Shots from Pfizer Inc. and GSK Plc that prevent respiratory syncytial virus received backing from a panel of US public health advisers for use in older adults, paving the way for the preventives to be used in a vulnerable population.
In two separate votes Wednesday, advisers to the Centers for Disease Control and Prevention recommended the shots in people aged 60 and older after consultation with their doctors. CDC Director Rochelle Walensky will decide whether to finalize the recommendations.
The annual cause of an estimated 64 million infections and 160,000 deaths worldwide, RSV is emerging as an attractive market for drugmakers. Yearly sales of RSV shots for older adults could total as much as $10 billion by 2032, according to an analysis in March. Approved by the Food and Drug Administration, the vaccines have been awaiting use recommendations from the CDC.
The shots reduce the risk of contracting RSV, trial data show. Yet some panel members raised concerns, including over pricing that has not been finalized and the possibility of rare side effects. Older people who get the shots should do so “using shared clinical decision-making”, the panel said.
The panel first voted 9-5 for its recommendation for adults 65 and older, then 13-0 with one abstention for adults aged 60-64.
Side Effects
Pfizer shares and GSK’s American depositary receipts were little changed in trading after US markets closed.
Researchers identified neurological disorders in a handful of people who received the vaccines, as well as a slightly higher rate of a heart condition called atrial fibrillation, though trials did not determine what caused the conditions. The companies will monitor people who receive the shot for side effects.
“No intervention is completely safe,” said Michael Melgar, co-leader of a working group that studied the vaccines, noting that other common vaccinations can cause rare side effects.
GSK’s shot was first to win US approval last month, after scientists spent decades searching for an effective RSV vaccine. Called Arexvy, it has been touted by the company as a potential blockbuster that could generate annual sales of $1 billion or more.
Supply Available
The FDA cleared GSK’s shot for people aged 60 and above, and the company is seeking a CDC recommendation for that age group based on results from its trials.
Pfizer gained US regulatory approval for its vaccine, called Abrysvo, in older adults less than a month after GSK. The companies will now go head-to-head to convince doctors and insurers to use their shots.
Pfizer was first to win a nod from an FDA advisory committee for a shot for pregnant mothers to protect their newborns, and it produced positive top-line results from a late-stage study to administer Abrysvo alongside flu vaccines in adults 65 and older. The drug giant is starting clinical trials for its RSV shot in young, healthy children and in high-risk children and adults.
Both Pfizer and GSK have said they expect to have supply available ahead of the next RSV season this fall.
(Updates with panel vote details, vote count and shares from fourth paragraph.)
