Pfizer has become the first western pharma firm to begin pediatric testing of its coronavirus vaccine, getting the nod from the FDA to expand its phase III trials to some 48,400 participants, among them kids as young as 12.
The multinational drug giant said it received federal approval to launch pediatric trials in an update on Monday, explaining that testing on younger volunteers will help researchers “to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds.” Now in its final phase, the trial will also add 4,400 new participants to the original 44,000 enrolled, Business Insider reported, citing a company spokesperson.
The expanded testing comes as Pfizer and a number of other drugmakers race to complete phase III trials and seek emergency FDA approval for their inoculations, with Pfizer currently the frontrunner and the first to begin testing for children. The company says it expects to have data on its vaccine’s effectiveness by the end of October.
Vaccine trials are typically carried out gradually, beginning with healthy adult volunteers and, as data accumulates, moving into age groups with different levels of vulnerability. While pediatric trials are a necessary stage before a vaccine can be rolled out for general use, researchers working on a jab for the novel coronavirus have focused more on older populations who are especially susceptible to the illness.
Moderna, one of other other leading drugmakers developing a coronavirus inoculation, says it plans to begin pediatric testing by the end of 2020, while Johnson & Johnson will open studies for children “later in the year,” after safety is established for adults.
Under new federal guidelines issued last week, vaccine manufacturers are encouraged to monitor trial participants for at least two months after their last immunization to detect any possible adverse effects, as well as whether they retain a strong immune response. Though Pfizer currently leads the pack among four other vaccine-makers in phase III trials, the new rules mean that emergency FDA approval won’t come until sometime in December at the earliest, likely frustrating hopes from President Donald Trump that an immunization will be ready by election day.
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