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Moderna Stock Surges As It Swings For Pfizer, GSK With New RSV Vaccine Results

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Moderna (MRNA) stock surged early Wednesday after the company said its experimental RSV vaccine proved nearly 84% effective against respiratory symptoms in older adults.

The company tested its vaccine in people age 60 and older. It was 83.7% effective against mild respiratory syncytial virus, or RSV. The virus causes cold-like symptoms. It can be deadly in infants who have virtually nonexistent immune systems and older adults who have weakened immunity.

The results are competitive with Pfizer (PFE) and GSK (GSK), both of which are approaching Food and Drug Administration review dates for their RSV vaccines in May. Johnson & Johnson (JNJ) and Bavarian Nordic trail with potential vaccines.

Moderna is planning to file for approval of its RSV vaccine in the first half of this year. Needham analyst Joseph Stringer expects the FDA to approve the shot before year’s end.

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“We think Moderna’s profile is competitive and has the potential to capture a meaningful share of the multi-billion dollar RSV market,” he said in a note to clients.

Moderna Stock: A Battle Brewing In RSV

In premarket action on the stock market today, Moderna stock surged 6.3% near 202.70.

Moderna Chief Executive Stephane Bancel says the results further prove the capabilities of the company’s platform in messenger RNA, or mRNA. In the body, messenger RNA carries the genetic instructions for making proteins. Vaccines take advantage of this process, telling the body to make specific proteins in order to prompt an immune response.

“Today’s results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older,”Bancel said in a written statement issued late Tuesday. “These data are encouraging and represent the second demonstration of positive Phase 3 (study) results from our mRNA infectious disease platform.”

Moderna tested its RSV vaccine in 37,000 adults age 60 or older in 22 countries, including the U.S. The company reported an interim analysis, examining the number of participants to develop two or more symptoms of RSV. Of the 64 people to develop symptoms, 55 received the placebo. Nine were vaccine recipients.

Another measure looked at participants to develop three or more symptoms of RSV. Moderna said there were 20 people in the study to hit that mark, including 17 placebo recipients and three vaccinated people. That put the effectiveness at 82.4% against so-called severe RSV.

An independent team of data monitors reviewed Moderna’s test results and said there have been no safety concerns.

The results help Moderna stock continue trending higher. Shares have turned around this month and have a strong Relative Strength Rating of 90 out of a best-possible 99, according to IBD Digital. This puts Moderna stock in the leading 10% of all stocks in terms of 12-month performance.

Comparing RSV Vaccines

Now, Moderna plans to submit the data to a peer-reviewed publication and present more data at a future infectious diseases conference.

By comparison, GSK has said its RSV vaccine was almost 83% effective overall and more than 94% protective against severe RSV in adults age 60 and older with underlying health problems. Pfizer’s shot was close to 67% protective overall and about 86% effective against severe disease.

“Based on high level comparison with vaccine effectiveness from RSV vaccines from competitors Pfizer, GSK and J&J, we see these results as likely approvable and plausibly competitive with those agents,” SVB Securities analyst Mani Foroohar said in a note. He noted the results are still early and comparing the various competitors’ studies “should consequently be taken with a grain of salt.”

Trailing, Bavarian Nordic plans to have its Phase 3 RSV vaccine results in the middle of the year. J&J is also in final-phase testing with results possible in the second half of 2024, Needham’s Stringer said.

Foroohar, the SVB analyst, expects Moderna to ask for a speedy review of its RSV vaccine.

This would allow “approval in time to give Moderna a more fulsome opportunity to participate in the 2023 contracting season,” he said. Foroohar boosted his price target on Moderna stock to 111 from 102, but kept his market perform rating.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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Whooping cough cases up slightly in N.L., as officials warn about risks to infants – CBC.ca

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Newfoundland and Labrador’s top doctor is warning people to stay up to date on whooping cough vaccinations after a small increase in cases this year.

The province usually sees three to four cases of the disease annually. Up to 10 cases have been reported already since January, however, prompting the province’s chief medical officer to raise the issue publicly.

The increase “generally means there’s a little bit more circulating in the community than what’s presenting for care and testing,” Dr. Janice Fitzgerald said Tuesday.

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While officials aren’t overly concerned about a future spike in cases, Fitzgerald said, higher infection rates place infants in particular at risk.

