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    Home > Medical News > Latest Medical News > Pfizer/BioNTech New Crown Vaccine Phase 1/2 Results Positive Neutralizing Antibody Levels In Rehab Patients

    Pfizer/BioNTech New Crown Vaccine Phase 1/2 Results Positive Neutralizing Antibody Levels In Rehab Patients

    • Last Update: 2020-07-15
    • Source: Internet
    • Author: User
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    The mRNA vaccine, called BNT162b1, is one of four mRNA vaccines currently being tested by the two companies in clinical trialsPfizer and BioNTech plan to select the most promising of the four vaccines for large,global 2b/3 clinical trials, which could begin as early as this monthBioNTech has also entered into a cooperation agreement with Fosun Pharma to develop and promote these vaccines in Chinaone of the important tools to combat the new crown outbreak is a safe and effective vaccineAccording to the World Health Organization, BioNTech and Pfizer are among 17 vaccine development projects that are currently in clinical phase worldwideThe two companies screened a total of four candidate vaccines for clinical trialsThey target the entire spike protein (spike protein) of the new coronavirus, or the receptor binding domain (RBD) on the stingprotein binding to the cell receptorBNT162b1 is a mRNA vaccine that targets the sting protein RBDIt encodes a tripolymer RBD that folds according to natural conformationdifferent variants of the BNT162 new coronavirus vaccine (Photo Source: References 2)this Phase 1/2 clinical trial is being conducted simultaneously in the United States and Europe, with healthy volunteers between the ages of 18 and 55 receiving different doses of candidate vaccinationSome of them received two vaccinations 21 days apart, while others received only one vaccinationdata from 45 volunteers who were initially vaccinated showed that volunteers who received two vaccinations 21 days apart produced a strong immune responseVolunteers who received doses of 10 sg and 30 ?g reached a peak level of IgG antibodies bound with RBD in the blood on the 7th day after the second vaccination, with the geometric average of the antibodies (GMC) at 4813 units per milliliter, and 27,872 units/ml, respectivelyThey were 8 times and 46.3 times the average antibody level in 38 serum samples obtained from COVID-19 rehabilitation patientsassessment of the neutralizing antibody titer of the new coronavirus showed that neutralizing the average titer (GMT) of the neutral antibody reached 168 and 267, respectively, among volunteers who were vaccinated at doses of 10 ?g and 30 ?gThese values are 1.8 and 2.8 times the neutralizing antibody titer in the serum of the recovered person 's interim immunogenicity data for BNT162b1 (Photo source: References2) in terms of safety, adverse events mainly include pain and fever at the injection site The occurrence of adverse events in volunteers who received doses of 10 ?g and 30 ?g showed dose correlation, mostly for temporary mild and moderate reactions After receiving the second dose, 8.3% of the volunteers who received a dose of 10 ?g and 75.0% of the supporters who received a dose of 30 ?g developed a fever of more than 38 degrees Celsius No serious adverse reactions were reported in the trial Interim data on the safety and tolerance of the BNT162b1 (Photo Source: References) BioNTech and Pfizer will continue to observe the volunteers for at least six months to assess the vaccine's safety and immune response, including the vaccine-induced T-cell response CD4 and CD8-positive T cells also play an important role in the removal of viruses Since it is not yet possible to predict the protective capacity of candidate vaccines for new coronavirus infections, the researchers will further explore the level of immune response to protective effects the role of the immune response caused by virus in suppressing the proliferation of the virus (Photo: References) BioNTech and Pfizer are also expanding the production capacity of the candidate vaccine, which, if successful and approved by regulators, estimates that it will be able to produce 100 million doses of the vaccine by the end of 2020 and could expand production to 1.2 billion by the end of 2021 at present, a number of new coronavirus candidate vaccineist is about to enter phase 3 clinical development stage, we look forward to hearing early good news of their clinical development, to overcome the new crown outbreak to bring a powerful weapon References: Pfizer and BioNTech Announce Early Positive Data from an Ongoing 1/2 Study of mRNA-Vaccine vis R Vs SARS-CoV-2 Retrieved July 1, 2020 from the Retrieved D July 1, 2020, from Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report medRxiv, doi:
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