Artur Widak | Nurphoto | Getty Images
Shares of Moderna closed more than 13% higher on Tuesday after Oppenheimer upgraded the stock to "outperform," saying the Covid vaccine maker could market five products by 2026.
The upgrade follows a dismal 2023 for Moderna, whose only commercially available product is its Covid shot. The company's stock has long been tied to its vaccine, and its shares fell nearly 45% last year as demand for Covid products plummeted worldwide.
Oppenheimer analyst Hartaj Singh said the company's Covid sales could hit a low point in 2024 due to factors such as vaccine fatigue. But the firm expects Covid vaccine sales to rise in 2025 and beyond as education about Covid and spending on awareness about the disease increase.
Singh was even more upbeat about Moderna's pipeline potential, highlighting a handful of possible product launches over the next 12 to 18 months that could boost sales in 2025.
That includes a potential approval this year for Moderna's experimental vaccine that aims to protect older adults from respiratory syncytial virus, which typically causes mild, cold-like symptoms but more severe cases in seniors and children.
The company has said that the Food and Drug Administration will make a decision on its RSV vaccine in April.
Moderna's experimental flu vaccine could also win approval in 2024 or 2025, Singh said. In September, the company said its shot produced a stronger immune response against four strains of the virus than a currently available flu vaccine in a late-stage trial.
Singh also said Moderna could file for FDA approval of its experimental personalized cancer vaccine in 2024 or 2025. The company may apply under the FDA's accelerated approval pathway, which allows for expedited approval of drugs that treat serious conditions and fill what the agency calls an "unmet medical need" based on a specific clinical trial metric.
Moderna and its partner Merck are currently studying the shot in combination with Merck's blockbuster therapy Keytruda for the treatment of patients with a deadly skin cancer called melanoma and other cancers.
Also on Tuesday, Moderna reiterated in a shareholder letter that it expects to see sales growth in 2025. The company highlighted its RSV vaccine and the possible approval for its combination shot targeting Covid and the flu, which could come "as early as 2025."
Moderna in its third-quarter earnings release in November said it expects revenue to fall to $4 billion in 2024 before it grows again in 2025.The company expects to "break even" in 2026. The company also said in November that it would only hit the low end of its sales forecast of $6 billion to $8 billion for 2023, reflecting weaker demand for Covid vaccines.
Moderna has also said it plans to launch up to 15 products in the next five years a goal it first outlined during its annual research and development day in September.
Don't miss these stories from CNBC PRO:
Correction: Moderna shares fell nearly 45% last year. An earlier version misstated the percentage.
Patients with rheumatoid arthritis (RA) receiving disease-modifying antirheumatic drugs (DMARDs) showed reduced immune responses to the COVID-19 vaccine compared with controls, in a recent study published in Journal of Rheumatic Diseases.1
Patients with RA carry increased risks for developing infections, including COVID-19. Since the introduction of the COVID-19 vaccine, additional concerns have emerged regarding the potential of vaccine-induced RA flare-ups or other forms of autoimmune or inflammatory phenomena. As DMARDs have provided benefits to patients with RA, such as reducing and modulating inflammatory and immune system responses, researchers conducted a cross-sectional study to investigate lacking data on COVID-19 vaccine responses in patients with RA receiving DMARDs.
From May 2022 to April 2023, patients with RA receiving DMARDs were evaluated at 2 tertiary care centers. Patients with seropositive as well as seronegative status were accepted. Investigators gathered data on individual COVID-19 infection and vaccination histories, prescribed and administered medications (DMARDs), as well as scaling on the Disease Activity Score-28 (DAS28). Blood samples of 10 mL were also taken for examination of erythrocyte sedimentation rate (ESR), complete blood count, C-reactive protein (CRP), liver and renal function, and neutralizing antibodies for COVID-19.
In total, 103 patients with RA were recruited and compared with 185 controls. In the RA group, 42% of individuals had comorbiditiesmost commonly, hypothyroidism (16.5%). The RA group was also vaccinated against COVID-19 at rates of 79.6% compared with 91.3% in the controls. No controls had a history of COVID-19 infection, but 13.6% of patients with RA did. Most of the patients with RA were identified as having low disease activity (mean DAS28 of 2.9).
Researchers observed that patients with RA had overall higher mean levels of ESR and elevated IL-6 compared with controls (ESR: 26.0 vs 19.2; P = .0004; IL-6: 15.8 vs 3.7; P < .0001).
