Phase I./II. Clinical trials of the German New Crown Vaccine have achieved phased results

, July 1 (Reporter Li Shan) On the evening of July 1, BioNTech Bio, a German company, announced on its official website the results of a phased clinical trial of some of the new crown candidate vaccines conducted jointly with Pfizer of the United States. According to the company, preliminary data indicate that BNT162b1 has good dose tolerance and can produce dose-dependent immunogenicity. With regulatory approval, BioNTech and Pfizer will conduct the next phase of a 30,000-person trial in the U.S. in late July.
Phase I./II. clinical trial of four candidate new crown vaccines, conducted by bioNTech in partnership with Pfizer, began in the United States on May 5 to determine and evaluate the safety, immunogenicity and optimal dose levels of the vaccine. The results of the trial of the candidate vaccine BNT162b1 were announced. Of the 45 healthy people aged 18-45, 24 were vaccinated twice - some at high doses; 12 ended up receiving only one high dose; and 9 were given two placebos in the control group. The interval between receiving two doses of injections for the same subject was 3 weeks. The results showed that 24 people who received two vaccinations produced antibodies, which were then laboratory tested to be virus-positive.
safety, BNT162b1 was inoculated at doses of 10 micrograms or 30 micrograms and no serious side effects were found. "Mild to moderate local and systemic reactions" associated with the dose were observed, including "mild to moderate" temporary pain at the injection site. Media attention was paid to the second dose of 30 micrograms of the group, three quarters of people have a fever of 38 degrees Celsius and above. In response, BioNTech CEO and co-founder Dr Ugg Shahin said: "We believe that if there is sufficient data to support this, the dose can be less than 30 micrograms. "They are testing more subjects at doses of 10 and 20 micrograms in the hope of reducing adverse side effects.
, a virus expert at the University of Marlborough in Germany, said the results were a "very good signal", especially as antibody concentrations were significantly higher than those produced in infected people. But it's unclear whether vaccination can produce so-called "immune memory", in which the body is effectively prepared for a new coronavirus infection. To prove this, several people need to be
to see how many of them will be infected with the new coronavirus under real conditions.
, BioNTech and Pfizer are raising their own funds to increase production capacity for major vaccine candidates. BioNTech, which has previously received a 100 million euro loan from the European Investment Bank, recently raised $250m from Temasek and other investors. BioNTech, which is listed on nasdaq, rose nearly 8 percent after the results were announced. If successful and approved, the two companies hope to produce 100 million doses by the end of this year and 1.2 billion by the end of next year.