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Refers to the preventive biological products of vaccines used for human inoculation in order to prevent and control the occurrence and prevalence of infectious diseases. Biological products refer to preparations made from microorganisms or their toxins, enzymes, human or animal serum and cells for prevention, diagnosis and treatment. Biological products used for vaccination include vaccines, vaccines and toxoids. Among them, the vaccine is made of bacteria; Vaccines are made of viruses, rickettsia and spirochetes, sometimes collectively referred to as vaccines.

kind

Vaccines are divided into two categories. Category I vaccines refer to vaccines provided by the government to citizens free of charge and accepted by citizens in accordance with government regulations, including vaccines determined by the national immunization program, vaccines added by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in the implementation of the national immunization program, and vaccines organized by people's governments at or above the county level or their health authorities for emergency vaccination or mass vaccination; The second category of vaccines refers to other vaccines that citizens voluntarily vaccinate at their own expense.

principle

Vaccine is an active immune preparation made of pathogenic microorganisms (such as bacteria, rickettsia, viruses, etc.) to prevent infectious diseases. ) and its metabolites are artificially attenuated, inactivated or genetically modified. The vaccine retains the characteristics that pathogenic bacteria stimulate the immune system of animals. When animals come into contact with this harmless pathogen, the immune system will produce certain protective substances, such as immune hormones, active physiological substances and special antibodies. When animals come into contact with this pathogen again, the animal's immune system will follow the original memory and produce more protective substances to prevent the harm of pathogens.

meaning

The discovery of vaccine is a milestone in the history of human development. Because in a sense, the history of human reproduction is the history of human constant struggle with diseases and natural disasters. Prevention is the most important means to control infectious diseases, and vaccination is considered to be the most effective measure. Facts have proved that smallpox virus, which threatened human beings for hundreds of years, was completely eliminated after the appearance of vaccinia vaccine, which ushered in the first victory of human beings against viruses with vaccines and made human beings more convinced of the role of vaccines in controlling and eliminating infectious diseases. In the next 200 years, the vaccine family has been expanding and developing. At present, there are more than 20 kinds of vaccines used for the prevention and treatment of human diseases, which are divided into traditional vaccines and new vaccines according to their technical characteristics. Traditional vaccines mainly include attenuated live vaccines and inactivated vaccines, while new vaccines are mainly genetic vaccines.

kind

artificial active immunization

1. Inactivated vaccine

Bacteria, viruses, rickettsia, spirochetes, etc. Select those with good immunogenicity, cultivate them artificially, and then kill them by physical or chemical methods.

vaccine

All right. The vaccine lost its reproductive ability, but retained its immunogenicity. The dead vaccine can't grow and reproduce after entering the human body, and the stimulation time to the body is short. To obtain lasting immunity, repeated vaccination is needed. For example, inactivated hepatitis A vaccine is a dead vaccine.

2. Live attenuated vaccine

Live vaccine or attenuated live vaccine is made by artificial directional mutation or screening live microorganisms with weakened toxicity or basically non-toxic from nature. Commonly used live vaccines include BCG (tuberculosis), measles vaccine and polio vaccine. After inoculation, it has the ability to grow and reproduce in the body, which is close to natural infection and can stimulate the body's lasting immunity to pathogens. The dosage of live vaccine is small, and the immune duration is long. The immune effect of live vaccine is better than that of dead vaccine. For example, varicella vaccine is an attenuated live vaccine, and leprosy and mumps vaccines are all live vaccines.

3. Toxoid

After formaldehyde treatment, extracellular toxins lose their toxicity and still retain their immunogenicity, so they are toxoid. A proper amount of aluminum phosphate and aluminum hydroxide are added to obtain the adsorption refined toxoid. Slow absorption in the body; It can stimulate the body for a long time, produce antibodies with higher titer and enhance the immune effect. Commonly used toxoids include diphtheria toxoid and tetanus toxoid.

artificial passive immunzation

1. antivirus

2. Human immunoglobulin preparation

3. Cytokine preparation

4. Monoclonal antibody preparation

Both artificial active immunity and artificial passive immunity can increase the body's disease resistance, but the latter lasts for a short time and is mainly used for treatment and emergency prevention.

