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Beauty and Anti-Aging

About RSV Vaccines

2 de agosto de 2023

4 min de lectura

Respiratory syncytial virus, or RSV, is a common lung or respiratory infection. Although the virus causes mild cold-like symptoms in adults and healthier children, it can cause severe symptoms in babies 12 months and younger.

Premature babies, older adults, people with a weak immune system, and those with a pre-existing heart or lung disease can experience severe respiratory problems with the virus.

Symptoms

RSV infection commonly mimics the common cold symptoms in healthy adults and children. The symptoms appear four to six days after exposure to the virus and may include:

Sore throat
Dry cough
Congested or runny nose
Low-grade fever
Headaches

In severe cases, the RSV virus can spread to the lower respiratory tract causing bronchitis or pneumonia with the following symptoms.

Severe cough
Difficulty in breathing
Wheezing, where a high-pitched noise is heard while breathing out
Fever
Bluish tinge in skin color because of lack of oxygen

Severely affected infants can show symptoms like:

Cough
Poor feeding
Irritability
Breathing difficulties with short, shallow, and rapid breathing
Lethargy or unusual tiredness

Most adults and children with RSV infection recover in one to two weeks. More severe cases may require hospital stays to make a full recovery.

FDA approves RSV vaccine for older adults

The U.S. Food and Drug Administration (FDA) has approved two new RSV vaccines for adults 60 and older. GSK’s Arexvy vaccine was approved on May 3, while Pfizer’s Abrysvo was approved on May 31, 2023.

Both vaccines are approved for older adults aged 60 and above, who are more vulnerable to the virus.

The vaccines would help prevent RSV infection in older adults, particularly those with an underlying health condition like a weakened immune system or a heart or lung disease that can increase the severity of the virus infection.

The Vaccine's Safety and Effectiveness

GSK’S Arexvy

The FDA’s approval of GSK’s vaccine, Arexvy, was based on research involving a clinical trial where a single dose of the vaccine was given to adults 60 years and older.

About 12,500 participants were given the vaccine Arexvy, while another 12,500 received a placebo.

The vaccine reduced the RSV infection risk by 82.6%, while the risk of developing a severe infection was decreased by 94.1%.

The common side effects experienced by participants receiving the vaccine were joint stiffness and pain, fatigue, muscle pain, and headache. Among all the participants, six people who received the vaccine and four who received the placebo had atrial fibrillation.

Two other studies were done where 2,500 older adults received the Arexby vaccine. In one study, the vaccine was given with an influenza vaccine. Two people had ADEM (acute disseminated encephalomyelitis), a rare brain and spinal cord inflammation; one died from the complication.

In the second study, one person had the Guillain-Barré syndrome.

The FDA has required the company to investigate the instances of ADEM and Guillain-Barré syndrome. The company has further committed to assessing the risks of atrial fibrillation through a post-marketing study.

Pfizer’s Abrysvo

The FDA has approved Abrysvo based on a clinical trial involving 17,000 participants who got the vaccine and another 17,000 people who received a placebo.

The vaccine reduced the risk of RSV with two or more symptoms by 66.7% while reducing the risk with three or more symptoms by 85.7%.

Pfizer’s Abrysvo was 62% effective in reducing RSV-related respiratory infections that may require hospitalization in older adults.

Some side effects reported were pain in the shot site, muscle pain, fatigue, and headache.

Ten people who got the vaccine and four who received a placebo experienced atrial fibrillation. One participant has Guillain-Barré syndrome, while another got a variant of it.

FDA required Pfizer to investigate the risks of Guillain-Barré syndrome. The company also offered to assess the risks of atrial fibrillation.

While both vaccines are considered comparable in effectiveness, no head-to-head comparison was done.

FDA Approves RSV Injection for Infants

The drug, called Beyfortus, is the first monoclonal antibody approved for all infants during their first RSV seasons.

The injectable drug can protect children up to 2 years old from respiratory syncytial virus.

How do the vaccines work?

Both GSK and Pfizer vaccines target the F protein present on the surface of the RSV virus. The protein changes shape, helping the virus infect the cells in humans.

The vaccines keep the K protein in its pre-fusion state to trigger the creation of antibodies that help the immune system in humans fight off the virus effectively.

What about the RSV vaccine recommended for pregnant women?

An FDA advisory panel is considering the approval of an RSV vaccine for infants. The vaccine made by Pfizer, if approved, would be given to pregnant women in their final semester to protect the unborn baby from RSV risks.

Sources:

ttps://www.cdc.gov/rsv/index.html#:~:text=Related%20Pages,for%20infants%20and%20older%20adults. https://www.mayoclinic.org/diseases-conditions/respiratory-syncytial-virus/symptoms-causes/syc-20353098 https://www.healthychildren.org/English/health-issues/conditions/chest-lungs/Pages/RSV-When-Its-More-Than-Just-a-Cold.aspx https://medlineplus.gov/respiratorysyncytialvirusinfections.html https://www.cdc.gov/media/releases/2023/s0629-rsv.html#:~:text=These%20vaccines%20provide%20an%20opportunity,to%20help%20prevent%20respiratory%20infections. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine

Información general, no consejo médico

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