On March 29, 2022, both the FDA and the CDC endorsed a 2nd Covid-19 booster vaccine dose. The FDA Advisory Committee on vaccines still has a meeting scheduled about vaccine boosters on April 6, 2022. Neither of the booster doses will be variant specific.
Tag: FDA
FDA Advisory Committee to Discuss Pfizer COVID-19 Vaccine for Children 5 Through 11 Years of Age
On October 26, 2021 the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss the extension of the Pfizer EUA for the COVID-19 vaccine for children 5 through 11 years of age. Some event materials are already available. The meeting is scheduled for at 8:30 AM-5:00 PM, ET.
FDA Authorizes COVID-19 Moderna and Janssen Boosters and Heterologous Boosting
The FDA just released a statement this afternoon announcing the extension of the EUA for COVID-19 boosting with Moderna and Janssen vaccine. The FDA also authorized heterologous boosting (mix and match).
FDA Advisory Meeting on Pfizer COVID-19 Vaccine Booster Announcement
The FDA announcement about the Advisory Committee meeting on the Pfizer COVID-19 vaccine booster for September 17, 2021 is here. The time will be 8:30 AM-3:45 PM ET (check your time zone provided on the FDA YouTube web page). Review materials (if available) will be posted at the FDA link provided in the announcement.
Update on COVID-19 Vaccine Boosters
The messaging on COVID-19 boosters is being clarified by the CDC and the FDA in separate announcements, posted September 1, 2021.
The CDC update is here. The FDA announcement is here. The FDA plans to hold a virtual meeting about the issue September 17, 2021 from 8:30 AM to 3:45 PM EST and it will be livestreamed on the agency’s YouTube channel. Background material will be made available to the public two days before the meeting.
“Those who are tardy do not get fruit cup.”
New FDA Warning Regarding association of Guillain-Barre Syndrome with J&J Covid-19 Vaccine
On July 13, 2021, the FDA issued a revision to the J&J COVID-19 vaccine fact sheets regarding the increased risk of Guillain-Barre Syndrome (GBS) with the vaccine. According to the announcement, the benefits still outweigh the risks for getting the vaccine and so far no causal association has been found. GBS is rare and has been associated with other vaccines, including the flu vaccine. GBS has not been associated with the mRNA vaccines, so far.
Update: CDC Emergency Meeting June 23-25, 2021 on COVID-19 Vaccine Safety Including Myocarditis
The CDC Advisory Committee on Immunization Practices (ACIP) emergency meeting is re-scheduled for June 23-25, 2021 to discuss COVID-19 vaccine safety including myocarditis after Vaccine Safety Technical Work Group assessment. You can find a webcast link and the draft of the working agenda details here. The Vaccines and Related Biological Products Advisory Committee report slide set summary as of May 31, 2021 is on slide 26. The American Academy of Pediatrics (AAP) news story is here.
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