La OMS, en colaboración con autoridades, instituciones e investigadores nacionales, evalúa de forma rutinaria si las variantes del SARS-CoV-2 altera la transmisión o las características de la enfermedad, o afecta la efectividad de las vacunas, la terapia, el diagnóstico o medidas sociales y de salud pública (PHSM) aplicadas para controlar la propagación de enfermedades. Posibles variantes depreocupación (COV),las variantes de interés (VOI) o las variantes bajo seguimiento (VUM) se evalúan regularmente en función del riesgo que representa para salud pública mundial.
Las clasificaciones de variantes se revisarán según sea necesario para reflejar la evolución continua de las variantes en circulación y su cambiante epidemiología. Criterios para la clasificación de variantes y las listas de las que circulan actualmente y Los VOC, VOI y VUM en circulación están disponibles en el sitio web de seguimiento de variantes del SARS-CoV-2 de la OMS. Nacional las autoridades pueden optar por designar otras variantes y se les recomienda enfáticamente que investiguen e informen variantes emergentes y suimpacto.
La OMS continúa monitoreando las variantes del SARS-CoV-2, incluidos los linajes descendientes de los COV, para rastrear los cambios en prevalencia y características virales. Las tendencias actuales que describen la circulación de los linajes descendientes de Omicron debe interpretarse teniendo debidamente en cuenta las limitaciones de los sistemas de vigilancia de la COVID-19. Éstos incluyen diferencias en la capacidad de secuenciación y estrategias de muestreo entre países, cambios en las estrategias de muestreo a lo largo tiempo, reducciones en las pruebas realizadas y secuencias compartidas por países, y retrasos en la carga de datos de secuencias a GISAID.

A nivel mundial, el número de nuevos casos semanales disminuyó un 6 % durante la semana del 10 al 16 de octubre de 2022 en comparación con la semana anterior, con más de 2,9 millones de nuevos casos notificados. El número de nuevas muertes semanales disminuyó en un 17% en comparación con la semana anterior, con alrededor de 8300 muertes reportadas. Hasta el 16 de octubre de 2022, se han notificado más de 621 millones de casos confirmados y más de 6,5 millones de muertes en todo el mundo.A nivel regional, el número de nuevos casos semanalesnotificados disminuyó o se mantuvo estable en cinco de las seis regiones de la OMS: la Región del Mediterráneo Oriental (-17 %), la Región de África (-15 %), la Región de las Américas (- 12 %), la Región de Europa (-11 %) y la Región de Asia Sudoriental (-3 %); mientras que el número de casos aumentó en la Región del Pacífico Occidental (+11%). El número de nuevas muertes semanales disminuyó o se mantuvo estable en cinco regiones: la Región del Mediterráneo Oriental (-35 %), la Región de las Américas (-20 %), la Región de Europa (-18 %), la Región del Pacífico Occidental (- 14%) y la Región de Asia Sudoriental (similar a la semana anterior); mientras que el número de muertes aumentó en la Región de África (61 frente a 18; +144%).

A nivel de país, el mayor número de nuevos casos semanales se notificó en Alemania (583 232 nuevos casos). casos; similar a la semana anterior), Francia (337 253 casos nuevos; -12 %), China (328 910 casos nuevos; -1 %), Italia (288 452 casos nuevos; +3%) y Estados Unidos de América (251 280 casos nuevos; -10%). Los números más altos de se informaron nuevas muertes semanales de los Estados Unidos de América (2274 nuevas muertes; -11%), la Federación Rusa Federación (702 nuevas muertes; -4%), Italia (478 nuevas muertes; +37%), China (431 nuevas muertes; +5%) y Japón (409 nuevas muertes; -28%). Las tendencias actuales en los casos y muertes reportados de COVID-19 deben interpretarse con cautela ya que varios países han estado cambiando progresivamente las estrategias de prueba de COVID-19, lo que ha resultado en un menor número total de pruebas realizados y, en consecuencia, menor número de casos detectados. Además, los datos de semanas anteriores son actualizado continuamente para incorporar retrospectivamente los cambios en los casos y muertes de COVID-19 notificados realizados por países.

The basic reproduction number, R0, plays a central role in measuring the transmissibility of an infectious disease, and it thus acts as the fundamental index for planning control strategies. In the present study, we apply a branching process model to meticulously observed contact tracing data from Wakayama Prefecture, Japan, obtained in early 2020 and mid-2021. This allows us to efficiently estimate R0 and the dispersion parameter k of the wild-type COVID-19, as well as the relative transmissibility of the Delta variant and relative transmissibility among fully vaccinated individuals, from a very limited data. R0 for the wild type of COVID-19 is estimated to be 3.78 (95% confidence interval [CI]: 3.72–3.83), with k = 0.236 (95% CI: 0.233–0.240). For the Delta variant, the relative transmissibility to the wild type is estimated to be 1.42 (95% CI: 0.94–1.90), which gives R0 = 5.37 (95% CI: 3.55–7.21). Vaccine effectiveness, determined by the reduction in the number of secondary transmissions among fully vaccinated individuals, is estimated to be 91% (95% CI: 85%–97%). The present study highlights that basic reproduction numbers can be accurately estimated from the distribution of minor outbreak data, and these data can provide further insightful epidemiological estimates including the dispersion parameter and vaccine effectiveness regarding the prevention of transmission. 

Omicron (B.1.1.529) was first detected in a sample collected in Botswana on November 11, 2021, and has rapidly replaced Delta as the dominant global variant given the robust transmissibility. Moreover, it displays a lower virulence than other variants. However, the pathogenicity of Omicron appears to be underestimated in view of the increasing levels of herd immunity through natural infection or vaccination. Additionally, the volume of hospitalizations and deaths increase in proportion to the number of cases due to the high transmissibility of Omicron. Therefore, vaccination remains an important public health priority. Notably, a series of important mutations in the Omicron spike protein, especially in the receptor-binding domain and N-terminal domain, appears to be associated with immune escape capacity, reducing the willingness of people to receive vaccines. Herein, we provide an in-depth discussion to assess the effectiveness of the second and third vaccination against Omicron variant. On the one hand, the two-dose vaccination program adopted by many countries is insufficient to prevent Omicron infection given the mutations correlated with immune escape and the decline in vaccine efficacy over time. On the other hand, booster dose significantly increases the protective efficacy against Omicron infection. Most importantly, heterologous third dose vaccination induces a more robust immune response than homologous booster dose. Therefore, under the special background of this pandemic, there is an urgent need to accelerate the third dose of vaccination, especially providing better booster vaccination strategies, to combat emerging Omicron variant.

