- Pfizer and BioNTech on Thursday announced the start of a Phase 1 study of a new COVID-19 vaccine candidate designed to spur a broader and potentially more durable immune response. The study will enroll healthy adults who have taken at least three doses of an mRNA-based vaccine and will evaluate the new shot’s safety and immunogenicity.
- The candidate contains messenger RNA that encodes for coronavirus proteins other than the characteristic spike and that are retained across mutations, the companies said. It’s meant to enhance the body’s T cell response for broader immunity than offered by the current version of Pfizer and BioNTech’s vaccine.
- The study is the next step for Pfizer and BioNTech as the partners work to develop better vaccines against the coronavirus. They recently won U.S. clearance for a reformulated booster shot designed to be more effective versus the omicron variant.
The study comes as public health officials remain concerned about the potential for colder weather and, potentially, newer virus variants to push COVID-19 cases higher in the U.S.
Uptake of the omicron-adapted booster shots from Pfizer and BioNTech, as well as Moderna, has remained low despite a government campaign encouraging their use. The Food and Drug Administration has also recently cleared a different type of COVID-19 vaccine from Novavax to be used as a booster in limited cases.
All of the companies have been working to adapt and update the shots to better target omicron. Pfizer and BioNTech recently released updated data supporting their reformulated booster, showing it raised omicron antibody levels in adults. However, data is still needed in children and young adults, and to evaluate how those antibodies protect against infection and disease over time.
Next year, distribution of COVID-19 vaccines in the U.S. will also shift, as the federal government intends to stop buying vaccine supplies in bulk. Instead, the vaccines will be available through more traditional channels, and covered by insurance.
In response, Pfizer and Moderna are contemplating charging higher prices for each dose. Pfizer is considering a price between $110 and $130 per dose, several times higher than the $25 to $30 effective per-dose price paid by the U.S. government in prior contracts.
Executives at Pfizer have emphasized, though, that people who are insured will not have to pay out of pocket for vaccination.
In the new study, Pfizer and BioNTech will test their next vaccine candidate alongside their bivalent booster and compared immune responses to that two-pronged shot alone.