copenlu/druid huggingface dataset:
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2023-03-26): The subgroup who received non-mRNA vaccines was more likely to be clinically vulnerable and may be at greater risk of adverse events following vaccination than the general population. [...] "We find no evidence that the risk of cardiac or all cause death is increased in the weeks following vaccination with mRNA vaccines. However, receiving a first dose of a non-mRNA vaccine was associated with an increased risk of cardiac death in young women. Vaccination with the main non-mRNA vaccine used in the UK was stopped for young people following safety concerns in April 2021, and most of the young people who received it would have been prioritised due to clinical vulnerability or being healthcare workers. Therefore, these results cannot be generalised to the population as a whole. [...] Another limitation is the selective administration of the vaccines. Vaccination with the main non-mRNA vaccine used in the UK was stopped for young people following safety concerns in April 2021. Young people who had been vaccinated up to this point were mostly those prioritised, for example, because of clinical vulnerability or being a healthcare worker. The young people who were clinically vulnerable are therefore likely to be at higher risk of mortality than the general population and more vulnerable to the SARS-CoV-2 virus.
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2022-09-01): Ineffective, harmful experimental COVID-19 vaccines – removal from the market 11.5.2022 [...] A recent study by the Charité University Hospital in Berlin on the ‘safety profiles of COVID-19 vaccines’ revealed that there are 40 times more cases of people with serious complications after being given these vaccines than previously reported by the Paul-Ehrlich-Institut. [...] - 1.Does the Commission think that the COVID-19 vaccines should be taken off the market until new and further information on the subject is available, especially as it is now known that they are ineffective as they do not prevent people from contracting the virus?
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2023-02-10): FACT: The technology used, called messenger RNA, or mRNA, is not new. Research on it actually began in the early 1990s, and two diseases that are very close to COVID—SARS (severe acute respiratory syndrome) in 2003, and MERS (Middle East respiratory syndrome)—helped bring the mRNA vaccine development to present day use.—Centers for Disease Control and Prevention, Understanding mRNA COVID-19 Vaccines [...] Hamer: COVID vaccines have been shown to be very powerful in preventing more severe disease and the need for hospitalization. Breakthroughs occur at a much, much lower rate than in people who are unvaccinated. The breakthroughs have been occurring more frequently with the Delta variant because of the high level of infectiousness (or transmissibility) of the Delta variant and lower protection of current vaccines against this variant. But people having breakthroughs have much more mild infection, more like an upper respiratory infection. The vaccines prevent severe disease and complications and allow people to return to a more normal state. [...] Hamer: COVID vaccines are not made with live virus SARS-COV-2 virus cells. They are not giving individuals the virus itself so you can’t get COVID from getting the vaccine.
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2023-07-10): Since the discovery of messenger RNA (mRNA), there have been tremendous efforts to wield them in the development of therapeutics and vaccines. During the COVID-19 pandemic, two mRNA vaccines were developed and approved in record-breaking time, revolutionizing the vaccine development landscape. Although first-generation COVID-19 mRNA vaccines have demonstrated over 90% efficacy, alongside strong immunogenicity in humoral and cell-mediated immune responses, their durability has lagged compared to long-lived vaccines, such as the yellow fever vaccine. Although worldwide vaccination campaigns have saved lives estimated in the tens of millions, side effects, ranging from mild reactogenicity to rare severe diseases, have been reported. This review provides an overview and mechanistic insights into immune responses and adverse effects documented primarily for COVID-19 mRNA vaccines. Furthermore, we discuss the perspectives of this promising vaccine platform and the challenges in balancing immunogenicity and adverse effects. [...] Recently, approved mRNA vaccines for COVID-19 from Pfizer/BioNTech and Moderna employed similar technological paths by utilizing antigenic mRNA encoding a nucleoside-modified prefusion form of the spike antigen (S-2P) packaged in ionizable cationic LNPs for delivery. Both formulations resulted in the strong induction of protective immunity in animal models and human vaccinees13. The immune response triggered by COVID-19 mRNA is characterized by robust production of spike-binding and neutralizing antibodies, as well as intermediate levels of T-cell responses (Fig. 1). Notably, after the first vaccination, moderate innate immune responses, including antiviral and interferon responses, were observed, while much broader and stronger inflammatory responses, such as sharp increases in inflammatory monocytes and IFN-γ, were observed after the boost immunization24.
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2023-11-20): Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med. 2020;383:1920–31. [...] Saresella M, Piancone F, Marventano I, Hernis A, Trabattoni D, Invernizzi M, et al. Innate immune responses to three doses of the BNT162b2 mRNA SARS-CoV-2 vaccine. Front Immunol. 2022;13:947320. [...] Lim WW, Mak L, Leung GM, Cowling BJ, Peiris M. Comparative immunogenicity of mRNA and inactivated vaccines against COVID-19. Lancet Microbe. 2021;2:e423.
