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COVID-19 vaccine (ZF2001 / Zifivax / ZF 2001)

✓ Approved

Anhui Zhifei Longcom Biopharma · Recombinant Proteins · Recombinant Proteins

What is COVID-19 vaccine?

COVID-19 vaccine is a recombinant proteins developed by Anhui Zhifei Longcom Biopharma. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesZF2001, Zifivax, ZF 2001
CompanyAnhui Zhifei Longcom Biopharma
Drug ClassRecombinant Proteins, Vaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Anhui Zhifei Longcom Biopharma

Therapeutic Indications

COVID-19 vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsCOVID-19✓ Approved

Related Research Articles

PubMedAIDS research and treatment2026-10-07

Effect of Antiretroviral Therapy, Immune Dysregulation, and COVID-19 Vaccination on SARS-CoV-2 Outcomes in PLWHA in Kenya.

Njue James Kinoti JK, Wekesa Lihana L, Maiyo Alex A, Mwangi Zakayo Maingi ZM et al.

People living with HIV (PLWHA) may experience increased vulnerability to SARS-CoV-2 infection and severe COVID-19 due to immune dysregulation, comorbidities, and treatment adherence challenges. Kenya has over 1.4 million PLWHA. However, only a few have been reported with severe COVID-19, suggesting potential protective roles of antiretroviral therapy (ART), management of comorbidities, and COVID-19 vaccination. This study was conducted across high HIV-prevalence regions in Kenya (Nakuru, Malindi/Mariakani, and Kisumu). A cross-sectional survey evaluates clinical characteristics and self-reported COVID-19 vaccination outcomes among 303 PLWHA. Quantitative data were collected through structured questionnaires and clinical records. Associations between ART, immune markers (CD4/CD8 counts; viral load), COVID-19 vaccination, and SARS-CoV-2 infection and severity were tested using Chi-square and Fisher's exact tests. An analysis of 303 participants (70.6% female, median age 40) revealed an 86.5% COVID-19 vaccination rate and 94.1% ART adherence. Only 9.2% reported prior SARS-CoV-2 infection, mostly mild, potentially indicating underreporting or asymptomatic cases. Interestingly, missing ART doses were significantly associated with contracting SARS-CoV-2 (p = 0.03). Furthermore, all participants reporting or demonstrating SARS-CoV-2 infection were vaccinated, compared to 85.1% of uninfected participants (p = 0.014). Due to incomplete health records, data for CD4 counts were available for only 7.6% of participants (n = 23), limiting conclusions regarding immune dysregulation. Low COVID-19 rates were observed. All cases occurred in vaccinated participants, likely reflecting health-seeking bias rather than vaccine failure. Missing ART doses were significantly associated with infection. Optimal risk mitigation requires integrated strategies prioritizing both high vaccine coverage and strict ART adherence.

PMID 42840250
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PubMedFrontiers in public health2026-10-07

COVID-19 outcomes in patients with inflammatory rheumatic diseases: associations with disease subtypes, treatments, and vaccination status.

Ak Feyza F, Kaya Zeynep Z

Patients with inflammatory rheumatic diseases (IRDs) may be at increased risk for adverse COVID-19 outcomes because of immune dysregulation, comorbidities, and immunomodulatory treatments. However, the effects of specific rheumatic disease subsets, treatment patterns, and vaccine types remain incompletely understood. To evaluate clinical characteristics and factors associated with COVID-19 infection and hospitalization among patients with IRDs. This retrospective observational cohort study included 1,024 adult patients with IRDs followed between March 2020 and January 2023. Demographic characteristics, rheumatic disease subtypes, treatments, vaccination status, COVID-19 infection, hospitalization, radiologic findings, and recovery duration were analyzed. Among all patients, 347 (33.9%) developed COVID-19 infection. Patients with COVID-19 were younger than those without COVID-19 (49.1 ± 13.4 vs. 51.5 ± 14.5 years, p = 0.007). Vaccination before infection was significantly more frequent in the COVID-19-negative group (92.3% vs. 23.9%, p < 0.001). Spondyloarthritis frequency was higher among COVID-19-positive patients (25.9% vs. 20.1%, p = 0.030), whereas methotrexate use was lower (14.4% vs. 22.6%, p = 0.002). Among COVID-19-positive patients, 40 (11.5%) required hospitalization. Hospitalized patients were older, had more frequent lung disease, longer rheumatic disease duration, increased radiologic involvement, and prolonged recovery duration (all p < 0.05). In univariate analyses, FMF, colchicine use, and BNT162b2 vaccination were associated with lower hospitalization rates; however, these associations were not retained after multivariable adjustment. Older age, pulmonary comorbidity, longer disease duration, and radiologic involvement were associated with COVID-19-related hospitalization in IRDs. In contrast, FMF, colchicine use, and BNT162b2 vaccination were associated with lower hospitalization rates.

