FDA Finds Rare Neurological Disorder Is a ‘Potential Risk’ With Pfizer Vaccine: Report

Guillain-Barre syndrome is considered a potential risk of a Pfizer RSV vaccine currently awaiting Food and Drug Administration approval.

According to a briefing document released by the federal regulatory agency, two people in their 60s were diagnosed with Guillain-Barre syndrome. They were among 20,000 participating in a phase three trial of the vaccine.

None of the individuals in the control group that received a placebo was diagnosed with the rare neurological disease, according to the report.

The FDA released the briefing document before a scheduled meeting of the Vaccines and Related Biological Products Advisory Committee, according to a report from The Epoch Times.

The report noted one of the two reportedly made a full recovery after three months. The other affected individual reportedly showed improvements after six months.

Pfizer will be required to conduct a safety study if its RSV vaccine “Abrysvo” is approved for use in the U.S. this spring, according to the FDA brief.

The advisory committee is scheduled to discuss RSV vaccines from Pfizer and GSK for adults aged 60 and older February 28.

Pfizer claimed in a corporate document that the Guillain-Barre syndrome reactions have possible explanations unrelated to its vaccine.

The pharmaceutical giant claimed no safety concerns were identified during the trial. Pfizer added it would conduct a safety study on its RSV vaccine if it receives U.S. approval.

RSV is a highly contagious virus that causes flu-like symptoms. Older people who contract RSV tend to have more severe symptoms. The Centers for Disease Control and Prevention estimates RSV kills 14,000 people in the U.S. over age 65 each year.

CDC estimates around 2.2 million experience symptomatic RSV illnesses each year with approximately 177,000 requiring hospitalization. The health agency equates it with influenza, a serious illness that causes up to 43,000 deaths each year among America’s elderly.

No vaccines have been approved for treatment of RSV by the FDA. That, of course, may change in the spring if the Pfizer vaccine candidate passes muster with agency evaluators.