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2021-10-07): Messenger RNA, or mRNA, was discovered in the early 1960s; research into how mRNA could be delivered into cells was developed in the 1970s. So, why did it take until the global COVID-19 pandemic of 2020 for the first mRNA vaccine to be brought to market? [...] Thanks to decades of research and innovation, mRNA vaccine technology was ready. With COVID, this technology got its moment and has proven to be extremely safe and effective. Pfizer’s COVID-19 vaccine is the first mRNA product to achieve full FDA approval in the U.S. [...] RELATED CONTENT - How to Update an mRNA Vaccine - For mRNA Vaccines, COVID-19 is Just the Beginning - The New Technology Behind COVID-19 mRNA Vaccines and What This Means for Future Outbreaks
Claim: COVID-19 mRNA vaccines are experimental, “ineffective and harmful” (Chris Oyakhilome, Sucharit Bhakdi, Peter McCullough, 2024-03-05)
Evidence (2021-11-13): The Pfizer and Moderna COVID-19 vaccines were the first mRNA vaccines that humans received outside of clinical trials. [...] Dr. Kenyon explained that mRNA vaccines deliver the coronavirus S protein’s genetic material. Our own cells then use the information stored in the mRNA to make the S proteins. The immune system is then "trained" to recognize these spikes, preparing it for a future attack. [...] Another concern is whether natural immunity would be more effective than a vaccine. However, a CDC study from November 2021 found that COVID-19 mRNA vaccines are about "Natural immunity is not better than vaccine-acquired immunity. These vaccines have the potential to provide you with protective immunity without the risks associated with infection," Dr. Yager told MNT.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-05-26): The COVID-19 vaccines authorized or approved by the U.S. Food and Drug Administration have been extensively tested and shown to be safe and effective against the disease. Emergency Use Authorizations allow for a faster distribution of vaccines in the context of an ongoing pandemic that poses a public health threat compared to a full approval which would require more time. As of 2023, the Pfizer-BioNTech and the Moderna vaccines are fully approved for people aged over 12 and 18, respectively. These vaccines as well as those by other companies have received emergency use authorizations for use in other age groups or as booster shots.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-09-17): - It is especially important to get your 2024–2025 COVID-19 vaccine if you are ages 65 and older, are at high risk for severe COVID-19, or have never received a COVID-19 vaccine. [...] People who recently received the 2023-2024 COVID-19 vaccine For most people the minimum interval between their last 2023–2024 COVID-19 vaccine dose and their 2024–2025 vaccine dose is 2 months. However, there are exceptions for those who are completing an initial vaccination series, including children aged 6 months–4 years, those with moderate to severe immunocompromise, and people receiving a Novavax initial series. For more information about intervals for those specific circumstances, please see Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-09-16): - ^ "Pfizer-BioNTech COVID-19 Vaccine". U.S. Food & Drug Administration. 11 December 2023. Retrieved 26 January 2024. [...] - ^ a b "(CDC) Janssen (Johnson & Johnson) COVID-19 Vaccine". U.S. Food & Drug Administration. 10 May 2023. [...] - ^ "Moderna COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 1 November 2023. Retrieved 26 January 2024.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-22): The Food and Drug Administration on Thursday approved the new Covid vaccines from Pfizer and Moderna. [...] The timing of the new vaccines — last year's rollout was in mid-September — is significant, since most of the U.S. is still caught in the summer wave of Covid illness. As of Monday, the Centers for Disease Control and Prevention reported, the number of people testing positive for Covid keeps rising and emergency room visits for Covid have been increasing since mid-May. Hospitalizations are rising, too. [...] As of May 11, only 22.5% of adults got last year’s updated Covid vaccine, according to data from the CDC. Only 14.4% of children ages 6 months through 17 years got vaccinated.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-09-11): The US Food and Drug Administration gave the green light Monday to updated Covid-19 vaccines from Moderna and Pfizer/BioNTech amid rising cases and hospitalizations. [...] The updated vaccines are approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old. As part of the FDA’s update, the bivalent Moderna and Pfizer/BioNTech Covid-19 vaccines are no longer authorized for use in the United States. [...] The FDA has not authorized an updated Covid-19 vaccine from Novavax, but the company said an updated version of its protein-based vaccine is currently under review by the FDA for authorization in people 12 and older.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-09-11): New COVID vaccines get FDA approval The Food and Drug Administration approved a new round of vaccines against COVID-19. [...] "Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-04-18): Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. [...] Today’s authorizations follow discussions that occurred during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Jan. 26. At that time, by a unanimous vote, the committee recommended harmonizing the strain composition of COVID-19 vaccines used in the U.S. There was also support for simplifying the vaccine dosing schedule. In June, the FDA will hold a meeting of its VRBPAC to discuss the strain composition of the COVID-19 vaccines for fall of 2023. Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year. Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability this fall.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-03-09): The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) to provide better protection against COVID-19 caused by circulating variants. [...] The following COVID-19 vaccines are approved by FDA: [...] Ingredients in FDA-approved COVID-19 vaccines are included in the Prescribing Information for healthcare providers and in the Information for Recipients and Caregivers for vaccine recipients under the question, "What are the ingredients in this vaccine?"
