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Novel coronavirus vaccine development

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Novel Coronavirus Vaccine

As of March 2022, China has provided more than 2.1 billion doses of vaccines to more than 120 countries and international organizations, accounting for one-third of the total global vaccine use outside China.

Inactivated vaccine

On December 31, 2020, the joint prevention and control mechanism of the State Council was released, and Sinopharm Group's China Bio-New Crown Inactivated Vaccine has been approved by the State Food and Drug Administration for listing with conditions.

Inhaled new crown vaccine - best antigen kit test

From November 12th to 14th, 2021, the world's first inhalable new crown vaccine was unveiled at the "2021 Fifth Hainan International Health Industry Expo". The world's first inhaled new crown vaccine was jointly developed by the team of Academician Chen Wei of the Academy of Military Medical Sciences and CanSino Biological Co., Ltd. The phase II clinical trial has achieved phased results, and the application for emergency use is being promoted. It is understood that the inhaled new crown vaccine and intramuscular injection use the same vaccine, and its formulation has not changed, only a different way of administration is used. Nebulized inhalation immunity uses a nebulizer to atomize the vaccine into tiny particles, which enter the respiratory tract and lungs through oral inhalation, thereby stimulating mucosal immunity, which cannot be brought about by intramuscular injection.Novel coronavirus vaccine development - UDXBIO

New therapeutic antibody drug

In November 2021, the new therapeutic antibody drug js016 jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Shanghai Junshi Biotechnology has obtained emergency use authorization in 15 countries around the world for use in combination with another neutralizing antibody.

New crown vaccine booster immunization

From 20:00 on January 25, 2022, the registration appointment for the booster immunization of Hong Kong and Macao compatriots aged 18 and above in Shanghai and the registration appointment for the vaccination of Hong Kong and Macao compatriots aged 3-11 will be launched, and the vaccination will start on January 26. .

On April 14, 2022, local time, Pfizer said that a study found that children aged 5 to 11 years old receive a booster shot of its new crown vaccine will produce a "high" immune response.

Specific medication for novel coronavirus

On November 22, 2021, according to the latest news, the clinical phase III of the combination of new crown drugs BRII-196 and BRII-198 jointly developed by Tsinghua University, Shenzhen Third People's Hospital and Tengsheng Biopharmaceuticals has been unblinded. After 28 days of treatment, zero deaths were achieved, and 8 cases in the control group died. The detailed results will be announced in the near future. This is also the fastest-growing antibody drug in my country, and it is expected to be approved for marketing with conditions by the end of December. Compared with the new coronavirus antibody drugs that have been approved for emergency use in Europe and the United States, this drug is the only one that has evaluated the treatment effect of patients infected with the mutant strain and obtained data.

In December 2021, led by Professor Zhang Linqi, professor of Tsinghua University School of Medicine and director of the Center for Global Health and Infectious Diseases and AIDS Research Center of Tsinghua University, the new crown monoclonal neutralizing antibody Ambavirumab/Romisevirumab was developed The combination therapy was approved by the China National Medical Products Administration on December 8 for the treatment of adults and adolescents (12-17 years old, weight ≥ 40kg) patients with novel coronavirus infection (COVID-19). Among them, adolescents (12-17 years old, weight ≥ 40kg) are subject to conditional approval.

COVID-19 Pre-Exposure Prophylaxis

AstraZeneca China "WeChat Official Account" news on December 11, 2021, recently, AstraZeneca's long-acting antibody (LAAB) combination Evusheld (combination of tixagevimab and cilgavimab) has been granted emergency use authorization (EUA) in the United States for new coronary pneumonia Pre-exposure prophylaxis, the first drugs will be available soon.

AstraZeneca said on May 23 that its new crown vaccine has been approved in the European Union as a third booster dose for adults. Its Vaxzevria vaccine is now available as a third booster dose for patients previously vaccinated with Vaxzevria or other EU-approved vaccines.

