The HAS took into consideration the following elements:

  • the results of clinical studies which indicate vaccine efficacy of BNT162b2 in reducing the number of symptomatic COVID-19 cases, including in patients over 65 years of age;
  • the results of phase II / III clinical studies which indicate a generally satisfactory safety profile of the BNT162b2 vaccine at the date of analysis of the study data (14/11/2020);
  • the results from the dynamic transmission type model, developed by the Institut Pasteur and the EHESP in collaboration with Public Health France and Inserm

Regarding the place of the vaccine in the vaccination strategy, the HAS considers that the COMIRNATY vaccine (BNT162b2) can be used in people 16 years of age and over, including in the elderly because of its efficacy and its satisfactory safety profile. HAS notes, however, that at this point:

  • vaccine efficacy could not be assessed in younger subjects (<18 years);
  • vaccine efficacy on viral transmission has not been evaluated;
  • the tolerance of the vaccine in subjects with a history of Covid-19 (documented by positive serology or positive PCR test) was good.

HAS reminds that:

  • At this stage, there is no need to systematically vaccinate people who have already developed a symptomatic form of Covid-19 unless they wish to do so following a decision shared with the doctor and within a minimum period of time. 3 months from the onset of symptoms.
  • However, the defined prioritization strategy does not exclude - on the basis of an assessment of the individual benefit / risk ratio on a case-by-case basis, vaccination of non-elderly but particularly vulnerable subpopulations [1] and exposed to COVID-19 (severe immune deficiencies, hematologic malignancies, renal insufficiency on dialysis, solid organ transplants, etc.), as soon as the doses of vaccines are available and the DGS will be able to organize locally the logistics circuits in connection with the ARS and the care structures.

The HAS also specifies the situations of pregnancy, breastfeeding and a history of allergy.

This vaccine cannot be co-administered with other vaccines at this time.

In addition, the HAS insists on the need to maintain all physical distancing measures at this stage.

  • Recommendation
  • Europe
  • France
  • Pfizer-BioNTech vaccine
  • COVID-19