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April 3, 2022/eMedClub News/--For a highly contagious and large-scale epidemic, effective prevention is the key in the absence of effective drugs
.
The development of a new crown vaccine is an extremely important task in the current fight against the epidemic
.
Governments have also long called on Big Pharma to contribute to a vaccine for the global pandemic
.
This is not only important but also urgent, especially as the current global epidemic situation worsens
.
In February 2021, the UK government approved the launch of a new coronavirus human challenge (human challenge) trial, the purpose of which is to determine the minimum amount of virus that causes infection, and the response of the human immune system to the virus, thereby revealing the impact of the new coronavirus on the human body.
harm, and provide a certain reference and basis for the development of new crown vaccines and specific drugs
.
On March 31, 2022, a paper titled "Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge" was published in Nature Medicine, announcing the results of the world's first new crown human challenge test
.
The study inoculated 34 healthy young adults between the ages of 18 and 29 who had not been infected with the new coronavirus and had not been vaccinated with a strain that was close to the original new coronavirus
.
Subjects are planned to be quarantined for at least 14 days after vaccination until they meet virological discharge criteria, and followed for 1 year to assess long-term symptoms, including olfactory and neurological impairments
.
After receiving the virus, each subject stayed in a separate room with negative pressure to ensure that the virus would not spread
.
In the end, 18 of the 34 subjects were confirmed to be infected with the new crown, accounting for 53%
.
Among the 18 infected individuals, the researchers quantitatively detected the virus by qPCR, which could be detected as early as 40 hours (about 1.
67 days) after inoculation in throat swabs, and as early as 58 hours (about 2.
4 days) after inoculation in nasal swabs.
days) checked out
.
The viral load in throat swabs peaked at 112 hours (about 4.
7 days) after infection, while in nasal swabs at 148 hours (6.
2 days), but the peak viral load levels in nasal swabs were higher than those in throat swabs
.
On the 14th day of infection, some subjects still tested positive for nucleic acid
.
After 28 days of infection, 33% and 11% of people still tested positive for nucleic acid in throat swabs and nasal swabs, respectively
.
However, infected people are no longer infectious after an average of 10.
2 days after exposure to the virus
.
Of the 18 infected, two were asymptomatic
.
The remaining 16 people developed mild to moderate symptoms 2-4 days after infection, with the infection site confined to the upper respiratory tract and no lung changes
.
Twelve infected people developed some degree of olfactory disturbance
.
Half a year after infection, 5 people still reported that their sense of smell had not fully recovered, but the degree was relatively mild
.
Six months after the study ended, one person's sense of smell was "improving, not returning to normal
.
"
Human challenge test is controversial Human challenge is one of various medical research methods.
It has a history of more than 200 years.
It has played a key role in the development of treatments and vaccines for malaria, typhoid fever, cholera and influenza, and it has also been criticized for a time.
, is still controversial
.
Some scientists have objected to human infection trials because not enough is known about the new virus, such as how likely patients are to become seriously ill, whether the virus will have sequelae, and the fact that even healthy young patients are at risk of death
.
But proponents, including ethicists, argue that it is unethical to use large randomised controlled trials to assess the effectiveness of new vaccines when several are already approved, and the small controlled infections planned in the UK Trials are an effective means of developing new vaccines
.
Vaccines or the ultimate hope to end the new crown At present, the main types of vaccines are as follows: Recombinant protein vaccines are the gene sequences that can express the surface antigen (S or S1) of the virus, and are transferred into prokaryotes by means of genetic engineering, so that they can The antigen protein is expressed in large quantities, and then the expressed antigen protein is extracted and purified for inoculation
.
Its biggest advantage is that the enriched or even modified recombinant antigen protein has strong immunogenicity, and the production process is relatively mature
.
Anhui Zhifeilong Kema Biopharmaceutical Co.
, Ltd.
's recombinant new coronavirus protein vaccine (CHO cells) was approved for registration with conditions on March 1, 2022.
This is the first approved domestic recombinant new coronavirus protein vaccine
.
Previously, the new crown vaccine was approved for emergency use in China on March 10, 2021.
It is reported that more than 200 million doses have been used at home and abroad
.
Inactivated virus vaccines use heat or chemical methods to inactivate the virus obtained by culture.
The inactivated virus loses its pathogenic toxicity while retaining the main antigenic characteristics of the virus capsid, which can stimulate a specific immune response in the human body
.
At present, the vaccines approved by Sinopharm Group China Biotechnology, Beijing Kexing Zhongwei and Wuhan Institute of Biological Products are all new coronavirus inactivated vaccines (Vero cells)
.
In terms of delivery methods, mRNA vaccines are mainly delivered by non-biological methods, such as packaging with nanomaterials.
