Pfizer, BioNTech begin Covid vaccine trial in children under 122 min read . Updated: 26 Mar 2021, 05:30 AM IST
- The first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said
American pharmaceutical Pfizer and its German partner BioNTech SE had begun clinical trials for its coronavirus vaccine in children under 12, an early sign of the next stage of the global immunisation campaign.
"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," the company said in a statement to news agency AFP.
"We are proud to start this much-needed study for children and families eagerly awaiting a possible vaccine option," the US drugmaker added.
According to details posted on the site clinicaltrials.gov, the company is testing three different dosing levels - 10, 20 and 30 micrograms - in a 144-participant Phase I/II trial for use in this age group, with hopes of expanding vaccination to that age range by early 2022.
They plan to later 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 young subjects.
The first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said.
The company is already testing the shots in children aged 12 to 15, and its US emergency authorisation covers people aged 16 and up.
Pfizer joins Moderna and AstraZeneca in testing their vaccines in children as young as 6 months, while Johnson & Johnson has plans to follow.
Only the Pfizer-BioNTech vaccine is being used in 16- and 17-year-olds in the United States. Moderna's shot was cleared for those age 18 and older, and no coronavirus vaccine has been authorised in younger kids yet.
While children are generally spared the worst of the disease and are less likely than adults to transmit the virus, rare cases of serious Covid and deaths do occur, as well as a post-infectious inflammatory condition called MIS-C.
Under-18s account for roughly a fifth of the US population of 330 million, and most experts believe it will be necessary to make inroads towards immunising children, in order to achieve population-level immunity.
The Pfizer-BioNTech Covid-19 vaccine was authorised by US regulators in late December for people age 16 and older. Around 66 million doses of the vaccine had been administered in the United States as of Wednesday morning, as per the data from the US Centers for Disease Control and Prevention.
Never miss a story! Stay connected and informed with Mint. Download our App Now!!