PMID 42840118
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PubMedRoyal Society open science2026-10-07

The Dunning-Kruger effect does not account for Covid-scepticism or vaccine hesitancy.

McIntosh Robert D RD, Claydon Justin J, Booth Tom T, Della Sala Sergio S

Vaccine-scepticism and vaccine hesitancy are sometimes explained using the Dunning-Kruger effect (DKE), which posits that individuals with low knowledge in relevant domains are overconfident in their understanding. However, prior evidence often relies on discrepancy-based measures of self-overestimation that are susceptible to statistical artefacts. It, therefore, remains unclear whether vaccine-scepticism genuinely reflects the defining features of the DKE. During the Covid-19 pandemic, a large UK sample (n = 537) completed a newly developed Covid-scepticism (CS) scale, with a knowledge test assessing biological knowledge and probabilistic reasoning, relevant to a viral pandemic. Item-level confidence ratings for each knowledge judgement were used to derive a measure of metacognitive bias, which indexes a person's overall tendency towards low or high confidence. Higher CS was associated with lower levels of knowledge. The relationship with low knowledge was strongest for sceptical attitudes towards vaccines and endorsement of conspiracy-adjacent beliefs. However, lower knowledge was not associated with overconfidence, as predicted by DKE accounts. Instead, metacognitive bias increased with knowledge, and higher vaccine-scepticism predicted lower overall confidence. These findings provide little support for accounts of vaccine-scepticism based primarily on the popular view of the DKE. The results underscore the importance of using appropriate measures of metacognition and caution against dismissive characterizations of vaccine-sceptic attitudes.

PMID 42841132
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PubMedInfection and drug resistance2026-10-07

Adverse Events Following Immunization: Mechanisms, Clinical Manifestations, Surveillance, and Public Health Management-A Narrative Review.

Patrick Tambwe T, John Omari Basombelwa OB, Dominique Bigabwa Baharanyi BB, Raoul Raha Zihindula RZ

Immunization is a cornerstone of global public health, preventing substantial morbidity and mortality worldwide. However, the long-term success of immunization programs depends not only on vaccine effectiveness but also on robust systems for monitoring and managing vaccine safety. Adverse Events Following Immunization (AEFIs), defined by the World Health Organization (WHO) as any untoward medical occurrence that follows immunization and does not necessarily have a causal relationship with vaccine use, remain an important challenge for vaccine safety surveillance and public confidence. This narrative review synthesizes evidence on the classification, biological and immunological mechanisms, clinical manifestations, surveillance, causality assessment, and public health management of AEFIs. Literature was identified through searches of PubMed/MEDLINE and Scopus, complemented by relevant grey literature from authoritative organizations, including WHO and the United States Centers for Disease Control and Prevention (CDC). The review considers evidence from both COVID-19 and non-COVID-19 vaccination programs, with emphasis on vaccine safety surveillance, pharmacovigilance, clinical assessment, and public health response. AEFIs were examined according to the WHO classification framework, comprising vaccine product-related, vaccine quality defect-related, immunization error-related, immunization anxiety-related, and coincidental events. Biological and immunological mechanisms range from expected innate inflammatory responses to rare immune-mediated and hypersensitivity reactions. Although most AEFIs are mild and self-limiting, rare serious events require timely recognition, investigation, and appropriate clinical management. Global vaccine safety monitoring capacity remains uneven, with substantial differences in reporting, surveillance infrastructure, diagnostic capacity, and health-system resources across settings. Strengthening pharmacovigilance, active and passive surveillance, healthcare worker training, causality assessment, and transparent risk communication is essential to ensure vaccine safety, sustain public confidence, and support the continued success of immunization programs worldwide.