.
The use of common packaging shells for mRNA vaccines significantly shortens the development time of formulations.
At the same time, the use of the human body's own cells to produce viral antigens can also ensure more specific immune responses in the human body
.
At present, two mRNA vaccines have been approved in the world, namely BNT162b2 jointly developed by German BioNTech, Pfizer and Fosun Pharma and mRNA-1273 of American Moderna
.
Viral vector vaccines package nucleic acids in virus capsids that have been detoxified, and deliver nucleic acids into cells by biological methods.
Commonly used viral vectors include adenovirus, measles virus, and influenza virus
.
The viral vector itself also causes the body's immune response, so its impact on the human immune system is also much more complicated
.
On February 25, 2021, the conditional listing application of the recombinant novel coronavirus vaccine developed by CanSino Bio Co.
, Ltd.
and the Institute of Bioengineering, Academy of Military Medical Research, Academy of Military Sciences, has been approved.
The vaccine uses adenovirus type 5 as a vector.
It is the first single-dose COVID-19 vaccine approved for conditional marketing in China
.
Live attenuated vaccines treat pathogens by specific means to mutate them, and then pass the virus on, pick out less virulent strains from the progeny, and repeat the process until a strain that does not cause disease is obtained
.
Live attenuated vaccines have stronger immunity and longer duration of action than inactivated virus vaccines
.
However, the process of pathogen passage and screening in the early stage is very long, and it is difficult to complete the development of early products in a short period of time
.
The new crown epidemic has no end in sight, and according to some scientists, a vaccine will be the ultimate hope for ending the global pandemic
.
Even though we have a wide range of vaccines now, it is still very likely that we will face challenges from new mutant strains in the future, and new vaccines may be needed.
Human challenge trials may be an effective way to rapidly develop vaccines
.
Reference: 1.
Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults.
Nature Medicine.
doi.
org/10.
1038/s41591-022-01780-92.
Lilac Garden "37500 yuan/person, active infection New crown: The results of the world's first human challenge test appear in the Nature sub-journal" 3.
Universal Science "In order to accelerate the development of vaccines, should people be actively infected with the new coronavirus? 》——List of recent popular activities——▼On April 12, diversified genetic modification helps CAR-T therapy to release application potential▼From July 1st to 3rd, Shanghai, 2022 Shanghai International Bio-Innovative Drug Industry Expo
.
The development of a new crown vaccine is an extremely important task in the current fight against the epidemic
.
Governments have also long called on Big Pharma to contribute to a vaccine for the global pandemic
.
This is not only important but also urgent, especially as the current global epidemic situation worsens
.
In February 2021, the UK government approved the launch of a new coronavirus human challenge (human challenge) trial, the purpose of which is to determine the minimum amount of virus that causes infection, and the response of the human immune system to the virus, thereby revealing the impact of the new coronavirus on the human body.
harm, and provide a certain reference and basis for the development of new crown vaccines and specific drugs
.
On March 31, 2022, a paper titled "Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge" was published in Nature Medicine, announcing the results of the world's first new crown human challenge test
.
The study inoculated 34 healthy young adults between the ages of 18 and 29 who had not been infected with the new coronavirus and had not been vaccinated with a strain that was close to the original new coronavirus
.
Subjects are planned to be quarantined for at least 14 days after vaccination until they meet virological discharge criteria, and followed for 1 year to assess long-term symptoms, including olfactory and neurological impairments
.
After receiving the virus, each subject stayed in a separate room with negative pressure to ensure that the virus would not spread
.
In the end, 18 of the 34 subjects were confirmed to be infected with the new crown, accounting for 53%
.
Among the 18 infected individuals, the researchers quantitatively detected the virus by qPCR, which could be detected as early as 40 hours (about 1.
67 days) after inoculation in throat swabs, and as early as 58 hours (about 2.
4 days) after inoculation in nasal swabs.
days) checked out
.
The viral load in throat swabs peaked at 112 hours (about 4.
7 days) after infection, while in nasal swabs at 148 hours (6.
2 days), but the peak viral load levels in nasal swabs were higher than those in throat swabs
.
On the 14th day of infection, some subjects still tested positive for nucleic acid
.
After 28 days of infection, 33% and 11% of people still tested positive for nucleic acid in throat swabs and nasal swabs, respectively
.
However, infected people are no longer infectious after an average of 10.
2 days after exposure to the virus
.
Of the 18 infected, two were asymptomatic
.
The remaining 16 people developed mild to moderate symptoms 2-4 days after infection, with the infection site confined to the upper respiratory tract and no lung changes
.
Twelve infected people developed some degree of olfactory disturbance
.