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-22): Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc. In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible. [...] For today’s approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2021-09-01): The Food and Drug Administration (FDA) approved the first Covid vaccine -- from Pfizer-BioNTech -- in the summer of 2021. It later approved the Moderna vaccine in January of 2022. This means the vaccine received the standard Biologic License Application (BLA) approval, which represents the FDA’s highest standard and requires a longer period of evaluation. The FDA had previously granted Emergency Use Authorization (EUA) to the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson vaccine. Additional vaccines are in Phase 3 of clinical trials and maybe submitting data for review with the FDA soon. Emergency Use Authorization exists to allow the FDA more flexibility to review and authorize products for use during public health emergencies, like a pandemic. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks (like serious side effects). While the EUA allows people to start receiving the vaccine, vaccine developers will continue to submit data to the FDA to achieve full FDA approval through a BLA.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2021-10-04): Johnson incorrectly claims there are no approved COVID-19 vaccines in America [...] Before that, each COVID-19 vaccine approved in the U.S. — Pfizer, Moderna and Johnson & Johnson — had received an emergency use authorization (or EUA) from the FDA, following an expedited process because of the public health emergency the pandemic triggered. [...] In an interview, Johnson claimed: "We do not have an approved (COVID) vaccine in America … the Pfizer vaccine available in the U.S. is not FDA approved."
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2021-07-22): To date, more than 339 million doses of Covid-19 vaccine have been administered to give people protection from the coronavirus; several studies show that the three vaccines authorized for emergency use in the United States work and are safe; and the government continues to give them out in schools and at ball fields, and yet, not one has been formally approved by the US Food and Drug Administration. [...] On Wednesday, President Joe Biden told CNN’s Don Lemon during a CNN Townhall that he expects Covid-19 vaccines could get full approval "quickly." [...] The Covid-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. "Although, when something’s 95% effective, you can assume it’s probably going to be highly effective for awhile," said Offit.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-03-05): Updated COVID-19 vaccines are being rolled out in the U.S., aimed at targeting the latest, prevalent variants of the disease. [...] The 2023-2024 vaccines, as the FDA and CDC have referred to them, come one year after the rollout of the vaccine makers’ bivalent booster vaccines, the first version of COVID-19 vaccines updated to target circulating variants. With the latest FDA action, the bivalent boosters are no longer FDA-authorized and won’t be available. [...] Dr. Beth P. Bell, a clinical professor at the University of Washington School of Public Health, agreed, saying "there’s all kinds of robust information" on the benefits and safety profile of COVID-19 vaccines — "granted, not exactly with this vaccine," but the 2023-2024 version is "a very, very similar vaccine."
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-09-15): FDA and CDC sign off on new COVID vaccines. Here's what to know about the updated shots for fall 2023. Updated COVID-19 vaccine shots are expected to be available nationwide as soon as Sept. 13, after a panel of the Centers for Disease Control and Prevention's outside vaccine advisers voted by a wide majority to back new shots retargeted for newer variants ahead of the fall virus season. [...] While the public has grown accustomed to calling additional shots "boosters," health officials are now moving away from the word "booster," instead calling this year's shots the "2023-2024 COVID-19 vaccine" or simply the "updated COVID-19 vaccine." This clarification helps distinguish previous additional doses from this year's updated vaccine formula.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-23): The COVID-19 vaccines the FDA recently authorized target a new variant. The FDA grants emergency use authorization to products when there aren’t effective, approved and available alternatives. The claim that the FDA shouldn’t be able to approve the new COVID-19 vaccines because there is no public health emergency and that other treatments are available is False. [...] U.S. Food and Drug Administration, FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants, Aug. 22, 2024
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-04-19): There has been better protection against severe disease, hospitalization, and death from COVID-19 since newly updated (2023–2024 formula) mRNA COVID vaccines became available last fall. Shots are available to protect everyone 6 months and older from serious illness, hospitalization, and death from the disease. [...] COVID vaccines are safe and effective, according to the CDC. The safety of COVID vaccines has been rigorously monitored and evaluated since their emergency use authorization (EUA) in December 2020. According to the CDC, the updated mRNA COVID vaccines for 2023-2024 are manufactured using a similar process to the previous vaccines. [...] The Pfizer-BioNTech and Moderna vaccines use messenger RNA (mRNA) technology, which instructs the body’s cells to make proteins that trigger an immune response against COVID. The Novavax protein-based vaccine uses an older, more traditional technology and a different mechanism—it directly injects the spike protein (formulated in a laboratory) and another ingredient into the body, leading to the production of virus-fighting antibodies and T cells. The Novavax vaccine is the only non-mRNA COVID vaccine available in the U.S.