新型冠状病毒灭活疫苗（Vero细胞）大规模紧急使用安全性评价

目的:评价新型冠状病毒灭活疫苗大规模紧急使用的安全性。方法:通过“疫苗接种信息采集系统”,收集在紧急使用中新型冠状病毒灭活疫苗（北京生物制品研究所、武汉生物制品研究所）接种人群的不良反应发生情况,采用流行病学与统计学方法分析相关信息。结果:截至2020年12月1日,共采集519 543人次接种信息,总不良反应发生率为1...     

Efficacy and safety of mRNA and AstraZeneca COVID-19 vaccines in patients with autoimmune rheumatic diseases: A systematic review

BackgroundPatients with autoimmune rheumatic diseases (ARD) are at a potentially higher risk for COVID-19 infection complications. Given their inherent altered immune system and the use of immunomodulatory medications, vaccine immunogenicity could be unpredictable with a suboptimal or even an exaggerated immunological response. The aim of this study is to provide real-time data on the emerging evidence of COVID-19 vaccines' efficacy and safety in patients with ARDs.MethodsWe performed a literature search of the PubMed, EMBASE, and OVID databases up to 11–13 April 2022 on the efficacy and safety of both types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines in patients with ARD. The risk of bias in the retrieved studies was evaluated using the Quality in Prognostic Studies tool. Also, current clinical practice guidelines from multiple international professional societies were reviewed.ResultsWe identified 60 prognostic studies, 69 case reports and case series, and eight international clinical practice guidelines. Our results demonstrated that most patients with ARDs were able to mount humoral and/or cellular responses after two doses of COVID-19 vaccine although this response was suboptimal in patients receiving certain disease-modifying medications including rituximab, methotrexate, mycophenolate mofetil, daily glucocorticoids >10 mg, abatacept, as well as in older individuals, and those with comorbid interstitial lung diseases. Safety reports on COVID-19 vaccines in patients with ARDs were largely reassuring with mostly self-limiting adverse events and very minimal post-vaccination disease flares.ConclusionBoth types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines are highly effective and safe in patients with ARD. However, due to their suboptimal response in some patients, alternative mitigation strategies such as booster vaccines and shielding practices should also be followed. Management of immunomodulatory treatment regimens during the peri vaccination period should be individualized through shared decision making with patients and their attending rheumatologists.     

Safety of simultaneous vaccination with COVID-19 vaccines in the Vaccine Safety Datalink

IntroductionSafety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged ≥5 years in the Vaccine Safety Datalink (VSD).MethodsWe utilized VSD’s COVID-19 vaccine surveillance data from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV. Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was ≥5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1–21 days following COVID-19 vaccine dose 1 and 1–42 days following dose 2 by SV type received (“All SV”, “Influenza SV”, “Non-influenza SV”).ResultsSV with COVID-19 vaccines was not common practice (dose 1: 0.7 % of 8,455,037 persons, dose 2: 0.3 % of 7,787,013 persons). The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV (6.5 vs. 6.8 per 10,000 persons). Statistically significant elevated RRs were observed for appendicitis (2.09; 95 % CI, 1.06–4.13) and convulsions/seizures (2.78; 95 % CI, 1.10–7.06) in the “All SV” group following dose 1, and for Bell’s palsy (2.82; 95 % CI, 1.14–6.97) in the “Influenza SV” group following dose 2.ConclusionCombined pre-specified health outcomes observed among persons who received SV with COVID-19 vaccine were rare and not statistically significantly different compared to persons who did not receive SV with COVID-19 vaccine. Statistically significant adjusted rate ratios were observed for some individual outcomes, but the number of outcomes was small and there was no adjustment for multiple testing.     

Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.

BackgroundOur near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations.MethodsWe conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell’s Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri).ResultsThe primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies’ results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP.ConclusionWe did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.     

