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By Brenda Goodman, CNN
Pfizer says it has enough promising information about its respiratory syncytial virus, or RSV, vaccine designed for newborns that it will finalize enrollment in the study and send it to the U. S. Food and Drug Administration. The U. S. government is expected to be approved until the end of the year.
RSV is a common respiratory virus that causes mild cold-like symptoms but can cause serious illness, especially in the elderly and infants. Pfizer’s vaccine candidate is given to pregnant women who then produce antibodies that cross the placenta and protect the baby after birth.
“The [study data tracking committee] recommended, based on the knowledge we have, that we deserve to approve and present, that this provides the possibility of a safe and effective vaccine that could significantly help save you from RSV in the winter season,” Dr. William Gruber, senior vice president of vaccine clinical studies and progression at Pfizer, told CNN.
In the trial, the vaccine was given to pregnant women and was approximately 80% effective in preventing severe RSV disease in their infants during the first 3 months of life. It also halves the threat that a baby will want to see a doctor for an RSV infection.
If approved, Pfizer’s inoculation will be the first RSV and first new product linked to the infection in more than two decades.
In March, the FDA designated Pfizer’s RSV vaccine as a breakthrough therapy, speeding up its review.
“This puts us in an ideal position to necessarily have something right before next winter,” Gruber said, noting that Pfizer and the FDA are aware of the strong RSV season underway in the U. S. U. S.
“It will be up to them whether or not they can think of some other path that could allow this to happen sooner,” he said.
Pfizer’s vaccine is the virus’ F protein, the site it uses to attach to human cells. The protein freezes in the way it folds before fusing with a cell, so the immune formula can produce antibodies opposite to it. Pfizer’s RSV vaccine is bivalent, containing F proteins from subgroups A and B of the RSV virus, which are the two most common strains in circulation.
In a study of 7400 pregnant women and infants, the vaccine is 82% effective in preventing serious respiratory tract infections in young children hospitalized during the first 3 months of life. It is approximately 70% effective in preventing severe RSV in infants hospitalized for six months.
Hospitalized toddlers had severe RSV if they breathed too fast, more than 70 breaths per minute in a 2-month-old; if your blood oxygen point has fallen below 93%; if they have needed high-flow oxygen in the intensive care unit for more than 4 hours; or if they didn’t respond.
The vaccine reduced the need for infants to see a doctor because of RSV by more than 50% on average compared to placebo. However, this result is not within a statistical diversity specified by the FDA before the trial began, so the company acknowledges that the vaccine missed that specific goal.
Gruber notes, however, that a 50% relief in doctor visits due to RSV is likely to remain a noticeable and significant benefit in the real world.
“Obviously, this is enough and, frankly, wonderful news to put our approval on record,” he said.
Pfizer also recently announced the effects in an ongoing trial of the same vaccine in older adults.
The drugmaker’s filing with the FDA would make it the first in a box packed with companies seeking RSV vaccines. GSK tests a maternal vaccine, but halted its study after learning of a protection issue.
GSK said on Monday that the test remained halted, not providing any major points on the security issue.
“Further research is underway to better understand the protection data from those trials,” spokeswoman Alison Hunt said in a statement to CNN. “The relevant regulatory government and trial investigators have been informed.
There have been no known protective considerations with the Pfizer vaccine, Gruber said, and a panel of independent reviewers who reviewed the vaccine’s effects as the trial progresses found no problems.
“The vaccine is very tolerable and no signs of protection have been identified,” he said, although full effects of the trial have not been published.
Although Pfizer is postponing enrollment in the maternal vaccination trial, Gruber says it will continue to track babies who are enrolled.
“We know that children who have RSV end up with compromised lung health and more susceptible, in many cases, to other respiratory infections that land them back in the hospital. So we’re very interested to know if this doesn’t just have a quick effect, since the vaccine was designed to have coverage rather than RSV, but it could have an added advantage by allowing those kids to do better in the long run,” he said.
El-CNN-Wire™
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