BACKGROUND: Recent observational studies suggest that vaccines may have little effect in preventing infection with the Omicron variant of severe acute respiratory syndrome coronavirus 2. However, the observed effects may be confounded by patient factors, preventive behaviours, or differences in testing behaviour. To assess potential confounding, we examined differences in testing behaviour between unvaccinated and vaccinated populations. METHODS: We recruited 1,526 Australian adults for an online randomized study about coronavirus disease 2019 (COVID-19) testing in late 2021, collecting self-reported vaccination status and three measures of COVID-19 testing behaviour: testing in past month or ever and test intention if they woke with a sore throat. We examined the association between testing intentions and vaccination status in the trial's baseline data. RESULTS: Of the 1,526 participants (mean age 31 y), 22% had a COVID-19 test in the past month and 61% ever;17% were unvaccinated, 11% were partially vaccinated (one dose), and 71% were fully vaccinated (two or more doses). Fully vaccinated participants were twice as likely as those who were unvaccinated (relative risk [RR] 2.2, 95% CI 1.8 to 2.8, p < 0.001) to report positive COVID testing intentions. Partially vaccinated participants had less positive intentions than fully vaccinated participants (RR 0.68, 95% CI 0.52 to 0.89, p < 0.001) but higher intentions than unvaccinated participants (RR 1.5, 95% CI 1.4 to 1.6, p = 0.002). DISCUSSION: Vaccination predicted greater COVID-19 testing intentions and would substantially bias observed vaccine effectiveness. To account for differential testing behaviours, test-negative designs are currently the preferred option, but their assumptions need more thorough examination. HISTORIQUE: Selon de récentes études observationnelles, les vaccins peuvent avoir peu d'effet sur la prévention de l'infection par le variant Omicron du coronavirus 2 du syndrome respiratoire aigu sévère. Cependant, les effets observés peuvent être biaisés par des facteurs liés aux patients, des comportements préventifs ou des différences de comportements liés aux tests. Pour évaluer les facteurs confusionnels potentiels, les auteurs ont examiné les différences de comportements liés aux tests entre les populations non vaccinées et vaccinées. MÉTHODOLOGIE : Les auteurs ont recruté 1 526 adultes australiens en vue d'une étude randomisée en ligne sur les tests de la maladie à coronavirus 2019 (COVID-19) à la fin de 2021, afin de colliger l'état vaccinal autodéclaré et trois mesures sur les comportements liés aux tests de la COVID-19 : test au cours du mois précédent ou jamais auparavant et intention de se soumettre à un test en cas de mal de gorge. Ils ont examiné l'association entre les intentions de se soumettre à un test et l'état vaccinal dans les données de référence de l'étude. RÉSULTATS : Sur les 1 526 participants (d'un âge moyen de 31 ans), 22 % avaient subi un test de COVID-19 au cours du mois précédent et 61 % n'en avaient jamais subi;17 % n'étaient pas vaccinés, 11 % l'étaient partiellement (une dose) et 71 % l'étaient pleinement (au moins deux doses). Les participants pleinement vaccinés étaient deux fois plus susceptibles que ceux qui ne l'étaient pas (risque relatif [RR] 2,2, IC à 95 % 1,8 à 2,8, p < 0,001) de déclarer des intentions de se faire tester contre la COVID-19. Les participants partiellement vaccinés avaient des intentions moins positives que les participants pleinement vaccinés (RR 0,68, IC à 95 % 0,52 à 0,89, p < 0,001), mais plus élevées que ceux qui ne l'étaient pas du tout (RR 1,5, IC à 95 % 1,4 à 1,6, p = 0,002). DISCUSSION : La vaccination était prédictive de plus grandes intentions de subir un test de COVID-19 et établissait un biais important à l'égard de l'efficacité réelle des vaccins. Pour tenir compte des comportements différentiels vis-à-vis des tests, les méthodologies de tests négatifs constituent actuellement la solution privilégiée, mais cette hypothèse doit être approfondie.

Background: This study was designed to investigate the effectiveness of CoronaVac in preventing COVID-19 in healthcare workers (HCWs) during the Alpha variant-dominant period. Materials & methods: Follow-up was initiated 14 days after the second dose for double-dose vaccinated HCWs and on 25 February 2021, for the unvaccinated group. The incidence rate ratio was calculated to estimate the unadjusted effectiveness. Cox regression was used to adjust the effectiveness of CoronaVac. Results & Conclusion: The adjusted effectiveness of CoronaVac against COVID-19 was 65% (95% CI: 50-75%). Compared with the results of the phase III trial conducted in Turkey, a lower effectiveness of CoronaVac against COVID-19 was detected in this real-life study. This finding suggests that mass vaccination and booster doses are needed.

We encountered a 55-year-old woman with possible autoimmune encephalitis associated with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant. She was not vaccinated against coronavirus disease 2019 (COVID-19). Consciousness disturbance, myoclonic-like movements and gait disturbance occurred 10 days after the COVID-19 symptom onset. Her neurological symptoms improved two days after methylprednisolone pulse therapy. Cerebrospinal fluid (CSF) was negative for SARS-CoV-2 reverse transcription-polymerase chain reaction, the CSF-to-serum albumin quotient was mildly elevated, and interleukin 6 and 8 levels were normal in serum but mildly elevated in CSF. Omicron variant infection may increase blood-brain barrier permeability and intrathecal inflammation, causing autoimmune encephalitis.

The SARS-CoV-2 Delta Variant of Concern is highly transmissible and contains mutations that confer partial immune escape. The emergence of Delta in North America caused the first surge in COVID-19 cases after SARS-CoV-2 vaccines became widely available. To determine whether individuals infected despite vaccination might be capable of transmitting SARS-CoV-2, we compared RT-PCR cycle threshold (Ct) data from 20,431 test-positive anterior nasal swab specimens from fully vaccinated (n = 9,347) or unvaccinated (n = 11,084) individuals tested at a single commercial laboratory during the interval 28 June- 1 December 2021 when Delta variants were predominant. We observed no significant effect of vaccine status alone on Ct value, nor when controlling for vaccine product or sex. Testing a subset of low-Ct (<25) samples, we detected infectious virus at similar rates, and at similar titers, in specimens from vaccinated and unvaccinated individuals. These data indicate that vaccinated individuals infected with Delta variants are capable of shedding infectious SARS-CoV-2 and could play a role in spreading COVID-19.

Fast surveillance strategies are needed to control the spread of new emerging SARS-CoV-2 variants and gain time for evaluation of their pathogenic potential. This was essential for the Omicron variant (B.1.1.529) that replaced the Delta variant (B.1.617.2) and is currently the dominant SARS-CoV-2 variant circulating worldwide. RT-qPCR strategies complement whole genome sequencing, especially in resource lean countries, but mutations in the targeting primer and probe sequences of new emerging variants can lead to a failure of the existing RT-qPCRs. Here, we introduced an RT-qPCR platform for detecting the Delta- and the Omicron variant simultaneously using a degenerate probe targeting the key DELTAH69/V70 mutation in the spike protein. By inclusion of the L452R mutation into the RT-qPCR platform, we could detect not only the Delta and the Omicron variants, but also the Omicron sub-lineages BA.1, BA.2 and BA.4/BA.5. The RT-qPCR platform was validated in small- and large-scale. It can easily be incorporated for continued monitoring of Omicron sub-lineages, and offers a fast adaption strategy of existing RT-qPCRs to detect new emerging SARS-CoV-2 variants using degenerate probes.

Background: Coronavirus infection of 2019 (COVID-19) is associated with significant morbidity and mortality. Vaccines supplement public health and social measures in preventing severe illness and mortality from COVID-19;however, vaccination rates remain inadequate in many regions. It is important to continuously explore the effective treatment due to the insufficient vaccination rate and increasing number of patients infected with virus. The emergence of new variants has led to multiple surges throughout the world requiring changes to treatment protocols. Method: We conducted a single-center observational study on all adult patients who received monoclonal antibody (mAb) infusion as a treatment for COVID-19 infection. Based on the predominant variant, patients were either offered Casirivimab (600 mg)/imdevimab (600 mg) or Sotrovimab (500 mg). Forty-six patients were given mAbs;24 were vaccinated, and the remaining unvaccinated. Result: The mean age was 56 years, and the majority (63.04%) of the patients were female. Clinical symptoms of COVID-19 improved within 3 days of infusion in the majority of the patients (70%). None of the patients who received mAb showed progression of disease or required hospitalization at 30 days follow-up. There were no deaths at 30 days follow-up. Monoclonal antibodies are highly effective in reducing hospitalizations and mortality when given within 7 days of symptoms onset in patients with high-risk factors for progression to severe COVID-19 infection. The mean number of days after the onset at which the mAbs were administered to the patient was 4. Conclusion: Monoclonal antibodies should be considered in both vaccinated and unvaccinated patients with COVID-19 infection if newer antiviral agents are contraindicated. Our study highlights the effectiveness of monoclonal antibody infusions when given early in the course of COVID-19 infection regardless of vaccination status

Omicron (B.1.1.529) is the most recent SARS-CoV-2 variant of concern, which emerged in late 2021 and rapidly achieved global predominance by early 2022. In this study, we compared the infection dynamics, tissue tropism, and pathogenesis and pathogenicity of SARS-CoV-2 D614G (B.1), Delta (B.1.617.2), and Omicron BA.1.1 (B.1.1.529) variants in a highly susceptible feline model of infection. Although D614G- and Delta-inoculated cats became lethargic and showed increased body temperatures between days 1 and 3 postinfection (pi), Omicron-inoculated cats remained subclinical and, similar to control animals, gained weight throughout the 14-day experimental period. Intranasal inoculation of cats with D614G- and the Delta variants resulted in high infectious virus shedding in nasal secretions (up to 6.3 log10 TCID50.Ml21), whereas strikingly lower level of viruses shedding (,3.1 log10 TCID50.Ml-1) was observed in Omicron-inoculated animals. In addition, tissue distribution of the Omicron variant was markedly reduced in comparison to the D614G and Delta variants, as evidenced by lower in situ viral RNA detection, in situ viral immunofluorescence staining, and viral loads in tissues on days 3, 5, and 14 pi. Nasal turbinate, trachea, and lung were the main--but not the only--sites of replication for all three viral variants. However, only scarce virus staining and lower viral titers suggest lower levels of viral replication in tissues from Omicron-infected animals. Notably, while D614G- and Delta-inoculated cats presented pneumonia, histologic examination of the lungs from Omicron-infected cats revealed mild to modest inflammation. Together, these results demonstrate that the Omicron variant BA.1.1 is less pathogenic than D614G and Delta variants in a highly susceptible feline model. [ FROM AUTHOR] Copyright of Journal of Virology is the property of American Society for Microbiology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full .

