Nov. 10, 2022 - Epoch Times
14:16
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| is a photo of someone getting the mRNA-based COVID vaccine. | |
| And if you remember back to the early part of 2021, just when the vaccine rollout program was beginning, just when all these different vaccine mandates were just starting to go into effect, Well, there were quite a lot of people making the argument that it would never stop at just two shots. | |
| And indeed, that's what actually wound up transpiring. | |
| The boosters eventually began to get rolled out, with countries that have vaccine passport systems beginning to require people to get more shots in order to continue participating in society. | |
| And this type of two-tiered system, well, it continues to this very day. | |
| In fact, just yesterday, I was looking up the requirements for entry into Japan... | |
| And they have two different sets of requirements. | |
| One set of requirements for the unvaccinated, and another less stringent set of requirements for people who have gotten at least three shots. | |
| And so, today, let's focus our discussion on the booster shots. | |
| Starting with the fact that a little over a month ago, drug regulators over at the FDA authorized an updated COVID vaccine booster shot, despite having no human clinical trial data for the modified formulations. | |
| Let me just repeat that. | |
| At the end of August, beginning of September, that period, the FDA granted a new emergency use authorization to both Pfizer as well as Moderna for their updated boosters, despite the fact that the only data available for that particular formulation was based on trials with mice, not humans. | |
| Let me back up for a moment and set the stage for you properly here. | |
| The original vaccines, the ones that were rolled out at the very beginning, were based on components of the virus that came out of Wuhan. | |
| Basically, the original formulation was based on the Wuhan strain of the virus. | |
| However, as the virus circled around the globe and continued to mutate, it became much more adept at evading the protection that the vaccine might have offered. | |
| And so, you enter the boosters. | |
| These updated formulations from both Moderna and Pfizer, they still contain components of the original Wuhan strain, but the new one that was just approved, it also contains components of the BA.4 as well as the BA.5 sub-variants of the Omicron virus. | |
| For your reference, the BA.5 sub-variant is the one that's currently dominant here in the U.S., And according to Dr. | |
| Peter Marks, who is the director of the FDA sub-agency that's actually responsible for evaluating and approving these vaccines, well, this new formulation, the one that was just approved, is exactly what the doctor ordered. | |
| Here's specifically what he said as a part of a statement regarding authorization. | |
| "The FDA has extensive experience with strain changes for annual influenza vaccines. | |
| We are confident in the evidence supporting these authorizations." Furthermore, Dr. Robinson, Robert Califf, the current commissioner of the FDA, he likewise came out and strongly encouraged people to get an updated booster if they're eligible in order to, quote, Now, that's all well and good, and I have no reason to doubt the FDA's recommendation. | |
| However, let's take a quick moment and examine the data that the FDA had to work with. | |
| Because, you see, this authorization came just eight days after Moderna requested it, and just nine days after Pfizer's request. | |
| That's a pretty quick turnaround, and so they obviously must have had very strong data to work with. | |
| But here's where the kicker comes in, which is that, for one, much of the data underpinning these companies' requests were actually made for a different formulation than what was eventually approved. | |
| And secondly, the preclinical data for the new booster shots, the formulation that was actually approved, was based only on mice, not humans. | |
| Now, that might sound almost unbelievable. | |
| However, that is indeed the case. | |
| When they submitted their request for authorization, the bulk of both Moderna and Pfizer's applications contained data for a different formulation of the booster. | |
| Specifically, this was a formulation that combined the original Wuhan strain with a BA-1 subvariant of Omicron, For your reference, the BA1 subvariant is an earlier subvariant of the virus that hasn't been dominant here in the U.S. for several months now. | |
| Regardless, that was the bulk of the research that they submitted. | |
| And apparently, at least according to their data, this formulation was rather effective. | |
| According to Moderna's application, their Phase 2 slash Phase 3 study of the BA1 booster, well, it apparently showed that this formulation triggered a stronger antibody response than their earlier booster shot, which was based solely on the original Wuhan strain. | |
