Muscle pain. Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever. Vaccine efficacy was 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 variant and 96.4% (95% CI, 73.8 to 99.4) against non-B.1.1.7 strains. MNT is the registered trade mark of Healthline Media. Novavax is considered to be a biologic because its partially made from living cells.*. Its the bodys response to revving up the immune system. If youre concerned about your risk of heart inflammation, talk with your doctor before receiving Novavax. Last updated on Sep 25, 2022. In Europe, the vaccine will be manufactured under the trade name Nuvaxovid and has been approved by the European Medicines Agency, and in India, the vaccine will be manufactured by It helps the immune system respond to that spike protein. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Centers for Disease Control and Prevention. Novavax was found to be 90.4% effective in preventing mild, moderate or severe COVID-19, according to the FDA. This vaccine comes with several precautions. One such vaccine is Novavax. MS: Can the Mediterranean diet help preserve cognitive health? The background documents are also availablehere. Initial safety information released for the vaccine shows that the most common reactions after the vaccine was administered included: 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. Overall, they were considered mild to moderate and usually went away within a day or two. COVID-19 vaccination is recommended for pregnant people. The Moderna COVID-19 vaccine for everyone ages 6 months and older contains only the following ingredients: Fact sheets for recipients and caregivers- Ingredients, how vaccine is administered, and other details from the FDA: Purpose The most commonly reported side effects that were rated as severe (Grade 3) were fatigue (3.8% after the first or second dose) and headache (2% after the second dose). More information is available, Travel requirements to enter the United States are changing, starting November 8, 2021. (For details about vaccines that contain live viruses, see this article.). Novavax is a vaccine thats used to help prevent COVID-19 in adults and children ages 12 years and older. There are four approved or authorized vaccines in the United States. For information about the effectiveness of Novavax, see the Novavax for COVID-19 section below. Causes an immune response that helps protect the body from getting sick with COVID-19 in the future. Medically reviewed by Drugs.com. Learn more about vaccine safety monitoringafter a vaccine is authorized or approved for use. These occurred in around 60% of those receiving a first dose and 80% with. They might feel a little like they have the flu, with a mild fever and fatigue. The vaccine is not recommended for people younger than 12 years of age. 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. The following information describes the usual Novavax dosages. We comply with the HONcode standard for trustworthy health information. Vaccine recommendations are based on age, the first vaccine received, and time since last dose. Serious side effects from Novavax are not common, but they can occur. Moderna. Sinopharm COVID-19 vaccine: Should you worry about the side effects? In fact, research shows that the risk of heart inflammation from a COVID-19 infection is much higher than from any COVID-19 vaccine, including Novavax. Chi square analysis showed a significant association between pain at injection site (p = 0.002), fever (p = 0.001), and vomiting (p = 0.04) with the type of vaccine received for the second dose Johns Hopkins Bloomberg School of Public Health. WHO does not recommend pregnancy testing prior to vaccination. The vaccine effectiveness reached 80% for this population. Data so far suggest, that on the whole, the Novavax vaccine may have fewer side effects than both the Pfizer and Moderna vaccines. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future. WHO recommends the use of the Novavax (NVX-CoV2373) vaccine in pregnant persons when the benefits of vaccination to the pregnant persons outweigh the potential risks. Food and Drug Administration. Keep in mind that COVID-19 itself can cause heart inflammation as a serious complication. Usually any side effects (very slight nausea, tiredness, constipation) hit the second day, so that fits. Novavax can be given as a booster if all the following criteria are met: If you meet all these criteria, you can receive Novavax as a booster regardless of which COVID-19 vaccines youve received in the past. Novavax comes in one strength: 0.5 milliliters (mL). Novavax is not authorized for use in children younger than age 12 years. If you do have mild side effects after getting your first dose, do not let that stop you from getting your second dose. Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Health experts, including members of the ACIP, are concerned that if people are worried about side effects, they might not get vaccinated. Pregnancy registries collect information that helps determine the safety of vaccines and drugs during pregnancy. If you have heart problems, Novavax may worsen them. Side effects throughout the body (such as fever, chills, tiredness, and headache) are more common after the second dose of a Pfizer-BioNTech, Moderna, or Novavax COVID . If you have a history of serious allergic reactions, talk to your provider before getting vaccinated. COVID-19 is a disease that can affect your respiratory system and other parts of your body. Wants to get the J&J/Janssen COVID-19 vaccine despite the safety concerns. Novavax also contains an adjuvant. Fran Kritz is a freelance healthcare reporter with a focus on consumer health and health policy. Heart inflammation or other heart problems. On a ratio of 2:1, they received two doses of either the Novavax vaccine or a placebo. On January 31, 2022, Novavax submitted a request to the Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine candidate. And Novavax does not contain a live virus. * For details, see FDA authorization in the What is Novavax? section above. Food and Drug Administration. Heart inflammation and other heart problems have been rarely reported in people who received Novavax. Data so far suggest, that on the whole, the Novavax vaccine may have fewer side effects than both the Pfizer and Moderna vaccines. Cases of myocarditis and pericarditis have also been reported in people who received Novavax COVID-19 vaccine. MMWR Morb Mortal Wkly Rep. 2021;70(2):46-51. doi:10.15585/mmwr.mm7002e1. This article provides a summary of those interim recommendations. Coronavirus (COVID-19) update: June 25, 2021. Systemic adverse events were reported in 47.7% of Novavax COVID-19 vaccine recipients following dose 1 compared with 69.5% following dose 2. The updated boosters provide added protection against the recent Omicron subvariants that are more contagious than the previous ones. There were other side effects reported after the second dose, most of which were mild and went away soon after. The actual spike protein is injected, in the form of nanoparticles, instead of inserting the genetic material enabling our cells to create the spike protein., It remains to be seen whether this will have consequences in terms of real-world effectiveness or safety; but the more different types of vaccine we have, the greater our ability will be to optimize effectiveness and safety in different groups.. The dosage for this age group is the same as the adult dosage. Note: For more information about the potential negative effects of Novavax, see the Novavax side effects section above. Generic name: sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant. If you have a weakened immune system, this vaccine may not work as well to help prevent COVID-19. Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met. You can also find more details in the vaccines fact sheet. A booster vaccine helps boost the effects of a previous vaccine that you received. Moving your arm around can also help. By Fran Kritz The CDC continues to recommend the COVID-19 vaccine, as the potential benefits clearly outweigh the known and potential risks. Novavax (NVX-CoV2373) has an emergency use authorization (EUA). Verywell Health's content is for informational and educational purposes only. According to data from the CDC, a small number of people have experienced anaphylactic reactions after getting the COVID-19 vaccine. PurposeFacilitates activation of the cells of the innate immune system. You should also talk with them if you have or have had other heart problems. The Food and Drug Administration (FDA) granted Novavax an emergency use authorization (EUA) for this purpose. Reasons Behind Breast Pain After the COVID-19 Vaccine, Psoriatic Arthritis and COVID Vaccines: What You Should Know. * For more information about allergic reaction and Novavax, see Allergic reaction below. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Be sure to talk with your doctor to find out whether Novavax is safe for you. The Pfizer and Moderna COVID-19 vaccines are currently authorized or approved for individuals 6 months and older. Novavax does not contain any genetic material known as mRNA. Moderna. Moderna COVID-19 vaccine. Medical News Today has contacted over 20 experts for comment on the potential side effects of the Novavax COVID-19 vaccine, Nuvaxovid. In this Snapshot, we take a closer look at the potential side effects associated with the Oxford-AstraZeneca COVID-19 vaccine, also known as Vaxzevria. Each dose contains 0.5 mL of the vaccine. This side effect was not seen among adults in the Novavax clinical trials. And Novavax does not contain a live virus. For further assistance with reporting to VAERS, call 1-800-822-7967. The CDC advises that people who have a history of serious allergies, including anaphylactic reactions, should talk to their provider before getting the COVID-19 vaccine., The CDC says that if a person has had a severe allergic reaction to any ingredient in either vaccine, they should not get the shot. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. Purpose If you are allergic to polysorbate, you shouldnotget Novavax or J&J/Janssen COVID-19 vaccine. Novavax isnt effective right away because it takes time for your immune system to build antibodies in response to the vaccine. U.S. COVID-19 Vaccine Product Information. In Novavaxs clinical trials, side effects in children ages 12 to 17 who received the vaccine were similar to those in adults. Some people also experience a rise in their blood pressure after the vaccine. Biologics are not made from chemicals and cannot be copied exactly. Updated COVID-19 boosters can help restore protection that has decreased since previous vaccination. Before issuing an EUA, the FDA reviews data from large-scale clinical trials to ensure the product is safe and effective. The results of Novavaxs clinical trials found the vaccine effective in helping prevent COVID-19. If you have questions about interactions that may affect you, talk with your doctor or pharmacist. If you have any concerns, talk to your healthcare provider. Learn more about the other symptoms and what to expect here. 