• XBB is a new version of Omicron that is evading existing treatments and immunity.

• It is spreading quickly in Singapore, and virus-watchers are worried it could spread in the US.

• BQ.1.1 is also emerging. Experts say: prepare for more COVID infections this winter.

As Halloween approaches, murmurs of another "nightmare" COVID variant on the way are spooking reporters and Wall Street analysts alike.

The new variant is called XBB, and it's already triggering a new wave of infections and hospitalizations in some south Asian countries, including India and Singapore.

XBB is just one of "multiple more-immune evasive Omicron subvariants on the rise around the world," infectious disease expert Dr. Celine Gounder, a Senior Fellow at the Kaiser Family Foundation, told Insider.

But "among the new variants, XBB has the most significant immune evasion properties," market forecasters at Morgan Stanley said Thursday in a memo.

Given that we've now seen nearly three full years of COVID variants — and nearly a year of different Omicrons before XBB emerged from them — how worried, really, should we be about this new version of the virus?

Experts say we should expect many more infections this fall and winter, including infections in vaccinated, boosted Americans. But there are some simple things you can do to prepare to battle XBB and other evasive COVID variants on the horizon.

What is XBB?

XBB is a recombinant variant – meaning that it's a combination of two other BA.2 Omicron subvariants (specifically, BA.2.10.1 + BA.2.75).

Like other Omicrons we've seen before, XBB is "finding ways to evade the way we get immunity from vaccines and previous infection, with changes on the spike protein," UC Berkeley infectious disease expert John Swartzberg told the San Francisco Chronicle.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a recently emerged pathogenic human coronavirus that belongs to the sarbecovirus lineage of the genus Betacoronavirus. The ancestor strain has evolved into a number of variants of concern, with the Omicron variant of concern now having many distinct sublineages. The ongoing COVID-19 pandemic caused by SARS-CoV-2 has caused serious damage to public health and the global economy, and one strategy to combat COVID-19 has been the development of broadly neutralizing antibodies for prophylactic and therapeutic use. Many are in preclinical and clinical development, and a few have been approved for emergency use. Here we summarize neutralizing antibodies that target four key regions within the SARS-CoV-2 spike (S) protein, namely the N-terminal domain and the receptor-binding domain in the S1 subunit, and the stem helix region and the fusion peptide region in the S2 subunit. Understanding the characteristics of these broadly neutralizing antibodies will accelerate the development of new antibody therapeutics and provide guidance for the rational design of next-generation vaccines.

Understanding the epidemic growth of the novel SARS-CoV-2 Omicron variant is critical for public health. We compared the ten-day secondary attack rate (SAR) of the Omicron and Delta variants in households using Norwegian contact tracing data, December 2021 - January 2022. Omicron SAR was higher than Delta, with a relative risk (RR) of 1.41 (95% CI 1.27-1.56). We observed increased susceptibility to Omicron infection in household contacts compared to Delta, independent of contacts' vaccination status. Among three-dose vaccinated contacts, the mean SAR was lower for both variants. We found increased Omicron transmissibility from primary cases to contacts in all vaccination groups, except 1-dose vaccinated, compared to Delta. Omicron SAR of three-dose vaccinated primary cases was high, 46% vs 11 % for Delta. In conclusion, three-dose vaccinated primary cases with Omicron infection can efficiently spread in households, while three-dose vaccinated contacts have a lower risk of being infected by Delta and Omicron.

Combined with inevitably large crowds, these factors set an unfortunate stage for Omicron’s latest highly infectious variant BF.7 to make waves over the coming days.

But what is this variant, and how does it differ from its predecessors? Listed below are answers to some FAQs, so we stay updated and safe from the disease that doesn’t seem to quit.

What is the Omicron BF.7 variant?

The BF.7 variant is the newest Omicron strain to surface and was initially detected in China’s Mongolia region on October 4.

After rapidly spreading through many districts of China, it found its way into the UK, Germany, France, the US, and now, India. Many of these countries have classified it as a variant of concern, with it already constituting a significant share of total positive cases.

Some experts believe this variant is a contender to replace the dominant one worldwide.

Where has the Omicron BF.7 variant been found in India?

The Gujarat Biotechnology Centre discovered the first case of the new BF.7 subvariant in Gandhinagar, Gujarat.

Is the new Omicron BF.7 variant more transmissible?

The BF.7 is highly transmissible and requires a far less viral load to infect someone, primarily due to its ability to bind much more effectively than previous variants.

What are the symptoms and the severity of an Omicron BF.7 infection?

Most reported symptoms of patients infected by the new subvariant remain the same as before — sore throat, congestion, bodily fatigue, cough, runny nose, loss of smell, etc. As before, carriers of the virus can also be asymptomatic.

Aside from these symptoms, we aren’t sure of the exact severity or any additional symptoms inflicted by the virus since scientists are still sequencing the data. We will receive more information in the coming days, as more positive people are tested.

Will this new Omicron BF.7 variant trigger a new wave?

While there is a good chance India might be in for a new COVID-19 wave, we cannot purely attribute it to the new variant. Large crowds and a lack of compliance with COVID-19 protective measures during the festival season means that all variants have an increased chance of jumping from patient to patient.

What precautions can we take against the new coronavirus variant?

Maintain social distancing as much as possible, wear a reliable mask, and maintain cough etiquette and basic hygiene to protect the most vulnerable groups (such as pregnant people and the elderly) as much as possible.

Currently, India’s weekly positivity rate stands around 1.02% per cent, and we must try to make sure that the figure isn’t the thing blowing up during the festival of joy.

Background Coronavirus disease 2019 (COVID-19) continues to be a major global public health challenge, with the emergence of variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Current vaccines or monoclonal antibodies may not well be protect against infection with new SARS-CoV-2 variants. Unlike antibody-based treatment, T cell-based therapies such as TCR-T cells can target epitopes that are highly conserved across different SARS-CoV-2 variants. Reportedly, T cell-based immunity alone can restrict SARS-CoV-2 replication. Methods In this study, we identified two TCRs targeting the RNA-dependent RNA polymerase (RdRp) protein in CD8+ T cells. Functional evaluation by transducing these TCRs into CD8+ or CD4+ T cells confirmed their specificity. Results Combinations of inflammatory and anti-inflammatory cytokines secreted by CD8+ and CD4+ T cells can help control COVID-19 in patients. Moreover, the targeted epitope is highly conserved in all emerged SARS-CoV-2 variants, including the Omicron. It is also conserved in the seven coronaviruses that infect humans and more broadly in the subfamily Coronavirinae. Conclusions The pan-genera coverage of mutant epitopes from the Coronavirinae subfamily by the two TCRs highlights the unique strengths of TCR-T cell therapies in controlling the ongoing pandemic and in preparing for the next coronavirus outbreak.

