Last October, Uğur Şahin traveled from Germany to New York to launch the initial public offering of his decade-old biotechnology company with a message about its new and unproven technology. “We rely on the patient’s immune system,” Şahin said before ringing the opening bell at Nasdaq’s market site. “We want to activate the patient’s immune cells to identify, to detect, and eliminate tumor cells.”
BioNTech said that it may file for authorisation of the COVID-19 vaccine it is developing with US drugmaker Pfizer in late November if trial data are positive. The efficacy results from the late-stage trial of Pfizer-BioNTech coronavirus vaccine will be available shortly, BioNTech chief executive Ugur Sahin said.
“We will certainly be smarter in a fortnight,” Sahin said in a video interview with regional publisher VRM posted online late on Thursday. “We are optimistic,” he said.
The regulatory filing for the vaccine could come as soon as safety data is available, possibly in the third week of November, Pfizer chief executive officer Albert Bourla said earlier.
“We have reached the last mile here,” Bourla said. “So let’s all have the patience that’s required for something so important for public health and the global economy.”
Bourla said the drug giant could supply some 40 million doses in the United States in 2020 if clinical testing proceeds as expected and regulators approve a vaccine.
The US Food and Drug Administration said earlier this month it wants at least two months of safety data on half of the trial participants before authorizing emergency use of any experimental coronavirus vaccine.
Pfizer’s coronavirus vaccine trial has enrolled more than 42,000 volunteers, the company announced Tuesday in third-quarter earnings report. It said nearly 36,000 of the volunteers have already received the second of its two-dose COVID-19 vaccine. In September, Pfizer expanded the enrollment of its phase three trial to up to 44,000 volunteers from the initial target of up to 30,000.
How Pfizer vaccine works
The experimental vaccine developed by Pfizer and BioNTech contains genetic material messenger called mRNA. The drugmaker inject people with the genetic material necessary to grow the “spike protein” of SARS-CoV-2 inside their own cells, thus eliciting an immune response the body will remember when it encounters the real virus. This effectively turns a person’s own body into a vaccine factory, avoiding the costly and difficult processes that more traditional vaccine production requires. The mRNA based vaccine candidate require deep-freezers for storage, which could limit distribution.
While vaccines are a crucial tool against the virus, experts have warned they can’t be a substitute for behavioral measures like masks and social distancing to curb transmission.
