Author Interviews, Moderna, NEJM, Pharmaceutical Companies, Respiratory, Vaccine Studies / 13.12.2023

MedicalResearch.com Interview with: Eleanor Wilson, M.D Moderna, 200 Technology Sq. Cambridge, MA 02139 MedicalResearch.com: What is the background for this study? What are the main findings and side effects (if any)? Response: The ConquerRSV trial is a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-associated lower respiratory tract disease (RSV-LRTD) defined as either two or more symptoms, or three or more symptoms of disease. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Most adverse reactions were mild to moderate in severity and included injection site pain, fatigue, headache, myalgia, and arthralgia. (more…)
Author Interviews, COVID -19 Coronavirus, Pediatrics, Vaccine Studies / 01.11.2023

MedicalResearch.com Interview with: Anna Rosemarie Yousaf MD CDC: U.S. Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multisystem inflammatory syndrome in children (MIS-C) is a rare but serious complication following SARS-CoV-2 infection or COVID-19 illness in children characterized by fever and multiple organ inflammation. This study looks at data from children with MIS-C reported to CDC’s national MIS-C surveillance system and compares the characteristics of children who died to children who survived. (more…)
Aging, Author Interviews, Geriatrics, NEJM, Pulmonary Disease, Respiratory, Vaccine Studies / 09.03.2023

MedicalResearch.com Interview with: Veronica Hulstrøm MD, PhD Senior Director Clinical Project Lead for RSV Older Adults GSK     MedicalResearch.com: What is the background for this study? Response: The AReSVi-006 phase III trial is designed to investigate the efficacy and safety of GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The phase III trial is a randomized, placebo-controlled, double-blind, international trial with 24,966 participants who received either the investigational vaccine or placebo. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity, Vaccine Studies / 10.02.2023

MedicalResearch.com Interview with: Kenya Colvin, MBS Department of Medical Education Scranton, PA MedicalResearch.com:  What is the background for this study?  Response: Vaccine hesitancy is a major driver of COVID-19 vaccination disparities between minority and non-Hispanic White communities. Our goal was to understand what factors influenced vaccine hesitancy among individuals in Eastern Pennsylvania to identify more effective ways to promote vaccine uptake within minority communities. (more…)
Author Interviews, Infections, NEJM, Pediatrics, Vaccine Studies / 02.02.2023

MedicalResearch.com Interview with: Manuel García Cenoz MD,  PhDInstituto de Salud Pública de Navarra - IdiSNA, Pamplona, SpainCIBER Epidemiología y Salud Pública, Madrid MedicalResearch.com: What is the background for this study? Response: Neisseria meningitidis is a major cause of severe disease in infants and children. After the introduction of serogroup C vaccines, serogroup B meningococcus has become the main cause of invasive meningococcal disease in Europe. The multicomponent protein-based meningococcal B vaccine (4CMenB, Bexsero, GSK) was licensed in the European Union in 2013. Its authorization was based on immunogenicity studies. Although some countries have introduced the 4CMenB vaccine into the publicly-funded infant immunization programs, the low incidence of the disease has limited the conduct of post-commercialization studies of effectiveness.Meningococcal B vaccine began to be used in Spain in children in 2014, recommended by the Spanish Association of Pediatrics, and paid by their families as it was not publicly-funded. We have conducted a nationwide study including all confirmed cases of invasive meningococcal disease in Spain between October 2015 and September 2019 in children aged two months to five years. (more…)
Author Interviews, HPV, JAMA, Vaccine Studies / 01.11.2022

MedicalResearch.com Interview with: Dr. Didem Egemen PhD Statistician, Division of Cancer Epidemiology & Genetics National Cancer Institute MedicalResearch.com: What is the background for this study? Response: Persistent infection with human papillomavirus (HPV), a sexually transmitted disease, is the cause of virtually all cervical cancers. Various studies have reported high effectiveness of HPV vaccination in preventing HPV infection and cervical cancer, particularly when administered at early ages. In this study, we looked at the proportion of females eligible for vaccination (<26 years of age in 2006 when the vaccine was FDA approved) who were unvaccinated, vaccinated against HPV before sexual debut, and vaccinated after debut. Then we estimated the prevalence of HPV 16 and 18, the two HPV genotypes that cause most cervical cancers, in each subset. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 02.08.2022

