USA—Health officials are probing a potential connection between occurrences of a rare neurological system condition in older people in the United States who were injected with two new RSV vaccines.   
Health officials announced on Thursday that the investigation is predicated on fewer than two dozen incidents observed among over 9.5 million vaccination users.  

The officials asserted they were committed to a thorough investigation on the matter but faulted the lack of sufficient data to ascertain whether the vaccinations played a role in the disorders. 

This comes amid a realization that the numbers are higher than expected, prompting a probe to determine whether the immunizations are the cause of the problem.  

According to officials, over 20 cases of Guillain-Barre syndrome, a rare condition where the immune system targets nerve cells, leading to muscle weakness and paralysis, were being investigated in a report submitted by an expert panel to the Centers for Disease Control and Prevention. 

Earlier, the CDC reported that between 3,000 and 6,000 Americans are projected to contract GBS annually, with older adults being more likely to contract the illness.  

Respiratory syncytial virus (RSV) is a common cause of cold-like symptoms, but it can pose a significant risk to infants and the elderly. 

Also read:

1: India drafts law to require pharma companies to package eye drops in transparent bottles

2: FDA withdraws two-year clinical ban on CytoDyn’s HIV trial

Last year, the CDC approved a recommendation put forth by the advisory panel for Americans aged 60 and above. The recommendation was for a single dose of the RSV vaccine, with two options available: one manufactured by Pfizer and the other by GSK. 

The CDC advised patients to consult with their healthcare providers about the vaccines and make an informed decision regarding vaccination. 

Officials were cognizant of instances of Guillain-Barre syndrome identified during clinical trials conducted prior to the approval of the vaccines for sale. Various monitoring systems were in place to detect any potential issues post-vaccination. 

During a Thursday meeting of the expert panel, CDC officials presented an analysis of reports collected by surveillance systems. 

Approximately two-thirds of the cases were observed in individuals who received Pfizer’s vaccine variant, Abrysvo. However, officials are also conducting follow-up monitoring in individuals who received GSK’s Arexvy. 

Health officials estimate that about two cases of Guillain-Barre syndrome may occur in every 1 million vaccine recipients. A CDC analysis revealed that the incidence rate associated with GSK’s vaccine was lower than this estimate, while 4.6 cases per million were reported among recipients of the Pfizer shot. 

Data from the U.S. Food and Drug Administration also indicated a higher-than-expected number of Guillain-Barre cases reported among recipients of the RSV vaccine, particularly among those who received the Pfizer shot. 

“Taken together, these data suggest a potential increased risk” in RSV vaccine recipients 60 and older that must be explored, said Dr. Tom Shimabukuro, a CDC vaccine safety monitoring official. 

In light of the potential risks, advisers to the Centers for Disease Control and Prevention are now weighing updates to their recommendation that older adults get vaccinated for respiratory syncytial virus. 

The debate is on whether, for some individuals at higher risk, a universal recommendation would be more appropriate.  

More data is required before making a decision, which according to Biopharma, will likely be submitted at a follow-up meeting scheduled for June 26 to June 28.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.