Baptism of St Zenobius and His Appointment as Bishop (Sandro Botticelli, 1500 - 05)

 Public Domain.

Source: WikiArt, https://www.wikiart.org/en/sandro-botticelli/baptism-of-st-zenobius-and-his-appointment-as-bishop-1505

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#Evolution of #Antiviral Drug #Resistance in #SARS-CoV-2

Abstract

The COVID-19 pandemic has had a significant impact and continues to alarm the entire world due to the rapid emergence of new variants, even after mass vaccinations. There is still an urgent need for new antivirals or strategies to combat the SARS-CoV-2 infections; however, we have success stories with nirmatrelvir. Drug repurposing and drug discovery may lead to a successful SARS-CoV-2 antiviral; however, rapid drug use may cause unexpected mutations and antiviral drug resistance. Conversely, novel variants of the SARS-CoV-2 can diminish the neutralizing efficacy of vaccines, thereby enhancing viral fitness and increasing the likelihood of drug resistance emergence. Additionally, the disposal of antivirals in wastewater also contributes to drug resistance. Overall, the present review summarizes the strategies and mechanisms involved in the development of drug resistance in SARS-CoV-2. Understanding the mechanism of antiviral resistance is crucial to mitigate the significant healthcare threat and to develop effective therapeutics against drug resistance.

Source: Viruses, https://www.mdpi.com/1999-4915/17/5/722

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#WHO #clinical practice #guidelines for #influenza: an #update

Abstract

Background

Every year, more than one billion people around the world are infected with influenza, an acute infection of the respiratory tract. Influenza spreads from person to person through air, contaminated hands or objects. Antiviral and immunomodulatory drugs are available for treatment of patients and prophylaxis of exposed persons. Reverse transcription polymerase chain reaction (RT-PCR), nucleic acid amplification tests (NAATs) and rapid tests are available for the diagnosis of influenza. 

Objective 

The aim of this World Health Organization (WHO) guideline is to provide recommendations for the diagnosis, drug treatment and prophylaxis of influenza.

Method

This updated guideline has been developed in accordance with standards for trustworthy guidelines. The recommendations are based on systematic reviews on safety and effectiveness. They take into account the magnitude of benefits and harms of treatments, the reliability of the evidence, and the needs of patients and healthcare professionals.

Results

For non-severe influenza, there is a conditional recommendation to use baloxavir if the risk of severe illness is high. Antivirals are not recommended if the risk is low. There is also a strong recommendation against the use of antibiotics if bacterial co-infection is unlikely. Oseltamivir is conditionally recommended for severe influenza. Not recommended are peramivir and zanamivir, as well as macrolide antibiotics (in the absence of co-infection), mTOR inhibitors and plasma therapy, and corticosteroids. Baloxavir and oseltamivir are conditionally recommended for prophylaxis in asymptomatic persons who have been exposed to seasonal influenza viruses and would be at very high risk of becoming hospitalised. For zoonotic influenza, laninamivir and zanamivir are also conditionally recommended in addition to baloxavir and oseltamivir, regardless of individual risk. For diagnosis, the use of NAAT or digital immunoassay (DIA) for suspected non-severe influenza and nucleic acid amplification test (NAAT) for suspected severe influenza is recommended.

Source: Gesundheitswesen, https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2571-3357#info

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    PubMed         Abstract available
    
    
52. WEETS CM, Wilson R, Swadley H, Katz R, et al
    Strengthening health security through routine vaccination policy: A comprehensive analysis of childhood vaccination laws across 194 countries.
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    PubMed         Abstract available
    
    
53. STONER MCD, Michaels J, Stocks JB, Mancuso N, et al
    Evaluating concurrency and gaps between self-report and vaccine card data for COVID-19 vaccination.
    Vaccine. 2025;54:127136.
    PubMed         Abstract available
    
    
54. TAKEUCHI N, Chang B, Ishiwada N, Cho Y, et al
    Nationwide population-based surveillance of invasive pneumococcal disease in children in Japan (2014-2022): Impact of 13-valent pneumococcal conjugate vaccine and COVID-19 pandemic.
    Vaccine. 2025;54:127138.
    PubMed         Abstract available
    
