REPEVAX (vaccin diphtérique, tétanique, coquelucheux (acellulaire multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en anti-gènes))

Key points

Approval of reimbursement for passive protection against pertussis during early childhood after maternal immunisation during pregnancy, according to the HAS guidelines in force of 7 April 2022.

Therapeutic improvement?

Therapeutic improvement in the care pathway.

Role in therapeutic strategy?

In April 2022, HAS drafted pertussis vaccination recommendations for pregnant women, updating the role of the BOOSTRIXTETRA and REPEVAX vaccines in the prevention strategy.

According to the vaccination guidelines adopted by the HAS Board on 07/04/2022, “HAS recommends pertussis vaccination for pregnant women from the second trimester of gestation, preferably the period between 20 and 36 amenorrhoea weeks (AW), in order to increase passive transplacental transfer of maternal antibodies and ensure optimal protection for the newborn. Vaccination during pregnancy may be performed with a trivalent vaccine (dTca) or tetravalent vaccine (dTcaP) depending on availability.

HAS recommends that pertussis vaccination be administered for each pregnancy. A woman who has received a pertussis vaccine before her pregnancy must also be vaccinated during the current pregnancy, in order to ensure that enough antibodies are transferred through the placenta to protect the future newborn. In any case, a minimum interval of one month must be observed with respect to the most recent dTP vaccine.

Failing vaccination of the pregnant woman during pregnancy, vaccination is recommended:

• for the mother in the immediate post-partum period, before she is discharged from the maternity hospital, even if she is breastfeeding, in accordance with the current cocooning strategy;
• for the newborn’s relatives (parents, siblings, grandparents, and other people liable to be in long-term close contact with the future infant for the first six months of their life) no later than at the time of the infant’s birth.

HAS specifies that, when the mother has been vaccinated during pregnancy, and at least one month has elapsed between vaccination and delivery, it is no longer necessary to vaccinate the infant’s close relatives.

However, HAS recommends that pertussis vaccination be preferably performed during pregnancy; this strategy has demonstrated a superior real-life vaccination efficacy in protecting infants in the first months of their lives, and while awaiting their own vaccination. HAS notes that the vaccination of pregnant women against pertussis may be administered at the same time as seasonal influenza and/or COVID-19 vaccination (however, while pertussis vaccination should preferentially be administered during the second or third trimester of gestation, COVID-19 and influenza vaccination should be administered as early as possible during pregnancy).

HAS stresses that infants’ vaccination schedules must be observed in accordance with the guidelines in force, whether the mother has been vaccinated during pregnancy or not.”

Role of the medicinal product

The Committee deems that REPEVAX (dTcaP vaccine) must be used in accordance with its marketing authorisation and in accordance with the vaccination guidelines in force for passive protection against pertussis in early childhood after maternal immunisation during pregnancy.

The Committee points out that vaccination is the most effective prevention tool against pertussis and the associated complication. Good vaccination coverage of young infants is essential.

Special recommendations

The Committee insists that communication be targeted at pregnant women and healthcare professionals with vaccination expertise, in order to increase pertussis vaccination uptake through the passive protection strategy based on immunisation during pregnancy.

The Committee supports the request expressed in the HAS vaccination guidelines of April 2022 that pertussis vaccines be made available in maternity hospitals and other care facilities providing care for pregnant women, for administration to the pregnant woman during a regulatory pregnancy check-up.

• Other requests

The Committee regrets the lack of availability to date of a monovalent acellular pertussis vaccine, its preferred pharmaceutical dosage form, as previously stated in its inclusion opinion for REPEVAX.