cdc immunization :: Article CreatorMerck's New Pneumococcal Jab Capvaxive Gets CDC Panel Vote
Merck (NYSE:MRK) announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to recommend MRK's newly approved 21-valent pneumococcal conjugate vaccine (PCV) Capvaxive. The FDA approved Capvaxive earlier this month for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Capvaxive became the first PCV specifically designed for adults to be approved by the FDA.
Capvaxive targets serotypes that account for approximately 84% of all invasive pneumococcal disease in older adults (50 years and older) in the United States, including eight serotypes not covered by currently licensed vaccines.
The ACIP recommends a single dose of Capvaxive for three distinct patient populations, the first being adults aged 65 years and older who have never received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The second eligible patient population includes adults aged 19-64 years with certain underlying medical conditions or risk factors who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown.
The final patient population for whom ACIP recommends Merck's Capvaxive are adults aged 19 years and older who have begun their pneumococcal vaccine series with 13-valent PCV (PCV13) but have not received all the recommended pneumococcal 23-valent polysaccharide (PPSV23) vaccine doses.
Additionally, the ACIP advises that shared clinical decision-making should be applied for the use of a supplemental dose of Capvaxive for adults aged 65 years and older who have already completed their vaccine series with both PCV13 and PPSV23.
These new recommendations highlight Capvaxive's potential to enhance protection against pneumococcal disease in older adults and those with specific health conditions. However, these recommendations are provisional, which means they are not legally binding. These will only be official when the CDC reviews and finalizes the same.
Year to date, shares of MRK have jumped 19.1% compared with the industry's 21.9% growth.
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Capvaxive's approval was based on data from four phase III studies conducted across a range of adult populations. In the studies, Capvaxive demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations.
Merck also has a 15-valent PCV called Vaxneuvance (V114) in its vaccine portfolio that was approved in 2021. Vaxneuvance generated sales of $665 million in 2023, down 2% year over year.
Merck & Co., Inc. Price and Consensus
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Zacks Rank and Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings, Annovis Bio (NYSE:ANVS) and Compugen (NASDAQ:CGEN), each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology's 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 60.8%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis' 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 67.9%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen's 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 11.1%.
CGEN's earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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CDC Strengthens RSV Vaccine Advice For Those Over 75
In new vaccination guidance issued Wednesday, U.S. Health officials now recommend that all Americans aged 75 and older get an RSV vaccine before fall arrives.
However, those a bit younger—ages 60 to 74—should only seek the shot if they are vulnerable to severe RSV because of chronic medical conditions such as lung or heart disease, or if they live in nursing homes, the U.S. Centers for Disease Control and Prevention advised.
The recommendations came from a committee of CDC advisers and the agency has approved that guidance, making the advice official.
"The CDC has updated its RSV vaccination recommendation for older adults to prioritize those at highest risk for serious illness from RSV," CDC Director Dr. Mandy Cohen said in an agency news release. "People 75 or older, or between 60-74 with certain chronic health conditions or living in a nursing home, should get one dose of the RSV vaccine to provide an extra layer of protection."
The new guidelines only apply to adults who did not get an RSV vaccine last year, the CDC noted, because people do not need to get a shot every RSV season. The best time to get vaccinated is in late summer and early fall, before RSV starts spreading through the country, the agency added.
Just a year ago, the same CDC advisory panel recommended that people 60 and older simply talk to their doctors about whether to get the shots. Physicians have said the tepid recommendation confused patients and is probably why less than 25% of older Americans have gotten a RSV shot, the Associated Press reported.
RSV (respiratory syncytial virus) is a common cause of cold-like symptoms, but it can be dangerous for infants and the elderly.
Last year, the U.S. Food and Drug Administration licensed two single-dose RSV vaccines, made by GSK and Pfizer, for older people. At the time, the vaccine advisers refrained from saying that all older Americans should get the shots because of questions about possible side effects and the duration of protection, the AP reported.
Some of those questions remain, and on Wednesday panel members said no to a request by vaccine manufacturers to recommend the shots for all Americans aged 60 and older. The panel also declined to endorse giving the GSK vaccine to people in their 50s, even though the FDA this month licensed the company's shot for that age group, the AP reported.
A newly approved RSV shot from Moderna will be subject to the same guidance.
Panel members said Wednesday that evidence has shown the shots make sense for all people 75 and older, because they are at higher risk for severe RSV. But they drew narrower guidelines for those aged 60 to 74.
Underlying the panel's hesitancy are reports of a nervous system disorder, Guillain-Barre syndrome. Though rare, there have been a higher-than-expected number of Guillain-Barre cases among RSV vaccine recipients, particularly in those who got the Pfizer shot.
FDA officials noted Wednesday there is no clear evidence the shots are causing the disorder, but some panel members noted research is still ongoing.
"I do agree with the overall conclusion that the risks of RSV vaccination are greatly outweighed by the overall benefits," said panel member Dr. Camille Kotton, an infectious diseases expert at Massachusetts General Hospital. "Nonetheless, I remain quite concerned" about recurring indicators of Guillain-Barre in vaccination surveillance data, she added.
