Background (taken from WHO and HHS documents):
The World Health Organization (WHO) relies on the scientific reviews and expertise of its Strategic Group of Experts (SAGE) on immunization to advise and craft relevant evidence-based recommendations on policies and strategies, targeting all levels, from global down to sub-national decision-makers. Likewise, at country level, National Immunization Technical Advisory Committees (NITAGs) are tasked with the substantial responsibility of guiding ministries of health and national immunization programmes in their policy development processes. Many NITAGs rely on evidence reviewed by SAGE and aim to adapt WHO’s recommendations to their respective contexts…. During the course of 2021, the SAGE was convened eleven times through virtual meetings to discuss COVID-19 vaccination. For each of the vaccine products listed by the World Health Organization (WHO) for Emergency Use, interim recommendations and accompanying evidence to recommendation frameworks were issued. Additional SAGE outputs related to the COVID-19 Pandemic have been a WHO-SAGE values framework for the allocation and prioritization of COVID-19 vaccination – published in September 2020 – and the WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines– first issued in October 2020 and last updated in January 2022. SAGE has also published interim recommendations on COVID-19 vaccination of immunocompromised persons, booster vaccination, and heterologous schedules, in addition to issuing multiple interim technical statements to clarify varied policy issues [1].

NITAGs are both a technical resource and a deliberative body to advise national authorities and policy makers seeking to make evidence-based decisions [2]. NITAGs are considered an essential component of a functioning immunization system [3]. They are recommended to operate as science-focused bodies independent of both government policy makers and of external public health and development partners; the latter groups’ resource allocation functions are often captured in Inter-agency Coordination Committees. The primary purpose of NITAGs is to assist Ministries of Health through the provision of information and guidance required to develop appropriate policies that consistently reflect the latest evidence, address national public health needs and contextual realities, and help build public confidence. In recognition of these important benefits, the WHO has made the establishment and strengthening of NITAGs a priority [4], [17]. The 2018 World Health Assembly also reaffirmed the importance of NITAGs for country ownership and credibility of national immunization programmes. Consequently, the number of NITAGs has tripled since 2010, bringing the total in 2021 to 170 [5]. Of these, over 72% are considered fully functional1 [6], serving over 85% of the world’s population [7]. Nevertheless, The Global Vaccine Action Plan2 2020 target of every country having established or being able to access a NITAG was not met [17], and the COVID-19 pandemic has highlighted new challenges and needs underpinning the important role of NITAGs [8].

HHS’s authority to act globally resides in three major areas:

(1) U.S. Code,

(2) appropriations law,

and (3) the International Health Regulations (IHR) (2005).

Within the U.S. Code, several titles authorize global action on health and human services issues:

Title 6—Domestic Security, relates to the control of communicable diseases; Title 21—Food and Drugs, relates to foods, human and veterinary drugs, biologics, medical devices, and tobacco products;

Title 22—Foreign Relations and Intercourse, covers research and training, as well as HIV/AIDS, tuberculosis, and malaria;

and Title 42—The Public Health and Welfare, which includes the codification and roles of the Public Health Service, covers research and research training, capacity building, and activities related to influenza and other infectious diseases, non-communicable diseases, border health, outbreak and emergency response, public health, immunization programs, social welfare, and international cooperation.

HHS’s global authorities are also embedded in appropriations law, legislative acts that authorize agencies to spend designated public funds for a specified purpose, for example the establishment of the Global Disease Detection program through the 2004 Consolidated Appropriations Bill, and funding for pandemic influenza preparedness and surveillance activities under the 2006 Defense Appropriations Act. pg 12

The United States is a signatory to the IHR (2005), a binding agreement, along with 196 countries, including all member states of WHO.

The IHR (2005) requires that countries conduct surveillance for potential international health threats of all kinds and report those to WHO within a narrow time frame. The IHR also requires that countries prepare for and respond effectively to contain disease outbreaks and other health hazards before they negatively affect trade and travel, and cooperate with one another to develop coordinated surveillance, communications, and response capabilities.

To accomplish its mission, most of the 11 operating divisions and 16 staff divisions in the HHS family of agencies engage in global health activities.

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH) lead a majority of global health research and programming. The Administration for Community Living (ACL) and the Administration for Children and Families (ACF) lead most of HHS’s global human services work (see Appendix A, HHS organization chart; and Appendix B, description of agencies and staff offices). HHS has over 2,500 individuals employed in more than 75 countries, including a significant number working within ministries of health and multilateral organizations.

HHS has seen a growing demand for scientific, technical, regulatory, and policy expertise and works to leverage its assets to maximize global impact.

HHS intends to accomplish this by continuing to:

(1) assess and set priorities for international engagements;**_

(2) improve collaboration and coordination among HHS agencies and offices;**_

(3) strengthen relationships within the USG and with multilateral and other partners, at headquarters and in the field;**_

and (4) support the global exchange of best practices and lessons learned.**_

In addition, HHS has included both global health and the social determinants of health as topic areas within Healthy People 2020 – the nation’s public health goals and objectives for the decade and the key measures by which HHS understands public health impact. HHS supports the USG’s strong leadership role in the global health arena, while HHS’s domestic programs and policies concurrently learn and benefit from the experiences and successes of other countries and partners pg 13 https://www.hhs.gov/sites/default/files/hhs-global-strategy.pdf

Partnership in the Global Environment HHS can be most effective outside the borders of the United States by collaborating with other actors to maximize impact and sustainability of our global efforts. Among them:

• U.S. Government Agencies: Key partners include the U.S. Agency for International Development (USAID); the U.S. Peace Corps; the Departments of Agriculture, Defense, Education, Homeland Security, Justice, Labor, State, and Treasury; as well as other agencies engaged in global efforts to improve development, health security, food security, nutrition, environmental health, and human services.

• National Governments: HHS has long-standing peer-to-peer relationships with more than 190 national ministries of health, scientific, and regulatory agencies, and other national bodies working to improve health and well-being, such as ministries of gender, sport, and children’s affairs.

• Multilateral Organizations: Key agencies include WHO and its regional offices; the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund); the Joint United Nations Programme on HIV/AIDS (UNAIDS); the UN Children’s Fund (UNICEF); the UN Food and Agriculture Organization (FAO); the World Bank Group; the UN Human Rights Council (UNHRC); the UN Office of Drugs and Crime (UNODC); Gavi, the Vaccine Alliance; and the International Labor Organization (ILO).

* Civil Society and Non-Governmental Groups: Although too numerous to list, these diverse global and local actors include international humanitarian service organizations, academic institutions, and private philanthropies. These entities also include civil society, faith- and community-based groups, and private sector enterprises, as well as advocacy groups that conduct research, operate programs, build capacity, provide expertise, protect rights, and raise awareness and funding necessary to confront specific global health threats. pg 15. https://www.hhs.gov/sites/default/files/hhs-global-strategy.pdf

Most people are unaware of the Department of Defense’s directing the development and distribution of the Pfizer-BioNTech Covid vaccine or the Military involvement in the WHO Prequalification Program or EUL.

The WHO Pre-qualification program (WHO-EMA-FDA/CBER et al) is named as the sole advisor to CR, according to testimony of CNVE and the CR Health Minister. See testimony from January 24, 2022: “because first time in humans”

To learn more: https://www.who.int/teams/regulation-prequalification/eul/eul-vaccines

Regulation and Prequalification Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

About us

Emergency Use Listing Procedure for vaccines

The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.

