In The Room Where It Happened

I’m on the committee that recommended that the U.S. Food and Drug Administration authorize the Pfizer and Moderna vaccines. We checked for members’ conflicts of interests, demanded high quality data and made sure that the vaccines were effective across racial and ethnic groups.

I went to law school, not medical school. So it’s odd to be repeatedly and erroneously called ​“Dr. Toubman” during an internationally-monitored meeting of medical experts.

How did this come to pass? I am the official ​“consumer representative” on the U.S. Food and Drug Administration’s advisory committee for the review of proposed vaccines, which goes by the official name ​“Vaccines and Related Biological Products Advisory Committee” (or VRBPAC).

The other members of the committee are highly-trained medical clinicians, researchers, infectious disease experts and biostatisticians. Think of the committee as a platoon of experts as thoughtful as Anthony Fauci.

My relevant expertise comes from over three decades as a legal aid attorney representing low-income consumers. Most of my clients have been individuals of color, the elderly and people with significant disabilities seeking access to healthcare. My other basis for input is from reviewing the public comments, sometimes numbering in the hundreds, that are submitted before each of the committee meetings.

I have been on the VRBPAC for over three years. We meet a few times a year. We meet twice a year to review the proposed influenza strain vaccine selections in the northern and southern hemisphere, and once in a while we meet to review an entirely new vaccine for some persistent problematic disease.

The committee’s meetings are all public, available online and recorded. Even though the FDA almost always follows the recommendations of this group of experts, the truth is that very few people pay attention …

… until Covid-19 struck and the world became desperate for a vaccine to combat it without millions of people dying, as happened in the 1918 flu pandemic.

Independence

I have been impressed by the thoughtfulness of the other members of the committee. Both the FDA and the committee take their independence from the pharmaceutical industry seriously. It is a model for ethical, public decision-making.

Every year, each committee member must disclose their income and assets and where they come from. Before every meeting, there is extensive screening for members’ conflicts of interest with the companies applying for FDA approval or authorization, as well as any of the company’s competitors. The review is rigorous. 

This level of accountability is a pain, but I am quite glad that it is required. It is critical to building trust in the decisions we come to.

The FDA cares about even the appearance of a conflict. For example, although our committee has been ably led the last two years by a highly respected virologist, that chair could not serve on the committee during the review of any Covid-19 vaccines as the head researcher for one of them. Another independent expert was recruited to chair the meetings.

State officials would be wise to look to the FDA’s process as a way to address the lack of credibility of some state advisory committees, whose members often have significant conflicts of interest. 

Robust Data

The review of any proposed vaccine involves an extensive review of the data regarding its safety and effectiveness. The committee is more likely to approve a vaccine if it has done through carefully constructed clinical trials and has proven to be highly effective and safe.

But, as over 350,000 individuals have already died of Covid-19 in this country in just 10 months, there is a compelling need for vaccines even before full clinical trials have been completed. In this situation, the FDA may approve a vaccine under ​“emergency use authorization” (or EUA) if the totality of circumstances and the data available show that the benefits outweigh the risks.

The FDA laid down a marker early on for granting EUA for Covid-19 vaccines, following the World Health Organization’s recommendation of a minimum of 50 percent effectiveness. 

It was very welcome news when the two Covid-19 vaccines developed by Pfizer and Moderna scored efficacy of about 95 percent and 94 percent based on a significant number of Covid cases occurring among the trial participants. The overwhelming majority of Covid-19 cases occurred in the groups receiving the placebo (the ​“control groups”), not those receiving the real vaccine. 

Those high numbers led many following the news to assume that the vaccines had already been recommended for emergency use authorization by the committee and then authorized by the FDA — before a discussion had even begun.

However, the committee’s recommendation was not a given.

The process was always going to be rigorous. That careful, methodical process became politicized when the Trump administration suggested that if a vaccine were not authorized by election day, it meant that government scientists — who have dedicated their lives to the scientific method in service of minimizing human suffering and death — were part of ​“the deep state” conspiring to deny the president a second term.

Both the FDA scientists and the independent scientists on the committee were undoubtedly aware of the public perception that the process might have been politicized, but they responded by sticking to the science and what the data showed.

The trials had to go on long enough with significant numbers of Covid-19 cases occurring so that safety and effectiveness could be determined. The FDA added another requirement for any application for EUA, in addition to the 50 percent effectiveness requirement: a minimum of two months of trial data for at least half of the trial participants. Cutting off data from the trials before that, to meet a political goal, would have been unsafe. 

Once submitted, the data from the trials of the two vaccines was subject to a rigorous analysis, with committee members asking probing questions — what was reported, what was missing, and what we simply do not know (yet) and need to study. As the consumer representative, it impressed me how seriously everyone took the data review and what was at stake in granting emergency use authorization.

In the end, after a nine-hour discussion about the Pfizer vaccine on Dec. 11, almost all members of the committee voted to recommend emergency use authorization, despite the lack of completion of the full clinical trials. The same occurred one week later, with EUA for the Moderna vaccine recommended. The FDA gave authorization for each of the vaccines the day after each committee decision.

Data Diversity

Over my three and a half years on the committee, I have noticed an increasing sensitivity to the need both to involve historically marginalized groups in vaccine development and to build trust in the vaccines approved or authorized. I and other committee members have emphasized the need for this in past discussions of clinical trials lacking such diversity. The reluctance of Black Americans to trust the scientific establishment is understandable, given the history of ghastly medical experiments without their knowledge or consent.

Covid-19 in particular has had a disproportionate impact on people of color, due to a combination of greater likelihood of exposure, and higher incidence of pre-existing medical conditions that put the person at greater risk of severe illness or death if exposed. The need for safe and effective vaccines for people of color is particularly compelling. 

In line with this sensitivity, the two companies developing the Covid-19 vaccines granted EUA made a particular effort to recruit people of color for their trials. Pfizer, for example, engaged with New Haven community groups to help recruit individuals who historically would be unlikely to participate. Read more here.

While not as robust as committee members would have liked, resulting participation by people of color in the Pfizer and Moderna trials was quite strong. And the very high effectiveness rates seen for the vaccines were about the same across racial and ethnic groups. We made sure we knew that the vaccines would work for everyone and that we could reassure people who might otherwise be reluctant to be vaccinated because of the racist history of medical experimentation in this country.

I am grateful that the FDA includes independent consumers in their decision-making, not just for this committee but generally. It builds trust and makes us all safer.

As to that ​“Dr. Toubman” thing — I do try to correct the record. I will have to continue to do so: the FDA just asked me to stay on as the consumer representative for VRBPAC for another six months, during which time most of the other Covid-19 vaccines in advanced development will likely come before the committee.

Sheldon Toubman is an attorney practicing in New Haven.