US pharmaceutical giant Pfizer and German biotechnology company BioNTech have announced that early tests for their COVID-19 vaccine candidate have shown positive results. The data on these studies is yet to be released by the companies.
According to the company’s announcement on Wednesday, preliminary findings in a pre-print paper showed that participants in a Phase 1/2 study of the vaccine responded favorably to the immunization, showing that the vaccine, called BNT162b1, was well tolerated by the sample.
The initial study was conducted with 45 participants aged 18 to 55 who were randomly assigned to either receive a certain dose of the vaccine or a placebo. 9 participants received placebo while three groups of twelve received various dosages of the vaccine. These were: two 10 microgram doses 21 days apart, two 30 microgram doses 21 days apart, and a single 100 microgram dose on day one of the study.
Though some participants reported pain at the injection site, fever or sleep disturbances, not adverse events were reported according to the paper.
Researchers then found that the vaccine generated antibodies against COVID-19 in all the participants who received it. Those who received the single 100 microgram injection showed antibodies within 28 days. Those who received 10 or 30 micrograms were found to have antibodies at 7 days after the second dose.
Pfizer and BioNTech said that this initial data will help them in determining the appropriate dose level for the vaccine. The data can also help them select which of their multiple vaccine candidates to process on a larger-scale global study. This phase, the Phase 2/3 study, can possibly begin as early as this month.