New vaccine

1. subunit vaccine

2. Conjugated vaccine

3. Synthetic peptide vaccine

4. Genetically engineered vaccine

(1) recombinant antigen vaccine (2) recombinant vector vaccine (3)DNA/RNA vaccine (4) transgenic plant vaccine.

Children's vaccine

According to China's planned immunization program, infants must complete five kinds of vaccines within 1 year, including the following:

Hepatitis b vaccine

Generally, 1 needle is injected within two days after birth, 1 month and 6 months respectively, and the injection of 1 needle is strengthened every 3 ~ 5 years. At present, genetic engineering hepatitis B vaccine is widely used, which can be used to prevent all known hepatitis B virus subtype infections.

The baby who cannot be vaccinated with this vaccine is: 1. Fever, acute infectious diseases, otitis media, active tuberculosis, heart, liver and kidney diseases; 2. Systemic weakness, allergic history or epilepsy; 3. Patients currently receiving immunosuppressive therapy.

BCG vaccine

BCG vaccination can prevent tuberculosis. The BCG vaccine can be inoculated after the birth of the general baby, and if it is not vaccinated at birth, it can be vaccinated within 2 months. At the age of 3, 7 and 12, if the tuberculosis test is negative, multiple cropping should be carried out.

If the baby suffers from these diseases, it can't be vaccinated with BCG, specifically tuberculosis, acute infectious diseases, nephritis, heart disease, immunodeficiency, eczema or other skin diseases.

Polio sugar pill

Oral polio sugar pills can prevent polio, that is, medical "polio." At present, they are all white trivalent mixed vaccines. Take it for the first time at the age of 2 months after birth, and then take it twice every 1 month, twice in a row, and strengthen it at the age of 4 1 time.

Infants who cannot be vaccinated with this vaccine are: those who have a serious illness, fever or a history of allergy (especially a history of egg allergy) are not allowed to be vaccinated.

DTP preparation

Injection of DTP mixture can prevent pertussis, diphtheria and tetanus. These three diseases will seriously threaten children's health and life. Vaccination is usually carried out when the baby is 3 months old. The first seed must be injected 3 times every 4 ~ 6 weeks, and replanted when the child is 1 2 years old 1 time.

Taboo of DTP: 1 Epilepsy, nervous system diseases and a history of convulsions are prohibited; 2. Patients with acute infectious diseases (including convalescence) and fever should stop injecting.

measles vaccine

Measles vaccine can prevent measles. The first vaccination should be carried out when the baby is 8 months old and reaches 2, 7, 12 years old.

Children with these diseases cannot be vaccinated with trivalent vaccine against measles, rubella and mumps: 1. Those who are allergic to neomycin and eggs or have allergic reactions; 2. Respiratory diseases accompanied by fever, active tuberculosis, hematological diseases, cachexia, etc. 3. Patients with primary and secondary immunodeficiency or receiving immunosuppressant treatment; 4. Individuals or families have a history of convulsions and brain trauma.

Tip: If the baby has a fever, vaccination when there is an acute infectious disease may induce and aggravate the original condition, and vaccination cannot be carried out. Parents should take the initiative to explain the child's physical condition when they take their children for vaccination, so that doctors can correctly grasp the contraindications, which can not only reduce the side effects of vaccination, but also achieve the purpose of preventing diseases. In particular, BCG is a live vaccine, and polio sugar pills and measles vaccine are attenuated live vaccines. For those children who are particularly weak after injection, we must closely observe their reactions and distinguish adverse reactions from other diseases.

Prescribed strong immune vaccine

According to national regulations, compulsory vaccination is compulsory, that is, compulsory vaccination is also free. In the future, children must have vaccination certificates when they go to kindergarten, go to school or even go abroad.

The following vaccines are compulsory (implemented on March 1 2006):

Birth: Hepatitis B vaccine (first time), BCG vaccine.

