copenlu/druid huggingface dataset:
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-27): On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024. [...] FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends. [...] March 24, 2023 - The FDA finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA’s recommendations for:
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-08): - Kharbanda EO, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Vesco KK, Daley MF, Donahue JG, Getahun D, Hambidge SJ, Irving SA, Klein NP, Nelson JC, Weintraub ES, Williams JTB, Vazquez-Benitez G. COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion. JAMA Network Open. 2023 May 19;6(5):e2314350. - Miller ER, Moro PL, Shimabukuro TT, Carlock G, Davis SN, Freeborn EM, Roberts AL, Gee J, Taylor AW, Gallego R, Suragh T, Su JR. COVID-19 vaccine safety inquiries to the centers for disease control and prevention immunization safety office. Vaccine. 2023 Jun 19; https://doi.org/10.1016/j.vaccine.2023.05.054 Online ahead of print. [...] - Romanson B, Moro PL, Su JR, Marquez P, Nair N, Day B, DeSantis A, Shimabukuro TT. Notes from the Field: Safety Monitoring of Novavax COVID-19 Vaccine Among Persons Aged ≥ 12 Years – United States, July 13, 2022 – March 13, 2023July 13, 2022 – March 13, 2023. MMWR Morb Mortal Wkly Rep. 2023 Aug 4. 72(31);850-851.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2021-04-08): The parallel execution of several stages of development that would usually be conducted in sequence, such as combining phase I and phase II clinical trials or building manufacturing capacity while the trials are still under way, has allowed pharmaceutical manufacturers to advance much more quickly through the development process than is typical for vaccines.2 One year after the first case of COVID-19 was diagnosed in the United States, three of the vaccines supported by BARDA funding had received emergency use authorizations from the FDA, and two other vaccines were in phase III clinical trials. (It ordinarily takes several years of research and testing before a candidate vaccine enters phase III clinical trials.3 Seasonal influenza vaccines take much less time to develop and approve because their technologies, and the regulatory and licensing procedures for those vaccines, have been used before.) According to the World Health Organization, more than 200 candidate COVID-19 vaccines were in development in February 2021.4 1. Most of the manufacturers have also received research support from or signed advance-purchase agreements with the European Union, several national governments, and two global partnerships supported by foundations and other donors (Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance).
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-10-09): The COVID-19 public health emergency (PHE) ended at the end of the day on May 11, 2023. View Infectious diseases for a list of waivers and flexibilities that were in place during the PHE. [...] After the FDA issues an emergency use authorization (EUA) or approves licensure of each COVID-19 vaccine product, CMS will identify the following for Medicare payment: [...] Together, these codes describe the administration of the COVID-19 vaccines and the monoclonal antibody products, as they become available. CMS and the AMA developed this code structure to make claims processing for administration of COVID-19 vaccines and monoclonal antibody infusions that get FDA EUA or FDA approval more efficient. Many of these codes may be placeholders and wouldn’t be effective until an authorized product is specifically assigned. It's possible that we won't use all codes. We'll issue specific code descriptors in the future as needed. Medicare effective dates for the codes will match with the date of the FDA EUA or FDA approval.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-06-15): There are FDA-approved COVID-19 vaccines in the U.S. as of May 2023, contrary to claim by Peter McCullough [...] Factually inaccurate: The claim that there are no FDA-approved COVID-19 vaccines as of 2023, is directly contradicted by FDA documents indicating approval of various COVID-19 vaccines. COVID-19 vaccine distribution began in the U.S. on 14 December 2020, following the authorization by the U.S. Food and Drug Administration (FDA) earlier that month. Almost two and a half years later, in May 2023, participants in an Arizona Senate hearing claimed that there was no FDA-licensed and approved COVID-19 vaccine on the market. However, this is inaccurate and contradicted by the FDA’s own press releases.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2022-01-10): - The Janssen (Johnson & Johnson) COVID-19 vaccine is no longer available in the United States. All government-issued doses expired on May 7, 2023. [...] At the time of this publication, three COVID-19 vaccines are currently approved under a BLA or authorized under an EUA by FDA: [...] Shortly following the rollout of COVID-19 vaccines CDC launched a v-safe pregnancy registry to collect additional data on COVID-19 vaccines during pregnancy. At the time the registry closed in May 2023 there were approximately 23,000 pregnant individuals enrolled. Data collected from the v-safe pregnancy registry did not indicate any safety concerns based on the reactogenicity profile and adverse events observed among pregnant individuals. Additionally, side effects were similar in pregnant and nonpregnant populations. Specific neonatal outcomes data published in The New England Journal of Medicine, along with pregnancy complication data from 275 completed pregnancies presented at the March 1, 2021 ACIP meeting are included in Table 1.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-02-06): In response to the unprecedented nature of the COVID-19 pandemic, the federal government spent billions of dollars in emergency funds between 2020 and 2022 to purchase medical countermeasures – vaccines, including boosters, treatments, and tests – and provided them free of charge to the public. In addition, Congress enacted several bills that included special requirements for their coverage by both public and private insurers, and the administration issued guidance and regulations to protect patient access and promote equitable distribution. The effective dates of many, though not all, of these requirements were tied to the public health emergency (PHE) declaration made pursuant to Section 319 of the Public Health Service Act, first declared in January of 2020 and renewed every 90 days through February 9, 2023, effectively ending the PHE on May 11, 2023. The availability of federally-purchased COVID-19 medical countermeasures ensured that they were provided free to all.