Questions Remain About What SARS-CoV-2 Variants Should Go Into the Annual COVID-19 Vaccines Proposed by the FDA.

This Medical News story examines the US Food and Drug Administration's proposed plans for an annual COVID-19 vaccination.

The Comparability of Anti-Spike SARS-CoV-2 Antibody Tests is Time-Dependent: a Prospective Observational Study.

Various commercial anti-Spike SARS-CoV-2 antibody tests are used for studies and in clinical settings after vaccination. An international standard for SARS-CoV-2 antibodies has been established to achieve comparability of such tests, allowing conversions to BAU/mL. This study aimed to investigate the comparability of antibody tests regarding the timing of blood collection after vaccination. For this prospective observational study, antibody levels of 50 participants with homologous AZD1222 vaccination were evaluated at 3 and 11 weeks after the first dose and 3 weeks after the second dose using two commercial anti-Spike binding antibody assays (Roche and Abbott) and a surrogate neutralization assay. The correlation between Roche and Abbott changed significantly depending on the time point studied. Although Abbott provided values three times higher than Roche 3 weeks after the first dose, the values for Roche were twice as high as for Abbott 11 weeks after the first dose and 5 to 6 times higher at 3 weeks after the second dose. The comparability of quantitative anti-Spike SARS-CoV-2 antibody tests was highly dependent on the timing of blood collection after vaccination. Therefore, standardization of the timing of blood collection might be necessary for the comparability of different quantitative SARS-COV-2 antibody assays. IMPORTANCE This work showed that the comparability of apparently standardized SARS-CoV-2 antibody assays (Roche, Abbott; both given in BAU/mL) after vaccination depends on the time of blood withdrawal. Initially (3 weeks after the first dose AZD1222), there were 3 times higher values in the Abbott assay, but this relationship inversed before boosting (11 weeks after the first dose) with Roche 2 times greater than Abbott. After the booster, Roche quantified ca. 5 times higher levels than Abbott. This must be considered by clinicians when interpreting SARS-CoV-2 antibody levels.

Analysis of COVID-19 Risk Following a Ring Vaccination Intervention to Address SARS-CoV-2 Alpha Variant Transmission in Montreal, Canada.

Importance: Given limited COVID-19 vaccine availability early in the pandemic, optimizing immunization strategies was of paramount importance. Ring vaccination has been used successfully to control transmission of other airborne respiratory viruses. Objective: To assess the association of a ring vaccination intervention on COVID-19 spread in the initial epicenter of SARS-CoV-2 Alpha variant transmission in Montreal, Canada. Design, Setting, and Participants: This cohort study compared COVID-19 daily disease risk in 3 population-based groups of neighborhoods in Montreal, Canada, defined by their intervention-specific vaccine coverage at the neighborhood level: the primary intervention group (500 or more vaccinated persons per 10 000 persons), secondary intervention group (95 to 499), and control group (0 to 50). The groups were compared within each of 3 time periods: before intervention (December 1, 2020, to March 16, 2021), during and immediately after intervention (March 17 to April 17, 2021), and 3 weeks after the intervention midpoint (April 18 to July 18, 2021). Data were analyzed between June 2021 and November 2021. Exposures: Vaccination targeted parents and teachers of children attending the 32 schools and 48 childcare centers in 2 adjacent neighborhoods with highest local transmission (case counts) of Alpha variant shortly after its introduction. Participants were invited to receive 1 dose of mRNA vaccine between March 22 and April 9, 2021 (before vaccine was available to these age groups). Main Outcomes and Measures: COVID-19 risk in 3 groups of neighborhoods based on intervention-specific vaccine coverage. Results: A total of 11 794 residents were immunized, with a mean (SD) age of 43 (8) years (range, 16-93 years); 5766 participants (48.9%) lived in a targeted neighborhood, and 9784 (83.0%) were parents. COVID-19 risk in the primary intervention group was significantly higher than in the control group before (unadjusted risk ratio [RR], 1.58; 95% CI 1.52-1.65) and during (RR, 1.63; 95% CI, 1.52-1.76) intervention, and reached a level similar to the other groups in the weeks following the intervention (RR, 1.03; 95% CI, 0.94-1.12). A similar trend was observed when restricting to SARS-CoV-2 variants and persons aged 30 to 59 years (before: RR, 1.72; 95% CI, 1.63-1.83 vs after: RR, 1.01; 95% CI, 0.88-1.17). Conclusions and Relevance: Our findings show that ring vaccination was associated with a reduction in COVID-19 risk in areas with high local transmission of Alpha variant shortly after its introduction. Ring vaccination may be considered as an adjunct to mass immunization to control transmission in specific areas, based on local epidemiology.

Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.

Longitudinal SARS-CoV-2 mRNA Vaccine-Induced Humoral Immune Responses in Patients with Cancer.

