Pfizer says it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants.
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Pfizer said it would soon publish data about a third dose of vaccine and submit it to the US Food and Drug Administration, European Medicines Agency and other regulators. The company specified it would seek FDA emergency use authorization for a booster dose in August.
But in an unusual move, two top federal agencies said Americans don't need boosters yet and said it was not up to companies alone to decide when they might be needed.
Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet.
"Americans who have been fully vaccinated do not need a booster shot at this time," they said.