Neutralizing antibody combination therapy

According to news on December 17, 2021, the State Food and Drug Administration recently announced the emergency approval of Tengshenghua's innovative coronavirus neutralizing antibody combination therapy drugs for the registration of ambavirumab injection and romisevirumab injection. Li Ankang, Chief Financial Officer of Tengsheng Biopharmaceuticals and Ph.D. of Biomedicine, said: Neutralizing antibody combination therapy is to find neutralizing antibodies specifically for the new coronavirus from the human body, further optimize it, and select a pair of antibodies that bind to different parts of the new coronavirus. Neutralizing antibodies are produced on a large scale to make stable and controllable drugs. Its advantages: first, it is a pair of long-acting antibodies; second, in terms of safety, it comes from the human body; third, in terms of effectiveness, it can reduce the risk of death and hospitalization by 80% in phase III clinical trials; fourth, It is a combination therapy with two antibodies at the same time, with high coverage of various mutant strains.

Oral drugs

On December 22, 2021, the U.S. Food and Drug Administration approved the first emergency-use oral drug for the treatment of COVID-19 in adults and children 12 years and older with mild to moderate COVID-19, as well as those with mild to moderate symptoms. People at high risk of severe illness. The oral drug, made by Pfizer, is called Paxlovid and consists of two antiviral drugs, the FDA said in a statement. Patients must take it as soon as possible after the diagnosis of the new crown, and start taking it within 5 days after the symptoms of the new crown appear, and the continuous use time cannot exceed 5 days. On January 21, 2022, the South Korean government decided to expand the use of new crown oral drugs from the current 65 years old and above to 60 years old and above.

On March 23, 2022, the Korean Ministry of Food and Drug Safety stated that it had decided to approve the emergency use authorization of Merck's new crown oral drug monupivir.

On April 21, 2022, the World Health Organization (WHO) official website reported that the WHO approved the use of Pfizer's new crown oral drug Paxlovid in high-risk patients with new coronary pneumonia.

On April 23, 2022, Japanese drugmaker Shionogi Pharmaceuticals said on the 22nd that the company has begun negotiations with the U.S. government to plan to supply its new crown oral drug currently under development.

In April 2022, according to The Wall Street Journal, the U.S. Food and Drug Administration (FDA) said on Monday that it had expanded the approval of remdesivir (Veklury) as the first new crown therapy for infants and young children. Previously, Veklury was only approved to treat certain adult and pediatric patients with COVID-19.

Plant protein technology vaccine

On February 24, 2022, Health Canada announced that the new crown vaccine Covifenz, developed by the country's pharmaceutical company Medicago, can be used for adults aged 18 to 64. This is the sixth new crown vaccine approved by Canada and the first locally developed new crown vaccine. Covifenz is the first new crown vaccine using plant protein technology.

AI technology develops long-acting new crown vaccine

According to a report on April 11, 2022, Japan's NEC Corporation announced on the 8th that it has begun to develop a new crown vaccine using the most cutting-edge artificial intelligence (AI) technology.

French Valneva new crown vaccine

On April 14, 2022, Bloomberg reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved a new crown vaccine developed by French biotech company Valneva, according to a government statement. The Valneva vaccine becomes the sixth MHRA-authorized Covid-19 vaccine.

Novavax new crown vaccine

On April 18th, a special group of Japan's Ministry of Health, Labour and Welfare agreed to approve the new crown vaccine developed by the US biotechnology company Novavax on the 18th. The Ministry of Health, Labour and Welfare plans to quickly approve it, which will be the fourth Covid-19 vaccine available in Japan.

On April 21, 2022, the British "Financial Times" reported that Novavax announced the clinical data of the first combined vaccine of new crown and influenza, and initially found that the two-in-one vaccine may be safe and effective.

On June 4, 2022, the Wall Street Journal reported that U.S. health regulators said Novavax's vaccine was 90 percent effective in preventing the new coronavirus in its pivotal clinical trial, but that performance It was before the emergence of the Omicron variant, which was more prone to immune evasion from vaccines than earlier viruses. Outside consultants are scheduled to discuss next week whether to recommend FDA approval of the vaccine after six people who received the Novavax vaccine developed heart inflammation of myocarditis and pericarditis in separate studies.

Ruike Bio's New Adjuvant Recombinant Protein New Coronary Pneumonia Vaccine

On May 2, 2022, Ruike Biotech issued an announcement announcing that its new adjuvant recombinant protein new crown vaccine ReCOV clinical trial application was approved by the Center for Drug Evaluation of the State Drug Administration. [96]

China discovers a new crown drug and obtains a patent, and its ability to inhibit the virus ranks high

On May 10, 2022, a new drug for the treatment of COVID-19 discovered by Chinese scientists was granted a national invention patent. The patent specification shows that 10 μm (micromol/liter) of fenugreek inhibits the replication of coronavirus by 15,393 times.

