FDA’s break for COVID vaccine rollout for Johnson & Johnson could bear fruit

  • The choice of when to discontinue a COVID vaccine during rare events is difficult.
  • News of adverse reactions can cause hesitation. But so can an appearance of complacency.
  • People who think it is clear whether the government has made the right call are too confident.
  • This is an opinion column. The thoughts expressed are those of the author.
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I’m not sure the Food and Drug Administration and the Centers for Disease Control & Prevention made the right choice by recommending an interruption in the administration of the Johnson & Johnson COVID vaccine, while rare but severe blood clotting events at women are examined. But I think people like Nate Silver, the founder of FiveThirtyEight, who seems to have made the wrong choice, is too confident.

It is important to remember that the marginal vaccine consumer is not like you.

Perhaps people have irrationally higher safety expectations regarding man-made pharmaceutical products than other naturally occurring products or diseases. Other legal products, like cigarettes, poses a clear and demonstrated risk of blood clots, as opposed to the J&J vaccine where there is only concern. But cigarettes are not a health aid, and we are not trying to convince the public to smoke them. You can track down anything you want against the abuse of the precautionary principle, but to some extent the government responds to public opinion about what activities the precautionary measures require.

It is fair and appropriate to tell a vaccine to the public that rarely – very rarely, with so far only six reported cases from approximately 7 million doses of J&J administered – a serious clotting event can cause you to remain safer, as the vaccine COVID occurs, which produces severe coagulation events (not to mention other adverse reactions) much more frequently.

But suppose the outcome of this pause is that the government decides in a few days that these rare incidents are sufficient to exclude women under 50 from receiving the J&J vaccine, or to add new safety protocols when it is administered to them. Wouldn’t it be an even better message to increase confidence in the vaccines – that health experts are adapting the deployment of vaccines to eliminate even the small risk that may exist here for a section of the population, while effective vaccines still be made available to the entire population?

Or perhaps officials will look at the data and decide there is insufficient reason to change the direction around J&J – that the link to these events is too vague and that the events are too rare. In that case, the interruption will still be clear to the public that they are monitoring the issue and that they are prepared to change course if necessary, which they believe is not the case.

If you acknowledge uncertainty, you can be more credible

One of the most popular responses in surveys of people who are reluctant to take the COVID vaccines is that they are waiting to see if the vaccines are safe. We’re all learning going – and that includes scientists, doctors and government officials.

The possible unwavering confidence of the government can reassure these people. But unwavering trust can also be suspicious. If the government never changes its mind about any aspect of vaccine administration in the light of new information, it may cause some cautious observers to believe that the government is not considering new information. An interruption like this shows that the government is working with the public to discourage conspiratorial thinking.

It’s worth remembering that there is literally a J&J handbook in which confidence in your product can be boosted in the long run if you acknowledge and draw attention to safety: the 1982 incident in which the company Tylenol pulled nationally off the shelves due to a series of poisoning incidents in Chicago area. shops.

We cannot afford to take the vaccine out of use for months, as was done with Tylenol at the time. But it shows how warning the public against potential, rare dangers they may be more likely to believe when you say something is safe.

Or it is possible that the decision will “affect” these rare events and make people more nervous than the FDA does not act.

I’m not sure. You’re not sure either. These adverse events will continue to be covered in the news, even if the FDA and the CDC have not acted, and the government cannot completely control whether members of the public who have not been vaccinated are concerned about adverse events. It has much more control over the public perception of how it responds to these adverse events.

The public forgives COVID errors

An sometimes confusing aspect of the COVID crisis is that elected officials around the world tended to increase their approval rates, even if they did not do the job of the crisis very well. Many of the same online commentators who are upset about the J&J break have also sharply criticized the government’s COVID response in the US and Europe. Their criticism was often correct: our leaders received more credit from the public than they deserved.

But since the interruption – if it is assumed to be short – can mainly affect public health by influencing the public perception of the vaccines, it is important to remember how the respondents of the polls differ from you.

The thrust of the tendencies of public opinion seems to me to be that people understand that this situation is difficult to manage and is full of strangers. From British Prime Minister Boris Johnson to the Government of New York, Andrew Cuomo, they see public officials apparently trying their best, and they understand that along the way it could mean making mistakes.

Even a year later, this situation is new and strange to all of us. This perspective of known uncertainty makes many people more skeptical about official leadership than you would be, but also more forgiving about the changes in leadership.

Obviously, you do not want to take the lead unnecessarily or delay the implementation. But with the public in this mindset, I think commentators tend to underestimate the risk that changing message may confuse the public, and the risk that taking a course to follow the course can make people more suspicious.

The FDA may be wrong here. But I think this is just one of the many things we should try not to be so sure about.

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