EU Drug Regulator approves Pfizer COVID-19 vaccine for children ages 5 to 11

CDC on November 2, 2021, officially approved Pfizer’s vaccine doses for children aged 5 to 11 years old. Know when will Pfizer COVID vaccine for kids under 12 years be available, trial highlights, and side effects.

Pfizer COVID-19 vaccine for children ages 5 to 11, Source: Reuters
Pfizer COVID-19 vaccine for children ages 5 to 11, Source: Reuters

The European Medicines Agency (EMA) on November 25, 2021, authorized the Pfizer-BioNTech COVID-19 vaccine Comirnaty for use in children aged 5 to 11 years old. For the first time, the EMA cleared a COVID-19 vaccine for young children in this age group. The vaccine is authorized for use in people aged 12 and above across 27-nation European Union. The EU’s drug regulator EMA is also evaluating the use of the Moderna COVID-19 vaccine for children ages 6 to 11 years old. The decision is expected to come within two months. Earlier this week, the Health Minister of Germany Jens Spahn said the shipping of COVID-19 vaccines for young children in the European Union would begin on December 20, 2021.

The US Centers for Disease Control (CDC) on November 2, 2021, officially approved Pfizer’s vaccine for children aged 5 to 11 years old in the US. The CDC encouraged health providers to begin vaccination of approximately 28 million children in age group 5 to 11 years. On October 30, 2021, the US Food and Drug Administration (FDA) had authorized the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years old. Pfizer COVID-19 vaccine for children, developed along with BioNTech, is the first COVID-19 vaccine for young children under 12 years of age in the US. 

Also read: COVID-19 vaccine works in children ages 5 to 11 years old: Pfizer

CDC approves COVID-19 vaccine for kids under 12 years – Significance

"During a 6-week period in late June to mid-August, COVID-19 hospitalizations among children and adolescents increased fivefold," the CDC's statement reads. Though children are less susceptible to developing severe coronavirus infection, but a small portion of them do.

Approximately 2,316 children in age group 5 to 11 years old have been reported to be suffering from the multisystem inflammatory syndrome in children or MIS-C which is a rare but serious COVID-related complication, as per CDC.

Additionally, the age group between 5 to 11 years has reported about 1.9 million COVID-19, at least 8,300 hospitalizations, and 94 deaths. Therefore, vaccination of 1 million children of this age group will help in preventing 58,000 COVID infections, 77 Intensive Care Unit (ICU) stays, 241 hospitalizations, and 1 death, as projected in a model by FDA.

When will Pfizer COVID vaccine for kids under 12 years be available?

From November 8, 2021 onwards, the 5 to 11 years age group kids vaccination program will be fully up and running, informed the White House coronavirus response team. Parents will be able to schedule appointments at convenient sites to get their kids vaccinated.

The White House further informed that 15 million doses of Pfizer COVID vaccine for kids will be moved to distribution centers. Pediatricians and pharmacists will receive the prescribed one-third of the full dose along with smaller needles to vaccinate kids.

Also Read: EU approves Pfizer-BioNTech COVID-19 booster dose, know details

Pfizer COVID-19 vaccine for kids aged 5-11 years  – Trials Highlights, Side Effects

Similar to the adult vaccine trials, Pfizer's COVID vaccination trial in kids was nearly 91 percent effective in preventing COVID-19 among children aged 5-11 years.

The clinical trials found that the Pfizer vaccine developed along with BioNTech was well tolerated in children aged 5 to 11 years old.  Children are experiencing fewer side effects overall. While monitoring for two rare heart inflammation conditions namely pericarditis and myocarditis, regulators found no cases of these during the trials of the Pfizer vaccine for kids.

The most common side effects were mild and comparable to those seen in the Pfizer vaccine trial of teenagers and adults aged 16 to 25. Common side effects include injection site pain (sore arm), muscle and/or joint pain, nausea and decreased appetite, fatigue, redness and swelling, swollen lymph nodes, headache, chills, fever.

Also read: US government approves Pfizer’s COVID-19 vaccine for children in 12-15 age group

Also read: ZyCoV-D: Zydus Cadila to begin vaccine trials for children aged 3-12 years

Also read: COVID-19 vaccine for children: Johnson & Johnson seeks approval for vaccine trials for 12-17 group in India

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