CDC Issues Monkeypox Alert, Recommends Two Doses of Vaccine Despite Questions About Efficacy
by Megan Redshaw, Childrens Health Defense:
The Centers for Disease Control and Prevention began sounding the alarm about a potential rise in mpox (formerly monkeypox) outbreaks this summer, just days before publishing studies suggesting that two doses of Bavarian Nordic’s Jynneos vaccine, rather than one, offer “real-world” protection.
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The World Health Organization (WHO) on May 11 ended the global health emergency for mpox — less than a week after it ended the COVID-19 emergency.
But on May 15, the CDC issued a health alert, warning that although mpox cases had declined since peaking last August, “the outbreak is not over.”
The alert informed clinicians and public health agencies that the CDC and local partners were investigating a cluster of mpox cases in the Chicago area, where 12 confirmed and one probable case of mpox had been reported to the Chicago Department of Public Health between April 17 and May 5.
Health officials should be aware of “the potential for new clusters or outbreaks of mpox cases,” the health alert warned. The CDC also warned that it was likely that “spring and summer season in 2023 could lead to a resurgence of mpox as people gather for festivals and other events.”
Nine of the possibly 13 infected men near Chicago were fully vaccinated against mpox, raising concerns over Jynneos’ efficacy. However, the CDC emphasized that “vaccination continues to be one of the most important prevention measures.”
The CDC’s announcement and the Chicago cases were widely covered in the press, leading cities like San Francisco to issue public health announcements encouraging vaccination.
On Thursday, just three days after the CDC issued its alert, the agency also published three new observational studies reporting that the Jynneos vaccine provides “real-world protection” against mpox, and two doses seem to be more effective than one.
Two of the studies were published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) and one was published in the New England Journal of Medicine.
In one of the MMWR studies, a real-world case-match study conducted in 12 U.S. jurisdictions, two doses of Jynneos was estimated to be 85.9% effective against mpox. At one dose, the vaccine was found to be 75.2% effective.
But the CDC real-world study conducted in a larger pool of individuals published in the New England Journal of Medicine, showed much lower efficacy of Jynneos.
In that case-control analysis, in more than 10,000 people from a nationwide electronic health record database, Jynneos was estimated to be 66% effective after two doses, whereas the one-dose efficacy was just 35.8%.
According to Dr. Christopher Braden, the CDC’s mpox response incident manager, “Vaccine effectiveness estimates from these studies ranged from 36% to 75% for one dose and 66% to 86% for two doses of Jynneos vaccine.”
“What we take away from these three studies is that the vaccine effectiveness is substantial and that two doses is definitely better than one,” Braden added.
One of the MMWR reports also stated that “information on Jynneos vaccine effectiveness is limited.”
And Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, also told The Defender that clinical trials were lacking to show effectiveness of the vaccine.
Nass reported on her Substack that the CDC began a study of monkeypox vaccine effectiveness in the Democratic Republic of Congo, but never reported the results.
The New York Times also questioned the vaccine’s effectiveness:
“Many questions remain about the vaccine, which had not been widely used before last summer’s outbreak of mpox, formerly called monkeypox, largely among men who have sex with men.
“None of the new studies were randomized controlled trials, and some of the analyses were small.
“More work is needed to determine how well the vaccine works in immunocompromised people, how long protection lasts and whether that varies depending on how the shots are administered.”
What is mpox?
Mpox is a disease caused by a poxvirus. Symptoms of monkeypox infection are usually mild and include fever, rash and swollen lymph nodes, and occasionally intense headache, back pain, muscle aches, lack of energy and skin eruptions that can cause painful lesions, scabs or crusts.
The virus rarely requires hospitalization — and those who are hospitalized are typically hospitalized for pain control. It is very rarely fatal. According to the WHO, of the nearly 90,000 mpox cases reported worldwide in 2022-2023, there were only 140 deaths.
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CDC Mengeluarkan Peringatan Cacar Monyet, Merekomendasikan Dua Dosis Vaksin Meskipun Ada Pertanyaan Tentang Khasiat
20 Mei 2023
Oleh Megan Redshaw, Pertahanan Kesehatan Anak-anak:
Pusat Pengendalian dan Pencegahan Penyakit mulai membunyikan alarm tentang potensi peningkatan wabah mpox (sebelumnya cacar monyet) musim panas ini, hanya beberapa hari sebelum menerbitkan studi yang menunjukkan bahwa dua dosis vaksin Jynneos Bavarian Nordic, bukan satu, menawarkan perlindungan "dunia nyata".
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Organisasi Kesehatan Dunia (WHO) pada 11 Mei mengakhiri darurat kesehatan global untuk mpox - kurang dari seminggu setelah mengakhiri darurat COVID-19.
Tetapi pada 15 Mei, CDC mengeluarkan peringatan kesehatan, memperingatkan bahwa meskipun kasus mpox telah menurun sejak memuncak Agustus lalu, "wabah belum berakhir."