The procedure is a key tool for companies wishing to submit their products for use during health emergencies.

Eligibility of candidate products

For vaccines to be eligible under the EUL procedure the following criteria must be met:

The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children);
Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);
The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs; and
The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.

Evaluation procedure

Evaluation will determine whether, in light of available WHO/international standards, the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety and effectiveness are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.

Application for an EUL

The submission for EUL of a vaccine should follow the ICH common technical document (CTD) format. The vaccine manufacturer must apply to WHO with the following information:

manufacturing quality data
non-clinical data and clinical data
a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
labelling details.

The contact email for EUL submission and more information is whoeul@who.int

Note: Plaintiffs copied the following EUL information from a very important document: “EMERGENCY USE OF UNPROVEN CLINICAL INTERVENTIONS OUTSIDE CLINICAL TRIALS: ETHICAL CONSIDERATIONS”

The following document is the WHO MEURI ethical framework which the WHO & HHS (the superiors that CR relies upon) says applies to covid vaccines:

The MEURI framework applies to all regulatory agencies and the evidence in the record proves they are all violating it daily.

Who Ethical In Emergency Interventions 2022 3.64MB ∙ PDF file
Download

How is the MEURI ethical framework related to the WHO EUL procedure?

WHO’s EUL is a procedure for assessing emergency use of unauthorized interventions (vaccines, therapeutics and in-vitro diagnostics) while further data are collected and evaluated. It is thus complementary to the considerations of the MEURI ethical framework. WHO established the “emergency use assessment and listing” procedure in 2015 in response to the outbreak of EVD in West Africa (83) for systematic evaluation and listing

QUESTIONS AND ANSWERS

EMERGENCY USE OF UNPROVEN CLINICAL INTERVENTIONS OUTSIDE CLINICAL TRIALS: ETHICAL CONSIDERATIONS of unlicensed medical products in order to expedite the availability of those products.

Judicial notice: The procedure was updated and renamed the EUL procedure in 2020 (64) to aid United Nations procurement agencies and the national regulatory authorities of Member States in determining the acceptability of “specific” unlicensed medical products.

For an intervention to be included in an EUL, the following criteria must be met (43):

The disease for which the product is intended is serious or immediately life-threatening and has the potential of causing an outbreak, epidemic or pandemic, and it is reasonable to consider the product for an EUL assessment, e.g. there are no licensed products for the indication or for a critical subpopulation (e.g. children).
Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines).
The product is manufactured in compliance with current good manufacturing practice in the case of medicines and vaccines and under a functional quality management system in the case of in-vitro diagnostics.

The applicant undertakes to complete development of the product (validation and verification in the case of in-vitro diagnostics) and apply for WHO prequalification once the data are collected.

Interest of Justice believes the foregoing is not met, therefore the non vaccines must be prevented and taken off the market and off the WHO’s EUL.

As stated in the EUL procedure document (43), the EUL is not equivalent or an alternative to WHO prequalification, and should not be thought of as such.

The EUL is a special procedure for unlicensed vaccines, medicines and in vitro diagnostics in the event of a PHE [public health emergency of international concern or other public health emergency authorized by the Director-General] when the community/public health authorities may be willing to tolerate less certainty about the efficacy and safety of products, given the morbidity and/or mortality of the disease and the lack or paucity of treatment, diagnosis/detection or prevention options. It is intended to provide a time-limited listing […] for unlicensed products in an emergency context when limited data are available and the products are not yet ready for application for prequalification. As part of the EUL, it is expected that the manufacturer will complete the development of the product and submit for licensure and WHO prequalification.

The document also states that WHO has “developed the EUL process to expedite the availability of unlicensed medical products needed in public health emergency situations, to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products in the context of a public health emergency, based on an essential set of available quality, safety, and efficacy/immunogenicity/ performance data. The EUL is not intended to interfere with ongoing clinical trials. This means that the clinical development should proceed as planned after the initial submission and subsequent updates. “

WHO-Member States have the sole prerogative to use the EUL as the basis to authorize the use of an unlicensed vaccine/ medicine/in-vitro diagnostics at the national level [original emphasis].

Prequalification Procedures and Fees: Vaccines

This section of the website is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification.

Who can participate in WHO prequalification of vaccines?

Any manufacturer can apply for prequalification assessment of a vaccine provided if that vaccine:

is included on the vaccines prequalification priority list
meets the mandatory characteristics for programmatic suitability (PSPQ)
has received a marketing authorization from the national regulatory authority (NRA) of the country of manufacture
and for which the NRA responsible for its regulatory oversight is a WHO-listed authority.

What are the steps of the prequalification process?

FOIA – provide proof each step below was met rigorously documented

The following is an overview of the prequalification process for vaccines:

The manufacturer requests a pre-submission meeting to advise WHO on the intention to submit a vaccine for evaluation. The pre-submission meeting should be requested as early as possible, by sending an email to vaccprequalification@who.int. A predefined agenda and presentation must be proposed by the manufacturer and shared with WHO at least two weeks before the scheduled meeting.
If the conditions for acceptance are fulfilled, the manufacturer submits an application letter to WHO providing specific details, such as country and manufacturing sites, licensing status, presentations to be made available for procurement and expected deadline for dossier submission.
A manufacturer whose application letter is accepted submits a Vaccine Prequalification Dossier (VPQD).
WHO screens the VPQD for completeness and compliance with the required format and contents. The programmatic suitability of the vaccine candidate for WHO prequalification is also assessed at this step.
The dossier is assessed in accordance with the WHO prequalification procedure for vaccines (WHO TRS 978, Annex 6), as well as verification of compliance of the manufacturing site with WHO Good Manufacturing Practices by means of inspection, where necessary.
WHO requests the manufacturer to submit vaccines samples for independent and initial testing. Testing is performed by WHO contracted and qualified laboratories.
An inspection of the vaccines manufacturing site is performed to assess that: the vaccine complies with WHO recommendations for production and quality control; it meets the UN tender specifications; the company has an adequate quality management system in place; and the vaccine is manufactured in compliance with WHO Good Manufacturing Practices.

Dossier submission deadlines

WHO has established three deadlines per years for the submission of a Vaccine Prequalification Dossier (VPQD):

31 January
31 May
30 September.

What happens when a vaccine is prequalified?

Vaccines that are considered to have met prequalification requirements are included on the WHO List of Prequalified Vaccines. On this website, users can find information about the vaccines listed, such as, manufacturer’s name, presentation, prequalification date and other product details. This is complemented with a WHO Public Assessment Report (WHOPAR) and a WHO Public Inspection Report (WHOPIR). The WHOPAR will summarize the assessment of the product information that was submitted in the product dossier. The WHOPIR(s) will provide the date, duration and scope of the inspection, and a summary of inspection observations and findings.

Posting of the WHOPAR and WHOPIR(s) generally occurs sometime after inclusion of the relevant product in the WHO List of Prequalified Vaccines. This is because their contents must be agreed with the manufacturer. In this way, WHO ensures that confidential information is not disclosed.

