Here is a summary of the situation of the National Agency for the Safety of Medicines and Health Products (ANSM) concerning the monitoring of adverse events following vaccination once morest covid 19. The adverse events of a new type that have appeared are listed from 03/25/2022 to 04/07/2022.
Preliminary remark on the interpretation of vaccine safety data published by the ANSM.
Overall, the number of adverse events following vaccination is very low when compared to the very high number of people vaccinated. The regular publication of post-vaccination adverse event monitoring data is a guarantee of transparency. However, a post-vaccination adverse event is not synonymous with an adverse effect attributable to the vaccine, even if the two terms are often used interchangeably. Let us recall that if, on a given date, a million people received a placebo (inactive preparation which is substituted for a drug) instead of a vaccine, we might observe in the following six weeks 1 to 7 deaths, 2 to 5 cases of Guillain-Barré syndrome and 30 to 90 cases of optic neuritis; per 10,000 pregnant women, the expected number of spontaneous abortions is 170. These average numbers are probably very variable according to time and place. Thus, since Guillain-Barré syndrome can occur during influenza, the frequency of this syndrome is probably higher in the context of an influenza epidemic. These data show that the development of a disease following administration of a vaccine, sometimes considered as the proof of the imputability of the vaccination, is in fact most often a temporal coincidence (see This article).
Post-vaccination adverse events are very similar and are subject to coordinated monitoring for the two licensed mRNA vaccines (Comirnaty and Spikevax).
1. Comirnaty (Pfizer-BioNTech)
No new signal or event over the period.
Conclusion : since the start of vaccination, 99,331 cases of adverse effects have been analyzed by the reporting CRPVs (Bordeaux, Marseille, Strasbourg and Toulouse). The majority of side effects are expected and not serious.
See the Adverse effects of this vaccine.
2. Nail Wax (Modern)
New potential signals over the period:
Vasculitis: 26 cases have been notified since the start of follow-up. These 26 cases of vasculitis, with favorable outcome following corticosteroid therapy, can be classified into 3 different categories:
- Vasculitis with involvement of large vessels: 9 cases have been reported since the start of follow-up in 6 men and 4 women with an average age of 71 years. The median time to onset is 6.5 days and these cases occurred following the 1st dose for 2 cases, following the 2nd dose for 3 cases and following the first booster dose for 4 cases.
- Vasculitis with involvement of small vessels: 10 cases have been reported since the start of follow-up in 3 men and 6 women with an average age of 59 years. The median time to onset is 7 days and these cases occurred following the 1st dose for 4 cases, following the 2nd dose for 4 cases and following the 1st booster dose for 1 case (1 case unknown).
- Other vasculitides: 7 cases have been reported since the start of follow-up in 1 man and 6 women with an average age of 52 years, for 4 cases following the 1st dose, 2 cases following the 2nd dose and 1 case following the 1st dose of reminder. The average time to occurrence is 4.2 days.
Cases found in the literature, the time to onset and the immuno-inflammatory mechanism of these events cannot currently exclude a role for the vaccine and make these effects a potential signal.
Conclusion : since the start of vaccination with the Spikevax vaccine (Moderna), 25,314 cases of adverse effects have been analyzed by the reporting CRPVs (Lille and Besançon). A large number of cases relate to non-serious local delayed reactions. As of November 8, 2021, use of the Spikevax vaccine is restricted to persons 30 years of age and older.
Following an analysis of cases of vasculitis (inflammation of blood vessels), the committee considers that this is a potential signal with the Spikevax vaccine. A total of 26 cases have been reported since the start of follow-up, all with favorable outcome following corticosteroid therapy. The time to onset as well as the immuno-inflammatory mechanism of these events cannot currently exclude a role for the vaccine. These events will be shared at European level.
See the Adverse effects of this vaccine.
3. Vaxzevria (AstraZeneca)
No new signal or event over the period.
Conclusion : since the start of vaccination with the Vaxzevria vaccine, 29,499 cases of adverse effects have been analyzed by the reporting CRPVs (Amiens and Rouen). The vast majority of these cases relate to flu-like syndromes, often of high intensity (high fever, body aches, headaches). Since March 19, 2021, the use of the Vaxzevria vaccine is restricted to people aged 55 and over.
See the Adverse effects of this vaccine.
4. COVID-19 Vaccine Janssen
No new signal or event over the period.
Conclusion : since the start of vaccination, a total of 1,492 cases have been analyzed by the reporting CRPVs (Lyon and Grenoble). The majority of undesirable effects are not serious, expected and of favorable evolution, in particular effects of reactogenicity (for example malaise). Vaccination with the Janssen vaccine began in France on April 24, 2021 in people over the age of 55.
See the Adverse effects of this vaccine.
5. Record of vaccinations carried out
More than 502,200 injections were performed from 03/25/2022 to 04/07/2022.
In total, more than 142,537,300 injections have been performed in total as of 07/04/2022, distributed as follows according to the vaccine:
- Comirnaty (BioNTech-Pfizer) : 109 573 900.
- Nail wax (Modern): 23 571 900.
- Vaxzevria (AstraZeneca) : 7 858 200.
- COVID-19 Vaccine Janssen : 1 086 300.
Reference