FDA panel discusses adding a third booster dose

“The panel listened to hours of contradictory presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts about the waning effectiveness of Pfizer and other vaccines over time.”

“Dr. Sharon Alroy-Preis, Israel’s head of public health services, said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine.”

“…in a remarkable public display of internal dissension, two F.D.A. scientists wrote a medical journal article this week arguing that there was no credible evidence yet in support of boosters for the general population. Those officials, who are leaving the agency this fall, joined outside experts at the Friday meeting in casting doubt on whether Pfizer’s request should be approved.”

“Dr. Philip Krause, one of the F.D.A. vaccine experts who wrote the medical journal review, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the F.D.A., arguing that problems in the modeling in a study underpinning the company’s case understated the vaccine’s efficacy.”

Source: NY Times