Specifically for Omicron! When will this vaccine be available?

A new vaccine targeting the Omicron variant of the novel coronavirus has begun its journey to market. On April 26, Sinopharm's Omicron variant novel coronavirus inactivated vaccine received clinical approval from the National Medical Products Administration.

Why do we need a vaccine specifically for Omicron? When will the new vaccine be available? How will the new vaccine be administered and what will be the vaccination strategy? On April 27, Sinopharm China Biologics held a media communication meeting to answer the above questions one by one.

Why is a specific Omicron vaccine needed?

As early as December last year, shortly after the Omicron variant appeared, the World Health Organization issued a warning: Preliminary evidence shows that the Omicron variant may reduce the effectiveness of the new crown vaccine, and people are at higher risk of repeated infection with this strain.

This suggestion was confirmed as Omicron gradually became the mainstream strain.

Regarding the question of how wide the mutation span of the new coronavirus is before a new vaccine is needed, Zhang Yuntao, chief scientist and vice president of Sinopharm China National Biotec Group, told Science and Technology Daily: When the neutralizing activity of neutralizing antibodies produced by the prototype strain against Omicron is greatly reduced, a new vaccine needs to be developed. Current research results show that the neutralizing activity of neutralizing antibodies against Omicron is indeed greatly reduced.

Therefore, vaccine researchers at home and abroad are looking for effective vaccines against Omicron to improve the protective effect of vaccines. However, so far, foreign countries have not achieved better results in immunogenicity than the original strain when developing a new generation of Omicron vaccines.

"During the immunogenicity research in preclinical animal experiments, we at China Biologic found that the neutralizing antibodies against Omicron were greatly improved, which is different from what we did abroad," said Zhang Yuntao.

When will the new vaccine be available?

"After obtaining the clinical trial approval, we are accelerating the relevant clinical research work." Zhang Yuntao introduced that the new vaccine plans to conduct clinical research in mainland China and Hong Kong in the short term. The clinical research work will be carried out in accordance with the relevant vaccine development and evaluation guidelines. The relevant clinical plan needs to be further discussed with experts and drug regulatory authorities and determined. It is expected to take about 3-4 months to complete.

It is reported that clinical trials in Hong Kong are being prepared in full swing and formal clinical trial vaccination work can begin in the near future.

Can breakthrough infections be prevented?

In the upcoming clinical trials, the research team will pay close attention to whether the vaccine can stimulate the human body to produce specific neutralizing antibodies against Omicron.

"This is the most core issue of vaccine effectiveness, and will be continuously observed in clinical studies." Zhang Yuntao said that further effects still need to be verified in humans to provide clinical data on vaccine effectiveness.

According to reports, during the development of the new vaccine, the research team also paid close attention to cellular immunity, and designed continuous testing of cellular immunity during the design of clinical studies. Cellular immunity will make up for the generally poor durability of neutralizing antibodies against the new coronavirus.

How to administer the new vaccine in the future?

In view of the current vaccination situation of the new coronavirus vaccine in my country, the clinical research plan for the new vaccine will be carried out along two routes.

Zhang Yuntao introduced that the clinical trial of the new vaccine is not designed as the fourth shot of the vaccine. The upcoming Omicron vaccine will be carried out for two groups of people, one of whom is the group that has received two or three shots of the inactivated COVID-19 vaccine, and the subsequent clinical research on the one-shot and two-shot Omicron vaccine will be carried out.

"We have also launched a vaccination study on the blank population." Zhang Yuntao explained that the Omicron vaccine will be directly injected into people who have not been vaccinated with the new coronavirus vaccine to observe its safety and immunogenicity. If this part of the clinical study obtains data, the blank population can be directly vaccinated with the new vaccine.

Source: Science and Technology Daily