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Everything to know About the First FDA-Approved RSV Vaccine

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  • The FDA has approved a vaccine to protect against RSV.
  • It’s the first time a vaccine for RSV has been approved in the U.S.
  • RSV is a virus that affects millions in the U.S. each year.

The Food and Drug Administration (FDA) on May 3 approved the first vaccine to protect against respiratory syncytial virus (RSV) infection.

The vaccine was developed by GlaxoSmithKline (GSK) for use in adults 60 and older.

This is the world’s first fully approved vaccine for older adults that targets RSV. In securing U.S. approval of its vaccine Arexvy, GSK beat out rival drugmakers Pfizer and Moderna.

GSK’s chief scientific officer Tony Wood said in a statement that the FDA approval “marks a turning point” in the company’s effort to “reduce the significant burden of RSV.”

“Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible,” he added. 

London-based GSK said April 26 in a call with investors that it has millions of doses of the RSV vaccine ready to ship.

RSV vaccine likely to be available later this summer

The Centers for Disease Control and Prevention (CDC) will have to recommend use of the vaccine before it can enter the marketplace. This will likely happen after the agency’s vaccine expert panel meets on June 21 and 22.

Although the FDA approved the GSK vaccine for people 60 years of age and older, the CDC could limit its recommendation to a smaller age range, based on data on the risks and benefits of the vaccine.

GSK’s Wood said the company will also work toward gaining regulatory approval of its vaccine in other countries.

The European Medicines Agency recommended last week that the vaccine be approved by the European Union for older adults.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that the approval of GSK’s vaccine is an “important public health achievement to prevent a disease which can be life-threatening.”

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” he added.

The vaccine should be available to help protect older adults for the next RSV season in the fall.

Parts of the United States saw a surge in RSV cases in children and older adults last fall, partly due to the dropping of masking and other COVID-19 public health measures that also slowed the spread of RSV.

In most people, RSV causes mild, cold-like symptoms. But each year the virus kills 6,000 to 10,000 older adults and 100 to 300 children younger than five, according to the CDC.

In addition, 60,000 to 160,000 older adults and 58,000 to 80,000 children younger than 5 years old are hospitalized each year due to RSV, the agency said.

Over 80% effective at stopping RSV

The approval of GSK’s vaccine is based on a randomized controlled trial conducted in adults 60 years and older in the United States and other countries, the FDA said in its statement.

This study found that the vaccine was 83% effective at preventing the risk of lower respiratory tract disease caused by RSV. Disease was defined as two or more symptoms such as shortness of breath, wheezing, cough or need for supplemental oxygen.

The most commonly reported side effects in people who received the vaccine were pain at the injection site, fatigue, muscle pain, headache and joint stiffness and pain, the FDA said.

The agency also flagged a potential safety issue. In one study of the vaccine, a person who received the vaccine developed Guillain-Barré syndrome. 

This is a rare disorder in which the body’s immune system damages nerve cells, resulting in muscle weakness and sometimes paralysis. Most people fully recover from this, although some people will continue to have muscle weakness.

The rate of this disorder is about one or two cases each year in every 100,000 people, according to the National Organization for Rare Disorders. The exact cause is unknown.

The FDA said in its statement that it will require GSK to continue monitoring people who receive the vaccine to assess the risk of Guillain-Barré syndrome and another condition.

Two people developed Guillain-Barré syndrome (including a variant of this disorder) after receiving the Pfizer RSV vaccine in a large phase 3 clinical trial in older adults.

Pfizer drugmaker is hoping to gain FDA approval of its vaccine later this month.

The company has also asked the FDA to approve an RSV vaccine designed to be given to pregnant people. This vaccine would generate antibodies that would protect both the pregnant person and their newborn.

No cases of Guillain-Barré were identified during Moderna’s clinical trial of its RSV vaccine for older adults. The company plans to request approval from the FDA of its vaccine during the first half of this year.



Everything to know About the First FDA-Approved RSV Vaccine
Source: Pinoy Lang Sakalam

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