I don’t have time to go thru all the vaccine info right now, but Moderna has a day 29 np swab, prior to volunteers getting the 2nd shot.
Whole point of that swab is to catch asymptomatic infections. There is also a secondary endpoint focused on asymptomatic infections: “To evaluate the efficacy of mRNA-1273 to prevent asymptomatic SARS-CoV-2 infection”.
The whole point of that swab is to catch asymptomatic infections and throw the people out of the study. Moderna doesn’t even start counting infections until two weeks after the second shot. That test is just to eliminate volunteers from the study if they’ve already had covid.
Moderna participants are getting blood draws at Day 57, Day 209, Day 394, and Day 759, to assess immunogenicity. Even if those samples are checked with PCR for current asymptomatic infection (and I didn’t see anything that said they were) this is not the same as ongoing screening for asymptomatic infection. Moderna is not doing ongoing surveillance for asymptomatic infection, and neither is Pfizer.
Here’s something weird: in the Moderna study, everybody is blinded. In the Pfizer study, everyone who handles the vaccine and the placebo, including the person who injects the vaccine or placebo into the volunteer, is unblinded. That person who’s giving the Pfizer shot knows whether they’re injecting vaccine or saline. This seems pointlessly careless.
Fundamentally, hundreds, if not thousands of highly capable people have participated in the creation and vetting of these protocols.
The protocols have also been approved by multiple regulatory agencies, including FDA, UK’s MHRA, and EU’s Medicines Agency.
I trust that these protocols have been thoroughly vetted by true EXPERTS in the field, believe there is support for every single word in these protocols, and reasons for every single step in the process, every single data collection piece, every endpoint, etc.
In both the Pfizer test and the Moderna test, participants get PCR tests before each of the two shots. Pfizer won’t give the shot to a person who has a positive PCR test. Moderna does the PCR test and the shot at the same time. In both cases, someone who tests positive doesn’t count for the efficacy results, obviously, because you can’t expect a vaccine to protect against an infection that has already happened. In both protocols, they calculate efficacy starting two weeks after the second shot.
In both of the protocols, there are no more PCR tests after the second shot, except for people who experience covid-like symptoms. There are no surveillance tests for anybody who doesn’t have symptoms. The studies can’t possibly be determining the effectiveness of their vaccines to prevent asymptomatic illness, because they are never testing for asymptomatic illness in people who didn’t already have covid when they got the shot.
I’m saying they’re doing nothing to catch asymptomatic infections, that’s all. We won’t know if the vaccines prevent infection, because they’re not looking for asymptomatic infections.
If the vaccine trial volunteers could be given books of the lick-the-strip tests to use one every day, that could help determine if the vaccine is associated with reduction in asymptomatic-but-contagious infections.
I’m sorry. Do you think you know better than the pharmaceutical companies? Wouldn’t they know how to do a trial? Hardly think they would want one of their vaccines o it there that does not work. That would not be a good look for them.
I don’t even understand why you’re picking a fight with me, @homerdog. I’ve looked at the Pfizer protocol and the Moderna protocol. Neither of these drug companies is doing anything to detect asymptomatic infections among their participants.
They know what they’re doing, and I know what they’re doing too: they’re attempting to discover whether their vaccines prevent illness. If one or more of the vaccines succeeds, that will be a great thing, and hopefully people will get vaccinated and they won’t get sick with covid, but we still won’t know whether their vaccines prevent infection because their protocols are not designed to detect that.
Since contagion from asymptomatic infections is an important, maybe the most important, driver of the pandemic, I don’t understand why the trials wouldn’t be including them. This is disturbing.
If we “won’t know whether their vaccines prevent infection,” what exactly are they demonstrating with the trials? Whether the vaccines prevent symptomatic infection?
@dragonmom my son’s college, University of North Texas, is using the Quidel Sophia 2 test for their testing protocol, so it is out there. They get results within an hour, which is great.
The Quidel Sophia 2 is an antigen test (not PCR, not antibody) and uses a nasal swab and needs specialized equipment—a machine— to run the test. Most recent info submitted from Quidel says it’s as accurate as PCR for diagnosing positive cases of Covid in the first five days of symptoms. I saw some report from UNT that they were getting some false positives but I can’t recall the exact source (Could have been parents fb page) so consider that more of a rumor. They are doing some asymptomatic surveillance testing of students with no known exposure as well as potentially exposed/symptomatic, so maybe the surveillance testing is the source of the rumored false positives, should they really exist.
Apparently the govt (HHS) has bought a bunch of these particular tests for use in nursing homes
These vaccines are judged by how well they prevent against symptomatic infection. Pfizer is giving half of the participants the vaccine, and half a placebo. When 32 people in total get symptomatic infections, they’re going to see how many of those people were vaccinated. If it’s six or fewer (so then 26 or more got the placebo, so the vaccine is much better than a placebo at preventing disease) they are going to ask for approval of the vaccine right then.
If more than six people got the vaccine out of the first 32 sick people, they’ll keep the trial going, hoping for good results with higher numbers of people infected. The other interim milestones are 62, 92, 130 and 164 people with symptomatic infection. If it gets to the 164 milestone, they’ll need at most 53 of those 164 people to have been vaccinated.
Other info from an article on the AstraZeneca vaccine:
“Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.”