pertussis vaccine pregnancy :: Article CreatorFDA Approves 1st Maternal RSV Vaccine To Help Protect Infants
The U.S. Food and Drug Administration has approved the first maternal vaccine intended to help protect newborns against respiratory syncytial virus (RSV). The vaccine would be given during late pregnancy to reduce the risk of severe RSV infection among newborns.
However, the vaccine won't be available on pharmacy shelves for pregnant women immediately. It is still awaiting an evaluation from an expert panel at the Centers for Disease Control and Prevention, and the CDC director's sign-off -- a regulatory process that is likely to take place in the coming weeks, according to a CDC spokesperson.
In the meantime, infants will have access to another newly approved tool called nirsevimab -- a monoclonal antibody shot that is recommended for all infants less than 8 months old.
"We're hopeful that these two [products] will work together so that we can provide the most protection to the most individuals possible," Dr. Elizabeth Schlaudecker, medical director in the division of infectious disease at Cincinnati Children's Hospital who was involved in the maternal vaccine clinical trial, told ABC News.
RSV, a common respiratory illness, can be deadly for infants because of their susceptibility to bronchiolitis, inflammation of the smallest airways that makes it hard for babies to breathe, and is a common cause of pneumonia in babies.
Thic Electron Micrograph Reveals The Morphologic Traits Of The Respiratory Syncytial Virus RSV.
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Two to three out of every 100 infants with an RSV infection may require hospitalization, and every year the virus leads to 58,000 to 80,000 hospitalized children less than 5 years old, according to the CDC.
The newly approved vaccine, manufactured by Pfizer as Abrysvo, is already available at major pharmacies for adults 60 years and older who are also a population at risk of severe infection from RSV.
This vaccine stimulates the immune system to make antibodies against a protein from the virus called the F protein that RSV uses to attach to human cells and cause infection.
The idea behind the maternal vaccine is that when given during the third trimester of pregnancy, there's enough time to build immunity against RSV and pass it along to the baby before birth. This immunity won't last forever but can help protect the youngest babies when they are the most vulnerable in the first six months of life.
"The great news about this vaccine is without even having to vaccinate a baby, before they're born they are starting to receive protection against one of our most feared viruses," said Schlaudecker.
This isn't the only vaccine that works in this manner. A booster of the tetanus, diphtheria, and pertussis vaccine, called Tdap, is also recommended to be given to pregnant women between 27- and 36-weeks' gestation to allow protective antibodies to pass on to the baby before birth.
Pfizer's maternal RSV vaccine is more than 80% effective at combatting severe illness that required a doctor's visit among infants through the first three months of life, and still reduced risk as far as 6 months, according to clinical trial results published in the New England Journal of Medicine.
While there were no major safety concerns or serious adverse events found during the clinical trials, four out of the fourteen experts on an independent FDA advisory committee that met in May this year said the data presented to them was not adequate enough to vote in favor of vaccine safety, citing concerns that the data signaled toward an association with increased premature births even though it was not statistically significant in the studies.
In its news release, the FDA said "the Prescribing Information for Abrysvo includes a warning to inform that a numerical imbalance in preterm births in Abrysvo recipients (5.7%) occurred compared to those who received placebo (4.7%). The available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo."
The FDA also said it's requiring Pfizer to conduct post-marketing studies "to assess the signal of serious risk of preterm birth and to assess hypertensive disorders of pregnancy, including pre-eclampsia."
The CDC's Advisory Committee for Immunization Practices (ACIP) will meet to discuss Abrysvo in the coming weeks. Now that there are two FDA-approved RSV products for infants, the CDC committee will likely need to determine specific recommendations for both products.
A pregnant woman receives a vaccine shot.
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Symptoms of RSV include coughing, fever, runny nose, sneezing, wheezing and a decrease in appetite, according to the CDC.
RSV typically causes a mild illness for most people but can be dangerous for the elderly, infants and babies, with some vulnerable children at an even greater risk of severe illness, including those born prematurely, immunocompromised children and those suffering from congenital heart and lung diseases, the CDC said.
"[RSV] can lead to difficulty breathing like fast breathing, and sometimes the infants have trouble feeding because they're breathing so hard. And that is certainly when we begin to get worried… it is something that we see very commonly in young children, but it can be very scary," Schlaudecker said.
Experts say that any tool to prevent severe infection from RSV benefits babies because there is no specific treatment for this virus other than supportive care.
Dr. Maria Deza Leon, a mother enrolled in the clinical trial and pediatric infectious disease fellow at Cincinnati Children's Hospital, told ABC News that she wanted to participate in the trial as another way to protect her unborn son after seeing countless babies in the hospital struggling to breathe from RSV.
"I was very excited to participate, because when I was a resident I saw so many cases of RSV bronchiolitis...It was a very scary thing to see. And I could see the parents faces and see how they were so scared to see their kids struggling to breathe… if there's a chance that I could protect my baby from this horrible viral infection. Sign me up," Deza Leon told ABC News.
Deza Leon said getting the shot was a lot like getting the Tdap booster in pregnancy but hasn't been told if she received the placebo shot or the maternal RSV vaccine yet. Since enrolling in the clinical trial, she has given birth to a healthy 18-month-old son who she said has never had RSV that she knows of yet.
Deza Leon hopes that her story will help more mothers want to get the vaccine when it's available.
"There's nothing scarier for a parent than seeing your kid struggling to breathe ... I think if you have the opportunity to protect your kids, then you should take it and getting the RSV vaccine if you're a pregnant mom is a great way to do that. So, I would 100% recommend it," she said.