| Now, the reason I say apparently is because the full results of their study have now been released. | |
| And so, we here at the Epoch Times and across the entire country, well, we just need to take Moderna's word for it. | |
| Likewise, in Pfizer's application, they also wrote that a Phase 2 slash Phase 3 study showed that their booster formulation, which likewise combined the Wuhan strain with the BA.1 variant, performed better than the original booster shot. | |
| However, once again, even for these claims from Pfizer, we hear at the Epoch Times, and actually people across the entire country, well, we just have to take Pfizer's word for it, because the results of their actual studies have yet to be released. | |
| We only got a press release from Pfizer saying that everything works really well. | |
| Regardless, if these companies are presenting their findings accurately, it means that their trial data does appear to show that the booster shots which contained the BA.1 subvariant worked better than the boosters which only contained the original Wuhan strain. | |
| But here's the kicker, and you might have noticed it yourself. | |
| The FDA approved a booster which combined the original Wuhan strain with components of the BA.4 and BA.5 subvariants of the Omicron virus, which is different than what we've been discussing so far. | |
| So far, these companies had only conducted Phase 2 and Phase 3 trials on a different formulation, one that combined the Wuhan strain with the BA.1 variant. | |
| And so obviously there's a disconnect. | |
| But have no fear, because within their applications, both Moderna and Pfizer also included preclinical data for the booster shots that eventually got approved, the ones containing the original Wuhan strain alongside the BA.4 and BA.5 variants, which sounds cool. | |
| Except for the fact that preclinical means that no humans were involved in the testing. | |
| These specific formulations, the ones that were actually approved, were only tested on mice. | |
| Think about that for a moment. | |
| The formulations, which actually got approval from the FDA, were only tested on mice. | |
| And not even a lot of mice. | |
| For instance, in the case of Pfizer, back in June, they told the FDA's vaccine advisory panel that their data was based on just eight mice. | |
| But don't worry, because Ms. | |
| Kenneth Swanson, Pfizer's vice president for vaccine research and development, told the FDA's panel that the mice data shows, quote, That is a lot of data to gather from just eight mice. | |
| But that was Pfizer. | |
| In the case of Moderna, though, it's not much different. | |
| According to one of their presentations, which they gave to the CDC, the data for Moderna's booster shot was based on only 16 to 20 mice, some of which actually received the original booster shot rather than this new formulation. | |
| Now, if you're worried about taking a shot which was only tested on mice, well, you shouldn't be, at least according to Dr. | |
| Peter Marks, who, as I mentioned earlier, is the director of the FDA subagency responsible for approving vaccines. | |
| According to him, quote, Likewise, in regards to why the government is willing to take this route, rather than wait for actual human trials, Rochelle Walensky, the current director of the CDC, she said that there's just no time. | |
| Here was specifically her statement, quote... | |
| If we wait for this data to emerge in human data, not just mice data, we will be using what I would consider to be a potentially outdated vaccine. | |
| Meaning that they have to move at a rapid pace before the virus mutates again. | |
| And indeed, just hours after the FDA approved this new booster shot formulation, the CDC issued an official memo which allows children as young as 6 to receive the Moderna booster and children as young as 5 to receive the Pfizer booster. | |
| Now, within the medical community, this approach is having, you can say, mixed reactions. | |
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| And now let's head back to the studio. | |
| Now, within the medical community, this approach is having, you can say, mixed reactions. | |
| For instance, Dr. | |
| Harvey Risch, who is a professor of epidemiology over at the Yale School of Public Health, he told us here at the Epoch Times by email that this move by the government was unprecedented. | |
| Here's what he wrote, quote... | |
| Remarkable that the FDA based this recommendation for children of this age group on no evidence whatsoever relevant to the currently circulating BA5 strain. | |
| Zero. | |
| Not even eight mice. | |
| On the flip side, however, you have people like Dr. | |
| John Moore, who is a vaccine expert over at Whale-Cornell, and while he thinks that the move is indeed unprecedented, he also believes that there is nothing to worry about. | |
| Here's what he said, quote,"...Relying on mouse data would be unprecedented, in my knowledge, and would certainly raise eyebrows." However, it's still the same vaccine, just with a small tweak. | |