    
55. CARTER DM, Bloom CE, Kirchenbaum GA, Tsvetnitsky V, et al
    Corrigendum to "Cross-protection against H7N9 influenza strains using a live-attenuated H7N3 virus vaccine" [Vaccine (2015) 33(1) 108-16].
    Vaccine. 2025;57:127174.
    PubMed        
    
    
56. MOU J, LaSalle G, Pflugeisen C, Sherls-Jones J, et al
    Practice, beliefs and intent in influenza vaccination among Hispanic patients during the pandemic: An interventional study.
    Vaccine. 2025;58:127207.
    PubMed         Abstract available
    
    
57. XU J, Davoudpour S, Phillips G 2nd
    Applying the health belief model (HBM) to understand COVID-19 vaccine uptake among youth and young adults: Findings from a 6-month follow-up study in the United States.
    Vaccine. 2025;54:127002.
    PubMed         Abstract available
    
    
58. MYBURGH L, Karsjens H, Blanas A, de Ligt A, et al
    Targeting the early life stages of SARS-CoV-2 using a multi-peptide conjugate vaccine.
    Vaccine. 2025;54:126989.
    PubMed         Abstract available
    
    
59. RICCI L, Fery C, Tubach F, Agrinier N, et al
    Health care institutions and their physicians are the greatest promoters of COVID-19 vaccine acceptance among health care workers.
    Vaccine. 2025;54:127005.
    PubMed         Abstract available
    
    
60. SKOCZYNSKA A, Golebiewska A, Wrobel-Pawelczyk I, Ronkiewicz P, et al
    The direct impact of mandatory PCV10 vaccination on invasive pneumococcal disease in Polish children.
    Vaccine. 2025;54:126999.
    PubMed         Abstract available
    
    
61. VEDEL JO, Furtado O, Almeida LL, Nehal KR, et al
    Childhood vaccination coverages in rural Guinea-Bissau before and during the early COVID-19 pandemic, a cohort study.
    Vaccine. 2025;54:127011.
    PubMed         Abstract available
    
    
62. DI CHIARA C, Karimi-Shahrbabak E, Peresin J, Farrar DS, et al
    A review of Canadian online resources providing information on COVID-19 vaccination for caregivers of children aged 5-11 years.
    Vaccine. 2025;54:126990.
    PubMed         Abstract available
    
    
63. FUJI N, Gonzalez E, Salamone FN, Bajorski P, et al
    Comparison of Streptococcus pneumoniae nasopharyngeal colonization, serotype-specific and protein-specific antibody and cytokine levels in young children prior to, during and post COVID-19 pandemic.
    Vaccine. 2025;54:126954.
    PubMed         Abstract available
    
    
64. DE SOUZA RA, Barreto FR, de Jesus Lima CCO, da Natividade MS, et al
    Efficacy of BCG vaccination on incidence, severity and clinical progression of COVID-19: A BCG-REVAC population analysis.
    Vaccine. 2025;54:126911.
    PubMed         Abstract available
    
    
65. DESILVA MB, Vazquez-Benitez G, Seburg EM, Henderson MSG, et al
    Pregnant persons perceptions and uptake of prenatal RSV vaccine - Minnesota, 2023-2024.
    Vaccine. 2025;54:126958.
    PubMed         Abstract available
    
    
66. DOWGIER G, Hobbs A, Greenwood D, Shawe-Taylor M, et al
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67. LEE DW, Nasir A, Elbashir S, Jani H, et al
    mRNA-1273 vaccines adapted to JN.1 or KP.2 elicit cross-neutralizing responses against the JN.1 sublineages of SARS-CoV-2 in mice.
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68. CARROLL M, Fox HB, Tran A, Chellappan G, et al
    SARS-CoV-2 conjugate vaccine elicits robust immune responses that can protect against evolving variants.
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69. MOORE M, Anderson L, Schiffer JT, Matrajt L, et al
    Durability of COVID-19 vaccine and infection induced immunity: A systematic review and meta-regression analysis.
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70. CHOI J, Feelemyer J, Choe K, Lynch K, et al
    Anti-vaccine attitudes and COVID-19 vaccine status at the end of the U.S. public health emergency.
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71. RASKIN N, Hiligsmann M, Luyten J, Tubeuf S, et al
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72. HAO T, Ryan GE, Lydeamore MJ, Cromer D, et al
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73. HAMID S, Simeone RM, Newhams MM, Halasa N, et al
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    Alcohol consumption does not influence SARS-CoV-2 vaccine immunogenicity: A stop the spread Ottawa cohort analysis.
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    Adverse events among early caregivers' COVID-19 vaccination correlated inversely with intention to vaccinate their children.
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    Virology