Longitudinal studies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine-induced immune responses in patients with cancer are needed to optimize clinical care. In a prospective cohort study of 366 (291 vaccinated) patients, we measured antibody levels [anti-spike (IgG-(S-RBD) and anti-nucleocapsid immunoglobulin] at three time points. Antibody level trajectories and frequency of breakthrough infections were evaluated by tumor type and timing of treatment relative to vaccination. IgG-(S-RBD) at peak response (median = 42 days after dose 2) was higher (P = 0.002) and remained higher after 4 to 6 months (P = 0.003) in patients receiving mRNA-1273 compared with BNT162b2. Patients with solid tumors attained higher peak levels (P = 0.001) and sustained levels after 4 to 6 months (P < 0.001) compared with those with hematologic malignancies. B-cell targeted treatment reduced peak (P = 0.001) and sustained antibody responses (P = 0.003). Solid tumor patients receiving immune checkpoint inhibitors before vaccination had lower sustained antibody levels than those who received treatment after vaccination (P = 0.043). Two (0.69%) vaccinated and one (1.9%) unvaccinated patient had severe COVID-19 illness during follow-up. Our study shows variation in sustained antibody responses across cancer populations receiving various therapeutic modalities, with important implications for vaccine booster timing and patient selection. SIGNIFICANCE: Long-term studies of immunogenicity of SARS-CoV-2 vaccines in patients with cancer are needed to inform evidence-based guidelines for booster vaccinations and to tailor sequence and timing of vaccinations to elicit improved humoral responses.

Procedural aspects of COVID-19 vaccinations for seafarers on ocean-going vessels.

The increasing availability of safe and authorised coronavirus disease 2019 (COVID-19) vaccines for the first time provides the opportunity to vaccinate seafarers on board their ships while in port. Speedy vaccination of seafarers secures their health and serves to avoid the international propagation of COVID-19 virus variants via maritime traffic. As a port medical clinic, we will share our practical vaccination experience on board of merchant vessels in German/European ports with our esteemed coastal colleagues to stimulate their participation in this endeavour. You will have to adapt the procedure to your national particularities, otherwise please freely share the information with interested parties. Detailed guidance on COVID-19 vaccination in shipping and accompanying legal issues was published by the International Chamber of Shipping (www.ics-shipping.org).

[SARS-CoV-2 vaccines and reaction of the immune system. Can the epidemic spread of the virus be prevented by vaccination?] / SARS-CoV-2-Impfstoffe und Reaktion des Immunsystems. Kann die epidemische Ausbreitung des Virus durch Impfung verhindert werden?

Since the end of 2019 a new coronavirus, SARS-CoV-2, first identified in Wuhan, China, is spreading around the world partially associated with a high death toll. Besides hygienic measurements to reduce the spread of the virus vaccines have been confected, partially based on the experiences with Ebola virus vaccine, based on recombinant human or chimpanzee adenovirus carrying the spike protein and its ACE2 receptor binding domain (RBD). Further vaccines are constructed by spike protein coding mRNA incorporated in lipid nano vesicles that after entry in human cells produce spike protein. Both vaccine types induce a strong immune response that lasts for months possibly for T-cell immunity a few years. Due to mutations in the coronavirus genome in several parts of the world variants selected, that were partially more pathogenic and partially easier transmissible - variants of concern (VOC). Until now vaccinees are protected against the VOC, even when protection might be reduced compared to the Wuhan wild virus.An open field is still how long the vaccine induced immunity will be sufficient to prevent infection and/or disease; and how long the time period will last until revaccination will be required for life saving protection, whether a third vaccination is needed, and whether revaccination with an adenovirus-based vaccine will be tolerated.

COVID-19 Vaccination for Endocrine Patients: A Position Statement from the Korean Endocrine Society.

Since the first outbreak of coronavirus disease 2019 (COVID-19), ongoing efforts have been made to discover an efficacious vaccine against COVID-19 to combat the pandemic. In most countries, both mRNA and DNA vaccines have been administered, and their side effects have also been reported. The clinical course of COVID-19 and the effects of vaccination against COVID-19 are both influenced by patients' health status and involve a systemic physiological response. In view of the systemic function of endocrine hormones, endocrine disorders themselves and the therapeutics used to treat them can influence the outcomes of vaccination for COVID-19. However, there are very limited data to support the development of clinical guidelines for patients with specific medical backgrounds based on large clinical trials. In the current severe circumstances of the COVID-19 pandemic, position statements made by clinical specialists are essential to provide appropriate recommendations based on both medical evidence and clinical experiences. As endocrinologists, we would like to present the medical background of COVID-19 vaccination, as well as precautions to prevent the side effects of COVID-19 vaccination in patients with specific endocrine disorders, including adrenal insufficiency, diabetes mellitus, osteoporosis, autoimmune thyroid disease, hypogonadism, and pituitary disorders.

Perioperative Coronavirus Vaccination-Timing and Implications: A Guidance Document.

EXECUTIVE SUMMARY: Cardiothoracic surgical patients are at risk of increased coronavirus disease severity. Several important factors influence the administration of the coronavirus disease vaccine in the perioperative period. This guidance statement outlines current information regarding vaccine types, summarizes recommendations regarding appropriate timing of administration, and provides information regarding side effects in the perioperative period for cardiac and thoracic surgical patients.

Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing.

BACKGROUND: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. METHODS: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. RESULTS: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. CONCLUSION: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.