Ensuring continued acceptability of prequalified vaccines

A rigorous post-prequalification process is also in place to ensure the continued acceptability of prequalified vaccines. It consists of the performance of the vaccine and its manufacturer. This is carried out annually through the evaluation of a Prequalification Annual Report (PQVAR), which includes a summary of changes on the product, report of complaints or adverse events following immunization (AEFIs), etc. Targeted testing of vaccines lots is also carried out to monitor compliance with product standards.

Lets get to know the Product Development for Vaccines Advisory Committee (PDVAC):

Established in 2014, the Product Development for Vaccines Advisory Committee (PDVAC) is an independent standing WHO committee of experts which provides external advice to WHO’s Department on Immunization, Vaccines and Biologicals (IVB) related to vaccine and antibody candidates for infectious diseases, generally at the Phase 2 stage of clinical evaluation or earlier. The committee’s remit covers disease areas where there is, or may be, substantial disease burden in low and middle income countries (LMICs), where none of these products currently exist, but where there is some ongoing product development activity which may benefit from WHO guidance. This committee may also have a role where vaccines are already licensed, and development of improved products, including novel presentations or innovative immunization technologies is a priority for WHO. PDVAC may also provide input, when requested, into vaccine and biological related activities that fall outside of its primary scope (for example in support of the WHO Research and Development Blueprint to prevent pandemics).

PDVAC is briefed on Strategic Advisory Group of Experts (SAGE) recommendations within the product development area, and provides reports to SAGE on its activities.
[version: June 2021] Terms of Reference for the Product Development for Vaccines Advisory Committee (PDVAC) (AG44) Established in 2014, the Product Development for Vaccines Advisory Committee (PDVAC) is an independent standing WHO committee of experts which provides external advice to WHO related to priority infectious disease pathogens, associated vaccine and monoclonal antibody approaches and related manufacturing and delivery technologies. The committee’s remit covers disease areas where there is, or may be, substantial disease burden in low- and middle-income countries (LMICs), where no vaccine related products currently exist, but where there is ongoing product development activity which may benefit from WHO guidance, or technologies that could expedite availability and access of vaccine products in LMICs. PDVAC may also have a role where vaccines are already licensed, and development of improved products, including those based on novel manufacturing technologies or innovative vaccine delivery approaches is a priority for WHO and its member states. PDVAC also provides, as called upon by WHO, a standing forum of external subject matter experts for conducting evaluations and recommendations within the scope described above.

As an example, in the context of the Covid-19 pandemic response and the work of the COVAX Manufacturing Task Force (MTF), PDVAC reviews the evaluations and suggestions from the MTF related to selection of priority platform manufacturing technologies for technology transfer (TT), and selection of regional hubs for COVID-19 vaccine and routine vaccine TT, and the TT recipients. It communicates its recommendation to WHO.

PDVAC also provides, in the context of the Immunization Agenda 2030 (IA2030), and specifically strategic priority area 7 on Research and Innovation, reviews of the outputs, workplans, and reports from the SP7 working group (WG) consultations on defining country and regional priorities.

