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The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

According to the Central Broadcasting Network, "On April 26, the inactivated new coronavirus vaccine developed by Sinopharm Group China Biologics and Sinovac Kexing based on the Omicron variant obtained clinical approval from the State Drug Administration on the same day. ”

The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

(Source: "China Biology" public number)

This is the first batch of NEW CROWN vaccines against the Aumecreon variant in China.

Omi kerong has become the main strain of the new crown virus in China and around the world[1].

The spread capacity of Omikeron has surpassed all the original and mutated strains of the new coronavirus, and at the same time, Omilon is constantly emerging new sub-variants: BA.1, BA.2, BA.2.12.1, XE, etc. At present, the epidemic situation in Shanghai and other places in China is caused by Omicron BA.2.

A model-calculated study in the United States showed that Omikejong BA.2 was 4.2 times more contagious than the Delta strain and 1.5 times more contagious than BA.1.[2]

Vaccination with previous vaccines (i.e., prototype vaccines) is still effective in preventing severe illness and death caused by Omi kerong. According to data from Hong Kong, China, the mortality rate of unvaccinated patients over the age of 80 reached 16.42%, and the mortality rate of patients receiving 3 doses of vaccine (full of 14 days) was only 1.08%[3], a decrease of 93.42%.

However, compared to prototype strains, these vaccines are less effective at preventing "infection" with the Omikejong variant.

According to model calculations, the immune escape ability of the Ami kerong BA.2 against the vaccine is 30% higher than that of BA.1 and 17 times higher than that of the Delta strain.[2]

Some studies have also found that serum from previously infected or vaccinated individuals is less effective at neutralizing Omiquerong than other variants [4,5,6].

The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

(Source: Health Protection Centre, Department of Health, Hong Kong)

Of the 1.18 million infected people in Hong Kong, 970,000 (about 81%) had been vaccinated with at least one dose, and nearly 190,000 (16%) had completed 3 doses.

This suggests that while prototype vaccines are good at preventing severe illness and death, the ability to prevent "infection" needs to be improved [3].

Therefore, researchers also call for the rapid development of new vaccines.

Last November, Omi kerong began to spread around the world.

In December, China Biologics and Kexing introduced the Aomi Kerong mutant strain from the University of Hong Kong, launched the research and development of the Aomi Kerong inactivated vaccine, and began to submit domestic clinical declaration materials to the Drug Evaluation Center of the State Food and Drug Administration in January this year to start the technical review.

On April 26, the two companies' respective inactivated vaccines for the New Coronavirus variant of the Omicron strain were approved by the State Food and Drug Administration of China on the same day.

Both companies have opted for the technical route of inactivated vaccines for reasons that may include:

Both companies already have marketed inactivated COVID-19 vaccine products and have rich experience and technology.

Compared with other technical routes, the development and production strategy of inactivated vaccines is a relatively conventional and mature technology, which can provide more comprehensive protection and higher safety than other types of vaccines [7].

The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

However, it should be noted that the two vaccines are not currently on the market informally, but have been approved for clinical trials.

According to the Central Broadcasting Network, "Sinopharm China Biologics will conduct sequential immunological clinical studies in people aged 18 years and above who have completed 2 or 3 doses of COVID-19 vaccination in the form of randomized, double-blind, cohort studies to evaluate the safety and immunogenicity of the New Coronavirus inactivated vaccine of the Aumecreon variant."

SINOVAC Also said that it will actively promote the study of various studies of the new coronavirus variant strain in different populations of the prototype vaccine, as well as the new crown vaccine prepared by the variant strain. ”

This means that the two vaccines will not be listed for use in a short period of time, and Tencent Medical Codex will continue to pay attention to the follow-up news of these two vaccines and synchronize them with everyone in a timely manner.

The inactivated vaccine against Ami kerong may make some people wonder: is this vaccine only effective for Aomi kerong? What if there are new mutant strains in the future?

Theoretically, the rate at which vaccines are "replaced" does often lag behind the rate at which viruses mutate. However, the Aumecreon strain still falls under the category of the new crown virus, so even if there is "immune escape", the vaccine against the Omiljung is still likely to be protective against other strains that already exist or may appear later (especially in preventing severe illness and death). But this will all require clinical studies and long-term observational data to verify.

