Vaccination reservation with the Janssen vaccine for certain cases
Given the new pharmacoepidemiology data from the EPI-PHARE report of January 18, 2022, the Director General of Health contacted HAS to clarify the place of the Janssen vaccine in the vaccination strategy against Covid-19.
These confirm the safety of mRNA vaccines regarding the risk of serious cardiovascular events in adults younger than 75 years. In addition, the results of this study suggest a slightly increased risk of myocardial infarction in the two weeks following vaccination with the Janssen vaccine in this same population. At this stage, these preliminary results should be interpreted with caution and confirmed by other studies at the international level. In particular, the HAS considers that these data should be promptly reviewed by the European Medicines Agency (EMA) in order to be compared with the European pharmacovigilance data available to date. To date, the pharmacovigilance data available worldwide, when more than 38 million doses of the Janssen vaccine have been administered, are reassuring and no signal related to the risk of myocardial infarction has been identified at European level or American.
First of all, HAS recalls, in accordance with its previous recommendations, that preference should be given to the use of mRNA vaccines in the context of primary vaccination, as well as for the administration of the booster dose when possible, even for those who have already received a dose of the Janssen vaccine as primary vaccination, due to its greater efficacy.
Pending the EMA’s conclusions, it recommends postponing vaccination with the Janssen vaccine, except for people at risk of a severe form of the disease who have a contraindication to administration of an mRNA vaccine. These people may continue to be offered the Janssen vaccine as part of a shared medical decision, after clear information about the potential benefits and risks has been provided.
Maintenance of unfavorable opinion for antigenic tests in saliva due to lack of demonstrated efficacy
On April 23, 2021, HAS ruled against reimbursement for rapid antigen detection of the SARS-CoV-2 virus in saliva samples due to lack of sufficient diagnostic performance. Since then, the presence of the Omicron variant has led the Ministry in charge of Health to contact the HAS to update its opinion on rapid antigenic tests on saliva samples. This would like HAS to position itself in the place of antigenic self-testing on saliva sampling in the iterative screening strategy, particularly in schools, given the potential positive impact that saliva sampling could have on the acceptability of screening. iterative by self-assessment.
HAS has thus carried out a critical analysis of the latest scientific data available on the performance of these tests. At the end of this work, it is concluded that the performance data of the antigenic tests in saliva samples are still insufficient because the sensitivity found in the selected studies is below the requirements of 50% in asymptomatic people and 80% in people. fixed symptoms by HAS. for quick tests. Furthermore, the first available data did not show a better performance of these tests in the presence of the Omicron variant than in the presence of the Delta variant.
The HAS also noted a lack of data on the use of rapid antigenic self-tests on saliva samples, either in the general population or in children. .
Taking all these elements into account, HAS does not recommend the use of rapid antigenic tests (TDR/TROD/self-test) for the detection of SARS-CoV-2 in saliva samples and, therefore, maintains its unfavorable opinion on the inclusion of these tests in the list of covered procedures and services. The opinion of the HAS is likely to evolve in accordance with scientific knowledge.
Early access authorization for Ronapreve® as a curative treatment
On August 6, 2021, the HAS issued a resolution granting early access authorization to Ronapreve® (casirivimab and imdevimab) from Roche-Regeneron for the preventive treatment (prophylaxis) of Covid-19 for certain immunocompromised patients with very high risk of developing a severe form of the disease.
Today, HAS reissues an early access authorization for Ronapreve®, following its recently obtained marketing authorization, in the curative treatment of Covid-19 in patients aged 12 years and older who are at high risk of serious illness and do not require oxygen therapy, subject to the sensitivity of the SARS-CoV-2 strain to Ronapreve®.
However, it restricts its use only to situations where it is impossible to prescribe the currently recommended drugs (Xevudy®, Evusheld®, Paxlovid®), and only after the patient is proven to be infected with a SARS-CoV-2 strain. susceptible to Ronapreve.®, except the Omicron variant. Thus, in a context of total replacement of the Delta variant by the Omicron variant, the use of Ronapreve® becomes very marginal.
The HAS took into account in its decision the data of good virological activity, efficacy and tolerance of Ronapreve® against the worrying variants, with the exception of the Omicron variant, and its potential interest in the continuation of the epidemic. Remember that this treatment should be administered as soon as possible in the days following the positive test results, subject to the sensitivity of the virus to Ronapreve®.