Things that will likely not be on the internet anymore soon. (Copy)
/https://www.bitchute.com/video/1eAkFlcxvxAq/?fbclid=IwAR0UamOOj1-IGL60CBKSOuTYukEBDZ1krXKcCuduNUuMbwIdXOKuwJrNwNs
2. https://ahrp.org/plague-of-corruption-puts-human-lives-at-risk/
3. https://www.drnorthrup.com/should-you-get-the-flu-shot-this-year/
4. https://www.facebook.com/ZDoggMD/videos/378953756778385 - unfortunately not this guy
5. https://www.youtube.com/watch?v=hK4MCF1i8MA Plandemic Doc 2
6. https://cormandrostenreview.com/report/?fbclid=IwAR3TjJK5hh1hr4J0p1xJfknkrT0HkLt3SU6tLFYf78gU0uE0VgU2AOBb25E
7. https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/?fbclid=IwAR2h8NtiOaxyiBMNyeIzSDSCoDETyT9rAwt3JtU7q4l0zQM4MrxvYOcgaz4:.
No evidence that COVID-19 vaccines cause more severe disease; antibody-dependent enhancement has not been observed in clinical trials
COVID-19 vaccines will cause more severe disease through antibody-dependent enhancement
VERDICT
SOURCE: Facebook user, Facebook, 21 Nov. 2020
DETAILS
Unsupported: Antibody-dependent enhancement (ADE) is theoretically a possible side effect of a COVID-19 vaccine. However, clinical trials so far have not shown ADE occurring in vaccinated participants.
Inaccurate: Some posts inaccurately suggest that non-neutralizing antibodies are irrelevant to protection. Although non-neutralizing antibodies can result in ADE, such antibodies can also participate in a process called antibody-dependent cell cytotoxicity, which kills infected cells and is an important part of a protective immune response.
KEY TAKE AWAY
Antibody-dependent enhancement (ADE) occurs when antibodies are unable to neutralize a virus’ infectivity, but instead enhance a virus’ ability to infect cells. Although ADE has been observed in humans who received the dengue vaccine, as well as in individuals that received a vaccine candidate for the respiratory syncytial virus, the evidence from COVID-19 vaccine clinical trials so far have not shown more severe disease occurring in vaccinated participants. People who have been given the COVID-19 vaccine will continue to be closely monitored to determine whether ADE occurs.
FULL CLAIM: “We will likely be warned of a new, more deadly “strain” of the virus, shortly after the vaccine is widely distributed, which will justify further lockdowns. It’s called antibody-dependent enhancement”; “Is no one concerned about the potential for disease enhancement and turning this current virus into a very real problem for the masses who are not currently at risk?”
SUMMARY
A Facebook post claiming that the COVID-19 vaccine will lead to more severe disease, was published in November 2020 and went viral on the social media platform. Similar claims have also been published in other social media posts, like this one and this one. The claim is based on the observation of more severe disease occurring in individuals who received a dengue vaccine and a vaccine candidate for the respiratory syncytial virus. Both are likely due to a phenomenon known as antibody-dependent enhancement (ADE), however ADE has not been shown to occur in individuals that received COVID-19 vaccines to date. One of the authors of these posts previously claimed to be a toxicologist, despite lacking the necessary training and credentials for that title.
Health Feedback reached out to experts to find out how ADE works and whether the claim is supported by scientific evidence [See scientists’ feedback in full].
Angeline Rouers, a research fellow at the Singapore Immunology Network, explained, “ADE is a well-known mechanism which was described for the first time in dengue patients. It occurs when antibodies do not neutralize the virus to prevent its entry into the target cells, for example, but instead facilitate the infection of other cells, such as macrophages (a type of immune cell).” However, Rouers added that there is “no clear evidence” showing that the virus which causes COVID-19, SARS-CoV-2, can infect macrophages.
