ABSTRACT
Background: Data are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease. Methods: This prospective observational study enrolled patients age 12–25 years with chronic underlying disease who received 2 doses of BNT162b2. A 18-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose. Results: Study participants were 429 patients (241 [56.2%] age 12–15 years;188 [43.8%] age 16–25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases;32% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12–15 years and in 2 (1.1%) patients age 16–25 years;all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12–15 years versus 16–25 years (1603.3 [1321.8–1944.7] U/mL vs. 949.4 [744.2–1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5–2314.7] U/mL vs. 467.9 [324.4–674.8] U/mL). Conclusions: Vaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease. © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
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In past decades, there have been abundant discussions regarding management of medical Intellectual Patent Rights (IPRs) since India's Indira Priyadarshini Gandhi, then Prime Minister, eliminated medical product patent protection and enacted India's Patents Act, 1970. There were many changes to IPRs related to AIDS drugs during the 1980's and 1990's. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement also hosted numerous discussions over the Doha Declaration, an issuance of compulsory licensure, and product patent waivers for least developed countries (LDCs). COVID-19 emerged in January 2000, making salient this controversial issue. Should medical patents be protected, waived, or pooled? Both USA President Joe Biden and Chinese President Xi Jinpin stated that they would support waivers for COVID-19 related IPRs in May 2021. The following week, pharmaceutical industry representatives released statements arguing for the protection of pharmaceutical IPRs. Meanwhile, developing countries, the World Health Organization (WHO), and other stakeholders contend that medical IPRs should be limited. This paper will first describe the current global status of the COVID-19 pandemic and then present COVID-19 related medical patent data using a commercial database offered by Clarivate Analytics. Based on this data, we will then closely analyze stakeholder positions on COVID-19 IPRs. In this study we selected three widely used schemes of pharmaceutical IPR and drug/vaccine distribution - COVAX, Medicines Patent Pool (MPP) and voluntary licensing. After close examination, we found voluntary licensing is the most applicable solution for COVID-19 pandemic at the time being. © 2022 PICMET.
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It is thought that Japan is one of a handful countries that have sufficient R&D ability to develop new pharmaceutical products. However, Japan has recently been revisiting its national policy to reinforce the local production ability for medical products combating infectious diseases, based on the failure to develop a COVID-19 vaccine. In contrast, India has a long experience exporting generic and/or voluntarily licensed pharmaceutical products to the world. However, India has not been able to fulfill its national demand, caused partly by the national provision system. Confronted with this contradiction amid the COVID-19 pandemic, India has no choice but to restrict their exportation of medical products responding to COVID-19, and India and other developing countries have proposed to the WTO TRIPS Council to ask for WTO members to recognize an IP protection waiver as far as needed to deal with the pandemic. This paper analyzes what divides the postures of these two countries, by comparing their national and global policy on pharmaceutical R&D and IP protection, before and after COVID-19. © 2022 PICMET.
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BACKGROUND: Data are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease. METHODS: This prospective observational study enrolled patients age 12-25 years with chronic underlying disease who received 2 doses of BNT162b2. A 19-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose. RESULTS: Study participants were 429 patients (241 [56%] age 12-15 years;188 [43.8%] age 16-25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases;33% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12-15 years and in 2 (1.1%) patients age 16-25 years;all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12-15 years versus 16-25 years (1603.3 [1321.8-1944.7] U/mL vs. 949.4 [744.2-1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5-2314.7] U/mL vs. 467.9 [324.4-674.8] U/mL). CONCLUSIONS: Vaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease.
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BACKGROUND: Food insecurity is an important social determinant of health that links to various health conditions and exacerbated by the COVID- 19 pandemic. Our previous (unpublished) study showed a progress on the food scarcity prevalence among US adults after December 2020 when US economy started recovering quickly. We developed a hypothesis that the rapid US economic recovery has had a greater impact on the food scarcity in the vulnerable groups (Hispanic/Black). METHODS: We conducted a secondary data analysis of nationwide US adults using Household Pulse Survey (HPS) from the US Census Bureau. HPS asks about impacts of COVID-19 pandemic on daily lives among US adults. Bi- weekly data tables summarize national estimates of food security and racial differences in their responses. Food scarcity is defined as those reporting “sometimes” or “often” not enough to eat in the last 7 days. We performed multi group interrupted time series analysis to compare the effect of US economic recovery that began in December 2020 on the racial disparity in food scarcity. We chose the vulnerable group (Black/Hispanic) as the treatment group and White as the control group. RESULTS: Among nearly 250,000,000 US adults per 2 weeks, 63% was White, followed by 17% Hispanic, and 5% Black. The food scarcity rate in the control group was incremental by 0.3% per 2 weeks in the pre-intervention period (b = 0.003, p < 0.001) but it started decreasing by 0.4% per 2 weeks in the post-intervention period (b = -0.004, p < 0.001). Figure shows the effect of economic recovery on the food scarcity rate between races. Black/Hispanic group had 0.10- point higher rate of food scarcity at the beginning (b = 0.10, p < 0.001) but showed an additional 0.5%-point decrement per 2 weeks in food scarcity rate on top of the baseline effect of 0.4% decrement (b = -0.005, p = 0.019) in the post- intervention. CONCLUSIONS: The gap in food scarcity between White and Hispanic/ Black groups decreased after US economy started recovering in December 2020. Our results indicate that the economic recovery provided the vulnerable group with additional benefits to reduce food scarcity.