77. LIU R, Song F, Sun L, Yan F, et al
    Exploring the pathogenic and transmission characteristics of JN.1 in golden hamsters based on different attack methods.
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78. CAO L, Shi S, Zhang C, Zhao C, et al
    A phycobiliprotein-based reporter assay for the evaluation of SARS-CoV-2 main protease activity.
    Virology. 2025;608:110540.
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History of Mass Transportation: The FS E.444.001 Italian Electric Locomotive

 

Source: Wikipedia, https://it.wikipedia.org/wiki/Locomotiva_FS_E.444

By Manfred Kopka - Opera propria, CC BY-SA 4.0

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Assessment of cross-reactive neutralizing #antibodies induction against #H5N1 clade 2.3.4.4b by prior seasonal influenza #immunization in retail #workers

Abstract

Highly pathogenic avian influenza (HPAI) H5N1 has been a global concern since its emergence in 1997, causing widespread outbreaks in birds and sporadic human infections. The clade 2.3.4.4b H5N1 virus has rapidly expanded across continents, infecting numerous mammalian species. In 2024, it was detected in dairy cattle for the first time in the U.S., along with human cases following exposure. In Canada, the first human case of this avian influenza was reported in a critically ill adolescent in late 2024. No human-to-human transmission has been documented, but concerns persist regarding mutations associated with enhanced virulence and human adaptation. Although seasonal influenza vaccines are not directed against H5N1, studies suggest that pre-existing immunity from prior infections or vaccinations may provide partial protection against severe H5N1 infections through cross-reactive immune response. Given the ongoing circulation of avian influenza and the rise in human infections, this study evaluated the effectiveness of neutralizing antibodies developed against seasonal influenza viruses and their cross-reactivity with recent H5N1 strains. Serum samples from 194 retail sector workers in Quebec, collected between late 2021 and 2022, were analyzed using a microneutralization assay. While strong neutralizing activity was found against seasonal influenza viruses, no neutralizing antibodies were detected against H5N1 strains in either vaccinated or unvaccinated individuals. These findings emphasize the need to evaluate cross-reactive antibodies against the neuraminidase protein of H5N1, assess cellular immune responses potentially linked to protection against severe HPAI H5N1 infections and targeted vaccine strategies against recently emerged H5N1 influenza viruses. Keywords: influenza, highly pathogenic avian influenza, H5N1, immunity, cross-reactivity, neutralization.

Source: MedRxIV, https://www.medrxiv.org/content/10.1101/2025.05.15.25327718v1

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#Brazil - High pathogenicity avian #influenza #H5N1 viruses (#poultry) (Inf. with) - Immediate notification

 

The Official Veterinary Services (OVS) received a notification of acute mortality, neurological and digestive signs in a breeder farm. From the start of the OVS investigation, the premise was quarantined, including suspension of the movement of birds and products. Laboratory analysis identified H5N1 virus clade 2.3.4.4b. OVS is conducting an epidemiological investigation of the event and implementing the restrictions and measures in accordance with the National Contingency Plan for high pathogenicity avian influenza (HPAI).

Source: WOAH, https://wahis.woah.org/#/in-review/6484

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#Czech Republic - #Influenza A #H5N1 viruses of high pathogenicity (Inf. with) (non-poultry including wild birds) (2017-) - Immediate notification

Sudden death of birds, clinical signs, non-commercial hobby flock of hens, products are used exclusively for own consumption in the same household.

