Will the spray vaccine change the new crowns?

Theoretically, spray or inhaled vaccine prevention infection effect

Better than muscle injection vaccine

But it depends on the confirmation of more large sample clinical test data

Combine the mucosal vaccine with other existing vaccines

Maximize the effect of epidemic prevention as much as possible

"This type of new crown vaccine can directly activate the human body's first line of defense -the mucosal immunity on the surface of the respiratory tract can help reduce personal infection and population transmission. Combined with the injection vaccine can produce more comprehensive immune protection." Local localities. On September 7th, at the press conference in Geneva, Switzerland, Michael Ryan, the head of the Health Emergency Project of WHO, said in a question. The vaccine mentioned by Ryan is the mucosal vaccine that is administered through the nose or mouth. At present, dozens of research teams and companies around the world are developing.

Before the meeting, two mucosal vaccines in China and India were approved. Among them, the inhaled adenovirus carrier vaccine developed by China Kangxino Bio -Kwwsa Wogi was an emergency use by the State Drug Administration as an enhanced needle on September 4. Two days later, the liquid dripping vaccine produced by the Parat company in India has obtained emergency use approval locally and is mainly used for those who have not been vaccinated. Both companies have not announced the clinical trial data of Phase III.

The successive approval of these two mucosal vaccines has aroused widespread attention in the industry. On September 6, "Nature" magazine published an article entitled "How to Change the Big Pop" entitled "Spray Vaccine".

"Spray or suction vaccine is not much different from the effect. They are all mucosal vaccines. They are administered through the upper respiratory tract to stimulate the body to produce mucosal immunity." Jin Dongyan, a professor at the School of Biomedicine and virus expert of the University of Hong Kong It is said that the two mucosal vaccines have been approved one after another, which means that the new crown vaccine has taken an important step, but the widespread use of such vaccines remains time.

More suitable as a enhanced needle

According to statistics from the University of Oxford, as of September 17, the world's vaccination has been vaccinated with more than 12.6 billion doses. Although the vaccination rate is constantly increasing, the cumulative number of infections continues to rise, and the cumulative number of infections around the world has exceeded 600 million.

Jin Dongyan analyzes that most of the new crown vaccines currently in use are muscle injection. Such new crown vaccines have significant effects on preventing severe illnesses and death, but they have limited effects in preventing infection. Generally, muscle injection vaccines enter the human body after entering the human body. The T cells produced can kill the infected cells, and B cells produce neutralized antibodies. These cells and antibodies are circulating in the blood, and they often have symptoms when they touch the nose and respiratory tract.

"The enemy has evolved, and the world needs the next -generation vaccine to deal with it." On May 16th, Ishizaki Iwasaki, a professor of immunology at Yale University, wrote in the "New York Times" column. Ideally, the vaccine can enter the nose in the nose. The mucus layer stimulates the body to produce antibodies, which gives it a blow before the virus causes symptoms. She said, "This is similar to setting up guards outside the house to patrol the invaders, rather than put the guards in the corridor of the building, hoping that they can catch the invaders."

Generally, the mucosa includes the moist surface of the nasal cavity, oral cavity, reproductive tract, or gastrointestinal tract. This is where most diseases enter the human body and are also called the first line of defense of the human body. In Jin Dongyan's view, muscle injection vaccines can induce systemic immune response, but it cannot stimulate mucous membrane immunity, and the effect of preventing infection is weak. The local immunity induced by mucosal vaccine is similar to natural infections. Theoretically, the effect of anti -infection is better than muscle injection vaccine, but the induced systemic immune effect is more suitable for enhanced needle.

Some mucosal vaccines, like injection vaccines, are only changed to nasal droplets, and some mucosal vaccines are different in component or preparation processes. The preparation components used in Kwaisa Wushayou are the same as the injection type vaccine, but the vaccine atomizes the vaccine into tiny particles with atomizer and completes the vaccination by oral inhalation. 0.1 ml.

The main way to measure muscle injection vaccine is to measure the neutral antibody level in the blood. The higher the level, the stronger the immune protection. The mucosal vaccine lacks clear reference.

Indian Ballat Biopharmaceutical Comparison compared the serum neutral and antibody levels measured by the nasal mucosal vaccine test with the neutral antibody level caused by muscle injection vaccine, but it is difficult to compare the real anti -infection effect of the mucosal vaccine. Constalo's comparative way is similar to it. In July, a research on the medical pre -printed platform MEDRXIV was evaluated and evaluated the immune effect and safety of the Kangshino inhaled vaccine. In the study, 419 adults who vaccinated two doses of the vaccine were included in the low -dose atomization group, high -dose atomization group, and activation group. vaccine. The results showed that the antibody level generated by inhalation reinforcement was higher than the antibody level caused by muscle injection vaccine.

