FDA mandates warnings for two RSV vaccines used in Singapore

[Chase]

FDA mandates warnings for two RSV vaccines used in Singapore
https://www.fda.gov/safety/medical-...scribing-information-rsv-vaccines-abrysvo-and

The U.S. Food and Drug Administration (FDA) ordered two respiratory syncytial virus (RSV) vaccine manufacturers to include a potentially paralytic side effect warning related to nerve damage on product labels. RSV is a common respiratory virus that infects the throat, nose, and lungs, and typically spreads during fall and winter seasons. Infected people can experience symptoms similar to that of a common cold such as a runny nose, congestion, sneezing, and coughing.

The FDA said the following statement is to be included in the Warnings and Precautions section of the two vaccines: “The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Abrysvo” or with “Arexvy” for that vaccine.

Arexvy is used by people aged 50 and older to deal with lower respiratory tract disease caused by RSV, while Abrysvo has been approved for use in adults aged 18 and above. Abrysvo is also used by pregnant women who are at 32 through 36 weeks of gestational age to protect infants from birth through six months of age.

The FDA determined that “the benefits of vaccination with Abrysvo and Arexvy continue to outweigh their risks.” In the study, the agency found there was an “increased risk of GBS during the 42 days following vaccination, with an estimated 9 excess cases of GBS per million doses of Abrysvo, and an estimated 7 excess cases of GBS per million doses of Arexvy administered to individuals 65 years of age and older.”




GSK Arexvy and Pfizer Abrysvo used in Singapore
https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals---july-2024
https://www.straitstimes.com/singap...ory-disease-approved-for-singaporeans-over-60

 

[laksaboy]

RSV was non-existent prior to 2020.

 

[Truthspeak]

Those who still believe vaccines save lives, remember to take the vaccine

 

[Leongsam]

What happens if the vaccine has been forced upon you and you then get a bulletin like this one?

fda.gov

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication​

Office of the Commissioner

3–4 minutes

---

[Posted 1/7/2025]

AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology

ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine. The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section:

• Abrysvo - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo.
• Arexvy - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.

BACKGROUND: GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

About Abrysvo

• Abrysvo was initially approved on May 31, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for the following:
  • prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV;
  • immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

About Arexvy

• Arexvy was initially approved on May 3, 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for use in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

RECOMMENDATION:

• Suspected adverse events may be reported to (VAERS) (https://vaers.hhs.gov/reportevent.html), which is co-managed by the FDA and the Centers for Disease Control and Prevention (CDC).

[01/07/2025 - FDA Safety Communication - FDA]

 

[k1976]

Any anti-vax trend may cause breakouts of preventable diseases, become very serious: Ong Ye Kung​

Judith Tan
PUBLISHED MAR 25, 2025, 05:00 PM


SINGAPORE – If the anti-vaccination movement had taken root in Singapore during the Covid-19 pandemic, the country’s death rates would have been much higher, said Health Minister Ong Ye Kung.

“The only reason why Singapore had one of the lowest excess deaths during the few years of Covid-19 was that the great majority of Singaporeans, especially seniors, took the vaccine and then with that, we could open up Singapore,” he said.

Excess deaths refers to higher rates of death than would normally be the case, and this has emerged as a leading measure of the overall impact of the Covid-19 pandemic.

​

 

[k1976]

What happens if the vaccine has been forced upon you and you then get a bulletin like this one?

fda.gov

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication​

Office of the Commissioner

3–4 minutes

---

[Posted 1/7/2025]

AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology

ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine. The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section:

• Abrysvo - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo.
• Arexvy - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.

BACKGROUND: GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

About Abrysvo

• Abrysvo was initially approved on May 31, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for the following:
  • prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV;
  • immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

About Arexvy

• Arexvy was initially approved on May 3, 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for use in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

RECOMMENDATION:

• Suspected adverse events may be reported to (VAERS) (https://vaers.hhs.gov/reportevent.html), which is co-managed by the FDA and the Centers for Disease Control and Prevention (CDC).

[01/07/2025 - FDA Safety Communication - FDA]

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