Walter Orenstein, a professor at Emory University’s School of Medicine and associate director of the Emory Vaccine Center, said, “Vaccine-enhanced disease is theoretically possible with SARS-CoV-2 vaccines, but it has not been seen as of yet in the clinical trials reported.”
Sanjay Mishra, a staff scientist and project coordinator at Vanderbilt University Medical Center who is also working in the COVID-19 and Cancer Consortium, concurred. “The major vaccine candidates that have so far progressed in the large-scale Phase 3 trials, such as the ones by Moderna, Pfizer, and AstraZeneca, have all ruled out any serious safety concerns,” he said.
Overall, all three scientists agreed that close monitoring of vaccinated people is important to ensure that ADE can be safely ruled out as a side effect of COVID-19 vaccines, but for the moment, the evidence has not shown the vaccines to have such an effect.
Indeed, preliminary findings released by frontrunners Moderna, Pfizer, and AstraZeneca have shown that among the trial participants who did develop COVID-19, those who received the vaccine did not show higher rates of severe disease compared to those who received the placebo. The vaccines were also able to prevent COVID-19 at a high efficacy. However, an important caveat of these findings is that these trials are still underway, and the number of people included in these interim analyses is relatively small.
Apart from the post’s unsupported claim linking ADE with COVID-19 vaccines, its suggestion that non-neutralizing antibodies are always ineffective for protection is inaccurate. The immune system has several ways to deal with viruses, and “Antibody-dependent cellular cytotoxicity, which can involve non-neutralizing antibodies, is another mechanism that is distinct from neutralization, that is also important for a protective immune response,” Rouers pointed out.
And contradicting Everly’s claim that “no one is concerned about it,” Health Feedback was able to find multiple articles published over the course of 2020 that discussed concerns about ADE with respect to the COVID-19 vaccine. Some examples are this article in The Scientist, this article in PNAS and these two articles in Nature[1,2], the latter two being highly respected journals in the scientific community.
Overall, while ADE is a theoretical possibility with a COVID-19 vaccine, clinical trials in people so far have not shown that participants who received the vaccine have a higher rate of severe illness compared to participants who did not receive the vaccine. Given the paramount importance of vaccine safety, scientists continue to encourage rigorous safety monitoring so as to completely rule out ADE as a potential side effect.
SCIENTISTS’ FEEDBACK
Sanjay Mishra, Staff Scientist, Vanderbilt University Medical Center:
Antibody-dependent enhancement (ADE) of virus infection[3] is a phenomenon in which virus-specific antibodies enhance the entry of a virus and in some cases, ADE can even facilitate the infection[4]. ADE has been well-established in dengue[5] and Zika viruses, and any poor-quality antibodies that bind the virus but do not neutralize can cause ADE. Indeed, some vaccine candidates, such as one against the respiratory syncytial virus resulted in deaths due to ADE[6]. However, no definitive role for ADE in human coronavirus diseases has yet been established, despite the concerns raised[7,8].
The opinion piece being cited in the viral Facebook post itself concluded that “the risk of ADE remains theoretical” in vaccines being developed against SARS-CoV-2. The major vaccine candidates that have so far progressed in the large-scale Phase 3 trials, such as the ones by Moderna, Pfizer, and AstraZeneca, have all ruled out any serious safety concerns. While more data is still needed, randomized controlled trial with convalescent sera has also shown to be beneficial in COVID-19 patients with moderate disease severity[9]. Just like other things related to this pandemic, we should wait and watch for better evidence to completely rule out ADE, but no evidence for ADE has been found so far.
Angéline Rouers, Research Fellow, Singapore Immunology Network:
ADE is a well-known mechanism which was described for the first time in dengue patients. It occurs when antibodies do not neutralize the virus (to prevent its entry into the target cells, for example) but instead facilitate the infection of other cells, such as macrophages. It might also happen with coronaviruses but for the moment, there is only in vitro demonstration of this with regards to SARS-CoV-2. The mechanisms in vivo might be different and there is also no clear evidence showing that SARS-CoV-2 can infect macrophages.
