Pfizer has said it will seek emergency authorisation in the US for its Covid-19 vaccine for children under the age of five after interim results from its clinical trial showed the jab is safe and highly effective.
The US drugmaker said on Monday that three doses of its children’s jab — each about a tenth of the size of an adult dose — produced a strong immune response with a favourable safety profile similar to a placebo in the age group.
An authorisation would open up the last large market for the Covid vaccine, potentially paving the way for a longer-term revenue stream if it became part of the childhood immunisation schedule.
The Covid vaccine market has rapidly moved from shortage to glut in 2022 after pharmaceutical companies expanded production and the rollout of jabs in developing countries proved slower than expected. Airfinity, a health analytics company, cut its forecasts for sales of all Covid vaccines this year by 20 per cent to $64.1bn.
But US parents have been among the most vocal about their desire to vaccinate the youngest children. Pfizer said the data would be shared this week with the US Food and Drug Administration, which is expected to consider whether to authorise the first Covid jabs for babies, toddlers and pre-school children next month.
Submissions to other regulatory authorities, including the EU, would follow shortly, said the company.
Pfizer, which developed its Covid vaccine with German partner BioNTech, delayed an application for emergency authorisation for jabs for pre-school children and younger in February over concerns that a two-dose regimen did not produce a strong enough immune response.
Its rival Moderna has already asked regulators in the US and EU to authorise its vaccine for children under six years of age.
Pfizer said 1,678 children had received a third dose of its vaccine in the late-stage clinical trial.
Vaccine efficacy of just over 80 per cent was observed 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 would be shared when it became available, it added.
“These top-line safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorisation,” said Albert Bourla, Pfizer’s chief executive.
The trial was conducted while Omicron was the most prevalent variant of coronavirus, making it hard to compare with the original phase 3 trial for adults.
Ugur Sahin, BioNTech’s chief executive, said the study suggested that the lower dose “provides young children with a high level of protection against the recent Covid-19 strains”.