Children under the age of one aren’t yet old enough for the whooping cough vaccine and don’t have immunity to the disease, Fitzgerald said. Infections in small children can be more severe and lead to pneumonia, neurological issues and hospitalization. 

Fitzgerald said parents, grandparents and caregivers should check to ensure their vaccinations are up to date.

Whooping cough, also known as pertussis, causes a persistent nagging cough that’s sometimes severe enough to cause vomiting. Vaccines for the disease are offered in early childhood, during high school and in adulthood. Booster shots should be given 10 years after the high school dose, Fitzgerald said.

“Immunity can wane over time,” she said. “Pertussis does circulate on a regular basis in our community.”

The small increase in cases isn’t yet ringing alarm bells for undervaccination within the general population, she added, noting the province still has a vaccination rate over 90 per cent. 

Download our free CBC News app to sign up for push alerts for CBC Newfoundland and Labrador. Click here to visit our landing page.

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Supervised consumption sites urgently needed, says study – Sudbury.com

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A study in the Canadian Medical Association Journal (CMAJ) said the opioid drug crisis has reached such a critical level that a public safety response is urgently required and that includes the need for expanded supervised consumption sites.

The report was published by the medical journal Monday and was authored by Shaleesa Ledlie, David N. Juurlink, Mina Tadrous, Muhammad Mamdani, J. Michael Paterson and Tara Gomes; physicians and scientists associated with the University of Toronto, Sunnybrook Research Institute and the Li Ka Shing Knowledge Institute at St. Michael’s Hospital.

“The drug toxicity crisis continues to accelerate across Canada, with rapid increases in opioid-related harms following the onset of the COVID-19 pandemic,” the authors wrote. “We sought to describe trends in the burden of opioid-related deaths across Canada throughout the pandemic, comparing these trends by province or territory, age and sex.”

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The study determined that across Canada, the burden of premature opioid-related deaths doubled between 2019 and 2021, representing more than one-quarter of deaths among younger adults. The disproportionate loss of life in this demographic group highlights the critical need for targeted prevention efforts, said the study.

The researchers found that the death rate increased significantly as fentanyl was introduced to the mix of street drugs that individuals were using, in some cases, unknowingly.  

The authors said this demonstrates the need for consumption sites, not only as overwatch as people with addictions consume their drugs, but also to make an effort to identify the substances and inform those people beforehand. 

“The increased detection of fentanyl in opioid-related deaths in Canada highlights the need for expansion of harm-reduction programs, including improved access to drug-checking services, supervised consumption sites, and treatment for substance use disorders,” the authors wrote. 

The study said a more intense public safety response is needed. 

“Given the rapidly evolving nature of the drug toxicity crisis, a public safety response is urgently required and may include continued funding of safer opioid supply programs that were expanded beginning in March 2020, improved flexibility in take-home doses of opioid agonist treatment, and enhanced training for health care workers, harm reduction workers, and people who use drugs on appropriate responses to opioid toxicities involving polysubstance use.

In conclusion, the authors wrote that during the height of the COVID pandemic in 2020 and 2021, the burden of premature death from accidental opioid toxicities in Canada dramatically increased, especially in Alberta, Saskatchewan, and Manitoba. 

“In 2021, more than 70 per cent of opioid-related deaths occurred among males and about 30 per cent occurred among people aged 30–39 years, representing one in every four deaths in this age group. The disproportionate rates of opioid-related deaths observed in these demographic groups highlight the critical need for the expansion of targeted harm reduction–based policies and programs across Canada,” said the study.

The full text of the report can be found online here.

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Business Plan Approved for Cancer Centre at NRGH – My Cowichan Valley Now

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A business plan for a new BC Cancer Centre at Nanaimo Regional General Hospital has been approved by the province. 

 

Health Minister Adrian Dix  says the state-of-the-art cancer facility will benefit patients in Nanaimo and the surrounding region through the latest medical technology.
 

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The facility will have 12 exam rooms, four consultation rooms and space for medical physicists and radiation therapists, medical imaging and radiation treatment of cancer patients. 

 

The procurement process is underway, and construction is expected to begin in 2025 and be complete in 2028. 

 

Upgrades to NRGH have also been approved, such as a new single-storey addition to the ambulatory care building and expanded pharmacy. 

 

Dix says Nanaimo’s population is growing rapidly and aging, and stronger health services in the region, so people get the health care they need closer to home. 

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