Respiratory Immune Barrier · Nasal Spray Administration · Needle-free Inoculation
The intranasal COVID-19 vaccine, jointly developed by Wantai Biopharm, Xiamen University and the University of Hong Kong, is administered by nasal spray. It simulates the natural infection route of the virus and aims to trigger an immune response in the respiratory tract, which helps to build an immune barrier at the "front line" of viral infection. Currently, this vaccine has obtained the emergency use authorization.
Main Features
The main features observed in the clinical trials of the intranasal COVID-19 vaccine
Protection against Severe Illness
The data from Phase III clinical trials show that it has a good protective effect against hospitalization and more severe diseases.
Broad-spectrum Resistance to Variants
Designed based on the prototype strain, it has shown a protective effect against the major variants including Omicron in the clinical trials.
Intranasal Inoculation
Administered by nasal spray, it avoids the discomfort related to injection and may increase the willingness to be vaccinated, especially suitable for those who are afraid of injections.
Suitable for Multiple Populations
The clinical trials cover the elderly and people with chronic underlying diseases. The safety and effectiveness data support its application in diverse populations.
Innovative Mucosal Immunity Technology
The intranasal Influenza Virus Vector COVID-19 vaccine is jointly developed by Wantai Biopharm, Xiamen University and the University of Hong Kong, and it is one of the five technical routes for the emergency research and development of COVID-19 vaccines in China. This vaccine is developed by using a double-attenuated Influenza A virus, which has been specially modified to improve its safety and effectiveness, as a vector and inserting the gene fragment of the spike protein RBD of the novel coronavirus.
This nasal spray vaccine uniquely mimics natural viral infection pathways to establish primary respiratory immunity against SARS-CoV-2. Utilizing an influenza virus vector that specifically targets respiratory tract cells susceptible to coronavirus infection, the formulation enables direct mucosal immunization for enhanced respiratory protection.
- Using the influenza virus vector technology, the safety has been carefully evaluated.
- Designed to induce multiple immune responses: mucosal immunity and systemic immunity.
- Through nasal spray, establish immune protection in the respiratory tract.
- Designed against multiple variants and has shown broad-spectrum protection potential in clinical trials.
Working Principle
How the intranasal COVID-19 vaccine forms immune protection in the respiratory tract
Nasal Administration
Administered by nasal spray, the vaccine directly reaches the respiratory mucosa.
Simulation of Mucosal Infection
The influenza virus vector simulates the natural infection route of the novel coronavirus.
Activation of the Immune System
Induce specific immune responses in the local and systemic immune systems.
Formation of the Immune Barrier
Form a frontline immune barrier against the virus in the respiratory tract.
Exertion of the Protective Effect
Induce a comprehensive immune protection mechanism against the novel coronavirus.
The intranasal COVID-19 vaccine employs an influenza virus vector delivered via nasal spray to interact with respiratory mucosal cells, stimulating dual immune protection by simultaneously activating mucosal immunity (producing local secretory IgA antibodies) and systemic immunity (generating circulating IgG antibodies and T-cell responses). Clinical research indicates this approach may effectively prevent infection, reduce symptom severity, decrease progression to severe illness, and provide cross-protection against multiple variants.
Clinical Research Data
Clinical trials involved 31,038 subjects coming from four countries around the world.
| Protection Indicator | Clinical Trial Protection Efficacy Data | Applicable Population and Instructions |
|---|---|---|
| Prevention of Hospitalization and More Severe Diseases | The observed protective efficacy in the clinical trial is 100%. | Data of the overall population in the Phase III clinical trial. |
| Efficacy of the Initial Immunization | The protective efficacy against cases with more obvious symptoms is 67%. | Subjects who have never received other COVID-19 vaccines. |
| Efficacy of the Sequential Booster Immunization | Compared with the placebo booster group, the protective efficacy is 63%. | Given as a booster vaccination on the basis of the inactivated vaccine. |
| Absolute Protection Rate of the Sequential Booster Immunization | 81% of the subjects are protected. | Given as a booster vaccination on the basis of the inactivated vaccine. |
| Symptomatic Infection | The protective efficacy is 55%. | Against any clinically symptomatic infection. |
| The Elderly and People with Chronic Diseases | The protective efficacy is comparable to that observed in healthy adult populations. | Including 4,557 elderly people over 60 years old and 4,441 patients with chronic diseases. |
Research and Development Process
Important milestones from scientific research to emergency use authorization.
February 2020
Xiamen University decided to organize its superior forces to carry out scientific research and development of the COVID-19 vaccine.
February 2020
The Ministry of Science and Technology approved an emergency project. The intranasal vaccine became one of the five technical routes for the emergency research and development of COVID-19 vaccines in China.
September-November 2020
Initiated Phase I and Phase II clinical trials in China.
July 2021
Initiated the clinical expansion test.
October 2022
Completed the unblinding of the Phase III clinical trial, confirming its effectiveness against the Omicron variant.
November 12, 2022
Passed the demonstration by the Vaccine Research and Development Special Class of the Scientific Research and Tackling Key Problems Group of the Joint Prevention and Control Mechanism of the State Council.
November 21, 2022
Large-scale emergency inoculation began in Changping District, Beijing, mainly targeting the high-risk workforce such as medical staff, public security police officers and community workers.
November 25, 2022
Passed the expert demonstration on emergency use organized by the Center for Drug Evaluation of the National Medical Products Administration.
December 2, 2022
Obtained the emergency use approval.
For more information : wtexport@ystwt.com
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