It works closely with the SP7 WG to develop an integrated strategy on research and development priorities and targets for R&D in immunization, across all three levels (country, regional, global). PDVAC is briefed on Strategic Advisory Group of Experts (SAGE) recommendations within the product development. PDVAC may also provide input to WHO, when requested, into vaccines and biologicals, their associated technologies and related activities that fall outside of its primary scope (for example in support of the WHO Research and Development Blueprint to prevent pandemics). The Advisory Group (’’PDVAC’’) will act as an advisory body to WHO in this field. I. Functions In its capacity as an advisory body to WHO, PDVAC shall have the following functions: o Assess and offer guidance to WHO on optimal methodologies and strategic approaches to determine the full value for vaccines, monoclonal antibodies, and related technologies, in the context of other disease interventions and competing R&D priorities (including the development of products that are targeted solely to high-income country markets but that may offer benefit in LMIC contexts); o Advise WHO on the global public health priority pathogens, based on full value of vaccine assessments developed in partnership with immunization stakeholders at the country and regional levels, and activities that are needed to advance development and access of vaccines and related products in LMICs; o Review, assist in development, and make recommendations to WHO on preferred product characteristics (PPCs) for a class of potential vaccines, specifically from the perspective of LMICs, with the goal of informing target product profiles to accelerate product development and reduce the timeframe to access of vaccines in LMIC contexts; o Review, assist in development, and make recommendations to WHO on technical R&D roadmaps for vaccines, monoclonal antibodies, and related technologies that articulate the research, product development, and capacity needs, and proactively optimally position a candidate for successful LMIC licensure and a positive policy recommendation; o Review, assist in development, and make recommendations to WHO on Preferred Policy Profiles (also called Evidence Considerations for Vaccine Policy Development) for vaccines and monoclonal antibodies, prior to phase III efficacy studies to guide evidence that would be helpful to collect prelicensure and align on expectations for licensure and policy assessment; o Develop and propose to WHO criteria for selection of target vaccine manufacturing technologies that may be suitable for technology transfer to regional manufacturing hubs, and for selection of technology hubs and technology recipients; to provide independent assessment of the landscape of target manufacturing technologies for potential technology transfer and to synthesise recommendations of potential manufacturers in accordance with criteria; o Horizon scanning to i) identify pathogen areas where vaccines do not currently exist and are urgently needed, particularly in low- and middle-income countries (LMICs), and to monitor the evolving vaccine candidate pipeline; and ii) identify novel platforms and technologies which could contribute to improved manufacturing processes, improved immunological responses, and/or easier vaccine delivery; o Advice WHO on building consensus among global stakeholders, particularly with respect to product development strategy, including clinical endpoints and regulatory pathways; o Highlight access and/or introduction issues or gaps that might occur during vaccine approval and uptake in LMICs, that should be considered and potentially addressed during early product development. II. Composition 1. PDVAC shall have up to [20] members1 , who shall serve in their personal capacities to represent the broad range of disciplines relevant to vaccine and monoclonal antibody product development. In the selection of the PDVAC members, consideration shall be given 1 Members serve as full participants and partake in the decision-making process of the meeting in which they are involved. to attaining an adequate distribution of technical expertise, geographical representation and gender balance. 2. Members of PDVAC, including the Chairperson (see 3. below), shall be selected and appointed by WHO2 following an open call for experts. Members of PDVAC shall be appointed to serve for a period of 3 years and shall be eligible for reappointment 3 . Their appointment may be terminated at any time by WHO if WHO’s interest so requires or, as otherwise specified in these terms of reference or letters of appointment. Where a member’s appointment is terminated, WHO may decide to appoint a replacement member. 3. The Chairperson’s functions include the following: – to chair PDVAC meetings; – to liaise with the WHO Secretariat between meetings. When appointing a Chairperson, consideration shall be given to gender and geographical representation. A Chairperson is eligible for reappointment as a member of PDVAC but is only permitted to serve as Chairperson for one term. Their appointment and/or designation as Chairperson may be terminated at any time by WHO if WHO’s interest so requires or as otherwise specified in these terms of reference or letters of appointment. 4. PDVAC members must respect the impartiality and independence required of WHO. In performing their work, members may not seek or accept instructions from any Government or from any authority external to the Organization. They must be free of any real, potential, or apparent conflicts of interest. To this end, proposed members/members shall be required to complete a declaration of interests form and their appointment, or continuation of their appointment, shall be subject to the evaluation of completed forms by the WHO Secretariat, determining that their participation would not give rise to a real, potential, or apparent conflict of interest. 5. Following a determination that a proposed member’s participation on PDVAC would not give rise to a real, potential, or apparent conflict of interest, the proposed member will be sent a letter inviting them to be a member of PDVAC. Their appointment to PDVAC is subject to WHO receiving the countersigned invitation letter and letter of agreement. Notwithstanding the requirement to complete the WHO declaration of interest form, PDVAC members have an ongoing obligation to inform the WHO of any interests real or perceived that may give raise to a real, potential, or apparent conflict of interest. 6. As contemplated in paragraph II.4 above, WHO may, from time to time, request PDVAC members to complete a new declaration of interest form. This may be before a PDVAC meeting or any other PDVAC-related activity or engagement, as decided by WHO. Where WHO has made such a request, the PDVAC member’s participation in the PDVAC activity or engagement is subject to a determination that their participation would not give rise to a real, potential, or apparent conflict of interest. 7. Where a PDVAC member is invited by WHO to travel to an in-person PDVAC meeting, WHO shall, subject to any conflict-of-interest determination as set out in paragraph II.6 above, issue a letter of appointment as a temporary adviser and accompanying memorandum of agreement (together ‘Temporary Adviser Letter). WHO shall not authorize travel by an PDVAC member, until it receives a countersigned Temporary Adviser Letter. 8. PDVAC members do not receive any remuneration from the Organization for any work related to the PDVAC. However, when attending in-person meetings at the invitation of WHO, their travel cost and per diem shall be covered by WHO in accordance with the applicable WHO rules and policies. III. Operation 1. PDVAC shall normally meet at least once each year. However, WHO may convene additional meetings. PDVAC meetings may be held in person (at WHO headquarters in Geneva or another location, as determined by WHO) or virtually, via video or teleconference. PDVAC meetings may be held in open and/or closed session, as decided by the Chairperson in consultation with WHO. (a) Open sessions: Open sessions shall be convened for the sole purpose of the exchange of non-confidential information and views, and may be attended by Observers (as defined in paragraph III.3 below). (b) Closed sessions: The sessions dealing with the formulation of recommendations and/or advice to WHO shall be restricted to the members of the PDVAC and essential WHO Secretariat staff. 2. The quorum for PDVAC meetings shall be two thirds of the members. 3. WHO may, at its sole discretion, invite external individuals from time to time to attend the open sessions of an advisory group, or parts thereof, as “observers”. Observers may be invited either in their personal capacity, or as representatives from a governmental institution / intergovernmental organization, or from a non-state actor. WHO will request observers invited in their personal capacity to complete a confidentiality undertaking and a declaration of interests form prior to attending a session of the advisory group. Invitations to observers attending as representatives from non-state actors will be subject to internal due diligence and conflict of interest considerations in accordance with FENSA. Observers invited as representatives may also be requested to complete a confidentiality undertaking. Observers shall normally attend meetings of PDVAC at their own expense and be responsible for making all arrangements in that regard. At the invitation of the Chairperson, observers may be asked to present their personal views and/or the policies of their organization. Observers will not participate in the process of adopting decisions and recommendations of PDVAC. 4. PDVAC may decide to establish smaller working groups (sub-groups of PDVAC) to work on specific issues. Their deliberations shall take place via teleconference or video-conference. For these sub-groups, no quorum requirement will apply; the outcome of their deliberations will be submitted to PDVAC for review at one of its meetings. 5. PDVAC members are expected to attend meetings. If a member misses two consecutive meetings, WHO may end his/her appointment as a member of PDVAC. 6. A yearly report shall be submitted by PDVAC to WHO (the Assistant Director-General of the responsible Cluster). All recommendations from PDVAC are advisory to WHO, who retains full control over any subsequent decisions or actions regarding any proposals, policy issues, or other matters considered by PDVAC. 7. PDVAC shall normally make recommendations by consensus. If, in exceptional circumstances, a consensus on a particular issue cannot be reached, minority opinions will be reflected in the meeting report. 8. Active participation is expected from all PDVAC members, including in working groups, teleconferences, and interaction over email. PDVAC members may, in advance of PDVAC meetings, be requested to review meeting documentation and to provide their views for consideration by PDVAC. 9. WHO shall determine the modes of communication by PDVAC, including between WHO and PDVAC members, and PDVAC members among themselves. 10. PDVAC members shall not speak on behalf of, or represent, PDVAC or WHO to any third party. IV. Secretariat WHO shall provide the secretariat for PDVAC, including necessary scientific, technical, administrative and other support. In this regard, the WHO Secretariat shall provide PDVAC members in advance of each meeting with the agenda, working documents, and discussion papers. Distribution of the aforesaid documents to Observers will be determined by the WHO Secretariat. The meeting agenda shall include details such as: whether a meeting, or part thereof, is closed or open; and whether Observers are permitted to attend. V. Information and documentation 1. Information and documentation to which members may gain access in performing PDVAC related activities shall be considered as confidential and proprietary to WHO and/or parties collaborating with WHO. In addition, by counter signing the letter of appointment and the accompanying terms and conditions referred to in section II(5) above, PDVAC members undertake to abide by the confidentiality obligations contained therein and also confirm that any and all rights in the work performed by them in connection with, or as a result of their PDVAC-related activities shall be exclusively vested in WHO. 2. PDVAC members and Observers shall not quote from, circulate, or use PDVAC documents for any purpose other than in a manner consistent with their responsibilities under these Terms of Reference. 3. WHO retains full control over the publication of the reports of PDVAC, including deciding whether or not to publish them.

Product Development for Vaccines Advisory Committee

PDVAC chair

Ruth Karron Professor of International Health, Johns Hopkins University, United States

Learn more

Current PDVAC members

Isabelle Bekeredjian-Ding

Head, Microbiology Division & Acting Director, Center for Pandemic Vaccines and Therapeutics, Paul-Ehrlich-Institut

Sophie Biernaux

Independent Consultant

Marco Cavaleri

Head of Office, Biological Health Threats and Vaccines Strategy

Hannah Clapham

Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore

Sinead Delany-Moretlwe

Medical Doctor, South Africa

Mark Jit

Head, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine

Mark Jit

Head, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine

Shaowei Li

Professor of Biochemistry and Structural Vaccinology, School of Life Sciences

Gustavo Santos

Research Scientist, International Vaccine Institute, Seoul, Korea.

Raman Rao

Chief Executive Officer, Hilleman Labs

Marian Wentworth

President and Chief Executive Officer, Management Sciences for Health, United States

Gerd Zettlmeissl

Independent Consultant

Here is their: PDVAC virtual meeting on Immunization Agenda 2030 and Strategic Priority 7 (Research & Innovation): Partnering with regions and countries to identify priority pathogens for vaccine development:

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PDVAC virtual meeting on Immunization Agenda 2030 and Strategic Priority 7 (Research & Innovation): Partnering with regions and countries to identify priority pathogens for vaccine development

18 July 2022 15:00 – 18:00 CET

Immunization Agenda 2030 (IA2030) is the global vision and strategy for immunization, aimed toward maximizing the impact of vaccines. (a false statement challenged by Plaintiffs with no reply to HHS and WHO) Within IA2030, “Research and Innovation” comprises the seventh strategic priority area, referred to as “SP7”. In the IA2030 Monitoring and Evaluation (M&E) Plan, Indicator 7.2 monitors progress of vaccine development towards a “short list” of global R&D targets.

