Covid-19: Pfizer-bioNTech announces that its vaccine is “safe” for 5-11 year olds

Is the vaccination of 5-11 year olds against Covid-19 coming soon? In any case, this possibility has taken a big step forward, with the announcement of Pfizer-bioNTech. The group has just published the results of a study that is optimistic for vaccinating young children, from 5 years old. In their press release, the pharmaceutical giants announce that the vaccine is considered “safe” and “well tolerated” by 5 to 11 year olds. The study also underlines that a dosage adapted to the morphology of this age group makes it possible to obtain an immune response qualified as “robust”, and “comparable” to the results observed in 16-25 year olds. This study was carried out 4 children between 500 months and 6 years old in the United States, Finland, Poland and Spain. It will be submitted to health authorities “as soon as possible,” according to Pfizer-bioNtech.

Advances for 2-5 year olds

Pfizer-bioNTech does not intend to stop there. The group should indeed publish “From the fourth quarter »Results for the 2-5 years age group, as well as 6 months-2 years, who received two injections of 3 micrograms. On the side of its competitor Moderna, a study on children under 12 is currently underway.

Covid-19: update on vaccination of children and adolescents

The anti-Covid-19 vaccine campaign is expanding. As we know, adolescents aged 12 to 17 can already benefit from the vaccine. What do we know about the safety of the vaccine for the youngest? Where are the research and recommendations? Where are the research and recommendations? We take stock.

Vaccination of 12-17 year olds against Covid-19: here is the parental authorization to download

Vaccination of adolescents aged 12 to 17 against Covid-19 began on Tuesday, June 15 in France. The authorization of both parents is required, as well as the presence of at least one parent. Oral consent from the adolescent is required. 

Which vaccine for adolescents?

Since June 15, 2021, adolescents aged 12 to 17 can be vaccinated against Covid-19. The only vaccine authorized to date in this age group, the vaccine from Pfizer / BioNTech. The Moderna vaccine is awaiting authorization from the European Medicines Agency.

Details from the Ministry of Health: « Access to vaccination is extended to all children aged 12 to 17 inclusive from June 15, 2021, with the exception of adolescents who have developed pediatric multisystem inflammatory syndrome (PIMS) following an infection. by SARS-CoV-2, for which vaccination is not recommended ».

Parental authorization essential

On its website, the Ministry of Health and Solidarity indicates that a permission from both parents is obligatory. The presence ofat least one parent is essential during vaccination.

However, the Ministry of Health states that “In the presence of only one parent at the time of vaccination, the latter undertakes on the honor that the parent with parental authority has given his authorization. “

As for the adolescent, he must give his oral consent, “Free and enlightened”, specifies the ministry.

Download parental authorization for the vaccination of adolescents from 12 to 17 years old

You can download theparental permission here. You will then need to print it out, fill it out and bring it to the consultation appointment.

COVID-19: vaccination of adolescents, a decision too fast according to the Ethics Committee

Last April, the Ministry of Health wished to obtain the opinion of the Ethics Committee on the question of opening up vaccination against COVID-19 to 12-18 year-olds from June 15. In its opinion, the organization regrets that the decision was taken so quickly: it mentions consequences that are limited from a health point of view, but important from an ethical point of view.

Less than a year after the start of the COVID-19 pandemic, the marketing of vaccines has changed the game by adding barrier measures to a major additional preventive tool. Some countries have even allowed vaccination for those under 18, like Canada, the United States and Italy. France is also on this path since young people aged 12 to 18 will be able to be vaccinated from June 15, announced Emmanuel Macron during his trip to Saint-Cirq-Lapopie. If this vaccination is done on a voluntary basis, with the parents’ agreement, was the green light given too early, in a rush? These are the reservations of the National Ethics Committee (CCNE).

The organization questions the speed of this decision, in a context of the decline of the epidemic. “Is there an absolute urgency to start vaccination now, when several indicators are green and the start of the September school year could mark the start of the campaign? He wrote in a press release. In its opinion, CCNE recalls that according to scientific data, serious forms of COVID-19 infection are very rare for those under 18 : the individual benefit derived from vaccination is therefore limited for the “physical” health of young people. But the objective of this measure is also to achieve collective immunity within the general population.

A useful measure for collective immunity?

In this area, experts concede “that it is unlikely that this objective can be achieved through vaccination of adults alone.” The reason is simple: studies estimate than collective immunity would only be reached if 85% of the whole population were immunized, either by the vaccine or by previous infection. Added to this is the fact that the ability of children to become infected and transmit the virus exists and increases with age, even showing itself to be close in adolescents to what is observed in young adults. For 12-18 year olds, vaccination can only be done with the Pfizer vaccine, currently the only approved in Europe for this population.

