Nature: Phase 1/2 of the new crown vaccine clinically produces an immune response

A midterm report from a clinical trial of the 1/2 new crown vaccine published online by nature, a leading academic journal, on August 12, showed that candidates for the new coronary RNA vaccine BNT162b1 can induce a strong immune response in healthy adults between the ages of 18 and 55. The study, entitled "Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults", was conducted by a team of researchers from the Langone Vaccine Center at New York University, the Grossman School of Medicine at New York University, the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Pfizer Inc., Cincinnati Children's Hospital, and was written by Dr. Judith Absalon of pharmaceutical giant Pfizer Inc.
RNA vaccine platform uses messenger RNA to induce immune response, and the safety of the vaccine is widely recognized, speeding up the development of vaccines against SARS-CoV-2. BNT162b1 encodes an antigen in the SARS-CoV-2 subject binding domain by intramyal injection. Researchers are conducting parallel studies of several similar candidate RNA vaccines to select suitable candidates for subsequent safety and pot trials. Absalon and colleagues reported interim data from the ongoing Phase 1/2 clinical study of BNT162b1. Forty-five healthy adults between the ages of 18 and 55 (23 men and 22 uncontromed women and 37 whites) were randomly injected with 10 micrograms( sg), 30 sg, or 100 sg of BNT162b1, or a placebo. Subjects in the 10-g group and the 30-g group were also injected with a second dose on the 21st day.The
team found that BNT162b1 generally had good tolerance, but some subjects experienced mild to moderate adverse reactions, including soreness, fatigue, headache, fever, and sleep disorders at the injection site, within 7 days of vaccination, which were directly related to the dose size.
studies have shown that the vaccine induces a strong immune response in the subjects, and that the level of the immune response increases with the dose and the second dose. SARS-CoV-2 antibodies appeared 21 days after all doses of a single injection, and after 7 days of injection of the second dose of 10 or 30 μg, the leveling of SARS-CoV-2 antibodies increased significantly. The immune response was much stronger in the 30-g group than in the 10-g group, but there was no significant difference between the 30-g group and the 100-g group. They did not receive a second dose because of the high adverse reactions in the 100 μg group.
study also showed that the subjects had levels of mesoth antibodies 1.9 to 4.6 times higher than those recovering from SARS-CoV-2 infection.
also stressed that while such comparisons could serve as an evaluation benchmark for vaccine-induced immune response and vaccine protection, phase 3 trials were needed to determine the effectiveness of BNT162b1. Currently, the study is recruiting adults between the ages of 65 and 85, and will later prioritize the recruitment of people who are more diverse.
it's worth noting that, against the backdrop of a global epidemic, the new crown vaccine, led by big pharmaceutical companies, is highly anticipated without a market. Earlier, on July 20th the British government announced that it had signed an agreement with pharmaceutical companies such as Pfizer to ensure that the UK would receive priority purchases of 90m vaccines once the new vaccine was developed. Then, on July 22, U.S. Health Secretary Alex Azhar announced that he had signed a contract with Pfizer to pay $1.95 billion for a new coronavirus vaccine once it was developed, and that the company would deliver 100 million doses in December.
July 31, the Japanese government also reached a basic agreement with Pfizer to provide 60 million copies of the vaccine by the end of June next year, the first time the government has reached an agreement with pharmaceutical companies to ensure the new crown vaccine.