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Moderna seeks to expand COVID-19 vaccine trial for kids

Moderna seeks to expand COVID-19 vaccine trial for kids

Moderna intends to expand a COVID-19 vaccine trial among kids under 12 to better monitor for potential rare side effects, a spokesperson confirmed to Fox News.”It is our intent to expand the trial and we are actively discussing a proposal with the FDA,” a Moderna spokesperson wrote to Fox News in an email. “The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events.””At this point we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue,” the statement continues in part.MAJOR HEALTH GROUPS CALL FOR COVID-19 VACCINE MANDATES FOR HEALTH CARE WORKERSThe news comes after The New York Times reported earlier Monday that, at the “urging” of the FDA, Pfizer and Moderna were broadening the “size and scope” of their respective trials in kids aged 5-11 in a “precautionary measure” to spot rare adverse events post-vaccination, including heart inflammation. The newspaper, citing one anonymous individual, said the agency requested that companies include 3,000 kids in the 5-11 cohort, said to double the initial size.When prompted by Fox News, an FDA spokesperson wouldn’t elaborate on interactions with drug sponsors, writing, “While we cannot comment on individual interactions with sponsors, we do generally work with sponsors to ensure the number of participants in clinical trials are of adequate size to detect safety signals.”A Pfizer spokesperson said the company expects early results of late stage trials in September for participants aged 5-11, with results for younger age groups, 2-5, expected “shortly after.” Findings among children as young as six months are expected in October or November. “Pfizer has not provided any updates to the previously stated timelines,” reads a statement shared with Fox News. “Pfizer began testing its COVID-19 vaccine in 5-11 year old children on June 8, 2021, with those younger than 5 starting June 21, 2021. The study will include up to 4,500 participants from the United States, Finland, Poland and Spain.”CLICK HERE TO GET THE FOX NEWS APPDr. Alejandra Gurtman, vice president of vaccine clinical research and development at Pfizer, last month noted company plans to vaccinate 4,500 participants with two doses spaced 21 days apart. In the same virtual symposium led by Johns Hopkins University-University of Washington, Dr. Sabine Schynder Ghamloush, director of clinical development at Moderna, said the company was in the first part of KidCOVE, Moderna’s pediatric trial, at the time said to involve about 7,000 children between 6 months to 11 years of age. 

Los Angeles detects mosquitoes infected with West Nile virus

Los Angeles detects mosquitoes infected with West Nile virus

A Los Angeles public health agency overseeing vector control has reported mosquito samples positive for West Nile virus, cautioning residents to take preventive steps.”West Nile virus is detected every summer by local public health agencies because it is endemic to Los Angeles County,” said Susanne Kluh, director of Scientific-Technical Services at the Greater Los Angeles County Vector Control District, in a release posted Thursday. “This virus is spread through our bird population and transmitted to humans through the bite [of] an infected mosquito.”COLORADO REPORTS PLAGUE-INFECTED FLEAS AND ANIMALS, BLAMES DISEASE FOR 10-YEAR-OLD’S DEATHPositive samples were gathered from mosquito traps in areas including Studio City and Tarzana, officials said, noting that a dead bird in the district also tested positive for West Nile virus.”Our agency will continue monitoring disease activity and treat affected areas to prevent a disease outbreak,” said Anais Medina Diaz, public information officer for the agency, in a statement. “But it is very important residents take precautions against mosquitoes and monitor for any symptoms of West Nile virus if they experience mosquito bites while outdoors during dusk and dawn.”CLICK HERE FOR FULL CORONAVIRUS COVERAGEMost people infected with West Nile virus don’t feel sick. However, one in five infected people typically develop a fever and other symptoms such as headache, vomiting or rash, according to the Centers for Disease Control and Prevention. An estimated one in 150 infected people develop a severe, potentially fatal, illness affecting the brain and spinal cord. Serious symptoms include high fever, muscle weakness, neck stiffness, coma and paralysis, Los Angeles officials said.There is no human vaccine to prevent illness from West Nile virus. To avoid West Nile virus, remove standing water in buckets and clogged gutters, apply insect repellent, cover up with long-sleeved shirts and long pants and keep mosquitoes out of the home by shutting windows and using the air conditioner or screened windows and doors, the CDC advises.For more information on mosquito-borne illness and prevention, click here.