Background Older adults are more susceptible to severe health outcomes for coronavirus disease 2019 (COVID-19). Universal vaccination has become a trend, but there are still doubts and research gaps regarding the COVID-19 vaccination in the elderly. This study aimed to investigate the efficacy, immunogenicity, and safety of COVID-19 vaccines in older people aged ≥ 55 years and their influencing factors. Methods Randomized controlled trials from inception to April 9, 2022, were systematically searched in PubMed, EMBASE, the Cochrane Library, and Web of Science. We estimated summary relative risk (RR), rates, or standardized mean difference (SMD) with 95% confidence interval (CI) using random-effects meta-analysis. This study was registered with PROSPERO (CRD42022314456). Results Of the 32 eligible studies, 9, 21, and 25 were analyzed for efficacy, immunogenicity, and safety, respectively. In older adults, vaccination was efficacious against COVID-19 (79.49%, 95% CI: 60.55−89.34), with excellent seroconversion rate (92.64%, 95% CI: 86.77−96.91) and geometric mean titer (GMT) (SMD 3.56, 95% CI: 2.80−4.31) of neutralizing antibodies, and provided a significant protection rate against severe disease (87.01%, 50.80−96.57). Subgroup and meta-regression analyses consistently found vaccine types and the number of doses to be primary influencing factors for efficacy and immunogenicity. Specifically, mRNA vaccines showed the best efficacy (90.72%, 95% CI: 86.82−93.46), consistent with its highest seroconversion rate (98.52%, 95% CI: 93.45−99.98) and GMT (SMD 6.20, 95% CI: 2.02−10.39). Compared to the control groups, vaccination significantly increased the incidence of total adverse events (AEs) (RR 1.59, 95% CI: 1.38−1.83), including most local and systemic AEs, such as pain, fever, chill, etc. For inactivated and DNA vaccines, the incidence of any AEs was similar between vaccination and control groups (p > 0.1), while mRNA vaccines had the highest risk of most AEs (RR range from 1.74 to 7.22). Conclusion COVID-19 vaccines showed acceptable efficacy, immunogenicity and safety in older people, especially providing a high protection rate against severe disease. The mRNA vaccine was the most efficacious, but it is worth surveillance for some AEs it caused. Increased booster coverage in older adults is warranted, and additional studies are urgently required for longer follow-up periods and variant strains.

Coronavirus disease (COVID-19) has caused unimaginable damage to public health and socio-economic structures worldwide;thus, an epidemiological depiction of the global evolving trends of this disease is necessary. As of March 31, 2022, the number of cases increased gradually over the four waves of the COVID-19 pandemic, indicating the need for continuous countermeasures. The highest total cases per million and total deaths per million were observed in Europe (240,656.542) and South America (2,912.229), despite these developed countries having higher vaccination rates than other continents, such as Africa. In contrast, the lowest of the above two indices were found in undeveloped African countries, which had the lowest number of vaccinations. These data indicate that the COVID-19 pandemic is positively related to the socio-economic development level;meanwhile, the data suggest that the vaccine currently used in these continents cannot completely prevent the spread of COVID-19. Thus, rethinking the feasibility of a single vaccine to control the disease is needed. Although the number of cases in the fourth wave increased exponentially compared to those of the first wave, ~43.1% of deaths were observed during the first wave. This was not only closely linked to multiple factors, including the inadequate preparation for the initial response to the COVID-19 pandemic, the gradual reduction in the severity of additional variants, and the protection conferred by prior infection and/or vaccination, but this also indicated the change in the main driving dynamic in the fourth wave. Moreover, at least 12 variants were observed globally, showing a clear spatiotemporal profile, which provides the best explanation for the presence of the four waves of the pandemic. Furthermore, there was a clear shift in the trend from multiple variants driving the spread of disease in the early stage of the pandemic to a single Omicron lineage predominating in the fourth wave. These data suggest that the Omicron variant has an advantage in transmissibility over other contemporary co-circulating variants, demonstrating that monitoring new variants is key to reducing further spread. We recommend that public health measures, along with vaccination and testing, are continually implemented to stop the COVID-19 pandemic.

OBJECTIVE: Estimating the response of different population cohorts to new SARS-CoV-2 variants is important to customize measures of control. Our goal was to evaluate how antibodies from sera of infected and vaccinated people recognize antigens expressed by different SARS-CoV-2 variants. METHODS: We compared sera from vaccinated donors and four patient/donor cohorts: Sera from critically ill patients collected 2-7 days and more than 10 days after admission to an intensive care unit, a NIBSC/WHO reference panel of SARS-CoV-2 positive individuals, and ambulatory or hospitalized (but not critically ill) positive donors. Samples were tested with an anti-SARS-CoV-2 ELISA kit coated with SARS-CoV-2 RBD recombinant antigens including mutations present in eleven of the most widespread variants. RESULTS: Sera from vaccinated individuals exhibited higher antibody binding (P<0.001) than sera from infected (but not critically ill) individuals when tested against the wild type (WT) and each of 11 variants' receptor binding domain (RBD). Antibodies' binding to the SARS-CoV-2 antigens of at least 6 variants, including Variants of Concern (VOCs), was reduced in comparison to the WT in vaccinated and non-critically ill convalescence individuals. CONCLUSION: Understanding differences between population cohorts in the antibody titers against WT vs variant RBD antigens can help design variant-specific immunoassays for surveillance and evaluation of the epidemiology of new variants.

WHO-defined SARS-CoV-2 variants of concern (VOC) drive therapeutics and vaccine development. The Omicron VOC is dominating the arena since November 2021, but the number of its sublineages is growing in complexity. Omicron represent a galaxy with a myriad of stars that suddenly rise and expand before collapsing into apparent extinction when a more fit sublineage appears. This has already happened with BA.1, BA.2, and BA.4/5 and is happening with BA.2.75. We review here the current PANGO phylogeny, focusing on sublineages with Spike mutations, and show how common convergent evolution has occurred in these sublineages. We finally summarize how Omicron evolution has progressively defeated the anti-Spike monoclonal antibodies authorized so far, leaving clinicians to again fall back on COVID19 convalescent plasma from vaccinated donors as the only antibody-based therapy available.

Omicron sublineage BA.2.75.2 escapes most antibodies, a study published in The Lancet Infectious Diseases journal says. The study, led by researchers at Karolinska Institutet in Sweden, suggests a risk of increased Covid-19 infections this winter. This is likely to happen unless the new updated bivalent vaccines help to boost immunity in the population. Bivalent Covid-19 vaccines include a component of the original virus strain to provide broad protection against Covid-19 and a component of the Omicron variant to provide better protection against Covid-19 caused by the Omicron variant, according to the Food and Drug Administration (FDA).

The new study was conducted in collaboration with researchers at ETH Zürich, Switzerland and Imperial College London, United Kingdom. 

Why is BA.2.75.2 more resistant to antibodies than its predecessor?

In a statement released by Karolinska Institutet, Ben Murrell, the corresponding author on the paper, said while antibody immunity is not completely gone, BA.2.75.2 exhibited far more dramatic resistance than variants previously studied. This resistance is largely driven by two mutations in the receptor binding domain of the spike protein. 

Time points at which samples were collected

Antibodies in random serum samples from 75 blood donors in Stockholm, Sweden were approximately only one-sixth as effective at neutralising BA.2.75.2 compared with the now-dominant variant BA.5, the study says. The researchers collected the serum samples at three time points. Some samples were collected in November last year, before the emergence of Omicron, some were collected in April, 2022 after a large wave of infections in Sweden, and some were collected at the end of August to early September this year after the BA.5 variant became dominant.

Which monoclonal antibody was able to neutralise the new variant?

Bebtelovimab was one of the clinically available monoclonal antibody treatments tested. Monoclonal antibodies are engineered in a laboratory and are given to a person directly in an infusion. These antibodies are used as antiviral treatments for people at high risk of developing severe Covid-19. Bebtelovimab was observed to be able to potently neutralise the new Omicron subvariant. 

According to the study, BA.2.75.2 is a mutated version of another Omicron variant, BA.2.75, and was first discovered earlier this fall. Since then, the variant has spread to several countries but so far represents only a minority of registered cases.

Covid-19 infections are likely to increase this winter

Murrell said in the statement that the new subvariant is just one of a constellation of emerging variants with similar mutations that will likely come to dominate in the near future. He added that people should expect infections to increase this winter. 

However, some questions remain. For instance, it is not known whether these new variants will drive an increase in hospitalisation rates. In general, current vaccines have had a protective effect against severe disease for Omicron infections. But there is no data which shows the degree to which the updated bivalent Covid-19 vaccines provide protection from new variants. 

Murrell said the vaccines are expected to be beneficial, but the extent to which they provide protection against Covid-19 variants is not known.

Based on mucosal immunization to promote both mucosal and systemic immune responses, next-generation coronavirus disease 2019 (COVID-19) vaccines would be administered intranasally or orally. The goal of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines is to provide adequate immune protection and avoid severe disease and death. Mucosal vaccine candidates for COVID-19 including vector vaccines, recombinant subunit vaccines and live attenuated vaccines are under development. Furthermore, subunit protein vac-cines and virus-vectored vaccines have made substantial progress in preclinical and clinical settings, resulting in SARS-CoV-2 intranasal vaccines based on the previously successfully used nasal vaccines. Additional to their ability to trigger stable, protective immune responses at the sites of pathogenic infection, the development of 'specific' mucosal vaccines targeting coronavirus antigens could be an excellent option for preventing future pandemics. However, their efficacy and safety should be confirmed.

