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After 60 Years of Work, World’s First RSV Vaccine Approved by US FDA

The vaccine, Arexvy, made by GSK is designed to be given as a single shot to adults 60 and older.

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On Wednesday, 3 May, the US Food and Drug Administration approved the world's first vaccine to prevent Respiratory Syncytial Virus (RSV), a respiratory ailment that can turn serious in infants and the elderly.

Key points to note: The vaccine, Arexvy was developed by UK-based pharmaceutical company GlaxoSmithKline, and has been approved for adults over the age of 60 as a single-dose vaccine.

The large study involved 25,000 participants.

The vaccine was found to be,

  • 94 percent effective at lowering the risk of severe illness

  • 83 percent effective at reducing symptomatic infection

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Why it matters: The vaccine had been in development for over six decades now.

In most people RSV presents as cold-like symptoms, however it happens to be the second leading cause of death during the first year of a child's life across the world.

In the US, it causes around 10,000 deaths and 160,000 hospitalisations in those over 65 every year, according to the US Centers for Disease Control and Prevention.

But, but, but: Although children under the age of 5 are more vulnerable to serious RSV, this particular vaccine has not been tested in, or approved for babies.

RSV in India: RSV is a virus that affects people all over the world, however, there isn't accurate data on cases of RSV in India.

There is no news as of yet on the vaccine's sale in India.

What's next: Now, the vaccine would need to be recommended by the US CDC before it is made available to the public.

In the meantime, the US FDA has asked the company to conduct a follow-up study to assess adverse effects like Guillain-Barré syndrome and ADEM from the vaccine.

There is another RSV vaccine in the pipeline, by Pfizer, that is also seeking an FDA approval.

(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

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Topics:  US FDA   Vaccine 

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