- Scientists say that late-stage RSV vaccine trials show "exciting promise" in treating the respiratory infection
- The experimental vaccine was found effective in preventing RSV-associated respiratory conditions
- The scientists also gave the vaccine to women in late-stage pregnancy and found it was 82% effective among infants
Scientists say that the late-stage RSV vaccine trials show "exciting promise" in the continued efforts to fight against the respiratory syncytial virus (RSV).
In one company-funded trial conducted on adults aged 60 and older, researchers published the results in the New England Journal of Medicine. The treatment was found to prevent RSV-associated lower respiratory tract illness. This includes acute bronchitis and pneumonia.
Late-Stage RSV Vaccine Trials Show Promise
Furthermore, scientists observed that the experimental vaccine prevented RSV-associated acute respiratory illness and had no apparent safety concerns. In a separate company trial, the interim results of which were published on Wednesday in the journal, the experimental vaccine was given to women during late-stage pregnancy.
Within that trial, the vaccine was effective in preventing severe RSV-associated lower respiratory tract illnesses such as bronchiolitis and pneumonia in infants. The former is the inflammation of the small airway passages entering the lungs, as per CNN.
Pharmaceutical company Pfizer is now seeking the approval of the United States Food and Drug Administration (FDA) for its RSV vaccine for older adults. The company also filed a separate request asking the health agency to approve its experimental vaccine for pregnant people to protect infants. Officials said that it expects to receive a decision on the matter by August.
Furthermore, the FDA is also considering a monoclonal antibody treatment designed to protect children up to two years old. Vaccine advisers to the FDA in March voted in favor of approving RSV vaccine candidates from Pfizer and GlaxoSmithKline (GSK) for people over the age of 60.
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Treatment on Infants
The latest vaccines could be the first maternal vaccine in the world if the FDA decides to approve and agree with the advisory committee's decision. The trials showed that the experimental vaccine is 82% effective in preventing severe infection among infants, according to The Hill.
Despite the promising results of the late-stage vaccine trials, scientists are urging for the monitoring of older adults for Guillain-Barre syndrome. This comes after two people were found to have developed the nervous system disorder after receiving the treatment.
The scientists added that if the experimental RSV vaccine is approved and recommended, there should be close monitoring for the adverse effects in future studies, real-world data, and postmarketing surveillance.
The condition is a rare disorder where a person's immune system mistakenly attacks the nerves inside the body. Symptoms of this syndrome can range from brief weakness to paralysis, based on data from the National Institutes of Health. Fortunately, most people who develop the disorder recover, even from severe cases.
Now, the scientists' call for monitoring the condition echoes the position of the FDA, which has asked Pfizer to include Guillain-Barre as an "important potential risk" to its experimental vaccine. They also asked the pharmaceutical company to develop a safety study to monitor for such cases if the treatment is approved in May, said CNBC.
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