BENGALURU :
BioNTech SE and Pfizer Inc’s coronavirus vaccine candidate is expected to be ready to seek regulatory approval by the end of 2020, the Wall Street Journal reported on Friday, citing the German biotech firm’s chief executive officer.
The experimental vaccine, which showed promise against the fast-spreading respiratory illness in early stage human testing, is expected to move into a large trial involving 30,000 healthy participants later this month, pending regulatory nod.
Known as BNT162b1, it produces antibody responses at or above the levels seen in any convalescent serum — blood from people who have recovered — at relatively low doses, according to BioNTech.
The vaccine relies on messenger RNA, genetic code that slips into human cells to make them generate antibodies that are specifically tailored to the coronavirus.
The preliminary data come from phase 1/2 trial that aimed to show the vaccine is not toxic and triggers an immune system response to prepare the body to fight off the virus.
Of 45 people aged 18 to 55 who took part in the trial, most received two doses, 21 days apart, of the vaccine or a placebo.
A relatively high number of participants developed a fever after the second dose, according to a study uploaded on the pre-publication website medrxiv.org. But this is not unexpected and is not considered a stumbling block.
If it receives marketing approval, the companies are preparing to make up to 100 million doses by the end of 2020 and another 1.2 billion doses by the end of 2021 at sites in Germany and the United States, Reuters reported last week.
Several hundred million doses could be produced even before the approval, according to the WSJ report.
BioNTech and Pfizer did not immediately respond to Reuters’ request for comment.