Clinical trials of innovative oral anti-COVID-19 drugs have been approved

On the evening of May 15, 2022, Zhongsheng Pharmaceutical issued an announcement that the clinical trial of oral anti-new coronavirus 3CL protease inhibitor RAY1216 tablets by Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd., a holding subsidiary of the company, was approved by the State Drug Administration. Received the "Notice of Approval for Clinical Trial of Drugs" and agreed to conduct clinical trials of RAY1216 tablets.

Moderna says its improved Covid-19 vaccine produces stronger immune responses to Omicron variants

On June 9, 2022, the Wall Street Journal reported that Moderna said that in a new study, an improved version of the new crown vaccine booster shot was compared with the company's original vaccine when targeting a mutant strain of Omicron. The immune responses were stronger, and the researchers found that people who received the modified vaccine had 1.75 times the level of neutralizing antibodies to Omicron than those who received the original vaccine booster.

Ruike Bio: Omicron Variant New Coronavirus mRNA Vaccine Obtained Clinical License in the Philippines

In June 2022, Ruike Biogroup's novel coronavirus mRNA vaccine R520A was approved for clinical trials by the Philippine State Food and Drug Administration.

Regis Bio: The world's first freeze-dried mRNA vaccine of new coronavirus Omicron strain enters clinical stage

On June 27, 2022, Shenzhen Regis Biotechnology Co., Ltd. announced that the freeze-dried new coronavirus Omicron strain mRNA vaccine RH109 was developed by its joint venture company (Wuhan Regis Biotechnology Co., Ltd.) in New Zealand and the Philippines. Obtain clinical approval. This approval marks that the world's first freeze-dried mRNA vaccine of the new crown Omicron strain has entered the clinical stage.

SK Biotechnology: The first Korean-made new crown vaccine is licensed

On June 29, 2022, the new coronavirus pneumonia vaccine developed by SK Bioscience received a variety approval decision at the final inspection committee of the Korea Food and Drug Safety Administration. So far, South Korea's new coronary pneumonia therapeutic agents and vaccines have the ability from independent research and development to finished product production. The Korea Food and Drug Safety Administration convened a final inspection committee and decided to approve SK Biotech's new crown vaccine "SKYCovione™" (GBP510).

Novavax: Anticipating the launch of a new crown vaccine against Omicron in the fourth quarter

On July 2, 2022, Reuters reported that Novavax, a US vaccine research and development company, expects to provide a new crown vaccine against Omicron BA.4 and BA.5 mutant strains in the fourth quarter of 2022. Make sure that the booster shots coming out in the fall contain ingredients that protect against the BA.4 and BA.5 mutant strains of Omicron.

Neutralizing Antibody Evusheld Infection Prevention Drug

On July 5, 2022, Haikou Customs was quoted as saying that Boao Airport Customs, a subsidiary of Haikou Customs, completed the approval for entry of special items for the first imported neutralizing antibody Evusheld (Enshide) in my country, with a total value of 21.9802 million yuan. The drug is mainly used for adults Pre-exposure prophylaxis against novel coronavirus pneumonia and adolescents (≥12 years old, body weight ≥40 kg).

China's first oral anti-new crown drug with independent intellectual property rights approved

On July 25, 2022, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, and approved Henan Zhenzhen Biotechnology Co., Ltd. Azvudine Tablets to increase the treatment of new coronavirus with conditions. Pneumonia Indication Registration Application.

On August 9, 2022, according to the National Health and Medical Commission, according to the State Food and Drug Administration's conditional approval of the application for the registration of azvudine tablets for the treatment of new coronavirus pneumonia, in order to further improve the antiviral treatment of new coronavirus pneumonia The treatment plan, after research, the drug was included in the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Ninth Edition)".

On August 15, 2022, local time, according to local media reports, the British medical regulator approved the booster shot of the new crown vaccine manufactured by the vaccine company Moderna. The vaccine is said to be able to fight both the original new coronavirus and the Omicron variant. The UK is the first country to approve the vaccine.

South Korea launches first domestically produced new crown vaccine

On September 13, 2022, South Korea's "Asia Daily" reported that starting from that day, South Korea started the first domestic new crown vaccine developed by SK Bioscience.