WHO EUL recommendation for BIBP



The WHO's emergency use listing (EUL) recommendations for SINOPHARM's COVID-19 vaccine, published on 4 June 2021, discuss the risk management plan and pharmacovigilance plan for this vaccine, as summarized below.  Risk management plan: 

  • Major risks identified: With regard to anaphylaxis, observation time after vaccination should be at least 15 minutes, given the life-threatening risk of anaphylactic/anaphylactoid reactions.
  • Potential risks: The manufacturer considered the risk of vaccine-associated enhanced disease (VAED); WHO includes, in addition, the risk of vaccine-associated enhanced respiratory disease (VAERD), and notes that there is a theoretical concern that vaccination against SARS-CoV-2 may be associated with enhanced severity of COVID-19 episodes which would manifest as VAED, which can be life-threatening, and requires early detection, careful monitoring, and timely medical intervention.

Programmatic errors: WHO requested the inclusion of risks related to programmatic errors under real use conditions, which should be monitored via routine pharmacovigilance activities and be presented in each PBRER/PSUR.  

Reactogenicity: Overview of safety information is limited to written descriptions of adverse events, without information on number of exposed or the description of relevant cases. The identified risks need to consider frequency, but also the importance of seriousness, severity, and impact.  

  • Missing information: WHO requested inclusion of the following:

Use during pregnancy and while breastfeeding. Pregnant and lactating women were not included in the clinical trials.  

Current or past SARS-CoV-2 infection: To be assessed in a post-emergency use or post-marketing study.  

Use in immunocompromised patients, including people living with HIV.  This population was excluded from the clinical trials.  

Subjects aged 60 and above. Current ongoing clinical trials include only a small proportion of participants aged 60 and above.  

Use in patients with comorbidities (e.g., chronic obstructive pulmonary disease [COPD], diabetes, chronic neurological disease, cardiovascular disorders).

In addition to interaction with other vaccines, WHO incorporated interchangeability or sequential use with other vaccines.

Use in pediatric population. WHO noted that no efficacy data are available from participants <18 years of age.

Use in patients with autoimmune or inflammatory disorders. There is a theoretical concern that the vaccine may exacerbate their underlying disease.  

Long-term safety: WHO indicated that it is taking additional steps to learn more in this regard.

Impact of the emergence of variants on vaccine efficacy/effectiveness and safety: WHO requested that BIBP provide it with any relevant data as soon as available, irrespective of source.  

Pharmacovigilance plan: 

WHO recommended monitoring of the following adverse events of interest: facial paralysis; Guillain-Barré syndrome and neurological disorders; coagulation disorders (thromboembolism, hemorrhage); reactogenicity following vaccination, and all serious adverse events. In addition, it emphasizes that routine pharmacovigilance activities should be implemented in all WHO regions, taking into account the regulations and particularities of each country. 

Source: https://extranet.who.int/pqweb/file/4960602/download

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