MedicalResearch.com Interview with: Dr Emma Wall Senior Clinical Research Fellow, UCLH-Crick Legacy study Consultant Infectious Diseases UCLH MedicalResearch.com:  What is the background for this study?  Response: Since April 2022, both the UK and US have changed their COVID-19 isolation and testing policies. The impact these changes in the guidance and vaccination on community-acquired COVID-19 caused by recent SARS-CoV-2 variants of concern (VOC) has not been fully tested, including infections with BA.2. We aimed to characterise both symptoms and viral loads over the course of COVID-19 infection in otherwise-healthy, vaccinated, non-hospitalised adults, to assess whether current guidance remains justified. All participants were included in the UCLH-Crick Legacy study, a prospective, observational cohort study of otherwise healthy adults who have been taking part in regular workplace testing for SARS-CoV-2 in London We sent swabs by same-day courier every other day to all adults who reported a positive PCR or lateral flow test to the study team up to day 10 after the start of each infection. We confirmed which variant caused the infection by PCR and sequencing. All participants completed linked symptom diaries. We compared symptoms and changes in the amount of virus detected in the nose and throat during infection between study participants reporting COVID-19 caused by VOCs Delta and Omicron BA.1 and BA.2. We then analysed how many of our participants would meet current UK/US isolation guidelines. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 15.06.2022

MedicalResearch.com Interview with: Hiam Souheil Chemaitelly Ph.D. Assistant Professor of Research in Population Health Sciences Population Health Sciences Weill Cornell Medical College   MedicalResearch.com:  What is the background for this study?    Response: The Omicron BA.1 and BA.2 variants resulted in a large wave of infections. The level of protection provided by prior infection or vaccination with Pfizer and Moderna mRNA vaccines or a combination of both against infection with Omicron BA.1 and BA.2 subvariants was unknown. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 22.04.2022

MedicalResearch.com Interview with: Ashley Otter, PhD Research scientist within Diagnostic Support for the rare/imported pathogens laboratory (RIPL) Public Health England (PHE) MedicalResearch.com:  What is the background for this study?  Response: The SIREN study is a national research project covering all four nations of the United Kingdom. Almost 45,000 healthcare workers from across the UK were enrolled midway through 2020, each providing monthly samples for antibody testing and fortnightly PCR testing. Using samples from participants from this project, we were able to take a snapshot of ~6,000 participants at different stages after they received their vaccination to see how different factors affect their antibody responses. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 10.02.2022

MedicalResearch.com Interview with: Carmit Cohen, PhD, MDV – Laboratory manager Infection Prevention and Control UNIT Sheba Medical Center MedicalResearch.com:  What is the background for this study?  Response: We, Professor Regev-Yochay research group, began this study when the first COVID-19 patients were diagnosed in Israel. We followed humoral immune response kinetics of recoverees in the first year of the pandemic for a year (before the introduction of the Delta variant) and compared them to a matched cohort of two doses Pfizer vaccinated that was followed for up to eight month (until they received the third dose). (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity, Vaccine Studies / 04.02.2022

MedicalResearch.com Interview with: Bianca V. Sanchez Department of Medical Education Geisinger Commonwealth School of Medicine Scranton, Pennsylvania MedicalResearch.com: What is the background for the study? Response: Hispanic populations have been disproportionately affected by the COVID-19 pandemic, as evident by their increased rate of infection with the virus, hospitalizations, and mortality. Previous literature has indicated that many of these individuals demonstrate increased rates of vaccine hesitancy, subsequently increasing their risk for infection. This study aimed to characterize the reasoning behind vaccine hesitancy in Hispanic populations in the hopes of addressing their concerns through targeted educational interventions. (more…)
Annals Internal Medicine, Author Interviews, COVID -19 Coronavirus, Kidney Disease, Vaccine Studies / 16.12.2021