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. You should always consult your doctor or another healthcare professional before taking any medication. Allergic reaction. Mild neurological effects of the COVID-19 vaccine include weakness, numbness, headache, dizziness, imbalance, fatigue, muscle spasms, joint pain, and restless leg syndrome are more common, while tremors, tinnitus, and herpes zoster are less common. The manufacturer of Novavax is conducting ongoing clinical trials to obtain additional data about the vaccines safety and effectiveness. Instead, its a protein-based vaccine. Modernas COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 COVE study. This was a rare side effect in clinical trials of this vaccine. But Who Will Take It? Fainting (syncope) after vaccination. The Novavax vaccine will be manufactured in two different facilities. The mRNA from the vaccines is broken down within a few days after vaccination and discarded from the body. Therefore, they recommend that pregnant people receive information about the risks of COVID-19 during pregnancy, the potential benefits of vaccination, and safety data limitations so that they can make their own decision. Novavax is authorized for use in children ages 12 and older. All rights reserved. These are considered vaccine-condition interactions. Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. Side effects are expected with many vaccines. This includes mild side effects such as: The Centers for Disease Control and Prevention (CDC) advises that people might feel a little unwell for a few days after they get the vaccine. Most of the side effects reported by the more than 30,000 participants in Moderna's vaccine clinical trial were mild and did not last long. 6 People were more likely to experience headaches and other . 2% erythema/redness at the injection site, Injection site pain, redness, or swelling, Injection site pain, swelling, and redness. Do you need to wait to get vaccinated after getting COVID-19 or getting treatment for COVID-19? This webpage was updated on 28 September 2022 to ensure consistency of formatting. However, as other protein-based vaccines have comparable efficacy in pregnant and non-pregnant people, they say that the Novavax vaccine may be the same. Learn more. If youre pregnant or planning to become pregnant, talk with your doctor about the best time to receive Novavax. Some of these side effects, such as fainting (syncope) are related to getting the shot (a vasovagal response). The most commonly reported side effects by vaccine recipients in the clinical trial were pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever. COVID-19 vaccine ingredients are considered safe for most people. A first booster dose is recommended 4-6 months after the completion of the primary series. Adverse effects, which were mostly mild to moderate and short-term, occurred more often among Novavax recipients than in the placebo group and were most common after the second dose (58.0% and 21.1%, respectively, after the first dose and 78.9% and 21.7%, respectively, after the second dose). cough difficulty swallowing dizziness fainting fast heartbeat hives, itching, skin rash puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue trouble breathing Other side effects Some side effects of sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant may occur that usually do not need medical attention. Rare side effects of Novavax People 18 and older may also get a Novavax booster based on the original virus strain six months after their last shot. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. These lists do not include all possible side effects. mRNA vaccines use mRNA created in a laboratory to teach our cells how to make a proteinor even just a piece of a proteinthat triggers an immune response inside our bodies. To further reduce the risk of severe disease, deaths and disruptions of health services, WHO recommends countries should consider a second booster dose 4-6 months after the first booster dose for all older persons, all persons with moderate and severe immunocompromising conditions, regardless of age, adults with comorbidities, pregnant persons and health workers. This may lead to life threatening complications. They help us to know which pages are the most and least popular and see how visitors move around the site. Sugars, salts, acid, and acid stabilizer: COVID-19 vaccines have undergoneand will continue to undergothe most intensive safety monitoring in U.S. history. It better equips the immune system to fight the virus. is compromised, these recommendations will be updated accordingly. Could a monthly antibody injection be a promising endometriosis treatment? Possibly, but its rare. For more information, see the Novavax and pregnancy section above. TheWHO Strategic