A Grade 3 Vaccine-Related Adverse Event is Serious

A Grade 3 Vaccine-Related Adverse Event is Serious

When Moderna, Inc. announced on May 18, 2020 the results of a Phase I human clinical trial for its experimental mRNA-1273 vaccine for COVID-19, the biotechnology company said the vaccine had produced no “serious adverse events” (SAEs) among the 45 people who participated in the trial and that it considered the vaccine to be “generally safe” and “well-tolerated.” Moderna acknowledged that four (nine percent) of the trial participants suffered Grade 3 adverse events to its vaccine.1 2 3 4 5

In its report (published in The Lancet on May 22) on the results of a Phase I human clinical trial for its experimental Ad5-nCoV for COVID-19, CanSino Biologics, Inc. said it had noted no “serious adverse event” among the 108 trial participants. The Chinese biotech company, working in partnership with China’s Academy of Military Medical Sciences’ Institute of Biotechnology, acknowledged that 10 (nine percent) of the participants suffered Grade 3 adverse events to its vaccine.6 7 8

On July 20, Pfizer, Inc. and Germany’s BioNTech SE announced the results of their Phase I/II human clinical trial for their jointly-developed experimental BNT162b1 vaccine for COVID-19. The companies reported “no serious adverse events” among its 45 trial participants, although they did acknowledge that two (four percent) of the participants suffered Grade 3 adverse events to their vaccine.9 10 11 12

Almost 1 in 10 COVID-19 Trial Participants Suffered Serious Reactions

A total of 198 healthy people participated in the Moderna, CanSino Biologics and Pfizer/BioNTech Phase I and Phase I/II clinical trials. The companies said no serious adverse events were experienced during the trials, and yet they acknowledged a total of 16 Grade 3 adverse events? How is that possible, given that 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”?13

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).13 Of the 198 participants in the Moderna, CanSino Biologics and Pfizer/BioNTech clinical trials, 16 (eight percent) of them suffered serious adverse events. Imagine if those vaccines had been given to 100 million people, which could have resulted in some 8 million serious adverse events and many questions about potential long-term adverse health outcomes

Of the 198 participants in the Moderna, CanSino Biologics and Pfizer/BioNTech clinical trials, 16 (eight percent) of them suffered serious adverse events. Imagine if those vaccines had been given to 100 million people.

AstraZeneca and University of Oxford Report Zero Serious Adverse Events in Clinical Trial for Their COVID-19 Vaccine

Most recently, the University of Oxford and British-Swiss pharmaceutical firm AstraZeneca plc reported the results of a Phase I/II human clinical trial for their experimental AZD1222 vaccine (formerly known as ChAdOx1 nCoV-19) for COVID-19. According to the results, published in The Lancet on July 20, there were no “serious adverse events” related to the vaccine among the 1,077 trial participants.14 15

A CNN headline about the Oxford/AstraZeneca clinical trial results read, “Oxford’s COVID-19 vaccine appears safe and induces immune response, early results suggest, but more research is needed.”

It appears safe?


References:

1 Moderna’s COVID-19 Vaccine Speeds to Phase III Trial After More Positive Data. Clinical OMICS July 15, 2020.
2 Business Wire. Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273). Moderna July 14, 2020.
3 Cáceres M. Healthy Clinical Trial Subjects Suffer Grade 3 Side Effects to Moderna’s mRNA COVID-19 Vaccine. The Vaccine Reaction May 24, 2020.
4 Cáceres M. Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial. The Vaccine Reaction May 30, 2020.
5 Press Release. Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Moderna May 18, 2020.
6 Branswell H. Early study of Covid-19 vaccine developed in China sees mixed resultsSTAT May 22, 2020.
7 Cáceres M, Fisher BL. 81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell LinesThe Vaccine Reaction July 6, 2020.
8 Hou LH, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trialThe Lancet June 13, 2020; 395 (10240): 1845-1854.
9 Herper M. Covid-19 vaccine from Pfizer and BioNTech shows positive resultsSTAT July 1, 2020.
10 Mulligan MJ, et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim ReportmedRxXiv July 1, 2020.
11 Press Release. Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data. Pfizer July 20, 2020.
12 TVR Staff. Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers. The Vaccine Reaction July 18, 2020.
13 U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Nov. 27, 2017.
14 Gumbrecht J, Thomas N, Vigue D, Howard J. Oxford’s Covid-19 vaccine appears safe and induces immune response, early results suggest, but more research is needed. CNN July 21, 2020.
15 Folegatti PM, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet July 20, 2020.

Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

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28 Responses to "A Grade 3 Vaccine-Related Adverse Event is Serious"

  1. Kirk   July 27, 2020 at 5:55 pm

    Somewhat confused by this. Are you saying that the AstraZeneca vaccine is the only one of the vaccines mentioned here that actually does appear to be safe?

    Reply
    • Greg   July 28, 2020 at 5:12 pm

      AZ did not report a breakdown so no one knows how safe it is. CNN is just a Propaganda rag and feeds us bullshit.

      Reply
  2. Beverly S   July 27, 2020 at 8:35 pm

    I cannot imagine in a million years why anyone would want to risk this vaccine, unless they are programmed by their tell-a-visions.

    Reply
  3. Monica   July 27, 2020 at 9:21 pm

    News flash: there is NO pandemic! Vaccines are poison and none of them are safe! I also have a problem with the government giving hospitals $30,000 per COVID death! They died from cancer but yet they say they died from COVID to get money!! The numbers are all fabricated and the government lies about everything! Don’t know anyone sick or dying from this so called virus! Why, because it’s all bs to get you to take one of their poisonous needles. No mask, no distancing, no shelter in place!!! And people who are falling for this lie are all a bunch of idiots! Will not and do not comply!! And Dr. Facci is a fake, and a liar! (probably spelled wrong). Don’t trust the health department or any government entity period, because they all lie!!!! Money seems to control their narrative and they like to see people suffer! Their scam is up because we aren’t falling for it. And by the way it takes years to created a deadly vaccine….I am so disgusted by this whole thing! Like a mask would really stop a pandemic if there was one!!! What a joke! These so called doctors are mad scientists! When you are forced to put something into your body or your child’s ,well I have a problem with that. That is called corruption especially when you can’t sue for damages from their poisonous vaccines. They can stick it where the sun doesn’t shine! In fact I hope these so called government liars will reap what they sow! Maybe we will get lucky and God will take these evil creatures out!

    Reply
    • Cynthia D.   July 28, 2020 at 12:24 pm

      Thanks Monica. 🌻

      Agree with everything you said. Masks protect nothing and do not keep viruses etc from anyone. That’s so silly. The masks actually limit oxygen intake which can create even more illnesses. We need to breathe…it is our connection to life. That’s one of the reasons we are having more people get sick and also because they are going to the pathogen infection filled hospitals and yes being diagnosed incorrectly for money. Many doctors were posting about it on YouTube and “they” took their posts down. Last place you want to go if your sick is a hospital.
      Try MMS,CD, collidial silver. I’ve used collidial silver for 17 years with my family (for every illness)and in the last two years used mms and cd- also great solutions.

      Social distancing is also inhumane. Going to other side of street to avoid someone for any reason is anti human and cruel for all parties involved. Our hearts become numb to this foolishness. We should never allow someone else tell us how to live and treat others. Do you actually believe the news media has your best interest in mind? No they do not. Their main objective is to spread fear to keep us distracted. Humans are connected and need interaction with each other and nature. I feel forced when I have to put a mask on to get on a plane to visit my daughters. They do not have my consent to be a part of this charade. Doctors only use masks during surgery to prevent saliva, etc going into the surgery site and that’s the only reason.

      God is already here in all of us spreading truth. Just have to open your heart to see/feel it.

      Reply
    • Dara   August 2, 2020 at 5:32 pm

      Hear, hear, Monica! That’s the way it is, and it has to stop. “Operation Paperclip” in full swing!

