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The Food and Drug Administration’s independent advisory panel recommended on Wednesday GlaxoSmithKline RSV vaccine for adults 60 years and older, although they highlighted potential safety issues related to nervous system disorders that could be related to vaccination.

Ten of the FDA advisers said GSK’s vaccine safety data was adequate, while two said it was not. The committee unanimously said the data on the vaccine’s effectiveness was sufficient.

The panel came to a similar conclusion Tuesday on Pfizer’s filing for approval of its RSV vaccine in a narrow 7-4 vote. While the consultants incorrectly recommended approval, they also raised concerns about a possible link to Guillain-Barré syndrome. In this vote, one scientist abstained.

Respiratory syncytial virus kills thousands of seniors every year. There is currently no approved vaccine against RSV. GSK injection is given as a single dose of 120 micrograms.

Both companies have asked the FDA to approve their RSV vaccine for adults age 60 and older. The agency is expected to make its decision on GSK’s vaccine by May 3, with Pfizer’s response also expected this month. GSK and Pfizer’s respective vaccines are set to become the world’s first approved vaccines to prevent the virus.

According to an FDA review of the company’s data, GSK’s vaccine was approximately 83% effective in preventing RSV-related lower respiratory tract disease during the study. Illness was defined as two additional symptoms, including shortness of breath, wheezing, coughing, increased mucus production, crackling, low oxygen saturation, or need for oxygen supplementation.

GSK had no data on how long protection from the vaccine lasts and how it works in people with compromised immune systems, according to the FDA.

“These data are robust and show potentially very high efficacy due to lower respiratory disease,” said Dr. Amanda Cohn, committee member and chief medical officer at the National Center for Immunizations and Respiratory Diseases.

However, the advisers discussed at length risks of rare diseases of the nervous system that may be linked to the vaccine. GSK said it is closely monitoring safety concerns during trials and will continue to do so after potential approval.

dr Hana El Sahly, the chair of the committee, said more safety data is needed before approval. There was one case of Guillain-Barre in the study, and two people developed another rare nervous system disorder after receiving both the RSV and flu vaccines, one of which died. dr Marie Griffin, who is also a member of the panel, agreed that more data is needed.

“I just don’t understand why there is such a rush to get this vaccine approved now,” said Griffin, a physician at Vanderbilt University Medical Center.

Guillain-Barre case

A 78-year-old woman in Japan was diagnosed with Guillain-Barré syndrome nine days after receiving the GSK vaccine. She was discharged from the hospital six months after the vaccination. The woman was the only case of Guillain-Barré syndrome out of 15,000 people who received the shot.

GSK said there was insufficient evidence to confirm a diagnosis. The FDA believes the case is vaccine-related.

Guillain-Barré Syndrome is a rare neurological disorder with symptoms ranging from weakness to paralysis. According to the National Institutes of Health, most people recover even from severe cases.

Two cases of Guillain-Barré syndrome were diagnosed during Pfizer’s RSV vaccine trials. Griffin said the fact that such a rare glitch appeared in both companies’ studies was troubling.

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Griffin noted that Johnson & Johnson recorded a case of Guillain-Barre during its Covid vaccine trial. The FDA finally issued a warning for the J&J vaccine after noting an increased rate of the disease. Large clinical trials of Pfizer’s and Moderna’s Covid vaccines have had no Guillain-Barre cases, she said.

“It’s not something you see routinely in one or two cases,” said Griffin, an FDA committee member who voted “no” to the safety of the shot but “yes” to its effectiveness.

dr Nicholas Geagan, an FDA official, agreed that the Guillain-Barre cases in the GSK and Pfizer studies are troubling. GSK has agreed to expedited reporting of cases of illness, Geagan said.

“It seems worrying to have observed these cases as part of a clinical development program,” Geagan told the committee. “That’s why we are discussing with the sponsor about the further development of future safety analyzes from GBS.”

The FDA said in a briefing document that the rate of Guillain-Barre syndrome in older adults is about 1 in 100,000 in people over the age of 60. In GSK’s study, it was closer to 1 in 15,000.

dr Ann Falsey, a professor of medicine at the University of Rochester, told the panel that the rate of the Guillain-Barre system increases with age and there are other studies that put the rate at 8 to 15 per 100,000. Falsey attended GSK’s presentation to the committee.

dr Peggy Webster, head of vaccine safety at GSK, said the rate of Guillain-Barré syndrome is higher in Japan, where the study participant who developed the disease lives.

Death during process with RSV and flu shots

There were also two cases of another nervous system disorder, including one death, during a GSK study in which the RSV and flu vaccines were given together. The patients developed what is known as acute disseminated encephalomyelitis, a sudden inflammation in the brain and spinal cord. These were the only cases of the disorder among 15,000 vaccinated recipients.

The FDA said the cases may be related to either GSK’s RSV vaccine or the flu shot that was administered with it.

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A 71-year-old man developed the neurological disorder 22 days after receiving RSV and influenza vaccines. He was taken to hospital after being found lying on the ground shaking and shaking. A woman of the same age suffered from headaches with double vision, forgetfulness, shaking hands and uncoordinated movements. She showed improvement, but her symptoms hadn’t completely gone as of the last update, according to the FDA.

