Former FDA Commissioner Scott Gottlieb on Covid Pill, Vaccines for Children

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The Covid-19 pandemic has propelled Scott Gottlieb from the relative obscurity of life as a former government official to a household name. In a new book, Uncontrolled spread: why Covid-19 crushed us and how we can beat the next pandemic, the

Pfizer

(ticker: PFE) Board member and former Food and Drug Administration commissioner paints a grim picture of the federal government’s response. But he also sees reasons for optimism. The vaccinations and the latest wave could leave Americans with a “wall of immunity,” he said in an interview.

On a phone call last week, Gottlieb walked Barron through its expectations for children’s vaccines (many to come in the next few weeks), variants (we will eventually need updated vaccines) and other key milestones in the pandemic. This transcript has been edited for clarity.

Barron: Merck recently announced data relating to a pill that he says could significantly reduce the risk of hospitalization and death. With that, what other advances can we expect?

Scott Gottlieb: Merck’s data looks pretty solid. This is probably the most profound result that I have seen in an oral antiviral for respiratory disease in modern times. In addition, behind this drug there are a number of others, including one from Pfizer which is in advanced development. There is a drug from Roche that is a bit further and also looks very promising. Then behind these three drugs are a host of other therapies in early stages of development. I think we will soon have one or more antiviral drugs available orally alongside effective vaccinations combined with therapeutic antibodies.

Overall, it’s going to become a manageable threat because of our technology.

What will the Covid prevention regiment ultimately involve?

It will be a lot like how we approach the flu. I think for the foreseeable future there will probably be an annual Covid vaccination.

However, for those who develop infections despite vaccination, for those whose vaccine effectiveness decreases, and for those who do not get vaccinated, there will be a therapeutic arsenal available that will treat not only those who become symptomatic, but also potentially prevent infection in people who are exposed.

Over time, antibody-based drugs will be available in a doctor’s office as a single injection instead of having to have an infusion. It’s just around the corner.

When is the Delta variant likely to disappear in America?

I think Thanksgiving is still a reasonable base case for the United States, and Delta is the last major wave of infection. We are emerging from the pandemic phase of this virus in the United States and entering an endemic phase. At the back of this wave of delta infection, we’ll have a population where 80-90% of Americans will have some form of immunity, either through vaccination or infection. It will be a strong enough wall of immunity to prevent this virus from continuing to spread at current levels.

How well do current vaccines work against the variants that have emerged?

The vaccine we use is basically made up of two variants removed from the virus. The vaccines are based on the old Wuhan variant. We had a wave of infection with the Wuhan variant, and we had a wave of infection with B117 [the variant that spread in early 2021]. Now we’ve had a wave of infection with Delta. It is fortunate that the current vaccine is still effective against the dominant variant. However, at some point we’re going to want to migrate the vaccines to look more like the strain that’s circulating.

How difficult will it be to modify the Covid vaccine?

The current challenge is that there really isn’t a comprehensive process to make this decision. We have a highly regulated process where variants go into the flu vaccine. Each year it is selected very carefully by meetings called by the World Health Organization. We don’t have a similar process for Covid yet, and we don’t really have an active effort underway to create such a process. We’re going to have to do it. We’re going to have to get global regulators to cooperate to make these decisions collectively.

What are your expectations for childhood vaccines?

Pfizer [recently] submitted clinical data to the FDA. They will continue to submit parts of this request to the agency. They also filed a formal request for emergency use authorization for children aged five to eleven. In an optimal scenario, we could potentially have an authorization by the end of October or mid-November.

Data for ages two to four should be available before the end of the year, possibly sometime in November. Data for children aged six months to two years is a bit further behind, so there is a possibility that this will creep in early 2022.

What do you think “normal” will look like?

Normal is going to be different. As a society, we have been oddly complacent about the risk of respiratory pathogens in winter.

We’re going to have to do business differently. Indoor spaces will need to focus much more on air quality and filtration with hospital grade air filters. We have “greened” buildings. Now we are going to have to renovate the buildings with better measures to improve the air quality. In some cases, industries have sealed buildings to improve their environmental attributes. Unfortunately, this is probably the opposite of what we need to do to make buildings healthier from a respiratory disease perspective.

What is the best message to give to someone who is hesitant to get the vaccine?

The most common reason I hear [for hesitancy] is a presumption that vaccines were developed very quickly. What I would say to this person is that we are at the point right now where there is a huge amount of clinical data on these vaccines and a huge amount of safety data. We have distributed nearly 400 million doses in the United States. The first clinical trials to evaluate these vaccines represent the largest clinical trial ever undertaken in modern times. We weren’t just evaluating the vaccine’s ability to generate an immune response. We also asked vaccines to show that they improve outcomes by preventing serious illness and hospitalization. People can feel increasingly reassured by the level of scrutiny these vaccines have been subjected to and the amount of data we now have confirming their safety and effectiveness in the market.

Thanks, Scott.