Vaccines and Antivirals Areas of Interest

In scope

• Epidemiological studies that describe Covid burden (e.g., acute illness, under-diagnosis and testing, risk of hospitalization or death by subgroup, secondary bacterial or co-infections, long-term symptoms or sequalae)
• Epidemiological studies describing risk factors (sociodemographic or clinical) for severe illness including evaluations in special populations (e.g., pregnant women)
• Studies evaluating patient characteristics (non-biomarker) associated with the development of long Covid in adults and children
• Studies evaluating the transmissibility or severity of new variants or sub-lineages
• Socio-behavioral studies that identify predictors of improving vaccine uptake (including healthcare communication and systems-level approaches), particularly in underserved or pediatric populations
• Studies that describe antiviral prescribing patterns including reasons for patient refusal, barriers to access or timely treatment, prescriber behavior and perceptions, and patient adherence to treatment
• Studies that evaluate interventions designed to improve time-to-treatment (including evaluation and management of drug-drug interactions) for antiviral therapy

Out of scope

• Basic research (clinical or non-clinical) including evaluations of biomarkers 
• Safety evaluations (includes studies of antiviral resistance or rebound) or studies of drug-drug interactions
• Immunogenicity studies
• Vaccine or treatment effectiveness studies (including comparative effectiveness)
• Studies evaluating heterologous vaccine schedules or combination of therapies 
• Pfizer is unable to provide COVID-19 vaccine as part of a grant

Research areas to be considered for Pfizer support include:

1. Epidemiology
   1. Clinical disease burden in different:
      1. age cohorts (e.g., adolescents, infants)
      2. settings (e.g., universities, military, mass gathering, travelers)
      3. clinical condition or patient population (e.g., individuals at increased risk of meningococcal disease)
   2. Nasopharyngeal carriage in different age cohorts and settings (examples above)
   3. Disease isolates characterization – genetic characterization, diversity and evolution, across geographic regions and time periods
   4. Understand incidence trends retrospectively and prospectively
2. Disease impact – individual and community
   1. Short and long-term clinical consequences, complications 
   2. Direct and indirect costs and quality of life, social and psychological parameters
3. Vaccine impact - in particular age cohort, setting or patient population
   1. Vaccine effectiveness 
   2. Vaccine impact on carriage dynamics – prevalence, transmission, acquisition
   3. Vaccination program impact on disease evolution and health economics
   4. Broader societal value of implementing meningococcal vaccination program
4. Implementation of vaccination programs or guidelines
   1. Knowledge/awareness, attitudes/perceptions & behaviors/practices
   2. Vaccination preferences
   3. Barriers and potential solutions including potential vaccine platforms

Research areas to be considered for funding include:

1. Studies evaluating the burden of pneumococcal disease and serotype distribution in children or adults or risk groups before, during, or following the implementation of PCV immunization programs, based on one or more of the following presentations:
   • Primary outcomes, including but not limited to
     • Lower respiratory tract infection, including pneumococcal pneumonia and all-cause pneumonia outcomes
     • Invasive Pneumococcal Disease (IPD)
     • Otitis Media in children
   • Secondary outcomes such as exacerbations of chronic underlying medical conditions or long-term sequelae or post hospitalization mortality over the long-term
   • Relationship between serotype distribution by syndrome or carriage (IPD, pneumonia, OM, NPC)
   • Humanistic burden, such as patient-reported outcome measures and quality of life
   • Mechanisms driving changes in serotypes causing disease following PCV introduction.
   • Other outcomes not captured above that may be modified by the introduction of pneumococcal conjugate vaccines 
   • Documentation of PCV impact on pneumococcal disease a population level following vaccine introduction 
2. Pneumococcal carriage in children or adults prior to, or following, the implementation of PCV immunization programs
   • Carriage prevalence, acquisition, duration or density that use adequate and current methodologies
   • Exploration of novel methods to more accurately describe the carriage burden.
   • Serotype distribution in carriage
   • Pneumococcal carriage in risk groups
   • Documentation of PCV impact on pneumococcal carriage a population level following vaccine introduction 
3. Association between pneumococcal infection or disease and respiratory viral illnesses such as those due to influenza, RSV, or SARS CoV2 in children or adults
   • The impact of respiratory virus on subsequent pneumococcal disease immunity and risk of respiratory infection 
   • Interaction between pneumococcal carriage / pneumococcal disease and respiratory viral disease viral or pneumococcal disease outcomes 
   • Impact of respiratory virus pandemics and associated non-pharmacologic interventions on pneumococcal disease epidemiology.
4. Translational research on the molecular epidemiology of pneumococcal disease or carriage and disease pathogenesis
   • Genomic pneumococcal epidemiology and mechanisms of pneumococcal disease pathogenesis
   • Serotype or risk group impact on the above
   • Novel laboratory evaluations to support pneumococcal research
5. Studies that assess implementation of vaccine programs
   • Strategies to improve vaccine access and uptake with focus the reduction of on equity
   • Understanding factors that impact vaccine uptake

