U.S. Authorizes a New Round of Covid Boosters, https://www.nytimes.com/2023/04/19/health/covid-boosters-seniors.html. Presentation - Novavax, Inc. Filip Dubosky, Rick Crowley: Recombinant COVID-19 vaccines. The bivalent vaccine targets the original variant of the coronavirus as well as variants BA.4 and BA.5, which were dominant last summer. Novavax's nanotechnology-based vaccine can become a . So far, the reformulated vaccines seem to prevent severe illness and hospitalization after infection with these variants. The study population included adolescents 12-17 years of age, who were either healthy or with stable chronic medical conditions. An illustration shows vials with COVID-19 vaccine stickers attached and syringes with the logo of U.S. biotech company Novavax, on Nov. 17, 2020. has consistently over-interpreted the performance of the bivalent formulation when given as a booster, Dr. Moore said. The .gov means its official.Federal government websites often end in .gov or .mil. On July 13, 2022, the FDA announced it had granted emergency use authorization for Novavax a new vaccine for COVID-19. With less stringent temperature requirements and a refrigerator life 8 months longer than messenger RNA (mRNA) vaccines for COVID-19, Novavax's product promises to buttress global vaccine supply as the Omicron variant spreads rapidly. is just trying to simplify given the reality on the ground, he said. The FDA has recommended that vaccine manufacturers create vaccine formulas for booster doses this fall or winter that target the newer version of omicron. Protein-based vaccines with adjuvants, like Novavax's, have been around for decades. By signing up, you will receive newsletters and promotional content and agree to our. Serious adverse events were determined to be rare, and evenly dispersed between the NVX-CoV2373 and placebo recipients. The CDC's committee of independent advisors voted unanimously to recommend the vaccine for people ages 18 and older after reviewing the shots' safety and effectiveness during an hourslong public meeting Tuesday. Notably, vaccine efficacy against the Delta variant, the only COVID-19 strain recognized by genomic sequencing, was 82.0%. now says that adults 65 and older may opt for another dose of the bivalent vaccine at least four months after their first shot. Older Americans and those with weakened immune systems, groups still particularly vulnerable to the virus, may receive additional shots of the reformulated vaccine, federal officials said. Bhiman JN, Richardson SI, Lambson BE, et al. said only about 43 percent of adults 65 and older had received their first booster shot. Anyone can read what you share. plans to encourage annual Covid shots in the fall, much as it does with flu shots. Michigan reports 16,445 cases, 149 deaths as COVID plateaus, Macomb, Washtenaw report monkeypox cases as states count reaches 19. Erck said in March last year that he expected the vaccine to be approved by May 2021, but problems in some of Novavax's factories reportedly delayed the company's application for FDA approval,. In a statement, the CDC said the shots will be available in the coming weeks. The CDC said in its recommendation that Novavax will be available in the coming weeks . Read our, An Overview of the Sanofi/GSK COVID-19 Vaccine, Novavax Says Its COVID-19 Vaccine Is 90% Effective. The Biden administration has secured 3.2 million doses of Novavax's vaccine so far, according to the Health and Human Services Department. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Anywhere from 26 million to 37 million adults are still unvaccinated in the U.S., according to CDC data, but it's unclear how many of those people will opt to take Novavax's vaccine. The C.D.C. For the purposes of this article, the vaccine will be referred to as Novavax (NVX-CoV2373). The FDA committee. A proposed deal between BioNTech/Pfizer and the EU for about 70 million Covid-19 shots a year until 2026 threatens to push rivals Moderna, Novavax, and Sanofi out of the . The two-dose vaccine works by introducing a protein that prompts an antibody response, which blocks the ability of future coronavirus to bind to human cells and prevents infection. Most adverse events were mild to moderate, were transient, and occurred more often after the second Novavax dose. And there does appear to be a group of folks holding out for this shot. Participants enrolled a median of 6 days after COVID-19 symptom onset. FDA Roundup: August 19, 2022. "The vaccine is expected to increase uptake in adolescents, more than 22% of whom have not yet received a full vaccination regimen with mRNA vaccines," the study authors wrote. It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (COVID-19), Stay Up to Date with COVID-19 Vaccines Including Boosters, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years, HHS, DOD collaborate with Novavax to produce millions of COVID-19 investigational vaccine doses in commercial-scale manufacturing demonstration project, Injection site pain, swelling, and redness. All Rights Reserved. It may be reasonable to assume that nearly all unvaccinated adults have already been infected at least once and can get by with just a single dose, said Deepta Bhattacharya, an immunologist at the University of