copenlu/druid huggingface dataset:
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-08-23): The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates. [...] "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 confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product," FDA Acting Commissioner Dr. Janet Woodcock said during a briefing on Monday, calling the approval "a pivotal moment" for the United States’ fight against the coronavirus pandemic. [...] Among the two other coronavirus vaccines authorized for emergency use in the United States, Moderna has begun applying for full approval for its Covid-19 vaccine in people ages 18 and up. Johnson & Johnson has not yet filed for full FDA approval of its vaccine.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-08-23): Pfizer becomes first Covid vaccine to gain full FDA approval Pfizer's two-dose Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) - the first jab to be licensed in the nation. [...] In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2023-04-18): Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines - For Immediate Release: 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. [...] 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: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-02-27): FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine [...] Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. "The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said Acting FDA Commissioner Janet Woodcock, M.D. "The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2024-08-23): The U.S. Food and Drug Administration on Aug. 22 approved and granted emergency use authorization for updated mRNA COVID-19 vaccines. [...] The emergency use authorization continues until the health secretary ends it. Existing product authorizations can continue, and new ones, such as the updated COVID-19 vaccines, can be issued as long as the declaration remains in effect. [...] 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.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-08-24): The Food and Drug Administration has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a "key achievement for public health." [...] But among the measures the FDA required for full approval that weren't required for emergency use were data on how people fared six months after being fully vaccinated. The FDA also inspected manufacturing facilities in the intervening months. [...] "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," Woodcock of the FDA said.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-06-01): On the 1-year anniversary of the World Health Organization (WHO) declaring COVID-19 a global pandemic, the development and rollout of safe and effective vaccines has fueled optimism for greater pandemic control. During the COVID-19 pandemic, medicine regulators have faced significant pressure from both the public and governments to expedite vaccine approval, while grappling with the challenges of novel vaccine clinical development and ensuring public trust and confidence in COVID-19 vaccines.1 Recognizing the gravity of this public health emergency, medicine regulators have introduced or activated accelerated mechanisms for restricted approval or permitted use of unapproved medical products in predefined circumstances (eg, Emergency Use Authorizations [EUA]).2 We investigated COVID-19 vaccine approvals at 3 medicine regulatory agencies, the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada (HC), characterized and contrasted regulatory review times, and analyzed the clinical evidence supporting authorization.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-12-09): Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older - First emergency use authorization in the United States for a COVID-19 vaccine booster in individuals 16 years and older [...] "Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "From the beginning, we aimed to provide strong, safe protection to as many people as possible in an effort to end this pandemic. While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended." [...] Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2023-11-09): FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants - For Immediate Release: 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 updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2022-08-31): The US Food and Drug Administration on Wednesday authorized updated Covid-19 vaccine booster shots from Moderna and Pfizer. This is the first time updated Covid-19 vaccines have received emergency use authorization in the United States. [...] On Wednesday, FDA officials defended their swift emergency use authorization of the updated Covid vaccine booster. Pfizer and Moderna submitted for authorization last week. [...] This is similar to the way annual flu vaccines are tested each year, but it’s a first for Covid-19 vaccines. The approach has generated some controversy among vaccine experts. In making the authorization, the agency did not call a new meeting of its independent vaccine advisers, who often weigh in on vaccine changes; the advisory group had offered its insight on updating the original vaccine in meetings over the summer.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
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. [...] "Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release Monday. "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." [...] 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.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2024-08-27): Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below. [...] 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. [...] - COVID-19 Vaccines - Emergency Use Authorization for Vaccines Explained - Infographic: The Path for a COVID-19 Vaccine From Research to Emergency Use Authorization (PDF, 723 KB)
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2023-02-10): Overview of Major Health-Related COVID-19 Federal Emergency Declarations [...] - A public health emergency (PHE) was initially declared by the Secretary of the Department of Health and Human Services (HHS) in late January 2020, pursuant to Section 319 of the Public Health Service Act. A PHE lasts for 90 days and must be renewed to continue; the PHE for COVID-19 has been renewed several times, most recently in February 2023, and is currently scheduled to expire on May 11, 2023. [...] - A separate emergency declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act was issued by the Secretary of HHS in February 2020. Based on this determination, on March 27, 2020, the Secretary declared that circumstances existed to justify emergency use authorization (EUA) of medical countermeasures for COVID-19. An EUA is a mechanism to facilitate availability and use of medical countermeasures that are determined to be safe and effective but have not yet been formally approved. An emergency declaration issued pursuant to Section 564 of the FD&C Act remains in effect until terminated by the HHS Secretary. The timing to conclude the EUA is to be determined; it will not conclude on May 11, 2023, with the other declarations.