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FDA Says Yes To MSD's 21-valent Adult Pneumococcal Jab

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The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD's new shot Capvaxive, the first to be aimed specifically at adults.

The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD's earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

The approval is the strongest challenge yet to Pfizer's pneumococcal vaccine franchise, led by its 20-valent Prevnar 20 shot, which generated $6.4 billion in sales last year from use for prevention of IPD in infants, children, and adults.

MSD's current jab Vaxneuvance – which covers 15 serotypes – is also approved for use in infants, children, and adults and made $665 million in worldwide sales last year.

With Capvaxive, MSD (known as Merck & Co in the US and Canada) is aiming to carve out a niche in the over-50s, positioning it as the go-to vaccine used to prevent invasive pneumococcal disease (IPD) in this group.

All told, Capvaxive encompasses the serotypes responsible for around 84% of IPD cases in adults aged 50 and over, compared to around 52% with Prevnar 20, according to data from the Centers for Disease Control and Prevention (CDC). The eight serotypes unique to MSD's vaccine account for more than a quarter (27%) of IPD cases in adults 50 and older.

The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on Thursday 27th June to discuss and make recommendations for the use of Capvaxive in adults. All eyes are on that meeting, as the wording of the ACIP's recommendations will give the clearest view of how competitive the new shot will be in the US market.

The CDC currently recommends pneumococcal vaccination for all adults age 65 and older and for younger adults who are immunocompromised or have certain other risk factors. If Capvaxive is recommended for the over-50s bracket, it could unlock a lucrative new category in the market, and that age-targeted approach is central to MSD's targeted pneumococcal vaccine strategy.

It is also deploying its age-targeted serotype selection approach to V117, a paediatric vaccine that is currently in phase 3 testing.

There are around 100 different pneumococcal serotypes, causing non-invasive disease like pneumonia confined to the lungs and invasive disease where the infection can spread to the bloodstream or tissues in the central nervous system. It is estimated that more than 150,000 adults are hospitalised from pneumococcal pneumonia each year in the US.

MSD also sells an older shot called Pneumovax 23, which covers 23 serotypes, but is based on an older polysaccharide technology that does not stimulate the immune response as strongly as the newer conjugate vaccines. It brought in $412 million in 2023, down from more than $600 million in the prior year.

New Recommendations For Pneumonia Vaccination

Published December 24, 2024 at 5:30 AM EST

This week Bobbi Conner talks with Dr. Jessica Lozier about new recommendations for pneumonia vaccination. Dr. Lozier is an Assistant Professor of medicine and a pulmonary and critical care physician at MUSC.

TRANSCRIPT:

Conner: I'm Bobbi Conner for South Carolina Public Radio with Health Focus here at the radio studio for the Medical University of South Carolina in Charleston. About 70% of people 65 and up get the pneumonia vaccine. Now, the CDC is recommending that individuals 50 and up should receive vaccination as well. Doctor Jessica Lozier is here to talk about the details. Doctor Lozier is an Assistant Professor of Medicine, and she's a pulmonary and critical care physician at MUSC. Doctor Lozier, first tell us about pneumonia.

Dr. Lozier: Pneumonia is an infection in the lungs that can be caused by many bacteria, viruses or fungi. The most common type is caused by a bacteria called streptococcal pneumonia, a bacteria that causes pneumonia and meningitis in adults. It can also cause bloodstream infections and ear infections. Annually, there's over 150,000 people hospitalized for pneumococcal pneumonia, and it leads to over 3,500 deaths. Here in South Carolina, we lose approximately 700 people a year to deaths related to pneumonia, and pneumococcal is the leading cause of this. About 90% of those that get sick are actually eligible for vaccination.

Conner: What causes pneumonia and who is at increased risk or at risk of serious complications.

Dr. Lozier: So pneumococcal pneumonia can be spread either through coughing or close contact with others who have the bacteria. Some risk factors for getting sick with this type of pneumonia, including older age, above 50 or being chronically ill with things like heart disease, lung disease, liver disease, or kidney disease. Other folks that have increased risk are immunocompromised from medications, cancer, HIV, or Asplenia. These at risk groups have over 9 to 18 times the risk of healthy adults.

Conner: And tell us about the pneumonia vaccine.

Dr. Lozier: So, the first licensed vaccine actually came out in 1977. The recommendations used to be for a combination of shots, including two different ones, to promote a broad and durable immunity. But with the newer version of the vaccine, you can get that immunity with just one vaccine, called either the PCV 20 or the PCV 21. In studies, the vaccine is 75% effective at preventing the serotype related invasive disease. How that translates to the real world in that it prevents about 10% of pneumonia hospitalizations, and it decreases death from any cause in folks that get the vaccine.

Conner: And doctor Lozier, how safe is this pneumonia vaccine?

Dr. Lozier: Thankfully, it's very safe. Most commonly, folks experience either body aches or a sore arm for less than 48 hours. Less than 0.3% had any more serious reaction.

Conner: Tell us about the new recommendations for the pneumonia vaccine.

Dr. Lozier: The old recommendation was for folks 65 or older to get the vaccine, but we realized that those greater than 50 were still at a really high risk and were getting sick at high numbers. So now the CDC is recommending all adults greater than 50 years old, regardless of prior immunization for pneumonia, get one dose of that PCV 20 or PCV 21 vaccine. And, then anybody 19 through 49 with any of the chronic medical conditions that we talked about earlier, they should get one dose of the PCV 20 or PCV 21 to protect themselves from this preventable disease. We know that those at higher risk groups, even those younger 19 to 49, only about 25% of those folks get their vaccination. We also know that some groups, like black Americans and those with lower socioeconomic status, have lower vaccination rates compared to our communities. So, I think it's something we can focus on as providers to help make sure that we're delivering care to these high risk groups.

Conner: Doctor Lozier, thanks for this information about the pneumonia vaccine.

Dr. Lozier: You're welcome.

Conner: From the radio studio for the Medical University of South Carolina in Charleston, I'm Bobbi Conner for South Carolina Public Radio.

Health Focus transcripts are intended to accurately represent the original audio version of the program; however, some discrepancies or inaccuracies may exist. The audio format serves as the official record of Health Focus programming.

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