Source: WOAH, https://wahis.woah.org/#/in-review/6471

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Novel #Orthohantavirus Associated with #Hantavirus Pulmonary Syndrome in Northern #Argentina

Abstract

In this work, we performed the genetic characterization of a new variant of orthohantavirus associated with a fatal case of hantavirus pulmonary syndrome, outside the known endemic region, in northwestern Argentina. We first confirmed an orthohantavirus infection by ELISA, testing for the detection of IgM and IgG antibodies. Then, we extracted RNA from 100 microliters of serum, the only sample available, followed by RT-PCR. The amplicons were sequenced using Sanger and next-generation sequencing technology. We obtained partial sequences of 1253 bp, 799 bp and 1675 bp from the S-, M- and L-segments, respectively, showing low sequence identities with all the previously characterized hantaviruses (10.9%, 13.5% and 15.1% of the divergence, respectively). The phylogenetic analysis showed that this virus belongs to the Orthohantavirus andesense species (ANDV), and among the ANDV-like variants, it is more closely related to the Lechiguanas clade. Similar percentages of divergence were considered sufficient to distinguish AND-like variants in previous works. As the patient had no travel history before the onset of disease was reported, we conducted rodent surveys to confirm the presence of reservoirs. The rodent assemblage was compatible with the transitional zone among different ecoregions (Yungas, Chaco and Monte). Moreover, one of the species captured, Oligoryzomys flavescens, was previously described as a reservoir of hantavirus. This species may either host several variants across its range or encompass a species complex, as proposed by some authors.

Source: Viruses, https://www.mdpi.com/1999-4915/17/5/717

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Yellow fever - Region of the #Americas (#WHO D.O.N., May 16 '25)

{Summary}

Situation at a glance

From 29 December 2024 and as of 26 April 2025 (with data for Ecuador updated as of 2 May 2025), a total of 212 confirmed human cases of yellow fever, including 85 deaths, have been reported to WHO by five countries in the Region of the Americas (case fatality rate (CFR) 40%). 

The cases have been reported in the Plurinational State of Bolivia, Brazil, Colombia, Ecuador and Peru. 

The 212 confirmed yellow fever cases reported so far in 2025 represent a threefold increase compared to the 61 confirmed cases reported in 2024. 

WHO is supporting affected countries in implementing coordinated actions to respond to the yellow fever cases and outbreaks. 

This includes: 

- enhancing preventive measures, 

- strengthening surveillance and case management, 

- improving risk communication and community engagement, and 

- implementing immunization activities. 

The current yellow fever situation in the Americas is driven by increased sylvatic transmission cycles. 

The occurrence of yellow fever cases outside of the Amazon basin, combined with high fatality, varying vaccination coverage across affected countries, and limited vaccine supply, contributes to the overall classification of yellow fever risk in the Region of the Americas, especially in endemic countries, as high. 

WHO emphasizes the importance of active surveillance, timely laboratory testing, cross-border coordination, and information sharing. 

Vaccination remains the primary means for the prevention and control of yellow fever. 

WHO continues to support countries in expanding vaccination coverage through routine immunization programs and mass vaccination campaigns to enhance population immunity and reduce the risk of outbreaks.

(...)

Source: World Health Organization, https://www.who.int/emergencies/disease-outbreak-news/item/2025-DON570

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#USA, Monitoring for Avian #Influenza A(#H5) Virus In #Wastewater (CDC, May 16 '25)

 

{Excerpt}

Time Period: April 27, 2025 - May 03, 2025

-- H5 Detection: 8 sites (2.0%)

- No Detection: 402 sites (98.0%)

- No samples in last week: 67 sites

(...)

Source: US Centers for Disease Control and Prevention, https://www.cdc.gov/bird-flu/h5-monitoring/index.html

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#Molnupiravir or #nirmatrelvir–ritonavir plus usual care vs usual care alone in patients admitted to #hospital with #COVID19 (RECOVERY)...

Summary

Background

Molnupiravir and nirmatrelvir–ritonavir are oral antivirals that have shown efficacy in preventing disease progression in outpatients with COVID-19. We aimed to evaluate these treatments for patients hospitalised with COVID-19 pneumonia, for whom data on these antivirals are scarce.