      Reply
  4. John Austin   July 27, 2020 at 10:36 pm

    Ox/AZ vaccine can only be described as APPEARS safe due to the early stage of trials. To state IS safe would be foolhardy so early on.

    Reply
  5. Julia Hill   July 27, 2020 at 11:17 pm

    Why take a vaccine when COVID can change in a 2 week period and many people have killed the virus in 2-3 days with CD (chlorine dioxide). Kvlab.Com Sells 5 kits for only $100.

    Reply
    • Peggy pings   July 31, 2020 at 12:24 pm

      Julia Hill, how do you use CD? What is the proper protocol? Is it just for wiping surfaces down to disinfect them? Do you put it in your drinking water, and if so, how much per gallon?

      Reply
  6. Julia Hill   July 27, 2020 at 11:23 pm

    Listen to Dr Carrie Madej who has researched the vaccine advances for 20 years. Could the vaccines cause us to spend thousands on medical bills for the diabetes, seizures, ADD, Autism, huge nerve damage vaccines have caused its victims?

    Reply
  7. Stephanie Hart   July 27, 2020 at 11:26 pm

    Looks like 90+% didn’t have any adverse effects. I’ll take those odds any day.

    Reply
    • Dave   July 28, 2020 at 11:20 pm

      Don’t be foolish. The FDA now is announcing they will license COVID vaccines that are only 30-50% effective. And they don’t even consider all the metals, toxins, and other “debris” included in the vaccines.

      Reply
  8. Nechama   July 28, 2020 at 3:10 am

    I think they wanted to make a difference between “appears” safe and “is safe”.

    Reply
  9. Jade Walker   July 28, 2020 at 9:42 am

    Kirk, I think it is generally pointing out that they all regularly use vague language that gives people a comfortable ‘warm and fuzzy’ that everything is great. One company uses that term “no serious adverse events” (yet they then acknowledge grade 3 events!), while another announces their “vaccine appears safe”… but don’t even clarify what that means… like they found 5% grade 3, only 50% grade 3, only 1% grade 4…? My take is that both are safer than directly injecting cyanide, but I still am not interested.

    Reply
  10. Beckie   July 28, 2020 at 10:14 am

    I also was confused. Are we to assume that because the previously listed vaccines were unsafe, even though they were touted as being safe, these last ones listed are unsafe as well? Especially because they were simply said to “appear” safe? I may personally assume that they’re unsafe because of my understanding of vaccines, but I don’t think you can or should do that in an article if you want to be taken seriously.

    Reply
  11. Kelly   July 28, 2020 at 1:32 pm

    Good luck to anyone that takes that vaccine they’re all poison there’s no such thing as a safe vaccine they’re not doing animal testing to make sure these are safe. It takes up to three years to test vaccines and they’re rushing this you are a complete fool if you want to put something like that in your body. The pharmaceutical companies could care less about anybody there based on greed greed and more greed they probably want people to be damaged because it makes them more money. The more damaged you are and poisoned by their vaccines the more money they make. Think about that. WAKE UP PEOPLE!!!

    Reply
    • Dara   August 2, 2020 at 5:35 pm

      One group tested on monkeys in oxford, UK. 10% of the simians had a Grade 5 “adverse effect,” ie 10% of the monkeys died.

      Reply
  12. Sandy   July 28, 2020 at 2:44 pm

    I agree with Monica !!! This is a scamdemic and people have died from being put on ventilators !!? That’s not how to treat Malaria / HIV which top scientist have figured out. See Doctor Mercolas article about that …..with Fauci experimenting with Gain of Function to spread Covid faster, which Obama told him to stop working on in the bioweapons Labs. But he continued to make this man made disease If you look at the symptoms of Malaria there the exact same as Covid that’s why Cloriquin and Zinc works so well and also Wormwood…..All for making money on vaccines, this was all planned. Bill Gates, WHO , Fauci, pharmaceutical companies…. I hope they go to prison for life…..in fact they create all these yearly viruses so they can make money on vaccines….