Advisory Group of Experts on Immunization (SAGE) has issuedinterim policy recommendationsfor the use of the Novavax (NVX-CoV2373) vaccine. An 8-week interval is recommended between primary series doses of NVX-CoV2373. CDC will continue to provide updates as we learn more. They were created in moth cells and then assembled into nanoparticles small particles made of a few hundred atoms. Side effects are more likely after the second dose. Although not all of these side effects may occur, if they do occur they may need medical attention. For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here. Work together to help the mRNA enter cells. After a second dose of the Pfizer vaccine: Meanwhile, after a second dose of the Moderna vaccine: Like the Novavax vaccine, side effects were more common after the second vaccine dose. What are the side effects of the Novavax COVID-19 vaccine? 8. When you take more than one dose of vaccine your immunity will keep on work in the fight against pathogenic organisms. The efficacy of Novavax(NVX-CoV2373) in adolescents 12 to 17 years of age was evaluated in an interim analysis of the paediatric expansion portion of the ongoing phase 3 study in United States. Can diet help improve depression symptoms? There are four COVID-19 vaccines, which include primary series and boosters, recommended in the United States. They also tracked side effects for 7 days after each dose. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Is the ketogenic diet right for autoimmune conditions? The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy. delaying pregnancy or terminating pregnancy because of vaccination. How Viagra became a new 'tool' for young men, Ankylosing Spondylitis Pain: Fact or Fiction. To help with these side effects, you can hold a cool, wet washcloth over the area where you got the injection. Everything to know about the Moderna COVID-19 vaccine, What to know about the COVID-19 vaccine and the immune system, mild skin reactions at the injection site, such as itching, swelling, redness, or discoloration, Heart problems, such as inflammation of the, pain, swelling, or warmth in a leg or an arm, swelling under your skin, typically in your eyelids, lips, hands, or feet, swelling of your tongue, mouth, or throat, its been at least 6 months since you last received a. Purpose Updates were made to both the Pfizer and Moderna COVID-19 vaccine fact sheets for healthcare providers and vaccine recipients and caregivers about the rare risk of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart). None of the COVID-19 vaccines affect or interact with our DNA and the following are not included in the vaccines: After the body produces an immune response, it discards all of the vaccine ingredients, just as it would discard any substance that cells no longer need. Side effects from a vaccine are very normal. Novavax is not an mRNA vaccine like other COVID-19 vaccines. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) receive reports made to VAERS. So, instead of generics, biologics have biosimilars. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK phase 3 trial [Press release]. No change was made to the vaccines formula with the name change. people under 18 years old, as research studying its safety and efficacy is still underway. Getting COVID-19 while pregnant can increase the risk of severe illness and pregnancy complications. This protein causes an immune response that helps to protect the body from getting sick with COVID-19 in the future. The vaccine is authorized for emergency use. If youre breastfeeding or plan to breastfeed and have questions about the Novavax vaccine, talk with your doctor or pharmacist. Check with your doctor or nurse immediately if any of the following side effects occur while taking sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant: Some side effects of sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant may occur that usually do not need medical attention. Each dose contains 0.5 mL of the vaccine. Food and Drug Administration. In this Snapshot feature, we look at the possible side effects of the Pfizer-BioNTech COVID-19 vaccine, and whether they warrant precaution. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. Some people may have mild to moderate side effects from this vaccine that may last one to three days. Work together to help the recombinant spike protein enter cells. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. In the Novavax clinical trial of about 40,000 people, there were six cases of myocarditis, or inflammation of the heart muscle, and one in the placebo group. Creech adds that not everyone who gets the vaccine will experience side effects. Novavax has a similar safety profile to the other vaccines, with a number of common immediate side effects. You can also catch COVID-19 by touching a surface that the virus is on, then touching your face, eyes, nose, or mouth. Stay up to date with your COVID-19 vaccines. Healthcare providers have been encouraged by the group to be honest with their patients about the vaccinesspecifically, about possible side effects. The only serious side effect in children in Novavax clinical trials was myocarditis (inflammation of the heart muscle). non-pregnant women of a similar age. Centers for Disease Control and Prevention. People will have