by Hugh McQuaid CTNewsJunkie
As Connecticut experiences a surge in respiratory syncytial virus (RSV) cases, U.S. Sen. Richard Blumenthal called Monday on drug manufacturers AstraZeneca and Sanofi to address an ongoing shortage of a new monoclonal antibody meant to prevent the illness in infants.
Blumenthal, who was among a group of senators to write to the pharmaceutical companies about the issue last week, stressed the urgency of the situation during a late morning press conference at the InterCommunity Health Care office in East Hartford.
Since Nov. 5, Connecticut has recorded around 1,000 cases of RSV, including four deaths, Blumenthal said.
“That ought to be an alarm for Connecticut and the nation that this severe shortage of RSV [treatment] is having practical, tragic consequences for our state and they are preventable consequences because this treatment can and should be available,” Blumenthal said.
RSV is a common virus affecting the lungs and is the leading cause of infant hospitalizations in the United States, according to the Centers for Disease Control.
The treatment, known as nirsevimab and sold under the trade name Beyfortus, is recommended for all babies younger than eight months and certain immunocompromised children up to 19 months as a preventative measure similar to a vaccine.
The monoclonal antibody was hailed as an unprecedented shift in the prevention of RSV when it was approved by the Food and Drug Administration back in July.
However, shortages of the treatment led the CDC to recommend prioritizing available doses for high-risk infants in October. Later, the CDC announced the release of 77,000 additional doses to be distributed to providers nationwide.
“CDC and FDA are committed to expanding access to this important immunization so that more parents have peace of mind during the winter virus season,” Dr. Nirav D. Shah, CDC deputy director, said in a press release.
Last week, Blumenthal was among a group of seven Democrats led by Illinois Sen. Tammy Duckworth, who wrote to AstraZeneca and Sanofi questioning when the manufacturers became aware of the shortage and what steps they had taken to address the issue.
The letter asked the companies to respond by Nov. 30. The senators had yet to receive a response as of Monday, Blumenthal told reporters. Meanwhile, neither company immediately responded to requests for comments left Monday.
Earlier this month, Dr. Manish Juthani, state public health commissioner, said Connecticut had plenty of access to the treatment. However, she expected supplies to dwindle as the season progressed.
As of Nov. 22, the Public Health Department had received requests for 14,432 doses and placed 10,905 orders for the antibodies, leaving a 3,527 dose shortfall, which a spokesperson attributed to lack of supply.
Given the surge in RSV cases, Blumenthal called on the manufacturers to create more of the treatment on an expedited basis.
“The point is it can be produced quickly and cheaply and that’s what these manufacturers should do,” Blumenthal said. “AstraZeneca and Sanofi owe it to the public, to patients, to parents and our hope is that they will help stem the surge of RSV.”
In addition to the antibody treatment for infants, there are two RSV vaccines that have been approved for adults aged 60 and older. The CDC has also recommended a vaccine be taken between 32 and 36 weeks into a pregnancy in order to provide immunity for newborns.
During Monday’s press conference, Dr. Chad McDonald, chief medical officer of InterCommunity Health Care, said patients should discuss inoculation options with their doctors.
“The importance of getting the RSV vaccine can’t be understated for patients that qualify and that decision is best made between a patient and their health care provider who knows them well,” McDonald said.