The committee is confident about the safety data of the vaccine, which with a few months’ hindsight, “make it possible vaccination for 12-17 year olds. “And this, even if” below this age, no data is available. “His reluctance is more of an ethical nature:” Is it ethical to make minors bear the responsibility, in terms of collective benefit, for refusing vaccination (or the difficulty of accessing it) for part of the vaccination? adult population? Isn’t there a sort of incentive for vaccination to regain freedom and return to normal life? He asks himself. There is also the question of a ” stigma for teens who would not wish to use it. “

Finally, another risk mentioned is that of “breaking their confidence if the return to normal life was compromised by the arrival of new variants », While the presence of the Indian variant (Delta) in France is gaining ground. While the Committee does not agree with this decision, and insists on respecting the consent of adolescents, it recommends that other measures be put in place in parallel. The first being a pharmacovigilance follow-up over the medium and long term in vaccinated adolescents. According to him, it is also necessary to optimize the famous strategy “Test, trace, isolate” in minors so that “it may be considered as an alternative strategy to vaccination.” », He concludes.

Vaccination of teens against Covid-19: the answers to our questions

Emmanuel Macron announced on June 2 the opening of the vaccination against the Sars-CoV-2 coronavirus to young people from 12 to 17 years old. Therefore, many questions arise, especially about the type of vaccine, possible side effects, but also parental consent or timing. Point.

Anti-Covid-19 vaccination possible from June 15, 2021

In a speech dated June 2, the President of the Republic announced the opening of vaccination for 12-18 year olds from June 15, “ under organizational conditions, sanitary conditions, parental consent and good information for families, ethical, which will be specified in the coming days by the health authorities and the competent authorities. »

The HAS rather in favor of a stepwise vaccination

It turns out that the President anticipated the opinion of the High Authority of Health, published on Thursday, June 3 in the morning.

If she admits that there is indeed “direct individual benefit”And indirect, and a collective benefit to the vaccination of adolescents, it however recommends proceeding step by step, by opening it as a priority to 12-15 year olds with a co-morbid condition or belonging to the entourage of an immunocompromised or vulnerable person. Secondly, she recommends extending it to all adolescents, “ as soon as the vaccination campaign for the adult population is sufficiently advanced.

Obviously, the President of the Republic preferred not to stagger, and announced that the vaccination of 12-18 year olds will be open to all, unconditionally.

Pfizer, Moderna, J & J: what will be the vaccine given to teens?

On Friday, May 28, the European Medicines Agency (EMA) gave the green light to administer the Pfizer / BioNTech vaccine to young people aged 12 to 15. For young people aged 16 and over, this mRNA vaccine has been authorized (under conditions) since December 2020.

At this stage, it is therefore the Pfizer / BioNTech vaccine that will be administered to adolescents as of June 15. But it is not excluded that Moderna’s vaccine in turn receives authorization from the European Medicines Agency.

Anti-Covid vaccine for adolescents: what are the benefits? 

The Pfizer / BioNTech clinical trial was conducted on 2 adolescents who have never contracted Covid-000. Of the 19 participants who received the vaccine, none subsequently contracted the virus, while 1 of the 005 teens who received a placebo tested positive sometime after the study. ” Which means that, in this study, the vaccine was 100% effective. Enthuses the European Medicines Agency. However, the sample remains quite small.

For its part, the High Authority for Health reports a “robust humoral response”, (Ie adaptive immunity by production of antibodies) induced by 2 doses of Comirnaty vaccine (Pfizer / BioNTech) in subjects aged 12 to 15 years, with or without a history of infection by SARS-CoV-2. She adds that “100% vaccine efficacy on symptomatic Covid-19 cases confirmed by PCR from the 7th day after the end of the vaccination“.

Anti-Covid vaccines: Moderna is 96% effective in 12-17 year olds, study finds

The first results of a clinical trial conducted specifically in a teenage population show that Moderna’s COVID-19 vaccine is 96% effective in 12-17 year olds. The pharmaceutical company hopes to receive official authorization soon, as does Pfizer.

Pfizer is not the only company whose the anti-Covid-19 vaccines would be likely to be used in the youngest. Moderna has announced that its COVID-19 vaccine, also based on messenger RNA, was 96% effective in young people aged 12 to 17, according to the results of its clinical trial called “TeenCOVE”. During this one, two-thirds of the 3 participants in the United States received the vaccine, and one-third a placebo. “The study showed a vaccine efficacy of 96%, generally well tolerated with no serious safety concerns identified to date. She said. For these intermediate results, participants were followed for an average of 35 days after the second injection.

The pharmaceutical company clarified that all side effects were “ mild or moderate “, most of the time pain at the injection site. After the second injection, side effects included ” headache, fatigue, myalgia and chills , Similar to those seen in adults who had received the vaccine. Based on these results, Moderna indicated that it was currently “ in discussion with regulators about a possible amendment to its regulatory filings To authorize the vaccine for this age group. The vaccin mRNA-1273 is currently only certified for people aged 18 and over in countries where it has already been approved.

