Covid: vaccinating 12-15 y.o. with Pfizer allowed in Europe

Published by Manon de Sortiraparis, Laurent de Sortiraparis, Cécile de Sortiraparis · Published on May 29th, 2021 at 10:24 a.m.
Following consultation, this Friday May 28, the European Medicines Agency has approved vaccinating teenagers from 12 years old with Pfizer. As for France, the country is still waiting for the report from the Haute Autorité de Santé likely to be handed over "next week".

Pfizer Covid vaccine does work against the virus, and especially in the youngest... According to results from a stage 3 clinical trial in 2,260 teenagers in the United States, results issued ahead of a release, the vaccine developed by the American drugmaker and their German partner, BioNTech, has "demonstrated 100% efficacy and robust antibody responses" in 12-15 y.o. Good news for this age range that was so far not involved in vaccination, and yet suffered from the epidemic, very violently, variants infecting more than the "classic" strain of the virus.

These encouraging results encouraged laboratories to seek approval for issuing vaccine to immunize teens between 12 and 15 years of age. This May 28, the European Medicines Agency approved. "EMA’s human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine to include use in children aged 12 to 15", the European regulator stated.

The U.S. and Canada have been already using the Pfizer vaccine to protect teens from 12, and Germany announced teens can make an appointment to get vaccinated from June 7. France is still waiting for the approval from the Haute Autorité de Santé likely to be given "next week". Will be taken into account: Pfizer vaccine safety and effectiveness on this age group, and of course the availability of doses and the vaccinal stratregy.

Moderna is to soon seek approval from the European Health bordies so their vaccine can be used to vaccinated the youngest population.

The effectiveness has been reassessed this past Feburary in adults... According to Israel's main healthcare provider Clalit, the vaccine is even 94% effective, according to results from a study they conducted in one million Israelis vaccinated since the campaign started. A study that consisted in tests performed by searchers in 600,000 people given the two doses on one hand, and an equivalent number of people not vaccinated on the other hand.

"There was a 94 per cent decrease in the rate of symptomatic infection and a 92 per cent decrease in the rate of serious illness in those vaccinated, compared to 600,000 [volunteers] who were not vaccinated" the provider explains in a release. They go on: "vaccine efficacy was found to be maintained in all age groups, including those over 70".

Encouraging results

A study which results are similar to those released several weeks ago by Pfizer laboratory. This past November 9, Pfizer and BioNTech announced their vaccine is “90% effective, according to preliminary results from phase 3, naming the last phase before applying for approval.

This “vaccine effectiveness” has been assessed by comparing the number of participants infected with the novel coronavirus in the group that has been given the vaccine and the one with a placebo, “seven days after the second dose” and 28 days following the first one, Pfizer and BioNTech explained in their release.

A few days later, on Wednesday November 18, both laboratories have announced their vaccine was ultimately 95% effective as shown by the full results of the 3rd phase of the clinical trial. The release also unveils two major data, that were still hazy when the preliminary results were shared this past November 9: on one side, the double injection is said not to have noticeable side effects on the length studied, and on the other side, the vaccine is said to be effective on all genders and age ranges.

Ongoing clinical trials

For the record, the vaccine has been developed “with the mRNA technology of BioNTech in mainland China, Hong Kong, Macao, and Taiwan”. This vaccine is one of the candidate vaccines currently being tested – or soon to be – in humans, like the one developed by Moderna Therapeutics or AstraZeneca’s, that was first expected to be available in September, but more likely to be ready for December 2020 according to the CEO.

Please also note clinical trials have been launched in a younger age group, still in the U.S. on a first group between 5 and 11 years of age. Another and younger group - between 2 and 5 - likely to be also given a dose of vaccine by early April, as part of this clinical trial.

Pfizer vaccine's third clinical trial stage is said to take two more years at least, in order to study the long-term basis of the treatment and potential long-term-based side effects. But it does not prevent marketing before the end of the study. Therefore, both companies hope to produce 50 million doses by the end of 2020 and 1.3 billion doses for late 2021.

Practical information