Pfizer plans to submit data on a 4th Covid shot to FDA

Pfizer plans to submit data on a 4th Covid shot to FDA Federal health officials are continuing to monitor whether another booster dose will be needed and, if so, when. NBC News

Pfizer is close to submitting data to the Food and Drug Administration on a fourth dose of its Covid-19 vaccine, according to CEO Albert Bourla.

“Clearly there is a need in an environment of omicron to boost the immune response,” he told CNBC in an interview Friday.

Protection from the first two doses of the Pfizer-BioNTech vaccine waned substantially against the omicron variant, research found, though a booster shot restored much of that protection.

But Bourla said Friday that Pfizer's scientists are now seeing the protection from the initial booster shot begin to wane against omicron after three or four months, meaning a fourth dose may be needed.

"We are going to submit to FDA a significant package of data about the need for a fourth dose," he said, noting that the FDA and the Centers for Disease Control and Prevention would need to come to their own conclusions.

Other countries, including Chile, Israel and Sweden, already allow for a fourth vaccine dose for certain vulnerable populations.

Kit Longley, a spokesperson for Pfizer, told NBC News in a separate statement that the company will submit data to the FDA on a fourth shot when the company is "ready." ...