Each group registered positive results for antispike antibodies; this was significantly higher in controls compared with patients with RA (95.9 vs 89.5; P < .0001). Interestingly, in patients with RA, age was positively correlated with levels of anti-spike antibodies (P = .0015), but this was not significant in controls. Antibody status in groups using different amounts of DMARDs were statistically significant, especially between individuals on a 3-drug regimen compared with those on a single-drug regimen of hydroxychloroquine alone (P = .0192). The authors noted that neither the presence of comorbidities nor the type of COVID-19 vaccine received, prior infection, or booster status had a statistically significant effect on antibody concentration.
The authors noted the positive takeaway that patients with RA exhibited robust immune responses following their COVID-19 vaccination, although this response was reduced compared with controls. They theorized that this could be due to disease-related or immunosuppressive treatment factors, and advocated for future research to be conducted to analyze responses following second vaccination doses.
This article originally appeared in AJMC.
Loading Video
This browser does not support the Video element.
Urgent Care facilities and emergency departments are seeing a lot of new patients coming in with respiratory symptoms. It's a viral "soup" of seasonal flue, colds, RSV and COVID-19 infections. Here's what you should do if you feel yourself getting sick.
ATLANTA - As the holiday travel season winds down, and people head back to work and school, COVID-19 infections continue to rise.
As of December 23. 2021, the latest Centers for Disease Control and Prevention estimate, 29,059 Americans were hospitalized with COVID-19, with infants and adults over 75 being hit the hardest.
Dr. Felipe Lobelo, who is a physician and epidemiologist with Kaiser Permanente Georgia, says U.S. hospitals are beginning to feel the impact of a combination of COVID-19, seasonal flu, and RSV.
"We're right on that border of things starting to become a stress on the health care systems," Dr. Lobelo says. "All the health care systems are thinking right now, Do we need to bring back masks, for example, for our physicians and our health care providers to protect themselves and also to protect others?"
A new highly contagious COVID-19 variant, JN.1, is driving about 44% of new U.S. infections, according to the CDC.
The agency says JN.1 does not appear to be more severe than other circulating or past strains of the virus, and the symptoms have stayed pretty consistent.
The most common symptoms include fever or chills, coughing, shortness of breath or difficulty breathing, fatigue and muscle or body aches.
Some people may experience headache, a new loss of taste or smell, a sore throat, congestion or a runny nose.
Nausea or vomiting and diarrhea are also symptoms of COVID-19.
The only way to know if you have a COVID-19 infection is to take a test, either an at-home rapid test or a PCR test available from a health care provider.
Childrens Healthcare of Atlanta has since a significant rise in patients during the COVID-19 pandemic. (FOX 5)
If you test positive for the virus, the CDC recommends you stay home and isolate yourself from others in your home for at least 5 days.
People at increased risk of severe complications of COVID-19 may qualify for Paxlovid or Molnupiravir, two antiviral therapies that can reduce the risk of hospitalization and death.
Both need to be started within 5 days of the onset of symptoms.
"With testing, we can sort of pinpoint the right treatment, if it's necessary for particular individuals that may need it," Dr. Lobelo says. "You want to start that early as possible."
The CDC is urging Americans ages 6 months and older to get an updated 2023-2024 COVID-19 vaccine.
But only about 18% of U.S. adults and 38% of seniors 75 and older have gotten the shot since it was recommended in September 2023.
Dr. Lobelo says most Americans have some level of immunity to the coronavirus, either from prior infections or previous vaccinations.
Still, he cautions that protection wanes with time.
"Really, after 4, 5, 6 months, your levels of protection start to drop off," Lobelo says.
So, he says, if it has been a couple of months since you have had COVID-19, or you haven't gotten an updated shot, get vaccinated soon.
"I strongly recommend it because the activity just keeps increasing," Dr. Lobelo says.
Request blocked. We can't connect to the server for this app or website at this time. There might be too much traffic or a configuration error. Try again later, or contact the app or website owner. If you provide content to customers through CloudFront, you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront (CloudFront)Request ID: 9HN8tCfeL_uOmKCnOu2XqqqeluHEFkyG-2x6lW2mmZz07-HzzjHejA==
Study design and participants
A retrospective cohort study was conducted at Nhan Dan Gia Dinh (NDGD) Hospital, a general tertiary hospital in Vietnam. Participant recruitment was taken by screening a sampling frame of patients under the management of NDGD Hospital from January 1, 2021, to January 31, 2022. We included patients who: (1) were 18 years old; (2) were fully vaccinated against COVID-19 before infection (received at least 2 doses, either homologous or heterologous, of the following vaccines: BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), AZD1222 (AstraZeneca), or BBIBP-CorV (Sinopharm), at least 2 weeks before getting first COVID-19); (3) had a confirmative diagnosis of COVID-19 (positive to either real-time polymerase chain reaction test or rapid antigen test with typical symptom(s) of COVID-19); and (4) agreed to participate. Patients were excluded if they: (1) were pregnant or breastfeeding; (2) were severely or critically ill before treatment (based on the clinical spectrum proposed by the NIH [13]); (3) were moderately or severely immunocompromised (immunosuppressive medications, moderate or severe primary immunodeficiency, advanced or untreated human immunodeficiency virus infection, active cancer treatment, or white blood cell count<4109/L); (4) were renally impaired (estimated glomerular filtration rate<30 mL/minutes/1.73 m2); or (5) were hepatically impaired (ChildPugh class B or C).