    Reply
    • Dara   August 2, 2020 at 5:38 pm

      Not just money on vaccines, but on the pharmaceuticals and procedures that will be required as a consequence of Grade 1,2,3,4 effects.
      Same thing with transplants – the beginning of a lifetime of dependency on drugs, more drugs and procedures.

      Reply
  13. DMS   July 28, 2020 at 3:45 pm

    Claiming that a vaccine is safe because researchers have found no evidence that it is harmful is a logical fallacy; absence of evidence is not evidence of absence. The history of medicine is littered with drugs that later turned out to have dangerous long term side effects. Thalidomide and, more recently, Vioxx come to mind. Clearly medicine is not particularly good at predicting harmful effects of therapies.

    In some cases it might make sense to use a potentially dangerous drug, if the disease being treated is itself deadly or debilitating. But COVID-19 is not; the death rate among those infected is very low, and almost all of the people who have died of it have been elderly and/or had other health conditions.

    Mass administration of a poorly tested vaccine alleged to prevent a mild, rarely fatal illness doesn’t make sense.

    Reply
  14. CAWS   July 28, 2020 at 6:00 pm

    Every year I download the Vaccine excipeints & Media Summary from the CDC. The ingredients list for the currently approved USA vaccines. It gets worse and longer every year. Look up the definitions of the ingredients you don’t recognize. It is horrifying what they want to inject us with. Then the side effects create more patients for life for the drug companies; yet no ability to sue them.
    READ today’s latest update on Hydroxychloroquine for Covid on punch dot com. It was deleted from You tube, Facebook and Twitter for false info but these are real doctors telling their experience and exposing the lies of Fauci & the media. This is the second MD who claims to have cured 350 people from Covid with HC. Many of the patients were also old & had co-morbid conditions. No one died! FDA,NIH,CDC,Fauci , Big Pharma & eugenicist Gates want to make billions off a vaccine & must keep us locked down & scared into accepting a vaccine that will not be safe or effective. Refuse!

    Reply
  15. Jess   July 29, 2020 at 12:46 pm

    Can we also note that the long term effects of this vaccine arent being studied? So of the 80 or so percent of people who had no immediate side effects, how many will develop some ailment in the long term? I’d say a good portion

    Reply
  16. Pam   July 29, 2020 at 6:57 pm

    We should not rush to have a vaccine. It needs to.be tested and we must make sure it’s safe. We have had alot of vaccines that have protected us, smallpox, polio etc. We can get covid under control by wearing masks and keeping our distance socially. Those who don’t spread covid.

    Reply
  17. Pam Becher Doster   July 29, 2020 at 9:15 pm

    We must make sure we take our time and really test and make sure we get a safe vaccine. We have saved lives in the past with vaccines for small pox, polio etc. Everyone one has a responsibility to wear a mask and social distance, if not, others may die.

    Reply
  18. Redpill   July 29, 2020 at 11:24 pm

    “It appears safe?”

    Yea, right. I have been looking but I haven’t seen if there are randomized double blind placebo testing done. Does anyone have a link to any studies based on the scientific standard of research? Also, have any of the participants had their immune systems challenged with the virus? Isn’t that how testing works?

    Reply
  19. Ro   July 31, 2020 at 9:03 pm

    WE need to INSURE that we have choice in order to live our lives healthy and long!

    Reply
  20. Dara   August 2, 2020 at 5:41 pm

    The “randomized double blind placebo testing” seems to lead to iatrogenic damage and heavy litigation.

    Vaccines and transplants lead to a lifetime of pharmaceuticals and procedures that will be required as a consequence of Grade 1,2,3,4 effects.
    There are better choices. The CRIME is that the public is denied information about and access to them.

    Reply
  21. Nedal   August 4, 2020 at 8:29 am

    I’m looking for twitter account of Cansino Biologics, Inc. please let me know @NedalAlomari1 🙏

    Reply

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