tetano
Editor, Senior Moderator
Front Immunol
. 2022 Apr 27;13:814365.
doi: 10.3389/fimmu.2022.814365. eCollection 2022.
Considerations for the Feasibility of Neutralizing Antibodies as a Surrogate Endpoint for COVID-19 Vaccines
Jianyang Liu[SUP] 1 2 3 [/SUP], Qunying Mao[SUP] 1 2 3 [/SUP], Xing Wu[SUP] 1 2 3 [/SUP], Qian He[SUP] 1 2 3 [/SUP], Lianlian Bian[SUP] 1 2 3 [/SUP], Yu Bai[SUP] 1 2 3 [/SUP], Zhongfang Wang[SUP] 4 [/SUP], Qian Wang[SUP] 1 2 3 [/SUP], Jialu Zhang[SUP] 1 2 3 [/SUP], Zhenglun Liang[SUP] 1 2 3 [/SUP], Miao Xu[SUP] 1 2 3 [/SUP]
Affiliations
Abstract
To effectively control and prevent the pandemic of coronavirus disease 2019 (COVID-19), suitable vaccines have been researched and developed rapidly. Currently, 31 COVID-19 vaccines have been approved for emergency use or authorized for conditional marketing, with more than 9.3 billion doses of vaccines being administered globally. However, the continuous emergence of variants with high transmissibility and an ability to escape the immune responses elicited by vaccines poses severe challenges to the effectiveness of approved vaccines. Hundreds of new COVID-19 vaccines based on different technology platforms are in need of a quick evaluation for their efficiencies. Selection and enrollment of a suitable sample of population for conducting these clinical trials is often challenging because the pandemic so widespread and also due to large scale vaccination. To overcome these hurdles, methods of evaluation of vaccine efficiency based on establishment of surrogate endpoints could expedite the further research and development of vaccines. In this review, we have summarized the studies on neutralizing antibody responses and effectiveness of the various COVID-19 vaccines. Using this data we have analyzed the feasibility of establishing surrogate endpoints for evaluating the efficacy of vaccines based on neutralizing antibody titers. The considerations discussed here open up new avenues for devising novel approaches and strategies for the research and develop as well as application of COVID-19 vaccines.
Keywords: COVID-19 Vaccines; national standard; neutralizing antibody; standard neutralization test assay; surrogate endpoints.
. 2022 Apr 27;13:814365.
doi: 10.3389/fimmu.2022.814365. eCollection 2022.
Considerations for the Feasibility of Neutralizing Antibodies as a Surrogate Endpoint for COVID-19 Vaccines
Jianyang Liu[SUP] 1 2 3 [/SUP], Qunying Mao[SUP] 1 2 3 [/SUP], Xing Wu[SUP] 1 2 3 [/SUP], Qian He[SUP] 1 2 3 [/SUP], Lianlian Bian[SUP] 1 2 3 [/SUP], Yu Bai[SUP] 1 2 3 [/SUP], Zhongfang Wang[SUP] 4 [/SUP], Qian Wang[SUP] 1 2 3 [/SUP], Jialu Zhang[SUP] 1 2 3 [/SUP], Zhenglun Liang[SUP] 1 2 3 [/SUP], Miao Xu[SUP] 1 2 3 [/SUP]
Affiliations
- PMID: 35572565
- PMCID: PMC9092276
- DOI: 10.3389/fimmu.2022.814365
Abstract
To effectively control and prevent the pandemic of coronavirus disease 2019 (COVID-19), suitable vaccines have been researched and developed rapidly. Currently, 31 COVID-19 vaccines have been approved for emergency use or authorized for conditional marketing, with more than 9.3 billion doses of vaccines being administered globally. However, the continuous emergence of variants with high transmissibility and an ability to escape the immune responses elicited by vaccines poses severe challenges to the effectiveness of approved vaccines. Hundreds of new COVID-19 vaccines based on different technology platforms are in need of a quick evaluation for their efficiencies. Selection and enrollment of a suitable sample of population for conducting these clinical trials is often challenging because the pandemic so widespread and also due to large scale vaccination. To overcome these hurdles, methods of evaluation of vaccine efficiency based on establishment of surrogate endpoints could expedite the further research and development of vaccines. In this review, we have summarized the studies on neutralizing antibody responses and effectiveness of the various COVID-19 vaccines. Using this data we have analyzed the feasibility of establishing surrogate endpoints for evaluating the efficacy of vaccines based on neutralizing antibody titers. The considerations discussed here open up new avenues for devising novel approaches and strategies for the research and develop as well as application of COVID-19 vaccines.
Keywords: COVID-19 Vaccines; national standard; neutralizing antibody; standard neutralization test assay; surrogate endpoints.