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EDITORIAL

Build public trust in the vaccine

The Food and Drug Administration needs to make transparency and public communication a priority when approving COVID-19 vaccines.

A patient enrolled in Pfizer's coronavirus vaccine clinical trial received a dose of the vaccine. It’s critical to build trust that the FDA not only require ongoing study of the long-term effects of the vaccines but also release the data as well as address head-on any serious negative reactions people have.
A patient enrolled in Pfizer's coronavirus vaccine clinical trial received a dose of the vaccine. It’s critical to build trust that the FDA not only require ongoing study of the long-term effects of the vaccines but also release the data as well as address head-on any serious negative reactions people have.Associated Press

The coronavirus is the enemy in this pandemic, but as we move toward government approval of vaccines, the virus has several allies: conspiracy theories, deep-seated distrust of government, and scientifically unfounded fear of immunizations.

That’s why, as the Food and Drug Administration considers emergency use authorization for vaccines from pharmaceutical companies Pfizer and Moderna, the agency must go to extraordinary lengths to reassure the public about vaccine safety and to deprive conspiracy theorists and anti-vaccination alarmists of opportunities to undermine this critical effort.

The FDA’s Vaccines and Related Biological Products Advisory Committee, from which the agency usually takes its cue, will consider the Pfizer (and partner BioNTech) vaccine on Wednesday, Moderna’s a week later. The FDA generally follows the recommendation of the advisory group.

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Given the simmering suspicions of vaccines in general, the politicized nature of this pandemic, which some Americans still believe is a hoax or overhyped, and the lamentable American tendency to credit conspiracy theories, it is vital that the approval process proceed in a transparent, confidence-inspiring manner.

Although the results those companies have reported are hugely encouraging, the Phase 3 trial data has not yet been peer-reviewed or published in medical journals. Given this public health emergency, there won’t be time for that prior to approval. But one way to inoculate the process against irrational suspicion would be for the FDA to ensure the full online release of all the Phase 3 data in a fashion that allows interested parties to review it. (Pfizer and BioNTech told the Globe editorial board they plan to submit their trial data for publication in a few weeks.) People also need an assurance that the government will keep track of, and advise the public about, possible longer-term effects of the vaccines. The FDA should follow up with a scientifically sound public information campaign about the vaccines, their efficacy, and side effects.

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The FDA already has some plans to be transparent with the public. The meeting of the advisory panel reviewing the vaccine makers’ applications for approval will be live-streamed. (More information is available on the agency’s website.) But though the FDA told the Globe, via e-mail, that more background material would be released two days before the meetings, it did not answer whether all the Phase 3 data sets would be made public. Nor did spokespeople specify whether the evaluation of longer-term side effects will be done; that said, agency officials have stipulated elsewhere that that is usually a part of FDA oversight. Beyond saying that the FDA has ongoing public information efforts, the agency didn’t respond to several queries about a public information campaign.

It’s critical to build trust that the FDA not only require ongoing study of the long-term effects of the vaccines but also release the data as well as address head-on any serious negative reactions people have.

Mind you, this isn’t merely a matter of process nitpicking or second-guessing. As we’ve seen in any number of other instances, conspiracy theories can crystallize around a mote of dust. It’s also instructive to remember that despite widespread scientific assurances that vaccinations are safe, the anti-vaccination hysteria has made significant headway. Even Robert F. Kennedy Jr., son of the late attorney general, has wandered into the swamp of unscientific vaccine suspicion, earning him a scolding from more level-headed Kennedy family members.

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That unfounded vaccination skepticism is particularly worrisome with COVID-19 because effectively curtailing a pandemic that has killed more than 270,000 Americans depends on having as many people as possible get the vaccine. According to recent polling compiled by the Societal Experts Action Network, though two-thirds of Americans say they are at least somewhat likely to get a vaccine once they are available, 62 percent say they would be at least somewhat uncomfortable being in one of the initial groups, and 21 percent say they are quite certain they won’t get vaccinated.

One way to allay suspicions is through a well-orchestrated, multifaceted public information campaign. It could feature several different messages. One might enlist prominent and respected Americans with scientific backgrounds who had reviewed the data and would vouch for the safety of the vaccine. Yet another could feature some of the people who participated in the Phase 3 trials discussing any side effects they had suffered. Well-known Americans, explaining that they had been briefed by scientific experts and trusted them enough to receive the vaccination themselves, could also be effective. There, the agency should take former presidents Bill Clinton, George W. Bush, and Barack Obama up on their offers to be vaccinated on TV. If President Trump or members of his family wanted to do the same, that would surely reduce suspicions among his supporters.

Tobe Berkovitz, a professor of advertising at Boston University, also suggests featuring celebrities and well-known athletes or entertainers getting their shots when their vaccination time arrives. These influencers should be chosen to appeal to diverse communities — think of everyone from Toby Keith to Beyonce. But there shouldn’t be line-jumping, Berkovitz stresses, since that could create public resentment.

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Widespread acceptance of the vaccines is critical to the future health of this country. To that end, the FDA must do everything it can to maximize information and transparency and minimize suspicion and doubt.


Editorials represent the views of the Boston Globe Editorial Board. Follow us on Twitter at @GlobeOpinion.