A panel of US public advisors has approved the use of respiratory syncytial viruses shots from Pfizer Inc., and GSK Plc in older adults. This will allow the vaccines to be used by a vulnerable group.
After consulting with their doctors, the Centers for Disease Control and Prevention (CDC) recommended that people 60 and older get the shot in two separate votes on Wednesday. CDC Director Rochelle Walensky will determine whether the recommendations are finalized.
RSV, which is responsible for approximately 64 million infections and 160 000 deaths annually in the world, is a growing market for pharmaceutical companies. According to an analysis published in March, the annual sales of RSV vaccines for older adults may reach $10 billion by 2032. The vaccines were approved by the Food and Drug Administration and are awaiting recommendations from the CDC.
Trial data shows that the shots reduce RSV risk. Nevertheless, some members of the panel expressed concerns about pricing which hasn’t been finalized as well as possible rare side effects. The panel suggested that older people should get the shot “using shared clinical decisions”.
The panel voted first 9-5 in favor of its recommendation for adults older than 65, and then 13-0 plus one abstention with adults 60-64.
After the US markets closed, Pfizer’s shares and GSK’s American Depositary Receipts traded little differently.
Researchers found neurological disorders among a few people who received vaccines. They also observed a slight increase in the rate of atrial fibrillation. However, the trials could not pinpoint the cause of the conditions. The companies will monitor the side effects of those who received the shot.
Michael Melgar said that “no intervention is 100% safe”, and that some common vaccines can have rare side effects.
GSK’s shot won the first US approval in last month after scientistsspent a decade searching for an RSV vaccine. Arexvy is a vaccine that the company has hailed as a blockbuster product with potential sales of up to $1 billion per year.
GSK is now seeking a CDC approval for its shot for those aged 60+ based on the results of their trials.
Pfizer received US regulatory approval less than one month after GSK for its Abrysvo vaccine in older adults. Both companies are now competing to convince insurers and doctors to use their vaccines.
Pfizer won the first FDA advisory committee approval for a shot to protect newborns from mothers during pregnancy. It also produced positive results in a late stage study that administered Abrysvo along with flu vaccines to adults 65 years and older. The drug giant has begun clinical trials of its RSV vaccine in healthy young children, as well as in children at high risk and adults.
Both Pfizer (Pfizer) and GSK (GSK) have stated that they anticipate having supply ready for the next RSV Season this fall.