PFIZER has started testing its Covid vaccine in babies as young as six months old, the US drugmaker revealed today.
The first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said.
The first participants, a pair of 9-year-old twin girls, were given the jab at Duke University in North Carolina, US, on Wednesday.
The paediatric trial will test kids between six months and 12 years and follows a similar one launched by Moderna Inc last week.
Pfizer and its German partner BioNTech plan to initially test the safety of their two-shot vaccine at three different dosages – 10, 20 and 30 micrograms – in a 144-participant Phase I/II trial.
They then plan to expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the children.
We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option.
In a statement to the AFP news agency, Pfizer said: “Together with our partner BioNTech, we have dosed the first healthy children in a global Phase 1/2/3 continuous study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech Covid-19 vaccine.
“We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option.”
The company is already testing the shots in children aged 12 to 15 in the US, and its US emergency authorisation covers people aged 16 and up.
Moderna is also already testing vaccines in younger kids, while Johnson & Johnson has plans to follow.
In February, Moderna announced that it would be trialling 3,000 12 to 17 year-olds as its Covid-19 vaccine continues to be rolled out across America.
The UK has approved the Moderna jab for use and in the next few months is set to receive around 17million doses of the jab.
As part of the new study, the company said it will do “age de-escalation” which means older participants will get the jab first, as well as “dose escalation”.
This means researchers will start with smaller doses of the vaccine and only work up to normal adult doses once the jabs have proven to be safe.
Meanwhile, Castillo said Pfizer/BionTech hope to have data from their trial in the second half of 2021.