Pneumococcal 7-valent conjugate vaccine(Pfizer Inc.)

With outbreaks of hantavirus and Ebola virus dominating the news, Pfizer vaccine chief Annaliesa Anderson, Ph.D., is traveling with face masks again for the first time in a while.\n After decades of developing vaccines to shield babies and adults from Streptococcus pneumonia infections, Pfizer is now taking another leap forward in its efforts to protect against one of the bacteria’s most dangerous strains—all while keeping an eye on the world’s several emerging global health threats.The pharma giant today shared data from a phase 2 study of its latest vaccine against Streptococcus pneumoniae, also called pneumococcus, which is designed to protect babies from 25 different variants of the pathogen.At the International Society of Pneumonia and Pneumococcal Diseases conference in Copenhagen, Pfizer revealed that its next-gen candidate—mellifluously named PF-07872412 or 25vPnC—produced stronger immune responses than the approved 20-variant vaccine Prevnar 20.Pfizer’s ultimate goal is to make a vaccine that hits 35 pneumococcus variants, known as serotypes, to cover 98% or 99% of all infections, the drugmaker’s vaccine R&D chief Annaliesa Anderson, Ph.D., told Fierce Biotech. But a leap from 20 to 35 serotypes takes time, and along the way the company realized that one variant in particular deserved special attention: serotype three.“Serotype three is a particularly serious serotype with high levels of associated morbidity and mortality,” Anderson explained. This variant causes 15% to 20% of infections, depending on the region, she said, and while Prevnar provides some protection against it, it doesn’t produce a strong enough immune response to halt community spread.Serotype three pneumococcus can invade the bloodstream and cause severe complications like pneumonia and meningitis, with fatality rates hitting as high as 47%.Pneumococcal vaccines work by generating antibodies that cling to the bacteria’s sugary surface. But serotype three’s sugars are thin and sparse, like a wire coat hanger that’s been straightened out, Anderson said, making it difficult to target.Pfizer recognized this challenge even before Prevnar 20 was licensed, she added, and the company put together an internal team of immunologists, bacteriologists and vaccine engineers to craft a solution. The team was able to assemble a “toolbox” of proteins that could effectively bind to serotype three’s bony sugar skeleton.In another presentation at the same conference, given yesterday, Pfizer pitted its next-gen serotype three approach against past attempts in adults and found it to be superior.But with 25vPnC now passing muster in infants, Pfizer is tightening the candidate’s focus all in the name of time. While a phase 3 trial in babies kicked off earlier this month, the pharma has decided to focus on its 35-variant candidate for adults instead.“Adult vaccines take less time to develop because you\'re not waiting for the baby to take all four vaccines and grow to a certain age,” Anderson said, which can take 12 or 18 months. “And we\'re not going to enroll all those babies overnight.”Because moving a 35-variant candidate forward in babies would take so long, the company is still advancing 25vPnC in order to get serotype three protection to the little ones as quickly as possible.Pneumococcus “used to be one of the most common diseases out there for babies, and now it\'s not,” Anderson said. “We want to keep it like that.” Head down Though anti-vaccine sentiment is currently dominating U.S. health agencies, Anderson is keeping her focus on the things she can control—ensuring Pfizer has a strong, science-backed portfolio of vaccines moving ahead.“Parents like to protect their babies,” the vaccine leader told Fierce. “The pneumococcal vaccines have got an incredibly safe safety profile. They\'re used all over the world.”Pfizer’s history in the field runs deep. Wyeth, which Pfizer acquired in 2009 for a whopping $68 billion, released its first pneumococcal vaccine—effective against seven variants of the bacteria—in 2000.Aside from working to subdue pneumococcus, Pfizer’s vaccine programs straddle very early-stage efforts as well as late-stage candidates meant to tackle areas of huge unmet medical need. That includes a shot for Clostridium difficile infection that failed a phase 3 trial in 2022 in adults 50 or older, which Pfizer is now pursuing in a narrower group of adults aged 65 and up.Another vaccine for Lyme disease also missed in phase 3 earlier this year, which Pfizer and partner Valneva attributed to lower-than-expected cases of the tick-borne illness. The pharma still plans to push ahead with an approval effort. Like pneumococcus, C. diff and Borrelia burgdorferi, which causes Lyme disease, are both bacteria.“They all meet unmet medical needs, and they\'re all critical,” Anderson said of these investigational immunizations. But she’s also excited by Pfizer’s continuing work in established disease areas like respiratory syncytial virus and COVID-19, which forms the other pillar of the company’s vaccine portfolio.But fighting infectious diseases is like playing Whack-A-Mole, with new threats popping up at an ever-increasing pace. Anderson is keenly aware of the new pathogens now dominating the news cycle, a hantavirus outbreak on a cruise ship and an Ebola epidemic in central Africa, now labeled a public health emergency of international concern by the World Health Organization.Both of the viruses in question, the Andes virus species of hantavirus and the Bundibugyo species of Ebola virus, currently lack vaccines.As the maker, along with partner BioNTech, of the first mRNA vaccine for COVID-19, Comirnaty, Pfizer is not hesitant to pitch in when health crises emerge, Anderson told Fierce.“We keep an eye on what\'s going on out there, and if public health emergencies happen, we are certainly comfortable to step in and see where we can help,” she said.Her concern is evident, she added, if one looks through the luggage she packed for her trip to Copenhagen for the conference. For the first time in a while, she made sure to bring face masks.

Pfizer on Wednesday detailed results supporting its decision to advance the investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 into Phase III studies, including data showing stronger immune responses than the approved 20-variant shot Prevnar 20. The findings were presented at the International Society of Pneumonia & Pneumococcal Diseases (ISPPD) meeting.The results come from a Phase II study, which randomised healthy infants to receive PF-07872412 or Prevnar 20 at months 2, 4, 6 and 12–15. While Prevnar 20 is approved for the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains, PF-07872412 seeks to build on this by adding protection against an additional five serotypes — 15A, 23A, 23B, 24F and 35B.In the trial, Pfizer said that PF-07872412 demonstrated "robust immunogenicity," including enhanced response against serotype 3, alongside expanded protection across the 25 serotypes. The company added that based on these immune responses, it is "confident" that the required non-inferiority thresholds will be achieved in further studies.Specifically, one month after the third dose, geometric mean titers for serotype 3 were 8.8-fold higher with PF-07872412 than with Prevnar 20 in the Phase II trial. Meanwhile, one month after dose four, geometric mean titers for serotype 3 were approximately 15-fold higher with the 25-valent vaccine than with Prevnar 20.Pfizer indicated that PF-07872412's safety profile was "consistent" with currently-approved pneumococcal vaccines, with the most common local reactions being redness, swelling or pain at the injection site."These…results reinforce our confidence in a next-generation vaccine," said Annaliesa Anderson, Pfizer's chief vaccines officer. "We are advancing our Phase III programme with the goal of delivering broader and more durable protection for children."The pivotal paediatric programme — which was initiated this month — is designed to investigate PF-07872412 versus Prevnar 20 in up to 2400 individuals. Pfizer hopes that if successful, the new vaccine will broaden protection to about 90% of disease-causing pneumococcal serotypes in US children.Prevnar 20 is currently approved in both infants and adults, with the vaccine, along with the older version Prevnar 13, generating combined sales of $6.5 billion last year. Pfizer said Wednesday that in an effort to maintain its current leadership in the adult market over the long term, it will move directly to a vaccine candidate covering 35 serotypes. The shot is expected to enter clinical development by the end of 2026.