First Human Trials Of Pfizer And BioNTech Vaccine Show Encouraging Results

First human trials of Pfizer and BioNTech vaccine show encouraging results

The experimental vaccine elicited stronger immune responses in healthy volunteers than in people with COVID-19.

Photo: Karolina Grabowska / Pexels

In early May, the American pharmaceutical giant Pfizer and its German partner BioNTech announced the beginning of a human trial of a new experimental vaccine. It used mRNA technology that could potentially "train" a healthy immune system to produce antibodies to fight infection. The day before, scientists shared the first results of drug trials in humans and said that the results obtained allow moving on to larger-scale clinical trials.

During the trial, 24 healthy volunteers from 18 to 55 years old received two injections of the drug, 10 mcg and 30 mcg with an interval of 21 days, another 12 received one dose of 100 mcg, 9 participants received two doses of placebo.

The highest titers of neutralizing antibodies were observed in the first group seven days after the first dose and 28 days after the second injection. According to experts, the level of antibodies in volunteers in this group was higher than that of those who had had coronavirus.

The side effects of the vaccine are fairly minor: fever, mild to moderate pain at the injection site, mild fever, and chills that lasted one to two days. Scientists believe that more extensive population studies of the vaccine are needed to confirm its safety and effectiveness.

First vector vaccine for COVID-19 shows effect in early phase of human study

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The data will be used by Pfizer and BioNTech to determine the dosage and the selection of participants in a global study, which is expected to involve at least 30,000 volunteers. Tests will begin at the end of July. If they are successful and the vaccine is approved, it is planned to release up to 100 million doses of the drug in Germany and the United States by the end of 2020.

Recall that on Monday, the Chinese biotechnology company China National Pharmaceutical Group (CNBG) announced successful trials of a coronavirus vaccine in humans. In a Phase I and II randomized trial, which is being conducted by CNBG Beijing scientists since April 27, 1,120 healthy volunteers received two doses of the inactivated vaccine. Based on the test results, it turned out that all participants developed high titer antibodies.

On June 16, specialists from CNBG's Wuhan division announced the successful completion of Phase I and II clinical trials of another coronavirus vaccine, according to the Global Times. On June 23, the company announced that it had received permission to conduct the final stage of drug testing in the United Arab Emirates. What kind of vaccine we are talking about, the CNBG did not specify.

If the tests are successful, the Chinese-made vaccines may receive permission for mass use as early as the end of October 2020.

Currently, about a dozen potential vaccines against coronavirus are undergoing human clinical trials in different countries. The largest pharmaceutical giants AstraZeneca, Johnson & Johnson, Merck, Moderna, Sanofi and CanSino Biologics are participating in the race for the vaccine. In Russia, the development of a vaccine is carried out by the National Research Center for Epidemiology and Microbiology. NF Gamalei and Research Center of Virology and Biotechnology "Vector".