JUST IN: FDA Approves New ‘Vaccine’

The FDA on Wednesday approved the world’s first respiratory syncytial virus (RSV) vaccine.

The shot, made by GlaxoSmithKline (GSK), will be for adults ages 60 and up.

According to NBC News, a late-stage clinical trial showed the one-dose shot “lowered the risk of symptomatic illness by 83% and of severe illness by 94%.”

Although the CDC must still give its greenlight for the shot before it becomes publicly available, we know the agency won’t say no.

The CDC’s advisory committee meets in June to discuss the new shot.

BREAKING: FDA approves the world's first respiratory syncytial virus, or RSV, vaccine made by pharmaceutical giant GSK. https://t.co/lytJTRRFgX

— NBC News (@NBCNews) May 3, 2023

NBC News reported:

Dr. Phil Dormitzer, GSK’s senior vice president and global head of vaccines research and development, said the company is already manufacturing doses of the vaccine, to be sold under the brand name Arexvy.

“The goal is to have shots available in the fall so that people can get them before the next RSV season coming up late fall and winter,” Dormitzer said, though he did not give specific production numbers.

RSV causes a lower respiratory illness that is typically mild for healthy adults. But in serious cases, the virus can lead to pneumonia or bronchiolitis, which inflames airways and clogs them with mucus. Older people and infants are particularly at risk: RSV kills up to 10,000 people ages 65 or older and up to 300 children under 5 every year in the U.S.

RSV cases typically peak between late December and mid-February, but cases last year started climbing in the summer as people left pandemic precautions behind.

As of late April, the rate of RSV hospitalizations for the current season was around 51 per 100,000 people, according to the CDC. That’s up from 19 hospitalizations per 100,000 people by the same point in the prior season.

The outlet noted that GSK’s trial is ongoing and they will “keep collecting data over the next two RSV seasons.”

Today we approved the first respiratory syncytial virus (RSV) vaccine, approved for use in the U.S., to prevent lower respiratory tract disease caused by RSV in individuals 60 years and older.

Learn more: https://t.co/V6ChIMKcYt pic.twitter.com/DgmkzjIR42

— U.S. FDA (@US_FDA) May 3, 2023

The FDA stated in its press release:

The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older. The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination. Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA’s analysis.

In this study, approximately 12,500 participants have received Arexvy and 12,500 participants have received a placebo. Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.

Among a subset of these clinical trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.

The FDA also noted:

The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the postmarketing study.

MedPage Today reported in February that Guillain-Barre syndrome was flagged as a potential risk with the RSV shot.

Ahead of a 2-day meeting with FDA’s vaccine advisors, reviewers at the agency highlighted a rare but potential risk for Guillain-Barré syndrome with two vaccine candidates for respiratory syncytial virus (RSV).

On Tuesday and Wednesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC)opens in a new tab or window will recommend whether the risk-benefit profile with Pfizer and GSK’s vaccine candidates support approval for reducing RSV-related lower respiratory tract infections in adults 60 and up.

Currently, no vaccines exist to protect against RSV infection. According to data from the CDCopens in a new tab or window, an estimated 177,000 older adults in the U.S. were hospitalized due to RSV infections in 2017 alone, and 14,000 died.

In phase III trials, Pfizer and GSK’s vaccine candidates demonstrated upwards of 66% efficacyopens in a new tab or window against RSV-related infections involving multiple symptoms.

But with Pfizer’s RSV prefusion F protein vaccine (RSVPreF), two cases of Guillain-Barré syndrome were observed at 7 and 8 days following vaccination among the nearly 20,000 participants who received the vaccine. FDA agreed with study investigators that the events were possibly related to the vaccine, according to a briefing documentopens in a new tab or window released ahead of the meeting.

Each year in the U.S., roughly 1.5-3.0 cases of Guillain-Barré syndrome occur per 100,000 people age 60 and older.

“Given the higher than background rate of GBS [Guillain-Barré syndrome] observed in the Phase 3 study, FDA will recommend a postmarketing study and enhanced surveillance for further evaluation of GBS and other immune-mediated demyelinating conditions with postmarketing use,” wrote FDA staff.

In the case of GSK’s RSV prefusion F protein vaccine (RSVPreF3 OA), among the more than 15,000 individuals who received the vaccine in multiple trials, one case of Guillain-Barré syndrome occurred 9 days after vaccination. Again here, the study investigator and FDA considered this to be “related to vaccinationopens in a new tab or window.” GSK had already planned to include the rare neurological condition as a potential immune-mediated disease (pIMD) risk in its pharmacovigilance plan.