As a note, it is false to say that non-neutralizing antibodies are inevitably non-efficient and potentially dangerous, as suggested in the Facebook post. Antibody-dependent cellular cytotoxicity, which can involve non-neutralizing antibodies, is another mechanism that is distinct from neutralization that is also important for a protective immune response.
This claim is particularly alarming for the public and unnecessarily invokes a conspiracy theory: “Most people don’t know this. Most people have never heard of this. Maybe the big media networks don’t find this important to share with the public, or maybe it’s just plain censorship. It’s probably censorship.” In fact, ADE is an immune response that is well-known to scientists and is described in immunology textbooks. ADE has to be assessed from the earliest stage of vaccine development. There is nothing hidden from the public—if ADE is detected during vaccine development, it will simply stop the trials. We can never be 100% sure it will not happen in some way at a later stage of clinical trials, but in the whole history of vaccines, this phenomenon is very rare.
The post also mentions that (a) antibodies might not be the most protective aspect in the context of SARS-CoV-2 and (b) there is a positive correlation between severity and level of antibodies in the patients. These claims are true but require more context to avoid readers’ misunderstanding. (a) Cytotoxic T cells have indeed been shown to be very important to fight the virus, however, antibodies are also doing part of the job and should not be neglected. (b) The level of antibodies is not necessarily predictive of their efficiency. Indeed, a high level (quantity) of antibodies might not be protective, and can even make things worse in the case of ADE. But a high level of efficient (i.e. neutralizing) antibodies is generally a good prognosis.
Overall, it is very important to keep in mind the difference between what is observed in the patients and what a vaccine aims to do. A vaccine does not aim to reproduce the immune response observed in an infected patient; on the contrary, it aims to elicit a neutralizing antibody response to fight the virus—this is something that is rarely observed in severely ill patients.
ADE is a concern that scientists have in mind and will assess carefully. Some vaccine candidates may have led to ADE at the early stages of trials, which halted their development. This demonstrates that the scientific community is careful and will do everything possible to release a safe vaccine for people. In conclusion, ADE is a theoretical danger in SARS-CoV-2 vaccine development, but it is taken seriously into consideration and very close monitoring will be applied.
Walter A. Orenstein, Professor, Emory University School of Medicine:
Thus far, there are no data supporting vaccination as a cause of vaccine-induced enhanced disease. Such enhancement has been seen with other vaccines such as the dengue vaccine. But for the vast majority of vaccines in use today around the world, such enhancement has not been seen.
There were concerns seen in animal studies with earlier coronavirus vaccines for SARS-CoV-1 and MERS. But not in human studies to date.
Vaccine-enhanced disease is theoretically possible with SARS-CoV-2 vaccines, but it has not been seen as of yet in the clinical trials reported. In contrast, SARS-CoV-2 is killing more than 1000 people a day in the US alone.
It will be important to monitor to see if enhanced disease happens. But there is no evidence for it in humans to date. In contrast, there is good information on efficacy.
REFERENCES
1 – Lee et al. (2020) Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nature Microbiology.
2 – Arvin et al. (2020) A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature.
3 – Tirado and Yoon. (2003) Antibody-dependent enhancement of virus infection and disease. Viral Immunology.
4 – Dejnirattisai et al. Cross-Reacting Antibodies Enhance Dengue Virus Infection in Humans. Science.
5 – Halstead and O’Rourke. (1977) Antibody-enhanced dengue virus infection in primate leukocytes. Nature.
6 – Kim et al. (1969) Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. American Journal of Epidemiology.
7 – Ho et al. (2005) Neutralizing Antibody Response and SARS Severity. Emerging Infectious Diseases.
8 – Zhao et al. (2020) Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clinical Infectious Diseases.
9 – Li et al. (2020) Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19. JAMA.
Published on: 27 Nov 2020 | Editor: Flora Teoh
Health Feedback is a non-partisan, non-profit organization dedicated to science education. Our reviews are crowdsourced directly from a community of scientists with relevant expertise. We strive to explain whether and why information is or is not consistent with the science and to help readers know which news to trust.