We followed the participants until March 31, 2022, or until they left the study. We reported this study in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement (Supplementary Checklist, available in the Supplementary File).
Two groups were investigated, of which patients were given: (1) standard of care (SoC, control group) or (2) standard of care plus antiviral (SoC+antiviral). In our study setting, SoC referred to treatment with appropriate medications (excluding antivirals) and supportive care that aligned with the guidelines of Vietnams Ministry of Health [14], WHO [11, 15], IDSA [12], and NIH [13]. Antivirals included remdesivir, molnupiravir, and favipiravir. Remdesivir was given by intravenous infusion to hospitalized patients, with 200mg on the first day and 100mg on the next 4 days. Molnupiravir was taken orally, with 800mg twice daily for 5 days. Favipiravir was also an oral antiviral with dosage of 1,600mg twice daily on the first day and 600mg twice daily on the next days (duration of 57 days).
The primary outcome was residual respiratory symptoms of COVID-19 breakthrough (including but not be limited to cough, dyspnea/shortness of breath/difficulty breathing, congestion, sore throat, loss of smell), measured in frequency. Based on our pilot data, the proposed timeframe cut-off to classify residual symptoms in COVID-19 breakthrough was 7 days. Thus, patients having respiratory symptoms after day 7 (from the day with first symptoms or diagnosis, whichever happened first) were counted towards the primary outcome. As these participants were under the management of NDGD Hospital, they were encouraged to self-report symptoms of COVID-19 every 12 days until resolution using MyCap platform [16]. For data collection, patients without self-reported records were contacted to retrieve the this outcome.
The secondary outcome was long COVID-19 [17,18,19], measured in frequency. This was diagnosed by specialized physicians in COVID-19 at NDGD Hospital using the guideline of the National Institute for Health and Care Excellence [19]. Following that, long COVID-19 includes ongoing symptomatic COVID-19 (signs and symptoms of COVID-19 from 4 weeks up to 12 weeks) and post-COVID-19 syndrome (signs and symptoms that develop during or after an infection consistent with COVID19, continue for more than 12 weeks and are not explained by an alternative diagnosis) [19]. We collected these data by screening patient health records for long COVID-19 diagnosis.
We calculated the sample size using the online website Power and Sample Size [20], with type I error rate () of 5%, power (1 - ) of 80%, and a sampling ratio of 1:1. Following the findings of Bergwerk et al., 31% of infected healthcare workers had residual symptoms 14 days after diagnosis [21]. Given that our study was conducted on the general population with a 7-day cut-off, we estimated the primary outcome could be found in at least 41% of the patients. For antivirals to be considered effective against COVID-19 breakthrough in low and middle-income countries like Vietnam, we expected a reduction of at least 50% in the primary outcome, resulting in a minimum sample size of 144 patients. Thus, we decided to recruit 150 patients.
Considering our study setting, the following factors were identified as potential confounders: gender (female/male), age (in years), weight (in kg), height (in cm), comorbidities, and concurrent medications. To avoid overadjustment bias, we excluded medications for comorbidities, keeping only those that were used for COVID-19 treatment.
We removed observations that were missing or lost to follow-up from analysis. We presented demographic and baseline data as mean with standard deviation for continuous variables or as frequency with percentage for categorical variables. Incidence rates (using Poisson regression) and odds ratio (OR, using logistic regression) were given with 95% confidence intervals (95% CI). As there were 3 nationally approved antivirals for COVID-19 in Vietnam during this study timeframe (remdesivir, molnupiravir, and favipiravir), effect estimates might be biased by favipiravir due to its lack of evidence. To test the robustness of our findings, we conducted a sensitivity analysis by removing observations with favipiravir use. Since antivirals were primarily recommended for high-risk patients, we also wanted to explore these medications effects on both outcomes with a priori subgroup analysis. The subgroups were pre-specified based on the following variables: gender (male/female), age (<65/ 65), comorbidities (yes/no), and corticosteroid use (yes/no). This subgroup analysis was considered exploratory to generate new hypotheses (if available), so we did not attempt to adjust for multiplicity. All statistical hypotheses were tested with a confidence level of 95%. We performed all analyses using R software (version 4.2.1, R Foundation for Statistical Computing, Vienna, Austria).
