"Today, FDA amended the (Emergency Use Authorizations) of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals," the FDA wrote on Twitter.. ], Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g or 60 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g or 60 g.. [TimeFrame:From before study vaccination (Day 1) to 6 months after study vaccination. See here for a complete list of exchanges and delays. Moderna completed enrollment in clinical trials on the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee on Thursday. The decision to focus on BA.5 did not leave enough time to wait for data from human trials ahead of a fall vaccine rollout. [TimeFrame:At 1 month after study vaccination. ], Cohorts 2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g to BNT162b2 30 g (C4591031 Substudy E). Finally, a small group of 200 unvaccinated adults will receive three doses of the new Omicron-targeted shot. The monovalent vaccines are the old shots that have been administered to millions of people in the U.S. over the past two years. Pfizers vaccines are designed to protect against childhood, adolescent, and adult infectionsincludingmeningococcal disease,influenza, Lyme disease, respiratory syncytial virus (RSV), and Clostridioides (C) difficile. "Healthy pilots are suffering from myocarditis and dropping dead on flights because of the COVID-19 vaccines. Pfizer also said it was developing a vaccine tailored to combat the omicron variant of the virus which has spread rapidly around the globe in recent weeks. [TimeFrame:From before study vaccination (Day 1) to 1 week after study vaccination. In recent days, Prof Andrew Pollard, who led the development of the Oxford-AZ vaccine, said Omicron had spread at such speed that it was "quite difficult to make and deploy an updated vaccine quickly enough" to make a difference. In the announcement, Dr. Peter Marks, the FDAs director of biologics evaluation and research, said that the new guidance aims to simplify the vaccine schedule and encourage future vaccination., Marks, in a call with reporters April 18, said the original monovalent vaccines would keep their biologics license applications, known as BLAs, and would likely be used for future updates to vaccine composition., U.S. Food and Drug Administration, Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines, April 18, 2023, YouTube, MEDIA CALL: Bivalent COVID-19 Vaccines 4/18/2023, April 18, 2023, U.S. Food and Drug Administration, Emergency use authorization for vaccines explained, Nov. 20, 2020, U.S. Food and Drug Administration, Licensed Products (BLAs), March 29, 2019, U.S. Department of Health and Human Services, COVID-19 Vaccines, accessed April 21, 2023, District of Columbia If anything, the pandemic showed us what an amazing crown jewel we had in Pearl River, and we dont need to go anywhere else to be successful, Bjornson told an audience of biopharma executives, business professionals and others at a recent event held by Builds Bio+, which advances life sciences development in the New York and Philadelphia regions, at Innolabs in Long Island City, NY. Weve been on a very rapid expansion over the last several years. (Clinical Trial). But Oliver noted that the risk of myocarditis following a BA.5 booster shot is unknown. 1800 I Street NW The bivalent doses were authorized for emergency use in August 2022.. ], Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g or 60 g [TimeFrame:At 1 week after study vaccination. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. ], Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g [TimeFrame:At 3 months after study vaccination. The eligible age groups can receive the boosters at least two months after completing their primary series or their most recent booster with the old shots. Two other Pfizer vaccine candidates are in Phase I: PF-07845104, a self-amplifying mRNA (saRNA) vaccine designed to prevent influenza in adults; and PF-07926307, which is designed to protect against both COVID-19 and flu by combining PF-07252220 with BioNTechs authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) vaccine. Participation in other studies involving receipt of a study intervention within 28 days before randomization. [TimeFrame:At 3 months after study vaccination. Vaccine makers Pfizer and BioNTech announced plans early Tuesday to test an omicron-specific COVID-19 vaccine in people. Bjornson said Pfizers decision to stay in Pearl River came down to people and money. Our only agenda is to publish the truth so you can be an informed participant in democracy. But once we do, we find that our attrition is lower, Bjornson observed. A continued decline in COVID-19 vaccines and related products caused a 34% revenue decline. Pfizer aims to build 260,000 new square feet of space, including 55,000 square feet of new labs. Listing a study does not mean it has been evaluated by the U.S. Federal Government. ClinicalTrials.gov Identifier: NCT05472038, Interventional With future plans that include more vaccines like the ones it has co-developed with BioNTech for COVID, Pfizer is planning a $470-million expansion of its Vaccine Research and Development facilities in Pearl River, NY, that it hopes to start work on next year. Another advantage for iCampus, Schwartz said, is its proximity to New York City and northern New Jerseythe two anchors of the regional biotech cluster ranked No. Other amenities for the expanded campus would include new indoor and outdoor gathering spaces, parking, a new fitness center, and a central caf that would replace kiosks now scattered in several of Pfizers buildings. Vaccine developers had always planned to tweak their original Covid vaccines as new variants emerged, but the arrival of the fast-spreading Omicron strain in the last two months has hastened that process. ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 Substudy E). We were thinking, could we get closer to New York City to access additional talent?. On April 18, the agency said it was revoking the emergency use authorization for the original Moderna and Pfizer-BioNTech monovalent vaccines to focus on newer, bivalent vaccines. ], Cohort 1: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g. On August 31, 2022, the Food and Drug Administration (FDA) authorized the Moderna and PfizerBioNTech bivalent Covid-19 vaccines, each containing equal observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials For Cohort 3, this study is seeking participants who are: Choosing to participate in a study is an important personal decision. [TimeFrame:Before study vaccination (Day 1). ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g in participants 18-55 yrs compared to participants >55 yrs. Chemtrails are being put into the atmosphere and are trickling down into soil and water, becoming the real cause of disease., "There is no Biden presidency. Walensky said her decision followed "a comprehensive scientific evaluation and robust scientific discussion.". Pfizer is planning a $470 million expansion of its Vaccine Research and Development facilities in Pearl River, NY, that it hopes to start work on next year. read more. WebPfizer Inc. and BioNTech SE have started a trial evaluating an adapted version of their Covid-19 vaccine that targets the Omicron variant of the coronavirus.. 2023 BBC. The Centers for Disease Control and Prevention cleared reformulated Covid shots that target the latest omicron subvariants for the fall, making it possible for many people to get an extra booster within days. The mice express the same cell protein as humans that the virus latches onto. "No safety concerns were identified and the 3 [microgram] dose demonstrated a favorable safety profile in children 6 months to under 5 years of age," they said. [TimeFrame:From before study vaccination (Day 1) to 3 months after study vaccination. To obtain contact information for a study center near you, click here. Watchlist Idea from Microsoft Start. It didn't ban the vaccine. Although there's no data on the real-world effectiveness of the new boosters, the U.S. is moving rapidly to roll them out in the hope that they will protect people this fall. The health agencies also reviewed data on the BA.5 shots from mouse studies. A Division of NBCUniversal. The U.S so far has secured 171 million doses of Pfizer's and Moderna's new boosters. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Long also voted in favor. Moderna is also trialling a "bivalent" version that combines the original vaccine, as well as the new Omicron-specific spike mRNA. They study is about 6 months long for each participant. ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels. U.S. Department of Health and Human Services. In the past two years, democracies have become stronger, not weaker. Over time, iCampus plans to add amenities that would benefit Pfizer and other tenants, including the conversion of an existing building into a hotelto be followed by a broader mix of uses that would include retail, office, industrial, and residential components. PolitiFact reached out to the FDA for more details but did not hear back. The agency now recommends a single dose of the bivalent vaccine for most people as booster doses or for primary vaccination for people who are unvaccinated.Other people, who are at greater risk for severe COVID-19, may be eligible for additional bivalent vaccine doses. ], Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 Substudy E). 33701 BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]. May 01, 2023 - 03:23 PM. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. The original vaccines, which were first authorized in December 2020, are no longer providing meaningful protection against infection because the virus has mutated so much over the past two years. At each clinic visit, a blood sample will be taken. The European Medicines Agency (EMA) said on Friday that international regulators want data from clinical studies like the one being done by Pfizer and BioNTech before approval of a new vaccine. ], Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g or 60 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g or 60 g. Participants 18-55 years old will receive 30 g of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. [TimeFrame:At 1 week after study vaccination. NEW YORK, Jan 25 (Reuters) - Pfizer Inc (PFE.N) and BioNTech SE said on Tuesday they started a clinical trial to test a new version of their vaccine specifically designed to target the COVID-19 Omicron variant, which has eluded some of the protection provided by the original two-dose vaccine regimen. BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]. There is no data from human trials on the new BA.5 boosters, so it's unclear how they will perform in the real world. ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: Differences in %s of pts with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g in pts 18-55 yrs compared to pts >55 yrs. The lack of human data for the BA.5 shots has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. - Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. ], Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g or 60 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g or 60 g.. [TimeFrame:From before study vaccination (Day 1) to 3 months after study vaccination. Pfizers main lab building would see new entrances for staffers and visitors. [TimeFrame:At 1 week after study vaccination], Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30g or 60g and BNT162b2 Bivalent(WT/OMI BA.1) 30g or 60g for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels. Dec. 5, 2022 Jackie Dishner hasnt been the same since June 2020, when COVID-19 robbed her of her energy level, The real Biden was executed for his crimes long ago along with Clinton.". They also work in a single dose rather than the multiple doses needed for the monovalent vaccines. [Pfizer]Pfizers expansion planwhich the company has dubbed Project Vitalitywould allow the pharma giant to expand the sites current workforce of more than 1,200 people (another 50 positions are open), by creating lab and office capacity for up to 370 additional staffers for future growth, and thus expand vaccine R&D operations that grew dramatically during the pandemic. "The goal of this vaccine is to protect against serious illness," said Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania. The Center for Disease Control and Prevention cleared the reformulated omicron boosters Thursday. [TimeFrame:At 3 months after study vaccination], Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30g or 60g and BNT162b2 Bivalent(WT/OMI BA.1) 30g or 60g for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels. [TimeFrame:At 1 month after study vaccination. Millions of Americans could be eligible for new Covid booster, Alzheimers patients may wait years to get treated with new drugs, putting them at risk of more severe disease, Carl Icahn calls Illumina Q1 results very disappointing, slams cost-cutting plan, DOJ sues Tennessee, alleging it discriminates against transgender youth with new law, Abortion pill mifepristone is banned or restricted in some states despite Supreme Court ruling, Eli Lilly says obesity drug tirzepatide resulted in weight loss of up to 34 pounds, Eli Lilly misses on earnings but raises full-year guidance, Merck results beat expectations despite a big drop in sales of Covid antiviral treatment, FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease, Mpox outbreak was wake-up call for smallpox preparation, vaccine maker Bavarian Nordic says, Johnson & Johnson to price shares of consumer spinoff Kenvue at $20 to $23 in IPO. Newest Booster Vaccines May Help You. Is climate change killing Australian wine? The FDA didnt "ban" or revoke the original doses with no replacement, and its decision is unrelated to any safety data. BioNTech declined to comment on what type of data it was asked to file with regulators. They will receive three doses of this new Pfizer also said 30 million of a planned 80 million treatment courses of its Paxlovid antiviral pill will be available in the first six months of 2022. Jan. 25, 2022, 3:45 AM PST / Updated Jan. 25, 2022, 4:36 PM PST By Berkeley Lovelace Jr. Pfizer and BioNTech announced Tuesday that they have started a I think the ability to retain talent is very good. All Rights Reserved. All vaccines in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. Pfizer aims to build 260,000 new square feet of space, including 55,000 square feet of new labs. Weve never had as robust a vaccine portfolio and R&D as we have today, and thats driven by investment in Pfizer in our area. The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b, RNA-based SARS-CoV-2 vaccine candidates given as a booster dose in adults to prevent COVID-19. A fourth dose in people ages 50 and older was 56% effective at preventing hospitalization after four months. ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 Substudy E). Alphabet beat on both the top and bottom line. Most populous nation: Should India rejoice or panic? The U.S. Department of Defense awarded a contract for COVID-19 research in Ukraine months before the virus was known. ], Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels. Still, some scientists question whether any change is currently needed. 3 by GEN last year. We might not have to wait too long to find out how well they work. Testing a third dose will cause a delay in submission of data to regulators to authorize use in the U.S. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. In addition to Pfizer, which earlier this year inked a lease for 86,000 square feet, iCampus has become a regional magnet attracting more than a half-dozen other life sciences tenant businesses, including: Beyond life sciences, iCampus is home to Momentive Performance Materials, a global maker of global high-performance silicones and specialties; Olaplex, a maker of hair repair treatments; and Pearl River Studios, where scenes have been filmed for shows ranging from Blacklist (NBC) to FBI-Most Wanted (CBS) to Punisher and Orange Is the New Black (both Netflix). P fizer said Saturday that using new versions of its Covid-19 vaccine as boosters led to a superior antibody response against the Omicron variant compared to its current shot. 727-821-9494, Why the FDA is recommending the newer, bivalent COVID-19 vaccines. ], Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 30 g (C4591031 Substudy E). A child, with parent in tow, arrives to receive the Pfizer COVID-19 vaccine for children 5 to 11 years old at London Middle School in Wheeling, Ill., last month. The new guidance was made to simplify the vaccine schedule and encourage future vaccination, the agency said. have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.5 is the most contagious and immune evasive variant yet, and breakthrough infections have become increasingly common as a consequence. Washington, DC A second group of 600 who received three doses of the current vaccine will get another of the current one or the Omicron vaccine. We need your help. Pfizer and Moderna were originally developing omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and develop BA.5 shots instead after the subvariant became dominant. ], Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 g and BNT162b2 Bivalent (WT/OMI BA.1) 30 g or 60 g [TimeFrame:At 3 months after study vaccination. Sign up for free newsletters and get more CNBC delivered to your inbox, Get this delivered to your inbox, and more info about our products and services., 2023 CNBC LLC. Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose. All Rights Reserved. Pfizer Inc and BioNTech SE said on Tuesday they started a clinical trial to test a new version of their vaccine specifically designed to target the COVID-19 [TimeFrame:At 1 month after study vaccination. View this study on Beta.ClinicalTrials.gov. [TimeFrame:At 1 month after study vaccination. The companies will run three Nam Y. Huh/AP The bivalent vaccines protect against multiple variants, including the more recent omicron strain. The FDA said it was authorizing the use of the current bivalent vaccines (that combat the original and omicron BA.4/BA.5 strains) for all people 6 months of age and older. Participants over 55 years old will receive 30 g of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. Pfizer's clinical trial is also ongoing, though company hasn't said when it expects results. Anticipated participation in other studies involving a study intervention from randomization through the end of this study. You have reached the maximum number of saved studies (100). 801 3rd St. S They see the opportunity to have a massive impact on public healththats what Pfizer wants to do, Bjornson said. Chick-fil-A donates another $1.8 million to anti-LGBTQ groups, backtracking on its promise not to. The companies, which produced the first vaccine against coronavirus infection authorized for use in the U.S., said they had made the decision "following a routine review by the external independent Data Monitoring Committee," which acts as a watchdog over the clinical trials. The industry leader for online information for tax, accounting and finance professionals. 1. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Cohort 1 and Cohort 2 (18 years and older): Observer-blind Cohort 2 (12-17 years) and Cohort 3: Open-label, AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b RNA-BASED VACCINE CANDIDATES AS A BOOSTER DOSE IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS, Experimental: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2), Experimental: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1), Experimental: Cohort 2 -Group 1: 12-17 years; 30 g, Experimental: Cohort 2 - Group 2: 18-55 years; 30 g, Experimental: Cohort 2 - Group 3: 18-55 years; 60 g, Experimental: Cohort 2 - Group 4: >55 years; 30 g, Experimental: Cohort 2 - Group 5: >55 years; 60 g, Experimental: Cohort 3 - Group 1: 18-55 years; 30 g, Experimental: Cohort 3 - Group 2: >55 years; 30 g, 12 Years and older (Child, Adult, Older Adult), Anaheim, California, United States, 92801, San Diego, California, United States, 92123, Valley Village, California, United States, 91607, Walnut Creek, California, United States, 94598, Milford, Connecticut, United States, 06460, Research Centers of America ( Hollywood ), Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Jacksonville, Florida, United States, 32256, Stockbridge, Georgia, United States, 30281, Bardstown, Kentucky, United States, 40004, Chesterfield, Missouri, United States, 63005, Saint Louis, Missouri, United States, 63141, Somers Point, New Jersey, United States, 08244, Rochester, New York, United States, 14609, Charlotte, North Carolina, United States, 28209, Charlotte, North Carolina, United States, 28211, Greensboro, North Carolina, United States, 27408, Wilmington, North Carolina, United States, 28401, Kaiser Permanente Northwest Center for Health Research, J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City, Utah, United States, 84109, J. Lewis Research, Inc. / Foothill Family Clinic South, Salt Lake City, Utah, United States, 84121, Midlothian, Virginia, United States, 23114.

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