| The same strategy is used every year to adjust the composition of the standard flu vaccines. | |
| I would draw an analogy to getting a new paint job on your car that would not trigger the need for a full service check into all the safety features. | |
| However, I think that many members of the public may be concerned, particularly ones who have listened to the lies from anti-vaxxers. | |
| However, regardless of what he meant by the term anti-vaxxers, well, it appears that data coming from Moderna itself might show that continued boosting might have the opposite intended effect. | |
| That's because, according to a new study, which was actually funded by Moderna, it shows that the effectiveness of Moderna's COVID vaccine against infection turns negative over time. | |
| Specifically, what the study found was that the effectiveness of a three-vaccine dose regimen against infection from the BA.1 subvariant of Omicron, well, it remained above 50% after 150 days. | |
| However, against more recent strains, including the currently dominant BA.5 strain, the effectiveness actually turned negative. Specifically, against the BA.2, BA.4, and BA.5 strains, the effectiveness went negative after 150 days. Likewise, against the BA.1, 1.2, 1 strain, the effectiveness turned negative after 91 days. And for your reference, negative effectiveness means that a vaccinated person is more likely to contract COVID than an unvaccinated person. | |
| Furthermore, these researchers also found that people who received three Moderna doses might actually be more likely to get infected when compared to people who only received two Moderna doses. | |
| And this effect even remained even after the researchers attempted to reduce potential bias by adjusting for things like comorbidities. | |
| In terms of their conclusion as to why this might be happening, the researchers wrote that some of the negative effectiveness could, quote, be due to differential risk behaviors among vaccinated and unvaccinated individuals when protection from antibodies becomes minimal. | |
| Meaning, I guess, that some people just go out and party or go to public events. | |
| Regardless, we here at the Epoch Times did reach out to these researchers, but they only responded to us by saying that they can't really comment. | |
| Here was their email to us, quote, We also reached out to Moderna, who did not respond. | |
| Regardless, though, this was not the first study which came to this conclusion. | |
| In fact, over the past several months now, there have been a slew of other studies which found that the effectiveness of COVID vaccines turns negative over time, including a study which estimated that protection for children aged 5 to 11 turned negative after about 18 months, an analysis of data from a CDC testing program which estimated that vaccine protection turned negative at around an analysis of data from a CDC testing program which estimated that vaccine protection turned negative at around six months, as well as a Swedish study which | |
| Here was what the Swedish study, published in September, said in part, quote, Somewhat implausibly, we even observed a negative VE against Omicron infection from week 14, indicating that vaccinated individuals experienced a higher risk of infection than those unvaccinated. | |
| This may relate to harvesting bias in this analysis of the first event of a common outcome, as infection with Omicron is getting close to ubiquitous in many areas now. | |
| More unvaccinated individuals had already been infected, leaving a larger pool of vaccinated individuals susceptible to their first infection later by Omicron. | |
| As a result, a higher risk among vaccinated individuals might be observed for a limited time period. | |
| Which, I guess, is a tacit acknowledgement of the power of natural immunity. | |
| Regardless, if you would like to read the preprint study that was funded by Moderna or any of these studies that we went through, I'll throw all them down into the description box below. | |
| Alongside anything related to those mice, those eight Pfizer mice and 16 Moderna mice, all that will be down in the description box below. | |
| And also, I'd love to know your comments and your thoughts on this topic as well. | |
| Do you believe that it's appropriate for the FDA to give approval to a formulation which was only thus far tested on mice? | |
| Do you think that's appropriate? | |
| Or not appropriate? | |
| Do you think it's fine because it's sort of only a variant of what they had approved before? | |
| Or do you think that you cannot do that without testing, at least having some testing on humans? | |
| I'd love to know your thoughts. | |
| Please leave them down in the comments below. | |
| I'll be reading them later today, but also later in the week as well. | |
| And then, until next time, I'm your host, Roman from the Epoch Times. | |
| Stay informed. |
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