Peringatan tersebut memberi tahu dokter dan lembaga kesehatan masyarakat bahwa CDC dan mitra lokal sedang menyelidiki sekelompok kasus mpox di wilayah Chicago, di mana 12 kasus mpox dikonfirmasi dan satu kemungkinan telah dilaporkan ke Departemen Kesehatan Masyarakat Chicago antara 17 April dan 5 Mei.
Pejabat kesehatan harus menyadari "potensi klaster baru atau wabah kasus mpox," peringatan kesehatan memperingatkan. CDC juga memperingatkan bahwa kemungkinan bahwa "musim semi dan musim panas pada tahun 2023 dapat menyebabkan kebangkitan mpox saat orang-orang berkumpul untuk festival dan acara lainnya."
Sembilan dari mungkin 13 pria yang terinfeksi di dekat Chicago telah divaksinasi penuh terhadap mpox, meningkatkan kekhawatiran atas kemanjuran Jynneos. Namun, CDC menekankan bahwa "vaksinasi terus menjadi salah satu tindakan pencegahan yang paling penting."
Pengumuman CDC dan kasus Chicago diliput secara luas di media, memimpin kota-kota seperti San Francisco untuk mengeluarkan pengumuman kesehatan masyarakat yang mendorong vaksinasi.
Pada hari Kamis, hanya tiga hari setelah CDC mengeluarkan peringatannya, agensi tersebut juga menerbitkan tiga studi observasional baru yang melaporkan bahwa vaksin Jynneos memberikan "perlindungan dunia nyata" terhadap mpox, dan dua dosis tampaknya lebih efektif daripada satu.
Dua studi diterbitkan dalam Morbidity and Mortality Weekly Report (MMWR) CDC dan satu diterbitkan di New England Journal of Medicine.
Dalam salah satu studi MMWR, studi kasus-pertandingan dunia nyata yang dilakukan di 12 yurisdiksi AS, dua dosis Jynneos diperkirakan 85,9% efektif melawan mpox. Pada satu dosis, vaksin ditemukan 75,2% efektif.
Tetapi studi dunia nyata CDC yang dilakukan di kumpulan individu yang lebih besar yang diterbitkan di New England Journal of Medicine, menunjukkan kemanjuran Jynneos yang jauh lebih rendah.
Dalam analisis kasus-kontrol itu, pada lebih dari 10.000 orang dari basis data catatan kesehatan elektronik nasional, Jynneos diperkirakan 66% efektif setelah dua dosis, sedangkan kemanjuran satu dosis hanya 35,8%.
Menurut Dr. Christopher Braden, manajer insiden respons mpox CDC, "Perkiraan efektivitas vaksin dari studi ini berkisar dari 36% hingga 75% untuk satu dosis dan 66% hingga 86% untuk dua dosis vaksin Jynneos."
"Apa yang kami ambil dari tiga studi ini adalah bahwa efektivitas vaksin sangat besar dan bahwa dua dosis pasti lebih baik daripada satu," tambah Braden.
Salah satu laporan MMWR juga menyatakan bahwa "informasi tentang efektivitas vaksin Jynneos terbatas."
Dan Dr. Meryl Nass, anggota komite penasihat ilmiah Pertahanan Kesehatan Anak, juga mengatakan kepada The Defender bahwa uji klinis kurang untuk menunjukkan efektivitas vaksin.
Nass melaporkan di Substack-nya bahwa CDC memulai studi tentang efektivitas vaksin cacar monyet di Republik Demokratik Kongo, tetapi tidak pernah melaporkan hasilnya.
The New York Times juga mempertanyakan keefektifan vaksin:
"Banyak pertanyaan yang tersisa tentang vaksin, yang belum banyak digunakan sebelum wabah mpox musim panas lalu, sebelumnya disebut monkeypox, sebagian besar di antara pria yang berhubungan seks dengan pria.
“Tidak ada studi baru yang merupakan uji coba terkontrol secara acak, dan beberapa analisisnya kecil.
"Lebih banyak pekerjaan diperlukan untuk menentukan seberapa baik vaksin bekerja pada orang dengan gangguan kekebalan tubuh, berapa lama perlindungan berlangsung dan apakah itu bervariasi tergantung pada bagaimana suntikan diberikan."
Apa itu mpox?
Cacar adalah penyakit yang disebabkan oleh virus cacar. Gejala infeksi cacar monyet biasanya ringan dan termasuk demam, ruam dan pembengkakan kelenjar getah bening, dan kadang-kadang sakit kepala hebat, sakit punggung, nyeri otot, kekurangan energi dan erupsi kulit yang dapat menyebabkan lesi, keropeng atau kerak yang menyakitkan.
Virus jarang memerlukan rawat inap - dan mereka yang dirawat di rumah sakit biasanya dirawat di rumah sakit untuk pengendalian rasa sakit. Sangat jarang berakibat fatal. Menurut WHO, dari hampir 90.000 kasus mpox yang dilaporkan di seluruh dunia pada 2022-2023, hanya ada 140 kematian.
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