Coronavirus Disease Research Community - COVID-19
Published January 31, 2021 | Version v1
Journal article Open

mRNA Based SARS-CoV-2 Vaccines and Ongoing Researches

Creators

  • 1. Department of Medical Microbiology, Gulhane Medical Faculty, University of Health Sciences, Ankara, Turkey
  • 2. Department of Medical Microbiology, Gulhane Institute Of Health Sciences, University of Health Sciences, Ankara, Turkey

Description

Özet

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) insanları ve bir dizi hayvan türünü enfekte eden ve insanlarda COVID-19 (coronavirus disease 2019) olarak adlandırılan hastalığa neden olan, yüksek bulaştırıcılık hızı ile ciddi bir sağlık krizi ve küresel pandemiye neden olan bir RNA virüsüdür. Tüm dünyada sosyoekonomik hayat üzerine yıkıcı etkilere neden olan SARS-CoV-2 pandemisinin kontrol altına alınmasında standart halk sağlığı önlemlerinin etkileri dönemsel ve bölgesel düzeyde sınırlı kalmış ve bu büyük krizi kontrol altına almada aşılara atfedilen önem en üst düzeye çıkmıştır. Geçmişte bir benzeri ile Zika virus salgınında karşılaşılmış olmasına rağmen, SARS-CoV-2 pandemisinde aşı çalışmaları tarihte eşi görülmemiş bir hıza ve kapsama ulaşmıştır. Son bir yıl içerisinde başlayan aşı çalışmaları arasında Dünya Sağlık Örgütü (DSÖ) tarafından izlenen aşı adaylarının sayısı 236’ya ulaşırken bunların 63’ü klinik çalışma aşamalarına ulaşmıştır. Bunlar içerisinde 30’a yakın mRNA aşı adayından ise 7’si klinik çalışma aşamalarına ulaşmış ve 2020 Aralık itibariyle yeni geliştirilen birkaç mRNA aşısı “acil kullanım onayları” ile milyonlarca kişiye uygulanmıştır. SARS-CoV ve MERS-CoV (Middle East respiratory syndrome coronavirus) üzerinde yapılan çalışmalar virüsün hücreye girişinde kritik önemi olan ve çok sayıda nötralizan epitop barındıran S proteininin aşı tasarımı için çekici bir hedef olduğunu ortaya koymuştur. Günümüzde de, S proteinini veya bu proteinin alt birimlerini kodlayan mRNA temelli aşılar kromozoma entegre olma veya enfeksiyon riski taşımamaları, düşük doz aşılama ile yüksek düzeyde antikor yanıtını uyarmaları, hızlı tasarım ve ölçeklenebilir üretim avantajları ile küresel aşılama programlarının baskın aşı platformları olmuştur. Türkiye’de ise bir mRNA aşı adayının preklinik çalışmaları devam ederken, farklı bir mRNA aşısının (BNT162b2) faz III çalışmalarına Türkiye’den birçok merkez dahil olmuştur. SARS-CoV-2 salgının başlangıcından itibaren izlenen yeni mutasyonlar mRNA aşılarının etkinliği ile ilgili endişelere neden olurken, yakın zamanda yapılan analizler ve laboratuvar çalışmaları (nötralizasyon testleri) yeni varyantların henüz aşı etkinliği üzerinde ciddi bir etkileri olmadığını göstermektedir. Yıkıcı etkileri olan küresel bir salgına hızlı müdahale amacıyla, klinik çalışmaları hızlı bir şekilde tamamlanan ve uzun dönem olası yan etkileri ile ilgili verilerin bulunmadığı bu aşılar için önümüzdeki süreçte güvenlik ve etkinlik ile ilgili daha detaylı verilere ulaşılacağı beklenmektedir.

Abstract

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) is an RNA virus that infects humans and a number of animal species and causes the disease called COVID-19 (coronavirus disease 2019) in humans, causing a severe health crisis and global pandemic with its high rate of transmission. In controlling the SARS-CoV-2 pandemic, which has devastating effects on socioeconomic life all over the world, the effects of standard public health measures have remained limited at periodic and regional levels, and the importance attributed to vaccines in controlling that great crisis has reached the highest level. Although a similar situation has been encountered in the Zika virus outbreak in the past, vaccination studies in the SARS-CoV-2 pandemic have reached an unprecedented speed and scope in history. Among the vaccine studies that started in the last year, the number of vaccine candidates monitored by the World Health Organization (WHO) have reached 236 and 63 of them have reached the clinical study stages. Among these, nearly 30 are mRNA vaccines and 7 of them have reached clinical study stages and as of December 2020, and several newly developed mRNA vaccines have been applied to millions of people with "emergency use authorization". Studies conducted on SARS-CoV and MERS-CoV (Middle East respiratory syndrome coronavirus) have revealed that the S protein, which has a critical importance in the entry of the virus into the cell and contains a large number of neutralizing epitopes, is an attractive target for vaccine design. Today, mRNA-based vaccines encoding the S protein or its subunits have become the dominant vaccine platforms of global vaccination programs, with the advantage of not having the potential risk of infection or being integrated to into the chromosome, stimulating a high level of antibody response with low dose vaccination, rapid design and scalable production. While the preclinical studies of an mRNA vaccine candidate are continuing in Turkey, many centers from Turkey have been involved in the phase III trials of a different mRNA vaccine (BNT162b2). New mutations monitored since the beginning of the SARS-CoV-2 outbreak raise concerns about the effectiveness of mRNA vaccines, recent analyzes and laboratory studies (neutralization tests) show that the new variants do not yet have a serious impact on vaccine efficacy. It is expected that more detailed data about safety and efficacy will be available in the upcoming period for these vaccines, for which clinical studies have been completed quickly and there are no data on long-term possible side effects in order to respond rapidly to a global epidemic with devastating effects.

Notes

mRNA Temelli SARS-CoV-2 Aşıları ve Devam Eden Çalışmalar

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