6 of 14 Worldwide COVID-19 Vaccines in Phase III from China
6 of 14 Worldwide COVID-19 Vaccines in Phase III from China. With the second outbreak of the global epidemic, the overseas epidemic situation has become more severe. At present, the cumulative number of new coronavirus infections worldwide has exceeded 60 million, and it is still increasing at a rate of hundreds of thousands of new cases every day. The successful research and development of vaccines is the key to humanity’s ultimate control of the COVID-19 epidemic and is an urgent global demand. Countries around the world have reported to the World Health Organization there are 214 candidate COVID-19 vaccines under development, of which 51 are in clinical trials (14 in China). In addition, 14 vaccine candidates worldwide have entered phase III clinical trials (6 in China), and many vaccine candidates have been mass-produced in advance. On December 2, the United Kingdom officially approved the COVID-19 vaccine produced by Pfizer and BioNTech to market, letting people see the dawn of victory.
COVID-19 vaccines research and development trends of vaccine companies as belows:
On March 16, the company announced that it would cooperate with BioNTech to develop an mRNA COVID-19 vaccine. At present, BNT162b2 under this cooperative project has been advanced to phase II/III clinical stage at the end of July. The vaccine is modRNA, which encodes the full-length S protein. On October 6, the European EMA has launched a rolling review of BNT162b2, and it is expected that the vaccine will be approved for marketing sooner after positive data in the phase III trial. On November 9th, Pfizer and BioNTech released the first interim analysis of its Phase III clinical trial for the new coronavirus mRNA vaccine BNT162b2, claiming that its effectiveness in protecting people from new coronaviruses exceeds 90%. On November 21, it submitted an emergency use authorization (EUA) application for its COVID-19 vaccine BNT162b2 to the US FDA. On December 2, the United Kingdom officially approved the listing of the BNT162b2 COVID-19 vaccine.
The vaccine developed by the National Institutes of Health and Moderna Corporation of the United States is called mRNA-1273. The first phase clinical trial of the vaccine was launched in mid-March, and the second phase trial began in May. The Phase III clinical trial will be launched around September 27. On November 16, Moderna announced that according to preliminary test data, the effective rate of its COVID-19 vaccine phase III trial was 94.5%.
On May 26, the company announced the development of a COVID-19 vaccine in cooperation with IAVI. According to WHO, this vaccine is a replicative viral vector vaccine, and the vector used is a replication-competitive VSV chimeric virus, which encodes the S protein. On the same day, the company announced the acquisition of Themis Bioscience, a company focused on the development of vaccines and immunotherapies for infectious diseases (including the COVID-19). According to the WHO, this vaccine is a replicative viral vector vaccine, and the vector used is the measles virus vector. At present, the COVID-19 vaccine jointly developed by Themis and the Pasteur Institute has started phase I clinical studies in Belgium and France in early August.
Sanofi/ GSK Pharmaceutical
On February 18, Sanofi announced the development of a COVID-19 vaccine in collaboration with BARDA. At March 27, Sanofi announced that it had cooperated with TranslateBio to develop a new mRNA vaccine that was still in the preclinical stage. On April 14, Sanofi and GSK announced that they have reached a cooperation to jointly develop a recombinant protein subunit COVID-19 vaccine. Among them, Sanofi provides the COVID-19 S protein antigen synthesized based on recombinant DNA technology, and GSK provides efficient adjuvant technology. At present, the vaccine has started Phase I/II clinical studies in the United States in early September. On November 16, Olivier Bogillot, President of Sanofi France, told French TV station CNEWS that the company is considering the possibility of simultaneously launching the third phase of trials and vaccine production procedures in December, and The company plans to market its COVID-19 vaccine by June 2021.
On April 30, AstraZeneca announced that it would work with Oxford University to develop a COVID-19 vaccine. According to AstraZeneca’s global official website, the name of the vaccine is ChAdOx1 nCoV-19, later called AZD1222, which is a recombinant adenovirus vaccine. On July 20th, AstraZeneca stated that phase II/III late-stage trials of the vaccine are currently underway in the United Kingdom, Brazil and South Africa, and will begin in the United States. p is one of the 10 COVID-19 vaccines currently entering phase 3 clinical trials in the world, and the fastest-growing COVID-19 vaccine project in the UK. On October 1, EMA announced the launch of a rolling review of the COVID-19 vaccine candidate AZD1222 developed by AstraZeneca/Oxford University. On November 23, AstraZeneca announced that the interim analysis of the vaccine III clinical trial showed that the effective rate was 70.4%.
According to a design brief released by Johnson & Johnson in the Federal Clinical Research Database, Johnson & Johnson plans to recruit up to 30,000 people in the United States and several countries including the United Kingdom and Germany to participate in the new Phase III trials.
