US FDA follows the European Medical Agency (EMA) to approve the world’s first RSV vaccine “Arexvy” for over 60’s – not yet priced but likely to be around the flu shot – 40-120 bucks

h/t Emily

Here is a link to the press announcement from manufacturer, GlaxoSmithKline of the UK.

US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults | GSK

“About Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Respiratory syncytial virus vaccine, adjuvanted, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.”

In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine.

Here are the EMA and FDA announcements:

Arexvy: Pending EC decision | European Medicines Agency (europa.eu)

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine | FDA

Nothing on the GSK’s home regulator the UK MHRA on Arexvy.

The regulatory agencies have given a tick to Arexvy after “three seasons” of clinical trials, though these are not yet complete. The CDC’s ACIP experts have yet to weigh in on how to recommend it.

Clinical trials are not complete, so this represents a continuation of the “accelerated approval process” that has become the norm for regulators to facilitate the roll-out of treatments.

How much of an issue is RSV – leaving aside any increases caused by the C19 mRNA injections:

RSV Surveillance and Research | CDC

“RSV Burden Estimates

Each year in the United States, RSV leads to approximately:

·        2.1 million outpatient (non-hospitalization) visits among children younger than 5 years old.(1)

·        58,000-80,000 hospitalizations among children younger than 5 years old.(1,2,3)

·        60,000-160,000 hospitalizations among adults 65 years and older.(4-8)

·        6,000-10,000 deaths among adults 65 years and older.(9-11)

·        100–300 deaths in children younger than 5 years old.(11

·        RSV season onset (indicating a sustained rise in the number of RSV-positive tests) ranged from mid-September to mid-November.

·        RSV season peak (indicating the maximum number of RSV-positive tests) ranged from late December to mid-February.

·        RSV season offset (indicating a sustained drop in the number of RSV-positive tests) ranged from mid-April to mid-May.

Florida has an earlier RSV season onset and longer duration than most regions of the country.”

So, will be ready for next years RSV “season”.

On the face of it, looks promising, far better researched than C19 mRNA injections and comparable in price to the (useless) flu shots.

The Lancet has published a couple of articles:

Decline of RSV-specific antibodies during the COVID-19 pandemic - The Lancet Infectious Diseases

Quantifying the RSV immunity debt following COVID-19: a public health matter - The Lancet Infectious Diseases

Not sure if the Lancet has recovered the credibility it lost when publishing false research, especially around Ivermectin!

Be good to see the actual clinical trial data – when it is finished – of course.

For what it’s worth, here is a link to the WHO page on RSV vaccines.

Respiratory Syncytial Virus (RSV) disease (who.int)

No surprises about fingers in pies – from December 2015.

Global Influenza Programme (who.int)

“The WHO Global Influenza Programme with support from the Bill & Melinda Gates Foundation, piloted a RSV surveillance strategy Phase I based on the Global Influenza Surveillance and Response System (GISRS) in 14 countries in order to standardized RSV surveillance and provide evidence to support Public Health and to inform RSV vaccination policy.”

More details on the WHO program here:

Approaches to use the WHO respiratory syncytial virus surveillance platform to estimate disease burden - Pebody - 2020 - Influenza and Other Respiratory Viruses - Wiley Online Library

Onwards!

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