Nov. 14, 2021 - Epoch Times
18:49
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| Good evening. | |
| Earlier today, the FDA released this statement right here and officially approved the Pfizer vaccine, making it the first fully authorized vaccine in America. | |
| This means that very likely, more businesses as well as more government agencies will be mandating vaccination as a term of employment. | |
| Meanwhile, two days ago, over in India, they became the first country in the world to approve a different kind of vaccine. | |
| They issued emergency use authorization for the world's first DNA-based COVID vaccine. | |
| Now what exactly does that mean? | |
| Well, let's go through that together. | |
| This is your daily Facts Matter update, and I'm your host, Roman, from the Epoch Times. | |
| And now let's begin today's discussion by talking about vaccines. | |
| And to start with, earlier today, the FDA gave their full approval for the Pfizer vaccine. | |
| Now, to give you a bit of background on this issue in case you haven't been following it, up until now, none of the vaccines in America were fully approved by the FDA. From December of 2020 up until now, all of the COVID vaccines, whether it's the Moderna, the Pfizer, or the Johnson& Johnson vaccine, they were all under what's known as emergency use authorization by the FDA. Meaning that, even though they have been tested, they were not fully approved. | |
| That was until earlier today. | |
| Because as we mentioned just a moment ago, the FDA, which is the Food and Drug Administration, they just granted full approval for the Pfizer-slash-Biotech vaccine. | |
| Here's the statement that they released, and here's what it says in relevant part right here. | |
| Quote, Now what this statement is saying is that this vaccine is now fully approved for individuals who are 16 years of age or older. | |
| And now that it's been approved, Pfizer can begin marketing it directly to consumers, which will be an interesting change because up until now, while it was under emergency use authorization, Pfizer was not allowed to market it directly to consumers. | |
| But now you'll probably be seeing a lot more ads for this particular product. | |
| Which is, as the statement said, is now called Comirnaty. | |
| That's the marketed name for the Pfizer vaccine. | |
| However, do know that this full authorization is only for those who are 16 years of age or older. | |
| Here's what the FDA statement says about people who are under that age. | |
| The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. | |
| And so what that means is that if you're between the ages of 12 and 15, or if you belong to the immunocompromised individual category and you're looking for a booster shot, this vaccine is still under emergency use authorization. | |
| Now, in making this announcement, here's what the commissioner of the FDA, Dr. | |
| Janet Woodcock, here's what she had to say about this authorization. | |
| The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. | |
| While this and other vaccines have met the FDA's rigorous scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. | |
| And indeed, with this new approval, more companies, as well as more schools around the country, might begin to push vaccine mandates. | |
| And to give you a bit of background on that front, up until now, people were really questioning whether they can be forced to get a vaccine that's under emergency use authorization. | |
| And even though last month, the Justice Department came out and they issued an opinion saying that emergency use vaccines can, in fact, be mandated, many businesses were still reluctant to do so. | |
| Partly because they didn't want to force people to do something against their will, but the other part was because the vaccines were not fully approved. | |
| However, now that one of them is fully approved, you can expect to see more businesses as well as more government agencies beginning to require them. | |
| In fact, right after this announcement from the FDA was made, just a few hours in fact after it was made, the New York City government, they came out and mandated that all teachers as well as all school staff members must be vaccinated before the start of the next school year. | |
| And it's almost guaranteed that America's largest employer, which is of course the U.S. military, they will start mandating that all service members will get the shot as well. | |
| Now Pfizer, naturally enough, welcomed this decision. | |
| We here at the Epoch Times reached out to them for comment, and here's what the Pfizer CEO emailed us back as a part of his statement. | |
| The approval affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. | |
| I'm hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. | |
| Now, just for your reference, according to federal data, as of Sunday, which is yesterday, over 201 million Americans have received at least one dose of the COVID vaccine. | |
| And naturally enough, you might be wondering about the safety of these vaccines. | |
| And so in this FDA approval statement, here's what they wrote in terms of the clinical trials that were conducted in order to get this vaccine approved. | |
| Quote, Now, | |
| although this statement from the FDA says that they found the vaccine to be 91% effective, as we discussed in a previous episode, there have been several studies recently published by the CDC which show that the efficacy of the vaccines in preventing infection seem to be waning. | |