1 month: Hepatitis B vaccine (second time)

2 months old: polio vaccine (first time)

3 months old: polio vaccine (second time), DTP (first time)

4 months old: polio vaccine (the third time), DTP (the second time)

5 months old: DTP (the third time)

6 months old: hepatitis B vaccine (the third time) and group A meningococcal vaccine (the first time)

8 months old: measles vaccine (first time), Japanese encephalitis vaccine (first and second inactivation), (first inactivation)

9 months old: group A meningococcal vaccine (second time)

18 months old: DTP (fourth time), measles vaccine (second time)

2 years old: Japanese encephalitis vaccine (third inactivation), (second inactivation)

3 years old: Group A meningococcal vaccine (the third time)

4 years old: polio vaccine (fourth time)

6 years old: Japanese encephalitis vaccine (fourth inactivation), (third inactivation), group A meningococcal vaccine (fourth inactivation) and refined DTP (first inactivation).

16 years old: Bai Po (second time)

There are also some vaccines that are not covered by compulsory exemption, such as measles, rubella, mumps, pneumonia, chickenpox and so on. These are all charges, you can choose to call or not. Remember, any vaccine that costs money needs parents' signature before it can be vaccinated.

Unplanned vaccine

Unplanned vaccines (Class II vaccines) are self-funded vaccines. It can be determined according to the baby's own situation, different conditions in different regions and the financial situation of parents. Those who choose to inject the second-class vaccine will be injected selectively without affecting the first-class vaccine. It should be noted that live vaccines (measles vaccine, Japanese encephalitis vaccine and poliomyelitis sugar pills) should be inoculated once every four weeks, and then dead vaccines (DTP, hepatitis B, epidemic cerebrospinal meningitis and all second-class vaccines) can be inoculated.

Infants with weak constitution can consider vaccination:

Influenza vaccine: suitable for babies with asthma, congenital heart disease, chronic nephritis and diabetes for more than 7 months. Once the flu is prevalent, they are prone to get sick, which may lead to the onset or aggravation of old diseases. Parents should consider vaccination.

Pneumonia vaccine: Pneumonia is caused by many kinds of bacteria, viruses and other microorganisms. The preventive effect of a single vaccine is limited, and the general healthy baby does not advocate choice. But sickly babies should be considered.

Vaccination in high endemic areas:

HIB vaccine: HIB vaccine has been included in routine immunization in more than 20 countries in the world. Infants under 5 years old are easily infected with Haemophilus influenzae type B, which can not only cause pneumonia in children, but also cause serious diseases such as meningitis, septicemia, myelitis, otitis media and pericarditis in children. It is the main pathogen that causes serious bacterial infection in infants.

Rotavirus vaccine: Rotavirus is the most common cause of viral diarrhea in infants aged 3 months to 2 years. Vaccination with rotavirus vaccine can avoid severe diarrhea in infants.

Rabies vaccine: The mortality rate after onset is almost 100%, and there is no effective way to treat rabies. Anyone who is bitten or scratched by sick or poisonous animals should be injected with rabies vaccine immediately. If severely bitten, such as head and face, multiple parts of the whole body, deep bite, etc. , should be combined with anti-rabies virus serum.

Vaccines to be considered for infants about to go to kindergarten:

Chickenpox vaccine: if the baby's resistance is poor, it should be selected; For a healthy baby, it can be used or not. The reason why it is not used is that chickenpox is a benign self-limiting "infectious disease" and is included in the scope of infectious disease management. Even if the baby has chickenpox, there are few complications.

Precautions for vaccination

1, usually you can't eat hot food for 40 minutes after eating polio sugar pills.

2. It is forbidden to take a bath the next day after injection of DTP vaccine. After 24 hours, the injection site appears red, swollen and hard scab, which must be hot compressed 3-5 times a day until the swelling is reduced.

3. You can't take a bath on the day of hepatitis B vaccination. It should be noted that all vaccines should be suspended when there is an acute disease.

4. After vaccination, if there are serious adverse reactions, such as collapse, shock, spasm, encephalitis or encephalopathy, and serious allergic reactions, follow-up injections or enhanced immunization should not be carried out.

5. Children with nervous system diseases, such as epilepsy or encephalopathy, should not be vaccinated with whole-cell pertussis vaccine, meningococcal vaccine and Japanese encephalitis vaccine.