The advent of the new coronavirus SARS-CoV-2 has created unprecedented situations, both in terms of health and socio-economic level, worldwide. The emergence of vaccines against this highly contagious virus has raised hopes for its effective inhibition. The efficacy of vaccines, in more than a year of their application in clinical practice, is indisputable, both in terms of reducing serious hospitalizations and deaths, especially in high-risk populations. As with any new medication, the quest and investigation for side effects are reasonable. Myocarditis is one of the extremely rare side effects reported in mRNA vaccines, especially in young males. We present two cases of myocarditis that occurred in our hospital in a short time between them and compare them point by point to identify similarities and differences in order to draw conclusions about the severity of this side effect and its outcome. The benefits of vaccination against Covid-19 outweigh possible untoward effects and especially myocarditis. Health workers must close monitor the vaccinated patients for possible future cardiovascular complications.

CoVID-19 is the most formidable unequaled global challenge invading 220 countries and territories in this millennium to uncountable saga of mortality, disability as humanity is witnessing devastation of socio-economy with more than 4 million deaths till date. The natural history of CoVID-19 from transmission through varied clinical features to overt complications is still under global research and research groups are on the run to trace its ramifications. This ranges from primary involvement of the pulmonary system to multisystem involvement through web of immunological pathways associated with susceptibility, clinical presentations, and severity of COVID-19. It has been hypothesized that the safe and effective mass vaccination program across the globe can ensure flattening of the pandemic curve to prepandemic normal life. This research group explored the basic and applied researches on molecular and immune mechanisms of SARS COV-2 virus. A sincere attempt has been made in futuristic research vision to find potential strengths, shortfalls, and efficacy of the plant-based immunotherapy, antibodies, and vaccine. Different research groups have hypothesized for the best possible use of these indigenous, stable, secure, efficacious natural products by searching their potential to accomplish emergency demands in this trying time. There is an urgent need to understand the inherent immunological predictors of the natural history of the disease spread over the spectrum from mild to severe forms of the disease and harp on these issues. In the wake of multiple waves with worse situations of evolving clinical features with the "variants of concern" and "variants of interest" and innovative interventions, this research group believes in optimum mix of microbial-derived biologicals with immune modifying drugs will broaden the preventive and curative spectrum. [ FROM AUTHOR] Copyright of Indian Journal of Health Sciences & Biomedical Research is the property of Wolters Kluwer India Pvt Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full.

Deze positieve aanbeveling komt van het wetenschappelijk comité van het Europees medicijnagentschap EMA

De coronavaccins Comirnaty (Pfizer) en Spikevax (Moderna) zijn goedgekeurd voor gebruik bij kinderen vanaf 6 maanden. Uit onderzoek blijkt dat de vaccins een afweerreactie opwekken tegen COVID-19 in deze doelgroep. De bijwerkingen zijn vergelijkbaar met die bij oudere leeftijdsgroepen. Hiermee zijn de voordelen groter dan de risico’s. 

Deze positieve aanbeveling komt van het wetenschappelijk comité van het Europees medicijnagentschap EMA. Medicijnautoriteit CBG is betrokken bij de beoordeling. De Europese Commissie neemt dit advies waarschijnlijk over. De vaccins van deze fabrikanten zijn al eerder goedgekeurd voor volwassenen en voor kinderen vanaf 5 en 6 jaar. Het gaat hierbij om de vaccins die zich richten op de oorspronkelijke stam van het coronavirus (Wuhan).

Lagere dosis, drie prikken
De dosis van beide vaccins is lager voor deze jongere leeftijdsgroepen. De basisserie voor kinderen van 6 maanden tot 4 jaar van Comirnaty bestaat uit 3 prikken (van elk 3 microgram). Tussen de eerste 2 prikken hoort minstens 3 weken te zitten. Minimaal 8 weken na de tweede prik volgt dan nog een derde prik. 

Kinderen vanaf 6 maanden tot 5 jaar kunnen Spikevax krijgen als basisserie van 2 prikken (van elk 25 microgram), met een tussenpoos van 4 weken. De prikken worden toegediend in de spieren van de bovenarm of de dij.
 
Afweerreactie
Drie prikken met de lage dosis (3 microgram) van Comirnaty wekken bij kinderen van 6 maanden tot en met 4 jaar een vergelijkbare afweer op als 2 prikken met de hogere dosering (30 microgram) bij 16- tot 25-jarigen.

Onderzoek met Spikevax liet zien dat de afweerreactie na 2 prikken met de lagere dosering (25 microgram) bij kinderen van 6 maanden tot en met 5 jaar vergelijkbaar was met die na 2 prikken met de hogere dosis (100 microgram) bij 18- tot 25-jarigen. 
 
Em. prof. dr. Ton de Boer, Collegevoorzitter: Het immuunsysteem van kinderen en volwassenen werkt in de basis hetzelfde. De afweerreactie van kinderen is wel sterker dan bij volwassenen, en dan vooral bij jonge kinderen. Daarom hebben zij genoeg aan een nog lagere hoeveelheid dan kinderen vanaf 5 of 6 jaar.

Bijwerkingen
De meest voorkomende bijwerkingen voor beide vaccins waren vergelijkbaar met die in oudere leeftijdsgroepen: 

• Prikkelbaarheid, slaperigheid, verlies van eetlust, huiduitslag en gevoeligheid op de prikplek waren ook vaak voorkomende bijwerkingen bij kinderen van 6 tot 23 maanden met Comirnaty. 
• Prikkelbaarheid, huilen, verlies van eetlust en slaperigheid waren vaak voorkomende bijwerkingen waren bij kinderen van 6 tot 36 maanden met Spikevax. 

Voor beide vaccins waren de bijwerkingen meestal mild of matig en gingen ze na enkele dagen over. 

Zoals voor alle vaccins en leeftijdsgroepen houden we de veiligheid en werkzaamheid nauwlettend in de gaten. Dit gebeurt via ons Europese geneesmiddelenbewakingssysteem, lopende studies en aanvullende studies door de fabrikanten en Europese autoriteiten. 
 
De Boer: De meeste kinderen die besmet raken met het coronavirus, krijgen alleen milde klachten. In zeldzame gevallen kunnen kinderen wel ernstige COVID-19 krijgen. Het risico hierop is het grootst bij kinderen met onderliggende aandoeningen. De oorspronkelijke coronavaccins blijven effectief tegen ernstige ziekte, ziekenhuisopname en overlijden.  Het is nu aan de Gezondheidsraad en de minister van Volksgezondheid of en hoe het vaccin ingezet gaat worden.

A new sub-variant ‘XBB’ of the Omicron variant of the coronavirus has been identified. The variant has infected a significant number of people in Singapore. In addition, the sub-variant ‘XBB’ has been found in human body of at least 17 countries including India, USA, Australia and Hong Kong.

The International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B) revealed the information in a press release on Sunday (October 23).

ICDDR,B reports, from September 10 to October 14, ICDDR,B sequenced 92 SARS-CoV genomes and found the virus keeps change over time. In the first two weeks of genome sequencing from September 10 to 23, Omicron BA.-2 was identified at 84 percent while BA.-5 at 16 percent.

The press release further states, most of these sub-variants have been replaced by an all-new sub-variant named ‘XBB’, which constituted 85 percent of the viruses spread across the country in the last three weeks (September 24 to October 14).

In addition to the new sub-variant ‘XBB’, another new sub-variant of the Omicron variant of the coronavirus has also been identified, the press release reads.

Depuis le regain épidémique au mois de septembre, les scientifiques observent l’émergence d’un nouveau sous-variant d’Omicron : le BQ.1.1. Il provoquerait des diarrhées, des vomissements et des maux de ventre. Des symptômes qui n’étaient pas associés jusqu’ici au coronavirus.

Le nombre de cas de Covid-19 se stabilise en France métropole selon le dernier bilan du 20 octobre 2022 de Santé publique France. Mais le nombre de malades reste « élevé » et les admissions en soins critiques (552, +8 %) ainsi que les décès (390, +23 %) continuent de progresser.

Depuis le regain épidémique observé fin septembre, la majorité des cas sont toujours issus du sous-lignage BA.5 du variant Omicron, à 93 %. Mais les scientifiques ont remarqué qu’un nouveau sous-variant d’Omicron prenait de plus en plus de place parmi les contaminations : le BQ.1.1.

