The only real solution to vaccine skepticism: We need more randomized trials and a new phase IV safety system

The way to address concerns about vaccines and other medical products is to hear what people are saying

Whether anyone likes it or not, covid-19 policy mistakes mean that more and more people are going to be critical of routine immunization for children. They are also going to be critical of serotonin re-uptake inhibitors for depression, cancer medications, cancer screening tests, and most public health advice.

In many of those cases, skepticism is warranted. Cancer drugs do tend to underperform in the real world as opposed to clinical trial settings. The US FDA has authorized many psychiatric medications on the basis of short-term studies, even though these medicines are taken for years or decades. (Discontinuation studies don’t address the question).

The current surveillance system for vaccine safety is so bad that other countries had to alert the United States to myocarditis. We did not detect myocarditis in young men. In fact, our CDC director told the American people she had not seen the link despite millions of doses given, and the agency downplayed the risk until it was so overwhelmingly obvious that she had to acknowledge it. Whoops!

Public health officials also closed beaches. They said rallies were okay if they were in support of Black lives matter, but not if they were in support but the candidacy of Donald Trump. They closed school for years, even though the risk to kids was minuscule, and most kids got COVID anyway long before vaccines. School closure has destroyed a generation of kids. The damage is still being counted. All of these were political choices, usually liberal ones, and all, undermine public health’s credibility.

Peter Marks at the US FDA repeatedly violated any reasonable interpretation of emergency use authorization to push covid vaccines in young populations. And to expedite the approval of a children's vaccine, on the basis of entirely ambiguous and unclear data. Then the CDC added the COVID19 vaccine to the public health vaccine schedule, a disastrous decision that would undermine faith in routine immunization.

Of course the American people have had enough.

In order for public health to regain credibility, more is needed than merely ‘re-educating’ the public. Experts need to admit to the errors perpetuated by the establishment and create new, impartial systems to adjudicate those errors. Specifically:

1. We must recommit to only authorizing or approving medical products after randomized trials show benefits on hard outcomes (living longer or better) and in populations that look like America.

   1. In other words, we can’t give Paxlovid to vaccinated teens based on data from unvaccinated older people

   2. In other words, you can’t approve a yearly booster based on antibody titers

   3. You can’t extrapolate data in people who didn’t have covid before to those who had it before

2. We need a new safety system that is capable of detecting very rare vaccine adverse events. This system should be observational, but a component must also leverage real-world randomization, whenever possible. In other words, after the debut of the COVID vaccine, the roll out should have been as part of a 5 million person randomized trial, with careful monitoring (active and passive) for any safety signal.

3. Older vaccines and medical products which are subject to growing public distrust— even those whose distrust is unjustified in the opinion of experts— should be re-examined for safety. It doesn’t matter why there is distrust. If there is distrust, information is valuable.

4. Trials of vaccine should contain at least 2 control arms. One a placebo arm of salt water, and another placebo arm perhaps containing adjuvant/ preservative/ or a different vaccine. Each control arm has different strengths and weaknesses. One allows accurate assessment of safety; the other preserves blinding, and or downstream behavioral change (think about it for a while).

5. FDA officials must be legally banned from revolving door politics for 5 years after service. Recently, Ashish Jha finished his term at White house where he worked on indoor air rules. Now he wins a *rarely* given award sponsored by the companies that benefit from these rules. The appearance of corruption is strong. These types of awards or jobs must be banned.

   

These are just a few, preliminary thoughts.

Public health is making a new mistake. It seeks to delegitimize critics and assert that it is correct. Wrong! The critics have good points. The only path back to trust is get down on your knees, beg for forgiveness, and compromise, creating better datasets that will answer concerns.