July 9, 2021 – Shortly after Pfizer announced plans to seek FDA clearance for a third COVID-19 vaccine on Thursday, the CDC, FDA and the National Institutes of Health responded the same day by a joint statement saying, in essence, that it is still too early.
In a battle of recall statements, the vaccine maker and the U.S. government are drawing very different conclusions based on the evidence to date.
Pfizer points to “encouraging data” for a third injection to be administered 6 months after the initial vaccination in an ongoing trial of its COVID-19 vaccine. The company said the study supports the vaccine’s efficacy against the beta variant of concern first identified in South Africa.
In addition, a study from June in Nature found that two doses of their vaccine produced strong neutralizing antibodies against the Delta variant in laboratory tests. “The companies predict that a third dose will further increase these antibody titers,” the Pfizer statement said.
Pfizer, along with partner BioNTech, also highlighted evidence from Israel that the existing two-dose mRNA vaccine regimen offers less protection against infection as Delta variant levels continue to rise in the United States. and elsewhere.
Put the brakes on a booster?
Hours later, U.S. government agencies issued a two paragraph joint statement.
“Americans who have been fully immunized do not need a booster at this time. The FDA, CDC, and NIH are in a rigorous and scientific process to determine if or when a booster might be necessary,” have said the agencies.
The US government appeared to recognize Pfizer’s decision, but stressed that it would continue to have the big picture. “This process takes into account laboratory data, clinical trial data, and cohort data – which may include data from specific drug companies, but does not rely exclusively on that data.”
The agencies add, “We continue to review all new data as it becomes available and will keep the public informed. We are ready for booster doses if and when science shows they are needed.”
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