US ‘Will Be Providing Boosters’ for COVID-19 Vaccines to Prepare for Fall Infection Increases, Says Former FDA Commissioner Scott Gottlieb

During a session at the NACDS 2021 Annual Meeting, Scott Gottlieb, MD, former commissioner of the FDA from 2017 to 2019, provided an overview of where the country is heading in its response to the COVID-19 pandemic and what challenges remain for the country to face in the near future.

With the country now at the tail-end of the acute phase of the COVID-19 pandemic, Gottlieb explained that despite SARS-CoV-2 remaining a persistent threat, the country will experience this challenge far differently than at the beginning of the pandemic.

“I think we’re going to be able to deal with it on much different terms than what we’ve been able to do over the past 12 months, in large measure because of innovations in technology and in part because so many people have now been exposed to the virus that there’s residual immunity in the general population,” Gottlieb said during the session.

Specifically, Gottlieb explained that over the next few weeks, he predicts that the infection rates will begin to decline dramatically. He noted that he based this prediction on the lack of a fourth wave of COVID-19 in the country, despite the B117 strain becoming the prevalent SARS-CoV-2 strain, mask mandates being lifted in many states, and many people becoming generally less compliant with some of the mitigation steps.

“I think that at worst we’ve seen a plateauing in the decline in cases across the country,” Gottlieb said during the session. “As more people get vaccinated, as we get into the warmer months, and as we get more of a seasonal backstop against the continued spread of this virus, I think at some point we’re going to see cases start to roll over.”

However, this doesn’t set aside the fact that there are outbreaks in some parts of the country, such as in Michigan, New Jersey, Boston, and New York.

“Generally, though, the trajectory is going to be down, and at some point, we’re going to reach an inflection point where cases start to decline more dramatically. Even if you look at the national trends right now, you can see that cases are starting to decline,” Gottlieb said. “So, I think in the near term, the outlook is it’ll be a relatively quiet summer in which infection levels will decline. We’re still going to record cases, though.”

There may never be a situation in which the country gets below 10,000 COVID-19 cases a day, Gottlieb noted. But the overall vulnerability of the country’s population has declined substantially, owing in large measure to vaccinations against COVID-19.

With these large numbers of immunized Americans, 10,000 COVID-19 cases a day will represent a lot less of a risk to society at large than this same number did the prior year. This is due to the number of Americans who have a significant risk from COVID-19 decreasing dramatically due to immunizations, while the number of testing kits easily accessible to Americans have increased.

“I think we need to look at cases very differently,” Gottlieb said during the session. “There’s a lot more testing going on in the market than what’s being recorded. So actually, the positivity rate is probably a lot lower than what we perceive it to be and all that testing is going to continue to pick up positive cases.”

Although the summer will most likely be quiet in terms of general COVID-19 outbreaks nationally, Gottlieb explained that in the fall, the virus will likely begin to spread more. This will occur as children go back to school and more people go back to work in offices, which will cause the infection rates to potentially increase.

“Coronavirus is a late winter pathogen typically, and there’s a risk that you’ll start to see spread. There’s also a risk that new variants will start to emerge and could become more prevalent here in the US. I don’t think in the near term that’s a risk,” Gottlieb said. “If you look at the Brazilian variant, or the South African variant, they represent a small percentage of cases in the single digits.”

However, there is uncertainty on the landscape in terms of variants, especially in the case of the strain circulating in India right now. Gottlieb noted that the increase in cases in India presents a reason to be concerned for the future in terms of the trajectory of the pandemic globally.

In the United States specifically, it’s possible for these variants from abroad to begin to build in the country. This has the potential to cause reinfections, which may put people who have already had the disease at risk.

Additionally, these strains from abroad could also make people who have been vaccinated more likely to get infected. However, Gottlieb noted that no variant has been identified yet that appears capable of fully obviating the vaccines, since the vaccines have continued to remain relatively effective against the new variants.

Yet, Gottlieb explained that it is still necessary to prepare and plan for a potential increase in infection rates in the fall.

“I think it is likely that we’ll be revaccinating at least some portion of the population. I think that we will be providing boosters to people. If you look at some of the data coming out about people who have been previously infected with the virus, one study found that 6 to 8 months out, those over the age of 65 only had about 47% protection against reinfection. Overall, the rate of protection from prior infection was 80%, but much lower in the older population.”

Although vaccines do provide more robust protection than what is provided by natural infection, the data suggest that immunity declines over time, particularly in an older population.

“I think this raises the possibility and the likelihood that we’ll be providing boosters for some portion of the population,” Gottlieb said during the session. “It’s likely going to be risk-based.”

Gottlieb noted that the assessment for the boosters will likely include recommendations regarding the duration of time since the individual had their first vaccination.

“Considering the fact that the people who were most vulnerable to COVID-19, people in nursing homes, elderly individuals, and certainly people over the age of 65 were the first to get vaccinated, they’ll be going into the winter of 2021 in many cases with a vaccination that may be a year old,” Gottlieb said. “I think that there is going to be an impetus to provide boosters to prepare for this.”

REFERENCE

Anderson SC, Paley L, Keyes R, Gottlieb S. Business Program I. National Association of Chain Drug Stores Annual Meeting 2021; April 26, 2021; virtual. Accessed April 28, 2021.