| In fact, just last week, several government officials, including the director of the FDA herself, they came out and announced a plan to start administering booster shots in order to counteract this decrease in vaccine effectiveness. | |
| Now, we here at the Epoch Times, we did reach out to the FDA in order to get more details about this specific trial, but we've yet to hear back. | |
| Regardless, there was this statement that was given by Dr. | |
| Dr. Peter Marks, who is the director of the FDA Center for Biologics Evaluation and Research, and here's what he said. | |
| Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. | |
| We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analysis of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing | |
| The public and medical community can be confident That although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S. Now, this approval statement by the FDA did list some of the most commonly reported side effects that trial participants experienced. | |
| And here's what it said on that front. | |
| Quote, The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. | |
| However, one side effect that they failed to mention in this report is a sudden desire to smash that like button for the YouTube algorithm. | |
| But seriously, if you remember, last month the FDA added a warning about potential heart inflammation to both the Pfizer and Moderna vaccines. | |
| Specifically, that young people were at an increased risk of experiencing some form of heart inflammation shortly after getting the shot. | |
| And this statement from the FDA says that they investigated this risk further. | |
| Here's what they said in this regard. | |
| The FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. | |
| The observed risk is higher among males under 40 years of age compared to females and older males. | |
| The observed risk is highest in males 12 through 17 years of age. | |
| Available data from short-term follow-up suggests that most individuals have had resolution of symptoms. | |
| However, some individuals required intensive care support. | |
| Information is not yet available about potential long-term health outcomes. | |
| This statement then goes on to say that the newly approved drug will have a warning about these potential risks written right on there. | |
| If you'd like to read this statement for yourself that was issued by the FDA earlier today, I'll throw a link to it in the description box below this video for you to check out. | |
| However, while we're on the topic of vaccines, let's move on over to India, where they have just authorized the world's first DNA-based COVID vaccine. | |
| Sorry. | |
| That's a great question, Roman. | |
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| However, while we're on the topic of vaccines, let's move on over to India, which is trying something new. | |
| Two days ago, India gave emergency use authorization for the world's first DNA-based COVID vaccine. | |
| That's right, the DCGI, which is India's equivalent to the FDA, they just granted emergency use authorization to the world's first plasmid DNA vaccine, specifically for those who are aged 12 years old and above. | |
| Now, what exactly is a plasmid DNA vaccine, you might be asking yourself? | |
| Well, this particular vaccine is called ZyCoV-D, and it contains little plasmids, which are small circular pieces of DNA, and these plasmids carry a section of genetic material from the SARS-CoV-2 virus. | |
| And once these plasmids get into the recipient's body, they instruct the person's own cells to make mRNA, which then instructs the cells to make proteins that mimic the SARS-CoV-2 virus spike protein. | |
| These spike proteins then appear on the surface of cells, eliciting an immune response in the body, with the goal being to teach the body how to fight the real virus. | |
| Here's specifically how the company describes the method of operation in a statement that they recently released. | |
| Quote, Di-COVID-D is a plasmid DNA vaccine, which when administered produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance. | |
| Now, this method is very similar to the mRNA vaccines which are currently used here in America, such as the Pfizer and Moderna vaccines. | |
| The main difference, though, is that the American vaccines contain mRNA, not DNA like the Indian vaccines. | |
| In fact, if you want to see the difference, here's how the FDA describes Pfizer's method of operation. | |
| The Pfizer vaccine contains messenger RNA, which is mRNA, a kind of genetic material. | |
| The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. | |
| The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. | |
| The mRNA in the vaccine is only present in the body for a short time and is not incorporated into, nor does it alter, an individual's genetic material. | |
| So that was a statement by the FDA of how the Pfizer vaccine works. | |
| On the flip side, though, this Indian vaccine essentially adds an extra step to this process and has your own body create this mRNA. | |
| And you might be asking yourself, why exactly are they doing it this way? | |
| Well, in terms of the benefits, here's what a statement from the Indian vaccine manufacturing company that actually makes this new product. | |
| Here's what they said, quote, And so their claim is that their vaccine is both effective as well as relatively easy to produce. | |