AstraZeneca COVID-19 vaccine protective against severe outcomes from delta variant, more data suggests

AstraZeneca COVID-19 vaccine protective against severe outcomes from delta variant, more data suggests

Early findings from the real-world vaccine rollout in Canada suggested one dose of Oxford-AstraZeneca’s COVID-19 shot, not yet authorized in the U.S., was protective against poor outcomes from the highly transmissible delta variant.Researchers affiliated with University of Toronto recently posted results in medRxiv ahead of peer review, analyzing nearly 70,000 individuals in Ontario aged over 16 and infected with COVID-19 from December to May, with a variant of concern behind 9.7% of cases.Results indicated just one dose of the AstraZeneca vaccine was 88% effective against severe outcomes from the delta variant, compared to 78% protection afforded by a single dose of the Pfizer vaccine and 96% from a single dose of the Moderna vaccine. The study couldn’t estimate vaccine effectiveness against delta after a full series of AstraZeneca or Moderna vaccine “due to zero vaccinated testpositive cases.”
 July 7, 2021: A health worker prepares to administer a jab of the AstraZeneca COVID-19 vaccine during a vaccination drive for people ages 30 to 39 in Mexico City.
( (AP Photo/Marco Ugarte))The delta variant has been detected in at least 124 countries, according to the World Health Organization.ASTRAZENECA, PFIZER COVID-19 VACCINES EFFECTIVE AGAINST DELTA VARIANT, STUDY FINDS”Our real-world vaccine effectiveness estimates suggest that even a single dose of these 3 COVID-19 vaccine products provide considerable protection against symptomatic infection and severe outcomes caused by these 4 currently circulating VOCs [variants of concern], and that 2 doses are likely to provide even higher protection,” study authors wrote. “Our findings have public health policy implications worldwide.”Researchers suggested areas with limited vaccine supply could delay the second dose to blanket vaccine wider across the population to first-time recipients. CLICK HERE TO GET THE FOX NEWS APPAstraZeneca lauded the results in a company statement released Friday, with BioPharmaceuticals R&D Executive Vice President Mene Pangalos writing, “With different variants threatening to disrupt our route out of the pandemic, this real-world evidence shows that Vaxzevria, along with other vaccines used in Canada, provides a high level of protection against the most serious forms of the disease, even after just one shot. It is essential that we continue to protect as many people as possible in all corners of the world in order to get ahead of this deadly virus.”

Common COVID-19 antibiotic flops in clinical trial: Experts weigh in

Common COVID-19 antibiotic flops in clinical trial: Experts weigh in

Azithromycin, an antibiotic used to treat COVID-19, was no more effective at freeing non-hospitalized patients of COVID-19 symptoms than a placebo, a study found. Findings from researchers affiliated with University of California San Francisco published in JAMA Network on July 16 analyzed 263 COVID-19 outpatients, 171 of whom were treated with a single 1.2-g oral dose of the antibiotic, while 92 patients were given a placebo. After two weeks, the study found “no significant difference in proportion of participants who were symptom free (azithromycin: 50%; placebo: 50%).” What’s more, by day 21, five participants in the treatment group were hospitalized, compared with zero in the placebo group.”Azithromycin is not a drug that should be used to treat Covid,” Dr. Aaron Glatt, who is uninvolved in the study, told Fox News in an email. Glatt, the chairman of the department of medicine and chief of infectious diseases at Mount Sinai South Nassau, added: “There is no evidence that it provides any benefit to treat Covid and it should not be used unless there is an appropriate bacterial indication.”CDC SAYS ‘NO PLANS TO UPDATE’ SCHOOL MASK GUIDANCE AFTER PEDIATRICS GROUP BREAKS FROM WHITE HOUSEAntibiotics like azithromycin are often used to treat bacterial infections like pneumonia and sexually transmitted infections, according to Dr. Anthony J. Santella, professor of health administration and policy and university COVID-19 coordinator at the University of New Haven. “Thus, exploring its use to prevent symptoms of COVID-19 makes sense using a robust clinical trial design,” he wrote, later adding, “we must remember this is one research study and we would never change treatment guidelines without replicating the study and getting an expert panel to independently review the study data.”The antibiotic was first introduced to COVID-19 care due to its anti-inflammatory properties hypothesized to help stop progression if administered early on, lead author Catherine E. Oldenburg, MPH, assistant professor with the UCSF Proctor Foundation, wrote in a news release posted to EurekAlert.org.”These findings do not support the routine use of azithromycin for outpatient SARS-CoV-2 infection,” Oldenburg wrote.Another expert called the results “concerning but not totally unexpected.”GET THE FOX NEWS APPDr. Ryan Miller, infectious disease specialist at Cleveland Clinic, noted that the antibiotic has been shown to reduce the number of readmissions of patients with chronic pulmonary obstructive disease (COPD), and adds that the treatment’s known anti-inflammatory effects help mitigate the effects of COPD.He warned that the antibiotic has significant and potentially lethal adverse effects, one of which can result in an abnormal heart rhythm preventing the blood from being pumped throughout the body, while also citing a study comparing azithromycin and amoxicillin for cardiovascular death, finding a 2.49 increased risk for those treated with azithromycin.”For these reasons, my fellow infectious disease physicians and I tend to err on the side of reluctance when giving additional therapies without proven benefit.  Every medication has a risk of adverse reaction,” he wrote.

