COVID-19 vaccines: progress and understanding on quality control and evaluation

The outbreak of COVID-19 has posed a huge threat to global health and economy.Countermeasures have revolutionized norms for working,socializing,learning,and travel.Importantly,vaccines have been considered as most effective tools to combat with COVID-19.As of the beginning of 2021,>200 COVID-19 vaccine candidates,covering nearly all existing technologies and platforms,are being research and development(R&D)by multiple manufacturers worldwide.This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines,especially in China,where five vaccine platforms are deployed in parallel.To accelerate the R&D progress of COVID-19 vaccines,the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide.The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D,which greatly supported the progression of vaccines R&D,and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates.In this paper,the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized,which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

Detection of mycobacterial and viral DNA in Kikuchi-Fujimoto disease: an analysis of 153 Chinese pediatric cases

Dear Editor,Kikuchi-Fujimoto disease(KFD),or histiocytic necrotizing lymphadenitis,was initially described in 1972 by Drs.Kikuchi and Fujimoto(Shirakusa et al.,1988).The main clinical manifestations are fever and cervical lymphadenopathy with or without pain,sometimes accompanied by tachycardia,nausea and symptomatic infiltrative erythematous lesions.The diagnosis of KFD is usually based on characteristic lymph node histologic findings of coagulative necrosis,histiocytic infiltrate,loss of nodal architecture,

Diagnosis and Treatment Guidelines for Mesenchymal Stem Cell Therapy for Coronavirus Disease 2019(Beijing,2021)

The coronavirus disease 2019(COVID-19)can be caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection,and has led to millions of deaths among more than 100 million infected people around the world according to the declaration from World Health Organization.Dysregulated immune response of both the innate and adaptive immune systems is subsistent on COVID-19 patients,of which the degree are associated with disease severity,lung damage and long term functional disability.Current treatment options have included antiretroviral drugs,anti-inflammatory factors,antibodies,immune checkpoint inhibitors,and convalescent plasma therapy.More recently,mesenchymal stem cell(MSC)therapy has been explored for the management and control of COVID-19,particularly with the aim of preventing or at least mitigating respiratory co-morbidities.Though the safety and efficacy of stem cell therapy have been validated in multiple phase I–III clinical trials,to date,no standardized stem cell preparation,administration dosage or interval,product QA/QC testing,storage,transportation,or disposal protocols have been established.The present paper proposes a systematic methodology that addresses all the foregoing process steps and evaluation criteria for the efficacious and safe administration of MSCs in the treatment of patients infected with COVID-19.