Approval of COVID-19 Boosters for All Adults Inches Closer to Reality

One of the many ramifications of COVID-19 is that the Food and Drug Administration (FDA)—which historically has been criticized for moving too slowly, most notably during the AIDS crisis—now moves very fast indeed. The FDA looks ready to approve COVID-19 booster shots for all eligible adults, even going so far as to sidestep its panel of advisors. Another agency that has been criticized for moving too slowly—the Centers for Disease Control and Prevention (CDC)—looks like it will probably approve the booster shot today. As the New York Times puts it: “If both the FDA and the CDC sign off this week, they will have acted strikingly quickly—a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.”

For some experts—such as Kevin Kavanagh, MD, a member of Infection Control Today^®’s Editorial Advisory Board—the approval of booster shots seems like a no-brainer. On October 25, in an ICT^® article headlined “COVID-19 Boosters Need to Be Encouraged,” Kavanagh wrote that “the disagreement over who should get a booster is not one of interpreting science, but one over the goals of giving boosters. As with most other infectious diseases, many feel the goal should be the prevention of disease and spread of disease, not just hospitalizations and deaths. The term ‘mild COVID-19’ is an oxymoron. The devastating long-term effects of long COVID, along with future emergence of cardiovascular disease in those with minimal initial symptoms, reminds us that all SARS-CoV-2 infections may pose grave dangers to those who contract the virus.”

The question for Kavanagh and other experts isn’t whether the FDA and CDC will approve booster shots for all adults, but whether that goes far enough. One of those experts is perhaps the most famous doctor in the US at the moment—Anthony Fauci, MD, the chief medical advisor to the White House. Fauci tells Reuters that everybody needs to get a booster shot if the country hopes to make COVID-19 evolve from pandemic to endemic.

“Look what other countries are doing now about adopting a booster campaign virtually for everybody,” Fauci tells Reuters. “I think if we do that, and we do it in earnest, I think by the spring we can have pretty good control of this.”

Kavanagh, too, has been looking at “what other countries are doing.” In an ICT^® article headlined “Confused Messaging About Boosters Might Cause 5th Wave of COVID,” that was posted on the ICT^® website on Monday, he notes that “because of waning immunity Israel started offering boosters to those over 60 years of age on July 30, 2021, and then extending this to all adults over 50 a few weeks later. By August 28, 2021 children as young as 12 were being encouraged to obtain boosters.”

Fauci tells Reuters that boosters and vaccinations are the best road to endemicity. He also admits that exactly what getting the virus under control means is debatable.

Monica Gandhi, MD, MPH, an infectious disease expert and a professor at the University of California, San Francisco predicted in a Q&A with ICT^® in October 2020 that the “old normal” will return by January 2022. She stuck to that prediction in a more recent Q&A with ICT^® on September 30. The vaccines prevent serious illness and death, Gandhi notes. That’s the point of the vaccines.

Fauci tells Reuters that “I don’t want to sit back when we have 70,000 to 85,000 new infections a day and say, ‘Oh, well, we can’t do any better than that. Let’s live with that.’ Sorry, that's not where we want to be…. For me, endemicity means a lot more people get vaccinated, a lot more people get boosted, and although you don’t eliminate or eradicate it, that infection is not dominating your life.”

This discussion takes place as the holidays fast approach (Thanksgiving Day is next Thursday) and COVID-19 cases are again on the rise. They rose nearly 27% in the last 3 weeks according to the latest CDC data. As of November 14, the 7-day average was at 80,823 daily cases, up from 63,852. Meanwhile only about 60% of the US public has been vaccinated.

As Kavanagh notes, in terms of vaccination rates, this puts the US “behind 50 other countries, including Cuba, Sri Lanka, Curacao, Fiji, Mongolia, Bhutan, and Cambodia, let alone the European Nations. This is very concerning with the looming AY.4.2 variant and the high rates of infections this variant is causing in the United Kingdom.”

William Schaffner, MD, a professor of Preventive Medicine at Vanderbilt University Medical Center, tells ICT^®’s sister publication Contagion^® simply that “it’s time. We’re ready for them, the public is ready for them, and providers are ready to recommend and give them.”

The CDC’s likely authorization of the COVID-19 vaccine booster dose from Pfizer/BioNTech coincides with an announced meeting of the CDC’s Advisory Committee for Immunization Practices (ACIP) tomorrow. Following ACIP’s advice, the CDC is also expected to make BNT162b2 the first widely-available COVID-19 vaccine booster dose for fully-vaccinated adults with an emergency use authorization (EUA).

The EUA would allow for adults who received a second dose of the mRNA vaccine in the last ≥6 months to receive a booster dose as soon as this weekend. According to the report from The New York Times, Moderna is anticipated to also seek EUA approval for its booster dose of mRNA-1273 in all US adults in the near future.

Pfizer/BioNTech originally submitted the EUA last week—a technical expansion that proceeds the FDA’s emergency authorization of BNT162b2 booster doses for individuals aged 18 to 64 years old with frequent or occupational exposure to SARS-CoV-2 in late October.

Though experts have varied greatly on the utility and prioritization of COVID-19 vaccine boosters in differing adult populations, previous real-world data has supported the waning immunogenic effect of the 2-dose vaccine after 6 or more months of full vaccination.

The original version of this article appeared in Contagion®.