FDA decision to limit COVID booster shots didn't satisfy anyone - opinion

• Published date: 04 October 2021
• Author: TEHILLA SHWARTZ-ALTSHULER
• Publication title: Jerusalem Post, The: Web Edition Articles (Israel)

The first thing that stood out was that even in this age of machine learning, when it comes to making important decisions, there is no substitute for a group of people coming together to review the data, consider alternatives, and choose one of them. There is still no magical technological machine that can do this for us, and having a single leader making decisions on his or her own has been tried on both sides of the Atlantic in recent years, without much success.

That said, simply gathering a group of intelligent people in a room does not guarantee that the decisions taken will be good ones. For this to happen, what is needed is a discussion that is open, creative, evidence-based, and relevant to the problem at hand, and that leads to a decision that is understood both by the participants and by those outside the room.

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Discussions of the type held by the FDA reflect three main challenges. The first relates to the familiar problems inherent in discussions: Unsuitable people being invited to take part, such as "public representatives" chosen by lottery rather than on the basis of their value to the discussion; faulty management of the discussion itself, including an inappropriate sequence of speakers; and failure to adhere to the schedule.

The FDA discussion was ostensibly being managed, but its format did not encourage active engagement of the participants. Most of them recited pre-written speeches, and each addressed a different topic: Does the drop in the level of antibodies necessarily require providing a third vaccination? Is the decline in protection common across all age groups? Does it represent reduced effectiveness against hospitalization and serious illness, or against infection? When the speakers were asked questions, there was no active moderator to say to them: please relate to the question that was asked.

The second challenge stems from the special nature of decision-making discussions. This relates to the ability to define the available alternatives, the parameters to be considered in choosing among them, and the relative weight of each. At the FDA, however, over the eight hours of discussion, no brainstorming took place. The two questions finally presented for the participants to decide on were prepared in advance, included only a small segment of the relevant possible alternatives, and did not reflect...