Methods

The RECOVERY trial is a randomised, controlled, open-label, adaptive platform trial testing treatments for COVID-19. In this study we report the molnupiravir and nirmatrelvir–ritonavir comparisons from the RECOVERY trial. In each comparison, participants aged 18 years and older were randomly allocated (1:1) to the relevant antiviral (5 days of molnupiravir 800 mg twice daily or 300 mg nirmatrelvir and 100 mg ritonavir twice daily) in addition to usual care, or to usual care alone. The molnupiravir comparison was conducted at 75 hospitals in the UK, two in Nepal, and two in Indonesia; the nirmatrelvir–ritonavir comparison was conducted at 32 hospitals in the UK. Participants could take part in both comparisons. The primary outcome was 28-day mortality, and secondary outcomes were time to discharge alive from hospital and progression to invasive ventilation or death. Analysis was by intention to treat. Both comparisons were stopped because of low recruitment. This study is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.

Findings

From Jan 24, 2022, to May 24, 2023, 923 participants were recruited to the molnupiravir comparison (445 allocated to molnupiravir and 478 to usual care), and from March 31, 2022, to May 24, 2023, 137 participants were recruited to the nirmatrelvir–ritonavir comparison (68 allocated to nirmatrelvir–ritonavir and 69 to usual care). More than three-quarters of participants were vaccinated and had antispike antibodies at randomisation, and more than two-thirds were receiving other SARS-CoV-2 antivirals. In the molnupiravir comparison, 74 (17%) participants allocated to molnupiravir and 79 (17%) allocated to usual care died within 28 days (hazard ratio [HR] 0·93 [95% CI 0·68–1·28], p=0·66). In the nirmatrelvir–ritonavir comparison, 13 (19%) participants allocated to nirmatrelvir–ritonavir and 13 (19%) allocated to usual care died within 28 days (HR 1·02 [0·47–2·23], p=0·96). In neither comparison was there evidence of any difference in the duration of hospitalisation or the proportion of participants progressing to invasive ventilation or death.

Interpretation

Adding molnupiravir or nirmatrelvir–ritonavir to usual care was not associated with improvements in clinical outcomes. However, low recruitment meant a clinically meaningful benefit of treatment could not be ruled out, particularly for nirmatrelvir–ritonavir.

Source: Lancet Infectious Diseases, https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00093-3/fulltext?rss=yes

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Identification of naturally occurring #drug-resistant #mutations of #SARS-CoV-2 papain-like #protease

Abstract

The SARS-CoV-2 papain-like protease (PLpro) is a cysteine protease that cleaves viral polyproteins and antagonizes the host immune response during viral replication. Jun12682 and PF-07957472 are the first-in-class PLpro inhibitors showing potent in vivo antiviral efficacy in mouse models. In this study, we characterize naturally occurring mutations at residues located at the drug-binding site of Jun12682. The results reveal several PLpro mutants showing significant drug resistance while maintaining comparable enzymatic activity as the wild-type PLpro. The physiological relevance of the identified drug-resistant mutants, including E167G and Q269H, is validated through independent serial viral passage experiments. Molecular dynamics simulations and perturbative free energy calculations show that drug-resistant PLpro mutants weaken hydrogen bonding and π-π stacking interactions. Collectively, this study identifies E167, Y268, and Q269 as drug-resistant hotspots for PLpro inhibitors that bind to the BL2 loop and groove region, which are valuable in informing the design of the next-generation PLpro inhibitors.

Source: Nature Communications, https://www.nature.com/articles/s41467-025-59922-9

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Molecular basis of #influenza #ribonucleoprotein complex #assembly and processive #RNA synthesis

Abstract

Influenza viruses replicate and transcribe their genome in the context of a conserved ribonucleoprotein (RNP) complex. By integrating cryo–electron microscopy single-particle analysis and cryo–electron tomography, we define the influenza RNP as a right-handed, antiparallel double helix with the viral RNA encapsidated in the minor groove. Individual nucleoprotein subunits are connected by a flexible tail loop that inserts into a conserved pocket in its neighbor. We visualize the viral polymerase in RNP at different functional states, revealing how it accesses the RNA template while maintaining the double-helical architecture of RNP by strand sliding. Targeting the tail loop binding interface, we identify lead compounds as potential anti-influenza inhibitors. These findings elucidate the molecular determinants underpinning influenza virus replication and highlight a promising target for antiviral development.

