Pfizer said it would seek emergency authorization in the United States for its Covid-19 vaccine for children under five after interim results from its clinical trial showed the vaccine to be safe and highly effective.
The US drugmaker said on Monday that three doses of its children’s jab – each about a tenth the size of an adult dose – produced a strong immune response with a favorable safety profile similar to a placebo in the group of ‘age.
Clearance would open up the last big market for the Covid vaccine, potentially paving the way for a longer-term revenue stream if it became part of the childhood immunization schedule.
The Covid vaccine market has rapidly moved from scarcity to glut in 2022 after pharmaceutical companies ramped up production and the rollout of shots in developing countries proved slower than expected. Airfinity, a health analytics company, cut its sales forecast for all Covid vaccines this year by 20% to $64.1 billion.
But American parents have been among those most vocal in their desire to have younger children vaccinated. Pfizer said the data would be shared this week with the US Food and Drug Administration, which is expected to consider whether to authorize the first Covid vaccines for babies, toddlers and preschoolers on next month.
Submissions to other regulators, including the EU, would follow shortly, the company said.
Final phase trial
Pfizer rival Moderna has already petitioned US and European regulators to authorize its vaccine for children under six.
Pfizer said 1,678 children received a third dose of its vaccine in the late-stage clinical trial.
Vaccine efficacy of just over 80% was seen in a descriptive analysis, which was based on 10 symptomatic Covid cases identified seven days after a third was administered, according to Pfizer. Final efficacy data will be shared as soon as it becomes available, he added.
“These leading safety, immunogenicity and efficacy data are encouraging, and we look forward to completing our submissions to regulators around the world soon in hopes of making this vaccine available to young children as quickly as possible. , subject to regulatory clearance,” Albert said. Bourla, CEO of Pfizer.
The trial was conducted when Omicron was the most prevalent variant of the coronavirus, making comparison with the original phase 3 trial for adults difficult.
Ugur Sahin, chief executive of BioNTech, said the study suggested the lower dose “provides young children with a high level of protection against recent strains of Covid-19”. – Copyright The Financial Times Limited 2022