Pfizer ‘encouraged’ by trial

‘Topline findings’ in early vaccine

Early data from a coronavirus vaccine candidate being tested in 45 subjects showed positive results, Pfizer and BioNTech announced Wednesday.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer.

The vaccine candidate, called BNT162b1, showed that volunteers given either a low or medium dose, in two shots about a month apart, had immune responses in the range expected to be protective, according to a release from Pfizer.

The vaccine candidate was well tolerated and no serious adverse effects were reported, aside from low-grade fever and pain at the injection site.

Dr. Ugur Sahin, CEO and co-founder of BioNTech, said the vaccine candidate is able to produce neutralizing antibody response at or above levels seen in coronavirus survivors.

The preliminary data will be used to determine a dose level and progress to a larger, global safety and efficacy trial, which could involve up to 30,000 health participants and is expected to start later this month.

If the vaccine is ultimately approved by the Food and Drug Administration, the companies expect to manufacture up to 100 million doses by the end of the year.

The vaccine candidate BNT162b1 is one of four investigational candidates from an mRNA-based vaccine program called Project Lightspeed.

About 15 different COVID-19 vaccine candidates are in human testing worldwide, with several, such as Cambridge’s own Moderna set to launch laststage studies to show efficacy and safety.

Messenger ribonucleic acid, or mRNA vaccines, which use a piece of the coronavirus genetic code to elicit an immune response seem to be a popular choice for candidates.

Earlier this week, Inovio Pharmaceuticals issued a news release saying its gene-based vaccine candidate showed encouraging results in similar early testing in 40 volunteers.

AP FIle IN THE WORKS: The first patient enrolled in Pfizer's vaccine clinical trial gets a shot in the arm at the University of Maryland School of Medicine in Baltimore. Early clinical data from the trial has showed positive results.