(Reuters) – A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Friday will vote on the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in pregnant women, likely paving the way for it to become the country’s first maternal shot for protecting babies from the virus.
A working group of panel members who are set to present their analysis on the vaccine backed recommending the shots from September to January for women in the middle of their third trimester of pregnancy, according to documents published ahead of the meeting.
The vaccine was approved by the U.S. Food and Drug Administration last month for use in women during the middle of the third trimester, at 32 to 36 weeks, to prevent lower respiratory tract infection and severe disease in infants until they are six months old.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. It is typically a seasonal illness, starting in the autumn and peaking in the winter in most of the U.S., according to the CDC.
An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data.
Pfizer’s vaccine, along with another made by GSK, won U.S. approval in May for use in people age 60 and older and are already available around the country.
Most of CDC’s working group members supported a full recommendation of the shot’s approved dosing timing at 32 through 36 weeks, which is likely to reduce a possible risk of preterm births and complications that might arise from giving it earlier in pregnancy, they said.
At an advisory meeting in May, FDA staffers had flagged a higher number of pre-term births among participants taking Pfizer’s vaccine in a clinical trial compared to those who received a placebo. However, the agency said the difference did not appear to be statistically significant, thus might have been due to chance.
(Reporting by Sriparna Roy in Bengaluru; Editing by Bill Berkrot)