Russia’s satellite V vaccine
Russia’s COVID-19 vaccine is called “Satellite V” (SPUTNIK V), which is a human adenovirus vector vaccine and consists of two adenovirus vectors. It was developed by the Russian National Research Center for Epidemiology and Microbiology “Gamalea”. It became the first COVID-19 vaccine registered in Russia in August and has entered the phase III clinical trial in Russia. This vaccine has carried out phase II and phase III combined clinical trials in India, and phase III trials in Belarus, United Arab Emirates, Venezuela and other countries. On November 27th, a large-scale COVID-19 vaccination project in the Russian army has been launched.
On September 2, 2020, it was announced that the Phase III clinical trial of the recombinant new coronavirus vaccine (adenovirus type 5 vector) has begun. The company signed an agreement with NPO Petrovax Pharm, LLC. According to the agreement, the company and Petrovax will jointly advance the Phase III clinical trial of Ad5-nCoV in Russia. The candidate vaccine was approved in June by the Military Special Needs Medicine Approval issued by the Health Bureau of the Logistics Support Department of the Central Military Commission. In August, it became the first COVID-19 vaccine candidate in China to be patented. On November 6, the international phase III clinical trial of the vaccine completed the first group of subjects enrolled and vaccinated in Mexico.
On February 1 this year, Sinopharm Sino Biotech won the emergency approval of the key special inactivated vaccine project of the Ministry of Science and Technology National Key Research and Development Program “Public Security Risk Prevention and Control and Emergency Technology and Equipment”. On April 12th and 17th, the inactivated COVID-19 vaccines developed by Wuhan Institute and Beijing Institute were approved for clinical use. On June 16th, the phase Ⅰ/Ⅱ clinical trial of Wuhan Institute of Biological Products showed that the safety after vaccination was good, and there was no serious adverse reaction. On June 23, Sinopharm China Bio-COVID-19 Inactivated Vaccine International Clinical (Phase III) was launched in the United Arab Emirates. On July 22, the emergency use of the COVID-19 vaccine was approved. At present, phase III clinical trials have been carried out in ten countries including the UAE, Bahrain, Egypt, Morocco, Peru, Argentina, and more than 50,000 people have been vaccinated. The total number of vaccinators will reach more than 60,000. The sample size of the vaccinated population covers 125 nationalities. . On November 25, it was reported that China National Pharmaceutical Group had submitted a COVID-19 vaccine application to the State Food and Drug Administration.
The COVID-19 virus inactivated vaccine “Kierlefor” developed by its subsidiary Kexing Zhongwei is an inactivated vaccine made by inoculating Vero cells with the COVID-19 virus and then culturing, harvesting, inactivating, purifying and aluminum adsorption. On April 13th, it was approved by the National Medical Products Administration to enter Phase I/II clinical trials. At present, Clareford is conducting Phase III clinical trials in Brazil, Indonesia, Turkey, Chile and other countries. Among them, the phase III clinical study initiated in Turkey on September 16 has been extended from medical workers to the general public; the phase III clinical study in Indonesia has been initiated on August 11, while in Chile, the phase III clinical study has been approved To be launched.
In March 2020, Fosun Pharma was authorized by BioNTech to exclusively develop and commercialize vaccine products against the new coronavirus based on its proprietary mRNA technology platform in mainland China, Hong Kong, Macao and Taiwan. On July 15 this year, the BNT162b1mRNA Covid-19 vaccine was approved by the State Drug Administration for clinical trials. On September 4, all 144 subjects of the Phase I clinical trial of BNT162b1 conducted in China completed two injections of primary immunization and booster immunization. On November 12, Fosun Pharma issued an announcement stating that the clinical application of BNT162b2 COVID-19 vaccine was accepted by the State Food and Drug Administration. At present, BNT162b2 is in phase III clinical trials in the United States, Germany, Argentina, Brazil, South Africa, and Turkey, etc., and has been approved by the US FDA (the US Food and Drug Administration) fast track review.
The “Recombinant Novel Coronavirus Vaccine (CHO Cell)” jointly developed by Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. and the Institute of Microbiology of the Chinese Academy of Sciences was approved for clinical trial by the National Medical Products Administration on June 19, 2020. Starting from June 23, healthy adults over 18 years old were recruited in Beijing, Chongqing, and Hunan Province, and randomized, double-blind, placebo-controlled phase I and II clinical trials have been carried out. On October 22, Anhui Zhifeilongkoma Company unblinded the key data on the safety and immunogenicity of phase I and II clinical trials, and the results were in line with expectations. On November 18th, Phase III clinical trials were launched in Xiangtan County, Hunan.
Institute of Medical Biology, Chinese Academy of Sciences
The new inactivated vaccine (Vero cell) for the novel coronavirus independently developed by the institute was officially approved by the National Medical Products Administration for clinical trials on May 13, and was in West China Second Hospital and Yunnan Province Disease Control and Prevention in May and June. The center initiated phase I and phase II clinical trials. On August 27-28, the phase I/II clinical trial data review meeting and unblinding meeting were held simultaneously in Kunming, Chengdu, and Gejiu. Preliminary results show that the vaccine has good safety and immunogenicity. The vaccine will start a Phase III clinical trial in Malaysia in December, and it will become China’s sixth COVID-19 vaccine to enter Phase III clinical trials.