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Speed over safety a recipe for vaccine disaster

This appeared in the Los Angeles Times.

As health experts keep reminding us, life will not return to anything resembling pre-pandemic normal until there is an effective and widely available coronavirus vaccine. And it will take at least a year to do the testing and clinical trials necessary to ensure that a vaccine candidate is safe for mass production.

So it’s more than a little unsettling that President Donald Trump’s effort to expedite a vaccine for COVID-19 has a significantly shortened timeline, one that seems suspiciously connected to the political calendar rather than sound science.

Operation Warp Speed, as its name implies, aims not just to have a viable vaccine candidate by the end of the year, but to have 300 million doses ready for the American public by January through a joint effort of government and the pharmaceutical industry. It’s an aspirational deadline, to be sure, but one that suggests shortcuts to the usual scientific standards.

History is filled with tales of slapdash efforts that had disastrous results. The one relevant to this moment is the terrible mishap that occurred in the rush to stop a polio outbreak in the 1940s and ’50s that was killing thousands of Americans, many of them children, and paralyzing many others. After a year of clinical trials, a vaccine was licensed to six companies to manufacture quickly to meet the demand of a desperately worried public.

But some of the batches made by California-based Cutter Laboratories failed to deactivate the live virus and ended up causing 40,000 polio infections, killing 10 children and leaving dozens more paralyzed. The incident led to better government oversight of vaccine production, but it’s also a cautionary tale about cutting regulatory corners.

And it seems they have to be cut to meet such an ambitious deadline. “I don’t see a path by which you can collect enough efficacy and safety data by the end of the year,” one member of a National Institutes of Health private-public partnership working on a COVID-19 vaccine told Science magazine. Even Trump’s own experts suggest the timeline is unrealistic.

Typically it takes years, not months, to complete the three phases of clinical trials that take place before a vaccine can be marketed. In the first phase, a small number of volunteers receive the vaccine candidate and are monitored by researchers who collect data about how it affects the participants.

In the second and third phase, an increasingly large group of participants representing different subsets of the population is inoculated with the proposed vaccine. These phases ensure that a successful vaccine candidate is safe for a broad cross-section of people and that it offers protection from the virus.

Even if the sped-up process produces a perfectly effective COVID-19 vaccine, it is going to require an extensive and aggressive public education campaign to counter the growing distrust of vaccinations in general. The skepticism has been whipped up by a few determined purveyors of disinformation, who overstate the incidence of vaccination injuries (which are real but rare) and hint that the “medical industrial complex” covers up adverse reactions so they can continue to profit from the drugs. As a result, vaccination rates have dropped in recent years, leading to the resurgence of fully preventable diseases such as measles.

Resistance to the COVID-19 vaccine has already been brewing on social media and in “documentaries” such as “Plandemic” that repeat conspiracy theories about coronavirus being made in laboratories and hint that the number of COVID-19 cases has been inflated by a corrupt government.

The fact that Operation Warp Speed is headed up by Moncef Slaoui — a former executive with pharmaceutical giant GlaxoSmithKline and a former board member of Moderna, a drugmaker now testing a COVID-19 vaccine — will be used to hint at nefarious motivations. Any further stumbles in the vaccine development process, or suggestions that safety processes were truncated, will no doubt be exploited by anti-vaccination foes and will make it harder for us to beat the disease into submission.

It’s not bad idea to marshal the full force of government and military to fast-track development of a vaccine and give it regulatory priority. But though this is a race of sorts, it’s not one that will be won with speed alone.
 

The Day editorial board meets regularly with political, business and community leaders and convenes weekly to formulate editorial viewpoints. It is composed of President and Publisher Tim Dwyer, Editorial Page Editor Paul Choiniere, Managing Editor Tim Cotter, Staff Writer Julia Bergman and retired deputy managing editor Lisa McGinley. However, only the publisher and editorial page editor are responsible for developing the editorial opinions. The board operates independently from the Day newsroom.

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