FDA panel recommends Pfizer’s RSV vaccine for UNBORN babies

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A Pfizer vaccine that could protect unborn babies against the common respiratory syncytial virus (RSV) has been recommended for approval by Food and Drug Administration advisors.

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The agency’s expert panel unanimously voted Thursday that the injection was effective in preventing severe illness from RSV in infants under six months old.

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But four of the 14 panelists expressed concern about whether the shot was safe, saying there was some evidence it could increase the risk of preterm birth.

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The vaccine is given in a single dose to pregnant women in the second or third trimester of pregnancy and works by generating anti-RSV antibodies that can then be passed through the placenta to babies in the womb.

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The FDA will still decide on the shot, but could approve it as early as August, just before RSV season, making it the world’s first infant RSV vaccine. It comes after the desk approved the world’s first-ever vaccine for RSV earlier this month.

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Virtually all children get RSV at least once by the time they are two years old, and most face a mild, cold-like illness.

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But the FDA says babies younger than six months are at particular risk of severe illness from the virus, which may be because their immune systems are still developing or because they can’t cough as vigorously as older children.

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Up to one in 50 children in this age group is hospitalized by the virus, the FDA says, with treatments such as IV fluids and mechanical ventilators. In the US, several hundred children under the age of five die each year from the infection.

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The Pfizer vaccine – called RSVpreF – works by exposing the mother to a protein from the surface of RSV, which triggers an immune response and the production of anti-RSV antibodies.

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These can then enter babies still in the womb through the placenta. They can also be transmitted after birth through the colostrum – the first milk a baby drinks from its mother.

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They can remain in a baby for up to six months, strengthening defenses as a baby gradually builds up their immune system.

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All 14 members of the FDA panel voted that the vaccine was effective in preventing serious illness in infants when administered to pregnant mothers, and 10 of the 14 voted that the safety data was “generally favorable” for use in pregnant women. women.

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The FDA will now decide whether to approve the vaccine, but the agency normally follows the advice of its expert panel.

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However, some members were concerned that the vaccine increased the risk of preterm birth.

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Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who has previously raised concerns about the Covid vaccine, said the safety data was “reassuring” overall.

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But he added, reports that ‘if you are somehow risking premature birth with this vaccine, I think there will be a high price to pay’.

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He also pointed out that GSK had suspended its trials of a similar RSV vaccine in pregnant women after noticing a rise in preterm birth and neonatal mortality, or when a baby dies during the first 28 days of life.

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Dr. Offit said the move “hung” over Pfizer’s own infant RSV injections.

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“If GSK really stops with a program for a similar, almost identical vaccine, it will stick [Pfizer’s] program.’

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Dr. Jay Portnoy, medical director at Children’s Mercy Hospital in Kansas City, who voted in favor of the vaccine’s safety and effectiveness, also warned that premature birth could dampen the jab’s benefits.

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“The problem is that if the child is born earlier, that also reduces the effectiveness of the treatment, because earlier birth means fewer antibodies are transferred,” he said.

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“So this is a really complicated thing, because now the damage actually diminishes the benefit. There is an interaction between the two.’

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Babies born prematurely — before week 37 of pregnancy — are at greater risk for many health complications, including breathing problems, infections and developmental delays.

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The approval was based on data from a phase three trial of the vaccine, which involved 7,400 pregnant women – half of whom received the shot while the rest received a placebo.

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This showed that it was 82 percent effective in preventing serious illness from RSV in newborns during the first 90 days of life.

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The injection was also about 70 percent effective during the baby’s first six months of life against serious illness.

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But the study also showed that there was a higher risk of preterm birth in mothers who received the injection compared to those who received the placebo.

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In the vaccine group, almost six percent of the mothers had a preterm birth, compared to 4.7 percent in the placebo group.

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Pfizer said the difference was not statistically significant, but this has still raised concerns among scientists.

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Pfizer’s senior vice president for vaccine research and development, Dr. William Gruber, supported the safety of their vaccine, saying: “Certainly, in our view, there is no definitive evidence to suggest that there is a risk of preterm birth.

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‘So the question is, are you holding the vaccine’s potential benefits hostage for something that you don’t have any statistical significance at this point in time?’

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