The HAS recommends a vaccination campaign against…

The French National Authority for Health (HAS) has updated its recommendations relating to the booster vaccination strategy once morest covid 19. They were put online on September 20, 2022 in three notices:

1. Booster vaccine strategy once morest covid 19 ;
2. Vaccination strategy once morest covid 19 – Place of the bivalent Spikevax Original/Omicron BA.1 vaccine (mRNA-1273.214) ;
3. Vaccination strategy once morest covid 19 – Place of Comirnaty bivalent vaccines Original/Omicron BA.1 and Original/Omicron BA.4-5.

In these texts, the HAS recommends:

• the organization of a vaccination campaign once morest covid 19 in the fall of 2022, during which a booster dose with a bivalent vaccine adapted to the Omicron variant (regardless of the number of boosters already administered previously) must be offered to people at risk of severe form of covid 19 as well as those around them;
• the coupling of this campaign with the vaccination campaign once morest seasonal influenza

All the recommendations contained in this recent opinion are detailed below.

1. Reminder on bivalent vaccines

Three bivalent vaccines suitable for the Omicron variant were authorized by the European Medicines Agency (EMA) in September 2022

• Spikevax bivalent Original/Omicron BA.1 (Moderna laboratory): 25 μg of mRNA encoding the spike protein of the Wuhan strain contained in the original Spikevax vaccine and 25 μg of the same adapted 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 Original/Omicron BA.1 15/15 μg (Pfizer-BioNTech laboratory): two SARS-CoV-2 mRNAs, one encoding the spike protein of the original Wuhan strain and the other encoding the spike protein of the BA.1 subline of the Omicron variant ( Marketing Authorization variation accepted by the EMA on September 1, 2022);
• Comirnaty bivalent Original/Omicron BA.4-BA.5 15/15 μg (Pfizer-BioNTech laboratory): two SARS-CoV-2 mRNAs, one encoding the spike protein of the original Wuhan strain and the other encoding a common sequence of the spike protein of the BA.4 and BA.5 of the Omicron variant (MA variation accepted by the EMA on September 12, 2022).

2. Updated recommendations from the French National Authority for Health

HAS has published the following recommendations.

2.1. Continue the second booster campaign (most often a fourth dose) for people at risk of suffering from a severe form of the disease, as well as for those around them and healthcare professionals:

• people aged 60 and over;
• residents of accommodation establishments for dependent elderly people (EHPAD) and long-term care units (USLD);
• immunocompromised people, whatever their age (however, bivalent vaccines are not authorized before the age of 12);
• adults aged 18 to 59 identified as being at risk of a severe form of covid 19;
• children and adolescents at high risk, and suffering from pathologies justifying it;
• pregnant women, from the 1st trimester of pregnancy;
• people living around or in regular contact with vulnerable or immunocompromised people, in a cocooning strategy;
• healthcare professionals, regardless of their age or state of health;
• all employees in the health and medico-social sector, home helpers working with vulnerable people, medical transport professionals, as well as firefighters, whatever their age, their mode of exercise or their state of health.

For memory :

• this second reminder is recommended:
  – 3 months following the first booster for people aged 80 and over, as well as for residents of nursing homes or USLDs and severely immunocompromised people, regardless of their age;
  – from 6 months following the first reminder for other eligible persons.
• for people who have been infected with SARS-CoV-2, an additional booster dose is still recommended, respecting a minimum period of three months following infection.
• as long as bivalent vaccines are not available, do not hesitate to carry out the second booster with a “conventional” vaccine.

2.2. Organize a vaccination campaign once morest covid 19 in the fall of 2022 with bivalent vaccines

HAS recommends that, during this campaign:

For people under the age of 30, the HAS recommends the preferential use of bivalent vaccines Comirnaty bivalent Original/Omicron BA.1 15/15 μg or Comirnaty bivalent Original/Omicron BA.4-BA.5 15/15 μg for the fall campaign.

The most fragile people will receive the bivalent vaccine as a priority. A sufficient number of doses have been ordered, and all people eligible for a booster vaccine once morest covid 19 (whether it is a first, a second or a third booster) will be able to receive a bivalent vaccine. . The vaccine Spikevax bivalent Original/Omicron BA.1 can be ordered from September 26, 2022.

2.3. Couple this reminder campaign once morest covid 19 with the vaccination campaign once morest seasonal flu

In the absence of an epidemic wave linked to covid 19 in the coming weeks, the start date of the vaccination campaign once morest covid 19 should be determined by the start date of vaccination once morest seasonal flunamely Tuesday, October 18, 2022.

The HAS recalls that:

• simultaneous administration of vaccines once morest influenza and covid 19 is possible: the two injections can be performed on the same day, but at two separate vaccination sites (one vaccine in each arm);
• for people who would not receive the booster dose once morest covid 19 (or for that matter a first or a second dose of this vaccine) and the flu injection simultaneously, there is no time limit to respect between the two vaccinations; this rule also applies to any association between vaccines once morest covid 19 and other vaccines in the vaccination schedule.

2.4. To improve vaccination coverage, which is still insufficient, and to continue studies in Classes

As of September 15, 2022, the vaccination coverage of people eligible for the second booster dose was only 32.9% among 60-79 year olds and 46.2% among 80 year olds and over.

2.5. In addition, the HAS insists on:

• The fact that patients most at risk of a severe form of Covid-19 and, in particular, people who are immunocompromised or have a very high-risk pathology regardless of their age, and patients over 65 years of age with risk factors risk of developing serious forms, must be able to benefit from preventive treatment with Paxlovidregardless of their vaccination status, as previously recommended by HAS.
• The importance of maintaining barrier gestures, including following vaccination.
• The fact that the studies in progress will have to be continued in order to be able to have longer-term immunogenicity, efficacy and tolerance data, as well as in the pediatric population, and wishes to be informed of any new results.

Finally, HAS regrets the absence of direct comparative data (clinical or pre-clinical) to compare the immunogenicity of the different bivalent vaccines adapted to the variants.

A next version of the vaccine decision support system will soon be available on MesVaccins.net : this version will take into account the dates of certain conditions (date of onset of pregnancy, date of SARS-CoV-2 infection) and their intervals with respect to possible vaccinations.

Source : High Authority of Health.

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