Please get in touch if you have any comment or think there is an important claim or article that would need to be reviewed.
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Staff Scientist, Vanderbilt University Medical Center
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Professor, Emory University School of Medicine
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7. https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19:
Moderna’s Work on a COVID-19 Vaccine Candidate
Time is of the essence to provide
a vaccine against this pandemic virus.
Moderna is proud to be among the many groups working to respond to this continuing global health emergency. This page summarizes key milestones in our work to advance mRNA-1273, our vaccine candidate against the novel coronavirus.
Learn more about mRNA-1273, Moderna’s COVID-19 vaccine candidate.
View Moderna’s standard Informed Consent Form and Authorization To Use and Disclose Protected Health Information for Protocol Number mRNA-1273-P301.
Nov 16
mRNA-1273 met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study with a vaccine efficacy of 94.5%
Nov 16
Moderna announced a longer shelf life for mRNA-1273 at refrigerated temperatures.
Oct 22
Moderna completed enrollment of the Phase 3 study of mRNA-1273.
Sep 29
Interim results from the older adult age cohorts (ages 56-70 and ages 71+) in the Phase 1 study of mRNA-1273 published in The New England Journal of Medicine
Sep 08
Moderna signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.
Aug 11
Moderna announced a supply agreement with the U.S. government for an initial 100 million doses of mRNA-1273.
Jul 28
Non-human primate preclinical viral challenge study of mRNA-1273 published in The New England Journal of Medicine
Jul 27
The Phase 3 study of mRNA-1273 being conducted in collaboration with the NIH and BARDA begins
Jul 26
BARDA expands agreement to support larger Phase 3 program for mRNA-1273
Jul 14
Interim results from the NIH-led Phase 1 study of mRNA-1273 published in The New England Journal of Medicine
Jul 08
Moderna completed enrollment of its Phase 2 study of mRNA-1273.
The cohorts of older adults and elderly adults in NIH-led Phase 1 study of mRNA-1273 completed enrollment.
Jun 25
Moderna and Catalent announced a collaboration for fill-finish manufacturing of mRNA-1273.
Jun 11
The cohort of younger adults (n=300) and the sentinel group of older adults (n=50) in Moderna’s Phase 2 study of mRNA-1273 completed enrollment.
May 29
The first participants in each age cohort were dosed in Moderna’s Phase 2 study of mRNA-1273.
May 18
Moderna announced positive interim Phase 1 data for mRNA-1273.
May 12
Moderna received FDA Fast Track designation for mRNA-1273.
May 06
Moderna reported that Anthony S. Fauci, M.D., Director of NIAID, participated in an interview with National Geographic, which described his assessment of the results of certain preclinical testing related to the ongoing Phase 1 clinical study of mRNA-1273.
May 01
Moderna and Lonza announced a worldwide strategic collaboration with the goal to enable manufacturing of up to 1 billion doses of mRNA-1273 per year.
Apr 27
Moderna submitted an IND to the U.S. FDA for Phase 2 study of mRNA-1273.
Apr 16
BARDA awarded Moderna up to $483 million to accelerate development of mRNA-1273 to enable large-scale production in 2020 for pandemic response.
The NIH-led Phase 1 study of mRNA-1273 completed enrollment of three dose cohorts (25 µg, 100 µg and 250 µg) and expanded to an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above).
Mar 27
The NIH announced that Emory University in Atlanta would begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273.
Mar 23
While a commercially-available vaccine is not likely to be available for at least 12-18 months, Moderna reported it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.1
Moderna confirmed that it is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials.2
Mar 16
The NIH announced that the first participant in its Phase 1 study of mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.
Mar 04
The FDA completed its review of the IND application filed by the NIH for mRNA-1273 and allowed the study to proceed to clinical trials.
Feb 24
Moderna shipped the first clinical batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study.
