ABSTRACT
Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.
ABSTRACT
Background@#Glyphosate and glufosinate use widely used as herbicide ingredients. There have been several reported cases of chemical burns caused by dermal exposure to glyphosatecontaining herbicide, and patients in these cases were discharged without fatal complications.There were no cases of severe symptoms due to non-oral exposure of glufosinate-containing herbicides. Here, we report a case of fatality accompanied with severe chemical burns in an 81-year-old man who did not wash his skin for more than 48 hours after dermal exposure to herbicide containing glyphosate and glufosinate with surfactant (HGlyGluS).Case presentation: An 81-year-old male with no underlying disease was admitted to the emergency department (ED). He had sprayed HGlyGluS with a manual knapsack sprayer 3 days ago and had not wash away the herbicide. On arrival, he was drowsy and had multiple severe corrosive skin lesions. Skin necrosis (10 × 15 cm) on the right shoulder and skin lesions with subcutaneous fat exposure (15 × 20 cm) on the right thigh were observed. Although he was treated including continuous renal replacement therapy, antibiotic apply, debridement operations, and so on, he was unable to recover and expired. @*Conclusions@#We suggest that prolonged dermal exposure to HGlyGluS induces fatality.Further studies including prolonged dermal exposure and ingredients of surfactants should be carried out. Also, it is necessary to educate farmers that it is very important to wash immediately after dermal exposure to pesticide.
ABSTRACT
Background@#Glyphosate and glufosinate use widely used as herbicide ingredients. There have been several reported cases of chemical burns caused by dermal exposure to glyphosatecontaining herbicide, and patients in these cases were discharged without fatal complications.There were no cases of severe symptoms due to non-oral exposure of glufosinate-containing herbicides. Here, we report a case of fatality accompanied with severe chemical burns in an 81-year-old man who did not wash his skin for more than 48 hours after dermal exposure to herbicide containing glyphosate and glufosinate with surfactant (HGlyGluS).Case presentation: An 81-year-old male with no underlying disease was admitted to the emergency department (ED). He had sprayed HGlyGluS with a manual knapsack sprayer 3 days ago and had not wash away the herbicide. On arrival, he was drowsy and had multiple severe corrosive skin lesions. Skin necrosis (10 × 15 cm) on the right shoulder and skin lesions with subcutaneous fat exposure (15 × 20 cm) on the right thigh were observed. Although he was treated including continuous renal replacement therapy, antibiotic apply, debridement operations, and so on, he was unable to recover and expired. @*Conclusions@#We suggest that prolonged dermal exposure to HGlyGluS induces fatality.Further studies including prolonged dermal exposure and ingredients of surfactants should be carried out. Also, it is necessary to educate farmers that it is very important to wash immediately after dermal exposure to pesticide.
ABSTRACT
BACKGROUND@#The objective of the present study is to identify differences in the prevalence of acute occupational pesticide poisoning across Korean orchard farmers' farming characteristics and the risk factors that have an effect on acute occupational pesticide poisoning.@*METHODS@#For 3 years (2014, 2015, and 2017), a questionnaire survey was conducted on 394 orchard farmers in some parts of south Chungcheong Province in relation to pesticide poisoning. 323 orchard farmers who responded to acute occupational pesticide poisoning were included for final analysis. With acute occupational pesticide poisoning as the dependent variable, a χ² test and a multiple logistic regression analysis were conducted.@*RESULTS@#The results of the prevalence of acute occupational pesticide poisoning across farming characteristics showed that the group wearing 4 or more pesticide personal protective equipment (PPE) had a lower prevalence of acute occupational pesticide poisoning than the group wearing 3 or less pesticide PPE (p < 0.05). Furthermore, an analysis by area of fruit farming revealed that the group with more than 12,000m² in the area of fruit farming had a higher prevalence of acute occupational pesticide poisoning (p < 0.05). Orchard farmers mainly use a speed sprayer to spray pesticides, and the speed sprayer can be categorized by presence of cabin. The analysis of the prevalence of acute occupational pesticide poisoning by speed sprayer's cabin existence found that existence of speed sprayer's cabin did not show a statistically significant difference in the prevalence of acute occupational pesticide poisoning.@*CONCLUSIONS@#The present study analyzed the prevalence of acute occupational pesticide poisoning depending on the speed sprayer's cabin existence and found no significant difference. The fact that famers using the cabinless style speed sprayer shows a higher percentage in wearing PPE than those using the cabin style speed sprayer is suggested to elucidate the result. As the first study in Korea which examined the prevalence of acute occupational pesticide poisoning by speed sprayer's cabin existence, the present study proposes the expected effect that increase of wearing pesticide PPE along with employ of speed sprayer's cabin can reduce the prevalence of acute occupational pesticide poisoning among orchard farmers.