distribution," he told STAT News.

    Initial vaccines may not be totally effective—and Americans may have to choose between them

    Another factor that could complicate plans to get Americans vaccinated is that the country's initial vaccines against the novel coronavirus may not be totally effective—and Americans will have to choose between getting one of these initial vaccines or waiting until they know which vaccine is the most effective.

    As the New York Times reports, the first round of coronavirus vaccines that become available in the United States "may provide only moderate protection, low enough to make it prudent to keep wearing a mask." And "[b]y next spring or summer, there may be several of these so-so vaccines, without a clear sense of how to choose from among them," according to the Times.

    That's because current late-stage trials on coronavirus vaccine candidates are testing the candidates against placebos, instead of against each other. If the experimental vaccines were being tested against each other, researchers would have information which vaccine candidates are more effective than others. But those trials aren't happening at this time, because some U.S. officials thought it would take too long to get such trials off the ground, the Times reports. As such, it will be difficult to know which among the first batch of authorized coronavirus vaccines is most effective, according to the Times.

    Further, because the first round of vaccines that become available in the United States may be effective to at least some degree, they could make it difficult for drugmakers working on potentially "superior" vaccines to conduct and complete clinical trials, the Times reports. That's because, instead of participating in a coronavirus vaccine trial or completing a vaccine trial in which they are already enrolled, Americans could choose instead to get an authorized coronavirus vaccine to acquire at least some protection against the virus.

    In addition, manufacturers of later coronavirus vaccine candidates may have to prove that their candidates are more effective than the initial batch of authorized vaccines. That could make it tough to gain FDA's approval, as "[t]he difference between two vaccines will be smaller than between a vaccine and a placebo. As a result, these trials may have to be bigger and run longer," and "[t]he steep cost may be more than many of the small start-ups working on innovative vaccines can afford," the Times reports.

    "That basically prevents the development of better vaccines," Naor Bar-Zeev, a vaccine expert at the Johns Hopkins University School of Medicine, told the Times.

    Overall, Gregory Poland, director of the Vaccine Research Group at the Mayo Clinic, told the Times that officials and scientists will need to be honest and open with Americans about how coronavirus vaccine candidates and what their effectiveness could mean in the future. "As long as you frame something in advance, people do better with it," he said (Spiro/Emanuel, Center for American Progress, 7/28; Twohey, New York Times, 7/16; Sun, Washington Post, 8/3; Sun, Cowan, Reuters, 7/31; Washington Post, 8/14; Fox, CNN, 8/19; Sun, Washington Post, 7/29; Silverman, "Pharmalot,"  STAT+, 7/30; Chen, Wall Street Journal, 7/30; Murray/Griffin, Bloomberg, 7/25; Loftus, Wall Street Journal, 8/5; Lupkin, NPR, 8/6; Rosenthal, Kaiser Health News, 7/8; Branswell/Silverman, STAT News, 10/9; Zimmer, New York Times, 10/12).

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