Arizona. WHO does not recommend pregnancy testing prior to vaccination. Until now, federal officials had required two doses of the older vaccine before recipients could begin to receive the bivalent boosters, a process some experts felt was confusing. The information in this article is current as of the date listed, which means newer information may be available when you read this. The one-size-fits-all policy was simple but not optimal, said Dr. Jeremy Faust, an emergency medicine physician and health policy expert at Brigham and Womens Hospital in Boston. The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. A total of 229 adults were randomly assigned for the IM study, and 119 were assigned to the IV study. The U.S. secured 3.2 million doses of Novavaxs COVID-19 vaccine in July 2022, and later ordered an additional 1.5 million doses in February 2023. The CDC, in a statement, said the vaccine will be available to the public in the coming weeks. Previously available only to adults 18 years and older, NVX-CoV2373 offers an alternative to the authorized messenger RNA (mRNA) COVID-19 vaccines. The background documents are also availablehere. Novavax investigational COVID-19 vaccine (NVX-CoV2373). The Summit County health department will hold a drive-thru COVID-19 vaccine clinic on Tuesday, May 2. Rachael is a freelance healthcare writer and critical care nurse based near Cleveland, Ohio. There were also delays in receiving authorization, as the FDA needed to review changes made to Novavax's manufacturing process. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. Serious adverse events were rare, and their occurrence was similar in both groups (15.9% in vaccine recipients vs 15.6% in the placebo group). The technology is also used in vaccines for the flu and whooping cough. The spike copies are harvested and purified from those cells for its vaccine. WHO lists 10th COVID-19 vaccine for emergency use : Nuvaxovid, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Independent Oversight and Advisory Committee, Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the Novavax NVX-CoV2373 vaccine against COVID-19, The Novavax vaccine against COVID-19: What you need to know. SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 12 and above. Clashes of values and political differences didn't cause the policy failures, but were the result of them, the group found. A randomized clinical trial has found that the COVID-19 vaccine produced by Novavax Inc. is "safe, immunogenic, and efficacious in preventing" the coronavirus in adolescents. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. WHO does not recommend discontinuing breastfeeding because of vaccination. No deaths or cases of anaphylaxis, Guillain Barre syndrome, blood clots, myocarditis, or pericarditis occurred, and no participants disenrolled from the study owing to adverse events. The company also announced that the vaccine was 60% effective in a Phase 2b clinical trial in South Africa and included protection from the Beta variant B.1.351. Novavax's shots were 90% effective at preventing illness overall and 100% effective at preventing severe disease when the alpha variant of Covid was dominant, according to clinical trial data. Monovalent (original) mRNA COVID-19 vaccines will no longer be recommended for use in the United States. Novavax also expects to initiate additional studies in younger children. The endorsement followed a daylong discussion by the C.D.C.s expert advisers. The investigators determined that the NVX-CoV2373 COVID-19 vaccine was safe, immunogenic, and efficacious against COVID-19 infection in adolescents 12-17 years of age. Emerging post-introduction pharmacovigilance data relating to the use of NVX-CoV2373 in pregnant women have not identified any pregnancy-related safety concerns and based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. (95% confidence interval [CI], 1.3 to 1.7). The official sign-off from CDC Director Dr. Rochelle Walensky followed an endorsement from the CDC's panel of public heath experts that advise the agency. If you subscribe to only one CNET newsletter, this is it. This timeline is the latest delay for Novavax's vaccine reaching unvaccinated adults, now more than six weeks after the company's shots won the near-unanimous backing of the FDA's outside. To help pregnant women make this assessment, they should be provided with information about the risks Previously available only to adults 18 years and older, NVX-CoV2373 offers an alternative to the authorized messenger RNA (mRNA) COVID-19 vaccines. The 1487 NVX-CoV2373 recipients and 745 placebo recipients averaged 52.5% male, 74.4% White, and 13.8 years of age. Novavax. Novavax had announced on June 14, 2021, that it completed enrollment of 2,248adolescents in its Phase 3 trial in adolescents ages 12 to 17. FDA Meetings, Conferences and Workshops, Recalls, Market Withdrawals and Safety Alerts, FDA Meetings, Conferences, and Workshops: Past Events, Public Calendar - Meetings With FDA Officials, Agenda - Workshop on Recombinant Protein-based COVID-19 Vaccines, Recombinant Protein-Based COVID-19 Vaccines. The Novavax COVID-19 vaccine (monovalent/non-mRNA) will remain authorized and available for primary series vaccinations and, in some cases, boosters*. If