Will we have successful COVID-19 candidate vaccine to market within one year？

It has been over six months since the first COVID-19 case was reported in Wuhan. But we are still in the first wave of the pandemic so far, which lead to 9 million infections and 500,000 death worldwide. A safe and effective vaccine is believed to be a strong tool to control the pandemic. However, the challenges and efforts needed to rapidly develop, evaluate, and produce the vaccine at scale are enormous. Researchers worldwide are working around the clock to find the vaccine. Experts estimate that a fast-tracked vaccine development process could potentially bring a successful candidate to market within one year or less.

As of June 25, there are 14 COVID-19 vaccines entered clinical trials, among which, Moderna and the University of Oxford/AstraZeneca are taking the leading position.^[1]

Moderna has finalized the protocol and plan to begin the Phase III clinical trial of its Covid-19 vaccine candidate, mRNA-1273, with 30,000 participants in July. The trial is set to be performed in partnership with the US National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID). The primary endpoint of the Phase III trial is the prevention of symptomatic Covid-19 disease while key secondary endpoints include the prevention of severe Covid-19 and SARS-CoV-2 infection. Based on the Phase I trial data, the 100μg dose was selected as the optimal dose level to maximize the immune response and minimize adverse reactions.

Compared to Moderna, the University of Oxford/AstraZeneca has a more global scope in terms of where they are doing and planning their vaccine trials. The University of Oxford/AstraZeneca last month announced the start of a Phase II/III UK trial of their COVID-19 vaccine, AZD1222, in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries.

According to the WHO Guidelines on clinical evaluation of vaccines, the humoral immune response is assessed through antibody titer measurement after vaccination.^[2] ACROBiosystems has developed several antibody titer measurement ELISA kits to help to evaluate the immunogenicity of the vaccine, and further improve the efficiency of the vaccine research and development. These ELISA products were characterized to have good specificity, high sensitivity, and good reproducibility, which can meet the requirements for vaccine characterization.

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