El Sahly, the FDA committee chair, said the rate of this neurological disorder is typically 0.1 in 100,000 patients, mostly in children.

“So two cases in elderly people three to four weeks after vaccination is highly anomalous from a statistical point of view,” said El Sahly, who voted “no” to safety but voted “yes” to efficacy.

Adam Berger, an official with the National Institutes of Health, said he viewed the acute cases of disseminated encephalomyelitis as being related to co-administration of RSV and the flu shot rather than a problem with GSK’s vaccine.

“I suggest relying heavily on post-marketing surveillance and not just relying on it, but making sure there is enforcement of the requirements to actually do it,” said Berger, who is a member of the FDA committee .

There have also been two cases of Bell’s palsy, which is a weakness or paralysis on one side of the face. There was also a case of Graves’ disease, or overproduction of thyroid hormone, a case of gout, and a case of a skin condition called psoriasis.

A report from the FDA said the cases may be related to the vaccine.

In adults age 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control Prevention. The risk of hospitalization increases with age, and adults 70 and older are more susceptible.

According to three seasons of CDC data, 19% of adults of all ages hospitalized with RSV require critical care and 4% die. Mortality is highest among the elderly.

GSK said the benefits the vaccine would offer in preventing RSV disease outweighed any potential risks.

“Our duty is to do what is right for the public,” said Dr. David Kim, a U.S. Health and Human Services official and a member of the FDA committee. “And in this case we have a bad disease, we have a good vaccine. The vaccine could be used to prevent disease,” he said.

Blood sample for Respiratory Syncytial Virus (RSV) test

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The Food and Drug Administration’s independent advisors on Tuesday recommended the world’s first RSV vaccine, a shot of Pfizer for adults 60 years and older, despite safety concerns after two study participants developed a rare neurological disorder.

A majority of FDA committee members supported the vaccine but wrestled separate votes on whether the safety and efficacy data were sufficient to support agency approval. The FDA’s decision is expected to be made in May.

There is currently no vaccine to protect older adults from respiratory syncytial virus, which kills thousands of seniors each year. Pfizer’s shot could be the first to receive FDA approval.

In Tuesday’s first vote, seven members of the FDA committee said the safety data was sufficient for approval, while four said it was not, and one member abstained.

The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barré syndrome in about 20,000 vaccine recipients. Guillain-Barre is a rare neurological disorder in which the body’s immune system mistakenly attacks nerves.

Symptoms can range from brief weakness to paralysis. Most patients, even those with severe cases, recover.

On the second vote, seven committee members said the data on the vaccine’s effectiveness was adequate, while four said it was not, and one member abstained.

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According to an FDA review of Pfizer’s data, the syringe protected about 86% against lower respiratory disease with three or more symptoms and 66.7% against the same disease with two or more symptoms. Symptoms included wheezing, shortness of breath, rapid and shallow breathing, and mucus production.

In adults age 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control Prevention. The risk of hospitalization increases with age, and adults 70 and older are more susceptible.

According to three seasons of CDC data, 19% of adults of all ages hospitalized with RSV require critical care and 4% die. Mortality is highest among the elderly.

Pfizer’s vaccine contains both RSV strains that circulate simultaneously in the fall and winter. The injection is given as a single dose of 120 micrograms.

The Guillain Barre Falls

The FDA considers the two Guillain-Barre cases during the study to be potentially vaccine-related, said Dr. Nadine Peart Akindele, an official at the agency. The FDA has asked Pfizer to develop a safety study to monitor post-approval Guillain-Barre risks, to which the company has agreed.

A 66-year-old man in the United States was diagnosed with Guillain-Barre, and a woman of the same age in Japan was diagnosed with Miller-Fischer syndrome, a variant of Guillain-Barre. They developed symptoms seven and eight days after vaccination, respectively. The woman has since recovered and the man’s symptoms have disappeared since the last update, according to the FDA.

However, Alejandra Gurtman, a Pfizer executive, claimed that the company did not identify any safety concerns during the study and that the vaccine was well tolerated.

Gurtman pointed to other possible causes of the Guillain-Barre cases, noting that the man had suffered a heart attack and the woman had an upper respiratory infection. But dr Marie Griffin, a member of the FDA Advisory Committee, said the cases raise serious safety concerns.

“It seems to me that a case is a red flag. Two cases are of great concern and I am concerned that Pfizer does not believe there are safety concerns,” said Griffin, professor of public health policy at Vanderbilt University Medical Center

The FDA says safety monitoring is critical

dr FDA Advisory Committee Chair Hana El Sahly also said the Guillain-Barre cases raise significant safety concerns. El Sahly said the disease has an incidence of about 1 in 100,000 in people aged 60 and over, but in the study the rate looks more like 1 in 9,000.

“So that’s of great importance when we look at it at that level,” El Sahly said, while noting that there is significant uncertainty about what the actual rate of the disease among vaccine recipients would be. “But nonetheless, it’s significant in terms of incidence,” she said.

dr David Kaslow, a senior official in the FDA’s Vaccine Division, said safety monitoring will be “vital” if Pfizer’s RSV vaccine is approved.