| Furthermore, it is administered in three doses, each dose being 28 days apart, And interestingly, it's done using a needle-free applicator which delivers the vaccine directly in between the layers of skin. | |
| Here's how the company describes the way that this vaccine is administered specifically. | |
| Zykov-D is an intradermal vaccine which will be administered in three doses. | |
| It will be applied using the PharmaJet needle-free system, Tropis, which can also lead to a significant reduction in any kind of side effects. | |
| Furthermore, with this new emergency use authorization, this is now the only vaccine available to people under the age of 18 over in India. | |
| And in terms of this DNA vaccine's effectiveness, according to a statement that was released by India's Ministry of Science and Technology, the most recent test results from their Phase 3 clinical trials, which by the way involved more than 28,000 volunteers, it showed an efficacy rate of 66.6% against COVID infections. | |
| Here's specifically what part of their statement said. | |
| Interim results from Phase III clinical trials in over 28,000 volunteers showed primary efficacy of 66.6% for symptomatic RT-PCR positive cases. | |
| This has been the largest vaccine trial so far in India for COVID-19. | |
| This vaccine has already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I and II clinical trials carried out earlier. | |
| Now, of course, it goes without saying that the long-term effects of this vaccine are not known. | |
| Regardless, after this official emergency use authorization was granted, the Prime Minister of India wrote this on Twitter. | |
| India is fighting COVID-19 with full vigor. | |
| The approval for the world's first DNA-based Zykov-D vaccine of Zydus Cardilla, which is the company that manufactures it, is a testimony to the innovative zeal of India's scientists. | |
| A momentous feat indeed. | |
| However, in regards to that clinical trial, there's not much transparency about it, and that has seemed to be the case with the other vaccine that was developed over in India as well. | |
| Their clinical trials are not really transparent, they're not forthcoming with their data. | |
| In fact, when you look for this information, There's not much available. | |
| The only available info about this new DNA vaccine is through their entry, through the company's entry in the clinical trial registry, but it's not really sufficient. | |
| All they say is that they had 28,000 participants, of which 1,000 were children between the ages of 12 and 18. | |
| And that's pretty much it, and that was only according to a press release by the company on July 1st. | |
| So that's how they operate. | |
| However, there was a statement that was put out by an England-based nonprofit called the Transparency International Global Health It's a non-profit that works against corruption in the pharmaceutical industry, and here's what they said about this vaccine specifically. | |
| We found 86 clinical trials are registered across the 20 COVID-19 vaccines. | |
| At least some clinical trial results have been announced for 18 vaccines, meaning that two vaccines developed by Angus and Zydus Cadilla had announced no trial results. | |
| And so, by the way, this is a very similar situation playing out with this DNA vaccine that played out earlier, a few months ago, with the other vaccine that was developed over in India. | |
| That one was called Covaxin, where there's a very kind of stark lack of transparency. | |
| Back with that vaccine as well, they were given emergency use authorization. | |
| Without having to offer the public any official trial data, which it looks like we're seeing now here with this new DNA vaccine. | |
| And by the way, these kind of scenarios, they led Dr. | |
| Jimmy Rao, who is both a public health physician as well as an independent researcher over in the UK, to say this about this vaccine. | |
| Quote... | |
| In sum, ZyCOVID may well be a remarkable innovation story for Indian science, but remarkability does not mean it can remain immune to demands of transparency and approval after due process with publicly available data. | |
| In fact, once again, we are on the cusp of a success story being turned into a blemish on the face of Indian science. | |
| For your reference, by the way, with this most recent authorization, India now has six vaccines which are available for use within their country. | |
| And they have a fairly ambitious goal. | |
| Their official vaccination program is aiming to have all eligible adults vaccinated by December, which is only four months from now. | |
| And the reason that I say that that goal is ambitious is because, according to data from John Hopkins University, close to only 9% of India's population is currently vaccinated. | |
| So we'll just have to wait and see what approach they take. | |
| Maybe they'll go the route of New York City and make it nearly impossible to live a normal life without showing a vaccine card. | |
| Who knows? | |
| If you'd like to read more about this India DNA-based vaccine, I'll throw the link to the statement as well as some more articles about it into the description box below this video, which is, by the way, that same description box that is right below that like button, which I hope you take a moment to smash. | |
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| And until next time, I'm your host, Roman from the Epic Times. |
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