Half a year after infection, 5 people still reported that their sense of smell had not fully recovered, but the degree was relatively mild
.
Six months after the study ended, one person's sense of smell was "improving, not returning to normal
.
"
Human challenge test is controversial Human challenge is one of various medical research methods.
It has a history of more than 200 years.
It has played a key role in the development of treatments and vaccines for malaria, typhoid fever, cholera and influenza, and it has also been criticized for a time.
, is still controversial
.
Some scientists have objected to human infection trials because not enough is known about the new virus, such as how likely patients are to become seriously ill, whether the virus will have sequelae, and the fact that even healthy young patients are at risk of death
.
But proponents, including ethicists, argue that it is unethical to use large randomised controlled trials to assess the effectiveness of new vaccines when several are already approved, and the small controlled infections planned in the UK Trials are an effective means of developing new vaccines
.
Vaccines or the ultimate hope to end the new crown At present, the main types of vaccines are as follows: Recombinant protein vaccines are the gene sequences that can express the surface antigen (S or S1) of the virus, and are transferred into prokaryotes by means of genetic engineering, so that they can The antigen protein is expressed in large quantities, and then the expressed antigen protein is extracted and purified for inoculation
.
Its biggest advantage is that the enriched or even modified recombinant antigen protein has strong immunogenicity, and the production process is relatively mature
.
Anhui Zhifeilong Kema Biopharmaceutical Co.
, Ltd.
's recombinant new coronavirus protein vaccine (CHO cells) was approved for registration with conditions on March 1, 2022.
This is the first approved domestic recombinant new coronavirus protein vaccine
.
Previously, the new crown vaccine was approved for emergency use in China on March 10, 2021.
It is reported that more than 200 million doses have been used at home and abroad
.
Inactivated virus vaccines use heat or chemical methods to inactivate the virus obtained by culture.
The inactivated virus loses its pathogenic toxicity while retaining the main antigenic characteristics of the virus capsid, which can stimulate a specific immune response in the human body
.
At present, the vaccines approved by Sinopharm Group China Biotechnology, Beijing Kexing Zhongwei and Wuhan Institute of Biological Products are all new coronavirus inactivated vaccines (Vero cells)
.
In terms of delivery methods, mRNA vaccines are mainly delivered by non-biological methods, such as packaging with nanomaterials.
.
The use of common packaging shells for mRNA vaccines significantly shortens the development time of formulations.
At the same time, the use of the human body's own cells to produce viral antigens can also ensure more specific immune responses in the human body
.
At present, two mRNA vaccines have been approved in the world, namely BNT162b2 jointly developed by German BioNTech, Pfizer and Fosun Pharma and mRNA-1273 of American Moderna
.
Viral vector vaccines package nucleic acids in virus capsids that have been detoxified, and deliver nucleic acids into cells by biological methods.
Commonly used viral vectors include adenovirus, measles virus, and influenza virus
.
The viral vector itself also causes the body's immune response, so its impact on the human immune system is also much more complicated
.
On February 25, 2021, the conditional listing application of the recombinant novel coronavirus vaccine developed by CanSino Bio Co.
, Ltd.
and the Institute of Bioengineering, Academy of Military Medical Research, Academy of Military Sciences, has been approved.
The vaccine uses adenovirus type 5 as a vector.
It is the first single-dose COVID-19 vaccine approved for conditional marketing in China
.
Live attenuated vaccines treat pathogens by specific means to mutate them, and then pass the virus on, pick out less virulent strains from the progeny, and repeat the process until a strain that does not cause disease is obtained
.
Live attenuated vaccines have stronger immunity and longer duration of action than inactivated virus vaccines
.
However, the process of pathogen passage and screening in the early stage is very long, and it is difficult to complete the development of early products in a short period of time
.
The new crown epidemic has no end in sight, and according to some scientists, a vaccine will be the ultimate hope for ending the global pandemic
.
Even though we have a wide range of vaccines now, it is still very likely that we will face challenges from new mutant strains in the future, and new vaccines may be needed.
Human challenge trials may be an effective way to rapidly develop vaccines
.
Reference: 1.
Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults.
Nature Medicine.
doi.
org/10.
1038/s41591-022-01780-92.
Lilac Garden "37500 yuan/person, active infection New crown: The results of the world's first human challenge test appear in the Nature sub-journal" 3.
Universal Science "In order to accelerate the development of vaccines, should people be actively infected with the new coronavirus? 》——List of recent popular activities——▼On April 12, diversified genetic modification helps CAR-T therapy to release application potential▼From July 1st to 3rd, Shanghai, 2022 Shanghai International Bio-Innovative Drug Industry Expo
