İlaç şirketleri Pazartesi günü (20 Eylül) yayımladıkları haber bülteninde, Pfizer-BioNTech koronavirus aşısının (yetişkinlere ve gençlere verilen miktarın üçte biri kadar) daha düşük dozunun 5 yaşından itibaren çocuklarda güvenli olduğunu ve güçlü bir bağışıklık tepkisini tetiklediğini duyurdu.
Low dose of Pfizer-BioNTech vaccine is safe and effective in children ages 5 to 11, companies’ study finds
Birçok ebeveyn ve çocuk doktoru tarafından heyecanla beklenen bulgu, iki aşamalı koronavirus aşı rejiminin okul çağındaki küçük çocuklarda yakın zamanda kullanılabilir olmasına yönelik çok önemli bir adım.
Son derece bulaşıcı delta varyantı okulların yeniden açılmasıyla rastlaşınca, çocukların neden aşılanması gerektiğini ortaya çıkardı. Amerikan Pediatri Akademisi’ne göre, Eylül ayının ilk haftasındaki vakaların yaklaşık yüzde 30’u çocuklardı. Çocuklar nadiren ciddi hastalığa maruz kalsalar da bunu yaşadıklarında yıkıcı olabilir. Aşı, nadir görülen ciddi hastalık vakalarına karşı koruma sağlayabilir, uzun süreli COVID riskini azaltabilir ve salgınları bastırabilir.
Şirketler, verileri hazırlayarak Gıda ve İlaç İdaresi (FDA)’ne sunma sürecini Eylül ayının sonuna kadar tamamlamayı umduklarını belirtmektedirler. Ardından, henüz yayınlanmamış veya hakem incelemesinden geçmemiş veriler, aşının güvenli ve etkili olduğundan emin olmak için düzenleyiciler tarafından incelenecektir. Bunun bir kaç hafta veya bir ay kadar sürebileceği bildiriliyor.
PFIZER AND BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS FROM PIVOTAL TRIAL OF COVID-19 VACCINE IN CHILDREN 5 TO 11 YEARS
- Results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age
- In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses
- Companies plan to submit these data to the FDA, EMA and other regulatory agencies around the world as soon as possible
- Results in children under 5 years of age are expected as soon as later this year
NEW YORK AND MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.
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“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
