Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept

Dear Editor,Vaccination is an effective strategy for controlling the COVID-19 pandemic and reducing the number of cases of hospitalization and deaths.1 Neutralizing antibody(Ntab)is one of the key indicators for evaluating the effectiveness of COVID-19 vaccines.2 Over 40 COVID-19 vaccines have been approved for emergency use,marketing,or marketing with conditions,and the available Ntab data from clinical trials have been published.

Non-small cell lung cancers(NSCLCs)oncolysis using coxsackievirus B5 and synergistic DNA-damage response inhibitors

With the continuous in-depth study of the interaction mechanism between viruses and hosts,the virus has become a promising tool in cancer treatment.In fact,many oncolytic viruses with selectivity and effectiveness have been used in cancer therapy.Human enterovirus is one of the most convenient sources to generate oncolytic viruses,however,the high seroprevalence of some enteroviruses limits its application which urges to exploit more oncolytic enteroviruses.

Immunogenicity and protective efficacy of a recombinant protein subunit vaccine and an inactivated vaccine against SARS-CoV-2 variants in non-human primates

Emerging SARS-CoV-2 variants and the gradually decreasing neutralizing antibodies over time post vaccination have led to an increase in incidents of breakthrough infection across the world.To investigate the potential protective effect of the recombinant protein subunit COVID-19 vaccine targeting receptor-binding domain(RBD)(PS-RBD)and whole inactivated virus particle vaccine(IV)against the variant strains,in this study,rhesus macaques were immunized with PS-RBD or IV vaccine,followed by a Beta variant(B.1.351)challenge.Although neutralizing activity against the Beta variant was reduced compared with that against the prototype,the decreased viral load in both upper and lower respiratory tracts,milder pathological changes,and downregulated inflammatory cytokine levels in lung tissues after challenge demonstrated that PS-RBD and IV still provided effective protection against the Beta variant in the macaque model.Furthermore,PS-RBD-induced macaque sera possessed general binding and neutralizing activity to Alpha,Beta,Delta,and Omicron variants in our study,though the neutralizing antibody(NAb)titers declined by varying degrees,demonstrating potential protection of PS-RBD against current circulating variants of concern(VOCs).Interestingly,although the IV vaccine-induced extremely low neutralizing antibody titers against the Beta variant,it still showed reduction for viral load and significantly alleviated pathological change.Other correlates of vaccine-induced protection(CoP)like antibody-dependent cellular cytotoxicity(ADCC)and immune memory were both confirmed to be existing in IV vaccinated group and possibly be involved in the protective mechanism.

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.

Construction and verification of an infectious cDNA clone of coxsackievirus B5

Dear Editor,Enteroviruses belonging to the family Picornaviridae are nonenveloped RNA viruses that cause hand-foot-mouth disease(HFMD),which can lead to severe neurological complications.Enteroviruses genomes represent a single open reading frame flanked by 5’-and 3’-untranslated terminal regions(UTRs).