Pfizer, BioNTech Say mRNA COVID-19 Vaccine Trials May Start This Month

Xconomy National — 

Multiple COVID-19 vaccine candidates that use a new technology called messenger RNA are now being readied for clinical trials that Pfizer and BioNTech plan to start in coming weeks.

The partnership pairs the mRNA vaccine technology of BioNTech (NASDAQ: BNTX) with the vaccine and clinical trial experience of Pfizer (NYSE: PFE). The companies said Thursday that the vaccine trials will initially be conducted at multiple sites in the US and Europe. These studies could begin as early as the end of April, assuming the companies receive regulatory clearance.

When Pfizer and BioNTech announced their COVID-19 vaccines collaboration in mid-March, few details were provided. On Thursday, the companies said that Pfizer will pay BioNTech $185 million up front, consisting of $72 million in cash plus a $113 million equity investment. Germany-based BioNTech could receive up to $563 million more if the research achieves milestones. Pfizer will pay for all of the development costs at first, according to the deal terms. If a vaccine reaches the market, BioNTech will repay half of the R&D costs.

The plan puts Pfizer and BioNTech on a fast track to develop a COVID-19 vaccine to address the pandemic, even as this type of vaccine technology remains unproven. Conventional vaccines use a weakened form of a virus or a piece of a virus that is enough to prompt an immune response but not enough to cause infection. Such vaccines take a long time to develop and manufacture. By contrast, the vaccines that Pfizer and BioNTech are developing are based on mRNA, which are molecular messengers that carry the genetic instructions for making proteins. An mRNA vaccine is intended to instruct cells to produce the proteins that prompt an immune response. These vaccines don’t take as long to manufacture compared to conventional vaccines, which gives them an advantage in addressing a pandemic—if they work.

According to the agreement, BioNTech will supply the mRNA vaccine that will be tested in clinical trials. While these studies are underway, the partners will also work together to scale up their capacity to make these vaccines ahead of any clinical data or regulatory decision. Other companies are also preparing for COVID-19 vaccine production. In late March, Johnson & Johnson (NYSE: JNJ) said it would establish new manufacturing for its experimental COVID-19 vaccine, which is designed using genetic material from the virus.

Companies are setting up manufacturing sites “at risk,” meaning they’re getting everything lined up for vaccine production before knowing whether they’ll be approved, or even if they work, according to Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine. Speaking via video at a National Press Foundation conference last week, Neuzil said that establishing this type of capacity is important in a pandemic because it ensures a vaccine can be distributed quickly if it’s approved. Wilbur Chen, an infectious disease physician and scientist at the Center for Vaccine Development, added that approval of one vaccine will not end work on others. The first vaccine might not be effective, and the hope is to have multiple vaccine options.

Pfizer and BioNTech are joining a handful of companies that are pursuing mRNA vaccines for COVID-19. Last month, a Phase 1 study began testing a vaccine from Cambridge, MA-based Moderna (NASDAQ: MRNA). In late March, Sanofi (NYSE: SNY) announced it would expand a collaboration with Translate Bio (NASDAQ: TBIO) to include COVID-19 mRNA vaccine research, which they expect could reach clinical testing by the end of the year.

In addition to its vaccine research with BioNTech, Pfizer is also developing an antiviral drug to treat COVID-19. The company announced Thursday that its lead candidate, a protease inhibitor, has shown activity against the virus that causes COVID-19 infection. More preclinical tests are planned, and Pfizer hopes to start a clinical trial in the third quarter of this year, which is sooner than its earlier estimates.

Image: iStock/RomeoLu