New this Week

 

September 22, 2022Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adultsThe Pfizer trial exhibited a 36 % higher risk of serious adverse events in vaccinated participants in comparison to placebo recipients: 67.5 per 10,000 versus 49.5 per 10,000; risk difference 18.0 per 10,000 vaccinated participants (95 % compatibility1 interval 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of SAEs in vaccinated individuals compared to those receiving placebo

September 22, 2022No significant increase in Guillain-Barré syndrome after COVID-19 vaccination in adults: A vaccine adverse event reporting system study  In our study, several lines of evidence suggest that in some cases, the association between GBS and COVID-19 vaccination is not entirely coincidental. Firstly, the increased reporting rate of GBS within the first 6 weeks after vaccination. 64 % of cases were reported after 6 weeks of COVID-19 vaccination. Self-controlled and case centered analyses confirmed a greater relative risk of GBS within the risk period compared to control period. Similar results were observed in several studies that suspected or established an association between some cases of GBS and vaccination.
 
September 22, 2022
Development and validation of a COVID-19 vaccine hesitancy scale for adults in the United StatesConsistent with prior studies, greater hesitancy was associated with African-American race (r = 0.21; p = 0.001), having children at home (r = 0.24; p < 0.001), living in rural areas (r = 0.40; p < 0.001), residing in the northeastern United States (r = 0.21; p = 0.002), and identifying as a Republican Party supporter (r = 0.39; p < 0.001) [11]. Higher education levels were correlated with lower levels of COVID-19 vaccine hesitancy (r = 0.20; p < 0.001) [12]. These findings support known-group validity.”

September 22, 2022Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax®, a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine “No serious AEs were reported. A total of 150 (92%) subjects reported 678 AEs, of which 259 were systemic AEs (111 subjects) and 419 ISRs (146 subjects). The vast majority (90.2%) of the subjects experienced at least one mild AE; 33.1% had at least one moderate AE and 1.2% had at least one severe AE (Table 4). A total of 71.8% of the subjects reported at least one AE that was considered certainly or possibly related to vaccination by the investigator.”

September 22, 2022Neutralizing antibody responses in healthcare personnel after three doses of mRNA BNT162b2 vaccine and association with baseline characteristics and past SARS-CoV-2 infection “In addition, our study provides information to understand the association between host factors, past SARS-CoV-2 infection, and immunogenicity after mRNA vaccination. Higher NAb titers after two doses of mRNA vaccine were detected over a 9-month period in women, younger individuals, no smokers, and individuals with past SARS-CoV-2 infection.”

September 22, 2022Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluationInferring the effectiveness of a new vaccine by comparing a vaccine-induced immune response biomarker (such as neutralizing antibody) against that elicited by a vaccine for which efficacy was previously demonstrated is known as “immunobridging”. Indeed, regulators from some countries have stated that they would authorize new vaccines based on superior neutralizing responses vs. two doses of Vaxzevria (AstraZeneca, Cambridge, United Kingdom of Great Britain and Northern Ireland), a globally distributed vaccine that is available for use in comparative studies.

September 22, 2022Enhancement of live vaccines by co-delivery of immune modulating proteinsWhile live-attenuated vaccines are by definition unable to disseminate or cause disease in competent hosts, they may be shed for a period after vaccination in immunocompromised hosts, and the (unlikely) possibility of reversion to virulence also exists for some attenuated vectors. Live attenuated vaccines might benefit from additional adjuvant strategies to improve efficacy. Natural immunity developed by infection with Salmonella typhi, Campylobacter jejuni, Helicobacter pylori, and mycobacterial infection does not confer protection against reinfection the generation of mucosal responses to additional (novel protective) antigens, or alternate immune responses is necessary.”

September 9, 2022 Health System Warns Exemptions to COVID Vaccines May Expire With New Options– — Holdouts who used religious exemptions to avoid vaccination can get Novavax now

September 9, 2022
COMMENTARY: No question monkeypox is an STI “So far, more than 95% of cases in the United States have been acquired during sexual contact among men who have sex with men (MSM). To not call it an STI is nearly equivalent to saying syphilis isn’t an STI because exceptions to sexual transmission are common in some settings.