Entre mi-septembre et mi-octobre, il est passé de 2 % à 16 % dans les séquences de tests Covid analysées par Santé Publique France. « Il est cependant encore trop tôt pour évaluer le possible impact de BQ.1.1 sur la dynamique de l’épidémie », affirme l’agence de santé.

Ce nouveau variant semble en augmentation dans d’autres pays d’Europe comme l’Italie, les Pays-Bas ou le Royaume-Uni, ou encore aux États-Unis.

Lire aussi : « Le Covid-19 n’est pas fini, l’épidémie tue encore », alerte le ministre de la Santé

L’hypothèse de symptômes digestifs remise en doute

Il est encore difficile de savoir quels symptômes sont engendrés par ce nouveau sous variant BQ.1.1. Plusieurs médecins auraient observé des diarrhées, des vomissements et des maux de ventre.

Mais cette hypothèse ne semble pas encore fiable : rien ne vient encore confirmer que le Covid en est la cause. Toutefois, si cela se révèle vrai, les scientifiques craignent que l’épidémie leur échappe car les patients ne feraient plus le lien avec le Covid et ne se testeraient plus.

Lire aussi : Gestion de l’épidémie de Covid : où en est l’enquête concernant les ex-membres du gouvernement ?

Un sous-variant plus résistant ?

Ce nouveau de la famille Omicron serait « criblé de mutations gênantes » qui pourraient « constituer une menace pour la réponse de notre système immunitaire », explique Docteur Eric Topol, fondateur du Scripps Research Translational Institute aux Echos .

Antony Fauci, conseiller médical du président des États-Unis, ajoute que ce variant est une « boîte noire » à plusieurs inconnues. Selon lui, son évolution déprendra « des vaccinations antérieures, des expositions antérieures et de la région du pays dans laquelle vous vous trouvez ».

Pour le ministre de la santé François Braun, interrogé sur BFM TV ce dimanche 23 octobre, BQ.1.1 « progresse » mais « le risque d’échappement immunitaire [l’inefficacité des vaccins] n’est pas prouvé. Les signes cliniques sont à peu près les mêmes que BA.5.Il n’a pas plus de gravité ».

A health expert reminded the public of the importance of Covid-19 vaccination amid the presence of new variants of coronavirus in the country.

Covid-19 vaccines can help prevent severe illness, said infectious disease expert and Department of Health (DOH)–Technical Advisory Group member Dr. Edsel Salvana in a recent media forum.

“Vaccines still work well against severe disease. Important ang first booster especially for Omicron (The first booster is important especially for Omicron),” he said.

“We really have to get boosted if we are 12 years old and above… Nato-top up talaga ang immunity pag nakakuha ka ng first booster lalo na (Immunity really tops up when you get the first booster, especially) for severe infections. The first booster is essential for Omicron,” he added.

Salvana also emphasized the importance of wearing face masks.

“Yung (The) preventive measures aside from our vaccines, yung (the) masks decrease risk by 85 percent,” he said.

“While we are still figuring out kung ano talaga yung impact ng XBB at XBC, siguro importante na ipagpatuloy natin yung pag wear ng mask natin kasi baka nga sumipa yung cases (it is still important that we continue to wear our masks because the cases might spike),” he added.

Salvana said “we need to continue our preventive measures until we know the full impact of these new variants.”

Last Oct. 18, the DOH reported that the presence of both Omicron subvariant XBB and XBC variant is already in the country.

There is now localized community transmission of the Omicron subvariant XBB in Western Visayas and the XBC variant in Davao region and Soccsksargen.

The DOH, however, noted that the number of severe and critical Covid-19 patients infected with the Omicron coronavirus variant and its subvariants remains low in the Philippines.

Viruses are obligatory protein-coated units and often utilize the metabolic functions of the cells they infect. Viruses hijack cellular metabolic functions and cause consequences that can range from minor to devastating, as we have all witnessed during the COVID-19 pandemic. For understanding the virus-driven pathogenesis and its implications on the host, the cellular metabolism needs to be elucidated. How SARS-CoV-2 triggers metabolic functions and rewires the metabolism remains unidentified but the implications of the metabolic patterns are under investigation by several researchers. In this review, we have described the SARS-CoV-2-mediated metabolic alterations from in vitro studies to metabolic changes reported in victims of COVID-19. We have also discussed potential therapeutic targets to diminish the viral infection and suppress the inflammatory response, with respect to evidenced studies based on COVID-19 research. Finally, we aimed to explain how we could extend vaccine-induced immunity in people by targeting the immunometabolism.

The optimal vaccination strategy to boost responses in the context of pre-existing immune memory to the SARS-CoV-2 spike (S) glycoprotein is an important question for global public health. To address this, we explored the SARS-CoV-2-specific humoral and cellular immune responses to a novel self-amplifying RNA (saRNA) vaccine followed by a UK authorised mRNA vaccine (BNT162b2) in individuals with and without previous COVID-19, and compared these responses with those who received an authorised vaccine alone. 35 subjects receiving saRNA (saRNA group) as part of the COVAC1 clinical trial and an additional 40 participants receiving an authorised SARS-CoV-2 vaccine only (non-saRNA group) were recruited. Antibody responses were measured by ELISA and a pseudoneutralisation assay for wildtype, Delta and Omicron variants. Cellular responses were measured by IFN-y ELISpot and an activation induced marker (AIM) assay. Approximately 50% in each group had previous COVID-19 prior to vaccination, confirmed by PCR or antibody positivity on ELISA. All of those who received saRNA subsequently received a full course of an authorised vaccine. The majority (83%) of those receiving saRNA who were COVID-19 naive at baseline seroconverted following the second dose, and those with previous COVID-19 had an increase in antibody titres two weeks following saRNA vaccination (median 27-fold), however titres were lower when compared to mRNA vaccination. Two weeks following the 2nd authorised mRNA vaccine dose, binding and neutralising antibody titres were significantly higher in the saRNA participants with previous COVID-19, compared to non-saRNA, or COVID-19 naive saRNA participants. Cellular responses were again highest in this group, with a higher proportion of spike specific CD8+ than CD4+ T cells when compared to those receiving the mRNA vaccine only. These findings suggest an immunological benefit of increased antigen exposure, both from natural infection and vaccination, particularly evident in those receiving heterologous vaccination with saRNA and mRNA.

COVID-19 vaccines are playing a vital role in controlling the COVID-19 pandemic. As SARS-CoV-2 variants encoding mutations in the surface glycoprotein, Spike, continue to emerge, there is increased need to identify immunogens and vaccination regimens that provide the broadest and most durable immune responses. We compared the magnitude and breadth of the neutralizing antibody response, as well as levels of Spike-reactive memory B cells, in individuals receiving a second dose of BNT126b2 at a short (3-4 week) or extended interval (8-12 weeks) and following a third vaccination approximately 6-8 months later. We show that whilst an extended interval between the first two vaccinations can greatly increase the breadth of the immune response and generate a higher proportion of Spike reactive memory B cells, a third vaccination leads to similar levels between the two groups. Furthermore, we show that the third vaccine dose enhances neutralization activity against omicron lineage members BA.1, BA.2 and BA.4/BA.5 and this is further increased following breakthrough infection during the UK omicron wave. These findings are relevant for vaccination strategies in populations where COVID-19 vaccine coverage remains low.

BACKGROUND: The COVID-19 pandemic has led to the death of many people worldwide. The World Health Organization (WHO) has declared vaccine resistance as one of the greatest health threats in the world even before the COVID-19 epidemic. The aim of this study was to evaluate the acceptance of COVID-19 vaccine in pregnant women. METHOD: We performed this systematic review and meta-analysis in accordance with the PRISMA guidelines. We applied the standard search strategy to the PubMed/Medline, Web of Science (ISI), Scopus, Science Direct, Cochrane Library, EMBASE, and EBSCO databases, and the Google Scholar search engine. Heterogeneity between studies was relatively high and therefore meta-analyses were performed based on random effects model with 95% CI using STATA version 16. RESULTS: In 16 articles with a sample size of 19219 pregnant women, the acceptance of COVID-19 vaccine was estimated 53.46% (95%CI: 47.64%-59.24%). Subgroup analysis was performed based on continent (p = 0.796), data collection method (p = 0.450) and meta-regression based on the month of the study (P<0.001), and only meta-regression was significant based on the month of the study. The effect of some variables such as graviad (OR = 1.02 [95%CI: 0.90-1.16]), maternal age was (OR = 1.02 [95%CI: 0.93-1.11]) and history of influenza vaccination (OR = 0.87 [95%CI: 0.71-1.06]) on COVID-19 vaccine acceptance was evaluated, which was not significant. CONCLUSION: The prevalence of COVID-19 vaccine acceptance in pregnant women was 53.46%, which was much lower than the general COVID-19 vaccination. Therefore, necessary interventions should be taken to increase the acceptance of the vaccine, address safety concerns and educate about it.