Repeat: Indicator 7.2 monitors progress of vaccine development towards a “short list” of global R&D targets.

Through regional stakeholder engagement, PDVAC has been charged with proposing the short list of pathogen targets for new vaccines (where vaccines do not yet currently exist), for endorsement by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) in April 2023.

PDR has been developing an approach for partnering with regional- and country-level stakeholders to derive a short list of priority pathogen targets. This approach relies on collaborating with members of the WHO regional immunization technical advisory groups (RITAGs), who are represented on the SP7 working group and leverages multi-criteria decision analysis (MCDA) to identify context specific priorities. The purpose of the PDVAC meeting held on 18 July was to review the proposed approach among key stakeholders.

**Meeting material

Agenda
List of participants
Executive summary
Presentations

WHO Vaccine Prequalification Program

WHO assessed CBER’s functionality as an NRA in 2007 and concluded it met the pre-specified indicators. The NRA is commonly referred to as the “reference” NRA when the WHO relies on that regulatory authority for vaccine prequalification.

On July 8, 2008, the FDA and WHO entered into a mutual confidentiality arrangement that included a commitment not to publicly disclose non-public information shared by and between the FDA and the WHO. The commitment satisfies the requirements of [[21 CFR § 20.89 (c)(1)(i) and enables CBER to serve as the reference NRA under the WHO vaccine prequalification program]].

CBER has affirmed its willingness to serve as the reference NRA for the following U.S. licensed vaccines:

Rotavirus Vaccine, Live, Oral, Pentavalent (Tradename: RotaTeq®; Manufacturer: Merck & Co., Inc.); Prequalified by WHO October 7, 2008
Influenza Virus Vaccine (Tradename: Fluvirin®; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 4, 2009
Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 9, 2009
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
(Tradename: Prevnar®; Manufacturer: Wyeth Pharmaceuticals Inc.); Prequalified by WHO December 28, 2009
Influenza Virus Vaccine (Tradename: Fluzone®; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 21, 2010
Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 27, 2010
Influenza A (H1N1) 2009 monovalent (No tradename; Manufacturer: MedImmune LLC); Prequalified by WHO February 25, 2010
Meningococcal ACYW-135 Polysaccharide, 10 dose vial (Tradename: Menomune; Manufacturer: Sanofi Pasteur), Prequalified by WHO May 22, 2013
Meningococcal (Serogroups A, C, Y, and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Tradename: Menactra; Manufacturer: Sanofi Pasteur); Prequalified by WHO March 21, 2014

WHO Cooperative Agreements

SEE: https://www.fda.gov/vaccines-blood-biologics/who-engagements/who-cooperative-agreements

The World Health Organization (WHO) is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. CBER has worked with WHO in the global community to improve human public health worldwide for many years. Strengthening regulatory capacity is integral to ensuring global access to safe and effective vaccines and other biological products.

CBER has awarded Cooperative Agreements to WHO to provide funding support and scientific guidance to advance projects of mutual interest. Activities supported by the Cooperative Agreements have included assessments of regulatory authorities, training workshops, development of WHO Guideline documents, collaborative studies that support standards development, activities to build pharmacovigilance capacity in low and middle income countries, and other regulatory capacity building projects. The Cooperative Agreements are responsive to global needs and CBER priorities, and are a means to provide support to further advance FDA’s goal of strengthening regulatory systems worldwide FOIA THIS STUFF

CONIS gave FDA doc below – Content current as of: 14/12/2020

![[Explanation of the Emergency Use Authorization for Vaccines _ FDA.pdf]]

Above FDA says: When the phase 3 portion of the human clinical study reaches a predetermined point reporting on the efficacy of the vaccine in preventing COVID-19, As discussed and agreed in advance with the FDA, an independent group ( called the Data Security Monitoring Board ) will review the data and report the results to the manufacturer. Based on the data and interpretation of these by this group, manufacturers decide whether and when to submit a US application to the FDA, taking into account FDA contributions.

also:

From a security point of view, the FDA expects that all cumulative safety data from phase 1 and 2 studies conducted with the vaccine will be included in the presentation of a USA, with the expectation that phase 3 data includes a median follow-up of at least 2 months ( which means that at least half of those receiving the vaccine in phase 3 of clinical studies have at least 2 months of follow-up ) after the end of the complete vaccination regimen.

In addition, the FDA expects the US request to include a phase 3 safety database of more than 3,000 people who have received the vaccine, representing a high proportion of participants enrolled in the phase 3 study,who have been followed up on serious adverse events and adverse events of special interest for at least one month after the end of the full vaccination regimen. Part of the FDA’s evaluation of a US application for a COVID-19 vaccine includes chemical evaluation, manufacturing, and vaccine control information. Sufficient data must be presented to ensure the quality and consistency of the vaccine. The FDA will use all available tools and information, including record reviews, site visits, and pre-compliance history, to assess compliance with current good manufacturing practices.

Fast forward to Corminarty –

Content current as of: [[Q&A for Corminarty]] 02/08/2022
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

Q&A for Comirnaty (COVID-19 Vaccine mRNA)

Does the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?

Yes. Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two dose primary series in individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty.

The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different authorized COVID-19 vaccine.

Can Comirnaty cause infertility in women?

There is no scientific evidence to suggest that the vaccine could cause infertility in women. In addition, infertility is not known to occur as a result of natural COVID-19 disease, further demonstrating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility. Reports on social media have falsely asserted that the vaccine could cause infertility in women and the FDA is concerned that this misinformation may cause women to avoid vaccination to prevent COVID-19, which is a potentially serious and life-threatening disease

![[EMA’s Pfizer authorization in CONIS reply COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH_ext_of_indication_11.6.2021 (1).pdf]]

from above:

CR refers us to EMA link https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1112667/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH_ext_of_indication_11.6.2021.pdf which says:

COVID-19 mRNA Vaccine BNT162b2 has been developed for use in healthy subjects to prevent COVID-19 on exposure to SARS-CoV-2. The vaccine has as its active agent messenger ribonucleic acid (mRNA), made by transcription of a DNA template, encoding for the full-length spike (S) protein of SARS CoV-2 with two point mutations, to lock S in an antigenically preferred prefusion conformation. Pharmacology This vaccine acts by intracellular translation of mRNA to the SARS-CoV-2 S protein to induce an immune response, a humoral neutralizing antibody response and Th1-type CD4+ and CD8+ cellular response, to block virus infection and kill virus infected cells, respectively The vaccine was tested for its ability to result in S protein expression in a mammalian cell population in vitro, for its immunogenicity in mice in two studies, and in one study in rhesus monkeys, including its capacity to prevent disease after challenge with SARS Cov-2 virus in rhesus monkeys. The vaccine also induced an immune response in rats in the two toxicity studies

II.4 Regulation 174 Authorisation for temporary supply of COVID-19 mRNA Vaccine BNT162b2 under this Regulation 174 has been given following review of batch analytical data by MHRA. Independent batch release by the National Institute for Biological Standards and Control (NIBSC) will be performed on all batches to be supplied to the UK. The quality data currently available for COVID-19 mRNA Vaccine BNT162b2 can be accepted as sufficient with specific conditions in place. There are no scientific objections arising from this review to the authorisation for temporary supply for this product under Regulation 174 of the Human Medicine Regulations.