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2024-09-18): The 2024-2025 COVID-19 vaccines have been approved to protect against severe illness. This page will be updated to include information and resources for everyone 6 months and older to get vaccinated. These vaccines will be available in San Diego sometime in September and October. [...] - Authorization or Approval – Before vaccines are available to people, the U.S. Food and Drug Administration (FDA) reviews data from clinical trials. FDA has determined COVID-19 vaccines meet FDA’s standards and has granted those vaccines Emergency Use Authorizations (EUAs) or full FDA approval. - Tracking Safety Using Vaccine Monitoring Systems – Like every vaccine approved for use in the United States, COVID-19 vaccines continue to be monitored for safety and effectiveness. Hundreds of millions of people in the United States have safely received COVID-19 vaccines. CDC and FDA provide updated information on the safety of U.S. authorized or approved COVID-19 vaccines using data from the Vaccine Safety Datalink (VSD), Vaccine Adverse Event Reporting System (VAERS), and other safety monitoring systems.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2022-11-08): COVID-19 Emergency Temporary Standards Frequently Asked Questions [...] A: Yes. As explained by the Department of Fair Housing and Employment, an employer may require employees to receive an FDA approved vaccination against COVID-19 infection so long as the employer: does not discriminate against or harass employees or job applicants on the basis of a protected characteristic; provides reasonable accommodations related to disability or sincerely-held religious beliefs or practices; and does not retaliate against anyone for engaging in protected activity (such as requesting a reasonable accommodation). For guidance on this topic, employers may wish to refer to information provided in the following FAQ resources provided by the federal Equal Employment Opportunity Commission (EEOC) and the California Department of Fair Employment and Housing at the following webpages: [...] A: Tests approved by the United States Food and Drug Administration (FDA) or that have an Emergency Use Authorization (EUA) from the FDA to diagnose current infection with the SARS-CoV-2 virus may be used. These include both PCR and antigen tests. The test must be administered in accordance with the FDA approval or FDA EUA, as applicable. - Q: In a non-outbreak setting, how does an employer determine which employees may have had close contact with a COVID-19 case?
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2023-08-09): The federal Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUA) for COVID-19 vaccinations. The federal government, through partnerships with state governments, contemplates that vaccines must be sent through a closed system of distribution, either directly from the manufacturer or through pre-determined licensed drug distributors for facility distribution to emergency response providers that include public health agencies with legal responsibility and authority to respond to a public health incident. [...] In response to the Governor’s emergency proclamation, and to facilitate the distribution, storage, mixing, and administration of FDA-authorized COVID-19 vaccine to California- or federally-approved facilities or providers that will administer the vaccines, and consistent with the authority of the Board to waive Pharmacy Law (Business and Professions Code section 4000, et seq.) and the regulations adopted pursuant to it (California Code of Regulations, title 16, section 1700, et seq.), the Board President through his delegated authority, issues the following waiver as detailed below: Storage and Redistribution of FDA-Authorized COVID-19 Vaccinations in Compliance with California Department of Public Health and CDC Guidance Related to Mass Vaccination Sites
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2023-05-05): In May 2023, three years after COVID-19 was designated as a pandemic, the World Health Organization (WHO) and the U.S. Department of Health and Human Services (HHS) declared the end of the Public Health Emergency (PHE) for COVID-19.3,4 While clinical and real-world data still show that existing COVID-19 vaccine options can help protect against the virus, we are continuing to follow the science by exploring new vaccine approaches that may be needed as the virus evolves. We also continue to run a COVID-19 clinical development program, consisting of completed and ongoing clinical trials, to evaluate our oral therapy for potential use in additional patient populations. [...] In the meantime, we believe that one of the best safeguards against the spread of COVID-19 is getting all eligible people up to date with their vaccination schedule, and for those who do get COVID-19, educating and encouraging them to speak with their healthcare professional about available treatment options.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2022-08-10): - I have received at least one dose of a US Food and Drug Administration (FDA) approved or authorized COVID-19 vaccine or a COVID-19 vaccine with World Health Organization Emergency Use Listing (WHO EUL). If not fully vaccinated, I will complete a recommended COVID-19 vaccine series within 90 days after arrival. If the COVID-19 vaccine I received cannot be determined or is not available in the United States, I will receive at least one dose of an FDA approved or authorized COVID-19 vaccine according to the guidelines: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html - I have not received at least one dose of an US Food and Drug administration (FDA) approved or authorized COVID-19 vaccine or a COVID-19 vaccine with World Health Organization Emergency Use Listing (WHO EUL) but qualify for an exception to this requirement because I am too young.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2024-08-30): Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. [...] 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 FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.
Claim: Food and Drug Administration approval for updated COVID-19 vaccines requires a public health emergency declaration. (Jeffrey Barke, 2024-08-23)
Evidence (2021-09-09): COVID-19 vaccines are widely available in the United States. They protect people from getting infected and severely ill, and they significantly reduce the likelihood of hospitalization and death. As of the date of this order, one of the COVID-19 vaccines, the Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty, has received approval from the Food and Drug Administration (FDA), and two others, the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine, have been authorized by the FDA for emergency use. The FDA has determined that all three vaccines meet its rigorous standards for safety, effectiveness, and manufacturing quality. [...] Accordingly, building on these actions, and in light of the public health guidance regarding the most effective and necessary defenses against COVID-19, I have determined that to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law.