Moderna is in talks with U.S. regulators to expand the size of an ongoing trial testing its COVID-19 vaccines in children aged between five and 11, the drugmaker said on Monday.
The objective of the discussion with the U.S. Food and Drug Administration is to enroll a larger safety database, which increases the likelihood of detecting rarer events, the company said.
Moderna expects to have a package that supports authorization in winter of 2021 or early 2022, a company spokesperson told Reuters.
Earlier in the day, the New York Times reported the U.S. regulators have asked Pfizer Inc-BioNTech and Moderna to expand the size of the trial.
They claimed the strength of the studies was inadequate to detect the rare side effects, including myocarditis, an inflammation of the heart muscle and pericarditis, an inflammation of the lining around the heart, the report said.
Pfizer said it has not provided any updates to its previously stated timelines. It had previously said it expects to have data for children aged between 5 and 11 in September.
The health regulator has asked the companies to include 3,000 children in their trials, almost double the original number of study participants, the NYT report said, citing people familiar with the matter.
FDA did not immediately respond to Reuters request for comment.
Protections for long-haulers
Meanwhile, President Joe Biden said Monday the White House is pushing for people with long-term symptoms of COVID-19 to be protected against discrimination, as he marked the anniversary of a landmark law for people with disabilities.
U.S. agencies will coordinate to ensure people suffering from severe long-term health problems are protected after the end of their infections with the novel coronavirus, he said.
“Many Americans who seemingly recovered from the virus still face lingering challenges like breathing problems, brain fog, chronic pain or fatigue,” Biden said. “These conditions can sometimes rise to the level of a disability.”
Around one in 10 COVID-19 patients are still unwell 12 weeks after their acute infection, and many suffer symptoms for far longer, according to a World Health Organization-led report published in February.
Biden spoke at a Rose Garden event celebrating the 31st anniversary of the enactment of the Americans with Disabilities Act, which makes it illegal to discriminate against people with disabilities in public accommodation, employment, transportation and community living. Nearly 57 million Americans had some form of disability in 2010, the U.S. Census bureau reported.
The new effort will be aimed at making sure people with those long-term COVID-19 symptoms “have access to the rights and resources that are due under the disability law,” Biden said.