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-05-15): The Covid-19 vaccine from Johnson & Johnson is no longer available in the United States, according to the US Centers for Disease Control and Prevention. [...] The mRNA vaccines from Pfizer/BioNTech and Moderna represented the vast majority of shots administered. Now that the Covid-19 Public Health Emergency is over in the US, these vaccines remain free as long as federal supplies last.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-08-30): The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient. [...] The FDA posted information regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. [...] Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age 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 (2023-10-06): The US government is no longer purchasing COVID-19 vaccines; therefore, the CDC COVID-19 Vaccination Program has ended. Updated 2023–2024 COVID-19 vaccines are now available for private purchase in the commercial marketplace. [...] With these FDA and CDC actions, the CDC COVID-19 Vaccination Program ended as of September 12, 2023, as it applied to the administration of the bivalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines previously provided by the US Government (USG). Now, with FDA’s authorization on October 3, 2023, of the 2023–2024 Novavax COVID-19 Vaccine, Adjuvanted, the CDC COVID-19 Vaccination Program has fully ended as of October 3, 2023. All authorized/approved doses of COVID-19 vaccine in the United States are now the 2023–2024 formulas. [...] Until September 12, 2023, all COVID-19 vaccine in the United States had been purchased by the United States Government (USG) for administration exclusively through the CDC COVID-19 Vaccination Program. Providers are prohibited from selling USG-purchased COVID-19 vaccine doses.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-11-09): Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5. [...] The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component. [...] The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was issued to Pfizer Inc.
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): Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine - This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older - Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Omicron-related sublineages including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris), which currently accounts for the largest portion of U.S. cases1 - The companies are working closely with pharmacies, hospitals, and clinics across the country to ensure rapid access to this season’s vaccine [...] Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-05-17): The Link Between J&J’s COVID Vaccine and Blood Clots: What You Need to Know [Originally published: April 21, 2021. Updated: May 17, 2023.] [...] In May 2023, existing doses of the J&J vaccine expired and the Centers for Disease Control & Prevention (CDC) directed providers to dispose of any that had gone unused. This article is no longer up to date. Read our primer on COVID vaccines for more information. [...] Both the AstraZeneca and Johnson & Johnson vaccines, as well as the Sputnik V vaccine in Russia (also not approved for use in the U.S.) are carrier—or vector—vaccines, which instruct human cells to make the SARS CoV-2 spike protein. For this vaccine technology, scientists engineer a harmless inactivated common adenovirus (which can cause colds and other illnesses when it is active) into a sort of Trojan Horse that carries genetic code to a vaccine recipient’s cells. The code then instructs the cells to produce a spike protein that trains the body’s immune system, which then creates antibodies and memory cells to protect against an actual SARS-CoV-2 infection.
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-07-19): Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, the Food and Drug Administration approved the first two vaccines for prevention of RSV lower respiratory tract disease (LRTD) for use in adults aged ≥60 years. [...] In May 2023, the Food and Drug Administration (FDA) approved the first vaccines for prevention of RSV-associated LRTD in adults aged ≥60 years. RSVPreF3 (Arexvy, GSK) is a 1-dose (0.5 mL) adjuvanted (AS01E) recombinant stabilized prefusion F protein (preF) vaccine (18). RSVpreF (Abrysvo, Pfizer) is a 1-dose (0.5 mL) recombinant stabilized preF vaccine (19).
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2024-10-02): FDA amends EUA to include Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), now authorized for use in individuals 12 years of age and older. Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States. October 3, 2023 [...] FDA approves and authorizes emergency use of updated mRNA vaccines (Moderna, Pfizer) for 2023-24. The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. September 11, 2023 [...] FDA amended EUAs of Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines. Bivalent vaccines were to be used for all doses given to individuals 6 months and older. Monovalent COVID-19 vaccines were no longer authorized for use in the United States. April 18, 2023
Claim: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023 (Peter McCullough, 2023-05-26)
Evidence (2023-12-06): COVID-19 vaccines are transitioning from federal procurement and distribution into the commercial marketplace during fall 2023. Under the Affordable Care Act (ACA), ACIP recommendations for routine immunization that have been adopted by CDC and are listed on CDC Immunization Schedules are required to be covered by group health plans and health insurance issuers offering group or individual health insurance coverage without cost-sharing requirements. The Coronavirus Aid, Relief, and Economic Security (CARES) Act expedited coverage for COVID-19 vaccines; since January 5, 2021, ACA-covered insurers must cover, without cost sharing, any COVID-19 vaccine FDA authorized under an EUA or FDA approved under a Biologics License Application immediately upon authorization or approval of the vaccine (19). Thus, for U.S. residents with applicable ACA commercial medical insurance coverage, COVID-19 vaccines will be covered immediately. In addition, COVID-19 vaccines are covered under Medicare Part B, and nearly all Medicaid beneficiaries can receive COVID-19 vaccines without cost-sharing. COVID-19 vaccines are also included in the Vaccines for Children Program,**** which provides vaccines to approximately one half of U.S. persons aged <19 years at no cost.
