Evening news| The Aumechjong new crown vaccine is coming! China Biologics and Kexing Biological Vaccines were approved to enter the clinic

1, Omicron new crown vaccine is coming! China Biologics and Kexing Biological Vaccines were approved to enter the clinic

On April 26, Sinopharm China Biologics and Kexing Holding Biotechnology Co., Ltd., the inactivated vaccine of the new crown virus developed based on the Aomi Kerong variant, received clinical approval from the State Drug Administration on the same day.

According to the Chinese Biological Official's micro-news, China Biologics will use random, double-blind, cohort studies to conduct sequential immunological clinical studies in people aged 18 years and above who have completed 2 or 3 doses of COVID-19 vaccination to evaluate the safety and immunogenicity of the Inactivated Vaccine of the New Coronavirus variant of the Ami kerong strain.

On the basis of the inactivated COVID-19 vaccine of the prototype strain that has been listed in the early stage and the completion of the research and development of the inactivated vaccine of beta and Delta variant strains, Sinopharm China Bio introduced the Omiljung mutant strain from the University of Hong Kong for the first time, and quickly launched the research and development of the Ao strain inactivated vaccine on December 9, 2021.

Official micro-information shows that its Inactivated Vaccine for the New Coronavirus of the Semikron variant can produce high-titer neutralizing antibodies against the Austin strain and a variety of variants.

On March 3 this year, the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products and the Hong Kong Research Institute determined the clinical plan and related details, and obtained the verification report of the China Institute of Pharmaceutical and Food Certification on March 26 and 30 respectively.

On 1 April, it submitted its clinical application materials to the Hong Kong Department of Health, received ethical approval on 12 April, and clinical research approval on 13 April, becoming the world's first inactivated vaccine approved to enter the clinic.

According to the official micro of Kexing Biology, on December 5, 2021, Kexing Bio obtained a nasopharyngeal swab sample of the new coronavirus Omiljung variant infection, and cooperated with the team of Professor Qin Chuan of the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences to carry out virus isolation and whole gene sequencing. Four days later, Coshing bio introduced samples of the Omiljunn strain of the new coronavirus isolated from the University of Hong Kong. The results of animal model studies show that The inactivated vaccine of the Omiljung variant of Cohin Biotech is safe and effective in test animals.

On January 30 this year, Kexing Bio began to submit pre-review materials for clinical trials to the Drug Review Center of the State Food and Drug Administration (CDE) on a rolling basis, and completed the submission of a full set of paper and electronic versions of the registration declaration materials on April 15, and officially applied for clinical trials to CDE.

At the same time, since the end of February, Kexing Bio has successively submitted clinical applications for inactivated vaccines for the Aomi Kerong variant to many countries and regions outside the Chinese mainland.

On April 14, the inactivated vaccine for the new crown virus developed by Cohin Biotech based on the Aomi Kerong variant was approved in the Hong Kong Sarde. (China Biological Official Micro, Kexing Biological Official Micro)

2. The latest clinical research in Germany: Pfizer mRNA vaccine may cause autoimmune hepatitis

The latest clinical studies from Germany have found that the covid-19 mRNA vaccine (BNT162b2) jointly developed by Pfizer/BioNTech may trigger a rare T-cell-mediated form of autoimmune hepatitis.

Autoimmune hepatitis is a chronic progressive hepatic inflammatory disease mediated by autoimmune response, which is characterized by varying degrees of elevated serum aminotransferases, hyper-γ-globulinemia, positive autoantibodies, histological features of interfacial hepatitis dominated by lymphocyte and plasma cell infiltration, and severe cases can rapidly progress to cirrhosis and liver failure.

The above study was published in the Journal of Hepatology, an international authoritative journal in the field of liver disease, on April 21, and the authors include the Faculty of Medicine of the University of Freiburg in Germany, the Institute of Pathology of the Technical University of Munich in Germany, and the German Cancer Society. With a 2021 impact factor of 25.083, the Journal of Hepatology is the number one academic journal in the field of gastrointestinal liver disease. (The Paper)

3. U.S. Centers for Disease Control and Prevention: 3 out of every 4 U.S. children are infected with COVID-19

The Associated Press quoted a report released by the US Centers for Disease Control and Prevention on the 26th that 3 out of every 4 American children were infected with the new crown virus, and more than half of americans had been infected with the new crown virus.

CDC researchers found that the number of people infected with COVID-19 in the United States rose sharply between December 2021 and February 2022 due to the more contagious outbreak of the Aomi Kerong virus. About 34 percent of Americans were infected with the coronavirus in December 2021. Just two months later, that number grew to 58 percent.

The CDC report also shows that children are the ones who have increased the most. Antibody positivity rates among people aged 17 and under rose from 45% in December 2021 to 75% in February 2022.

At present, the United States provides new crown vaccine boosters for children aged 12 years and older, and Pfizer and BioNTech recommended on the 26th that the National Food and Drug Administration allow healthy elementary school students to also receive vaccination boosters. The companies cite a study in which a vaccine booster needle given to children between the ages of 5 and 11 boosts antibodies against the Omiljung virus variant. Pfizer offers one-third of the dose of vaccines for children aged 12 years and older. (Overseas Network)

4. A case of human infection with H3N8 avian influenza was found in Henan Province

The National Health Commission announced on April 26 that a human infection with H3N8 avian influenza had been found in Henan Province.

The child, a 4-year-old male, currently residing in Zhumadian City, Henan Province, had chickens and crows in his home before the onset of the disease, and there were wild duck activities around the home. On April 5, he developed fever and other symptoms, and on the 10th, he was admitted to a local medical institution for treatment due to his aggravation of his condition. On the 24th, the Chinese Center for Disease Control and Prevention tested the patient specimens sent from Henan Province, and the results were positive for the H3N8 avian influenza virus. In Henan Province, medical observation and sampling tests were carried out on close contacts of the children, and no abnormalities were found.

The National Health Commission has guided Henan Province to carry out prevention and control in accordance with relevant plans and organized experts to carry out risk assessments. Experts have preliminarily assessed that the H3N8 avian influenza virus is avian-derived and does not yet have the ability to effectively infect people. H3N8 virus has been previously detected globally in horses, dogs, poultry and seals, but no human cases of H3N8 have been reported. The outbreak is an occasional bird-to-human cross-species transmission, and the risk of large-scale transmission is low. Experts suggest that the public should avoid contact with sick and dead poultry in daily life, try to avoid direct contact with live poultry; pay attention to dietary hygiene, and separate raw and cooked food in the process of food processing; improve self-protection awareness, and those who find fever and respiratory symptoms should wear masks and seek medical treatment as soon as possible. (National Health Commission)