thevaccinereaction--2020-11-09--CureVac’s COVID-19 Vaccine Produces Grade 3 Adverse Events

Biopharmaceutical company CureVac NV of Tübingen , Germany has released the interim results of its Phase 1 clinical trial on its experimental CVnCoV vaccine COVID-19 .
The vaccine , which was given to more than 250 healthy adults 18 to 60 years of age , is based on messenger ribonucleic acid ( mRNA ) technology.1 2 Unlike traditional vaccines , mRNA vaccines “ introduce an mRNA sequence ( the molecule which tells cells what to build ) , which is coded for a disease specific antigen , ” wrote Rishma Parpia in an article in The Vaccine Reaction earlier this @ @ @ @ @ @ @ press release by CureVac , the CNnCoV vaccine was “ generally well tolerated across all tested doses ( 2-12µg ) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation.
” Trial participants were vaccinated intramuscularly with two doses 29 days apart .
These included doses of two , four , six , eight and 12 milligrams ( µg ) .
Each dose level was given to groups consisting of up to 10 participants who had previously tested positive for the SARS-CoV-2 virus that can cause @ @ @ @ @ @ @ the interim Phase 1 data .
It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement of our vaccine candidate , ” said Dr. Franz-Werner Haas , CEO of CureVac .
“ Following further data readouts and discussion with regulatory authorities , we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020.
” 1 While CureVac reported that it observed no “ serious adverse events ” related to the CVnCoV vaccine , the company noted that some of the @ @ @ @ @ @ @ µg experienced Grade 3 adverse events mostly after being injected with the second dose .
These reactions included fatigue , headache , chills , muscle pain and fever .
CureVac reported that the reactions were “ transient ” and usually resolved within 24 to 48 hours.1 A Grade 3 adverse event is defined by the U.S. Department of Health and Human Services ( HHS ) as , “ severe or medically significant but not immediately life-threatening ; hospitalization or prolongation of hospitalization indicated ; disabling ; limiting self care ” such as “ @ @ @ @ @ @ @ self , using the toilet , taking medications.
” In other words , a Grade 3 adverse event is serious .
It is only one grade removed from “ life-threatening ” ( Grade 4 ) and just two grades from “ death ” ( Grade 5 ) .4 5 CureVac is currently negotiating a deal to provide the European Union ( EU ) with 225 million doses of CNnCoV , with an option to supply EU countries with an additional 180 million doses , for a total of 405 million doses once the @ @ @ @ @ @ @ 6