CDC and Pfizer at Odds Over Need for COVID-19 Booster Shots

Damian McNamara

July 09, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Shortly after Pfizer announced its intention to seek FDA authorization for a third COVID-19 vaccine shot on Thursday, the CDC, FDA, and NIH countered with a joint statement the same day saying, essentially, it's still too soon.

In a battle of the booster shot statements, the vaccine manufacturer and the US government are drawing very different conclusions based on the evidence to date.

Pfizer points to "encouraging data" for a third shot to be given 6 months after initial vaccination in an ongoing trial of its COVID-19 vaccine. The company said the study supports vaccine efficacy against the Beta variant of concern first identified in South Africa.

Furthermore, a study published last month in the journal Nature found two doses of their vaccine produced strong neutralizing antibodies against the Delta variant in laboratory testing. "The companies anticipate that a third dose will boost those antibody titers even higher," the Pfizer statement reads.

Pfizer, along with its partner BioNTech, also pointed to evidence from Israel that the existing two-dose mRNA vaccine regimen provides less protection against infection as the Delta variant levels continue to grow in the US and elsewhere.

Putting the Brakes on a Booster?

Just hours later, the US government agencies released a two-paragraph joint statement.

"Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary," the agencies said.  

"Hopefully, the FDA, CDC, Dr. Fauci, and the WHO will come to a consensus soon about who requires a booster and who does not. They -- not pharmaceutical companies -- should dictate decisions about public health, including the need for vaccine boosters," Priya Nori, MD, an infectious disease physician at Montefiore Health System in the Bronx, New York, told Medscape Medical News.

"At present, there is not enough data to suggest that boosters will be required for the general population, and public health authorities like Rochelle Wolensky and Anthony Fauci are very confident in available vaccines. Third doses may ultimately be required for certain severely immuno-compromised individuals but not for the majority of the public," she said.

The US government appeared to acknowledge Pfizer's move but emphasized they will continue to look at the big picture. "This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively."

The agencies add, "We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed."

Nori, who is also an associate professor of medicine and orthopedic surgery at Albert Einstein College of Medicine in the Bronx, said the real need right now lies elsewhere:

"Respected scientists and public health epidemiologists around the world are much more focused on vaccine equity and prioritize this issue above the potential need for boosters. There are still thousands of healthcare workers in low- and middle-income countries who have not been vaccinated with even one dose. This is tragic."

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and neurology. Follow Damian on Twitter: @MedReporter.

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