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The missing dimension in COVID-19 vaccine development

Editor’s Commentary: There’s nothing safe or effective about a vaccine people refuse to take

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While they race to create COVID-19 vaccines, governments, drug companies and the public health community must avoid a deadly mistake that has limited the effectiveness of other vaccines.

From the moment a new medical product is conceived through the day it is approved, the focus is almost exclusively on characterizing, enhancing and demonstrating its safety and efficacy.

A third dimension is equally important but usually overlooked: trust.

There is nothing safe or effective about a medicine that many people refuse to take.

Anti-vaxxers have caused measles outbreaks around the world with tragic consequences for pediatric cancer patients and others who are unable to be vaccinated. The consequences of large-scale rejection of a COVID-19 vaccine would extend beyond the pandemic, tarnishing faith in other vaccines, and more fundamentally chipping away at the shared values that make democratic societies possible.

A virtual army of real people and bots, many set in motion by foreign governments seeking to destabilize Western democracies, is already spreading fear and misinformation about COVID-19 vaccines.

So far, manufacturers of COVID-19 candidate vaccines have failed to integrate trust-building measures into their development programs. In the U.S., the erratic comments on medical topics of President Donald Trump, sidelining the CDC and demonizing the WHO, have made the job tougher.

The urgency of the pandemic and the intense attention focused on vaccines makes it even more important than in the past to mount a sustained, intelligent campaign to earn the public’s confidence.

Vaccines created at “warp speed” will do no good if they are not widely and quickly accepted.

Promises to break speed records must be balanced with believable assurances that safety hasn’t been compromised. Those assurances aren’t only important for vaccine deniers. It isn’t irrational to be afraid of a vaccine that hasn’t been thoroughly and honestly tested.

To build trust in COVID-19 vaccines, people need to be told honestly what to expect and when they can expect it to happen.

Vaccine denial is not inevitable. The story of the creation of polio vaccines, a drama that caught the imaginations of people around the world and led the U.S. and the USSR to set aside Cold War antagonisms, could and should be repeated now that the world again faces a common threat. No one who saw the deaths and suffering inflicted by polio had to be coerced into vaccinating their children.

To build trust in COVID-19 vaccines, people need to be told honestly what to expect and when they can expect it to happen.

Much of the anti-vax movement is built on the falsehood that thimerosal, a preservative, causes harm. To assuage that concern, vaccine manufacturers have largely switched to formulations that don’t require preservatives.

Shortages of the specialized glass used to make vaccine vials and distribution constraints will make it necessary to use multi-dose containers for COVID-19 vaccines. Thimerosal will have to be added to the vials to keep the vaccines safe.

The time to start slaying the thimerosal myth is now. It will be too late when vaccines are already being distributed.

It is possible that two or more doses of vaccines will need to be administered over the course of several weeks. That means there must be clear communication about the consequences of failing to show up for booster shots, as well has how long it takes for protection to kick in.

If vaccines reduce the severity of symptoms but do not eliminate them and don’t prevent the spread of infection, that will have to be explained. The danger is that many who expect complete protection will be so disappointed by anything less that they forgo vaccination.

The risk of a collapse in public confidence must also be taken into consideration by officials who are considering authorizing emergency use of vaccines in the absence of long-term safety experience. A botched vaccine roll-out could be far more dangerous than a delayed launch.

Like many other aspects of pandemic response, it isn’t clear who is or should be responsible for creating and implementing vaccine trust plans. If a vigorous communications strategy isn’t part of the Trump administration’s Operation Warp Speed, it should be added to the mission. Similar initiatives are needed around the world.

Drug company CEOs have an important role in building trust. Making extravagant claims suggesting the inevitability of success and disregarding the potential for delays does wonders for a company’s stock. Unmet promises and unrealistic expectations will be remembered long after investors and executives have pocketed profits.

The world’s hopes are resting on the success of the biopharmaceutical industry. In a business that constantly veers between disaster and triumph, it should be obvious that there’s too much at stake, for everybody, including drug companies, to blow it by over-promising.

Editors’ commentaries do not necessarily reflect the views of BioCentury.

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