At present, it is not excluded that a new COVID-19 vaccine needs to be developed from time to time and continuously, depending on the mutation and epidemic situation of the virus.

In fact, the well-known flu vaccine is a very similar situation: the influenza virus is a pathogen of influenza (influenza) and has caused worldwide pandemics many times [8].

The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

Influenza viruses have a high mutation rate, which affects the ability of the human immune system to resist the mutated strains. As a result, the World Health Organization (WHO) annually predicts and recommends influenza antigens contained in vaccines in the current season based on global surveillance of influenza viruses circulating at the end of the previous influenza season [9].

Vaccine manufacturers will develop and produce new vaccines for the current season influenza virus in accordance with WHO recommendations. It generally takes at least 6 months to select the strain to the final marketing inoculation.

Therefore, in the future, we may and will need to strengthen the COVID-19 vaccine every year or every few years.

Almost all current studies show that no matter what kind of vaccine, it is better to be vaccinated than not to be vaccinated, and it is better to receive a booster vaccine than to not be vaccinated.

Wu Zunyou, chief epidemiologist at the Chinese Center for Disease Control and Prevention, suggests: "It's not that 90% is enough, everyone needs to be vaccinated, and everyone needs to be given a booster injection." ”

The Omiljung vaccine has been approved for clinical trials, does it need to be re-vaccinated? A fourth shot may be required

In addition, it is still uncertain when the Ami kerong vaccine will complete clinical trials and be widely rolled out. However, the newly approved study of the AUMECREON vaccine includes booster vaccination for those who have completed 2 or 3 doses of the vaccine, which means that even if the booster needle (the third dose) is given, there may be a chance of a fourth dose later.

Therefore, if you have met the conditions for vaccination of the booster needle but have not yet been vaccinated, it is recommended to make an appointment for the vaccination of the booster needle in time.

If you wish to receive the Semikeron vaccine, you can continue to follow the information or ask your local CDC if there is an Option for the Semikron vaccine.

Reviewer: Wang Xi

Deputy Chief Physician of Public Health, Shanghai Minhang District Center for Disease Control and Prevention

bibliography

[1] General Office of the National Health Commission, Office of the State Administration of Traditional Chinese Medicine. 2022. Diagnosis and treatment plan for novel coronavirus pneumonia (trial version 9).

[2] Chen J, Wei G W. Omicron BA. 2 (B. 1.1. 529.2): high potential to becoming the next dominating variant[J]. Research Square, 2022.

Preliminary data analysis of COVID-19 death reports[EB/OL]. Centre for Health Protection, Department of Health. 2022/2022 -04 -27. https://www.covidvaccine.gov.hk/pdf/death_analysis.pdf.

[4] R ssler A, Riepler L, Bante D, et al. SARS-CoV-2 Omicron Variant Neutralization in Serum from Vaccinated and Convalescent Persons[J]. New England Journal of Medicine, 2022.

[5] VanBlargan L A, Errico J M, Halfmann P J, et al. An infectious SARS-CoV-2 B. 1.1. 529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies[J]. Nature medicine, 2022: 1-6.

[6] Dejnirattisai W, Shaw R H, Supasa P, et al. Reduced neutralisation of SARS-CoV-2 omicron B. 1.1. 529 variant by post-immunisation serum[J]. The Lancet, 2022, 399(10321): 234-236.

Deng Kaili, Shu Lei, Wei Jing, et al. Research progress of novel coronavirus vaccine[J]. International Respiratory Journal, 2021, 41(8):6.

Li Fan, Xu Zhikai. Medical Microbiology (8th Edition)[M]. People's Medical Publishing House, 2013.

[9] Patricia L Hibberd. Seasonal influenza vaccination in adults[EB/OL]. Uptodate. 2022/2022 -04 -27. https://www.uptodate.com/contents/zh-Hans/seasonal-influenza-vaccination-in-adults.

Author: Chen Zexiong

Editors: Ye Yichu, Wu Jiaxiang, Ye Zhengxing

Typesetting: Han Ningning | Proofreader: Wu Yihe

Operations: Li Yongmin | Coordinator: Ye Yichu

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