- A Pfizer vaccine candidate meant to protect against 20 different strains of pneumococcal disease was well-tolerated, safe and elicited an immune response in a Phase 2 study.
- The 20-valent vaccine includes the 13 serotypes contained in Pfizer's blockbuster Prevnar 13 plus seven additional ones that are associated with high case-fatality rates, antibiotic resistance and meningitis.
- If approved, the experimental vaccine could help to bolter Pfizer's $6 billion pneumococcal franchise into the next decade, potentially helping the pharma stay competitive against rival Merck & Co., Evercore ISI analyst Umer Raffat wrote in an investor note.
Prevnar 13 is already a big moneymaker for Pfizer, bringing in about $5.8 billion in revenue in 2018 and contributing to the 2% overall revenue growth the drug giant saw last year compared to 2017.
Now, Pfizer has its sights set on a broader vaccine to protect against more strains of the disease that would compete against Merck's 23-valent Pneumovax (pneumococcal vaccine polyvalent).
Pneumococcal disease is responsible for thousands of bacterial infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in the U.S. every year. Children under the age of 2 and adults over 65 are especially at risk.
Pfizer’s 20-valent vaccine is being investigated for the prevention of invasive disease and pneumonia in adults aged 18 years and older. The 20 serotypes included in the vaccine are responsible for the majority of currently circulating pneumococcal disease in adults in the U.S. and globally, according to the company.
In a randomized, double-blinded trial that enrolled 444 adults between the ages of 60 to 64, participants received either a single dose of the 20-valent pneumococcal vaccine or Prevnar 13. One month later, those who received the 20-valent vaccine were given an injection of saline placebo, and subjects who received Prevnar 13 were given the 23-valent polysaccharide vaccine. There was no placebo control group.
Robust levels of serotype-specific bacterial killing were observed for all 20 vaccine serotypes. No adverse events or deaths were reported, and severe injection site reactions or systemic events were reported in less than 1% of those who received the 20-valent vaccine. The results were presented this week at the European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam.
Kathrin Jansen, senior vice president and head of vaccine research and development for Pfizer, said the results suggest the vaccine could offer "comprehensive coverage" against additional serotypes that cause pneumococcal disease, both in the U.S. and around the world.
"There continues to be a global health need to protect against the potential effects of invasive pneumococcal disease and pneumonia caused by additional serotypes not yet covered by existing conjugate vaccines," she said in a company statement.
The 20-valent vaccine moved to Phase 3 testing in December, and Pfizer expects to submit a biologics license application to the FDA by the end of 2020.