different reactions, or none at all, as is the case with all vaccines, Wen says that when she and her fellow doctors advise patients on the COVID-19 vaccines, we should not be minimizing the side effects; we should be explaining them.. This process is a part of normal body functioning. For details about vaccines that contain live viruses, see this article. and Mexico trials used the same case definitions, and these consistent results, therefore, provide much confidence in the use of this vaccine for the global population. The World Health Organization (WHO) recommends Novavax for: The WHO the following not to get the vaccine: The WHO also highlights that data on having the vaccine during pregnancy is not yet available. A COVID-19 vaccine can cause mild side effects after the first or second dose, including: Pain, Marley Hall is a writer and fact checker who is certified in clinical and translational research. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Currently, there are no known interactions between Novavax and alcohol. Saving Lives, Protecting People, Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the, The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. Viral vector vaccines use a harmless, modified version of a different virus (a vector virus), and not the virus that causes COVID-19. * To learn more about side effects of Novavax, see the Novavax side effects section above. If you have additional questions about Novavax or how it works, talk with your doctor or pharmacist. There is a potential cause-and-effect relationship between J&J/Janssen COVID-19 vaccine and a rare and serious adverse event. COVID-19 can affect your respiratory system and other parts of your body. If you developed heart inflammation after having a previous COVID-19 vaccine, talk with your doctor before receiving Novavax. We now await the peer-reviewed publication. Unlike mRNA vaccines, such as Pfizer and Moderna, the Novavax vaccine uses a longer-standing protein-based technology. Sometimes they may affect a person's ability to do daily activities. I'm about to be on Day 5 post first dose of Novavax. Call 911 or your local emergency number if your symptoms feel life threatening or if you think youre having a medical emergency. Both Pfizer and Moderna advise that if people develop certain symptoms within a few hours of receiving a COVID-19 vaccine, they should seek medical care right away. What to Know About the COVID-19 Vaccine If You Have Diabetes, Shingrix Second Dose: Everything You Need to Know. WHO does not recommend She is a former staff writer for Forbes Magazine and U.S. News and World Report. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future. 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%. Would otherwise remain unvaccinated for COVID-19 due to limited access to Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines), or to Novavax. If you have questions about what to expect after the COVID-19 vaccine or you are worried that what you are experiencing is not normal, talk to your doctor. Any side effects from the vaccine were largely mild to moderate and transient. As Novavax The manufacturer of Novavax is conducting ongoing clinical trials to obtain additional data about the vaccines safety and effectiveness. Possible side effects after getting a COVID-19 vaccine. Its really important that people understand what they should be expecting, Leana Wen, MD, MSc, an emergency physician and and visiting professor of health policy and management at George Washington University, tells Verywell. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed. Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. If you receive Novavax while pregnant, you can enroll in the COVID-19 pregnancy registry by visiting the registry website. And Novavax does not contain a live virus. So, the vaccine may pose a greater risk to people who have or have had heart problems. Thats short for severe acute respiratory syndrome coronavirus 2. Learn more about how long COVID-19 test results. After learning how to respond to the spike protein, the immune system will be able to respond quickly to the actual virus spike protein and protect you against COVID-19. The most commonly reported side effect that was rated as severe after the first dose was pain at the injection site (2.7%). The Novavax COVID-19 vaccine uses more conventional vaccine technology compared to the Pfizer, Moderna, and Johnson & Johnson vaccines. The most commonly reported side effects after the second dose of vaccine that were rated as severe were: 9.7% fatigue. You can talk with your doctor to find out whether Novavax is recommended for you. Other people can have severe symptoms. AMA Chief Experience Officer Todd Unger hosts. But individuals may choose to delay vaccination for 3 months following the infection. You should also talk with your doctor to determine whether Novavax is safe for you. However, they need to be prevented because people can get injured when they faint. Food and Drug Administration. In 2022, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Novavax. Centers for Disease Control and Prevention. The Novavax COVID-19 vaccine is the fourth COVID-19 vaccine to be authorized for use in the U.S. It's given as a two-dose primary series, 3 weeks apart.
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