PMID 42841057
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PubMedDementia & neuropsychologia2026-10-07

Prior COVID-19 vaccination and cognitive outcomes after SARS-CoV-2 infection: a mini-review.

da Silva Lucas Gomes LG, Oliveira Jordano César Milagres JCM, Fini Bruna Carmeni Di BCD, Porto Aline Arantes AA et al.

COVID-19 infection has been frequently associated with cognitive deficits that persist for months after the acute phase, but the impact of vaccination on preventing these deficits remains uncertain. Evidence suggests that immunization reduces the incidence and severity of post-COVID symptoms, yet few studies have evaluated its influence on cognition using objective measures. To address this gap, a mini-review was conducted using a systematic search strategy, following PRISMA recommendations where applicable, with a protocol registered in PROSPERO (CRD42025636772). Searches were carried out in the PubMed/MEDLINE and Scopus databases, and eligible studies were those that assessed cognition using objective measures and compared vaccinated and unvaccinated individuals at the time of infection. A total of 1,796 records were identified, of which only five met the inclusion criteria. The included studies varied considerably in cognitive assessment tools, study designs, and sample sizes. Four of the five studies found no association between prior vaccination and cognitive deficits, whereas the only study that identified a subtle difference among individuals who had received at least two doses of the vaccine had a substantially larger sample than all the others combined. Methodological inconsistencies in cognitive assessment, variability in the definitions of vaccination status, and the lack of stratification by specific cognitive domains limit the interpretation of the current findings. Although vaccination may play a role in protecting against cognitive deficits following COVID-19 infection, the evidence remains limited and inconclusive. Further studies with standardized definitions of vaccination status and comprehensive objective assessments are needed to clarify this relationship.

PMID 42841133
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PubMedEXCLI journal2026-10-07

Real-time pharmacovigilance and cardiac risk communication during the COVID-19 vaccination campaign in Israel.

Ophir Yaakov Y, Shir-Raz Yaffa Y

During the early phase of the COVID-19 vaccination campaign, the Israeli Ministry of Health (IMOH) informed international health authorities that it had identified "a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine." This study discloses and analyzes an internal pharmacovigilance dataset obtained from within the IMOH to examine the case-level record associated with this early safety signal and trace how the signal was subsequently communicated to physicians and the public. The anonymized dataset, provided as Supplementary Data File 1, includes 531 hospitalization records and 67 unique deaths reported to Pfizer between March 2021 and May 2022. Reported events spanned cardiac, neurological, inflammatory, and other serious clinical categories and involved a substantial proportion of younger individuals, with 211 of 530 hospitalization records with valid age data (39.8 %) involving patients under 30 years of age. Myocarditis was recorded in two of the nine unique deaths among individuals under 50 years of age (22.2 %), while myocarditis or pericarditis was identified in 250 of 531 hospitalization records (47.1 0 %), rising to 151 of 211 records involving patients under 30 (71.6 %). Among younger hospitalized patients, 134 of 211 (63.5 %) had no meaningful medical history identified under the study definition; within this subgroup, 99 of 134 (73.9 %) had myocarditis or pericarditis, of whom 90 (90.9 %) were male. The safety signal was communicated to clinicians and the public only after approximately three to four months, primarily in ways that emphasized its rarity, generally mild clinical course, and lower concern relative to COVID-19 outcomes. The accuracy and completeness of this characterization, together with the implications of the case-level patterns and communication timeline documented in this study, are discussed in the broader contexts of pharmacovigilance, risk communication, and informed consent during large-scale public health interventions. See also the graphical abstract(Fig. 1).

PMID 42840454
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