Feb 07
The first clinical batch of mRNA-1273 was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.
Jan 13
The NIH and Moderna’s infectious disease research team finalized the sequence for mRNA-1273. Moderna mobilized toward clinical manufacture.
NIAID, part of NIH, disclosed their intent to run a Phase 1 study using mRNA-1273 in response to the coronavirus threat. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Jan 11
Chinese authorities shared the genetic sequence of the novel coronavirus.
About mRNA-1273, Moderna's Vaccine Candidate Against COVID-19
Frequently asked questions about our technology & platform
What happens after the Phase 1?+Expand
Phase 1 safety and immunogenicity data from the trial being run by the NIH is expected to guide our next steps. This Phase 1 study will provide important data on the safety and immunogenicity of mRNA-1273. Immunogenicity means the ability of the vaccine to induce an immune response in participants. Given the pandemic, we have started to work in parallel to responsibly accelerate further development.
Are you working on further supply of the vaccine?+Expand
Moderna has already started to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit. We are working around-the-clock to make sure a vaccine is available as quickly and as broadly as possible. We will continue to work together, with government, industry and other third parties to enable the best chance for success.
How well validated is your mRNA platform?+Expand
mRNA is an emerging platform. Over the past few years, we have demonstrated its potential in vaccines across more than 1,000 subjects in our clinical trials. This includes successful early-stage (Phase 1) clinical trials against five other respiratory viruses (two pandemic influenza strains, RSV, hMPV, and PIV3). Over the last four years, we have started 9 clinical trials for mRNA vaccines.
However, it is important to emphasize that we are still early in the story. Our most advanced vaccine program (CMV) is in Phase 2 clinical testing and we have no approved drugs to date.
Despite this, we are doing everything we can to help in the current emergency by working to develop a safe and effective vaccine for this novel coronavirus.
Have you ever worked on other coronaviruses?+Expand
We had previously collaborated with the NIH on a vaccine for MERS-CoV, which is a different type of coronavirus than the current pandemic. While the program was only at the research stage, it provided significant insights as we launched our efforts for mRNA-1273. Before the Phase 1 study for mRNA-1273, we had not previously tested a coronavirus vaccine in humans.
How was mRNA-1273 able to move so quickly?+Expand
mRNA is an information molecule and we design our mRNA vaccines using the sequence of the virus, not by working on the virus itself. Our mRNA platform provides significant advantages in speed and efficiency, across basic science, manufacturing, and clinical development.
Moderna currently has 9 development candidates in its prophylactic vaccines modality. To date, Moderna has demonstrated positive Phase 1 data readouts for 6 prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3 and CMV).
For mRNA-1273, we were able to leverage our experience in vaccines to move rapidly on design and manufacture of material for the Phase 1 clinical trial. This included our broad understanding of the safety of our platform to date across more than 1,000 subjects. We also benefited from the use of our well-established manufacturing capabilities, which produced over 100 batches of mRNA medicines for use in human clinical trials in just the last two years.
Related Resources
Press Releases
January 23: Moderna Announces Funding Award from CEPI to Accelerate Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
February 24: Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study
March 16: NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins
March 27: Atlanta Site Added to NIH Clinical Trial of a Vaccine for COVID-19
March 30: HHS Accelerates Clinical Trials, Prepares for Manufacturing of COVID-19 Vaccines
1 Any emergency use would be subject to authorization by the appropriate regulatory agencies, based on the emergence of clinical data for mRNA-1273 that would support use of the vaccine prior to licensure.
2 As has previously been disclosed, the ability of the Company to make millions of doses per month is contingent on investments in the scale up and further buildout of the Company’s existing manufacturing infrastructure.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel Coronavirus, the conduct and timing of the Phase I study of mRNA-1273, the planning, conduct and timing of a potential Phase 2 and any subsequent trials of mRNA-1273, and potential manufacturing capabilities. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this summary and FAQ are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this summary and FAQ in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
