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FDA approves Merck vaccine designed to protect adults from…

18 June 2024
by admin

Merck’s new pneumococcal vaccine.

Courtesy: Merck

The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form.

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia.

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer.

Merck’s competitive edge

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028.

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts.

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said.

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers.

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021.

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data.

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

Science & Environment

FDA approves GSK’s RSV vaccine for high-risk adults ages…

7 June 2024
by admin

A view shows GlaxoSmithKline headquarters in London, Britain, January 17, 2022.

Hannah Mckay | Reuters

The Food and Drug Administration on Friday expanded the approval of GSK‘s respiratory syncytial virus vaccine to adults ages 50 to 59 who are at increased risk of getting severely sick from the potentially lethal virus.

The shot, called Arexvy, is the first vaccine cleared by the FDA to protect that population from RSV. The agency first approved GSK’s jab in May 2023 for patients 60 and above, who are more vulnerable to severe cases of the virus.

RSV causes thousands of hospitalizations and deaths among seniors each year, according to data from the Centers for Disease Control and Prevention. But the virus can also cause severe illness in adults 50 and up — or even younger — with underlying chronic conditions such as asthma, diabetes and congestive heart failure.

About 13 million Americans ages 50 to 59 are at high risk of severe illness from RSV, said Phil Dormitzer, GSK’s head of vaccines research and development and infectious disease research, in an interview.

“It’s useful both because, of course, you can meet the medical needs of that age group,” Dormitzer told CNBC, “but it’s also nice for pharmacists to have a single vaccine that they can administer to a wider population, so that provides simplicity.”

GSK’s shot won’t reach that new patient population just yet. An advisory panel to the CDC will vote later in June on recommendations for GSK’s vaccine, along with a rival shot from Pfizer and a newly approved jab from Moderna.

The FDA’s expanded approval could help GSK maintain its dominance in the RSV market later this fall and winter, when the virus typically spreads more widely in the U.S. The British drugmaker’s shot booked around £1.2 billion in sales last year, outpacing the $890 million (about £699 million) in revenue that Pfizer’s vaccine raked in.

GSK Chief Commercial Officer Luke Miels said on an earnings call in May that the company remains “very confident” that Arexvy can bring in more than £3 billion in peak annual sales over time.

Dormitzer said GSK had a successful last RSV season, but noted that the company will always “take the competition seriously.”

He said Arexvy showed strong efficacy in patients who have underlying medical conditions.

In a late-stage trial, a single dose of the shot elicited an immune response in high-risk adults ages 50 to 59 which wasn’t worse than that observed in people 60 and above.

A previous late-stage trial on that older age group found the shot was nearly 83% effective at preventing lower respiratory tract disease caused by RSV and around 94% effective at preventing severe disease.

Safety data in adults ages 50 to 59 was also consistent with data in adults 60 and above, according to GSK. Side effects included fatigue, headache and muscle pain, among others, which were mostly mild to moderate in severity.

A single dose of GSK’s shot was only slightly less effective in adults 60 and up after two seasons of the virus, showing 67.2% efficacy against lower respiratory tract illness. Dormitzer said the company will test the vaccine’s efficacy over three RSV seasons to see if it can provide even longer protection.

GSK is also studying Arexvy in other patient groups to expand the shot’s reach in the future. The company is expected to announce trial data later in 2024 on two separate patient groups: people ages 18 to 59 who are at increased risk of severe RSV, and adults with weakened immune systems.

Dormitzer added that the company is also expanding the shot’s reach in other countries. Regulatory agencies in Europe, Japan and other areas are currently reviewing GSK’s application to expand Arexvy’s approval to high-risk adults ages 50 to 59.

GSK’s shot is approved in nearly 50 countries, a spokesperson for the company told CNBC.

Science & Environment

FDA approves Moderna’s RSV vaccine for seniors, the company’s…

31 May 2024
by admin

The FDA has approved Moderna’s RSV vaccine for older adults.

Courtesy: Moderna

The Food and Drug Administration on Friday approved Moderna’s vaccine for respiratory syncytial virus for adults ages 60 and above, the company’s second-ever product to enter the U.S. market.

The decision is a win for Moderna, which desperately needs another revenue source amid plunging demand for its Covid jab, its only commercially available product.

The approval of Moderna’s shot is based on a late-stage trial on older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.

Moderna’s shot will be marketed under the brand name mRESVIA. It is the first messenger RNA vaccine to get approved for a disease other than Covid. The company’s shot is also the only RSV vaccine to be available in a pre-filled syringe, which is designed to make it easier to administer to patients.

An advisory panel to the CDC will vote in June on recommendations for the use and intended population of Moderna’s shot. The company expects an equal recommendation to existing RSV shots from GSK and Pfizer, Moderna executives said during an earnings call on May 1.

A positive recommendation from the CDC would allow Moderna’s vaccine to compete against GSK and Pfizer, which launched their respective shots in the U.S. last fall. Pfizer’s vaccine has so far lagged behind GSK’s, but both shots have so far recorded hundreds of millions in sales.

Moderna’s full-year 2024 sales guidance of roughly $4 billion includes revenue from its RSV vaccine.

The approval demonstrates the versatility of Moderna’s messenger RNA platform beyond treating Covid. The biotech company is using that technology to tackle a range of different diseases, including RSV, cancer and a highly contagious stomach bug known as norovirus.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in a release. “With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”

The biotech company currently has more than 40 products in development, several of which are in late-stage trials. They include its combination shot targeting Covid and the flu, which could win approval as early as 2025.

More CNBC health coverage

Moderna is also developing a stand-alone flu shot, a personalized cancer vaccine with Merck and shots for latent viruses, among other products.

Moderna has said it expects to return to sales growth in 2025 and to break even by 2026, with the launch of new products.

Investors have high hopes for the long-term potential of Moderna’s mRNA product pipeline: Shares of the company are up more than 60% this year after falling nearly 45% in 2023.

Vaccine trial data

The FDA was initially slated to make a decision on Moderna’s jab on May 12. The agency delayed the approval, citing internal “administrative constraints.”

A phase three trial on roughly 37,000 people showed that Moderna’s vaccine was 83.7% effective at preventing at least two symptoms of RSV at around three months. New data from that study in February showed the shot’s efficacy declined to 63% at 8.6 months.

At the time, those results raised concerns among investors that the shot’s efficacy declined faster than that of shots from GSK and Pfizer. Moderna in a statement said comparisons can’t be made without head-to-head trials on shots.

The company added that its trial had different study populations, geographic locations and case definitions for RSV, among other differences.

No significant safety concerns were identified in patients who took the shot in the trial. Most side effects were mild to moderate and included injection site pain, fatigue, headache, muscle pain and joint pain.

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