France to closely monitor side effects of Covid-19 vaccine

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France is about to deploy a national system to monitor possible side effects of Covid-19 vaccines after the start of the first injections in January 2021.
The monitoring system will be rolled out by medical safety agency the National Agency for Medicines and Health Products Safety (ANSM).

He will follow people who have received the vaccine to check the vaccine’s effectiveness – to see if it is actually meeting its goals, which are to reduce the number of cases, hospitalizations and deaths linked to Covid-19.

The system will also be attentive to any possible side effects of the vaccine and “identify any possible side effects that may not have been observed in clinical trials”.

Another objective of the process is to help improve support for people in France for the vaccine as a whole. Polls have shown growing mistrust and reluctance towards the vaccine and vaccination in general in France.

Read more: Covid: Can the French be convinced to get vaccinated?

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Monitoring of side effects

France will consider six vaccinations – pre-ordered by the European Union – which use four different types of vaccine technology, on a vaccination schedule yet to be confirmed.

These vaccines will be evaluated by the Committee for Medicinal Products for Human Use (CHMP) and should then be placed on the market, according to the European Medicines Agency.

The process will then move on to the next step. This will see several hundred thousand people being injected, which will allow authorities to monitor any unwanted side effects seen in previous steps.

The Regional Safety Center of the Toulouse Regional Pharmacovigilance Center reminded the public that “all drugs have side effects”, and vaccines are unlikely to be any different.

However, he said: “Clinical trials are evaluating the benefits but not sufficient or studying the medical risk because they include too few patients, are too short or frequently exclude subjects at risk.

“Follow-up only after marketing [of the vaccine] will allow us to be clear about the side effects and therefore the benefit / risk ratio of the drug.

Data from clinical trials and scientific publications will also be closely scrutinized to establish an “evolving list” of possible side effects to consider.

Side effects in the elderly and those who have suffered from severe forms of Covid-19 will mostly be monitored because clinical trials often do not include them, said Rosemary Dray-Spira, co-director of Epi-flagship, an independent committee working with the ANSM. and Health Insurance.

Dr Dray-Spira said: “Our goal is to be very responsive and not take six months to respond. [to any issues]. »

Epi-flagship will also carry out its own studies on specific groups in order to identify possible problems. The French medical research center Inserm will also carry out its own tests.

France will also look to other countries for information on possible side effects.

Professor Bernard Bégaud, specialist in pharmacology who was chairman of the ANSM clinical trials commission for 14 years, told a news source FranceInfo: “When we start to vaccinate in France, the English will have already vaccinated more than a million people.

“It’s very precious [data] for us, because we will have a perspective of at least a month on mass vaccination. ”

Close monitoring

The vaccines and their effects will be “systematically monitored very closely”, as is the case for all new vaccines, said Dr Annie-Pierre Jonville-Bera, president of the pharmaceutical watch network of the French network of regional centers of pharmacovigilance.

She said: “We will systematically record as much as possible, monitor very closely, so as not to miss anything.”

The ANSM declared that “the form to report [any side-effects] will be adapted so that we can collect all the necessary additional data regarding Covid-19 ”.

The form will be available online through the government’s existing health care side effect site here.

Cathy Gaches, chair of the Immunization Victims Network the Vaccine Accident Victims Network (Revav), said the website is “very tedious” even though “most people don’t even know it”.

Doctors and pharmacists are already required by law to report any side effects suspected of being related to a drug or treatment to the government.

The ANSM assured the public that any side effects would be communicated.

Another platform, SI-Vaccination, will also collect data on vaccine distribution, profile or patients who have had it, as well as other relevant conditions and information.

Dr Jonville-Bera said: “For the vaccines we currently have (eg influenza or hepatitis B) we know that after three months there are no more side effects, even for very rare effects. The goal now, with the new vaccines, is to make sure it’s true [for these too]. »

Data from testing and monitoring will be published weekly by ANSM, with the aim of keeping the data as transparent and in “real time” as possible, and to communicate alerts quickly.

The European Medicines Agency said it would do the same.

What if a side effect is noted?

Vaccination centers will also be assisted in ensuring that they only report actual side effects that may require further investigation.

Dr Jonville-Bera said: “If it says on the medicine box that there might be a localized skin reaction or some redness around the injection site, it is not necessary to point out that [as a side-effect] unless it is particularly prevalent or has additional complications, for example.

The ANSM declared: “If a security alert is validated, measures adapted to the nature of the risk will be put in place. These will aim to reduce the likelihood of additional risk among those vaccinated. ”

In the UK, for example, an additional warning was issued after two people had an allergic reaction to the Pfizer / BioNTech vaccine.

But Professor Bégaud sought to reassure the public that the assessment process was standard procedure and was not of concern.

He said: “It is perfectly normal to watch the data in real time. We don’t know what’s going to happen, but it’s normal. Pharmacovigilance is an open system that is used to surprises. We know how to deal with it.

“We are going to have several million people who will be vaccinated in the early stages. This is not huge compared to what we are used to studying in pharmacovigilance.

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