September 9, 2022News Scan for Sep 09, 2022 COVID boosters for pregnant, lactating women; Enterovirus D68 warning; More polio in 5 countries “As of Apr 4, 2022, 17,014 participants reported they had received a COVID booster or third dose. Of those 11.8% were pregnant, 60.4% were lactating, and 27.8% were neither. Most (82.8%) reported a local reaction, and 67.9% reported at least one systemic symptom after the additional vaccine dose.”

September 8, 2022Non-Pharmacological Management for Vaccine-Related Pain in Children in the Healthcare Setting: A Scoping Review (pdf) “The management measures for vaccine-related pain in children mainly involve taste, tactile, olfactory, visual, exercise, and postural interventions and injection technique. The pain outcomes of different studies were generally similar, mainly including a series of physiological parameters such as heart rates, blood oxygen saturation, blood pressure, as well as pain scales, crying time and behavioral variations. Non-pharmacological interventions are known to be safe and effective, but their application in vaccine-related pain needs further promotion.

September 8, 2022
Risk of BA.5 Infection among Persons Exposed to Previous SARS-CoV-2 VariantsOverall, we found that breakthrough infections with the BA.5 subvariant were less likely among persons with a previous SARS-CoV-2 infection history in a highly vaccinated population, especially for previous BA.1 or BA.2 infection, than among uninfected persons.”

September 8, 2022 Americans likely to need annual COVID-19 booster, officials say — but questions abound Fauci said the new boosters are meant to add to the “broad coverage” people got from the original vaccines, noting that the original vaccines have provided protection against some portion of nearly all variants of SARS-CoV-2 thus far, and he encouraged people to get their initial vaccinations if they have not already..

September 8, 2022 COVID-19 vaccine-induced antibody and T-cell responses in immunosuppressed patients with inflammatory bowel disease after the third vaccine dose (VIP): a multicentre, prospective, case-control study “Interpretation A third dose of COVID-19 vaccine induced a boost in antibody binding in immunosuppressed patients with IBD, but these responses were reduced in patients taking infliximab, infliximab plus thiopurine, and tofacitinib. Funding Pfizer.

September 8, 2022 Froedtert Hospital says employees who claimed COVID vaccine exemption must get new option that does not use fetal cell lines The email said those employees can now be vaccinated by the U.S. Food and Drug Administration-approved Novavax vaccine. Novavax is protein, not mRNA-based. This means fetal cell lines were not used in its development.”

September 8, 2022Strengthening Routine Adult Vaccination Programs “Public health authorities—the Food and Drug Administration, Centers for Disease Control and Prevention, the World Health Organization, and other bodies—are discussing approaches to evaluating and harmonizing strain composition decisions to ensure available COVID-19 vaccines continue to meet public health needs, beginning with the introduction of reformulated booster vaccines this fall.

September 8, 2022 How Pharmacists Can Address Vaccine Hesitancy for the Flu and Beyond “One study found that when people reject evidence-based information the reasons are because of high levels of reactance (such as being nonconformist), having conspiratorial worldviews, and having strong disgust reactions to blood and needles. APhA also listed conformity bias as an issue, when the behavior of groups of other people cause individuals to make similar decisions.

September 8, 2022 Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years’ follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial Interpretation A booster dose of R21/Matrix-M at 1 year following the primary three-dose regimen maintained high efficacy against first and multiple episodes of clinical malaria. Furthermore, the booster vaccine induced antibody concentrations that correlated with vaccine efficacy. The trial is ongoing to assess long-term follow-up of these participants and the value of further booster vaccinations. Funding European and Developing Countries Clinical Trials Partnership 2 (EDCTP2), Wellcome Trust, and NIHR Oxford Biomedical Research Centre.