Relationship between pre-existing allergies and anaphylactic reactions post mRNA COVID-19 vaccine administration

Two mRNA vaccines for COVID-19, Pfizer-BioNTech and Moderna, are approved for emergency use in the United States. After their approval and dosing in millions of recipients, reports of anaphylaxis began to appear in the Vaccine Adverse Reporting System (VAERS). Here we provide an analysis of the relationship between prior history of allergy and/or anaphylaxis and anaphylaxis rates following the administration of mRNA COVID-19 vaccines. Overall reported incidence of anaphylaxis was estimated to be rare at 4.2 cases per million doses. It appeared that the relative incidence of anaphylaxis following administration of these COVID-19 vaccines was two and seven times higher for recipients with a prior history of allergies and/or anaphylaxis, respectively. This report provides valuable metrics to make evidence-based decisions for subjects with pre-existing allergic conditions receiving a COVID-19 mRNA vaccine.     

Background rates of all-cause mortality,hospitalizations, and emergency department visits among nursing home residents in Ontario,Canada to inform COVID-19 vaccine safety assessments

BackgroundNursing home (NH) residents are prioritized for COVID-19 vaccination. We report monthly mortality, hospitalizations, and emergency department (ED) visit incidence rates (IRs) during 2010–2020 to provide context for COVID-19 vaccine safety assessments.MethodsWe observed outcomes among all NH residents in Ontario using administrative databases. IRs were calculated by month, sex, and age group. Comparisons between months were assessed using one-sample t-tests; comparisons by age and sex were assessed using chi-squared tests.ResultsFrom 2010 to 2019, there were 83,453 (SD: 652.4) NH residents per month, with an average of 2.3 (SD: 0.28) deaths, 3.1 (SD: 0.16) hospitalizations, and 3.6 (SD: 0.17) ED visits per 100 residents per month. From March to December 2020, mortality IRs were increased, but hospitalization and ED visit IRs were reduced (p < 0.05).ConclusionWe identified consistent monthly mortality, hospitalization, and ED visit IRs during 2010–2019. Marked differences in these rates were observed during 2020, coinciding with the COVID-19 pandemic.     

U.S. public support for COVID-19 vaccine donation to low- and middle-income countries during the COVID-19 pandemic

As COVID-19 vaccines become available to the public, there will be a massive worldwide distribution effort. Vaccine distribution has historically been unequal primarily due to the inability of nations with developing economies to purchase enough vaccine to fully vaccinate their populations. Inequitable access to COVID-19 vaccines will not just cause humanitarian suffering, it will likely also be associated with increased economic suffering worldwide. This study focuses on the U.S. population and its beliefs about future COVID-19 vaccine donation by the U.S. to low- and middle-income countries.This study carried out a survey among 788 U.S. adults. Variables include demographics, COVID-19 vaccine priority status, COVID-19 vaccine donation beliefs, and Social Dominance Orientation.Analyses showed that older respondents were both less likely to endorse higher levels of COVID-19 vaccine donations and were more likely to want to wait until all in the U.S. who want the vaccine have received it; those who identified as Democrats were more likely to endorse higher levels of future COVID-19 vaccine donation than Republicans; and those scoring higher on SDO were both less likely to endorse higher levels of COVID-19 vaccine donations as well as more likely to want to wait until all in the U.S. who want the vaccine have received it. Policymakers, as well as healthcare providers and public health communication professionals, should give consideration to those messages most likely to engender support for global prevention efforts with each audience segment.     

Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: Findings from the CDC v-safe surveillance system

BackgroundPost-authorization monitoring of mRNA-based COVID-19 vaccines is needed to better characterize their reactogenicity. We assessed reactions reported during the 2 weeks after receipt of BNT162b2 (Pfizer–BioNTech) and mRNA-1273 (Moderna) vaccines.MethodsWe monitored persons who enrolled in v-safe after vaccination health checker^SM, a U.S. smartphone-based vaccine monitoring system, after receiving BNT162b2 or mRNA-1273. V-safe participants received text message prompts to complete web-based surveys. We analyzed responses from persons who received BNT162b2 or mRNA-1273 from December 14, 2020 through March 14, 2021 and completed at least one survey by March 28, 2021. We measured the proportion of participants reporting local and systemic reactions solicited in surveys completed days 0 through 7 post-vaccination. For day 14 surveys, participants described new or worsening symptoms in a free-text response. We assessed the proportion of participants reporting new or worsening local and systemic reactions.ResultsOne-third of participants were aged <45 years, two-thirds were female, and approximately half received BNT162b2 vaccine. A total of 4,717,908 participants reported during the 7 days after dose 1 and 2,906,377 reported during the 7 days after dose 2. Most reported at least one injection-site reaction (68.5% after dose 1; 72.9% after dose 2) or at least one systemic reaction (50.6% after dose 1; 69.5% after dose 2). Reactogenicity was greater after dose 2 and among mRNA-1273 recipients, persons aged <45 years, and females. New or worsening local and systemic reactions were uncommon during week 2 after either dose; the most frequent were local reactions for dose 1 mRNA-1273 recipients (2.6%). These reactions were reported more often among females after dose 1 mRNA-1273 (3.6%).ConclusionsDuring post-authorization monitoring among >4 million vaccinees, local and systemic reactions were commonly reported following mRNA-based vaccines. Reactions were most common during the first week following dose 2 and among persons aged <45 years, females, and mRNA-1273 recipients.     

