Committee Discussion up now! https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d

How will unblinding to perform additional analyses affect the conduct of the study? Study sponsors understand the ethics of continuing surveillance of long term safety follow up in placebo (untreated) patients for BLA application.

One committee member is asking about the possible risk/toxicity associated w the the lipid molecules. Getting at the possibility of needing to do another study with vaccine vs. placebo containing the lipid delivery (these studies have just saline for placebo)

I remember someone on twitter arguing w me that lipids aren't toxic; lmao

Now they're touching on the risk of anaphylaxis and the UK findings in initially vaccinated. The committee member wants to know more info on the cases that occurred in the UK. Pfizer acknowledges that participants were excluded due to hypersensitivity to vaccines.

During the course of the trial however, no one was excluded from having a second dose due to a hypersensitivity reaction.

More info on the 2 anaphylaxis cases in the UK (all in the hospital environment); 44 and 49 y.o.; one female had a medical history of severe anaphylaxis to foods and reaction occurred within 2 mins of dose administration;
other patient also medical history to drug allergy

Both were administered medical treatment to treat the anaphylaxis.

The FDA/Sponsor said they will not recommend vaccinating anyone w a known history of hypersensitivity reaction to any component of the vaccine. The committee member says this is not reasonable because the lipid moiety used is novel

So the committee member wants a specific study performed in people w a known history of egg/peanut/drug allergy to look at whether the lipid is triggering it. Who on twitter was arguing w me about lipids being neutral. LMAO

Committee member is saying there is huge concern around vaccinating a pregnant woman w a novel mRNA vaccine technology given the potential adverse effect on a developing fetus

Committee member wants to move the rudimentary EUA to a more thorough BLA application ASAP

Also, side note, can't compare the 16-17 age group AE profile to the 18 and greater age group because the way in which AEs were collected (one passive one active) were different. This is a huge caveat in my mind and if i was a committee member, this would be my concern

Nobody on the committee is raising concerns around the 16-17 younger cohort, the small number of patients, the differing AE data collection methods, the small number of COVID cases and confidence in the data. This shocks me.

Committee member is asking why FDA/Pfizer did not collect data on virus shedding in the placebo vs. active group. Wants nucleic acid tests in cases and look at placebo vs. active group to look at shedding.

Pfizer is saying they want to conduct studies to do PCR testing to look for prevention of virus acquisition; has data on nonhuman primates showing vaccine prevents infection of lung and virus is more transiently detected in vaccinated animals vs control animals; no human data tho

Committee member says they want to see safety/efficacy broken out by HIV status (and other conditions HepB/HCV/HPV). Says not at point now that have enuf individuals to look at but will by BLA is filed.

I'm signing off now. Need to spend time w family and help with dreaded homework. Cheers!