🌟💉 Pfizer’s R.S.V. Vaccine Approved by F.D.A. Fo’ Kupuna Adults 60 an’ Up 🌟💉

Da Food an’ Drug Administration (F.D.A.) wen’ give da nod on Wednesday to Pfizer’s vaccine fo’ tackle da respiratory syncytial virus, o’ R.S.V., fo’ kupuna adults 60 an’ ola. Dis da second vaccine approval dis month fo’ help fight against dis virus, braddahs an’ sistahs. 🌬️💪💉

Befo’ Pfizer, GSK, anodda drug company, was da first fo’ get da F.D.A.’s permission fo’ market an R.S.V. vaccine on May 3. Dese vaccines stay suppos’ to come out in da fall just in time fo’ da R.S.V. season, wen’ dis nasty bug stay goin’ wild. 🍂🌊💉

Eh, why dis matter? Well, dis bug stay goin’ afta’ da older folks mo’ hard. Every year, ‘bout 60,000 adults dat stay 65 an’ up end up in da hospital ‘cause of R.S.V., an’ ‘bout 6,000 to 10,000 end up passin’ away from dis virus, da F.D.A. wen’ estimate. Da Centers fo’ Disease Control an’ Prevention, or C.D.C., wen’ figga’ dat fo’ prevent one R.S.V. death in da older folks, mo’ den 21,000 people would need fo’ take da GSK vaccine, an’ fo’ da Pfizer shot, da numba’ wen’ be near 25,000. Dass plenny, yeah? 😷👴👵💔

Dis virus wen’ be one big part of da “tripledemic” dis past winter, along wit’ da Covid, da flu, an’ da R.S.V. Ehu, dis stay mo’ tough on da small kids, an’ da hospitals wen’ get swamped tryin’ fo’ handle everyting. 😰🤒🤧

No just da older folks, but da babies an’ small keiki stay at risk too, yeah? R.S.V. stay one top killer of da infants all ova’ da world. Scientists stay checkin’ out different treatments, like one vaccine fo’ da mamas an’ one monoclonal antibody fo’ da infants fo’ fight against R.S.V. But still unda’ agency review, so we gotta wait an’ see, brah. 👶👀🌎

Okay, goin’ back to da past, wen’ da doctors get togedda’ fo’ talk story ‘bout da vaccines, dey wen’ talk ‘bout da safety stuffs. Pfizer’s vaccine, dey call ‘um Abrysvo, stay gettin’ ‘bout 67 percent effective ‘gainst da virus wen’ get two symptoms, an’ 86 percent effective wen’ get three o’ mo’ symptoms. Dass da data da F.D.A. wen’ get from ‘um. Da GSK vaccine, dey call ‘um Arexvy, stay gettin’ ‘bout 83 percent effective ‘gainst da severe kind of R.S.V. 💪🔬💊

But, ho, da doctors wen’ get one concern too, you know. Dey wen’ notice few cases wea’ da folks who wen’ get da vaccines start gettin’ autoimmune syndromes not long afta’ dey take da shots. Eh, das not good, yeah? 🤔😬

One patient who wen’ get da R.S.V. vaccine from Pfizer, out of ‘bout 34,000 patients, one week afta’ da shot, wen’ come down wit’ dis real bad case of Guillain-Barré syndrome. Das one condition wea’ da immune system wen’ attack da nervous system, can be life-threatenin’. Den, anodda patient wen’ get one subtype of dat condition called Miller Fisher syndrome, eight days afta’ da shot. Dese cases wen’ make da rate of dat condition go up to ‘bout one in 9,000. But normally, das suppos’ to happen at ‘bout one in 100,000 in da general population. Some doctors wen’ feel kinda worried, cuz da numba’ of severe R.S.V. cases in da patient group was pretty low. But still, da F.D.A.’s advisory panel wen’ vote 7 to 4 fo’ say da Pfizer vaccine stay safe an’ effective. Dey wen’ vote 10 to 2 fo’ say da GSK vaccine stay good too, even dough dat one had one Guillain-Barré case an’ two odda cases wea’ da disorder stay possibly connected. 😨💉💔

Okay, wat’s next? Wea’ da shots stay? Da C.D.C. doctors stay goin’ talk ‘bout da recommendations fo’ da healthcare providers in one meetin’ next month. Dey stay sayin’ so far, da data from da GSK an’ Pfizer trials stay showin’ dat da vaccines stay good fo’ da folks 65 an’ ola. Da spokeswoman fo’ Pfizer, Jerica Pitts, wen’ say da company stay ready fo’ ship da vaccine. But she no tell us how much da vaccine goin’ cost, but she say if da Medicaid an’ Medicare say da vaccine stay medically necessary, no need pay nottin’. GSK wen’ say earlier dat dey vaccine goin’ come out in da fall. So, we jus’ gotta wait an’ see, braddahs an’ sistahs. 🚚💲💉