A quality target product profile for the finished product has been established taking into consideration the World Health Organization’s “WHO Target Product Profiles for COVID19 Vaccines”.

Below is the  “WHO Target Product Profiles for COVID19 Vaccines”.:

The World Health Organization has provided technical support to its Member States in the field of vaccine-preventable diseases since 1975. The office carrying out this function at WHO headquarters is the Department of Immunization, Vaccines and Biologicals (IVB). IVB’s mission is the achievement of a world in which all people at risk are protected against vaccine-preventable diseases. The Department covers a range of activities including research and development, standardsetting, vaccine regulation and quality, vaccine supply and immunization financing, and immunization system strengthening. These activities are carried out by three technical units: the Initiative for Vaccine Research; the Quality, Safety and Standards team; and the Expanded Programme on Immunization. The Initiative for Vaccine Research guides, facilitates and provides a vision for worldwide vaccine and immunization technology research and development efforts. It focuses on current and emerging diseases of global public health importance, including pandemic influenza. Its main activities cover: i) research and development of key candidate vaccines; ii) implementation research to promote evidence-based decision-making on the early introduction of new vaccines; and iii) promotion of the development, evaluation and future availability of HIV, tuberculosis and malaria vaccines. The Quality, Safety and Standards team focuses on supporting the use of vaccines, other biological products and immunization-related equipment that meet current inter-national norms and standards of quality and safety. Activities cover: i) setting norms and standards and establishing reference preparation materials; ii) ensuring the use of quality vaccines and immunization equipment through prequalification activities and strengthening national regulatory authorities; and iii) monitoring, assessing and responding to immunization safety issues of global concern. The Expanded Programme on Immunization focuses on maximizing access to high quality immunization services, accelerating disease control and linking to other health interventions that can be delivered during immunization contacts. Activities cover: i) immunization systems strengthening, including expansion of immunization services beyond the infant age group; ii) accelerated control of measles and maternal and neonatal tetanus; iii) introduction of new and underutilized vaccines; iv) vaccine supply and immunization financing; and v) disease surveillance and immunization coverage monitoring for tracking global progress. The Director’s Office directs the work of these units through oversight of immunization programme policy, planning, coordination and management. It also mobilizes resources and carries out communication, advocacy and media-related work.

![[2012 WHO Assessing the Programmatic Suitability of Vaccine Candidates for WHO Prequalification 1.pdf]]

The Initiative for Vaccine Research guides, facilitates and provides a vision for worldwide vaccine and immunization technology research and development efforts. It focuses on current and emerging diseases of global public health importance, including pandemic influenza. Its main activities cover: i) research and development of key candidate vaccines; ii) implementation research to promote evidence-based decision-making on the early introduction of new vaccines; and iii) promotion of the development, evaluation and future availability of HIV, tuberculosis and malaria vaccines.

The Quality, Safety and Standards team focuses on supporting the use of vaccines, other biological products and immunization-related equipment that meet current inter-national norms and standards of quality and safety. Activities cover: i) setting norms and standards and establishing reference preparation materials; ii) ensuring the use of quality vaccines and immunization equipment through prequalification activities and strengthening national regulatory authorities; and iii) monitoring, assessing and responding to immunization safety issues of global concern.

The Expanded Programme on Immunization focuses on maximizing access to high quality immunization services, accelerating disease control and linking to other health interventions that can be delivered during immunization contacts. Activities cover: i) immunization systems strengthening, including expansion of immunization services beyond the infant age group; ii) accelerated control of measles and maternal and neonatal tetanus; iii) introduction of new and underutilized vaccines; iv) vaccine supply and immunization financing; and v) disease surveillance and immunization coverage monitoring for tracking global progress.

The Director’s Office directs the work of these units through oversight of immunization programme policy, planning, coordination and management. It also mobilizes resources and carries out communication, advocacy and media-related work.

**Never proved its a vaccine preventable disease

what media related work – give all emails, press releases etc

Prequalificiation

WEB:

WEF Covid Action Platform
WHO Vaccine Pre-quaification EUA
PDVAC

WHO Department of Regulation and Prequalification

with inputs from WHO Departments and technical units responsible for:

developing and maintaining the WHO Guidelines (MHP/HPS/TSS13);
coordinating global and regional workshops on the Guidelines (MHP/HPS/TSS);
managing the WHO-NNB (MHP/RPQ/REG14);
managing the WHO Prequalification of vaccines programme (MHP/RPQ/PQT15);
and the COVID vaccines regulatory and safety preparedness and deployment coordination (MHP).
An initial draft was reviewed by the following stakeholders: WHO Departments: IVB16, UHC17, Science Division and WHE18;
WHO Regional Advisors for access to medicines and COVID task force members;
WHO EPI managers;
UNICEF, CEPI and GAVI with their technical advisors.

CBER participates in ongoing international pharmacovigilance efforts, including those organized by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). CBER’s collaborations with ICMRA facilitate information exchange during the ongoing COVID-19 pandemic among global health regulatory authorities. Also, CBER facilitates important exchanges of information and views on the following ICMRA Working Groups: COVID-19 Working Group, Pregnancy and Lactation in COVID-19, COVID-19 Pharmacovigilance Network, Observational Studies and Real World Evidence.
CBER has a wide range of collaborations with the WHO to support preparedness and global response to the COVID-19 pandemic. CBER is actively engaged in the R&D Blueprint discussions on prioritizing COVID-19 vaccine research to address critical issues, including response to variants, in real time. CBER experts contribute to SARS-CoV-2 standards development activities and participate as members of WHO Working Groups on animal models and immune assays – activities that are integrally linked to global COVID-19 vaccine development efforts. As a national regulatory authority of reference, CBER has a significant role in WHO’s Emergency Use Listing (EUL) of two COVID-19 vaccines that are being used globally, and which are part of the U.S. vaccine donation program to increase access to COVID-19 vaccines in all regions of the world.

CBER has been proactive in sharing information with the WHO at the global level and through regional networks. Examples include CBER’s engagement with the African Vaccine Regulatory Forum (AVAREF) and collaboration with the African Union Smart Safety Surveillance (AU-3S) program which is focused on vaccine safety monitoring as immunization programs for COVID-19 are implemented in African countries. In addition to information sharing, these multilateral collaborations contribute to regulatory systems strengthening globally and increase preparedness to respond to the current and future public health emergencies.

CBER continues to engage structured scientific and policy discussions under confidentiality commitments with foreign regulatory counterparts.

For example, CBER participates in regulatory “clusters” (working groups) with international partners such as the European Medicines Agency (EMA) and the Health Products and Food Branch of Health Canada. Clusters are made up of regulatory experts who meet routinely to discuss regulatory and scientific issues of mutual interest. (GET ALL MUTUAL CONFIDENTIALITY AGREEMENTS) CBER is a principal participant in the Clusters for Blood Products, Advanced Therapy Medicinal Products, and Vaccines, and additionally participates as appropriate in the Agency Oncology, Pediatric, Pharmacovigilance, Biosimilar and Pharmacogenomic Clusters.

CBER participates in discussions in various cluster meetings to ensure a deeper understanding of agencies regulatory approaches and undertake mutual information sharing on COVID-19 products safety and efficacy, and inspection activities. CBER technical experts contribute to international COVID-19 vaccine safety efforts by participating in the FDA/EMA pharmacovigilance cluster.