On November 12, 2021, Haikou City, Hainan, Kangshino Biological Co., Ltd., with the inhaled adenovirus carrier, appeared at the 5th Hainan International Health Industry Expo. Visitors use pure water to experience fustorizing inhalation vaccine. Photography/Reporter Luo Yunfei

"The company carried out the inhalation of tens of thousands of people in the new crown vaccine sequence of immunization clinical trials." On September 6, Kangshino Bio revealed on the interactive platform that a large amount of safety and immunogenic data accumulated showed that headaches, fatigue and fever, etc. The total number of adverse reactions in the inhalation vaccine has decreased sharply, especially in the elderly to decrease larger; 28 days after the use of the inhalation vaccine sequence is enhanced, the cross neutral and antibody titration of the Omikon virus virus is the titer. It is 22.8 times the reinforcement of homologous vaccines. In July of this year, Conchino said that the inhaled vaccine developed by the company can effectively respond to the mutant strain of the new crown Omikon BA.1. However, the company has not yet studied the neutralization of Omikon BA.4 and BA.5 mutant strains.

Sun Jiayi, a post -doctoral school at Cornell University, told China News Weekly that in theory, inhaled vaccines can improve neutralized antibody titers and local induced antiviral immunity, and the first stage of the virus into the human body is neutralized. However, most of these effects are still reflected in animal models, and there are no more samples of evidence disclosure, which proves that nasal spray vaccines are significantly better than ordinary vaccines in the human body.

On September 14, a research published by researchers at the Carolinska College of Sweden gave the latest data on "whether mucosal immunity to prevent infection" in "New England Medical Magazine". In the study, a total of 338 medical staff who vaccinated 3 doses of vaccine joined the group and participated in the follow -up, of which 57 subjects were infected with the new coronal virus during the follow -up. The results showed that 99 % of the subjects had high -level serum antibodies in their bodies, and 62 % of the subjects had mucosal immunoglobulin A antibody in their bodies. High -level immunoglobulin A antibody can reduce the risk of Omikon in infection by more than half. "These findings show that the mucosal antibody in the respiratory tract helps prevent infection from infection. To confirm whether the mucosa vaccine has more protective effects than the muscle injection vaccine, it still needs further research." Researchers wrote in the paper. It is worth noting that the study did not disclose specific information about the type of vaccine type vaccine in vaccination.

How long is the immune response last is still unknown

"Although this type of new crown vaccine has the advantages of convenient administration and triggering mucosal immunity, related research has also invested a lot, but the application is not ideal, and there are few successful cases." German Chinese virusologist and Essen University School of Medicine. The professor Lu Mengji told "China News Weekly" that if the mucosal vaccine wants to achieve breakthroughs, the effectiveness of the vaccine must be verified in clinical practice. Clinical trial difficulty.

For decades, the mucosal vaccine of other viruses has been developed. At present, at least nine mucosal vaccines have been approved for the human body. The pathogens that work include spinal ash virus, influenza, and cholera. Eight of them are oral vaccines, one for the influenza nasal spray vaccine.

"Oral spinal ashgainitis vaccine contains poisonous poisonous gryomitis virus. It is a typical example of the gastrointestinal gastrointestinal tract and caused an immune response in the host body. This type of drug reduction vaccine will mutate and cause disease in individual immune defects in a few cases. Disar -reduction vaccines are not the same as mucosal vaccine, but many poisoning live vaccines are vaccinated by oral or nasal injection, which also belongs to mucosal vaccine.

Jiang Qingwu, an expert in epidemiological diseases and a professor at the School of Public Health University of Fudan University, told China News Weekly that taking inhalation vaccines as an example, atomized granular vaccines enter the human body, which is not easy to produce an effective immune response. Effect of size and nature.

Muscle injection is easier to provide accurate dose drugs, and nasal injection vaccines are difficult to achieve. Because after the vaccine particles enter the human body, they must first pass through the natural immune barrier of the nostrils and the dense mucus layer of the respiratory tract, which will also be affected by sneezing. Iwasaki Iwasaki mentioned in the "New York Times" column article that the mucus layer is a difficult barrier. It simply sprays conventional vaccines on the nose, which is difficult to cause a strong immune response. At present, FLUMIST approved the influenza nasal vaccine, enters the nasal cells by weakening the toxicity of the vaccine to stimulate the immune response.

The staff of the Kangxino Bio told "China News Weekly" that the atomizer that inhaled the vaccine was a mechanical automation equipment, which was relatively simple to make the dose accurately to 0.1 ml. Monthly efficient immunity. "The entire process of atomization is mechanized automated, such as the size of the atomized particles, inhalation dosage, etc. The size of the atomization particles has strict production standards to ensure effective activation of mucous membrane immunity." The staff member said that the vaccine is now now Just approved and not started to use it yet. So where the atomization equipment will be used is uncertain. In the future, if nasal spray or inhalation vaccines are vaccinated by themselves, it also involves how to ensure the effectiveness of vaccination and how to upload and supervise the vaccination information.