MedicalResearch.com Interview with: Shuchi Anand, MD MS (she/her) Assistant Professor in Medicine Director, Center for Tubulointerstitial Kidney Disease Stanford University School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A majority of  people on dialysis who completed vaccination as of September 2021 have had a decline in antibody response to levels that would render them vulnerable to infection. Antibody response immediately after vaccination and circulating antibody response is strongly associated with risk for breakthrough after the initial vaccination series. (more…)
Author Interviews, COVID -19 Coronavirus, NEJM, Vaccine Studies / 13.12.2021

MedicalResearch.com Interview with: Ronen Arbel, PhD Outcomes Research, Community Medical Services Division Clalit Health Service Tel Aviv, Israel Director, Maximizing Health Outcomes Research Lab Sapir College, Sderot, Israel.  MedicalResearch.com: What is the background for this study? Response: The emergence of the SARS-CoV-2 delta variant and reduced effectiveness over time of the BNT162b2 vaccine (Pfizer-BioNTech) led to a recent Coronavirus 2019 disease (Covid-19) resurgence in early vaccinated populations. The Israeli Ministry of Health was the first in the world to approve a third (booster) dose of BNT162b2 to cope with this resurgence. (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, NEJM, Vaccine Studies / 02.12.2021

MedicalResearch.com Interview with: Dr. Barbra Dickerman, PhD CAUSALab investigator and instructor Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Early randomized trials showed that the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines were both remarkably effective at preventing symptomatic disease, when comparing each vaccine with no vaccine. However, head-to-head comparisons of these vaccines have been lacking, leaving open the question of which vaccine is more effective.  In this study, we analyzed the VA’s high-quality databases in a way that emulated the design of the hypothetical trial that would have answered this question. Specifically, we used the findings from the original trials to benchmark our methods and then extended them to provide novel evidence for the comparative effectiveness of these two vaccines in a real-world setting and across diverse subgroups and different time periods. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, Vaccine Studies / 04.11.2021

MedicalResearch.com Interview with: Rani Elwy, PhD Bridge Quality Enhancement Research Initiative Program, Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System Bedford, Massachusetts Department of Psychiatry and Human Behavior, Alpert Medical School Brown University, Providence, Rhode Island  MedicalResearch.com: What is the background for this study? Response: The VA operates a very robust, embedded quality improvement and implementation science program, of which our team is involved. As the VA was one of the first US healthcare systems to rollout COVID-19 vaccination programs, we were asked to evaluate these efforts in real-time, to provide input to VA healthcare leaders on what was going well and what could be improved. This survey reported in JAMA Network Open is one of the quality improvement efforts we engaged in. (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Vaccine Studies / 02.11.2021

MedicalResearch.com Interview with: Catherine H. Bozio, PhD MPH Epidemiologist Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? Response: We wanted to understand what protection previous infection with SARS-CoV-2 (the virus that causes COVID-19) and COVID-19 vaccination can provide. (more…)
Author Interviews, HPV, Vaccine Studies / 01.10.2021

MedicalResearch.com Interview with: Holly Frost, MD Assistant Professor Pediatrics University of Colorado Anschutz School of Medicine Thersia Sebastian, MD Pediatrics, Denver Health  MedicalResearch.com: What is the background for this study? Response: Among children with acute otitis media (AOM) S.pneumoniae, H.influenzae, and M.catarrhalis are the predominant bacterial otopathogens. Historically, the gold standard for diagnosing otopathogens has been through middle ear fluid (MEF) culture. The challenge with MEF culture is that it is time-consuming and requires expert training often only done by specialists, thereby limiting its diagnostic utility to guide routine clinical care. Recent studies have shown that there is a high correlation between nasopharyngeal (NP) and MEF organisms during AOM. It is easier to collect NP swabs and less training is required. Thus, NP samples could serve as a surrogate for detection of otopathogens, potentially making identification of otopathogens practical and feasible in a typical practice environment compared to a MEF collection. Identification of otopathogens could be critical in treatment management of AOM, especially in the era of antimicrobial stewardship efforts to overall reduce unnecessary antibiotic use. Our goal was to compare the sensitivity and specificity of NP PCR to NP culture for common bacteria that cause ear infections.  (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Vaccine Studies / 30.09.2021

