First RSV Emergency Declared as Pfizer and GSK Race to Get Vaccines Approved

By  Michael Nevradakis, Ph.D.

Southern California’s Orange County Health Department this month declared a local health emergency over concerns around the rising number of pediatric cases of Respiratory Syncytial Virus (RSV) amid news Pfizer, GlaxoSmithKline are close to seeking approval for new RSV vaccines.

Southern California’s Orange County Health Department this month declared a local health emergency over concerns around the rising number of pediatric cases of Respiratory Syncytial Virus (RSV).

County officials also declared a Proclamation of Local Emergency, allowing them to access state and federal resources in response to the spread of RSV.

The news came amid media warnings of a looming “tripledemic” of RSV, influenza and COVID-19 and news that Pfizer and GlaxoSmithKline (GSK) are close to securing regulatory approval for their RSV vaccine candidates — including Pfizer’s RSV vaccine for pregnant women.

RSV was first identified in 1956, and frequently affects children, with a majority of childhood cases occurring before age 2. For most children, symptoms are similar to those of the common cold, according to the Centers for Disease Control and Prevention (CDC).

It can, however, cause serious symptoms in the very young and the elderly, although childhood deaths are infrequent, according to CDC data.

According to California attorney Rita Barnett-Rose, there’s no evidence to support claims that Orange County hospitals are overextended, or to justify a state of emergency.

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Is pharma using COVID playbook to push RSV vaccines?

Dr. Regina Chinsio-Kwong, Orange County’s health officer, said in a press release county officials issued the declaration due to “rapidly spreading virus infections causing record numbers of pediatric hospitalizations and daily emergency room visits.”

The declaration will allow the county to access state and federal resources and to allow non-pediatric hospitals to offer beds to sick children, Chinsio-Kwong said.

Children’s Health Defense (CHD) California Chapter notes that this declaration was unanimously ratified “over the objections by members of the public who showed up to speak against the declarations.”

Dr. Melaine Patterson, chief nursing officer for Children’s Health Orange County, said area hospitals are seeing an “unprecedented” volume of children visiting their emergency rooms — approximately 400 per day, with wait times of “four to 12 hours.”

She also said that, as of Nov. 1, there were 285 patients in her hospital, compared to 188 on that date last year, adding that 11 of those current patients were placed in ICU as a result of RSV infections. RSV cases also are on the rise nationally.

Chinsio-Kwong advised the public to remain “up to date with other vaccinations such as flu and COVID-19” to “reduce the burden on hospitals this fall and winter.”

“Our best shot at protecting ourselves and our children from respiratory illnesses continues to be the same things we practiced throughout the pandemic including the use of masks when indoors around others and staying home when you are sick,” Chinsio-Kwong said.

However, Barnett-Rose said hospitals in Orange County may be overextended not due to an unusually high number of admissions, but due to unvaccinated staff having been let go.

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Barnett-Rose said the emergency declaration in Orange County may be tied to the fact that there are multiple RSV vaccines already in the pipeline:

“The reason this is becoming really huge news is because this is what happened with the COVID state of emergency, too, it kind of went like that in dominoes.

“Once Biden declares a national state of emergency, then that triggers all of the emergency use authorizations that allowed the so-called vaccines for COVID. And I’m sure you already know that there’s vaccines in the works now for RSV that they’re floating out there in the news as well.”

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Up to 30 RSV vaccine candidates already in pipeline

Pharmaceutical industry publication FiercePharma reported that Pfizer and GSK “moved closer to regulatory approvals” in the past week, and “could each see the first-ever approvals for an RSV vaccine in 2023.”

GSK’s candidate will be reviewed May 3, 2023, while Pfizer is “eyeing an approval filing by year-end.”

In all, up to 30 RSV candidate vaccines have been identified by the National Institutes of Health (NIH).

GSK has secured priority review status for its RSV vaccine following the submission of data from its AReSVi-006 phase 3 trial. The candidate vaccine exclusively targets adults 60 and older, and the data reportedly “showed high overall vaccine efficacy against RSV lower respiratory disease” at a rate of 82.6%, Fierce Biotech reported.

GSK initially intended to develop an RSV vaccine for older adults and for infants, but plans for the latter were shelved due to a “safety concern.” Nevertheless, GSK CEO Emma Walmsley in a call last week with investors described GSK’s new vaccine as “a very significant scientific achievement.”

Previous efforts to develop an RSV vaccine have failed because they “had a persistent tendency to cause worse disease,” due to “a phenomenon known as antibody-dependent enhancement (ADE).”

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Pfizer, in its Nov. 1 announcement, claimed that its bivalent RSV prefusion vaccine candidate RSVpreF, also known as PF-06928316, delivered “broadly positive” results — namely, a significant reduction in the rate of respiratory illness in newborns and their mothers.

Pfizer claimed 81.8% efficacy against severe cases of RSV for babies up to three months, and 69.4% efficacy after six months.

Pfizer’s MATISSE (MATernal Immunization Study for Safety and Efficacy) trial involved 7,400 pregnant women and their newborns, tracking the infants for one year following birth, and some for two years. It was conducted in 18 countries beginning in June 2020.

Pfizer’s vaccine trial did not deliver statistically significant results regarding the prevention of infant medical visits caused by RSV, including for non-severe cases.

Nevertheless, Pfizer said there are “no major safety concerns” with its product, adding:

“At the recommendation of the DMC [Data Monitoring Committee], and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer has stopped enrollment in the study.

On March 2, 2022, Pfizer’s candidate vaccine received a Breakthrough Therapy Designation from the FDA, while previously, in November 2018, the FDA granted it Fast-Track status, according to the Pfizer release.

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Media tout benefits, ignore safety concerns

Online news portal Vox described the development of new RSV vaccines as “very, very good news” in a recent article.

Coupled with media coverage about “rising” RSV cases nationwide, it appears the stage is being set to create an emergency in the public consciousness, which could lead to EUAs being granted to the new vaccines and a rush to get the public vaccinated.

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As previously reported by The Defender, RSV itself originated in monkeys housed in a Maryland facility where they were used to conduct polio vaccine research. Remarking on this and the connection to RSV vaccine development today, Brian Hooker, CHD’s chief scientific officer, told The Defender, “It is incredible that the vaccine industry can create a disease — RSV from the polio vaccine — and then create another vaccine to ‘prevent’ that disease. Talk about a business proposition!”

Via https://childrenshealthdefense.org/defender/rsv-emergency-vaccine-race-pfizer-gsk/