Even with these obstacles, from the past experience, nasal spray vaccines are not favored by the market. Taking Flumist as an example, it is the only influenza nose vaccine in the world. Since its debut in 2003, the sales volume is not ideal. Nasal spray flu vaccine is approved for healthy non -pregnant women aged 2 to 49, and people with certain diseases are not recommended to vaccinate. The elderly over 50 years old occupy the largest share in the influenza vaccine market. "At present, most of the influenza vaccines on the United States are still inactivated vaccines, because nasal injection vaccines are risky to specific groups, and the effects have no obvious advantages." Sun Jiayi said. "Nasal spray influenza vaccine will be higher in side effects among the elderly." Jin Dongyan said that based on risk -based considerations such as risk, the new nasal spray vaccine in the future may also be limited in applicable people and age. For example, immune defects Or use the low -immune people to use it with caution.

The antibodies produced in the nose are usually short -lived. “相对针头注射，很多人对鼻喷雾剂接受度可能更高。但现在鼻腔疫苗面临的问题是免疫力能在人体持续多久。”在岩崎明子看来，目前为止，在动物实验中，抗体和Memory immune cells can only last for several months in the nasal cavity. If this kind of immunity has weakened over time, such vaccines are used as non -prescribed categories, and every 4 to 6 months is used to deal with the most meaningful popularity of the new crown.

Chen Xi, an associate professor at the Global Health Policy and Economics of Yale University in the United States, told China News Weekly that as far as mucosal vaccines are concerned, although many companies are developing, if such vaccines are effective, it cannot exceed the existing MRNA vaccine, which is unlikely A substantial changes will be made to the existing vaccine pattern.

The mucosal vaccine is combined with other existing vaccines to maximize the effect of immunity and prevention as much as possible. Photo/Visual China

It should be jointly used with injection vaccine

In addition to mucosal vaccines, the unit price and two -price vaccine for Omikon have been listed one after another. "Some vaccines involving BA.5 mutations have been approved before clinical trials. Some people have used these vaccines as the fourth pins to strengthen immunity." Jin Dongyan said.

On August 15, the British government approved the new -generation vaccine developed by Modner as a reinforcement agent for large -scale vaccination. In a statement on the same day, the British Drugs and Health Products Administration said that in each dose of the newly approved Modner binary new crown vaccine, the dosage of the original new crown poison strains and Omikon strains each accounted for half, All 25 micrograms. The clinical trial data shows that the vaccine has "strong immune response" to both Omikon BA.1 and the primitive new crown virus, and can also provide immune protection for the latest Omikon BA.4/BA.5.

On August 22, Pfizer and Biontech announced that it had applied to the US Food and Drug Administration (FDA) to apply for a trial two -year -old new crown vaccine for the 12 -year -old or above. BA.4 and BA.5 strains. On August 31, the application was approved. It is worth noting that the new vaccine does not have no new human clinical trial data. The authorization is based on mouse experiments and the MRNA vaccine data used by pharmaceuticals so far.

Other pharmaceutical companies such as Kexing and Chinese Medicine Group in China are also starting the research and development of Omikon and its sub -type vaccines. According to Jin Dongyan's understanding, the clinical trial of the new -generation unit price vaccine carried out by Hong Kong University of China has been close to the end, and it will also apply for listing approval recently.

Chen Xi believes that the current vaccine market is basically close to saturation. In this case, the nasal injection vaccine will win how much market size can win in the future, and there is a certain commercial risk. At the same time, the preparation technology of the MRNA vaccine is relatively mature. Once a new mutant plant appears, it usually takes only a few days to adjust it to the vaccine version of the new mutant strain. At present, nasal injection vaccines seem to be unable to reach the level of flexible response in terms of production technology.

In early September, Britain launched the fourth pins of the new crown vaccine to prepare for the epidemic that may occur in autumn and winter. At the same time, many countries have or undergoing enhanced needle vaccination. The epidemic data shows that the total number of infections in the United States is about 100 million. "The actual number of infections should be more." Chen Xi said that many people around him had fourth -shot vaccine. With the advent of autumn and winter, more and more people would be vaccinated.

The well -known German viralist Christian Drusten said in March this year that spraying vaccines in the nose or throat is a way to prevent the spread of new crowns.

Lu Mengji said that for domestic, strengthening vaccine vaccination is currently the simplest and most effective way to respond to the epidemic, especially in places with weak medical conditions. In the winter, a scale may also spread. If the vaccine coverage rate is relatively low, the impact on the elderly will be great.

A number of virus experts told China News Weekly that whether the new crown vaccine is needed every year in the future, depending on the lethality of the mutant strain. In Jin Dongyan's view, whether it is the MRNA vaccine, an active vaccine, or the mucosal vaccine, and the binary vaccine against Omikon, it should play its advantages. The mucosal vaccine should be combined with other existing vaccines to maximize the effect of immunity and prevention as much as possible.

Send 2022.9.26 Total Issue 1062 "China News Weekly" magazine

Magazine title: Will the spray vaccine change the new crowns?

Reporter: Niuhe ([email protected]) Editor: Du Wei

Operation editor: Wang Lin

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