Vaccine to Protect Infants from RSV Could Be Approved Soon

RSV infections are no joke. These lower respiratory tract infections can take their toll on those who become infected. Historically, infants have been a “particularly vulnerable group.” According to an article by Jennifer Henderson from MedPage Today, hospitalization rates peak in early infancy and “mortality rates for hospitalized infants range from 1% to 3% . . . .”
Some risk factors such as prematurity, immunodeficiency, and chronic lung or heart disease affect transmission of RSV infections, but the fact remains that healthy infants who become infected with RSV are not spared from illness and death, especially if they are younger than six months.

That’s why the safety data for Pfizer’s RSV prefusion F protein vaccine, which is given to expectant mothers in the second or third trimester, is so encouraging. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 14-0 in support of this vaccine. While the FDA has already approved this vaccine for older adults, additional studies have resulted in data that supports the effectiveness of this vaccine for infants.

A trial involving nearly 7,000 mothers helped determine the efficacy of the vaccine. Half of the expectant mothers received the vaccine and half received a placebo. According to Christina Jewett’s article in The New York Times, “for the first 90 days after birth, six infants in the vaccination group had a serious case of R.S.V., compared with 33 in the placebo group, translating to an efficacy of nearly 82 percent.”

However, the effectiveness of the vaccine does appear to wane over time, as the vaccine efficacy was 69.4% at 180 days after birth. Nineteen babies fell ill in the group that had the vaccine compared to 62 in the placebo group. Thus, the vaccine provides stronger protection for infants in the first three months of their lives.

Furthermore, the FDA staff deemed the vaccine safe for infants. With respect to adverse events, there were no consequential differences among the infants when the mothers who received the placebo were compared to the mothers who received the vaccine. Expectant mothers who were administered the vaccine experienced some muscle pain and injection site pain, but it was short term, lasting only a few days.

There is some concern, however, that the vaccine is associated with premature delivery. Of the mothers who received the vaccine, 5.6% had preterm births, while 4.7% of the mothers in the placebo group had preterm births. However, FDA officials believed that this “imbalance” was “not statistically significant.”

Now that the RSV vaccine has been recommended by FDA staff, the FDA will review the information and make a final decision. Given our commitment to stay up to date on health issues affecting pregnant women, we’ll be following these developments closely.

Why The Eisen Law Firm cares about a Vaccine to Protect Infants from RSV

We believe that in order to do our job of advocating for patients, including the youngest among us, we need to stay abreast of the latest technology and research in healthcare and medicine. And of course, we need to stay aware of the latest changes in the laws affecting medical issues, too. We only get involved when something goes wrong, but knowing what is right is part of the equation.

If you or someone you love has been seriously hurt by a medical provider, please give us a call at (216) 687-0900 or contact us online today.