Amerikanska läkemedelsjätten Pfizer räknar med att höja priset på sitt covid-vaccin till ungefär fyra gånger det nuvarande priset, till ungefär 110 till 130 dollar per dos. Detta efter att den amerikanska regeringens nuvarande inköpsplan upphör, skriver Reuters och hänvisar till en talesperson från bolaget.

Talespersonen förväntar sig att vaccinet – som för närvarande tillhandahålls gratis för alla av regeringen – kommer att göras tillgängligt utan kostnad för personer som har privat försäkring eller statligt betald försäkring. Detta väntas ske tidigast under Q1 2023.

Bolaget förväntar sig att covid-19-marknaden kommer att vara ungefär lika stor som marknaden för influensavacciner.

Pfizer har samutvecklat sitt covid-19-vaccin med tyska Biontech.

COVID-19 caused, as of September, 1rst, 2022, 599,825,400 confirmed cases, including 6,469,458 deaths. Currently used vaccines reduced severity and mortality but not virus transmission or reinfection by different strains. They are based on the Spike protein of the Wuhan reference virus, which although highly antigenic suffered many mutations in SARS-CoV-2 variants, escaping vaccine-generated immune responses. Multiepitope vaccines based on 100% conserved epitopes of multiple proteins of all SARS-CoV-2 variants, rather than a single highly mutating antigen, could offer more long-lasting protection. In this study, a multiepitope multivariant vaccine was designed using immunoinformatics and in silico approaches. It is composed of highly promiscuous and strong HLA binding CD4(+) and CD8(+) T cell epitopes of the S, M, N, E, ORF1ab, ORF 6 and ORF8 proteins. Based on the analysis of one genome per WHO clade, the epitopes were 100% conserved among the Wuhan-Hu1, Alpha, Beta, Gamma, Delta, Omicron, Mµ, Zeta, Lambda and R1 variants. An extended epitope-conservancy analysis performed using GISAID metadata of 3,630,666 SARS-CoV-2 genomes of these variants and the additional genomes of the Epsilon, Lota, Theta, Eta, Kappa and GH490 R clades, confirmed the high conservancy of the epitopes. All but one of the CD4 peptides showed a level of conservation greater than 97% among all genomes. All but one of the CD8 epitopes showed a level of conservation greater than 96% among all genomes, with the vast majority greater than 99%. A multiepitope and multivariant recombinant vaccine was designed and it was stable, mildly hydrophobic and non-toxic. The vaccine has good molecular docking with TLR4 and promoted, without adjuvant, strong B and Th1 memory immune responses and secretion of high levels of IL-2, IFN-γ, lower levels of IL-12, TGF-β and IL-10, and no IL-6. Experimental in vivo studies should validate the vaccine's further use as preventive tool with cross-protective properties.

Tidigt i pandemin utvecklade Astrazeneca och forskare vid Oxford University covid-19-vaccinet Vaxzevira. Målet var att vidareutveckla det till ett vaccin att kunna tas som nässprej.

En nyligen avslutad fas I-studie med en nässprejsvariant av Vaxzevria blev dock en besvikelse. Vaccinet visade sig ge sämre, eller som bäst lika bra, immunsvar jämfört med samma vaccin givet som intramuskulär injektion, vilket Läkemedelsvärlden var först att rapportera om. Studien är publicerad i Lancet eBioMedicine.

Projektet läggs därför ner då det enligt forskarna inte är motiverat att fortsätta utvecklingen av vaccinet.

Att kunna ge covid-19-vaccin i form av nässprej har väckt stort intresse då det både skulle kunna förenkla administreringen av vaccinet och ge ett lokalt vaccinskydd i nässlemhinnan. Höga nivåer av antikroppar i luftvägarna har bland annat visat sig halvera risken för att smittas av omikron-varianten, enligt en studie på personal vid Danderyds sjukhus, som Läkartidningen tidigare rapporterat om.

Flera nässprejsbaserade covid-vaccin är under utveckling och nyligen godkände både Indien och Kina varsitt nässprejsvaccin.

LONDON, Oct 17 (Reuters) - Moderna Inc (MRNA.O) has agreed to provide its new variant-adapted COVID-19 vaccine to the global scheme aiming to deliver shots to the world's poorest people.

The biotech company and vaccine alliance GAVI will cancel their existing supply deal for vaccines based on the original coronavirus strain. Instead, Moderna will supply up to 100 million doses of its new, variant-adapted vaccines at its lowest available price from 2023.

Et si les vaccins anti-Covid passaient par le nez? Malgré quelques revers, cette piste de recherche reste prise au sérieux par les scientifiques, dans l'espoir d'offrir une protection plus efficace qu'une injection classique.

Un tel vaccin, qui peut passer par un spray en aérosol ou bien des gouttes comme un sérum physiologique, présente en effet un intérêt théorique: en agissant par les voies respiratoires, en particulier les muqueuses, il pourrait empêcher d'entrée de jeu l'infection par le coronavirus.

Cela constituerait un grand pas par rapport aux vaccins actuels contre le Covid. Ces derniers restent très efficaces contre les formes graves mais sont loin d'empêcher les simples contaminations.

Dans certains pays, ces vaccins nasaux sont en passe de devenir réalité. Deux d'entre eux viennent d'être approuvés, respectivement en Chine et en Inde, à la fin de l'été.

Mais ces autorisations ont été données sans que des données publiques attestent d'une plus grande efficacité de ces vaccins contre le fait d'attraper le Covid.

Et, plus récemment, cette piste de recherche a connu un important revers. Au Royaume-Uni, des chercheurs de l'université d'Oxford, qui étudiaient l'intérêt d'administrer par le nez le vaccin d'AstraZeneca, ont annoncé début octobre l'échec d'un premier essai clinique.

Au terme de celui-ci, mené sur une trentaine de personnes et publié dans la revue eBioMedicine, les patients avaient développé une moindre réponse immunitaire qu'avec une vaccination classique par injection.

Cependant, pour les scientifiques interrogés par l'AFP, cet échec ne rend pas caduque la piste des vaccins nasaux.

Il ne faut pas "être trop découragés" par ces résultats, assure le virologue Connor Bamford, de la Queen's University de Belfast.

Même quand ils sont mauvais, souligne-t-il, de tels résultats donnent une base pour aller plus loin, en comprenant ce qui n'a pas marché.

Il remarque, par exemple, que les rares vaccins nasaux en circulation - contre la grippe ou la polio - sont "vivants": ils utilisent une version atténuée du virus pour stimuler le système immunitaire.

Ce n'est pas le cas du vaccin d'AstraZeneca - développé avec l'université d'Oxford - qui fonctionne par "vecteur viral": un virus, inoffensif et distinct du coronavirus, transporte une part d'ARN de ce dernier.

- Manque de financement -

Un vaccin vivant anti-Covid aurait-il plus de succès? Peut-être. Les chercheurs d'Oxford évoquent une autre hypothèse: leur spray ne parvient pas assez loin et le vaccin pourrait être efficace s'il atteignait les poumons.

"C'est possible que ce vaccin nasal soit tout simplement avalé et détruit par l'estomac - on éviterait ça s'il atteignait les poumons", a avancé dans un communiqué le chercheur Sandy Douglas, qui a mené ces essais.

Un élément, en tout cas, est de bon augure. Aucun effet secondaire grave n'a été noté, que ce soit lors de cet essai ou ceux menés pour les vaccins nasaux chinois et indien.

Mais les promoteurs des vaccins nasaux ne se heurtent pas seulement à des défis scientifiques. Ils risquent fort de pâtir d'un manque de demande: dans de multiples pays, notamment développés, les doses de vaccins se sont déjà accumulées.

Un projet français a ainsi pâti de cette situation. La biotech TheraVectys s'était lancée dès 2020, de concert avec l'institut Pasteur, dans le développement d'un vaccin nasal.

Mais celui-ci n'a jamais dépassé le stade des tests sur animaux, pourtant prometteurs.