youre unsure about which vaccines and boosters youve received, contact OHAs ALERT Immunization Information System and request your COVID-19 vaccination records at 800-980-9431; email alertiis@state.or.us. An 8-week interval is recommended between primary series doses of NVX-CoV2373. It was also 100% effective against moderate and severe disease. The vaccine is safe and effective for all individuals aged 12 and above. Novavax marks the fourth COVID-19 vaccine available in the U.S. COVID-19 Vaccines: Stay up to date on which vaccines are available, who can get them, and how safe they are. WHO does not recommend "At present, there are no mAbs [monoclonal antibodies] available with activity against the circulating SARS-CoV-2 variants. The Centers for Disease Control and Prevention signed off on Novavax's Covid-19 vaccine on Tuesday. RELATED: Omicron subvariant BA.5 is spreading fast: What to know about the new COVID strain. And then it will just be a matter of finding a provider or pharmacy near you again, not everyone will have it and, for instance, CBS said that a CVS rep said they didnt plan to carry it, that receives an allotment. The vaccine efficacy of the Novavaxs NVX-CoV2373 was 79.5% in adolescents. People 18 and older may also get a Novavax booster based on the original virus strain six months after their last shot. of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant persons. But BA.4 and BA.5 were quickly supplanted by newer versions. Novavax COVID-19 vaccine 3 weeks (or 21 days) after the first dose. The U.S. funds were given as a part of Operation Warp Speed andfrom the Biomedical Advanced Research and Development Authority (BARDA). The Centers for Disease Control and Prevention on Tuesday signed off on Novavax's two-dose Covid-19 vaccine as a primary series for adults, offering people who are unvaccinated a choice to receive a shot based on conventional technology in use for more than 30 years. Adults who took part in Novavax's Phase 3 trials were asked to record any local or systemic reactions after each dose of the vaccine. Novavax's Covid-19 vaccine, already available for use in 170 countries and most well-known for being a non-mRNA vaccine alternative, could be approved for use in the U.S. in February . In February 2022, the company reported that the vaccine demonstrated 82% clinical efficacy against the Delta variant and planned to seek FDA authorization for this age group. The most commonly reported side effects were: Injection site pain lasted less than three days and fatigue, headaches, or muscle pain lasted less than two days in the Phase 3 trials. This method was also used for the three COVID-19 vaccines that received approval or emergency use authorization (EUA) from the FDA. Ask an Infectious Disease Expert: Will COVID-19 Vaccines Work Against New Variants? The new regimen acknowledges that theres now an extraordinary spectrum of Covid risk, from mild to massive, depending on who you are.. Updated July 14, 2022. In Novavax's trial, participants were not directly exposed to the virus, but instead researchers used a natural infection approach. Adolescents with moderate to severe immunocompromising conditions belong to the highest priority-use group. Moderna RSV Vaccine Protects Older Adults Against Disease, Early Data Finds, FDA Is Considering Annual COVID Vaccines. Ideastream Public Media | You may experience bothersome side effects after getting a dose. You can find out more about our use, change your default settings, and withdraw your consent at any time with effect for the future by visiting Cookies Settings, which can also be found in the footer of the site. The Novavax COVID-19 vaccine is available for everyone 12 years and older. 2023 Advance Local Media LLC. U.S. health officials believe changing the formula of the vaccines to target omicron variants as well as the original strain that emerged in Wuhan, China, in 2019 will provide more durable protection against the virus this fall. The study had previously shown efficacy among 18- to 25-year-olds. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy. Rachael is a freelance healthcare writer and critical care nurse based near Cleveland, Ohio. However, Novavax was behind its competitors when it came to clinical trials. Pfizers primary series consists of one bivalent dose for people ages 5 and older; three doses for ages 6 months through 4 years. Walensky, in a statement, said the Novavax vaccine will provide another option for people who do not want to take Pfizer's and Moderna's shots. Roughly 250 people in the United States are still dying from Covid-related causes each day, a vast majority of whom are over 70 or have impaired immune systems. Panel Discussion "Therapeutic options for COVID-19 remain limited," the researchers wrote. Novavax CEO Stanley Erck has said the vaccine could be authorized by U.S. regulators as early as February. 