Pfizer and Moderna in the race to vaccinate children

Its press release specifies, however, ” that since the incidence rate of COVID-19 is lower in adolescents, the case definition is less strict than for COVE (study in adults), which results in an efficacy of the vaccine against a milder disease. The announcement comes as the Food and Drug Administration is set to announce whether it will grant emergency use authorization for the Pfizer-BioNTech vaccine for adolescents 12 to 15 years old, while Canada has become the first country to have given its authorization for this age group. 

This is also the case for Moderna which, for its part, launched in March a phase 2 clinical study in children aged 6 months to 11 years (KidCOVE study). If the vaccination of adolescents is becoming a subject more and more discussed, it is because it represents the next step in vaccination campaigns, necessary according to scientists to manage, in the long term, to contain the coronavirus epidemic. At the same time, the American biotech unveiled encouraging results with regard to potential “boosters”, a possible third injection. It would be a formula developed specifically against the Brazilian and South African variants, or a simple third dose of the initial vaccine.

Where will the adolescent vaccination take place?

Vaccination for 12-18 year olds will take place from June 15 in vaccination centers and other vaccinodromes implemented since the start of the vaccination campaign. This was confirmed by the Minister of Health at the microphone of LCI.

As for the vaccination schedule, it will be a priori the same as for adults, i.e. 4 to 6 weeks between the two doses, a period which may be extended to 7 or even 8 weeks during the summer, to give more flexibility to holidaymakers.

Vaccination for 12-17 year olds: what side effects are to be expected?

At a press conference, Marco Cavaleri, head of vaccine strategy at the European Medicines Agency, said the immune response of adolescents was comparable to that of young adults, or even better. He assured that the vaccine was “well tolerated”By adolescents, and that there was“no major concerns”As to possible side effects. However, the specialist acknowledged that “the sample size does not allow detection of possible rare side effects“.

Note that the Pfizer / BioNTech vaccine has been administered to adolescents for several weeks already in Canada and the United States, which provides more pharmacovigilance data. The American authorities have notably announced rare cases of “mild” heart problems (myocarditis: inflammation of the myocardium, heart muscle). But the number of cases of myocarditis, which would appear rather after the second dose and rather in men, would not, for the moment, exceed the frequency of occurrence of this affection in normal times in this age group.

For its part, the High Authority for Health reports “ satisfactory tolerance data Obtained in 2 adolescents aged 260 to 12 years, followed over a median of 15 months in the clinical trial of Pfizer / BioNTech. “ Most of the adverse events reported consisted of local events (pain at the injection site) or general symptoms (fatigue, headache, chills, muscle pain, fever) and were generally mild to moderate».

Vaccination for 12-17 year olds: what form for parental consent?

Since they are still minors, young people from 12 to 17 years old can be vaccinated provided they have parental authorization from one parent. From the age of 16, they can also be vaccinated without their parents’ consent.

Note that there are a few rare cases in France for which a minor can obtain medical treatment without the consent of one or both parents (contraception and in particular the morning-after pill, voluntary termination of pregnancy).

What does the law on parental consent say about vaccines?

Regarding compulsory vaccines, 11 in number, the situation is different.

At the legal level, it is generally considered that along with ordinary childhood illnesses and care for minor injuries, compulsory vaccines are part of the usual medical procedures, from everyday life. They oppose unusual acts (prolonged hospitalization, general anesthesia, long-term treatments or with many side effects, etc.).

For usual medical procedures, the consent of one of the two parents is sufficient, while the agreement of both parents is necessary for unusual acts. A priori vaccination against Covid-19 will therefore fall within this category of non-usual act, since it is not compulsory.

Covid-19: will the vaccination of 12-17 year olds be compulsory?

At this stage, as for older French people, vaccination against Sars-CoV-2 remains on a voluntary basis and will not be compulsory, assured the Minister of Solidarity and Health.

Why vaccinate adolescents since they are less at risk of severe forms?

Admittedly, young adolescents are at low risk of contracting serious forms of Covid-19. However, by becoming contaminated, they can infect others, including the most vulnerable (grandparents in particular).

Therefore, the idea behind the vaccination of adolescents is that ofachieve collective immunity faster of the French population, but also ofat the start of the 2021 school year, avoid class closures in middle and high schools. Because even if infection by Sars-CoV-2 is often only slightly symptomatic in young people, it generates a heavy and restrictive health protocol in schools.

Will vaccination be open to children under 12?

At this stage, vaccination against Sars-CoV-2 is not open to children under 12 whoever they are. If this is not yet on the agenda, it is not excluded that the situation may evolve in favor of vaccination of under 12s, if the studies on this subject are conclusive and if the health authorities judge the favorable benefit / risk ratio.