The ending of the COVID-19 PHE will not affect the FDA's ability to authorize various products, including tests, treatments, or vaccines for emergency use. The most common adverse events reported for both vaccines were headaches (20%), fatigue (17%), and fever (16%). To evaluate the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older, the FDA analyzed immune response data among approximately 600 adults greater than 55 years of age who had previously received a 2-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine. But several FDA advisors said there could be a significant safety issue after two vaccine recipients out of about 20,000 developed Guillain-Barre syndrome. In response to the lawsuit, FDA in November proposed releasing around 500 pages of the review documents each monthwhich would fulfill the organization's FOIA request in around 55 to 75 years. Sen. Ron Johnson hosted a panel discussion in Washington, D.C., in January called COVID-19: A Second Opinion. Attorney Thomas Renz presented data from whistleblowers inside the U.S. medical system. The Massachusetts biotech firmapplied for an emergency use authorizationlast week after finding the shot was 94.1 percent effective in a clinical trial. Historically, theVAERS adverse events are underreported by a factor of 100. The symptoms included wheezing, shortness of breath, rapid and shallow breathing as well as mucus production. The risk of hospitalization increases with age, and adults ages 70 and older are more vulnerable. To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine. Typically adult vaccine mandates have been limited; even the seminal U.S. Supreme Court vaccine mandate decision, Jacobson v. Massachusetts, only involved a state-imposed $5 penalty, and school vaccine mandates have historically had liberal religious or personal belief exemption policies. Dr. Hana El Sahly, who chairs the FDA advisory committee, also said the Guillain-Barre cases raise a significant safety concern. The FDA has asked Pfizer to develop a safety study that will monitor Guillain-Barre risks after an approval, which the company has agreed to do. People get their first look at the reports the FDA wanted to keep secret for three-quarters of a century. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy. The FDAs excuses were incredible. In clinical trial participants 37 months through 5 years of age, other commonly reported side effects included fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting. In January, PfizerCEOAlbert Bourla said: We know the two-dose vaccine offers very limited protection if any. Bourla then recommended a third dose. The National Health Service in the United Kingdom reported that theFebruary 2022data sets clearly show there are more vaccinated people in hospitals and becoming infected in nearly every age demographic. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnatys safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, said Peter Marks, M.D., Ph.D., director of FDAs Center for Biologics Evaluation and Research. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDAs standards for approval. The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc. The virus killed more than 15,600 people across the country over the last seven days and the nationwide infection count is approaching 15 million, according toJohns Hopkins University data. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Cormirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. Get this delivered to your inbox, and more info about our products and services. However, this has not stopped anti-vaccine advocates from using the released documents to question the safety of Covid-19 vaccines, MedPage Today reports. In one clinical study, the safety of a single booster dose of monovalent Moderna COVID-19 Vaccine was evaluated in 145 clinical study participants 6 months through 5 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of the monovalent Moderna COVID-19 Vaccine two-dose primary series. Do the vaccines actually protect against infection? The FDA responded to a Freedom of Information Act (FOIA) request for more than 300,000 pages of data related to the licensure of Pfizer's COVID-19 vaccine by proposing a processing schedule. The Food and Drug Administration was ordered by a federal judge Thursday to release tens of thousands of more pages a month about the data used in its approval process for Pfizer's COVID-19. The monovalent Moderna COVID-19 Vaccine is authorized as a two-dose primary series in individuals six months of age and older and as a third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. We are confident in the evidence supporting these authorizations, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Gurtman pointed to other potential causes of the Guillain-Barre cases, noting that the man had suffered a heart attack and the woman had an upper respiratory tract infection. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. The Comirnaty Prescribing Information includes a warning about these risks. By Marie Rosenthal, MS. October 12, 2022: FDA authorizes bivalent. It will take time to see if this prediction is true, but initial data seem to support this analysis. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older . The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to . However, U.S. District Judge Mark Pittman of the Northern District of Texas in January issued a court order requiring FDA to significantly speed up the release of the documents. The purpose of FOIA is government transparency. Specifically, in the FDA's review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have. Other advisors were frustrated by a lack of efficacy data on people with weak immune systems and nursing home residents. Aaron Siri is the managing partner of Siri & Glimstad LLP, and has extensive experience in a wide range of complex civil litigation matters, with a focus on civil rights involving mandated medical procedures, class actions, and high-stakes disputes. The Food and Drug Administration has decided its 55-year request to release all of the data it relied upon to license the Pfizer Covid-19 vaccine was actually too quick of a turnaround time . The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The researchers also found that women and individuals ages 65 and younger were more likely to report adverse events after vaccination, leading them to suggest that "mild-to-moderate transient reactogenicity should be anticipated, particularly among younger and female vaccine recipients. For each of the bivalent COVID-19 vaccines authorized today, the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. For all vaccines, the FDA evaluates data and information included in the manufacturers submission of a biologics license application (BLA). The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive spike protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The site is secure. Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine. FDA-approved vaccines undergo the agencys standard process for reviewing the quality, safety and effectiveness of medical products. FDA says it needs 75 years to fully release Pfizer COVID-19 vaccine data to the public. The approval was granted to BioNTech Manufacturing GmbH. Dr. Jay Portnoy, an FDA committee member, said he concluded the safety data was adequate because Guillain-Barre syndrome is rare, and otherwise adverse events in the trial occurred at about the same rate among people who received the vaccine and those who did not. And these are just the reported cases. The scientists also found the vaccine was similarly effective regardless of the recipients age, gender, race or ethnicity and among people with underlying medical issues that put them at risk for severe coronavirus infections. This article does not necessarily reflect the opinion of The Bureau of National Affairs, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners. The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine. The available efficacy and safety data is from the first season. For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children 6 months through 5 years of age, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults of a booster dose of Modernas investigational bivalent COVID-19 vaccine that contained a component corresponding to the original strain of SARS-CoV-2 and a component corresponding to the omicron lineage BA.1. The FDA vaccine panel is scheduled to discuss Modernas COVID-19 shot at a separate meeting on Dec. 17. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The meeting will come as the COVID-19 pandemic rages through a deadly new phase in the US. Pfizer is conducting its clinical trial over two RSV seasons with more than 34,000 people enrolled. It would be laughable if any multibillion-dollar company came before a court and claimed poverty to escape making a document production, but that was the FDAs position. The Moderna COVID-19 Vaccine, Bivalent is also authorized for use in individuals 6 years and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 02.24.2023 Vaccines Covid-19 Vaccines Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster 02.22.2023 Pfizer's Elranatamab Receives FDA and EMA Filing Acceptance The Centers for Disease Control and Prevention says the vaccines are safe and effective. The side effects listed on theCDCwebsiteare called extremely rare and include tiredness, headache, muscle pain, chills, fever and nausea. If people need to make informed decisions on vaccination, why were the 1,200 adverse effects and fatalities not released to the public until now? The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.. Yet doctors have no explanation for why the vaccine is causing this issue. When it comes to the Pfizer vaccine, the need for transparency is unprecedented. To support the FDAs approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. The data accrued with the investigational Moderna bivalent COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. The data would then be used to determine whether the FDA needs to make any adjustments to how the shot is used, she said. Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. NEW YORK & MAINZ, Germany-- (BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies' COVID-19 vaccine (BNT162b2) for future licensure. Another studyfrom theJournal of Pediatric and Adolescent Gynecologyfound that increased use of the Pfizer vaccines in kids 12 years old and over correlated with an increase in post-vaccination genital ulcers. Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. Wasn't able to find the original documents released by the FDA. FDA Statement Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses The following is attributed Peter Marks, M.D.,. For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children 6 months through 5 years of age, the FDA relied on immune response data that it had. The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2. Her press release is from Thursday. Akindele, the FDA official, said real-world evidence after a vaccine rollout could answer how much protection it provides for those in fragile health. However, they added, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission.. A U.S. federal judge in Texas has denied attempts by the U.S. Food and Drug Administration (FDA) to conceal data on Pfizer's COVID-19 vaccine. Overall, approximately 12,000 recipients have been followed for at least 6 months. El Sahly said the disease has an incidence of about 1 in 100,000 among people ages 60 and older, but in the trial the rate looks more like 1 in 9,000. Jan. 18, 2022, 1:00 AM Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto Aaron Siri Siri & Glimstad A group of scientists and medical researchers sued the FDA under FOIA to force release of hundreds of thousands of documents related to licensing of the Pfizer-BioNTech Covid-19 vaccine. This brings into stark focus the need to open the door and involve independent scientists. More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so especially as we head into the holidays and winter months where more time will be spent indoors, said FDA Commissioner Robert M. Califf, M.D. The spike proteins of BA.4 and BA.5 are identical. This should shake our faith in medical science, shouldnt it? The adverse effects are becoming increasingly clear. The failure of the governments closed-door approach is exemplified by the fact that the FDA did not send a representative to the court hearing because, as the government attorney explained, the FDAs Covid-19 protocols would not permit it. Importantly, Pfizer has made billions of dollars off of the vaccines. January 10, 2022 A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech's COVID-19 vaccine and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. Who is eligible to receive a single booster dose and when: The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19, said FDA Commissioner Robert M. Califf, M.D. The April 2022 Trumpet magazine exposes this corruption and the agenda behind covering up the adverse effects and aggressively pushing the vaccines. FDA said the agency branch responsible for handling the request has only 10 employees and is currently processing 400 other FOIA requests, MedPage Today reports. FDA issues EUA for Novavax COVID-19 Vaccine to provide a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine FDA Approval - 10/19/22 The FDA has the authority to require such a study after approval if the agency determines that is necessary. The data accrued with the investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these vaccines are manufactured using the same process. At the time of Tuesday's meeting, there was not enough data to evaluate the effectiveness of Pfizer's vaccine against severe disease requiring hospitalization, oxygen support or a mechanical ventilator, according to the FDA. Todays milestone puts us one step closer to altering the course of this pandemic in the U.S.. In his ruling, the judge recognized that the release of this data is of paramount public importance and should be one of the FDAs highest priorities. