Posted on 06/22/2021 7:05:18 PM PDT by DoodleBob
...Moderna...says it also intends to test the effectiveness of a third dose of its original coronavirus vaccine, and is looking into the possibility of a multivalent vaccine, said Tal Zaks, Moderna’s chief scientific officer, in a 25 January call with investors. But before deciding on any path, researchers will need to study how animals, and probably humans, respond to any potential vaccine update, says Subbarao.“It’s not going to be as simple as [altering] an amino acid site and saying ‘okay we got it’.”
...
How will vaccines be trialled and approved?
Vaccine developers tested the currently available COVID-19 vaccines in phase III trials involving tens of thousands of participants before regulators authorized the drugs' use. But that kind of testing for a revamped vaccine would be slow and difficult now that the first-generation vaccines are being deployed worldwide, says immunologist Drew Weissman at the University of Pennsylvania in Philadelphia: “I can’t imagine how they could do a phase III trial for a variant.”
It’s unclear how much clinical data would be needed to approve a COVID-19 vaccine update. New seasonal flu vaccines typically do not require fresh trials. But regulators do not have the assurance of decades of experience and clinical data with COVID-19 vaccines. “They might say, ‛It’s a brand new vaccine, let’s do a couple of clinical trials,’” says Weissman.
The size and duration of those trials could depend on whether researchers can find ‛correlates of protection’: measurable features of an immune response, such as a particular level of neutralizing antibodies, that can provide a marker for protection against COVID-19. With such markers, researchers would not need to wait for trial participants to become infected with coronavirus to know whether the vaccines are working — they could simply measure immune responses after each dose.
(Excerpt) Read more at nature.com ...
"I'm not concerned about variants like I was a few months ago," he said. "Every single variant has been looked at with a vaccine and has been found to be effective...If the variants do start to become problematic, the vaccines can be adjusted. On the fly, they can change the genetic code that's in an mRNA vaccine."(emphasis added)
Changing the secret sauce in a vaccine requires a retest of the new recipe. Even under the EUA, there was a test and placebo group (the observation period was 2 weeks vs 2-3 years, but there WAS a test).
It'll be important to keep watch in case Moderna et al have been granted approval in the EUA to change the genetic code "on the fly" without any testing or, even worse, not telling the public.
ping. Thank you.
Thanks!
Ha! So much for the efficacy of these experimental and unproven shots.
Let’s do boosters!
No, wait! Let’s create brand new money maker ‘designer’ shots!
Regardless.....Follow the 💰cience!!
Nah, just go play in the dirt!
Only problem: “variants” is (are?) a strawman to this argument.
One has to buy into Covid (a common cold in search of a vaccine) mantra in the first place, to then pontificate on how new “vaccines” are required to combat these “variants”.
Agree!!!
Well, that’s what I told my kids, anyway ;-)
>> Even under the EUA, there was a test and placebo group (the observation period was 2 weeks vs 2-3 years, but there WAS a test).
My understanding is that there is no long term placebo group. EVERYONE in the control group has already gotten the real vax shots.
Researchers located those who had SARS1 in 2003 and tested them once again with SARS1. Those people were immune, indicating they maintained their immunity from SARS1 for 17 years.
Then they tested those same SARS1 people with SARS2 (Covid). They were immune.
SARS1 and SARS2(Covid) differ in 22% of their genomes, and that was not enough to end immunity.
The variants are only 1% to 2% different from Covid so if you have had Covid, or SARS1 or any number of similar coronaviruses, you are already immune.
The ‘threats’ of variants are to cover vaccination deaths and keep people locked down and obedient.
It’ll be important to keep watch in case Moderna et al have been granted approval in the EUA to change the genetic code “on the fly” without any testing or, even worse, not telling the public.
~~~~~~~~~~~~
The CDC proactively rule that ‘booster’ shots will not have to go through ANY trials. :(
My non-expert conclusion after reviewing FDA and CDC websites is that any fiddling with the messenger RNA secret sauce SHOULD trigger clinical trials. Indeed, annual influenza vaccine updates require SOME trials. However, it also seems from my reading of FDA and CDC websites that the FDA *could* waive trials or perhaps we’d see annual EUAs.
It's worth monitoring, especially of this IS a seasonal bug.
I only got my Pfizer because it’d quiet Mrs. E.T.S.
That’s it though. The hell with it. I’m not so sure I want to do anything to extend my time on the cold, hard rock.
A tetanus booster is just that...the same secret sauce 10 years later.
If a Moderna booster is simply the messenger RNA that was granted EUA, that'd be in line with a Webster-like definition of "booster."
If they "tweak" the secret sauce, that should NOT be a booster and SHOULD go through trials etc. Unless some bureaucrat uses The Clintonian definition...
~~Vaccine developers tested the currently available COVID-19 vaccines in phase III trials involving tens of thousands of participants before regulators authorized the drugs’ use.
Absolute rubbish
Moderna Clinical Trial Study Protocol Aug 2020
https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
Pfizer Clinical Trial Study Protocol Nov 2020
https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
Pfizer Clinical Trial on Clinicaltrials.gov
https://clinicaltrials.gov/ct2/show/study/NCT04368728
The general public is Phase III minus the excluded participants listed in their docs, like pregnant women and those who’ve already had covid. The numbers of REAL, VOLUNTARY trial participants is not even close to “tens of thousands”
I was surprised to see one of the Covid ‘vaccine’ companies actually tweaked the forumula between the trial and what was administered! If the FDA/CDC allowed that, then I expect they will allow recklessness in implementing new forumulas for boosters.
I can’t see the variants being so much different from the original virus that my body cannot recognize that and fight it off just like it would if it encountered the original again.
When they are finding people who are immune to COVID because 17 years later they were exposed to SARS whatever back in 2004, some little minor variant mutation in COVID will not present an obstacle to my immune system to over come it.
The ‘threats’ of variants are to cover vaccination deaths and keep people locked down and obedient.
Exactly.
And, precisely what Dr Lee Merritt warned they would try to do/use, for just that.
From what I’ve read vaccinating into a pandemic is not smart. It’s just a way of incubating and letting escape, all sorts of variants.
I was surprised to see one of the Covid ‘vaccine’ companies actually tweaked the forumula between the trial and what was administered! If the FDA/CDC allowed that, then I expect they will allow recklessness in implementing new forumulas for boosters.
Where is the media coverage of this tweaking of their trial vs administered-to-the-masses formula??
>>>>crickets<<<<
I wouldn’t be surprised if they aren’t working on Booster 3.0, as we type. (Booster 3.0 follows Booster 1.0 and 2.0, which follow shots 1 and 2....just to be clear :)
Maybe even CREATING them, too.
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