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U.S. reports cases of new COVID variant NB.1.8.1 behind surge in China
By
Alexander Tin
Edited By Melissa Gaffney
May 22, 2025 / 8:54 PM EDT / CBS News
The Centers for Disease Control and Prevention's airport screening program has detected multiple cases of the new COVID-19 variant NB.1.8.1, which has been linked to a large surge of the virus in China.
Cases linked to the NB.1.8.1 variant have been reported in arriving international travelers at airports in California, Washington state, Virginia and the New York City area, according to records uploaded by the CDC's airport testing partner Ginkgo Bioworks.
Underlying Conditions and the Higher Risk for Severe COVID-19 ...
Background
Age is the strongest risk factor for severe COVID-19 outcomes. Patients with one or multiple certain underlying medical conditions are also at higher risk.(1-3)
Providers should consider the patient's age, presence of underlying medical conditions and other risk factors, and vaccination status in determining the risk of severe COVID-19-associated outcomes for any patient.
... Age
Age remains the strongest risk factor for severe COVID-19 outcomes, with risk of severe outcomes increasing markedly with increasing age. Based on data from the National Vital Statistics System (NVSS) at NCHS (Risk for COVID-19 Infection, Hospitalization, and Death By Age Group), compared with ages 18–29 years, the risk of death is 25 times higher in those ages 50–64 years, 60 times higher in those ages 65–74 years, 140 times higher in those ages 75–84 years, and 340 times higher in those ages 85+ years. Notably, these data include all deaths in the United States that occurred throughout the pandemic, from February 2020 to July 1, 2022, including deaths among unvaccinated individuals.
Risk of severe outcomes is increased in people of all ages with certain underlying medical conditions and in people who are 50 years and older, with risk increasing substantially at ages >65 years.4,5Residents of long-term care facilities are also at increased risk, making up less than 1% of the U.S. population but accounting for more than 35% of all COVID-19 deaths.6-10
...
Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE
May 31, 2025
mNEXSPIKE becomes Moderna's third FDA-approved product
CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).[1]
"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health."
The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.
In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.
Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA®, the Company's approved respiratory syncytial virus (RSV) vaccine.
mRNA-1283 is under review with regulators in multiple markets around the world.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
mNEXSPIKE®, mRESVIA® and Spikevax®are registered trademarks of Moderna.
INDICATION
mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are:
• 65 years of age and older, or
• 12 years through 64 years of age at high risk for severe COVID-19.
Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.
IMPORTANT SAFETY INFORMATION
You should not get mNEXSPIKE if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.
What are the risks of mNEXSPIKE?
There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:
Trouble breathing
Swelling of your face and throat
A fast heartbeat
A rash all over your body
Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported in clinical trials with mNEXSPIKE include:
Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.
General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever
Tell your vaccination provider about all of your medical conditions, including if you:
have any allergies
had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received any other COVID-19 vaccine
have ever fainted in association with an injection
These may not be all the possible side effects of mNEXSPIKE. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.
Please click for mNEXSPIKE Full Prescribing Information.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mNEXSPIKE; and the availability of Moderna's respiratory vaccines for the 2025-2026 season. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651 Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834 Lavina.Talukdar@modernatx.com
This map shows the current wastewater viral activity level of SARS-CoV-2 (the virus that causes COVID-19) for each state or territory. Tap or hover over a state or territory to see the viral activity level and number of sites reporting data. Time Period: July 27, 2025 - August 02, 2025
Week 33, 9 - 15 August 2025
...
Based on detections of SARS-CoV-2 in non-sentinel specimens (laboratory detections from a mix of primary care and other sources, including hospitals), increasing trends in detections and test positivity continue to be observed in multiple countries.
...
Following a winter period with limited SARS-CoV-2 circulation, a steady increase in indicators of SARS-CoV-2 circulation has been observed in several countries. However, overall SARS-CoV-2 hospital admissions, ICU admissions, and deaths remain lower than during the same period in 2024. Individuals aged 65 years and above continue to be at increased risk of developing severe COVID-19 outcomes, including hospitalisation, ICU admission and death.
Following a winter with low SARS-CoV-2 circulation, population immunity against SARS-CoV-2 may have partly waned. Test positivity for SARS-CoV-2 is currently higher than that for other respiratory viruses. This may lead to some increases in COVID-19 hospitalisations, particularly among older adults and people vulnerable to severe outcomes, as described in ECDC’s recently published Epidemiological update.
...
Could this allergy nasal spray help prevent COVID?
by: Hayley Boyd, Alix Martichoux
Posted: Sep 14, 2025 / 05:09 PM EDT
(WGN Radio) – An over-the-counter nasal spray for allergies could actually protect you from catching COVID, a recent randomized trial found.
Using a nasal antihistamine that contains azelastine three times a day for eight weeks was found to reduce the instances of COVID-19 infection by 69%. Incidentally, the study found people who used the nasal spray were also far less likely to get the common cold (rhinovirus) when compared to the placebo group.
Dr. Thomas Moran, chief medical officer at Central DuPage Hospital in Illinois, explained how it works in an interview with WGN Radio:
“Now when you think about what are the reasons that we’re taking nasal sprays, we get nasal passageway inflammation. That inflammation causes breakdown in the mucus membrane. That membrane in our nasal passages help prevent us from getting viruses and bacteria that can enter into our bodies. And this nasal spray looks like it tamps down a little bit of a protein that increases inflammation overall, and it kind of makes it difficult for the COVID virus to enter in and affect us.”
...
“Azelastine nasal spray could provide an additional easily accessible prophylactic to complement existing protective measures, especially for vulnerable groups, during periods of high infection rates, or before traveling,” Bals said in a press release.
Dr. Moran agreed: “Relatively safe, not really many side effects – sometimes you get a little bit of congestion with it – and it’s fairly inexpensive overall to use.”
...
JAMA Int. Med: Azelastine Nasal Spray for Prevention of SARS-CoV-2 Infections (https://afludiary.blogspot.com/2025/09/jama-int-med-azelastine-nasal-spray-for.html)
#18,866
Unless and until the CDC's ACIP (https://www.cdc.gov/acip/index.html) makes a ruling on the availability of the COVID vaccine, tens of millions of
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