Claim: Human-caused carbon emissions’ effect on climate is ‘non-discernible’. Measurements of carbon isotope ratios in atmospheric CO2 indicate that it is the recent expansion of a more productive biosphere that has led to increased CO2 concentrations in the atmosphere. (Chris Morrison, 2024-04-08)
Evidence (2024-04-08): Carbon isotope ratios are actually one of the key measurements that show human-caused emissions are responsible for climate change. CO2 emissions from fossil fuels have lower concentrations of both carbon-13 and carbon-14 than CO2 placed in the atmosphere by the natural carbon cycle. Therefore, burning fossil fuels is linked to decreased concentrations of both isotopes in atmospheric CO2.
Claim: Human-caused carbon emissions’ effect on climate is ‘non-discernible’. Measurements of carbon isotope ratios in atmospheric CO2 indicate that it is the recent expansion of a more productive biosphere that has led to increased CO2 concentrations in the atmosphere. (Chris Morrison, 2024-04-08)
Evidence (2024-04-26): Cherry-picking: The article supports its claim with only two papers while ignoring the vast body of existing evidence that disproves it. The two papers in question are written by authors with no background in climate science and have been debunked by scientists who showed that they relied on flawed methodologies and made fundamental errors. For example, a more productive biosphere would be a net carbon sink and therefore decrease CO2 concentrations in the atmosphere, rather than increasing them. [...] An article authored by Chris Morrison in The Daily Sceptic, an outlet with a track record of scientifically unfounded messages, makes a conflicting claim: that changing isotope signatures in atmospheric CO2 result from the biosphere, rather than human causes like fossil fuel emissions. The article primarily cites "a new paper" published in February 2024 and supports its claim with a second paper published two years earlier. The article then upholds the two papers’ findings as scientific evidence that the human impact on climate change is "non-discernible". [...] Therefore, the scenario that a more productive biosphere could simultaneously push down δ13CO2 and increase the amount of CO2 in the atmosphere makes little sense. "If [the carbon-12] were coming from the biosphere, we would have had to lose carbon," Graven told Science Feedback.
Claim: Human-caused carbon emissions’ effect on climate is ‘non-discernible’. Measurements of carbon isotope ratios in atmospheric CO2 indicate that it is the recent expansion of a more productive biosphere that has led to increased CO2 concentrations in the atmosphere. (Chris Morrison, 2024-04-08)
Evidence (2022-11-16): Skip to main content [...] In the late 19th century, the scientist (and suffragette) Eunice Newton Foote published a paper suggesting that a build-up of carbon dioxide in the Earth’s atmosphere could cause increased surface temperatures1. In the mid-20th century, the British engineer Guy Callendar was the first to concretize the link between carbon dioxide levels and global warming2. Now, a century and a half after Foote’s work, there is overwhelming scientific evidence that human behaviour is the main driver of climatic changes and global warming. [...] Author & Researcher services
Claim: Human-caused carbon emissions’ effect on climate is ‘non-discernible’. Measurements of carbon isotope ratios in atmospheric CO2 indicate that it is the recent expansion of a more productive biosphere that has led to increased CO2 concentrations in the atmosphere. (Chris Morrison, 2024-04-08)
Evidence (2023-12-28): Human emissions of greenhouse gases are the primary driver of climate change today.1 CO2 and other greenhouse gases like methane and nitrous oxide are emitted when we burn fossil fuels, produce materials such as steel, cement, and plastics, and grow the food we eat. If we want to reduce these emissions, we need to transform our energy systems, industries, and food systems. [...] Lacis, A. A., Schmidt, G. A., Rind, D., & Ruedy, R. A. (2010). Atmospheric CO₂: Principal control knob governing Earth’s temperature. Science, 330(6002), 356-359.
Claim: Human-caused carbon emissions’ effect on climate is ‘non-discernible’. Measurements of carbon isotope ratios in atmospheric CO2 indicate that it is the recent expansion of a more productive biosphere that has led to increased CO2 concentrations in the atmosphere. (Chris Morrison, 2024-04-08)
Evidence (2024-01-01): Measurements of the forms (isotopes) of carbon in the modern atmosphere show a clear fingerprint of the addition of "old" carbon (depleted in natural radioactive 14C) coming from the combustion of fossil fuels (as opposed to "newer" carbon coming from living systems). In addition, it is known that human activities (excluding land use changes) currently emit an estimated 10 billion tonnes of carbon each year, mostly by burning fossil fuels, which is more than enough to explain the observed increase in concentration. These and other lines of evidence point conclusively to the fact that the elevated CO2 concentration in our atmosphere is the result of human activities.