Wuhan’da (Çin Halk Cumhuriyeti) “viral pnömoni” vakalarında bir salgın bulunduğu ilan edildikten sonra bu yeni virüsün varlığı 31 Aralık 2019 tarihinde Dünya Sağlık Örgütüne/World Health Organization (WHO) bildirildi¹. Ocak ayı sırasında günlük temelde binlerce yeni vakaya tanı konarak teyit edilmiş vakaların sayısı 30 Ocak 2020 tarihine kadar birdenbire arttı ve bu tarihte COVID-19 salgını WHO tarafından uluslararası önemde acil halk sağlığı durumu olarak ilan edildi. WHO 11 Mart 2020’de COVID-19 durumunu küresel bir pandemi olarak resmen ilan etti³.

Enfekte olan insanların çoğunluğu hafif ila orta düzeyde bir solunum hastalığı hissetmekte ve özel bir tedaviye gerek duymadan iyileşmektedir. Ama bazıları ağır hasta olmakta ve tıbbi bakım gerektirmektedir. Yaşlı kişilerde ve altta yatan sağlık durumlarına sahip olan kişilerde – kardiyovasküler hastalık, diyabet, kronik solunum hastalığı veya kanser – ağır hastalık geliştirme olasılığı daha yüksektir⁴. 

Enfekte olmuş bir kişi virüs içeren çok küçük solunum parçacıkları ve damlacıkları ile soluk verdiği zaman COVID-19 yayılmaktadır. Bu solunum parçacıkları ve damlacıkları başka kişiler tarafından soluk çekilirken alınabilir veya gözlerinin, burnunun veya ağzının üzerine düşebilir. Bunlar bazı durumlarda başka kişilerin dokunduğu yüzeylere bulaşabilir. COVID-19 bulaşmış olan herhangi bir kişi, kendisi bir belirti göstermediği hâlde hastalığı yayabilir⁵.

COVID-19 bakımından HIPRA’nın taahhüdü

Aşı geliştirerek bulaşıcı hastalıklarla mücadelede 50 yıldan çok deneyime sahip olan HIPRA, sağlığa, insanlara, topluma ve ilerlemeye bağlı olan bir şirkettir. HIPRA bu nedenle, olağanüstü bir durum karşısında, SARS-COV-2’ye karşı bir rekombinant protein aşı geliştirerek daha başlangıçtan itibaren kendi bilgi birikimini pandemiye karşı mücadeleye katmayı seçmiştir (EMA Pazarlama Ruhsatı, 31 Mart 2023).. 

- What is BIMERVAX® and what is it used for? 

BIMERVAX® is the vaccine developed by HIPRA to prevent COVID-19 in adults over 16 years of age. The vaccine is authorized as a booster dose for those who have already been immunized at least 6 months after a previous mRNA COVID-19 vaccine. The vaccine is based on a recombinant protein. Specifically, the vaccine is based on the receptor binding domain (RBD) of the virus surface, which is added to an adjuvant that amplifies the body's immunogenic response. 

- How is it used? 

The COVID-19 HIPRA’s vaccine is given as an injection, usually in the muscle of the upper arm. It is given as a booster at least 6 months after a previous mRNA COVID-19 vaccine. For more information about using it, see the package leaflet or consult a healthcare professional. 

- How does it work? 

BIMERVAX® works by preparing the body to defend itself against COVID-19. The vaccine contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the virus. It also contains an ‘adjuvant’, a substance to help strengthen the immune response to the vaccine. When a person is given the vaccine, their immune system will identify the combined protein as foreign and produce natural defenses — antibodies and T cells — against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells. 

- What benefits of BIMERVAX® have been shown in studies? 

The benefits of this vaccine were assessed in an immunobridging study, which compared the immune response induced by this new vaccine with that induced by the authorised mRNA vaccine Comirnaty, which targets the original (Wuhan) SARS-CoV-2 spike protein. The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty and who were subsequently given a booster dose of either BIMERVAX® or Comirnaty. Although BIMERVAX® triggered the production of lower levels of antibodies against the original strain of SARS-CoV-2 than Comirnaty, it led to higher levels of antibodies against the Beta and Omicron variants and comparable levels against the Delta variant. Supportive data were provided from an ongoing study that included 36 adolescents aged 16 to 17 years old, with immune response data available for 11 of them. This study found that BIMERVAX® given as a booster produced an adequate immune response in these adolescents, with antibody production comparable to that seen in adults who received BIMERVAX®.

 - What are the risks associated with BIMERVAX®? 

The most common side effects (which may affect more than 1 in 10 people) are pain at the injection site, headache, tiredness and muscle pain. Lymphadenopathy (enlarged lymph nodes), diarrhoea, vomiting, nausea (feeling sick), fever, pain in the armpits and reddening, hardness or swelling at the injection site may affect less than 1 in 10 people. Other less frequent adverse effects may affect less than 1 in 100 people are listed in the SmPC. Allergic reactions may occur. As for all vaccines, BIMERVAX® should be given under close supervision with appropriate medical treatment available. 

- Why is BIMERVAX® authorized in the European Union?

 Based on data comparing the immune response triggered by BIMERVAX® with that triggered by an authorised mRNA COVID-19 vaccine, EMA concluded that BIMERVAX® is expected to be at least as effective as the comparator at restoring protection against COVID-19 in people aged 16 years and older. The safety profile of BIMERVAX® is comparable to that of other COVID-19 vaccines. The most common side effects seen with BIMERVAX® were usually mild to moderate and cleared within a few days after vaccination. EMA therefore decided that BIMERVAX®’s benefits are greater than its risks and that it can be recommended for authorisation in the EU. BIMERVAX® received a marketing authorisation valid throughout the EU on 30 March 2023. Further information on HIPRA’s COVID-19 vaccine can be found on the European Medicines Agency website: ema.europa.eu/medicines/human/EPAR/bimervax

Bibliyografi referansları:

^{1. Dünya Sağlık Örgütü/World Health Organization. COVID-19 hakkında temel bilgiler. [Internet] Şurada bulabilirsiniz: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Son ziyaret tarihi: 8 Mart 2023)}

^{2. “Halk için bilgiler. Yeni COVID-19 Koronavirüs hakkında Sorular ve Yanıtlar [Internet]”. Şurada bulabilirsiniz: https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Son ziyaret tarihi: 8 Mart 2023)}

^{3. Hu B, Guo H, Zhou P, Shi ZL. SARS-CoV-2’nin ve COVID-19’un özellikleri. Nat Rev Microbiol. 2021;19(3):141-154.}

^{4. Dünya Sağlık Örgütü/World Health Organization. Koronavirüs. [Internet] Şurada bulabilirsiniz: https://www.who.int/health-topics/coronavirus#tab=tab_1 (Son ziyaret tarihi: 8 Mart 2023)}

^{5. Hastalık Kontrol ve Önleme Merkezleri. [Internet]. Şurada bulabilirsiniz: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Son ziyaret tarihi: Mart 2023)}

^{6. Dünya Sağlık Örgütü/World Health Organization. COVID-19’un yayılması hakkında Sorular ve Yanıtlar. [Internet] Şurada bulabilirsiniz:  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Son ziyaret tarihi: Mart 2023)}