This study was approved by the Institutional Review Board of NDGD Hospital, Ho Chi Minh City, Vietnam, under approval number 85-2021/CN-HDDD. All recruited participants gave their informed consent.
January 02, 2024
1 min read
Add topic to email alerts
Receive an email when new articles are posted on
Back to Healio
Two separate analyses of studies and trials suggest that COVID-19 rebound is not linked to Paxlovid or other antiviral drugs.
The findings contradict other studies that indicated a higher frequency of COVID-19 rebound among people treated with Paxlovid (nirmatrelvir/ritonavir, Pfizer).
Rebound is typically described as a recurrence of symptoms after recovery or a new positive viral test after testing negative, Pragna Patel, MD, MPH, DRM&H, chief medical officer in the Coronavirus and Other Respiratory Viruses division of the CDCs National Center for Immunization and Respiratory Diseases, told Healio. We found that there was no consistent association between treatment for COVID-19 and COVID-19 rebound. Also, we found that COVID-19 rebound can happen among patients whether they received antiviral treatments or not.
It was the top story in infectious disease last week.
Another top story was a collection of articles about ID-related guidelines released in 2023, including recommendations on sexually transmitted disease prevention, diabetic foot infections and more.
Read these and more top stories in infectious disease below:
Paxlovid unlikely to contribute to COVID-19 rebound
SARS-CoV-2 rebound risk is more likely related to the individual person, rather than reinfection or resistance to treatment such as Paxlovid, according to two studies. Read more.
Doxy-PEP, diabetic foot infections and more: The year in ID guidelines
New guidance was published in 2023 for STD prevention, diabetic foot infections, infective endocarditis and more. Read more.
COVAX to end as COVID-19 vaccines move to routine immunization programs
COVAX, the multinational program launched in 2020 to deliver COVID-19 vaccines to low- and lower-middle income countries, will end on Dec. 31, 2023, as the vaccines shift to routine immunization programs. Read more.
Pneumonia, candidiasis and more: The non-vaccine approvals of 2023
The FDA in 2023 approved treatments for several hospital-associated infections and fully approved a long-used COVID-19 medication, among other non-vaccine-related regulatory decisions. Read more.
Developments in hepatitis care: New CDC recommendations and more
As viral hepatitis continues to be a major health concern in the infectious disease field, recent research has highlighted the importance of testing and treatment. Read more.
Add topic to email alerts
Receive an email when new articles are posted on
Back to Healio
Specialty
Please choose I'm not a medical professional. Allergy and Immunology Anatomy Anesthesiology Cardiac/Thoracic/Vascular Surgery Cardiology Critical Care Dentistry Dermatology Diabetes and Endocrinology Emergency Medicine Epidemiology and Public Health Family Medicine Forensic Medicine Gastroenterology General Practice Genetics Geriatrics Health Policy Hematology HIV/AIDS Hospital-based Medicine I'm not a medical professional. Infectious Disease Integrative/Complementary Medicine Internal Medicine Internal Medicine-Pediatrics Medical Education and Simulation Medical Physics Medical Student Nephrology Neurological Surgery Neurology Nuclear Medicine Nutrition Obstetrics and Gynecology Occupational Health Oncology Ophthalmology Optometry Oral Medicine Orthopaedics Osteopathic Medicine Otolaryngology Pain Management Palliative Care Pathology Pediatrics Pediatric Surgery Physical Medicine and Rehabilitation Plastic Surgery Podiatry Preventive Medicine Psychiatry Psychology Pulmonology Radiation Oncology Radiology Rheumatology Substance Use and Addiction Surgery Therapeutics Trauma Urology Miscellaneous
LAKELAND, Fla. (WFLA) Dr. Tim Regan drove to work Tuesday mentally preparing himself for what he knew would be a busy day in the Lakeland Regional Health emergency room.
Right after New Years and theres a lot of respiratory illness in the community, people have now shaken off their holiday and are looking to feel better. So we do see a lot of traffic through the emergency department this time of year, said Dr. Regan, the hospitals Chief Medical Officer.
According to Dr. Regan, patients with COVID-19 and flu have doubled at Lakeland Regional Health, with those cases still making up less than 10% of total hospitalizations.
Most COVID-19 infections now are causing cold-like symptoms, he said, which can be treated with ibuprofen and decongestants.