Specialist confirmed allergic reactions to COVID-19 mRNA vaccines at a mass vaccination site

Healthcare providers can play a key role in reaching the target for vaccine uptake through educating the public on the risk may be of severe allergic reactions to COVID-19 vaccines. Thus, it is important to resolve reports in the literature which present conflicting data on vaccine safety. We performed a prospective study of Pfizer-BioNTech vaccinations administered at the Albany Community Vaccination Center. All potential vaccinees to the site were screened for allergic history prior to triage by a board-certified allergist. In the first 14 days of operation, our site vaccinated 14,655 individuals, 3.9% of which had a personal history of anaphylaxis. While some vaccine recipients had non-allergic complications, none of the visitors suffered any objective, immediate allergic symptoms. Our findings indicate that specialist-confirmed rates of immediate allergic reaction to mRNA SARS-CoV-2 vaccination are far lower than self-reported rates defined by subjective, unconfirmed symptoms.     

Effectiveness of adenovirus type 5 vectored and inactivated COVID-19 vaccines against symptomatic COVID-19, COVID-19 pneumonia,and severe COVID-19 caused by the B.1.617.2 (Delta) variant: Evidence from an outbreak in Yunnan,China, 2021

BackgroundIn partial response to the coronavirus disease 2019 (COVID-19) pandemic, countries around the world are conducting large-scale vaccination campaigns. Real-world estimates of vaccine effectiveness (VE) against the B.1.617.2 (Delta) variant are still limited. An outbreak in Ruili city of China provided an opportunity to evaluate VE against the Delta variant of two types of COVID-19 vaccines in use in China and globally – inactivated (CoronaVac and BBIBP-CorV) and adenovirus type 5 vectored (Convidecia) vaccines.MethodsWe estimated VE using a retrospective cohort study two months after the Ruili vaccination campaign (median: 63 days). Close contacts of infected people (Chinese nationality, 18 years and above) were included to assess VE against symptomatic Covid-19, COVID-19 pneumonia, and severe COVID-19. We calculated the relative risks (RR) of the outcomes for unvaccinated compared with fully vaccinated individuals. We used logistic regression analyses to estimate adjusted VEs, controlling for gender and age group (18–59 years and 60 years and over).We compared unvaccinated and fully vaccinated individuals on duration of RT-PCR positivity and Ct value.FindingsThere were 686 close contacts eligible for VE estimates. Adjusted VE of ad5-vectored vaccine was 61.5% (95% CI, 9.5–83.6) against symptomatic COVID-19, 67.9% (95%CI: 1.7–89.9) against pneumonia, and 100% (95%CI: 36.6–100) against severe/critical illness. For the two inactivated vaccines, combined VE was 74.6% (95% CI, 36.0–90.0) against symptomatic COVID-19, 76.7% (95% CI: 19.3–93.3) against pneumonia, and 100% (95% CI: 47.6–100) against severe/critical COVID-19. There were no statistically significant differences in VE between two inactivated vaccines for symptomatic COVID-19 and for pneumonia, nor were there statistically significant differences between inactivated and ad5-vectored VE in any of the three outcomes. The median durations of RT-PCR positivity were 17 days for fifteen people vaccinated with an inactivated vaccine, 18 days for forty-four people vaccinated with the Ad5 vectored vaccine, and 26 days for eleven unvaccinated individuals. InterpretationThese results provide reassuring evidence that the three vaccines are effective at preventing Delta-variant COVID-19 in short term following vaccination campaign, and are most effective at preventing more serious illness. The findings of reduced duration of RT-PCR positivity and length of hospital stay associated with full vaccination suggests potential saving of health-care system resources.     

