Pfizer’s Vaccine Is Recommended By European Regulator For Children Aged 12 To 15

BERLIN — The European Medicines Agency proposed on Friday that the use of Pfizer’s Vaccine be expanded to children aged 12 to 15, a move that will give younger and less at-risk groups across Europe access to a COVID-19 shot for the first time.

The Pfizer-BioNTech vaccine was the first to be approved across the European Union in December when it was approved for use in anyone aged 16 and up. Since then, the EU has administered over 173 million doses, accounting for around three-quarters of all vaccination shots provided in the 27-nation bloc.

“Extending the protection of a safe and efficient vaccination to this younger demographic is a significant step forward in the fight against this pandemic,” said Marco Cavaleri, the EMA’s head of health threats and vaccination strategy.

After receiving data from the United States demonstrating that the vaccine is very effective against illness, the EU authorities approved it for use in younger adolescents. According to Cavaleri, none of the 2,000 teenagers who received the vaccine acquired COVID-19, compared to 16 in a control group who received a placebo.

“The vaccine was well-tolerated, and the adverse effects in this age range were quite similar (to) what we’ve observed in young adults, so there’s no need to be concerned,” he added.

The European Commission must approve the EMA decision, and national authorities must decide whether the vaccine will be administered to children under the age of 16 in their respective countries.

The proposal comes after similar decisions by authorities in Canada and the United States last month, as developed countries work to meet adult vaccination objectives and immunize as many people as possible.

For additional two years, researchers will assess the long-term protection and safety of the Pfizer-BioNTech vaccination in study participants. Cavaleri recognized that uncommon side effects may have gone unnoticed in the tiny study that led to the permission.

“Once the vaccine is deployed, it will be critical to continue monitoring its performance and determining if there are any safety concerns,” he said, adding that previous months have proved that Europe’s reporting system is capable of detecting any vaccination problems.

After several nations reported a very tiny percentage of the millions vaccinated having experienced uncommon blood clots, the EMA last month added warnings about the possible risk of rare blood clots in patients who had received a dose of vaccines produced by AstraZeneca or Johnson & Johnson.

The majority of COVID-19 vaccines have been approved for adults around the world, who are at a higher risk of serious sickness and death from the coronavirus. However, vaccinating children of all ages may be crucial to preventing outbreaks, since some evidence suggests that older children may play a role in spreading the virus while not becoming critically ill from COVID-19.

According to the American Academy of Pediatrics, children account for around 14% of all coronavirus cases in the United States, with at least 316 deaths. Doctors have also discovered a unique inflammatory disease in a tiny percentage of COVID-19-infected children.

Immunizing children against COVID-19 may also offer authorities greater confidence in reopening schools, as convincing children to wear masks and engage in the social distance has proven difficult in the past.

The World Health Organization, on the other hand, has chastised rich countries for vaccinating their younger and less vulnerable populations, arguing that the extremely limited number of COVID-19 vaccines should instead be shared with poor countries so that they can protect their health workers and the most vulnerable.

“I understand why some countries want to vaccinate their children and adolescents, but for the time being, I urge them to reconsider and instead donate vaccines to COVAX,” WHO Director-General Tedros Adhanom Ghebreyesus said earlier this month, referring to a United Nations-backed initiative to distribute vaccines fairly. Fewer than 2% of the more than 1 billion COVID-19 doses given around the world have gone to underprivileged countries.

Other vaccine companies are looking into whether their vaccines are safe and effective in youngsters. Moderna Inc. announced earlier this week that its injection protects children as young as 12 years old and that it will file an emergency use authorization request to the US Food and Drug Administration next month. Another American business, Novavax, is working on a COVID-19 vaccine and has just started a study in 12- to 17-year-olds.

Both Moderna and Pfizer-BioNTech have been testing their vaccinations on children aged 6 months to 11 years old; the dose given to them is lower than that given to teenagers and adults. Sinovac, a Chinese company, has also submitted preliminary data to the country’s regulators in the hopes of demonstrating that its vaccine is safe in youngsters as young as three years old.