Source: ChildrensHealthDefense.org
Describing it as a “long-sought scientific achievement,” the U.S. Food and Drug Administration (FDA) on Wednesday approved Arexvy, the first vaccine for respiratory syncytial virus (RSV).
GlaxoSmithKline Biologicals (GSK) developed Arexvy under the FDA’s Priority Review designation. The FDA approved it for people ages 60 and older.
According to CNBC, the U.S. “suffered an unusually severe RSV season” this past winter. The New York Times reported on a “tripledemic” involving RSV, flu and COVID-19, “that swamped children’s hospitals and some I.C.U. wards.”
One U.S. county — Orange County, California — declared a local health emergency and issued a proclamation of local emergency in November 2022, citing rising RSV cases among children in the region.
GSK described results from clinical trials for Arexvy as “positive,” and the company said the U.S. launch of the vaccine is planned before the 2023-24 RSV season.
Other RSV vaccines, including one produced by Pfizer, are in the pipeline and expectations are that the FDA will approve them.
During clinical trials for both the GSK and Pfizer vaccines, several participants were diagnosed with rare conditions such as Guillain-Barré syndrome (GBS) and acute disseminated encephalomyelitis (ADEM). One of the individuals who developed ADEM later died, according to the FDA.
Aside from concerns over potential serious adverse events related to RSV vaccines, some experts have questioned the need for such a vaccine in the first place.
According to the journal Science, “RSV is a common respiratory infection” with symptoms “similar to a cold,” adding that “The majority of individuals recover within a few days from an uncomplicated RSV infection, although occasionally the virus can cause lower respiratory infections requiring medical attention.”
Dr. Peter McCullough, a cardiologist, told The Defender:
“Respiratory syncytial virus is a negligible threat to even the most frail elderly adults. The effort of widespread vaccination is simply not worth it. Even rare side effects will outweigh any theoretical benefit.”
And in a November 2022 episode of “RFK Jr. The Defender” podcast, several medical and public health experts expressed concerns about RSV vaccines.
“We have to stop these shots,” said Dr. Meryl Nass, an internist and biological warfare epidemiologist. “It’s just extraordinary that we’re still vaccinating people … we have a lot of work to do.”
Robert F. Kennedy Jr., then-chairman and chief litigation counsel for Children’s Health Defense (now chairman on leave), described RSV as “a vehicle for re-implementing the COVID-19 playbook all over the country and responding with vaccines.”
And according to the National Vaccine Information Center (NVIC), “Cost analysis data presented to the ACIP [Advisory Committee on Immunization Practices] did not show the RSV vaccines to be cost-effective at reducing the burden of costs associated with RSV illness.”
Nevertheless, more RSV vaccines are expected to receive FDA approval this year — including a Pfizer RSV vaccine for pregnant women that led to a high incidence of adverse events for both the women and their infants during clinical trials, as well as several deaths and stillbirths.
Arexvy approval ushers in new ‘highly competitive and lucrative vaccine market’
The RSV vaccine market is estimated to be worth up to $10 billion by 2030….