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BEIJING, June 24, 2020 /PRNewswire=KYODO JBN/ --

A news report by Qu Jian from Science and Technology Daily:

The Phase I/II clinical trials of the world's first inactivated COVID-19

vaccine, developed by Wuhan Institute of Biological Products under the China

National Biotec Group (CNBG) affiliated to the China National Pharmaceutical

Group (Sinopharm), produced antibodies in every participant, it was announced

on Tuesday.

According to a meeting held simultaneously in Beijing and Henan province on

Tuesday, the clinical trial results showed that the vaccination was safe

without any serious adverse reaction, and after different procedures and

different doses of vaccination were adopted, participants in the vaccine group

all produced high titers of antibodies.

People who received two doses of the vaccine at an interval of 28 days, saw

their neutralizing antibody positive conversion rate reach 100%.

According to CNBG, the Phase I/II clinical trials were randomized,

double-blind, placebo-controlled clinical studies. On April 12, the vaccine

obtained the world's first clinical trial approval, and Phase I/II clinical

trials were then launched in Wuzhi county of Henan province.

Under the leadership and guidance of the Henan Center for Disease Control and

Prevention, the clinical trials were conducted for 66 consecutive days and

obtained data on the safety and efficacy of the COVID-19 inactivated vaccine

after the administration of the two injections. The data presented research

results on different ages, different procedures, different doses, and different

injection times in a relatively comprehensive manner. This is also the clinical

COVID-19 vaccine research that has the longest time span, produces the most

comprehensive data and obtains the best research results, thus providing

scientific and evaluable data for epidemic prevention and control as well as

emergency use.

CNBG said the study was designed to evaluate the safety and immunogenicity of

the COVID-19 inactivated vaccine in healthy subjects aged from 18 to 59 for

low, medium and high dosages and injections at intervals of 14, 21 and 28 days.

The study focused on the changes in cellular immunity after vaccination and

explored vaccination procedures, immunization dosage, safety, immunogenicity

and changes in antibody levels in vivo. Up to now, all the 1,120 subjects that

took part in the Phase I/II clinical studies have completed two injections.

For those aged 18 - 59 who received two medium-dose injections through the

14-day and 21-day interval procedures, they had a neutralizing antibody

positive conversion rate of 97.6%.

For those who received two medium-dose injections at an interval of 28 days,

the neutralizing antibody positive conversion rate reached 100%.

In response to recent new cases in Beijing and the discovery of a new genotype

of the virus through whole-genome sequencing, some experts worry that for the

new genotype, "the vaccine may weaken or even not work."

However, Yang Xiaoming, chief scientist of the national "863 Program" vaccine

project and chairman of CNBG, told Science and Technology Daily he had noticed

the new genotype, but it is "still within the coverage of the vaccine whose

Phase I/II unblinding occurred today", so it will not affect the effectiveness

of the current inactivated vaccine.

CNBG also said that it is now actively developing overseas cooperation in the

Phase III clinical research and has confirmed cooperative intentions with

companies and institutions in various countries. It has completed building a

high biosafety grade production workshop, which is currently the only COVID-19

vaccine production workshop in the world meeting the requirements of biosafety

and GMP standards and capable of meeting the needs of widespread emergency

vaccination.

SOURCE  Science and Technology Daily