July 9, 2021 – Shortly after Pfizer announced its intention to apply for FDA approval for a third COVID-19 vaccine on Thursday, the CDC, FDA and the National Institutes of Health countered with a joint statement on the same day which essentially says it is still too early.
In a battle over the statements about booster vaccinations, the vaccine manufacturer and the US government draw very different conclusions based on the findings so far.
Americans who have been fully vaccinated against # COVID19 do not currently require a booster vaccination. The FDA, CDC, and NIH are working on a science-based, rigorous process to see if or when a refresher might be needed. Read the full CDC / FDA statement. https://t.co/njQ4dLv8dW
– CDC (@CDCgov) July 9, 2021
Pfizer notes “encouraging data” for a third vaccination given 6 months after primary vaccination in an ongoing study of its COVID-19 vaccine. The company said the study supported the vaccine’s effectiveness against the worrisome beta variant, which was first identified in South Africa.
In addition, a June study in Nature found that two doses of their vaccine produced strong neutralizing antibodies against the Delta variant in laboratory tests. “The companies assume that a third dose will increase these antibody titers even further,” said the Pfizer statement.
Pfizer, along with its partner BioNTech, also pointed to evidence from Israel that the existing two-dose mRNA vaccine regimen offers less protection against infection as the levels of Delta variants continue to rise in the US and elsewhere.
Attach brakes to a booster?
Just hours later, US government agencies issued a two-paragraph joint statement.
“Americans who have been fully vaccinated currently do not need a booster vaccination. The FDA, CDC, and NIH are working on a science-based, rigorous process to check if or when a booster might be needed,” the authorities said.
The US government appeared to recognize Pfizer’s move, but insisted it would continue to look at the bigger picture. “This process takes into account laboratory data, clinical trial data, and cohort data – which may include data from certain pharmaceutical companies, but cannot rely solely on that data.”
The agencies add, “We will continue to review all new data as it becomes available and will keep the public informed. We are prepared for booster doses when and when science shows it is needed.”
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Nature: “BNT162b2-induced neutralization of B.1.617 and other SARS-CoV-2 variants.”
Pfizer: “Pfizer and BioNTech provide an update on the booster program in the light of the Delta variant.”
HHS.gov: “Joint CDC-FDA Declaration on Vaccine Boosters.”
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