In a statement released hours after Pfizer signaled its intention to apply for emergency use of a COVID-19 booster shot, the FDA and the Centers for Disease Control and Prevention (CDC) said fully vaccinated Americans “have not need “an extra dose at this time. Health agencies said the United States “is fortunate to have highly effective vaccines that are widely available” for eligible populations.
“People who are fully vaccinated are protected from serious illness and death, including from the variants currently circulating in the country such as Delta,” the statement said. “People who have not been vaccinated remain at risk. Almost all COVID-1
The agencies, which are repeating federal officials, urged Americans who have not yet received their shots to do so “as soon as possible.”
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Vaccine efficacy data against the Delta variant, particularly in recipients who received one-shot Johnson & Johnson jab, have in part pushed the booster debate. However, health officials have stressed that fully vaccinated individuals have a high degree of protection and that the real risk is for non-vaccinated populations.
“Americans who have been fully vaccinated do not need a booster shot at this point,” agencies said Thursday. “The FDA, CDC and NIH are involved in a scientifically based, rigorous process to consider whether or when a booster may be needed. This process takes into account laboratory data, clinical trial data and cohort data – which may include data from specific drug companies, but “We do not rely solely on this data. We will continue to review new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when science demonstrates their need.”
Pfizer had announced Thursday that it would seek EUA for a boost in August. Dr. Mikael Dolsten, a Pfizer director, told the Associated Press that early data showed that a booster saw antibody levels jump five to ten times after the third dose compared to the second dose given months earlier.
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Even if the FDA granted Pfizer’s boosters the EUA, health authorities would have to decide if they were really needed, Drs. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, to the Associated Press, adding that it would be a “huge effort” while the country is still struggling to get enough first doses for humans.