🏥👶💉 Eh, Braddahs an’ Sistahs, No Worries, F.D.A. Get One Shot Fo’ Da Keikis Against R.S.V.!
⬇️ Pidgin | ⬇️ ⬇️ English
Ho, check dis out, da Food and Drug Administration, or as we all call ’em, da F.D.A., wen green light one kine shot for da small keikis, da infants, fo’ protect dem from respiratory syncytial virus, or da buggah we call R.S.V. Dis kine virus stay making da keikis and da small kids choke up and sick all ova da world. 🌍👶🏾🤒
Da kine shot, one monoclonal antibody kine, going be ready jus’ in time fo’ da fall season when da R.S.V. cases usually start going up. 🍁🍂🌡️💉 F.D.A. also stay tinkin’ if fo’ let one R.S.V. vaccine by Pfizer fo’ da wahines when dey get hapai, da pregnant ones, so da vaccine can protect da newborns from da virus. 👩🦱🤰👶💊
Da new treatment approved on Monday, da one dey calling Beyfortus from da guys at Sanofi and AstraZeneca, stay attacking one illness dat can be real mean fo’ da kupuna and da young keikis. Every year, da virus put about 80,000 keiki who stay 5 years old or younger in da hospital, so says da Centers for Disease Control and Prevention. 🦠👶🏾👵🏾🏥
Ho, da R.S.V. can make keikis sick, real sick, and plenty kids gotta see da doctor or go emergency room cause of it every year,” said Dr. John Farley from da F.D.A. Center for Drug Evaluation and Research. “Da approval we just wen give stay helping with da big need we get for products fo’ make da impact of R.S.V. disease on da keikis, da ohana, and da health care system less.” 👨⚕️📚🏛️💊
But no worries, da shot not only fo’ da keikis, da kupuna also going get chance for protect themselves against da R.S.V. Not too long ago, da F.D.A. wen let two vaccines against da virus for adults 60 and older. Every year, da virus stay connected to 60,000 times kupuna gotta go hospital and up to 10,000 times kupuna gotta make, according to da C.D.C. 🧓👵💉🏥
Da F.D.A. advisors wen talk story about da shot for da infants and all of them wen say yes for letting da treatment for da infants in June. Ova 3,200 small keikis wen get da shot in da studies dat Sanofi and AstraZeneca wen show da F.D.A. One study for six months wen find dat da shot was 79 percent good at fighting da really bad R.S.V. dat need medical help. 🗂️📊👶💉
But, da F.D.A. advisors stay more careful about one R.S.V. shot by Pfizer meant for da wahines when dey get hapai. In May, one group wen say 10 to 4 dat da vaccine stay safe, but had some concerns about da wahines who wen get hapai early after getting da vaccine, compared with da ones who got one placebo. 👩🦱🤰💉👨👩👧
Da studies of one similar vaccine by GSK wen stop cause da researchers wen see more wahines giving birth early. Da agency still stay thinking about dat maternal Pfizer vaccine, da one dey calling Abrysvo, but one company wahine wen say dat da approval probably going happen in da coming weeks. 👩🦱🤰👶💊🕐🔜
NOW IN ENGLISH
🏥👶💉 Hey, Brothers and Sisters, No Worries, F.D.A. Has a Shot for Babies Against R.S.V.!
Listen up, the Food and Drug Administration, which we all know as the F.D.A., approved a shot on Monday to protect infants and vulnerable toddlers from the respiratory syncytial virus, or the one we know as R.S.V. This kind of virus is a global threat to babies and young children, making them severely ill. 🌍👶🏾🤒
This shot, a monoclonal antibody type, is expected to be ready just in time for the fall season when R.S.V. cases usually start to increase. 🍁🍂🌡️💉 The F.D.A. is also contemplating approval of an R.S.V. vaccine by Pfizer for pregnant women that is intended to protect infants from the virus. 👩🦱🤰👶💊
The treatment that was approved on Monday, named Beyfortus by its developers Sanofi and AstraZeneca, targets an illness that can be severe in older adults and young infants. According to the Centers for Disease Control and Prevention, about 80,000 children aged 5 and under are hospitalized each year due to the virus. 🦠👶🏾👵🏾🏥
“R.S.V. can cause serious illness in infants and some children, leading to a large number of visits to the emergency department and physician’s office every year,” said Dr. John Farley, an official in the F.D.A. Center for Drug Evaluation and Research. “Today’s approval addresses the significant need for products to help reduce the impact of R.S.V. disease on children, families, and the healthcare system.” 👨⚕️📚🏛️💊
Good news, the potential to mitigate the effects of R.S.V. will extend to older adults too. In recent months, the F.D.A. has approved two vaccines against the virus for adults aged 60 and above. The virus is associated with 60,000 hospitalizations and up to 10,000 deaths each year in people aged 65 and older, according to the C.D.C. 🧓👵💉🏥
Agency advisors, when considering the antibody shot for infants, cast a unanimous vote in favor of approving the treatment for infants in June. More than 3,200 infants were given the shot in the studies that Sanofi and AstraZeneca submitted to the F.D.A. A six-month-long study found that the shot was 79 percent effective against very severe R.S.V. that required medical attention. 🗂️📊👶💉
But F.D.A. advisors were more cautious about a shot by Pfizer intended for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, reflecting concerns about slightly elevated rates of preterm births among mothers who received the vaccine, compared to those who received a placebo. 👩🦱🤰💉👨👩👧
Studies of a similar vaccine by GSK were halted after researchers observed an increase in preterm births. The agency has yet to make a decision on that maternal Pfizer vaccine, called Abrysvo, though a company spokesperson said that approval was anticipated in the coming weeks. 👩🦱🤰👶💊🕐🔜