World is 'moving further away' from end of COVID-19 pandemic: WHO official

World is 'moving further away' from end of COVID-19 pandemic: WHO official

A top scientist at the World Health Organization (WHO) warned on Monday that the world is shifting further away from the end of the COVID-19 pandemic, owing to factors like viral variants, social mixing, the flouting of public health measures and vaccine inequities.Dr. Maria Van Kerkhove, epidemiologist and WHO COVID-19 technical lead, noted an 11.5% increase in global cases over the last week, with a 1% increase in deaths. Europe saw a 21% uptick in infections last week, while the Western Pacific experienced a nearly 30% increase, for instance. Though data reflects a slight dip in the African region, Kerkhove warned Africa is experiencing a high level of cases and an approximate 60% increase in deaths.The highly transmissible Delta variant is the latest of four such viral variants of concern under surveillance. The variant, detected in at least 111 countries, has also been blamed for COVID-19 cases rising across the U.S. CDC Director Dr. Rochelle Walensky on Friday warned that the outbreak in the U.S. is becoming “a pandemic of the unvaccinated” because nearly all hospital admissions and deaths are among those who hadn’t been immunized.WHO SAYS IT WILL FIX MULTIPLE ‘UNINTENDED ERRORS’ IN REPORT WITH CHINA ON COVID-19 ORIGINS: REPORT
Dr. Maria Van Kerkhove, epidemiologist and WHO COVID-19 technical lead, noted an 11.5% increase in global cases over the last week, with a 1% increase in deaths.
(Fabrice Coffrini/Pool via REUTERS)COMMON CHOLESTEROL DRUG MAY REDUCE COVID-19 SEVERITY, STUDY FINDS”In the context of virus variants, increased social mobility, social mixing, inappropriate use of public health and social measures and inequitable vaccine distribution, we’re in a very dangerous situation,” Kerkhove said. “It’s becoming more and more challenging and we’re moving further away from the end of this pandemic than we should be at this point in time.”The comments follow the eighth meeting of the International Health Regulations Emergency Committee last week, which noted “governments are making increasingly divergent policy decisions that address narrow national needs which inhibit a harmonized approach to the global response,” per a WHO release.”The Committee noted that, despite national, regional, and global efforts, the pandemic is nowhere near finished,” adding that the current state of the pandemic still needs “a coordinated international response.”GET THE FOX NEWS APPNearly a quarter of the global population, or 24.7%, has received at least one dose of COVID-19 vaccine, with over three billion doses administered, the WHO reported as of July 13.  Nearly 30 million doses are administered worldwide daily, and 1% of people in low-income countries have received at least one dose, figures show.The Associated Press contributed to this report.