Source: Science, https://www.science.org/doi/10.1126/science.adq7597

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#Statement on the #antigen #composition of #COVID19 #vaccines (#WHO, May 15 '25)

 

Key points

-- Vaccination remains an important public health countermeasure against COVID-19. As per the WHO Director General’s standing recommendations for COVID-19, Member States are recommended to continue to offer COVID-19 vaccination based on the recommendations of the WHO Strategic Advisory Group of Experts on Immunization (SAGE).

-- SARS-CoV-2 continues to undergo sustained evolution since its emergence in humans, with important genetic and antigenic changes in the spike protein.

-- The objective of an update to COVID-19 vaccine antigen composition is to enhance vaccine-induced immune responses to circulating SARS-CoV-2 variants.

-- The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) advises manufacturers that monovalent JN.1 or KP.2 vaccines remain appropriate vaccine antigens; monovalent LP.8.1 is a suitable alternative vaccine antigen.

-- In accordance with WHO SAGE policy, vaccination should not be delayed in anticipation of access to vaccines with an updated composition.

The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continues to closely monitor the genetic and antigenic evolution of SARS-CoV-2 variants, immune responses to SARS-CoV-2 infection and COVID-19 vaccination, and the performance of COVID-19 vaccines against circulating variants. 

Based on these evaluations, WHO advises vaccine manufacturers and regulatory authorities on the implications for future updates to COVID-19 vaccine antigen composition. 

In April 2024, the TAG-CO-VAC recommended the use of a monovalent JN.1 lineage vaccine antigen as one approach to induce enhanced neutralizing antibody responses to JN.1 and its descendent lineages. 

In December 2024, the TAG-CO-VAC advised retaining the use of a monovalent JN.1 lineage vaccine antigen. 

Multiple manufacturers (using mRNA, recombinant protein-based, and adenovirus-vectored platforms) have updated COVID-19 vaccine antigen composition to monovalent JN.1 lineage formulations (JN.1 or KP.2). 

Several of these vaccines have been approved for use by regulatory authorities and introduced into vaccination programmes in some countries during the second half of 2024. Previous statements from the TAG-CO-VAC can be found on the WHO website.

The TAG-CO-VAC reconvened on 6-7 May 2025 to review: 

- the genetic and antigenic evolution of SARS-CoV-2; 

- immune responses to SARS-CoV-2 infection and/or COVID-19 vaccination; 

- the performance of currently approved vaccines against circulating SARS-CoV-2 variants; and 

- the implications for COVID-19 vaccine antigen composition.

Evidence reviewed

The published and unpublished evidence reviewed by the TAG-CO-VAC included: 

(1) SARS-CoV-2 genetic evolution with additional support from the WHO Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE); 

(2) Antigenic characterization of previous and emerging SARS-CoV-2 variants using virus neutralization tests with animal antisera and further analysis of antigenic relationships using antigenic cartography; 

(3) Immunogenicity data on the breadth of neutralizing antibody responses elicited by currently approved vaccine antigens against circulating SARS-CoV-2 variants using animal and human sera; 

(4) Preliminary immunogenicity data on immune responses following infection with circulating SARS-CoV-2 variants; 

(5) Available vaccine effectiveness (VE) estimates of currently approved vaccines during periods of JN.1 lineage circulation; and 

(6) Preliminary non-clinical and clinical immunogenicity data on the performance of candidate vaccines with updated antigens shared confidentially by vaccine manufacturers with TAG-CO-VAC. 

Further details on the data reviewed by the TAG-CO-VAC can be found in the accompanying data annex. Confidential data reviewed by the TAG-CO-VAC are not shown.

Summary of available evidence

There are persistent and increasing gaps in the reporting of cases, hospitalizations and deaths, from WHO Member States, making epidemiological trends difficult to infer. 

Nonetheless, in 2025, SARS-CoV-2 continues to circulate globally, causing severe disease, post COVID-19 condition, and death. 

The majority of COVID-19 deaths continue to occur in individuals aged 65 years and older and those with coexisting conditions. 

