Trouble in paradise–will blog FDA meeting here for now

Valerie Marshall is the CBER officer who makes the necessary disclosures, stating that all experts in the VRBPAC have been screened for conflicts of interest.

FDA determined that all members are in compliance with COI laws. Waivers have been issued to special government employees when they are needed. Based on today’s agenda, no waivers have been issued.

Dr. Robert Natzee is the industry rep. Dr. Portnoy is the consumer rep. Speakers have also been screened for COIs. FDA encourages but does not require all speakers to identify COIs.

Dr. Monto is chairing again. Dr. Jerry Weir will give the introduction. The purpose of the meeting is to review covid vax data and strains for making recommendations of strains for the next winter season, as if the covid shots are like the seasonal flu shots.

Dr. Kanta Subarao who was in Australia working on strains for WHO collaborating center is now in Canada doing the same thing for COVID. It appears that only one strain vaccine is being recommended for the committee to vote on at the end of the day.

Dr. Meyer is a new federal person/ Weir does not want to answer her question. She is dressed as a Public Health Service person. Dr. Portnoy asks have 2 strains been considered? Is that possible? Weir says it depends on the data. Duh. But now we have not seen 2 different lineages circulating that are equally common.

CDC presents (Natalie Thornberg) chief of respiratory virus disease lab. She will discuss the epidemiology of SARS-CoV-2 since last year. Very mild winter wave was seen and dynamics “unremarkable” (?)

JN-1 predominated just before the past 12 months and since then we have had derivatives of JN-1. She spends a lot of time to convince us that JN-1 is what we want.