Research areas not funded

• Studies on vaccine efficacy, effectiveness or immunogenicity
• Studies evaluating the serotype distribution in community-acquired pneumonia using Pfizer’s urinary antigen detection test
• Evaluations of competitor pneumococcal vaccines in isolation

Adult (non-pregnant)

IN SCOPE

• Increase understanding of burden of disease of RSV in adults considered at high risk for RSV disease due to advanced age or chronic medical conditions (for example, chronic cardiopulmonary disease, immunocompromised individuals, frail/long-term care/nursing home residents)
• Identify new risk factors that increase risk of severe RSV disease and describe their impact on disease burden 
• Studies adding new information on previously identified risk factors for severe RSV disease and their impact on disease burden
• Studies describing/documenting complications and long-term sequela of RSV disease using appropriate control groups
• The role of RSV in non-respiratory diseases (such as cardiac disease, thromboembolic events, functional outcomes)
• Studies evaluating the sensitivity of RSV testing approaches/sampling
• Studies on strategies to improve RSV vaccine implementation and uptake in adults
• Increase understanding of immune response to RSV infection in adults considered at high risk for RSV disease due to chronic medical conditions and in older adults

OUT OF SCOPE

• Interventional, safety, effectiveness, or immunogenicity studies related to vaccine use
• Incidence studies (although collaborative research proposals can be considered)
• Any studies that do not fit at least one of the in-scope criteria listed above

Maternal Immunization

IN SCOPE

• Studies evaluating the burden of RSV in pregnant individuals (including, but not limited to, incidence, clinical course of disease, assessment of pregnancy/birth outcomes) and burden of RSV during the first 12 months post-birth/pregnancy (including, but not limited to, incidence, clinical course of disease)
  • Research which evaluates the association of RSV burden with indicators of equity (including but not limited to socioeconomic status, race, ethnicity, household characteristics, and geography) are of particular interest
  • The approach must consider the expected low rate of presentation to care among pregnant/postpartum individuals with mild to moderate respiratory symptoms potentially caused by RSV, and the low rate of RSV specific testing in routine clinical settings
  • Studies which utilize systematic approaches to assess pregnant and postpartum individuals for RSV signs/symptoms and/or diagnostic testing – such as in antenatal care clinics for pregnant individuals or pediatric care/other settings in which postpartum individuals present their infant for care – will be prioritized
• Studies which evaluate population access to and uptake of routine antenatal care in accordance with national guidelines and impact on the opportunities and challenges for maternal immunization, particularly during the gestational age window of 24 to 37 weeks
• Studies which evaluate bacterial and viral etiology of lower respiratory tract infections among young pediatric patients (<5 years of age) using sensitive and specific diagnostic tools
• Studies which evaluate the epidemiology of RSV co-infection and acute otitis media in infants <12 months of age

OUT OF SCOPE

• Interventional, safety, effectiveness, immunogenicity related to vaccine use, and/or breastmilk studies
• Any studies that do not fit at least one of the in scope criteria listed above

Research areas to be considered for Pfizer support include:

Identification of new TBE-endemic areas, virus-epidemiology

• Tick surveillance, reservoir animals, human infection, human disease

Explore Burden of Disease:

• Characterization of the clinical course or the natural course after infection
• Diagnostics (e.g., adherence to guidelines, improvement of diagnostics, etc.)
• Disease and sequelae in children and adults

New vaccination targets:

• TBE in travelers
• TBE in other exposed subjects (i.e., children, elderly, occupation related)