More information: The CDC has more on RSV.
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CDC Advisory Panel Opts For A Go-slow Approach On Expanding Usage Of RSV Vaccines
Makers of RSV vaccines for older adults saw their plans to try to expand usage hit a significant hurdle on Wednesday, when an expert committee that advises the Centers for Disease Control and Prevention on vaccines recommended changes that will likely see fewer older adults qualify for insurance coverage for these products.
In a related move, the Advisory Committee on Immunization Practices opted not to make a recommendation yet on use of GSK's Arexvy vaccine in adults 50 to 59, saying the committee didn't have enough data with which to make such a recommendation. Earlier this month the Food and Drug Administration approved use of the GSK vaccine to include adults in their 50s at high risk of developing severe disease if they contract respiratory syncytial virus, or RSV. When it was initially approved in May 2023, its use was restricted to people 60 and older.
The decision is a blow to GSK, which has been racing to secure market share in a field that now includes two competitors, Pfizer and Moderna. To that end, GSK used a priority review voucher to speed its age extension application through the FDA approval process. The agency is currently reviewing an application from Pfizer to extend the license for its RSV vaccine, Abrysvo, to include adults 18 and older who have health conditions that put them at risk of severe illness from RSV infection.
In a statement, GSK said it will continue to generate data on the vaccine to add to what it called "the existing robust clinical data package," to help guide future policy making decisions.
Without a recommendation for use from the ACIP and the CDC, insurance companies are unlikely to cover the cost of the GSK vaccine for people in their 50s. And at nearly $300 a dose — not including administration fees — those individuals may be reluctant to pay out of pocket.
The final decision on vaccination use policy rests with the CDC director, Mandy Cohen. Late Wednesday the CDC issued a statement adopting the recommendations the ACIP had approved about an hour before.
"The CDC has updated its RSV vaccination recommendation for older adults to prioritize those at highest risk for serious illness from RSV," Cohen said in the statement.
In particular, the work group suggested it needs information on how adults in their 50s who have immunocompromising conditions react to the vaccine — what kind of antibody responses it generates — more data on whether additional shots will boost protection that has waned. Some of the data to date suggest the reaction to booster shots is not as powerful as the response to the initial vaccine. ACIP member Sarah Long, a pediatrics professor at Drexel University College of Medicine in Philadelphia, worried that if boosting isn't effective, giving the RSV vaccine too soon might squander a tool that could be more needed later in life.Long and others on the committee worried that given the possible link to GBS, the risk-benefit ratio for people in their 50s may not favor vaccination in the way it does in older adults.
RSV vaccines for older adults are new. The first two, from GSK and Pfizer, were approved last spring and were rolled out for the first time in the autumn. Initially licensed only for adults 60 and older, the ACIP opted last June not to make a universal recommendation for their use, in the way that everyone is urged to get an annual flu shot. Instead, it suggested people who were eligible could get one of the vaccines, but should first talk to a health care provider to weigh the risks and benefits of getting vaccinated.
That approach, called shared decision-making, made sense to a committee that was reluctant to urge everyone 60 and older to get a shot, given that there are concerns that a small number of people who get the Pfizer and GSK vaccines — particularly the former — may develop Guillain-Barré syndrome, a form of progressive paralysis from which people normally recover, but after an extended period of hospitalization. There were no reports of Guillain-Barré syndrome among people in the clinical trials that led to the approval of Moderna's RSV vaccine, mResvia, which was just approved by the FDA at the end of May.
Doctors and pharmacists complained about the shared decision-making recommendation, indicating they didn't always know how to advise patients. There are concerns that the recommendation may have depressed uptake of the vaccine.
So the ACIP's RSV work group proposed changing the recommendation in two ways, both of which were unanimously accepted by the full committee. In a vote of 11 to 0, the committee recommended that people aged 75 and older should get an RSV shot, if they have not yet had one. While it's known the protection of these vaccines wanes with time, it's not yet clear what the optimal cadence for revaccination is. So at present there is no recommendation for people who were vaccinated already to get another RSV shot.
In the second vote, the committee recommended that people aged 60 to 74 who have health conditions that put them at high risk of severe illness from RSV should also get the vaccine. People aged 60 to 74 who do not have one of the health conditions named could still get the vaccine, if they wish. But without an ACIP/CDC recommendation, they would have to pay out-of-pocket, committee chair Helen Keipp Talbot noted.
The health conditions listed include lung disease, cardiovascular disease, diabetes with end organ damage, severe obesity, neurological or neuromuscular conditions, advanced chronic kidney disease, liver disorder, or blood disorders. Adults aged 60 to 74 who live in long-term care facilities or who are deemed frail would also qualify, as would people who are moderately or severely immunocompromised.
While a couple of members of the public raised concerns about the effect the new recommendation may have on vaccine uptake in people aged 60 to 74, committee members noted that the science on use of these products is evolving, and policy on their use will as well. ACIP member Matthew Daley noted after the votes that the panel perhaps should have added the words "at this time" to the wording of the votes, to make that point clear.
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