The HAS recommends a vaccination marketing campaign in opposition to…

The HAS recommends a vaccination marketing campaign in opposition to…

The French Nationwide Authority for Well being (HAS) has up to date its suggestions regarding the booster vaccination technique in opposition to COVID-19. They have been posted on September 20, 2022 in three opinions:

  1. Booster vaccine technique in opposition to covid 19;
  2. Vaccination technique in opposition to covid 19 – Place of the bivalent Spikevax Unique/Omicron BA.1 vaccine (mRNA-1273.214);
  3. Vaccination technique in opposition to covid 19 – Place of the Comirnaty bivalent vaccines Unique/Omicron BA.1 and Unique/Omicron BA.4-5.

In these texts, the HAS recommends:

  • the group of a vaccination marketing campaign in opposition to covid 19 within the fall of 2022, throughout which a booster dose with a bivalent vaccine tailored to the Omicron variant (whatever the variety of reminders already administered beforehand) have to be supplied to individuals susceptible to a extreme type of covid 19 in addition to to these round them ;
  • the coupling of this marketing campaign with the vaccination marketing campaign in opposition to seasonal influenza.

All of the suggestions contained on this current opinion are detailed under.

1. Reminder on bivalent vaccines

Three bivalent vaccines appropriate for the Omicron variant have been approved by the European Medicines Company (EMA) in September 2022:

  • Bivalent Spikevax Unique/Omicron BA.1 (Moderna laboratory): 25 μg of mRNA encoding the spike protein of the Wuhan pressure contained within the authentic Spikevax vaccine and 25 μg of the identical tailored mRNA containing the coding sequence of the spike protein of the BA.1 subline of the Omicron variant (MA variation accepted by the EMA on September 1, 2022);
  • Comirnaty bivalent Unique/Omicron BA.1 15/15 μg (Pfizer-BioNTech laboratory): two SARS-CoV-2 mRNAs, one encoding the spike protein of the unique Wuhan pressure and the opposite encoding the spike protein of the BA.1 subline of the Omicron variant ( Advertising Authorization variation accepted by the EMA on September 1, 2022);
  • Comirnaty bivalent Unique/Omicron BA.4-BA.5 15/15 μg (Pfizer-BioNTech laboratory): two SARS-CoV-2 mRNAs, one encoding the spike protein of the unique Wuhan pressure and the opposite encoding a typical sequence of the spike protein of the variant BA.4 and BA.5 sublines Omicron (MA variation accepted by the EMA on September 12, 2022).

2. Up to date suggestions from the French Nationwide Authority for Well being

HAS has printed the next suggestions.

2.1. Proceed the second booster marketing campaign (most frequently a fourth dose) for individuals susceptible to affected by a extreme type of the illness, in addition to for these round them and healthcare professionals:

  • individuals aged 60 and over;
  • residents of lodging institutions for dependent aged individuals (EHPAD) and long-term care items (USLD);
  • immunocompromised individuals, no matter their age (nonetheless, bivalent vaccines aren’t approved earlier than the age of 12);
  • adults aged 18 to 59 recognized as being susceptible to a extreme type of covid 19;
  • kids and adolescents at excessive danger, and affected by pathologies justifying it;
  • pregnant ladies, from the first trimester of being pregnant;
  • individuals residing round or in common contact with weak or immunocompromised individuals, in a cocooning technique;
  • healthcare professionals, no matter their age or state of well being;
  • all staff within the well being and medico-social sector, dwelling helpers working with weak individuals, medical transport professionals, in addition to firefighters, no matter their age, their mode of train or their state of well being.

For reminiscence :

  • this second reminder is really helpful:
    – 3 months after the primary booster for individuals aged 80 and over, in addition to for residents of nursing houses or USLDs and severely immunocompromised individuals, no matter their age;
    from 6 months after the primary booster for different eligible individuals.
  • for individuals who have been contaminated with SARS-CoV-2, an extra booster dose continues to be really helpful, respecting a minimal interval of three months after an infection.
  • so long as bivalent vaccines aren’t out there, don’t hesitate to hold out the second booster with a “standard” vaccine.

2.2. Manage a vaccination marketing campaign in opposition to covid 19 within the fall of 2022 with bivalent vaccines

HAS recommends that, throughout this marketing campaign:

For individuals below the age of 30, the HAS recommends the preferential use of bivalent vaccines Comirnaty bivalent Unique/Omicron BA.1 15/15 μg The place Comirnaty bivalent Unique/Omicron BA.4-BA.5 15/15 μg for the autumn marketing campaign.

Probably the most fragile individuals will obtain the bivalent vaccine as a precedence. A adequate variety of doses have been ordered, and all individuals eligible for a booster vaccine in opposition to covid 19 (whether or not it’s a first, a second or a 3rd booster) will be capable of obtain a bivalent vaccine. . The vaccine Bivalent Spikevax Unique/Omicron BA.1 will be ordered from September 26, 2022.

2.3. Couple this reminder marketing campaign in opposition to covid 19 with the vaccination marketing campaign in opposition to seasonal flu

Within the absence of an epidemic wave linked to covid 19 within the coming weeks, the beginning date of the vaccination marketing campaign in opposition to covid 19 ought to be decided by the beginning date of vaccination in opposition to seasonal fluspecifically Tuesday, October 18, 2022.

The HAS recollects that:

  • the simultaneous realization of vaccines in opposition to influenza and covid 19 is feasible: the 2 injections will be carried out on the identical day, however at two separate vaccination websites (one vaccine in every arm);
  • pFor individuals who don’t obtain the booster dose in opposition to covid 19 (or for that matter a primary or second dose of this vaccine) and the flu injection concurrently, there isn’t any time restrict to respect between the 2 vaccinations; this rule additionally applies to any affiliation between vaccines in opposition to covid 19 and different vaccines within the vaccination schedule.

2.4. To enhance vaccination protection, which continues to be inadequate, and to proceed research in Courses

As of September 15, 2022, the vaccination protection of individuals eligible for the second booster dose was solely 32.9% amongst 60-79 yr olds and 46.2% amongst 80 yr olds and over.

2.5. As well as, the HAS insists on:

  • The truth that sufferers most susceptible to a extreme type of Covid-19 and, particularly, immunocompromised individuals or individuals with a really high-risk pathology no matter their age, and sufferers over 65 years previous with danger elements danger of creating critical types, should be capable of profit from preventive remedy with Paxlovidno matter their vaccination standing, as beforehand really helpful by HAS.
  • The significance of sustaining barrier gestures, together with after vaccination.
  • The truth that the research in progress must be continued so as to have the ability to have longer-term immunogenicity, efficacy and tolerance knowledge, in addition to within the pediatric inhabitants, and desires to learn of any new outcomes.

Lastly, HAS regrets the absence of direct comparative knowledge (scientific or pre-clinical) making it doable to check the immunogenicity of the totally different bivalent vaccines tailored to the variants.

A subsequent model of the vaccine choice assist system will quickly be out there on MesVaccins.internet: this model will consider the dates of sure situations (date of onset of being pregnant, date of SARS-CoV-2 an infection ) and their intervals in relation to doable vaccinations.

Supply: Excessive Authority for Well being.


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