In addition, the CBER International Affairs Team collaborates with CBER scientific experts to identify strategic technical areas across CBER for which collaboration with foreign counterparts will add value to CBER’s mission.

The information sharing mutually complements the work CBER’s COVID-19 product authorization activities. CBER utilizes the FDA Confidentiality Commitments tools for regulatory and research exchanges. All agency confidentiality commitments are listed on the FDA website for reference.
[[CARDS/Catch All/WHO/FDA CBER WHO AND MORE RELATIONS FOR GLOBAL AUTH]]

The WHO provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. The WHO does so through its vaccine prequalification program. An important part of the program is the WHO’s reliance upon the national regulatory authority (NRA) of the country of manufacture of the vaccine if the NRA is determined to be “functional” based on assessment performed by a WHO team. This assessment uses WHO established indicators (i.e., critical indicators defined by WHO experts) to ensure there is consistency in the standards applied when evaluating level of functionality of national regulatory systems. In order for WHO to designate an NRA as being “functional”, the NRA must meet a set of criteria defined by critical indicators in the NRA assessment tool. The regulatory authority, supported by legislation, should be able to fulfill the following functions: licensing; post-marketing surveillance; lot release; laboratory access; regulatory inspections; and authorization/evaluation of clinical trials. WHO assessed CBER’s functionality as an NRA in 2007 and concluded it met the pre-specified indicators. The NRA is commonly referred to as the “reference” NRA when the WHO relies on that regulatory authority for vaccine prequalification. On July 8, 2008, the FDA and WHO entered into a mutual confidentiality arrangement that included a commitment not to publicly disclose non-public information shared by and between the FDA and the WHO. The commitment satisfies the requirements of 21 CFR § 20.89 (c)(1)(i) and enables CBER to serve as the reference NRA under the WHO vaccine prequalification program. CBER has affirmed its willingness to serve as the reference NRA for the a list of U.S. licensed vaccines. see: https://www.fda.gov/vaccines-blood-biologics/who-engagements/who-vaccine-prequalification-program – Content current as of: 03/23/2018 (last visited March 30 2023)

[[WHO Operational Tool for efficient and effective lot release of SARS-CoV-2 (Covid-19) vaccines version 1 20 January 2021]] – says: Development history of the Document The document was drafted by the WHO Department of Regulation and Prequalification with inputs from WHO Departments and technical units responsible for: developing and maintaining the WHO Guidelines (MHP/HPS/TSS13); coordinating global and regional workshops on the Guidelines (MHP/HPS/TSS); managing the WHO-NNB (MHP/RPQ/REG14); managing the WHO Prequalification of vaccines programme (MHP/RPQ/PQT15); and the COVID vaccines regulatory and safety preparedness and deployment coordination (MHP). An initial draft was reviewed by the following stakeholders: WHO Departments: IVB16, UHC17, Science Division and WHE18; WHO Regional Advisors for access to medicines and COVID task force members; WHO EPI managers; UNICEF, CEPI and GAVI with their technical advisors.

Product Development for Vaccines Advisory Committee

About us

PDVAC is an independent standing WHO committee of experts which provides external advice to WHO related to priority infectious disease pathogens, associated vaccine and monoclonal antibody product development approaches and related manufacturing and delivery technologies. The committee’s remit covers disease areas where there is, or may be, substantial disease burden in low- and middle-income countries (LMICs), where no vaccine related products currently exist, but where there is ongoing product development activity which may benefit from WHO guidance, or technologies that could expedite availability and access of vaccine products in LMICs. PDVAC may also have a role where vaccines are already licensed, and development of improved products, including those based on novel manufacturing technologies or innovative vaccine delivery approaches is a priority for WHO and its member states.

PDVAC’s mission is to accelerate product development of vaccines and technologies that are urgently needed and ensure they are appropriately targeted for use in low and middle income contexts.

The majority of PDVAC’s scope of work focuses on the following core activities:

Identifying priority pathogens and technologies where there is evident public health need for a vaccine, and defining how WHO engagement would result in a clear benefit related to product development;
Defining the strategic public health goals and global value proposition for vaccines and technologies, in the context of other disease interventions and competing R&D priorities (including the development of products that are targeted to high income country markets);
Developing the preferred product characteristics of vaccines, specifically from the perspective of LMICs, with the goal of informing target product profiles to accelerate product development and reduce the timeframe to access of vaccines in LMIC contexts;
Developing technical R&D roadmaps for vaccines and technologies that articulate the research, product development and capacity needs, and proactively position a candidate for LMIC licensure and a positive policy recommendation;
Building consensus among global stakeholders, particularly with respect to product development strategy, including clinical endpoints and regulatory pathways;
Educating vaccine developers and other stakeholders with respect to the specific data needs for vaccine approval and uptake in LMICs, and advocating for these to be considered early on in product development.

Contact

giersingb@who.int or secretariat
https://www.who.int/groups/product-development-for-vaccines-advisory-committee/about

MEMBERS

PDVAC chair

Ruth Karron

Professor of International Health, Johns Hopkins University, United States

Learn more

Current PDVAC members

Isabelle Bekeredjian-Ding

Head, Microbiology Division & Acting Director, Center for Pandemic Vaccines and Therapeutics, Paul-Ehrlich-Institut

Sophie Biernaux

Independent Consultant

Marco Cavaleri

Head of Office, Biological Health Threats and Vaccines Strategy

Hannah Clapham

Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore

Sinead Delany-Moretlwe

Medical Doctor, South Africa

Mark Jit

Head, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine

Mark Jit

Head, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine

Shaowei Li

Professor of Biochemistry and Structural Vaccinology, School of Life Sciences

Gustavo Santos

Research Scientist, International Vaccine Institute, Seoul, Korea.

Raman Rao

Chief Executive Officer, Hilleman Labs

Marian Wentworth

President and Chief Executive Officer, Management Sciences for Health, United States

Gerd Zettlmeissl

Independent Consultant

Previous PDVAC members

Bader Al Ruwahi

Director, Communicable Disease Surveillance and Control and EPI Manager, Ministry of Health, Oman

Klaus Cichutek

President, Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, Germany

Barney S. Graham

Deputy Director of the Vaccine Research Center, NIAID, NIH, United States

Doctor Jaleela Jawad

David C. Kaslow

Director of the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research, United States Food and Drug Administration

Dr Gagandeep Kang

Professor and Laboratory Director, The Wellcome Trust Research Laboratory

Jerome H. Kim

Director General of the International Vaccine Institute, Switzerland/ United States

Claudio F. Lanata

Senior Researcher, Nutritional Research Institute, Peru

Beno Nyam Yakubu

Assistant Director, National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria

Yiming Shao

Chief Expert on HIV/AIDS and Director of Virology and Immunology Division, Center for Disease Control, China

Kavita Singh

Director of the South Asia office, Drugs for Neglected Diseases Initiative

Professor Peter Smith

Professor of Tropical Epidemiology, London School of Hygiene &Tropical Medicine (LSHTM), United Kingdom

WHO Vaccine Prequalification Program

[[WHO PHEIC declaration and prequalification ALL CONFIDENTIALITY AGREEMENTS SPONSORS INFO]]

On July 8, 2008, the FDA and WHO entered into a mutual confidentiality arrangement that included a commitment not to publicly disclose non-public information shared by and between the FDA and the WHO. The commitment satisfies the requirements of 21 CFR § 20.89 (c)(1)(i) and enables CBER to serve as the reference NRA under the WHO vaccine prequalification program.

