Since the outbreak of COVID-19 in 2019, many kinds of COVID-19 vaccines, COVID-19 preventive drugs and COVID-19 therapeutic drugs have been approved worldwide. The approved COVID-19 vaccines include inactivated vaccine, adenovirus vaccine, recombinant protein vaccine, mRNA vaccine and DNA vaccine, and the therapeutic drugs include chemical drugs, antibodies and Chinese patent medicines. Next, I will summarize the approved COVID-19 vaccines and therapeutic drugs in the U.S. and China.
COVID-19 vaccines and drugs approved by FDA
Up to now, FDA has approved at least 3 types of COVID-19 vaccines (2 mRNA vaccines and 1 adenovirus vaccine), 1 pre-exposure preventive drug and 9 COVID-19 therapeutic drugs. Jointly developed by AstraZeneca and Vanderbilt University Medical Center, Evusheld is a long-acting neutralizing antibody combination therapy, which consists of two neutralizing antibodies tixagevimab and cilgavimab that bind different epitopes of SARS-CoV-2 spike protein. In December 2021, it was granted the emergency use authorization (EUA) by FDA for pre-exposure prophylaxis (PrEP) of SARS-CoV-2 infection (COVID-19) in specific adults and adolescents (aged ≥ 12 years old and weighted ≥ 40kg). It is currently the only authorized pre-exposure prophylaxis therapy for COVID-19 in the U.S.
Actemra/RoActemra is the first humanized monoclonal antibody drug against IL-6 receptor (IL-6R) in the world, which can play an anti-inflammatory role by blocking IL-6 signal transduction by targeted binding with IL-6R. It has been approved for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman's disease, Takayasu's arteritis and systemic sclerosis-related interstitial lung disease. In June 2021, Actemra/RoActemra intravenous injection was granted the emergency use authorization by FDA to treat COVID-19 hospitalized adults and pediatric patients (aged 2 and above) who are receiving systemic corticosteroids and in need of oxygen supplementation/non-invasive or invasive ventilation/extracorporeal membrane oxygenation (ECMO).
Sotrovimab is a neutralizing antibody jointly developed by GlaxoSmithKline (GSK) and Vir Biotechnology, which has dual functions and can block viruses from entering healthy cells and clear infected cells at the same time. Sotrovimab can bind to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus causing SARS), which is highly conserved and may make it more difficult to produce drug resistance. In addition, with the use of Xencor's Xtend technology, sotrovimab is also designed to achieve high concentration in the lungs to ensure optimal penetration of airway tissue affected by SARS-CoV-2 and a prolonged half-life. In May 2021, it was granted the emergency use authorization by FDA for the treatment of mild to moderate COVID-19 adults and pediatric patients with high risk (aged 12 and above and weighing at least 40kg), which includes: patients with positive results of direct SARS-CoV-2 virus test and at high risk of developing into severe COVID-19 (including hospitalization and death).
REGEN-COV is a kind of cocktail therapy, which was firstly invented by Regeneron, and jointly developed by Regeneron and Roche. It is composed of casirivimab and imdevimab monoclonal antibodies, which target two independent and non-overlapping sites in the receptor binding region of spike (S protein) in SARS-CoV-2, and have synergistic effect. It can reduce the risk of virus mutation escaping and protect people from invasion of virus variants with mutation of S protein. Preclinical research data show that the neutralizing activity of casirivimab and imdevimab is kept, which is used to fight against key emerging variants. In November 2020, REGEN-COV was granted the emergency use authorization ...
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