Milestones :: Perspectives :: Research
Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021 [Pfizer-BioNTech COVID-19 vaccine BNT162b2]
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) was held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).
Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing
WHO Team: WHO Headquarters (HQ)
Reference numbers: WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/2021.1
Copyright CC BY-NC-SA 3.0 IGO
Full text PDF: https://apps.who.int/iris/rest/bitstreams/1326072/retrieve [7 pages]
[Selected Excerpts; Full text at pdf link above]
… General goal and strategy for the use of the mRNA vaccine BNT162b2 against COVID-19 (Pfizer–BioNTech)
The COVID-19 pandemic has caused significant morbidity and mortality throughout the world, as well as major social, educational and economic disruptions. There is an urgent global need for effective and safe vaccines. On 31 December 2020, WHO listed the COVID-19 mRNA vaccine BNT162b2 for emergency use, making the Pfizer–BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year earlier. 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.
BNT162b2, an mRNA vaccine against COVID-19 developed by BioNTech and Pfizer, has been shown to have an efficacy of approximately 95%, based on a median follow-up of two months. The data reviewed by WHO at this time support the conclusion that the known and potential benefits of BNT162b2 outweigh the known and potential risks. As sufficient vaccine supply will not be immediately available to immunize all who could benefit from it, countries are recommended to use the WHO Prioritization Roadmap  and the WHO Values Framework  as guidance for their prioritization of target groups. As long as vaccine supplies are very limited (stage I in the WHO Prioritization Roadmap), in settings with community transmission, the Roadmap recommends that priority be given initially to health workers at high risk and older people with and without comorbidities. Protecting high-risk health workers has a threefold purpose: (i) to protect the individual health workers; (ii) to protect critical essential services during the COVID-19 pandemic, and (iii) to prevent onward transmission to vulnerable people. Protecting older people will have the greatest public health impact in terms of reducing the number of deaths. As more vaccine becomes available, additional priority groups should be vaccinated as outlined in the WHO Prioritization Roadmap , taking into account national epidemiological data and other relevant considerations…
… Considerations for deferring the second dose
WHO acknowledges that a number of countries face exceptional circumstances of vaccine supply constraints combined with a high disease burden. Some countries have therefore considered delaying the administration of the second dose to allow for a higher initial coverage. This is based on the observation that efficacy has been shown to start from day 12 after the first dose and reached about 89% between days 14 and 21, at the time when the second dose was given. No data on longer term efficacy for a single dose of the mRNA vaccine BNT162b2 currently exist, as the trial participants received 2 doses with an interval between doses in the trial ranging from 19 to 42 days. Of note, neutralizing antibody responses are modest after the first dose and increase substantially after the second dose.
Countries experiencing exceptional epidemiological circumstances may consider delaying for a short period the administration of the second dose as a pragmatic approach to maximizing the number of individuals benefiting from a first dose while vaccine supply continues to increase. WHO’s recommendation at present is that the interval between doses may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data. Should additional data become available on longer intervals between doses, revision of this recommendation will be considered. Countries should ensure that any such programme adjustments to dose intervals do not affect the likelihood of receiving the second dose…
Persons in settings such as refugee and detention camps, prisons, slums, and other settings with high population densities, where physical distancing is not implementable, should be prioritized for vaccination as outlined in the WHO Prioritization Roadmap , taking into account national epidemiological data, vaccine supply and other relevant considerations.
As noted in the WHO Prioritization Roadmap, national programmes should give special consideration to groups that are disproportionately affected by COVID-19 or that face health inequities as a result of social or structural inequities. Such groups should be identified, barriers to vaccination should be addressed, and programmes should be developed to enable equitable access to vaccines.
In the current period of very limited vaccine supply, preferential vaccination of international travelers would counter the principle of equity. Because of this and the lack of evidence on whether vaccination reduces the risk of transmission, WHO currently does not recommend COVID-19 vaccination of travelers (unless they are also part of a high-risk group or in epidemiological settings identified in the WHO Prioritization Roadmap ). With increasing vaccine supply, these recommendations will be revisited…
…Community engagement, effective communication, and legitimacy
Community engagement and effective communication (including risk communication) are essential to the success of COVID-19 vaccination programmes. Prioritization decisions should be made through transparent processes that are based on shared values, the best available scientific evidence, and appropriate representation and input by affected parties. Furthermore, communication about the mechanism of action of mRNA vaccines, and efficacy and safety data derived from clinical trials and post-marketing studies, needs to be strengthened. Strategies should include: (1) culturally acceptable and linguistically accessible communications regarding COVID-19 vaccination made freely available; (2) active community engagement and involvement of community opinion leaders and trusted voices to improve awareness and understanding of such communications, and (3) inclusion of diverse and affected stakeholder opinions in decision-making. Such efforts are especially important in subpopulations who may be unfamiliar with or distrustful of health care systems and immunization…
…Recommendations on addressing current knowledge gaps through further research
In order to confirm the safety profile demonstrated in the clinical trials in the short term, active surveillance of large numbers of vaccinated individuals is necessary in the general population studied for a longer duration, as well as of specific at-risk subpopulations. It is essential for Pfizer–BioNTech and vaccination providers to report the following to adverse event reporting systems in countries: all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome (MIS) following vaccination, anaphylaxis and other serious allergic reactions, Bell`s palsy, and cases of COVID-19 following vaccination that result in hospitalization or death.
WHO recommends the following research and post-authorization monitoring activities:
vaccine effectiveness over time;
ongoing collection of safety data in vaccine recipients;
surveillance for COVID-19 among vaccinated individuals, looking for vaccine-induced enhanced disease (possibly as vaccine-induced antibody levels decline);
safety data from inadvertently vaccinated pregnant women during trials and post-authorization;
safety data from pregnant women who receive vaccine because they are members of prioritized groups, e.g. health workers;
prospective studies on the safety of BNT162b2 in pregnant women;
impact on infants of vaccination of breastfeeding mothers;
safety data on vaccination in immunocompromised persons, including persons living with HIV and persons with autoimmune disease;
impact of delayed second dose as currently implemented by certain countries;
clinical trials on the efficacy and safety of vaccination of children below the age of 16 years;
immunogenicity and safety studies of co-administration with other vaccines, including influenza and pneumococcal vaccines, to adults and older persons;
studies to determine how protection changes with time since vaccination and whether protection can be prolonged by booster doses;
studies to demonstrate whether this vaccine reduces SARS-CoV-2 transmission and viral shedding;
stability of vaccine under alternative cold-chain distribution and storage conditions;
effectiveness of the proposed strategies for the prevention and management of anaphylactic reactions;
interchangeability and “mix and match” studies within and across COVID-19 vaccine platforms;
global surveillance of virus evolution and the impact of virus mutants on vaccine effectiveness to support possible update of vaccines if needed;
head-to-head studies with other vaccines on extent and duration of immunity using standardized neutralization assays and mucosal immunity assays.
Please find related materials for the meeting, including a final agenda, list of participants, declaration of interests, background materials and presentations made during the meeting, below.
:: Introduction, session objective setting, update on regulatory decisions and overview of Working Group deliverables H. NOHYNEK. pdf, 4.1Mb
:: Safety monitoring S. Pal. pdf, 1Mb
:: Assessment of Evidence (SAGE working group)