MedicalResearch.com Interview with: Anne Hause PhD Epidemiologist Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? Response: On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose following completion of a primary vaccination series to eligible persons with moderate to severe immunocompromise.  (more…)
Author Interviews, COVID -19 Coronavirus, Pediatrics, Vaccine Studies / 28.09.2021

MedicalResearch.com Interview with: Jonathan Baktari, MD CEO of e7health.com Dr. Baktari, CEO discusses Pfizer’s recent announcement that their vaccine trial for children ages 5-11 has been safe and effective, marking a major milestone in the fight against COVID-19.   MedicalResearch.com: What risks should parents weigh? Response: Pfizer has already said that based on their studies the lower dose two shot COVID vaccine for children is safe, meaning that their data shows minimal side effects. If that data is correct, then we should expect the same minor symptoms we see with teenagers to the COVID vaccine  (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Vaccine Studies / 17.09.2021

MedicalResearch.com Interview with: Scott Pauley Press Officer, News Media Branch Division of Public Affairs Office of the Associate Director for Communication MedicalResearch.com: What is the background for this study?
  • In this real-world study of vaccine effectiveness:
    • Researchers compared hospitalized patients who tested positive for the virus that causes COVID-19 (case patients) to hospitalized patients who tested negative for the virus (control patients)
    • Vaccine effectiveness was calculated for each type of vaccine by comparing the proportion of cases patients and control patients vaccinated
    • 3,689 patients were included (1,682 case-patients and 2,007 control-patients)
Vaccination status breakdown: 2,362 unvaccinated; 476 fully vaccinated with Moderna; 738 fully vaccinated with Pfizer-BioNTech; and 113 fully vaccinated with Janssen vaccine. (more…)
Author Interviews, CDC, HPV, JAMA, Vaccine Studies / 17.09.2021

MedicalResearch.com Interview with: Kalyani Sonawane, PhD Assistant Professor of Management, Policy and Community Health UTHealth School of Public Health in Houston MedicalResearch.com: What is the background for this study? Response: Safety concern regarding the HPV vaccine is one of the most significant barriers to vaccination. Our objective was to determine how many US adolescents did not initiate the HPV vaccine during 2015-2018 because their parents had concerns regarding the vaccine’s safety. We also analyzed vaccine adverse event reporting data, in parallel, to understand if the public sentiment of HPV vaccine safety is in alignment with evidence from the vaccine safety surveillance system.  (more…)
Author Interviews, Cancer Research, HPV, JAMA, Vaccine Studies / 07.09.2021

MedicalResearch.com Interview with: Yuehan (Jenny) Zhang, ScM PhD Candidate in Cancer Epidemiology Johns Hopkins Bloomberg School of Public Health MedicalResearch.com: What is the background for this study? Response: Human Papillomavirus (HPV) is the most common sexually transmitted infectious virus worldwide. Oral HPV infection has resulted in a continual increase in the incidence of oropharynx cancer over the past two decades in the US. New HPV infections are preventable with vaccines, which first entered use in the US in 2006. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, Vaccine Studies / 03.09.2021

MedicalResearch.com Interview with: Jeffrey M. Wilson MD Assistant Professor of Medicine Allergy and Immunology University of Virginia MedicalResearch.com: What is the background for this study? What are the main findings? Response: To date there have been few head-to-head studies evaluating the immune responses to COVID-19 vaccines. Here we measured IgG antibodies to the SARS-CoV-2 spike-RBD in adults who received full vaccination with either the Pfizer/BioNTech or Moderna vaccine. Our study is distinguished from many others because we developed a quantitative test with a read-out in standardized units (expressed as micrograms/mL). We found that antibody levels to the SARS-CoV-2 spike receptor-binding domain were lower in recipients of the Pfizer/BioNTech than Moderna vaccine. The difference in the antibody levels between vaccines was most evident in relatively older subjects. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 02.09.2021