Das da scoop, yeah? Da F.D.A. wen’ say okay to Pfizer’s R.S.V. vaccine fo’ da kupuna adults. We stay hopeful dis vaccine goin’ help protect our older folks an’ keep ‘em safe from dis virus. Stay tuned fo’ more updates, cuz we stay all in dis togedda’. 🌟💪🌬️💉

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NOW IN ENGLISH

🌟💉 Pfizer’s R.S.V. Vaccine Approved by FDA for Kupuna Adults 60 and Up 🌟💉

The Food and Drug Administration (FDA) has given its approval to Pfizer’s vaccine for combating the respiratory syncytial virus (R.S.V.) in kupuna adults aged 60 and older. This marks the second vaccine approval this month aimed at fighting against this virus. 🌬️💪💉

Prior to Pfizer, another pharmaceutical company, GSK, became the first to receive FDA permission to market an R.S.V. vaccine on May 3. These vaccines are expected to be available in the fall, just in time for the R.S.V. season when this harmful virus tends to spread widely. 🍂🌊💉

Why does this matter, you ask? Well, this virus particularly affects older individuals. Every year, around 60,000 adults aged 65 and above end up hospitalized due to R.S.V., and approximately 6,000 to 10,000 people die from this virus, according to estimates by the FDA. The Centers for Disease Control and Prevention (CDC) has determined that to prevent one R.S.V. death in older individuals, more than 21,000 people would need to receive the GSK vaccine, and for the Pfizer shot, the number would be close to 25,000. That’s quite significant, isn’t it? 😷👴👵💔

During the past winter, R.S.V. was a major part of the “tripledemic” alongside Covid and the flu. This was particularly challenging for young children, and hospitals faced difficulties handling the overwhelming number of cases. 😰🤒🤧

It’s not just older individuals who are at risk but also babies and young children. R.S.V. remains a leading cause of infant mortality worldwide. Scientists are exploring different treatments, such as a vaccine for mothers and a monoclonal antibody for infants, to fight against R.S.V. However, these treatments are still under agency review, so we’ll have to wait and see. 👶👀🌎

Now, let’s go back to when the doctors discussed the vaccines and their safety. Pfizer’s vaccine, known as Abrysvo, has shown an effectiveness of around 67 percent against the virus with two symptoms, and 86 percent effectiveness with three or more symptoms, based on the data reviewed by the FDA. The GSK vaccine, called Arexvy, has demonstrated around 83 percent effectiveness against the severe form of R.S.V. 💪🔬💊

However, the doctors have expressed a concern as well. They have observed a few cases where individuals who received the vaccines developed autoimmune syndromes shortly after receiving the shots. That’s not good, right? 🤔😬

For instance, one patient who received Pfizer’s R.S.V. vaccine, out of approximately 34,000 patients, developed a severe case of Guillain-Barré syndrome one week after the shot. Guillain-Barré syndrome is a condition where the immune system attacks the nervous system and can be life-threatening. Another patient developed a subtype of that condition called Miller Fisher syndrome eight days after the shot. These cases increased the incidence rate of the condition to about one in 9,000, whereas in the general population, it typically occurs at a rate of about one in 100,000. Some doctors expressed concerns because the number of severe R.S.V. cases in the patient group was relatively low. Nonetheless, the FDA’s advisory panel voted 7 to 4 in favor of the safety and efficacy of the Pfizer vaccine. They voted 10 to 2 to support the GSK vaccine as well, despite one Guillain-Barré case and two other possibly connected cases of the disorder. 😨💉💔

So, what’s next? Where are the shots? CDC doctors will discuss recommendations for healthcare providers in a meeting next month. They have stated that the data from the GSK and Pfizer trials so far indicate that the vaccines are suitable for individuals aged 65 and older. Pfizer’s spokesperson, Jerica Pitts, mentioned that the company is ready to ship the vaccine. However, she did not disclose the cost of the vaccine, but she stated that if Medicaid and Medicare deem the vaccine medically necessary, there will be no charge. GSK previously announced that their vaccine would be available in the fall. Therefore, we’ll have to wait and see, my friends. 🚚💲💉

That’s the scoop, right there! The FDA has given the green light to Pfizer’s R.S.V. vaccine for kupuna adults. We remain hopeful that this vaccine will help protect our older population and keep them safe from this virus. Stay tuned for more updates because we’re all in this together. 🌟💪🌬️💉