6. People suffering from immunodeficiency or using immunosuppressants should not be vaccinated with live vaccines.

7. Children should suspend vaccination during infectious diseases, even during the recovery period of infectious diseases.

8. If there are serious organic diseases, such as active tuberculosis and serious diseases such as liver, lung and kidney, vaccination should be suspended.

9. Vaccination was suspended during the fever.

Vaccine reaction

Although the vaccine has been inactivated or attenuated, it is still caused by a protein or other antigenic substances, which still has a certain stimulating effect on the human body. In fact, this is also a kind of self-protection of the human body, just like a cold and fever, and the body is resisting bacteria or viruses.

vaccine

Orthogonal reaction

Local reactions such as mild swelling and pain. After DTP vaccination, induration on buttocks is a common phenomenon after adsorption preparation vaccination.

General reactions after vaccination include fever and general malaise. Generally, the fever is below 38.5℃ for 1 ~ 2 days, which is a normal reaction. Normal reaction, whether local or systemic, generally does not need special treatment, just feed more water and pay attention to rest. If you have a high fever, you can take antipyretics, do physical cooling, eat nutritious and digestible food, feed more water, and pay attention to the changes of your condition.

Abnormal reaction

Local infection, aseptic abscess; Dizziness and hysteria; Rash, angioneurotic edema, anaphylactic shock, etc.

In case of needle fainting and anaphylactic shock, you should lie flat immediately, lower your head and take warm water or sugar water orally; At the same time, please ask the doctor to treat the symptoms immediately.

If you have a rash, you can apply desensitizing drugs under the guidance of a doctor.

Anaphylactic shock generally manifests as pallor, cold limbs, cold sweat, dyspnea and even unconsciousness and convulsions within a short time after inoculation. At this time, the general doctor will immediately inject adrenaline subcutaneously, and at the same time give hormones and desensitizers for observation and treatment. [ 1]

Adult vaccine

Hepatitis B vaccine, hepatitis A vaccine, pneumonia vaccine, varicella vaccine, leprosy vaccine, influenza vaccine, rabies vaccine, bronchitis vaccine, epidemic cerebrospinal meningitis vaccine, Japanese encephalitis vaccine, typhoid vaccine, dysentery vaccine, cervical cancer vaccine, cholera vaccine and so on.

There are also AIDS vaccine and type A H 1N 1 vaccine.

biological product

It refers to preparations prepared from microorganisms or their toxins, enzymes, human or animal serum and cells for prevention, diagnosis and treatment. Biological products used for vaccination include vaccines, vaccines and toxoids. Among them, the vaccine is made of bacteria; Is made of virus, rickettsia and spirochete.

vaccine

Some are vaccines, sometimes collectively referred to as vaccines.

In-depth investigation and investment strategic planning of vaccine industry in China: a prospective market overview

In recent years, the global vaccine market has attracted the interest of many pharmaceutical companies. Especially under the fear of the possible outbreak of influenza, China vaccine industry is increasingly optimistic about in-depth research and investment strategic planning. In recent years, the market has been growing at an average annual rate of double digits, which has greatly expanded the global influenza vaccine market. In 2005, the size of this market was estimated to reach $654.38+0.6 billion. It is predicted that the growth trend of this market will continue. According to the recent report released by Datamonitor, a market research organization, it is predicted that by 20 10, the market size of influenza vaccine in only seven markets in the world may exceed $3 billion.

Vaccine difference

1940, after successfully culturing virus strains in egg embryos, the US military developed an anti-influenza vaccine. 1945 anti-influenza vaccine was first marketed. 65438-0957 Whole virus influenza vaccine is widely used, which consists of inactivated whole virus particles. From 65438 to 0968, split influenza vaccine was widely used. The vaccine not only contained surface antigens hemagglutinin and neuraminidase, but also contained virus core-shell and matrix protein. 1976 subunit influenza vaccine was used, which contained more pure surface antigen, hemagglutinin and neuraminidase. Influenza vaccine has been used in the world for more than 60 years. At present, hundreds of millions of vaccines are used every year, making it the largest vaccine in the world. The production process of the vaccine is very mature and stable, and its safety and effectiveness have been fully verified.

