Nun offiziell: HHS Experten empfehlen - falls FDA +ACIP zustimmen - Booster Shots für mRNA-Geimpfte (Corona)

Reviewer, Mittwoch, 18.08.2021, 21:44 (vor 1589 Tagen) @ Vito_Corleone

Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.

We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.

Department of Health and Human Services / CDC

Wie zu erwarten war wird auf FDA (und ACIP) gewartet.

Der Pfizer-BioNTech-Impfstoff wird um Labor Day herum wohl eine reguläre Zulassung (BLA) erhalten. Ph I-Daten zu Booster-Impfung sind schon eingereicht, Ph III-Ergebnisse stehen noch aus.

Moderna hat noch nicht alle Unterlagen für den BLA-Antrag eingereicht und könnte daher etwas später das Okay für den Booster bekommen.

Janssen/J&J erwarten ihre Ph III-Daten zu einem 2-Dosen-Regime in den nächsten Wochen, gibt noch keinen Antrag auf eine BLA.

AstraZeneca hat gar keine Emergency Use Authorization.