The French Agency for the Safety of Health Products (AFSSAPS) analyzes a case of abortion in utero occurred after vaccination against influenza A (H1N1), said Thursday its CEO, Jean Marimbert the course of a press conference at the Ministry of Health.
This is a health professional who has received the adjuvanted vaccine Pandemrix * (GlaxoSmithKline), which was at 38 weeks gestation (nine months of pregnancy).
She developed “mild symptoms VACCINATION classic in the day following the vaccination, then a little less than two days after vaccination, had strong contractions. She went to motherhood, which noted that “the fetal heart stopped beating,” reported Jean Marimbert.
The latest weekly bulletin of Pharmacovigilance Afssaps on immunization against influenza A (H1N1), released Thursday, suggests a “context febrile two days after vaccination” in which the abortion occurred in utero.
An autopsy was requested and various tests are underway, including bacteriological, virological and pathological, to try to ascertain the cause of death of the fetus, “said CEO Afssaps.


But “at this stage there are no data linking this event to vaccination. There are each year in France about nine premature interruptions of pregnancy per 1,000 live births. Specifically within this set of four for 1000 these events occur in utero before any work is more than 3,000 each year, “he said.
Jean Marimbert indicated that there were “many possible causes usually identified: hypertension, infections, malformations, diseases of the cord, abruption …”. In the third ballot pharmacovigilance agency, it is stated that 30% of cases remain unexplained despite extensive investigations.


This case is the only new serious cases listed by the previous bulletin Friday, continuing the analysis for the previous four serious cases whose outcome was “positive”.
The latest newsletter, which includes 200,000 doses of vaccine administered Pandemrix since the start of the season October 20 through Sunday, has identified a total of 107 reports of adverse reactions.
“Almost all are (…) of mild to moderate intensity. Most correspond to the expected effects of the vaccine listed in the summary of product characteristics [SPC] pain and inflammatory reactions at the injection site, fever and headache passengers within 24 to 48 hours, erythema, urticaria localized …”, commented Jean Marimbert.
The health minister, Roselyne Bachelot, said that “to date, adverse events reported [were] consistent and even fewer in all European countries, which was expected”.

No deaths associated with vaccination, some syndromes of Guillain-Barre, according to WHO
Dr Marie-Paule Kieny, Director of the Initiative for Vaccine Research at the World Health Organization (WHO) also expressed reassuring about the safety of vaccines against influenza A (H1N1), Thursday during a press conference.
The specialist said that “a few deaths” were reported worldwide after vaccination. A spokesperson for WHO said later there were 41 in six countries.
But “although investigations are ongoing, the results of those completed and have been provided to WHO have ruled that the pandemic vaccine is the cause of death,” said Dr Kieny.
Regarding the Guillain-Barre less than a dozen suspected cases after vaccination were reported. But “only a few could be related to pandemic vaccine (…) and the patients recovered,” she added.
Generally, “no new safety concerns were identified from reports [Pharmacovigilance] aired today (…). This confirms earlier that the vaccine against pandemic influenza is as safe as the vaccine against seasonal influenza, “she assured, deploring the conspiracy theories about vaccines that were circulating on the internet.
The specialist added that no difference in safety profile were detected between different types of vaccine available.
So far, 16 countries reported having administered a total of 65 million doses of vaccine. But the numbers are probably higher, because campaigns have been launched in 40 countries, said Marie-Paule Kieny.