"Nous n'avons pas suscité l'intérêt des organismes de subvention, ni des +big pharmas+, pour initier les phases cliniques chez l'Homme", a rapporté à l'AFP Pierre Charneau, qui a mené le volet scientifique de ce projet.

Pour être financées, de telles recherches doivent en effet convaincre de leur intérêt, qui n'est pas évident alors que les vaccins existants restent très efficaces contre les décès et les hospitalisations.

A quoi bon, alors? Il s'agit de parvenir à interrompre les vagues épidémiques, suggèrent certains acteurs du secteur balbutiant des vaccins nasaux, telle la biotech américaine Meissa.

"La seule manière de prendre le contrôle de ce virus, c'est de casser les chaînes de transmission. (...) Avec un vaccin nasal, on peut le faire", avance auprès de l'AFP Martin Moore, son responsable scientifique.

Une représentante de Pfizer a-t-elle "admis" que son entreprise avait commis une erreur en indiquant que le vaccin développé par la société pharmaceutique pour lutter contre le Covid-19 n'avait "jamais été testé sur la prévention de la transmission" du virus ? De nombreuses publications sur les réseaux sociaux affirment, en effet, que Pfizer aurait menti au sujet des résultats de ses tests cliniques. Cependant, cette affirmation est inexacte. En effet, les essais cliniques des vaccins en vue d'obtenir leur autorisation sur le marché visaient à établir leur sûreté et leur efficacité sur la prévention des formes graves de la maladie. La capacité du vaccin à prévenir la transmission du coronavirus a été évaluée plus tard car il s'agissait à l'époque, avant tout, de pouvoir fournir une réponse rapide à la pandémie.

This week, Twitter exploded with outrage about a study that seemed to have created a Frankenstein COVID-19 virus: a version of SARS-CoV-2 that combines Omicron, the fast-spreading but relatively mild variant that’s now everywhere, and a deadlier strain from early in the pandemic. The labmade virus killed 80% of mice infected with it, compared with no deaths with the unmodified Omicron variant, according to a preprint posted online on 14 October by Boston University (BU) researchers.

“Totally irresponsible” and “This is madness,” tweeted critics worried that the hybrid virus, known as a chimeric virus, could escape the lab and cause a deadly outbreak. Richard Ebright, a molecular biologist at Rutgers University, Piscataway, pointed to the work, partially funded by the National Institutes of Health (NIH) and conducted at BU’s National Emerging Infectious Diseases Laboratories, as an example of controversial “gain-of-function” (GOF) research that makes risky pathogens more dangerous.

An official from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) added to concerns by telling STAT her division was unaware of the specific experiments. She said they likely should have been evaluated to see whether they needed to go through a special review for NIH-funded GOF studies that create so-called enhanced potential pandemic pathogens. BU officials, however, say NIH funds weren’t used directly for the study and they are “in continued conversation” with NIAID.

But several virologists argued on Twitter that the study is not as alarming as it first appears. For one thing, the hybrid virus was less lethal than the early variant modified in the study. They also noted that other researchers have published the results of similar experiments that did not draw similar concerns. And it’s not clear the study is very different from other chimeric virus studies that NIAID has exempted from review.

Here’s a quick guide to the controversy.

What did the BU researchers do, and why?

They took the gene for Omicron’s surface protein, or spike protein, which SARS-CoV-2 uses to enter cells and added it to the genome of a “backbone” virus—a variant of SARS-CoV-2 from Washington state that was identified soon after the pandemic first emerged in Wuhan, China, in early 2020. The objective was to tease apart whether Omicron’s spike protein explains why it is less pathogenic (meaning it causes less severe disease). The answer could lead to improved COVID-19 diagnostic tests and better ways to manage the disease, the preprint authors say.

Somewhat surprisingly, the hybrid virus killed eight of 10 infected mice, whereas mice infected with Omicron got sick but did not die. This suggests the mutations that make Omicron less pathogenic must involve changes in proteins other than the spike protein, the authors say.

What are critics of the study saying?

They question the scientific value of the study and argue its potential risks and benefits were not properly reviewed before it took place.

Under current U.S. government policy, any proposal to conduct a federally funded experiment that is “reasonably anticipated” to make an already highly virulent and transmissible virus more dangerous is supposed to get a special review. BU has said the experiment didn’t meet that criterion (see below). Some researchers, however, believe it does. They note that although the new hybrid was less lethal to mice than the original Washington variant, it is likely more transmissible.

Some scientists also question the study’s relevance to protecting human health. They note that findings made in mice often do not translate to humans. Given such limitations, the argument for doing this work “generally doesn’t feel overly convincing to me,” tweeted virologist Francois Balloux of University College London.

Some researchers also feel the public should have a greater say in such work. Gene therapy researcher Alina Chan of the Broad Institute, an outspoken critic of GOF research, called the study “a bit worrying to me” because she fears the impact if the hybrid virus leaked into Boston, where she lives. Local residents “were not consulted,” she tweeted. (BU says the experiments were approved by a biosafety committee that includes community representatives as well as Boston’s public health board.)

What are the counterarguments?

The study was “far less alarming” than some suggest, tweeted virologist Stuart Neil of King’s College London, emphasizing that the hybrid virus was less lethal than the original Washington state strain.

It was also tested in mice that are “exquisitely sensitive” to SARS-CoV-2 because they have been engineered so their lung cells are packed with the receptor that SARS-CoV-2 uses to break into human cells, Neil noted. The scientists forced a huge amount of virus up the noses of the mice, far more than a person would typically encounter. As a result, the mouse mortality rate of 80% was far higher than the human mortality from the original SARS-CoV-2 variant, which is about 1% or less.

Also reassuring, Neil noted, is that the experiments were conducted in a biosafety level-3 (BSL-3) lab, which has a series of sealed doors, negative air pressure cabinets, and workers in protective suits. That is just short of the safety precautions seen in the most secure BSL-4 laboratories, which are reserved for extremely deadly pathogens such as Ebolavirus.

Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, believes the experiment is less concerning because similar hybrid SARS-CoV-2 variants have already emerged naturally and later faded into the background. One such naturally emerging virus, for example, featured the Omicron spike protein on a Delta strain backbone. “Mother Nature did it already a while ago IN HUMANS and nobody cared,” he tweeted.

Should the experiment have undergone stricter review?

BU has said it did not think the study met the federal review criteria because “It did not amplify the [backbone] SARS-CoV-2 virus strain or make it more dangerous. In fact, this research made the virus replicate less dangerous,” BU said in a statement. Today, BU added that NIAID funds were only used for “tools and platforms” and that BU was not required to report the study.

Emily Erbelding, director of the NIAID division that helped fund the work, said the hybrid virus experiments weren’t described in BU’s grant proposal or progress reports. But she said if BU had informed NIAID about its plans, the institute probably would have evaluated it to determine whether it qualified for review by a special Department of Health and Human Services (HHS) committee.

In the past, however, NIAID has deemed similar research exempt from review. For example, the agency has exempted studies that made chimeras of certain bat coronaviruses that are distant cousins of SARS-CoV-2. In that case, the agency noted that the researchers did not anticipate that the hybrid viruses would be more transmissible or pathogenic than the starting viruses.

Other groups have done experiments that were similar to the BU study but did not get reviewed. For example, a recently published study conducted at the U.S. Food and Drug Administration also created a hybrid of Omicron and an early SARS-CoV-2 variant and got essentially the same result: Most infected mice died. And earlier this year, a privately funded team in Texas reported it had created similar COVID-19 chimeras to test vaccines.

That work encountered “no problem” from GOF critics, Krammer notes. The reaction to the BU experiment was different, some say, because the researchers highlighted the 80% mouse fatality rate in the preprint abstract, instead of simply noting the hybrid virus was still lethal even with the swapped-in Omicron spike protein. It was “not the smartest launch of a preprint,” tweeted virologist Marion Koopmans of Erasmus University Medical Center, who faulted the BU team for a “communication” error. Even Chan lamented that “a single line taken out of context can lead to explosive headlines.”

What’s next?

The dust-up is sure to add impetus to an ongoing review of the federal oversight policy for risky GOF research by a panel called the National Science Advisory Board for Biosecurity (NSABB). In September, an NSABB task force issued a draft report that recommended the review policy be expanded to sweep in some kinds of research, and some pathogens, that are now exempt. And experts on all sides of the GOF debate have said the criteria for review need to be clearer. The government is expected to release new rules as early as next year.