The FDA is currently reviewing Pfizer’s proposal to study the risk of Guillain-Barré syndrome in Medicare beneficiaries. The FDA has the authority to request such a post-approval study if the agency deems it necessary.

dr Jay Portnoy, a member of the FDA committee, said he had concluded that the safety data was adequate given that Guillain-Barre syndrome was rare and there were otherwise adverse events in the study in people who received the vaccine and occurred at about the same rate in those who did not receive it.

Adam Berger, an official with the National Institutes of Health, said he was concerned about the Guillain-Barre cases but said a larger study population was needed to determine if there was an actual link to the gunshot. The post-approval study planned by the FDA and Pfizer could help answer that question, he said.

“I felt I could vote yes at this point, with a strong bias towards the actual requirements of this post-market surveillance study,” said Berger, who is also a member of the FDA committee.

Incomplete efficacy data

At the time of Tuesday’s meeting, there weren’t enough data to evaluate the effectiveness of Pfizer’s vaccine against serious illnesses that require hospitalization, oxygen support, or a mechanical ventilator, according to the FDA. According to the authority, there was also no data on how long the protection provided by the vaccine would last.

Pfizer also had no data on how effective the vaccine is for older people with weak immune systems or for those with frail health, according to the FDA, according to the FDA.

Griffin, the doctor at Vanderbilt University Medical Center, said she was concerned the vaccine was being tested on a relatively healthy population where hospital admissions were low and that there was no data on nursing home residents and those with frail health.

Akindele, the FDA official, said real-world evidence once a vaccine is released could answer how much protection it offers for those in frail health. The data would then be used to determine if the FDA needs to make adjustments to how the shot is used, she said.

Pfizer is conducting its clinical study over two RSV seasons with more than 34,000 enrolled individuals. The available efficacy and safety data are from the first season.

When asked what would happen if the second-season data isn’t as strong following an approval, Akindele said the FDA will reevaluate the shot and meet again with the committee to determine how to proceed.

Pfizer estimates that if 50% of people age 60 and older get the vaccine, the vaccine could prevent more than 5,000 deaths, 68,000 hospital admissions, 51,000 emergency room visits and more than 422,000 outpatient visits.

Paquita Bonillo, 84 years old, receives the fourth dose of Covid-19 and flu vaccine in the garden of the Feixa Llarga nursing home in Barcelona, ​​Spain, September 26, 2022.

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The flu vaccine was 68% effective at preventing hospitalizations in children but was less protective for seniors this season, according to preliminary data released Wednesday by the Centers for Disease Control and Prevention.

The vaccine was 35% effective in preventing hospitalizations in the elderly in one study and 42% effective in a second analysis.

For people with weakened immune systems, the vaccine reduced the risk of hospitalization by 44% in one study and 30% in another.

The flu hit early this season when the weekly hospitalization rate peaked in December and has since declined, according to CDC data. The flu has caused 25 million illnesses, 280,000 hospitalizations and 18,000 deaths since October. More than 100 children have died from the flu this season.

Influenza cases rose sharply last autumn after two years in which the virus circulated at low levels due to masking and social distancing measures put in place during the Covid-19 pandemic.

dr Jose Romero, director of the National Center for Immunization and Respiratory Diseases, said the co-circulation of Covid, flu and respiratory syncytial virus is putting significant pressure on hospitals and drug supply chains across the United States

“Following a brief and expected spike in hospitalizations and cases around the holidays, we are now seeing a steady decline in Covid, influenza and RSV cases and hospitalizations nationally,” Romero told the CDC’s Independent Advisory Committee on Wednesday.

“While influenza activity is declining, it remains possible that a second wave could occur later in the season, as has been the case in the past,” Romero said.

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Children and the elderly are typically at the highest risk for serious illness from the flu. By the end of January, about 52% of children and 70% of seniors had received a flu vaccine, according to CDC data. The CDC recommends seasonal vaccination for everyone 6 months and older.

The effectiveness of influenza vaccines can vary greatly from season to season, depending on how well the strains included in the shots are matched to the circulating viruses. dr Lisa Grohskopf, a CDC official, said vaccines and circulating flu strains have been fairly well-matched this season.

Hospitals were hit last fall by the simultaneous spread of Covid, flu and respiratory syncytial virus. The Children’s Hospital Association had urged the Biden administration to declare a public health emergency in November, calling the rise in hospitalizations of children at the time “alarming.”

While there are widely available Covid and flu shots, there are no vaccines for RSV. Several companies are developing syringes for older adults that could receive Food and Drug Administration approval this year.

Pfizer is developing a vaccine that protects infants from RSV, and Sanofi has asked the FDA to approve an antibody called nirsevimab that also protects children up to two years old.

Join us for CNBC’s Healthy Returns on March 29, where we’re hosting a virtual gathering of healthcare CEOs, scientists, investors and innovators to reflect on the advances made today in reinventing the future of medicine. We also have an exclusive look at the best investment opportunities in biopharma, healthcare technology and managed care. Learn more and register today: http://bit.ly/3DUNbRo