---
title: "Vaxcyte’s VAX-31 meets Phase 3 endpoints; FDA delays Novo Nordisk hemophilia A review over manufac"
id: "stat-news-1-stat-pharmalittle-we-re-reading-about-a-vaxcyte-pneumococcal-shot-increasing"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-a-vaxcyte-pneumococcal-shot-increasing"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "STAT News"
source_url: "https://www.statnews.com/pharmalot/2026/10/05/vaxcyte-pneumococcal-vaccine-rising-pharma-mergers-acquisitions/?utm_campaign=rss"
published_at: "2026-10-05T13:10:03.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Vaxcyte’s VAX-31 meets Phase 3 endpoints; FDA delays Novo Nordisk hemophilia A review over manufac
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-a-vaxcyte-pneumococcal-shot-increasing
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/pharmalot/2026/10/05/vaxcyte-pneumococcal-vaccine-rising-pharma-mergers-acquisitions/?utm_campaign=rss)
- **Published At:** 2026-10-05T13:10:03.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Vaxcyte reported that its experimental **pneumococcal vaccine**, VAX-31, met primary endpoints in a Phase 3 trial, positioning the company to challenge market incumbents. VAX-31 targets 31 pneumococcal serotypes, compared with 20 for Pfizer’s Prevnar and 21 for Merck’s Capvaxive. - Vaxcyte still must complete two additional trials before seeking regulatory approval: one assessing VAX-31 given concurrently with an influenza vaccine and another in adults who previously received a different pneumococcal vaccine. Those trials are required to deliver results prior to a filing. - The U.S. **Food and Drug Administration (FDA)** extended its review of Novo Nordisk’s experimental hemophilia A drug, denecimig, because of ongoing remediation at a manufacturing facility. The extension was linked to facility issues rather than concerns about clinical safety or effectiveness. - Novo Nordisk submitted the denecimig application in September 2025 and expected an FDA decision in the third quarter of 2026; the FDA has not set a new decision timeline. Novo stated the regulator did not raise safety or effectiveness concerns and that the manufacturing site issues do not affect its other marketed medicines. - The report summarizing these items was published as a Pharmalittle column on Oct. 5, 2026, by Ed Silverman and includes a STAT+ exclusive component for subscribers. The article noted competitive implications for Vaxcyte if the remaining trials and filings succeed. - Details on exact trial sizes, statistical results, timelines for the two remaining Vaxcyte studies, and the FDA’s new deadline for denecimig were not reported in the source article.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)Newsletter[Pharmalot](https://www.statnews.com/category/pharma/pharmalot/) # Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more ## FDA extended its review of an experimental hemophilia A drug from Novo Nordisk * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * [Save this story for later](https://www.statnews.com/my-account/saved/) * [Share this article](https://www.statnews.com/pharmalot/2026/10/05/vaxcyte-pneumococcal-vaccine-rising-pharma-mergers-acquisitions/?utm_campaign=rss) ![an anthropomorphized red and blue pill illustrated in the style of the famous american gothic painting](https://www.statnews.com/wp-content/uploads/2015/11/PHARMALOT_LITTLE-copy-645x645.jpg) Alex Hogan/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) By [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) Oct. 5, 2026 Pharmalot Columnist, Senior Writer ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) 1. [](https://www.linkedin.com/in/edsilverman/ "Linkedin") 2. [](https://x.com/Pharmalot "X") ed.silverman@statnews.com Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? After all, the world — such as it is — continues to spin. So to nudge it in a better direction, we are relying, as always, on a cuppa stimulation. Our choice today is blueberry hibiscus. Of course, you are welcome to join us. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. … **Vaxcyte disclosed that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up a competition with Pfizer and Merck** , [STAT](https://www.statnews.com/2026/10/05/vaxcyte-pneumococcal-vaccine-study-pfizer-merck/) writes. Vaxcyte’s shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer’s Prevnar and 21 strains for Merck’s Capvaxive. The company needs two more trials to deliver results before it can file for approval: a study looking at VAX-31 administered alongside an influenza vaccine and a study in adults who previously received a different pneumococcal shot. Advertisement **The U.S. Food and Drug Administration has extended its review of an experimental hemophilia A drug from Novo Nordisk due ​to ongoing remediation work at a manufacturing facility** , [Reuters](https://www.reuters.com/legal/litigation/us-fda-extends-review-novo-nordisks-hemophilia-drug-over-facility-issues-2026-10-02/) notes. Novo had submitted the application for the drug, called denecimig, in ​September 2025 and was expecting an FDA decision in the third quarter of 2026. While the regulator has not yet set ​a new timeline for its decision, Novo said ​the FDA did not raise any concerns regarding the safety ‌or ⁠effectiveness data from the drug’s clinical trials. Novo added that the manufacturing site issues do not impact any of its other medicines currently on the market. STAT+ Exclusive Story Already have an account? 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