Helping patients with ethical concerns about COVID-19 vaccines in light of fetal cell lines used in some COVID-19 vaccines

Many persons with religious convictions report hesitancy about COVID-19 vaccines, in part due to ethical concerns that fetal cell lines are used in the development of certain vaccines. The issue of abortion is contentious and, given the potential impact on COVID-19 vaccination, it is important for clinicians to be aware of this issue, whatever their personal beliefs. I provide four responses that clinicians may offer their patients: 1) Ethical analyses of moral complicity and COVID vaccines. 2) Altruism and protecting others from a virus that is often transmitted while asymptomatic or pre-symptomatic. 3) Religious texts and many religious leaders support prevention and, therefore, vaccination. 4) Administration of vaccines not developed in fetal cell lines. Although I wish for all my patients to be vaccinated, I respect their autonomy to make the choice to be or not to be vaccinated and understand that many have a deep regard for fetal life.     

SIRVA (Shoulder Injury Related to Vaccine Administration) following mRNA COVID-19 Vaccination: Case discussion and literature review

Shoulder injury related to vaccine administration (SIRVA) is an increasingly recognised complication after vaccination and presents with significant shoulder pain and stiffness. SIRVA is thought to occur as a result of improper administration of vaccine into the subdeltoid bursa or shoulder joint. This results in an inflammatory cascade that damages the structures in the shoulder region. The incidence of SIRVA is relatively higher for influenza vaccination due its widespread administration. We present a reported case of SIRVA following a mRNA COVID-19 vaccination and review the current literature. As we embark on a worldwide scale of COVID-19 vaccination, it is of utmost important that we use proper vaccination techniques and screen patients at risk of SIRVA. This would improve the efficacy of the vaccine and improve the outcomes of the vaccination programme.     

Anaphylaxis rates associated with COVID-19 vaccines are comparable to those of other vaccines

We retrieved data on 8940 anaphylaxis cases post-COVID-19 vaccination from the US Vaccine Adverse Event Reporting System and the European EudraVigilance from week 52/2020 through week 31/2021 and compared them with those of other vaccines. Overall, 837,830,000 COVID-19 vaccine doses were delivered in the US and Europe during the study period, for which the vaccine name was known. The mean anaphylaxis rate was estimated at 10.67 cases per 10⁶ doses of COVID-19 vaccines (range: 7.99-19.39 cases per 10⁶ doses depending on the vaccine). COVID-19 vaccines ranked fifth in reported anaphylaxis rates, behind rabies, tick-borne encephalitis, measles-mumps-rubella-varicella, and human papillomavirus vaccines (70.77, 20, 19.8, and 13.65 cases per 10⁶ vaccine doses, respectively). COVID-19 vaccines are within the range of anaphylaxis rates reported across several common vaccines in these two passive reporting systems. These data should be communicated to reassure the general population about the safety profile of COVID-19 vaccines.     

Perceived facilitators and barriers to intentions of receiving the COVID-19 vaccines among elderly Chinese adults

Elderly adults hold different beliefs regarding vaccination and are at higher risks for COVID-19 related illnesses and deaths. The current study aims to explore elderly (aged 65 or above) Chinese adults’ intentions to get vaccinated against COVID-19 and the facilitators and barriers to vaccination intentions. We conducted in-depth interviews with 35 elderly adults in China through the lens of the integrative model of behavioral prediction. The results identified a number of facilitators, including convenience (both individual and collective), psychological and physiological wellbeing, collective wellbeing, supportive normative referents, and trust in the government, and some barriers, including vaccine ineffectiveness, side effects, safety, unsupportive normative referents, and the accessibility, affordability, and availability of COVID-19 vaccines. In addition, the results revealed participants’ decision-making process: collective wellbeing and trust in the government overrode perceived barriers and perceived individual-level risks, which eventually overwhelmingly led to a high level of intentions to get vaccinated. Practical implications related to vaccine promotion and trust in the government were discussed.