Some countries have reported an increase in incidence of COVID-19-related hospitalizations and deaths among children under 1 year of age, as compared to young adults, although this group still accounts for a small proportion of total COVID-19 hospitalizations and deaths.

As of May 2025, currently circulating SARS-CoV-2 variants are derived from JN.1. 

The weekly proportion of Variant Under Monitoring (VUM) LP.8.1 among all SARS-CoV-2 sequences submitted to GISAID continues to increase. 

The weekly proportion of JN.1 (Variant of Interest, VOI) is slowly increasing, largely due to increases in LF.7 and its descendent variants, while all other VUMs (KP.3, KP.3.1.1, XEC, and LB.1) are declining. 

Several JN.1 derived variants have independently evolved changes in the spike protein at epitopes known to be targeted by neutralizing antibodies.

Published and unpublished data using antisera from naïve hamsters infected with JN.1, KP.2, KP.3.1.1, XEC or LP.8.1 or mice immunized with mRNA vaccine antigens JN.1, KP.2 or KP.3 showed that JN.1, KP.2, KP.3.1.1, XEC, and LP.8.1 are antigenically closely related to each other (approximately 1 antigenic unit in cartographic analysis, which corresponds to a two-fold-difference in neutralization).

In published and unpublished data from humans, vaccination with monovalent JN.1 or KP.2 antigens significantly increased neutralizing antibody titers against all JN.1 descendent lineages tested:

-- Analysis of pre- and post-vaccination sera from JN.1 lineage (i.e. JN.1 or KP.2) immunized individuals demonstrated significant rises in neutralization of JN.1 and its descendent lineages, including KP.3.1.1, XEC, LF.7.2.1, and LP.8.1.

-- Neutralization titers against LP.8.1 were generally modestly lower (2-fold reduction) than those against the homologous JN.1 or KP.2 antigen.

Contemporary vaccine effectiveness (VE) estimates are relative (rVE), rather than absolute (comparing vaccinated to unvaccinated individuals), and demonstrate the added or incremental protection of recent vaccination over and above pre-existing infection- and vaccine-derived immunity. 

Monovalent JN.1 or KP.2 COVID-19 vaccines were introduced into some vaccination programmes in the second half of 2024. There are only a few studies estimating rVE for the monovalent JN.1 or KP.2 mRNA COVID-19 vaccines during periods of JN.1 descendent lineage circulation. 

Both vaccines demonstrated additional protection—relative to pre-existing immunity—against symptomatic and severe COVID-19 during the first three to four months after vaccination.

Data shared confidentially with the TAG-CO-VAC by vaccine manufacturers showed that:

-- Immunization of naïve mice, as well as of mice previously immunized with SARS-CoV-2 variants, with monovalent JN.1 or KP.2 vaccines resulted in high neutralizing antibody titers against JN.1 and its derivatives including KP.2, KP.3.1.1, XEC, LP.8.1, and LF.7.2. However, neutralization titers against LP.8.1 were typically lower than those against the homologous immunizing antigen.

-- Immunization of naïve mice, as well as of mice previously immunized with SARS-CoV-2 variants, with monovalent LP.8.1 vaccine candidates elicited high neutralizing antibody titers against the homologous antigen. Cross-neutralizing antibody titers elicited against other JN.1 lineage variants including JN.1, KP.2, KP.3, KP.3.1.1, XEC, and LF.7.2 were similar or modestly higher than those elicited by JN.1 or KP.2 antigens.

-- In humans, vaccination with monovalent JN.1 or KP.2 antigens resulted in robust neutralizing antibody responses to JN.1 and descendent variants, including KP.3.1.1, XEC, LP.8.1, and LF.7.2.

As in non-clinical data, analysis of pre- and post-vaccination sera from JN.1 or KP.2 immunized individuals showed some variation in neutralizing antibody titers against LP.8.1 and LF.7.2 across different studies. In most instances, they were similar or lower than those against the homologous JN.1 or KP.2 antigens.

Overall, the currently approved monovalent JN.1 or KP.2 vaccines continue to elicit broadly cross-reactive immune responses to circulating JN.1-derived variants. 