69 F Novavax Vaccine getting ready to apply for full approval September 7, 2021 WDEF News CHATTANOOGA, Tenn (WDEF) - T he Novavax Covid vaccine has undergone months of clinical trials. Unvaccinated people will receive a single dose of the bivalent vaccine, rather than multiple doses of the original monovalent vaccine. Science magazine reported that the company had sold some of its manufacturing facilities and had to rely on more contractors to manufacture many of its vaccines. The Technical Advisory Group for Emergency Use Listing listed Nuvaxovid (NVX-CoV2373) vaccine against COVID-19 and Covovax (NVX-CoV2373) vaccine against COVID-19 for emergency use on 20 December 2021 and 17 December 2021 respectively. No safety signals were observed with IM or IV treatment. Novavax's vaccine candidate generated a lot of interest because early animal study data showed that it was highly effective at preventing replication of the coronavirus in nasal passages. The US Centers for Disease Control and Prevention recommendedNovavax's COVID-19 vaccineTuesday for adults who haven't been vaccinated yet. A total of 2232 participants were included and randomized 2:1 to receive injections of either NVX-CoV2373 or placebo, administered 21 days apart. The Novavax vaccine will be manufactured in two different facilities. Of the two Phase 3 trials, both found that the efficacy of the vaccine against mild, moderate, and severe disease is 90%. Immunocompromised people may continue to receive additional bivalent doses at intervals decided by their health care providers. The spike copies in the vaccine prepare the body's immune system to produce antibodies that block the virus from invading human cells. Novavax's vaccine also has an additional ingredient called an adjuvant that is derived from the bark of a South American tree to produce a broader immune response to fight the virus. Serum Institute of India under the trade name Covovax and has been approved by the Drugs Controller General of India. F.D.A. Children under 6 with compromised immune systems may be eligible for an additional bivalent booster dose. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed. Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. All rights Reserved. There are about 53 million adults 65 and older in the United States, accounting for about 16 percent of the population, according to the Census Bureau. While Pfizer and Modernas vaccines use mRNA technology, Novavax, which is located in Maryland, uses more traditional science, relying on copies of the COVID-19 spike protein to fire up the immune system and teach cells how to fight off the virus. Before sharing sensitive information, make sure you're on a federal government site. Following discussion by the Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices, the CDC recommended the changes yesterday. A Novavax Booster Is Here. This was followed by a second Phase 3 trial in the United States and Mexico in December 2020. Vaccine reactogenicity was mild-to-moderate and brief; reactogenicity occurred with greater frequency after the second dose of NVX-CoV2373. The average age among 1,487 Novavax recipients and 745 in the placebo group was 13.8 years, 52.5% were boys, 74.4% were White, and 16.1% had previously tested positive for COVID-19. Novavax has been awarded more than $2 billion globally for its efforts to develop a COVID-19 vaccine, with $1.6 billion from the U.S. government alone. Novavax's vaccine uses a different platform than Pfizer's and Moderna's shots. The ratio of neutralizing antibody geometric mean titers in adolescents compared with 18- to 25-year-olds was 1.5 (95% confidence interval [CI], 1.3 to 1.7). Aside from proving safety and efficacy, manufacturers will need to show that their products generate full immune responses for . In December 2021, Novavax began development of a vaccine targeting the Omicron variant. In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%. Novavax has been available to adults and teens as young as age 12 as the original or primary vaccine, . It's given as a two-dose primary series, 3 weeks apart. XBB.1.16 doesn't seem to come with additional health risks compared to XBB.1.5, but it may become dominant in some countries. "COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19," FDA Commissioner Dr. Robert M. Califf said in a news releaselast week. The vaccine effectiveness (VE) of the Novavax COVID-19 vaccine was 79.5% among US adolescents before the SARS-CoV-2 Omicron variant emerged, but the monoclonal antibody combo tixagevimab and cilgavimab showed little benefit for nonhospitalized COVID patients, according to two randomized, controlled trials published today in JAMA Network Open. The Centers for Disease Control and Prevention signed off on Novavax's Covid-19 vaccine on Tuesday. Early vaccine trial results published by Novavax revealed a strong antibody response to the vaccine in animals. Most adverse events were mild to moderate, were transient, and occurred more often after the second Novavax dose. Best Debt Consolidation Loans for Bad Credit, Personal Loans for 580 Credit Score or Lower, Personal Loans for 670 Credit Score or Lower. In a statement, the CDC said the shots will be available in the coming weeks. The Novavax vaccine is also authorized as a first booster dose, but only for people who cannot or choose not to receive an mRNA vaccine. And it was 100% effective against moderate and severe disease. Most were unvaccinated. A favorable safety profile, convenient storage and transportation requirements, and induction of broad, cross-reactive immune responses with the potential to provide protection