Dr. Jade A Cobern, M.D., M.P.H. Is a licensed and practicing physician, board-eligible in pediatrics and preventive medicine, and is a member of the medical unit.
What To Know About The RSV Vaccine In Pregnancy
RSV is the leading cause of infant hospitalization in the US, reports the CDC, but we may soon have another tool to prevent severe illness in babies. The FDA recently approved Abrysvo, the first vaccine approved for pregnancy to prevent lower respiratory tract disease caused by RSV in babies from birth through 6 months.
Respiratory syncytial virus, or RSV, is a common virus that nearly every child will have contracted by age 2, but it can be especially severe for infants under 12 months, especially those with pre-existing conditions, as well as older adults. The virus is the most common cause of the lung infection bronchiolitis and pneumonia in children under 1 in the US. More than 58,000 to 80,000 children under 5 are hospitalized due to RSV each year, according to the CDC.
Approved for use at 32 weeks through 36 weeks of pregnancy, Pfizer's Abrysvo has already been authorized for adults over age 60 and is given as a single injection into the muscle. The vaccine works by passing antibodies to developing infants from maternal circulation across the placenta during pregnancy, acting as a protective shield against the virus once they're born. "Maternal immunization has been used for decades to help prevent infectious disease in infants such as influenza, tetanus, pertussis, and more recently COVID-19, and can be especially beneficial for diseases that are most severe in very early life," a Pfizer spokesperson tells Motherly.
"RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. "This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."
An antibody-like therapy, Beyfortus, was also recently approved by the FDA and CDC for use in babies born during or entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
In a study of approximately 7,400 pregnant women, who were randomized to receive either a 1-shot dose of the Pfizer RSV vaccine or a placebo during the late second or early third trimester, researchers saw a vaccine efficacy rate of 81.8% against severe disease from RSV in infants from birth through the first 90 days of life. Results also showed 69.4% efficacy against severe disease through the infants' first six months of life.
The August 21 approval comes after an FDA advisory committee voted to support the approval of the maternal RSV vaccine in May, attesting that the available data supported the efficacy and safety of its use. The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety, as some experts were concerned about the adequacy of data to support the vaccine's safety profile.
The vaccine was well-tolerated, but there was some evidence that study participants who were vaccinated may have been more likely to have a preterm birth. In the study, Abrysvo recipients experienced preterm births at a slightly higher percentage (5.7%) compared with placebo recipients (4.7%), though it's unclear whether the vaccine itself caused the difference. FDA officials noted that the difference was not considered statistically significant. To avoid potential risk of preterm birth, it's recommended to get the vaccine later in pregnancy, between weeks 32 and 36 of gestation.
The most commonly reported side effects by pregnant individuals who received Abrysvo were pain at the injection site, headache, muscle pain and nausea. In clinical trials where Abrysvo was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% Abrysvo versus 4.4% placebo) and jaundice (7.2% Abrysvo versus 6.7% placebo).
Even more rare, preeclampsia was reported in 1.8% of pregnant people who received Abrysvo compared to 1.4% of pregnant people who received placebo. It's worth noting that the FDA's final approval of Abrysvo shows that the benefits of receiving the vaccine outweigh any potential risks.
"Newborns and young infants—whose immune systems are still developing and are not yet strong enough to defend against infections—may now be protected from RSV from the moment of birth through maternal immunization," said Eric A.F. Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, in a press release. "The approval of Pfizer's ABRYSVO is a major triumph as it helps ensure no delay in potential RSV protection during an infant's most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV."
We don't yet know when the RSV vaccine in pregnancy will be available, though Pfizer has been manufacturing the vaccine ahead of the 2023/2024 RSV season, the Pfizer spokesperson tells Motherly, which usually starts in September. The CDC still has to review and sign off on the vaccine, though the committee that advises the agency on vaccine recommendations is expected to meet soon to determine recommended use.
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Free TDAP Vaccination For All Pregnant Women From Next Year, Says Dr Zaliha
Health Minister Dr Zaliha Mustafa said all pregnant women in the country, including non-citizens, will receive the Tdap vaccine for free. — Bernama pic
PUTRAJAYA, Aug 28 — Starting next year, all pregnant women in the country, including non-citizens, will receive the Tdap (tetanus, diphtheria and acellular pertussis) vaccine for free, said Health Minister Dr Zaliha Mustafa.
She said this new initiative involving an annual allocation of RM25 million for an estimated 500,000 pregnant women yearly, aims to reduce the risk of pertussis (whooping cough) infection especially among babies who are below five months.
She said in a statement today that the implementation will begin after the procurement of the Tdap vaccine supply is completed and its supply is available at the Ministry of Health's (MoH) facilities nationwide.
"Once implemented, all pregnant women, including non-citizens, will be given a dose of the Tdap vaccine for free in the second or third trimester of pregnancy (between the 13th to 36th week of pregnancy) at MoH premier health facilities around the country," she said.
According to Dr Zaliha, giving the Tdap vaccine to pregnant women will give protection to the foetus until the baby is born, and until they can complete three primary doses of the pertussis vaccine at the age of five months.
She also said babies below five months form the group with the highest risk of contracting pertussis and experiencing complications arising from diseases such as pneumonia, encephalopathy, and leading even to death.
Dr Zaliha added that this happens because the antibodies in a baby's body will only reach an optimal level of protection when the baby has received three doses of the pertussis vaccine given under the National Immunisation Programme at the age of five months.
Until Aug 23 (this year), she said a total of 343 cases of pertussis, with 24 deaths, were recorded in the country.
From these 343 cases, 172 cases or 50.4 per cent were infants under the age of five months, while of the 24 deaths recorded, 19 were infants under the age of five months. — Bernama
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