MedicalResearch.com Interview with: David H. Canaday, MD Associate Director of Research Geriatric Research, Education and Clinical Center (GRECC),  Cleveland VA Professor, Division of Infectious Disease, Case Western Reserve University Cleveland, Ohio MedicalResearch.com: What is the background for this study? Response: We were interested in following up on a prior study where we determined that nursing home residents, and in particular those that were given the Pfizer shot who never had COVID-19 in the past, had 4 fold less antibodies against the key Spike protein of the coronavirus than did the group of health care workers who were the other group studied. We wanted to see how those antibodies levels in these groups held up over 6 months.  (more…)
Allergies, Author Interviews, COVID -19 Coronavirus, JAMA, Vaccine Studies, Vanderbilt / 27.07.2021

MedicalResearch.com Interview with: Kimberly G. Blumenthal, MD, MSc Massachusetts General Hospital The Mongan Institute Boston, MA 02114 Matthew S. Krantz, MD Division of Allergy, Pulmonary and Critical Care Medicine Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee   MedicalResearch.com: What is the background for this study? Response: During the initial COVID-19 vaccine campaign with healthcare workers in December 2020, there was an unexpected higher than anticipated rate of immediate allergic reactions after Pfizer and Moderna mRNA vaccines.  This prompted both patient and provider concerns, particularly in those with underlying allergic histories, on the associated risks for immediate allergic reactions with the mRNA vaccines. Because of the significantly improved effectiveness of two doses of an mRNA vaccine compared to one dose, it was important to determine if those who experienced immediate allergic reaction symptoms after their first dose could go on to tolerate a second dose safely.    (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 22.06.2021

MedicalResearch.com Interview with: Dr Boby Varkey Maramattom MD,DM, FRCP, FRCPE Fellow in Critical care neurology (Mayo Clinic) Lead Consultant Neurologist Aster Medcity, Kochi, Kerala Associate Director- Clinical Research Centre, Aster Medcity. Convener, Neurocritical care subsection Indian academy of Neurology  (IAN) MedicalResearch.com: What is the background for this study? Response:  Approximately 2-3 months after the vaccination programme commenced in India, we began to notice an uptick in the incidence of Guillain-Barré Syndrome (GBS) in our community. All the cases that presented to us during this period had almost the same clinical presentation. They presented within a few days ( usually within 1-2 weeks) of the first dose of the ChAdOx1-S/nCoV-19 vaccine. Most of the patients were women and it seemed to involve the middle aged to elderly age groups. As a result of this observation, we started to compile the clinical findings of these patients and collate them. (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 23.05.2021

MedicalResearch.com Interview with: Jonathan Baktari, MD CEO of e7health.com Dr. Baktari dicusses COVID-19 vaccinations as well as the nine vaccinated New York Yankees have now tested positive for COVID-19.  They all received the J&J vaccine. MedicalResearch.com:  There are nine known COVID positive results among members of the Yankees, previously immunized with the J&J vaccine.  Do you know if the players have become ill or just tested positive on routine testing? Response: Only 1 out of the 9 was mildly symptomatic and were all picked up as part of MLB testing protocol. MedicalResearch.com: Do you know how long after they were vaccinated that they tested positive?  Do you know of other incidences of positive reactions after vaccinations?  Response: According to MLB, all players tested positive after receiving the J&J vaccine.  All were at least 14 days after the vaccine was administered.  The 14 days post vaccination is when J&J is supposed to be effective in preventing serious illness and death. (more…)
Author Interviews, Cancer Research, Gender Differences, HPV, JAMA, Vaccine Studies / 27.04.2021

MedicalResearch.com Interview with: Michelle M. Chen, MD/MHS Clinical Lecturer Department of Otolaryngology-Head and Neck Surgery University of Michigan MedicalResearch.com: What is the background for this study? Response: HPV is the most common sexually transmitted infection in the United States and associated with several malignancies including oropharyngeal, cervical, vaginal, vulvar, penile, and anal cancers. In 2020, the FDA expanded the indications for HPV vaccination to include the prevention of oropharyngeal cancer, which is the most common HPV-associated malignancy and about 80% of oropharyngeal cancer patients are male. HPV vaccination rates are closely tracked for adolescents but less is known about vaccination rates for young adults. The goal of our study was to understand HPV vaccinations for young adult men and women, ages 18-21.  (more…)