Patients are also coming in with RSV.
You tend to talk about RSV in children, but elderly people and people who are at risk for illness are at risk for RSV as well and it can have bad outcomes, he said.
Pamela Wood, who lives in Lakeland, said she had a persistent cough and her doctor tried everything to prevent her from getting RSV.
Just had a head cold and normally I can shake them off and this time I didnt, had a bad cough. Went to the doctor and he gave me an antibiotic and steroid shot and meds, she said. When you get 70 years old, you cant shake this stuff off like you could when you were younger.
Jo Hair, a snowbird who winters in Lakeland, said her family had a firsthand experience with severe respiratory illness.
We did have a child in the family up north that was hospitalized with RSV so it brings to light everybody should be paying attention, continue doing what you should be doing, she said.
Luckily, that infant recovered.
Meanwhile, data from the Centers for Disease Control & Prevention shows COVID-19 hospitalizations are low in all Florida counties except for Sarasota, Desoto and Charlotte counties, which are medium.
When it comes to influenza, according to the CDC as of Dec. 23, Florida is at a high level of cases, surrounded by states at a very high level.
That is to be predicted this time of year, with influenza being very seasonal throughout central Florida. Weve seen greater numbers of influenza which sort of correlates to years in the past, said Dr. Jarett Gregory, an urgent care physician at Watson Clinics south campus.
He said it is the combination of cooler weather, people traveling and visiting with family over the holidays and snowbirds coming to Florida that leads to the spike in illness.
Weve certainly seen a higher number of acuity, higher number of cases, certainly quite a bit busier than we have been in the months previous, said Dr. Gregory.
He said the timing of a doctors visit is an important factor when it comes to getting effective treatment.
If a patients had cough, cold, fever or body aches for one to two days, they want to act more promptly rather than waiting. If they can be seen and evaluated over the next 24 to 48 hours treatment and be initiated and often make a big difference and help them to recover much more quickly, said Dr. Gregory.
jsonline.com wants to ensure the best experience for all of our readers, so we built our site to take advantage of the latest technology, making it faster and easier to use.
Unfortunately, your browser is not supported. Please download one of these browsers for the best experience on jsonline.com
December 28, 2023
2 min read
Add topic to email alerts
Receive an email when new articles are posted on
Back to Healio
COVAX, the multinational program launched in 2020 to deliver COVID-19 vaccines to low- and lower-middle income countries, will end on Dec. 31, 2023, as the vaccines shift to routine immunization programs.
The program has been jointly led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (GAVI), UNICEF and WHO, which raised $2 billion to procure vaccines and delivered its first vaccination in a low-income nation in January 2021, 39 days after the vaccines had become available.
COVAX has delivered roughly 2 billion COVID-19 vaccine doses to 146 nations and is estimated to have prevented the deaths of at least 2.7 million people, achieving a two-dose coverage of 57% of people in lower-income nations, according to a joint press release from the four organizations.
Millions of people are alive today who would not have been here without COVAX. Those averted deaths mean mothers can continue to nurture their children, and grandparents can enjoy watching future generations flourish, Jane Halton, chair of the board for CEPI, said in a press release.
Despite being built and funded from scratch amid the deadliest pandemic the world has seen in more than a century, COVAXs lifesaving accomplishments were considerable. It should take its place in history and be proud of what it was able to accomplish but also serve as a reminder to us all that we can and must do better next time, she said.
COVAX was created to overcome a global imbalance of access to COVID-19 vaccines after they started rolling out in higher income nations like the United States, which re-engaged with WHO and joined the COVAX initiative in January 2021.
The program was designed based on lessons from the H1N1 pandemic, most significantly advocating that no one is safe until everyone is safe, focusing on global vaccine equity for at least people who were at greatest risk for hospitalization or death, with 190 nations joining the effort by the end of 2020.
Of the 146 nations that received COVID-19 vaccine doses from COVAX, 92 lower income nations are eligible to continue receiving doses and delivery support through Gavis regular vaccination programs in 2024 and 2025. According to Gavi, 58 of the 92 nations have already requested roughly 83 million doses to vaccinate various high-risk groups of people.
We knew that market forces alone would not deliver equitable access to vaccines and other tools, WHO Director-General Tedros Adhanom Ghebreyesus, MD, said in a press release. The creation of ACT-A and COVAX gave millions of people around the world access to vaccines, tests, treatments and other tools who would otherwise have missed out. COVAX has taught us valuable lessons that will help us be better prepared for future epidemics and pandemics.
Add topic to email alerts
Receive an email when new articles are posted on
Back to Healio
