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    Home > Active Ingredient News > Drugs Articles > R&D news is frequent, and pharmaceutical companies lock in the national supply agreement for COVID-19 vaccine

    R&D news is frequent, and pharmaceutical companies lock in the national supply agreement for COVID-19 vaccine

    • Last Update: 2020-07-31
    • Source: Internet
    • Author: User
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    On July 20, local time, The Lancet released the latest results of the Phase 1/2 clinical trials of two new crown virus vaccines (COVID-19) in China and the UK.
    China-Chen Wei academician team / Kangsino this trial was conducted in Wuhan on April 12, in the form of random double-blindness, into the group of 508 people: high-dose group, 1E11 virus particles, n,n,n,5E10 virus particles, n,n,129; placebo group, n,126.
    results showed that after 28 days of single vaccination, 99.5% of the subjects produced specific antibodies, 95.3% produced neutralized antibodies, and 89% of the subjects had a specific T-cell immune response.
    follow-up results showed that from day 14, the high-dose group and the low-dose group detected a receptor binding domain (RBD)-specific ELISA antibody response in the Ad5 vector COVID-19 vaccine.
    on the 28th day, 244 participants in the high-dose group (96%) and 129 participants in the low-dose group (97%) showed serum transformation of RBD-specific ELISA antibodies, while the placebo group participants did not change.
    comprehensive consideration of safety and immunogenicity results, determine the target dose, for the smooth implementation of Phase III international clinical trials laid a solid foundation.
    , the team will follow the subjects for up to six months to monitor the dynamic changes in the levels of antibodies in the subjects, determine the duration of the immune response, and determine the duration of possible booster needle vaccinations.
    According to China's Vaccine Management Law, the vaccine has met the technical requirements for emergency use.
    Oxford University/AstraZeneca COV001 is a blind, multi-center, randomized controlled Phase I/II clinical trial with 1,077 participants.
    the trial evaluated the effect of AZD1222 on a single drug administration and the control of the endemic meningococcal meningitis vaccine MenACWY.
    , 10 subjects received AZD122 two administrations in one month.
    test results showed that in the volunteers who received a ChAdOx1nCoV-19 inoculation, antibody levels with the neo-coronavirus sting protein peaked at the 28th day after vaccination and remained at high levels 56 days after vaccination.
    among the volunteers who were vaccinated twice, the level of antibodies against the sting protein was significantly higher than that of the volunteers who received the first vaccine.
    in terms of safety, short-lived local and systemic reactions are common in the AZD1222 group, and other adenovirus vector vaccines are comparable, including temporary injection site pain and tenderness, mild to moderate headache, fatigue, chills, fever, discomfort and muscle soreness, and no serious adverse events were reported in the trial.
    Pfizer/BioNTech released the results of two clinical trials of vaccines in The Lancet, Pfizer and BioNTech also announced further results of their new mRNA vaccine Phase 1 clinical trials on medRxiv.
    in the trial, 60 participants, 48 of whom were vaccinated twice at different doses of BNT162b1 at intervals of 21 days, and 12 volunteers received only one vaccination.
    results showed that after the second injection, the vaccine caused high dose-dependent SARS-CoV-2 and RBD-combined IgG concentration, compared with a group of SARS-CoV-2 infection recovery human serum, the 43rd day SARS-CoV-2 and geometric means in the range of 0.7 times (1 micrograms) to 3.2 times (50 micrograms). In addition,
    , it was also proved for the first time that BNT62b1 candidatedrugs simultaneously induced high-level CD4 plus and CD8-T cell responses for SARS-CoV-2RBD.
    COVID-19 vaccine research and development race in the running, with the experimental data continue to come up with good news, COVID-19 vaccine competition in the main participating enterprises, in addition to accelerating research and development, are also actively increasing production capacity, seeking multi-supply, with a view to achieving adequate dose and sales of the vaccine.
    in China, on April 15, the Beijing Institute of Biological Products completed the country's first and only high-grade bio-safe production facilities, put into use after the new crown vaccine production capacity will reach 120 million doses / year. On July 1,
    , the new crown vaccine research and development laboratory and workshop complex of The Wuhan Biological Products Research Institute of China was inaugurated in Wuhan.
    it is known that the workshop design capacity of 100 million doses.
    at present, China's new crown vaccine production capacity reached 220 million doses / year.
    the capacity and availability of the new crown vaccine AstraZeneca's new crown vaccine Agreement AstraZeneca (AZ) set the tone for the supply boom, working with a number of companies, and on June 13aaaaaaaaaaaaaaaaae said its current production capacity is expected to be 2 billion doses per year.
    May, AstraZeneca signed an agreement with the United States and Britain to provide 400 million doses of the vaccine by 2020.
    and signed an agreement in June to supply 400 million doses of unprofitable vaccine to the European Union.
    to date, AstraZeneca has reached commitments with the UK, USA, Europe's Inclusive Vaccine Alliance, The Epidemic Preparedness Alliance, the GAVI Vaccine Alliance and the Serum Research Institute of India to supply more than 2 billion doses of the vaccine.
    The new Pfizer/BioNTech vaccine signed an agreement with the UK yesterday, Pfizer and BioTeCo signed an agreement with the UK government to supply 30 million doses of mRNA-based COVID-19 vaccine over the next two years.
    Pfizer said the deal with the UK was only a small part of the deal, with the aim of producing 100m doses of the vaccine in a year and 1.3m by 2021. "There are in-depth negotiations with a number of other government agencies and we hope to announce more supply agreements soon," Ugur Sahin, CEO and Co-Discovery M.D.,
    BioNTech, said in a statement.
    ."
    other companies are seeking opportunities to sign COVID-19 vaccine supply agreements with the European Union, Japan and others, And Sonsha Group aims to increase the production capacity of the new crown vaccine to 1 billion doses per year.
    , a range of drug makers, including Johnson and Johnson, Sanofi, Moderna and Pfizer, are seeking national supply agreements for their new vaccines.
    Johnson and Johnson is in talks with the Japanese government and the Bill and Gates Foundation. Joe Wolk, chief financial officer of the
    , said that if Johnson and Johnson's vaccine sought international recognition, Japan and the Gates Foundation would seek to lock in "certain minimum levels of supply" to ensure that vaccine supplies reached "a certain minimum level".
    and Joe said no agreement had been finalized, but a potential agreement would be similar to the $1.2 billion development agreement agreed by AstraZeneca in May with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Agency (BARDA) to secure U.S. supply capacity.
    .
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