Every February, WHO holds an expert meeting to determine the recommended strains of influenza vaccine in the northern hemisphere for the next influenza season. The determination of the strain was inferred from the strains isolated from the influenza surveillance network distributed all over the world in the previous year. Compared with the recommended strains in last year, 1 strain, 2 strains or even 3 strains may be replaced, and in rare cases, the strains will not be replaced. It is precisely because the strain needs to be changed every year that everyone needs to be vaccinated again every year. After obtaining the virus strain, various manufacturers began to quickly put into vaccine production, usually ending production in July and August, and then the vaccine can be directly marketed after being distributed in batches to prevent the flu season of that year, without clinical trials. At present, only a few countries require small-scale safety verification tests.

Whether it is seasonal influenza vaccine or current influenza A vaccine H 1N 1, its strains are distributed by the World Health Organization, and their safety has been evaluated before distribution. Seasonal influenza vaccine has three antigenic components: A H 1N 1, A H3N2 and B influenza virus. The antigen component of each adult seasonal influenza vaccine is 15μg/ dose, which means that one vaccine contains 45 μ g of antigen component. The new influenza A vaccine (H 1N 1) contains only one antigenic component, and the approved dosage for human use is 15 μ g/dose. Because the antigenic composition of the new influenza A vaccine H 1N 1 is only 1/3 of that of the seasonal influenza vaccine, it is theoretically inferred that the safety of the new influenza A vaccine H 1N 1 should be higher than that of the seasonal influenza vaccine on the basis of the same production technology and quality standards.

It can be seen from the above introduction that the new influenza A vaccine H 1N 1 is not a new vaccine variety, and it is quite normal that the domestic influenza A vaccine H 1N 1 can be marketed in less than three months. Because for each manufacturer, it is equivalent to producing one antigen component in seasonal influenza vaccine, and in the production process, only the steps of mixing three antigens are reduced. The production of seasonal influenza vaccine is antigen-antigen. After one antigen is produced, it needs cleaning and disinfection to produce the next antigen. Therefore, the production cycle of seasonal influenza vaccine is longer than that of influenza A vaccine H 1N 1.

Hypothesis: If a new type of influenza A (H 1N 1) appeared and was isolated last year, it is very likely that WHO recommended this new type of influenza A virus as the corresponding strain when recommending seasonal influenza vaccine in February this year, and thus it was included in seasonal influenza. Recently, the expert group of the World Health Organization has two opinions on the recommendation of 20 10 seasonal influenza vaccine in the southern hemisphere. One is to list the new influenza A strain as the corresponding strain A 1 in the trivalent seasonal influenza vaccine, and the other is to regard the new influenza A H 1N 1 as a single epidemic influenza vaccine, and then take the antigen components A 3 and B in the seasonal influenza vaccine as new bivalents.

In fact, the success rate of influenza A vaccine is very high. In China, the failure rate of influenza A vaccine is about 0.3‰, which is almost even lower than other types of vaccines. But any kind of vaccine can only play a preventive and protective role, and it is impossible to completely resist it. So even if you are vaccinated, it doesn't mean that you won't get A-H 1N 1, so even if you are vaccinated, you must still be in a state of prevention.

Generally speaking, H 1N 1 vaccine is only useful in about 15 days. In the meantime, if you have any other medicines to use, please consult your doctor before taking them:

Competition pattern

Influenza vaccine model

At present, there are 38 vaccine production enterprises in China, which can produce 44 kinds of vaccines and prevent 26 kinds of infectious diseases. Compared with the international market, China's vaccine production enterprises are large in number and small in scale. International vaccine production is mainly supplied by developed countries in Europe and America, forming a pattern in which Sanofi Pasteur (ASP), Pfizer (Wyeth), Merck, GlaxoSmithKline (GSK) and Novartis compete for hegemony. Due to the influence of economic and other technical factors, China's vaccine production enterprises are still in a relatively backward situation in general, except for individual varieties that have comparative advantages.