CureVac’s COVID-19 Vaccine Produces Grade 3 Adverse Events

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 year.3 She added:

Once produced within the body, vaccine developers say the antigen is recognized by the immune system and stimulates a strong inflammatory response to produce antigens to fight the pathogen. Messenger RNA vaccines are faster and cheaper to produce than traditional vaccines and do not utilize any parts of the pathogenic virus or bacteria.3

According to a 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 COVID-19.1

“We are very encouraged by 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 trial participants who received doses of 12 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 “bathing, dressing and undressing, feeding 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 vaccine is approved by European regulatory authorities.2 6


References:

1 Press release. CureVac : CureVac Reports Positive Interim Phase 1 Data for its COVID-19 Vaccine Candidate, CVnCoV. CureVac Nov. 2, 2020.
2 Taylor NP. CureVac links COVID-19 vaccine to immune response, setting it up to enter pivotal trial. Fierce Biotech Nov. 2, 2020.
3 Parpia R. Moderna to Use New mRNA Technology to Develop Coronavirus Vaccine. The Vaccine Reaction Feb. 12, 2020.
4 Cáceres M. A Grade 3 Vaccine-Related Adverse Event is Serious. The Vaccine Reaction July 26, 2020.
5 U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Nov. 27, 2017.
6 Saigol L. CureVac and EU in advanced talks for 225 million Covid-19 vaccine doses. Market Watch Aug. 20, 2020.

8 Responses to "CureVac’s COVID-19 Vaccine Produces Grade 3 Adverse Events"

  1. Jenny Dunn   November 10, 2020 at 11:10 pm

    What worries me with these Mrna messenger vaccines….. does the body keep producing the spike protein for the rest of our lives!! Thereby keeping our immune system in perpetual state of war. Sounds like what happens with an autoimmune disease.

    Reply
  2. cindy   November 11, 2020 at 12:18 am

    A grade 3 fever for me or anyone else that has immunocompromised systems will be devastating. If the researchers are worried about the T cell count, why don’t they use Vitamin C?

    I read countless research studies from different medical websites that Vitamin C drops inflammation and assist the macrophages removal of excess WBCs and infection. Go onto: https://www.ncbi.nlm.nih.gov and add vitamin C or any supplement in the search bar. No medical license is needed.

    It erks me that these people cannot and will not look “outside of the box”.

    Reply
  3. Zuto   November 11, 2020 at 1:26 am

    Why are they testing the vaccine people who have already tested positive for SARS-CoV-2? Aren’t vaccines supposed to prevent diseases? I guess this is in line with the low bar for “efficacy” of COVID vaccines: they do not have to prevent the disease; they only have to mitigate symptoms. Woo hoo.

    “Preventing” a disease can’t even be proved. Development of an immune response to vaccine ingredients might indicate the immune system has been awakened and is doing its job. But if the vaccine causes illness anyway, what’s the point of paying for your immune response if you can get it for free naturally? And if they used something other than a saline placebo, there is no way to prove “mitigation” of symptoms.

    There is some really shady experimentation being passed off as “science.” Don’t even get me started on the abject stupidity of injecting RNA into any experimental animal (yep – that means me and you too). If it starts synthesis of antigens to illicit an immune response, how do you stop it from continuing to synthesize antigens? This is like asking us to volunteer for a lifelong autoimmune disease. Think of all the autoimmune diseases that could be prevented by refusing to take RNA vaccines! Remarkable!

    Reply
  4. Zuto   November 11, 2020 at 1:30 am

    More apologies for typos (if my initial comment gets through). It’s a proven fact that even thinking about COVID causes transient brain damage.

    Reply
  5. Amanda   November 13, 2020 at 1:31 am

    I’m with you Cindy. And Vit D and zinc are also essential. Very affordable and not wasting our tax dollars!

    Reply
  6. Jan Schmidt   November 13, 2020 at 5:19 pm

    Good grief. Why would they test it in people who had already tested positive for Covid-19?! Those people should already have some immunity so, of course, it would give positive results in many of them. And, if it produces grade 3 symptoms in some people, why would you want a vaccine that could give you worse symptoms than the actual disease? So ludicrous.

    Reply
  7. Nata   November 16, 2020 at 10:16 am

    If the participants being injected have previously tested positive, shouldn’t they already be immune? Then, what’s the point of the vaccine, other then to make it appear to be effective?

    Reply
  8. Lynn M Hicks   November 29, 2020 at 3:41 am

    Why get a vaccine for a virus that is 99.4% recoverable from:

    Reply

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