Registrato anche il primo vaccino cinese anti Covid. Ma anche qui manca la “fase 3”

Fedaisf editorial staff

August 17, 2020

COVID-19. China has patented its first coronavirus vaccine

Future Internet editorial staff Monday 17 August 2020

China has given its first approval to a possible vaccine against Covid-19: è l’Ad5-nCoV, sviluppato da CanSino Biologics, in collaborazione con l’Istituto di biotecnologia dell’Accademia delle scienze mediche militari. L’azienda farmaceutica cinese secondo i media statali cinesi a marzo era stata la prima a portare un vaccino alla fase di sperimentazione.

As last week's news about the vaccine developed and registered in Russia, even today's one should be taken with great caution. According to official data from the World Health Organization, neither the vaccine registered in Russia nor the one patented by CanSino is among the six that are currently in "phase 3" of experimentation, i.e. the most advanced and reliable for evaluating its efficacy, but even the most delicate.

According to Chinese state media, the "phase 3" trial of the patented vaccine is expected to begin this month in Saudi Arabia, while CanSino said it was in talks with other countries - Russia, Brazil and Chile - to start further trials.
Meanwhile CanSino Biologics shares, following the latest developments, posted solid gains on the Hong Kong (+13.90%) and Shanghai (+4.33%) stock exchanges.

RESEARCH INFO

The research involved 320 "healthy volunteers" between the ages of 18 and 59, 96 of whom participated in Phase 1 and 224 in Phase 2. According to Xinhua, the results indicate that the vaccine actually induced neutralizing antibodies in the volunteers and demonstrated a "good ability to procure an immune response".

WHERE THE STUDIES WERE CONDUCTED

The studies were conducted by the Wuhan Institute of Biological Products and the Wuhan Institute of Virology under the auspices of the Sinopharm-affiliated National Biotechnology Group of China (CNBG) and the China Academy of Sciences, he wrote. Nova Agency.

AIFA

Phase 2 is useful in demonstrating the non-toxicity and activity of the new one active principle experimental.
However, there are still other questions that need to be answered: how effective is the drug? Does it have any additional benefits compared to similar drugs already on the market? And what is the relationship between risk and benefit?

Phase 3

All these questions are answered with the study of stage 3 (or therapeutic-confirmatory). In this case, the "enlisted" patients are no longer a few dozen, but hundreds or thousands. The drug's efficacy on symptoms, quality of life, or survival is compared to a placebo (substance without therapeutic efficacy), with other drugs already in use, or with no treatment.

Phase 3

The type of study of reference in this phase is lo Clinical study randomized controlled.
This is a type of study in which patients are randomly assigned the new one active principle a controller drug (typically the standard treatment for the specific disease being researched).
The clinical study randomized controlled trial is very reliable in defining the efficacy of a drug. In fact, the random assignment of the new drug or the control drug ensures that the two groups are similar in all characteristics except for the drug taken. Therefore, at the end of the trial, it will be possible to attribute any difference in the health of the participants exclusively to the treatment and not to errors or chance.
Durante questa fase vengono controllate con molta attenzione l’insorgenza, la frequenza e gravità degli side effects. The duration of the administration of the drug varies according to the objectives that the experimentation sets itself, but generally it lasts for months. The period of monitoring the effects of the drug is instead often longer, reaching 3-5 years in some cases.