Shanghai's first mRNA vaccine approved for clinical trial

A Shanghai-developed COVID-19 mRNA (messenger ribonucleic acid) vaccine has been approved by the Center for Drug Evaluation under the National Medical Products Administration, and volunteer recruitment for the phase-I clinical trial has wrapped up.

It is Shanghai's first mRNA vaccine approved for clinical trial.

The phase-I trial for the vaccine produced by Stemirna Therapeutics is double blind, meaning one group will receive the vaccine and another will receive a placebo. Volunteers are divided into adult group (between 18 and 59) and elderly group (people aged 60 and older).

Phase-I clinical trials are carried out among healthy volunteers to evaluate the safety, tolerability and pharmcokinetics of new drugs.

According to Shen Haifa, Stemirna's chief technology officer, its mRNA vaccine can produce COVID-19 antibodies and activate a person's own immunity to defend against infection and prevent serious health problems for those who are infected.

For elderly people, researchers will study their immunogenicity – the ability of a vaccine to provoke an immune response in the human body – and immunity durability, which means how long the antibody exists after receiving the vaccination, after being injected with the vaccine.

One-hundred-twenty people are taking part in the phase-I clinical trial, who will receive two shots with a 21-day interval. The first shots have already been administered.

During the trial process, researchers will study participants' blood tests to assess the vaccine's safety, effectiveness and any adverse reactions.

The vaccine involves a unique mutation of the Omicron and Delta variants of COVID-19, which can offer effective protection against the current dominant variants, according to the company.

It is based on mRNA technology, which is used to deliver genetic material to the body and make human cells create a protein from the virus, training the immune system to attack if it encounters SARS-CoV-2.

As a result, mRNA vaccines are more effective than inactivated vaccines, the company said.

Stemirna officials said the company has completed phase-I and phase-II clinical trials in Laos. None of the participants in the phase-I trial have been infected with COVID-19, and there have been no serious adverse reactions reported.

The company said it has built modern vaccine plants in the Pudong New Area's Zhoupu area as well as Fengxian District, which can produce around 400 million vaccine doses annually.