CBER has affirmed its willingness to serve as the reference NRA for the following U.S. licensed vaccines:

Rotavirus Vaccine, Live, Oral, Pentavalent (Tradename: RotaTeq®; Manufacturer: Merck & Co., Inc.); Prequalified by WHO October 7, 2008
Influenza Virus Vaccine (Tradename: Fluvirin®; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 4, 2009
Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 9, 2009
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
(Tradename: Prevnar®; Manufacturer: Wyeth Pharmaceuticals Inc.); Prequalified by WHO December 28, 2009
Influenza Virus Vaccine (Tradename: Fluzone®; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 21, 2010
Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 27, 2010
Influenza A (H1N1) 2009 monovalent (No tradename; Manufacturer: MedImmune LLC); Prequalified by WHO February 25, 2010
Meningococcal ACYW-135 Polysaccharide, 10 dose vial (Tradename: Menomune; Manufacturer: Sanofi Pasteur), Prequalified by WHO May 22, 2013
Meningococcal (Serogroups A, C, Y, and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Tradename: Menactra; Manufacturer: Sanofi Pasteur); Prequalified by WHO March 21, 2014

About us

PDVAC is an independent standing WHO committee of experts which provides external advice to WHO related to priority infectious disease pathogens, associated vaccine and monoclonal antibody product development approaches and related manufacturing and delivery technologies. The committee’s remit covers disease areas where there is, or may be, substantial disease burden in low- and middle-income countries (LMICs), where no vaccine related products currently exist, but where there is ongoing product development activity which may benefit from WHO guidance, or technologies that could expedite availability and access of vaccine products in LMICs. PDVAC may also have a role where vaccines are already licensed, and development of improved products, including those based on novel manufacturing technologies or innovative vaccine delivery approaches is a priority for WHO and its member states.

PDVAC’s mission is to accelerate product development of vaccines and technologies that are urgently needed and ensure they are appropriately targeted for use in low and middle income contexts.

The majority of PDVAC’s scope of work focuses on the following core activities:

Identifying priority pathogens and technologies where there is evident public health need for a vaccine, and defining how WHO engagement would result in a clear benefit related to product development;
Defining the strategic public health goals and global value proposition for vaccines and technologies, in the context of other disease interventions and competing R&D priorities (including the development of products that are targeted to high income country markets);
Developing the preferred product characteristics of vaccines, specifically from the perspective of LMICs, with the goal of informing target product profiles to accelerate product development and reduce the timeframe to access of vaccines in LMIC contexts;
Developing technical R&D roadmaps for vaccines and technologies that articulate the research, product development and capacity needs, and proactively position a candidate for LMIC licensure and a positive policy recommendation;
Building consensus among global stakeholders, particularly with respect to product development strategy, including clinical endpoints and regulatory pathways;
Educating vaccine developers and other stakeholders with respect to the specific data needs for vaccine approval and uptake in LMICs, and advocating for these to be considered early on in product development.

Contact

giersingb@who.int or secretariat
https://www.who.int/groups/product-development-for-vaccines-advisory-committee/about

NITAG

https://www.nitag-resource.org/resources/systematic-review-coronavirus-disease-2019-vaccine-efficacy-and-effectiveness-against

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A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection…

Resources / Systematic reviews (SYSVAC)

A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Disease

https://doi.org/10.1093/ofid/ofac138

Date of last literature search:

Feb 2022

Number of studies:

107

Publication year:

2022

Abstract

Billions of doses of coronavirus disease 2019 (COVID-19) vaccines have been administered globally, dramatically reducing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) incidence and severity in some settings. Many studies suggest vaccines provide a high degree of protection against infection and disease, but precise estimates vary and studies differ in design, outcomes measured, dosing regime, location, and circulating virus strains. In this study, we conduct a systematic review of COVID-19 vaccines through February 2022. We included efficacy data from Phase 3 clinical trials for 15 vaccines undergoing World Health Organization Emergency Use Listing evaluation and real-world effectiveness for 8 vaccines with observational studies meeting inclusion criteria. Vaccine metrics collected include protection against asymptomatic infection, any infection, symptomatic COVID-19, and severe outcomes including hospitalization and death, for partial or complete vaccination, and against variants of concern Alpha, Beta, Gamma, Delta, and Omicron. We additionally review the epidemiological principles behind the design and interpretation of vaccine efficacy and effectiveness studies, including important sources of heterogeneity.

All age groups
Efficacy/effectiveness
Vaccine/vaccination
COVID-19

National Immunization Technical Advisory Groups

[[NITAG A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Disease]] – NITAG DOC 2022 about covid vax

WHO Vaccine Pre-qualification (EUL) Network

Emergency Use Listing Procedure for vaccines

Eligibility of candidate products

Evaluation procedure

Application for an EUL

How is the MEURI ethical framework related to the WHO EUL procedure?

As stated in the EUL procedure document (43), the EUL is not equivalent or an alternative to WHO prequalification, and should not be thought of as such.

Prequalification Procedures and Fees: Vaccines

Who can participate in WHO prequalification of vaccines?

What are the steps of the prequalification process?

Dossier submission deadlines

What happens when a vaccine is prequalified?

Ensuring continued acceptability of prequalified vaccines

Lets get to know the Product Development for Vaccines Advisory Committee (PDVAC):

Product Development for Vaccines Advisory Committee

Repeat: Indicator 7.2 monitors progress of vaccine development towards a “short list” of global R&D targets.

**Meeting material

WHO Vaccine Prequalification Program

Related External Links

WHO Cooperative Agreements

Q&A for Comirnaty (COVID-19 Vaccine mRNA)

Prequalificiation

CBER continues to engage structured scientific and policy discussions under confidentiality commitments with foreign regulatory counterparts.

About us

MEMBERS

WHO Vaccine Prequalification Program

Related External Links

About us

NITAG

A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Disease

Join Class Action Charges Against WHO Chief Scientist Filed Prior To Leaving Office November 30!

Proposed IHR Amendments To Be Adopted In Secret 28-December 2, 2022 WHO Meeting!

Pandemic Treaty Draft And Dates Officially Released!

Emergency Use Listing Procedure for vaccines

Eligibility of candidate products

Evaluation procedure

Application for an EUL

How is the MEURI ethical framework related to the WHO EUL procedure?

As stated in the EUL procedure document (43), the EUL is not equivalent or an alternative to WHO prequalification, and should not be thought of as such.

Prequalification Procedures and Fees: Vaccines

Who can participate in WHO prequalification of vaccines?

What are the steps of the prequalification process?

Dossier submission deadlines

What happens when a vaccine is prequalified?

Ensuring continued acceptability of prequalified vaccines

Lets get to know the Product Development for Vaccines Advisory Committee (PDVAC):

Product Development for Vaccines Advisory Committee

Repeat: Indicator 7.2 monitors progress of vaccine development towards a “short list” of global R&D targets.

**Meeting material

WHO Vaccine Prequalification Program

Related External Links

WHO Cooperative Agreements

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CBER continues to engage structured scientific and policy discussions under confidentiality commitments with foreign regulatory counterparts.

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NITAG

A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Disease