Common cholesterol drug may reduce COVID-19 severity, study finds

Common cholesterol drug may reduce COVID-19 severity, study finds

Coronavirus patients taking statins prior to hospitalization substantially reduced their odds of in-hospital death and severe COVID-19, researchers found, confirming earlier findings. Statin drugs are frequently used to lower blood cholesterol levels and prevent cardiovascular disease.A team of scientists from University of California San Diego School of Medicine published findings in PLOS ONE last week, analyzing anonymized records on over 10,500 hospitalized COVID-19 patients admitted across 104 U.S. hospitals between January-September 2020 and enrolled in the American Heart Association’s COVID-19 Cardiovascular Disease (CVD) Registry.At the start of the pandemic, researchers speculated statins could act against COVID-19 through their “known anti-inflammatory effects and binding capabilities, which could potentially stop progression of the virus,” Lori Daniels, MD, lead study author, professor and director of the Cardiovascular Intensive Care Unit at UC San Diego Health, wrote in a news release. Statins upregulate the ACE-2 receptor to convert angiotensin and control blood pressure, however ACE-2 is also a doorway for the virus causing COVID-19. Medications for cholesterol and high blood pressure help stabilize underlying diseases, and likely boost patients’ odds of recovering from COVID-19 disease, study authors said.AN AVOCADO A DAY COULD LOWER ‘BAD’ CHOLESTEROL LEVELS, STUDY SUGGESTSCDC PANEL TO WEIGH COVID-19 BOOSTER SHOTS IN IMMUNOCOMPROMISED PATIENTSPatients were 66 years old on average, and most patients (71%) had high blood pressure, cardiovascular disease, or both. Over 80% of all patients taking statins were also taking at least one drug to treat high blood pressure, and patients taking either class of medication or both were typically older, female and had a number of health issues.Results indicated patients taking a statin alone saw a 46% lower odds of death, and about 25% lower risk of developing severe COVID, versus patients on neither class of medication. Patients taking both a statin and anti-hypertensive dropped risk of death by 40%.GET THE FOX NEWS APP”As with any observational study, we cannot say for certain that the associations we describe between statin use and reduced severity of COVID-19 infection are definitely due to the statins themselves; however, we can now say with very strong evidence that they may play a role in substantially lowering a patient’s risk of death from COVID-19,” Daniels said. “We hope that our research findings are an incentive for patients to continue with their medication.”Use of an anti-hypertensive drug alone was linked to a “smaller albeit still substantial 27% lower odds [of death],” the team found. Of the total 10,540 hospitalized patients, 21% died, 39% had a severe outcome, nearly one-third were sent to the ICU and 19% needed mechanical ventilation.Daniels noted that most benefits were seen among patients with a history of cardiovascular disease or high blood pressure, linked to a 32% lower risk of death.

Coronavirus antibodies persist at least nine months after infection: study

Coronavirus antibodies persist at least nine months after infection: study

A study in northern Italy found coronavirus antibodies persisted in detectable levels for at least nine months after infection, regardless of a symptomatic or asymptomatic course of illness, though results differed depending on test used.Researchers from Imperial College London and the University of Padova published findings in Nature Communications on Monday, stemming from an analysis in Vo’, Italy, where a mass testing campaign saw 86% (2,602 people) of the community tested in February/March and May 2020, about 6% of whom tested positive and were tested again in November.Results indicated 98.8% of COVID-positive individuals had detectable levels of antibodies by November, and nearly 20% had increased levels or reactivity since May, suggesting potential reinfection. Scientists tracked antibody levels through three tests manufactured by Roche, DiaSorin and Abbott and found differing rates of decay in antibody levels. US HEAT WAVE SPARKED SURGE IN EMERGENCY DEPARTMENT VISITS, CDC REPORT FINDS”The May testing demonstrated that 3.5 percent of the Vo’ population had been exposed to the virus, even though not all of these subjects were aware of their exposure given the large fraction of asymptomatic infections,” Professor Enrico Lavezzo of the University of Padua said in a news release posted to EurekAlert.org on Monday.”However, at the follow-up, which was performed roughly nine months after the outbreak, we found that antibodies were less abundant, so we need to continue to monitor antibody persistence for longer time spans.”Other evidence has suggested antibodies linger at least six months after initial infection, while another team found detectable levels of antibodies 11 months later, claiming even a mild case of coronavirus could leave people with lifelong protection against the virus.In the study at hand, lead author Dr. Ilaria Dorigatti, lecturer at Imperial College London, said the team “found no evidence that antibody levels between symptomatic and asymptomatic infections differ significantly, suggesting that the strength of the immune response does not depend on the symptoms and the severity of the infection.”CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGEShe urged caution over comparing infection estimates among populations administered different tests at various time intervals.A further analysis of household contacts suggested a 1 in 4 probability that an infected individual would transmit the virus to others, and a minority of infections generated a large number of secondary infections.”It is clear that the epidemic is not over, neither in Italy nor abroad,” Dorigatti said. “Moving forward, I think that it is of fundamental importance to continue administering first and second vaccine doses as well as to strengthen surveillance including contact tracing. Encouraging caution and limiting the risk of acquiring SARS-CoV-2 will continue to be essential.”

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