LP.8.1 as a vaccine antigen offers similar or modestly increased cross-reactive antibody responses to circulating JN.1-derived variants, as compared to monovalent JN.1 or KP.2 vaccines. Mathematical modeling indicates that an increase in neutralizing antibody titers may translate into an improvement in vaccine effectiveness and duration of protection.

The TAG-CO-VAC acknowledges several limitations of available data: 

-- There are persistent and increasing gaps in the reporting of cases, hospitalizations and deaths, from WHO Member States, as well as in genetic/genomic surveillance of SARS-CoV-2 globally, including low numbers of samples sequenced and limited geographic diversity. The TAG-CO-VAC strongly supports the ongoing work of the WHO Coronavirus Network (CoViNet) and the Global Influenza Surveillance and Response System (GISRS) to address this information gap.

-- The timing, specific mutations and antigenic characteristics of emerging and future variants are difficult to predict, and the potential public health impact of these variants remain unknown. There are JN.1-derived variants and long branch saltation variants that are currently detected in low or very low proportions, and which will continue to be monitored and/or characterized. The TAG-CO-VAC strongly supports the ongoing work of the TAG-VE. 

-- Although neutralizing antibody titers have been shown to be important correlates of protection from SARS-CoV-2 infection and of estimates of vaccine effectiveness, there are multiple components of immune protection elicited by infection and/or vaccination. Data on the immune responses following JN.1 descendent lineage infection or monovalent JN.1 or KP.2 vaccination are largely restricted to neutralizing antibodies. Data and interpretation of other aspects of the immune response, including cellular immunity, are limited. 

-- Immunogenicity data against currently circulating SARS-CoV-2 variants are not available for all COVID-19 vaccines. 

-- Estimates of rVE against recently circulating JN.1 variants are limited in terms of the number of studies, geographic diversity, vaccine platforms evaluated, populations assessed, duration of follow-up, and contemporary comparisons of vaccines with different antigen composition.

Recommendations for COVID-19 vaccine antigen composition

-- Monovalent JN.1 (NextStrain: 24A, GenBank: PP298019, GISAID: EPI_ISL_18872762) or KP.2 vaccines remain appropriate for ongoing use; monovalent LP.8.1 (NextStrain: 25A; GenBank: PV074550.1; GISAID: EPI_ISL_19467828) is a suitable alternative vaccine antigen.

Other approaches that demonstrate broad and robust neutralizing antibody responses or efficacy against currently circulating JN.1 descendent lineage variants could also be considered.

As per the WHO Director General’s standing recommendations for COVID-19, Member States are recommended to continue to offer COVID-19 vaccination based on the recommendations of the WHO SAGE. Vaccination should not be delayed in anticipation of access to vaccines with an updated composition.

Further data requested

Given the limitations of the evidence upon which the recommendations above are derived and the anticipated continued evolution of the virus, the TAG-CO-VAC strongly encourages generation of the following data (in addition to the types of data outlined in March 2025): 

-- Immune responses and clinical endpoints (i.e. VE and/or comparator rates of infection and severe disease) in varied human populations who receive currently approved COVID-19 vaccines against emerging SARS-CoV-2 variants, across different vaccine platforms.

-- Strengthened epidemiological and virological surveillance, as per the Standing Recommendations for COVID-19 in accordance with the International Health Regulations (2005), to determine if emerging variants are antigenically distinct and able to displace circulating variants.

-- Strengthened epidemiological surveillance to characterize disease severity in immunologically naïve and/ or immature individuals (i.e. birth cohorts).

-- Clinical evaluation of relevant new vaccine antigens derived from more recent SARS-CoV-2 variants.

As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of SARS-CoV-2.

The TAG-CO-VAC will continue to closely monitor the genetic and antigenic evolution of SARS-CoV-2 variants, immune responses to SARS-CoV-2 infection and COVID-19 vaccination, and the performance of COVID-19 vaccines against circulating variants. The TAG-CO-VAC will also continue to reconvene every six months, or as needed, to evaluate the implications for COVID-19 vaccine antigen composition. At each meeting, recommendations to either maintain current vaccine composition or to consider updates will be issued. Prior to each meeting, the TAG-CO-VAC will publish an update to the statement on the types of data requested to inform COVID-19 vaccine antigen composition deliberations.

Source: World Health Organization, https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines

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