This policy paper was originally published by the Mercatus Center at George Mason University as a part of their Policy Response to Coronavirus and COVID-19 series.
Without a vaccine for COVID-19, the pandemic will be here for some time. Measures such as social distancing and robust surveillance can control the spread of the disease, but there will always be a risk that a flare-up will take lives, especially those of elderly and immunocompromised individuals. A return to normalcy depends on the availability of a vaccine, or possibly of several vaccines, as the virus continues to mutate over time.
America needs to return to normal as soon as possible, for the sake of the economy if not people’s sanity. Unfortunately, the FDA approval process is not likely to result in a marketable vaccine until sometime next year. To resolve this mismatch in timelines, Congress should create an expedited process to allow patients, via a process of informed consent, to use vaccine candidates that have not yet completed the full FDA approval process.
Good news and bad news about vaccines
Meeting the need for a vaccine is a “good news, bad news” proposition. The good news is that creating vaccines has never been easier. Thanks to modern science, scientists have ever-advancing tools and more possible approaches than ever before. In addition to traditional whole-pathogen approaches, scientists today can make subunit vaccines as well as state-of-the-art DNA and RNA vaccines. Synthetic biology is being used as a design tool to make these vaccines more effective than ever.1 San Diego–based Inovio Pharmaceuticals claims to have designed a DNA vaccine candidate for COVID-19 only three hours after the publication of the SARS-CoV-2 genome.2
The bad news is that vaccine trials for new diseases take a long time. “The traditional vaccine timeline is 15 to 20 years,” says Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative.3 Given the urgency of addressing the COVID-19 pandemic, the world is moving faster: for example, researchers have skipped the usual animal testing of Moderna’s mRNA vaccine candidate and have already begun human clinical trials in Seattle.4 Even so, experts say it will take between a year and 18 months to get an FDA-approved COVID-19 vaccine on the market. This means that even if society “flattens the curve” and gets some respite from warm summer weather, the population will still be unprotected in the fall, when colder weather could be expected to drive an increase in COVID-19 contagion.
Safety and effectiveness of vaccines should be thoroughly studied, but in this extreme situation all should recognize that safety and effectiveness are not all-or-nothing properties. A vaccine that is available this summer that is probably (but not guaranteed to be) safe could be better than no vaccine going into a second wave of the pandemic this fall. And effectiveness even for approved vaccines is known to be incomplete and variable. According to the Centers for Disease Control and Prevention, the flu vaccine for the 2018–2019 flu season was only 29 percent effective (see figure 1).5 That said, even a partially effective vaccine improves herd immunity and drives the effective reproduction rate of the virus down so that outbreaks are easier to contain. The seasonal flu is a challenging target, and there is every reason to expect that a coronavirus vaccine could have higher effectiveness, but even partial effectiveness creates significant value.
Read the full policy brief here.
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