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BACKGROUND: Food insecurity is a part of social determinants of health associated with various health conditions. Increase in households with food insecurity has been reported in the COVID-19 pandemic, but the racial disparity and trend of food insecurity during the pandemic remains unclear. METHODS: We conducted an exploratory data analysis of Household Pulse Survey (HPS) from the US Census Bureau. HPS is a biweekly survey of nationally representative samples of adults in the households. US Census Bureau defines “food scarcity” as respondents who reported “sometimes” or “often” not enough to eat in the last 7 days. We created time series plots of the following national estimates over 34 weeks from June 2020 to September 2021: proportion of (1) food scarcity, (2) at-risk of food scarcity, (3) food sufficient groups stratified by race as well as (4) sources of money to buy food (5) experienced/expected unemployment in 4 weeks. RESULTS: Of an estimated average of 249,546,185 US adults per survey, 62.5% were White, 17.1% Hispanic, 11.4% Black, 5.2% Asian, and 3.8% Other. Age between 25-54 was the most common (51.6%) while 22% were 65 and older. Female comprised 51.6%. On average, 12.1% of Hispanic, 14.0% of Black, and 11.3% of Other adults were classified as having food scarcity as compared to 5.3% of White and 3.1% of Asian adults. Time series plots (Figure) suggested that the proportion of food scarcity was incremental from June to December 2020 and began decreasing after December 2020. This trend was seen across all racial groups, but the gaps in food scarcity rates narrowed between Black/Hispanic and White races. CONCLUSIONS: US adults/households suffered from food scarcity amid COVID-19 pandemic but there have been improvements in food scarcity after December 2020. We hypothesize that the observed improvement was not because of food assistance but because US economy started recovering and they started gaining regular income sources. Racial disparity, however, remains to be the concern especially for Black and Hispanic populations.
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BACKGROUND: COVID-19 Pandemic worsened food insecurity and mental health. However, little is known about risk factors for mental health (MH) symptoms and access during the pandemic. We aimed to examine the associations between food scarcity and mental health/access to mental health care and their population health factors. METHODS: We retrospectively analyzed a national cross-sectional survey, the week-39 data of Household Pulse Survey (HPS), collected between 09/29 and 10/11/2021 by US Census Bureau. Food scarcity is defined as those reporting “sometimes” or “often” not enough to eat in the last 7 days. Dependent (binary) variables included depression and anxiety defined as 3 points or above on PHQ-2 and GAD-2, respectively and lack of access to MH care defined as not being seen by MH providers in the last 4 weeks despite needing care. Multiple logistic regression models were adjusted for demographic and socio-economic factors and time-invariant unobserved factors between states were accounted for by including state fixed effects. RESULTS: We found an estimated total of 250,265,449 US adults. Male comprised 48.4%. Age between 25-39 and 40-54 was the most common (26.3% and 25.4%) followed by 65 and above (22.3%). White race was dominant (62.3%), followed by Hispanic (17.3%), Black (11.3%), or Other (9.1%). Descriptive analysis found that 30.6% of respondents who screened positive for depression had the lack of MH care access. On the multiple logistic regression model, the odds of depression, anxiety, and lack of mental health access were 2.84, 3.08, and 1.74, respectively (all p values < 0.001). We also found that female, young age between 18-24, lower income, unemployment in the last 4 weeks, and reduced mobility were significantly associated with depression, anxiety, and lack of MH access (Table). CONCLUSIONS: The prevalence of MH symptoms and lack of MH care access among US adults remained high in 2021. The most vulnerable population may be young low-income adults who also suffer from food insecurity, unemployment, or limited functional capacity.
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The COVID-19 pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to global public health. Since the deadly virus spread out across the world rapidly, several countries experienced a collapse in their medical care systems. Not only developing countries, but developed countries as well have been suffering from a lack of medicines, hospital beds, doctors/nurses, and medical machines and equipment. Under these circumstances, managing the intellectual property rights (IPRs) of vaccines, medicines, and medical machines and equipment has become a big issue. Since developing a new product in the medical industry takes a long time and requires a huge amount of investment, the IPRs of vaccines, medicines, medical machines and equipment are highly protected. However, under national emergencies, such as the COVID-19 pandemic, how should the IPRs of these products be dealt with? This study analyzed how to handle medical IPRs, focusing on the medical machines and equipment industry. For this purpose, this study first provided an overview of the current status of the COVID-19 pandemic worldwide as well as the medical machines and equipment industry. Next, this study examined patent regulations and governmental policies, along with citizens' and industries' movements to "not to exercise"IPRs. This article presents potential solutions and/or has implications for the post-COVID-19 era and the "New Normal"era with COVID-19. © 2022 IEEE.
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Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was first identified in December 2019 in Wuhan, China, and has resulted in global pandemic. There is currently no effective therapeutic strategy for the management of mechanical ventilation or antiviral drugs for the treatment of this disease. As such, the development of a therapeutic strategy is urgently needed and should be established as soon as possible. In this case series, a therapeutic strategy was initially developed based on previous treatment methods used for the treatment of SARS and MERS in the absence of treatment options for COVID-19 due to a lack of information. During the search for a potential treatment, clinical findings were obtained from patients with severe COVID-19, and one therapeutic strategy was established. This therapeutic strategy was then applied to severe COVID-19 patients. In addition, we can require some interesting clinical features and characteristics of COVID-19 from blood analysis and physical findings. Here, we reported on the clinical features and characteristics of a therapeutic strategy for the treatment of severe COVID-19 pneumonia at our institution.