On Wednesday, Pfizer spokesperson Sharon Castillo confirmed that the company along with its German partner, BioNTech SE already began testing their coronavirus vaccine in children.
Castillo said the first volunteers in the early-stage trial were given their first dose of injections.
In December last year, the U.S. Food and Drug Administration (FDA) authorized the vaccine for people who are 16 years old and above.
Pfizer hopes they will be able to expand vaccination to that age range by early 2022, Castillo said.
The pediatric vaccine trial also includes children as young as six months old.
The safety of Pfizer’s two-shot vaccine is available at three different dosages – 10, 20, and 30 mg — in a 144-participant trial.
According to clinicaltrials.gov, the researchers plan to expand to a 4,500-participant late-stage trial wherein children will be split into three groups. Ages six months to two years, ages two to five years, and ages five to 12.
In each group, half will receive the two doses 21 days apart and for the other half, a placebo will be given.
Moreover, the research team will test the safety, tolerability, and immune response from the vaccine by measuring antibody levels in children.
If the trial is successful, and if the vaccine is proven to be safe and effective, the test will be unblinded at the six-month follow-up. This means that those who received the placebo will be offered the vaccine.
Castillo added that the companies are hoping to have data from the trial in the second half of 2021.
The children are the last group to be tested during clinical trials because they are not little adults.
Children’s bodies and immune systems behave differently and might have different needed treatments.
The young age bracket may also need different doses and needle sizes depending on their height, weight, and age. Because of this, the group is only given the doses after proven effective in the adult population.
At the time of this writing, 85.4 million Americans or around 25.7% of the population have received at least one dose while 46.3 million or 14% are fully immunized.