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as. On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. Even more problematic is that Americans, if injured, cannot sue Pfizer. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. America has some of the greatest institutions of learning the world has ever known. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individuals genetic material. In response, the FDA produced nothing. The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 participants 18 years of age and older who had previously received a two dose primary series and one booster dose of the monovalent Moderna COVID-19 Vaccine, and then at least 3 months later, received a second booster dose with either the monovalent Moderna COVID-19 Vaccine or Modernas investigational bivalent COVID-19 vaccine (original and omicron BA.1). The longer time goes on, the more and more adverse events become manifested in people. But there isnt yet enough data to prove whether the shot can prevent vaccinated people from carrying and spreading the virus or whether it can ward off asymptomatic infections, the FDA said. The reported side effects are just the tip of the iceberg. Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. On March 14, he said a fourth dose may be needed to fight off new variants. The monovalent Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.. Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Staff turnover: 4 key takeaways from Advisory Board's survey of 224 hospitals, The most innovative companies in health care, biotech, and more, according to Fast Company, Modern Healthcare's 'Top Women Leaders in Healthcare' for 2022, How WFH is better (and worse) for the environment, Around the nation: Florida's surgeon general recommends against Covid-19 vaccines for children, March 9, 2022 | Advisory Board Daily Briefing, Why FDA is releasing 55K pages of Covid-19 vaccine data every month. The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. When asked what would happen if data from the second season is not as strong after an approval, Akindele said the FDA would reevaluate the shot and meet with the committee again to determine how to proceed. Pfizers experimental coronavirus vaccine is highly effective and poses no safety risks that would prevent it from being cleared for emergency use, Food and Drug Administration scientists said Tuesday. (Reuters) - In advance of a court hearing before a federal judge in Fort Worth, Texas, Tuesday, the Food and Drug Administration has offered by the end of January to make public 12,000 pages of. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. TheFDAhas issued a warning that the vaccines can induce apositive syphilis test. In fact, Health Canada has already posted some of the Pfizer vaccine data the researchers are seeking in their. Pfizer also did not have data on how effective the vaccine is for elderly individuals with weak immune systems or for those in frail health, according to the FDA. The federal government created this unprecedented situation. Pfizer's shot could become the first to receive FDA approval. Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory. Meaning, despite a reported vaccination rate of over 96% across federal health agencies back in November 2021, and the FDAs claim that the vaccines are effective, Covid-19 is still disrupting everyday life. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. A studyin Poland that is yet to be peer-reviewed discovered that the mRNAvaccine has an effect on the vitro lial cells in the brain. However, some individuals required intensive care support. This situation therefore warrants unprecedented transparency. Despite the limitations, the data offered the public an in-depth look at how well the Pfizer jab works before Thursdays highly anticipated meeting of the FDAs vaccine advisory panel. Read CNBC's latest global health coverage: The shot was about 86% protective against lower respiratory tract illness with three or more symptoms, and 66.7% effective against the same condition with two or more symptoms, according to an FDA review of Pfizer's data. The FDA considers the two Guillain-Barre cases during the trial as possibly linked to the vaccine, said Dr. Nadine Peart Akindele, an agency official. FDA asks for 55 years to release data on Pfizer's COVID vaccine The FDA promised "full transparency" due to "tremendous public interest" in a drug that it approved after studying the data. Even a recent little-publicized and less comprehensive CDC report notes that among those 18 years of age or older across 25 U.S. jurisdictions, from early April to late December 2021 1 in 5 deaths were associated with the vaccinated, according to the study, suggests protection weaker than the public has been led to believe.. We help leaders and future leaders in the health care industry work smarter and faster by providing provocative insights, actionable strategies, and practical tools to support execution. This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including potential in children 5 to <12 years of years of age and a study in children 6 months The FDA has determined that the available data show that the vaccine's known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. Blood sample for respiratory syncytial virus (RSV) test, Lilly to cut insulin prices by 70%, cap prices at $35 per month for people with private insurance, FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks, Novavax raises doubts about its ability to remain in business, Op-ed: DEA and FDA rules exacerbate Adderall shortage, Democratic attorneys general sue FDA to drop all remaining restrictions on abortion pill, FDA says Guillain-Barre syndrome is possible risk of Pfizers RSV vaccine for older adults, Medicare rejects Alzheimers Association request for unrestricted coverage of treatments like Leqembi, Moderna misses on earnings as costs rise from surplus production capacity, lower demand for Covid shots, West Virginia asks judge to dismiss lawsuit seeking to overturn state restrictions on abortion pill, CDC advisors recommend mpox vaccine for at-risk adults in future outbreaks, Flu vaccine was 68% effective at preventing hospitalization in children, but less protective for seniors this season, Pfizer RSV vaccine that protects infants could receive FDA approval this summer, Senators call on Medicare to offer broad coverage of Alzheimers treatments as public pressure grows, Maker of promising Alzheimers drug Leqembi expects full FDA approval this summer, expanded Medicare coverage.

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