What to know as BA.2 cases continue to dominate.
. The second booster can only be administered to individuals at least four months after they have received their first booster shot of any authorized COVID-19 vaccine.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.
The FDA’s latest decision was primarily shaped by safety surveillance data provided by the Ministry of Health of Israel. This data included the administration of around 700,000 second booster shots of the Pfizer vaccine. These were given at least four months after the first booster dose in adults aged 18 years and older, though the vast majority were aged 60 years and older. Their analysis revealed “no new safety concerns.
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