against new variants suggest that NVX-CoV2373 offers an important choice for vaccination of younger individuals in the fight against the current COVID-19 pandemic worldwide, the study authors concluded. By, A case of measles is confirmed in Summit County, 'Don't let me die.' Novavax submitted to the FDA for emergency use authorization in January -- well into the COVID-19 vaccine response --and its vaccine is authorized for use in other countries,including Canada. People 12 and older who had all recommended doses of a COVID-19 vaccine can choose between the Pfizer-BioNTech and the Moderna COVID-19 updated, or bivalent, vaccine booster at least two months after their last shot. YouTubes privacy policy is available here and YouTubes terms of service is available here. Omicron subvariant BA.5 is spreading fast: What to know about the new COVID strain. Novavax is a Maryland-based biotech company that has taken a traditional approach to developing a vaccine against COVID-19. In an ongoing expansion of the phase 3 randomized, controlled PREVENT-19 trial, a team led by Novavax researchers assessed the neutralizing antibody response to the vaccine among 2,232 adolescents aged 12 to 17 years enrolled at 73 sites from April 26 to June 5, 2021. What does the BCI investigation into Jayland Walker's death show? In July 2022, the FDA authorized the Novavax COVID-19 vaccine. The Johnson & Johnson vaccine, though its use has been restricted in the US, is a viral vector type. The U.S. is planning to tweak the vaccines to target the more transmissible BA.4 or BA.5 omicron subvariants, which are now dominant, ahead of an expected fall vaccination campaign. What You Need to Know About the Updated COVID-19 Boosters. For adolescents 12-18 years of age, there is currently insufficient evidence for recommending a booster dose, except for those with immunocompromising conditions. Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (COVID-19). Recombinant COVID-19 vaccines. A Division of NBCUniversal. Data is a real-time snapshot *Data is delayed at least 15 minutes. Added coconut oil to cheap coffee before keto made it cool. (People ages 65 and older who have. How Long Will COVID-19 Vaccine-Induced Immunity Last? A joint test across all time points favored treatment. A later study comparing three doses of the Novavax vaccine and three doses of an mRNA vaccine found that they produced similar immune responses against the Omicron variants BA.1 and BA.4/BA.5. On July 13, FDA granted Emergency Use Authorization (EUA) for the two-dose Novavax COVID-19 vaccine for people 18 and over. Food and Drug Administration. The small Maryland biotech company received $1.8 billion of taxpayer money from Operation Warp Speed, but struggled to get its manufacturing base in place and ultimately fell behind Pfizer and Moderna. For most Americans, the F.D.A. mRNA vaccine. A total of 20 mild COVID-19 infections were identified after a median of 64 days of follow-up, including 6 cases among Novavax recipients (incidence, 2.90; 95% CI, 1.31 to 6.46 cases per 100 person-years) and 14 cases among the placebo group (incidence, 14.20; 95% CI, 8.42 to 23.93 cases per 100 person-years), for a VE of 79.5% (95% CI, 46.8% to 92.1%). It may also offer an alternative for consumers wary of currently available vaccines that deliver RNA or DNA . Throughout the development of their vaccine, Novavax has faced challenges and experienced significant delays due to manufacturing issues. Novavax's authorization comes as omicron's extremely contagious BA.5 subvariant is responsible for most cases of COVID-19 in the country, but the available vaccines are expected to remain protective against severe disease and death. Those with weakened immune systems may do so two months after their previous bivalent dose, and may choose to receive more doses in consultation with their health care provider. This webpage was updated on 28 September 2022 to ensure consistency of formatting. Centers for Disease Control and Prevention. and hospitalization due to COVID-19. Recombinant Protein-Based COVID-19 Vaccines Workshop Event Page, Pandemic preparedness, target product profile, timelines, and the need for continued investment, Epidemiology, disease burden, continued need for COVID-19 vaccines, Features of novel vaccines, need for next generation vaccines. CDC Allows Novavax Monovalent COVID-19 Boosters for Adults Ages 18 and Older Media Statement For Immediate Release: Wednesday, October 19, 2022 Contact: Media Relations (404) 639-3286 Today, CDC's Director Rochelle P. Walensky, M.D., M.P.H., signed a decision memo allowing Novavax monovalent COVID-19 boosters for adults. 90% effective against symptomatic COVID-19 in a clinical trial, Do Not Sell or Share My Personal Information. Novavax COVID-19 vaccine demonstrates 89.3% efficacy inUK phase 3 trial. "The primary target population for Novavax will be the 10% to 13% of those that are unvaccinated," said Dr. Oliver Brooks, a CDC vaccine committee member and chief medical officer at Watts HealthCare Corporation in Los Angeles. Wadman M. Will a small, long-shot U.S. company end up producing the best coronavirus vaccine? john coates kingsport, tn obituary, mobile homes for sale in arab, al,

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