Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.
The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.
In a viral infection model, macaques received two injections with 100 µg of the vaccine candidate and macaques that received saline control injections were challenged 55 days after the second immunization with a high viral inoculum of about 1 million plaque-forming units of SARS-CoV-2. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while the control group demonstrated evidence of viral RNA.
Among the anti-viral effects demonstrated by the vaccine were concomitant high neutralizing antibody titers and a TH1-biased cellular response in both rhesus macaques and mice. BNT162b2 also induced potent SARS-CoV-2 neutralizing antibodies in the vaccinated macaques, plus viral antigen-specific CD4+ and CD8+ T cells.
“Collectively, these preclinical results, combined with our clinical data collected to date, continue to support the promise and validity of our mRNA-based vaccine program against SARS-CoV-2 and selection of the BNT162b2 candidate, which we believe has the potential to prevent many millions of COVID-19 cases,” Pfizer senior VP & head of vaccine R&D Kathrin Jansen said in the release. “We are encouraged by the data thus far and confident in our progress towards developing a safe and effective vaccine candidate to help address this current pandemic.”
“The data we have shared today include the characterization of our lead candidate BNT162b2, as well as key animal studies that were the basis for our clinical programs. They have enabled us to advance BNT162b2 into Phase 3 evaluation,” added BioNTech founder & CEO Dr. Ugur Sahin. “This is another development milestone for providing a safe and effective potential vaccine to the global community to help end this pandemic.”
Pfizer and BioNTech have now commenced a global (excluding China) Phase II/III safety and efficacy clinical trial for the vaccine candidate, with over 25,000 participants between 18 and 85 years old enrolled in the U.S., Argentina and Brazil. Enrollment is expected to expand to Germany, Turkey and South Africa.
The companies said in the release that they are on track to seek regulatory review for BNT162b2 as early as October 2020, with plans to supply up to 100 million doses worldwide by the end of 2020 and 1.3 billion doses by the end of 2021.
In July, the U.S. Dept. of Health and Human Services and the U.S. Defense Dept. agreed to a large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million doses initially agreed upon, the U.S. government will be able to acquire an additional 500 million doses.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
Was the covid vaccine for both Pfizer and Moderna studied on animals?
where are the references to the animal trials? where are the results published? where is the proof?
At the time these results were announced, the data was published here and was being peer-reviewed:
https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1
IT’S IN THE TEXT: “The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models.”
I think this article is misleading because it doesn’t address the possibility of disease enhancement and it doesn’t mention long term effects. If you are really going to do an article on the vaccine, why not give us all the information like what ingredients will be added to the vaccine when they are approved for Humans? Also it would be nice to see all the results of the testing good and bad, so we can decide for ourselves if it’s safe or not.
Were the animals infected with wild coronavirus after vaccination?
What were the side effects and potential longer term study results? Any deaths of non-humans that participated in the trial?
It’s important to note that the “Challenge Test” wasn’t administered after vaccination. They only seem to monitor for common short-term side effects. Previous mRNA vaccine attempts failed the Challenge Test which is when the test animal is introduced to the virus itself after vaccination. In many cases they had an amplified cytokine response.
Clif – Do you have a source for the reference to “Previous mRNA vaccine attempts failed the Challenge Test”? I agree with your point but want to see the evidence. Thanks.
Hi Martin, this study just came on my radar. It’s from last spring and it speaks to previous mRNA vaccines that were in development for SARS-COV and MERS being scrapped due to poor outcomes in animals during challenge tests. I just read another article that mentioned that even though human and animal testing are running in tandem for the C19 vaccines (this one cited Modena), they’re finding “normal” lab rats don’t seem susceptible to the SARS-COV-2 virus and are trying to breed mice that *should* be to continue their studies with. I’m not finding a follow-up report so I don’t know where they are with that.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7142689/
Hi Jackie,
Humans have something called an ACE-2 receptor, which is the target for the receptor-binding domain of the SARS-CoV-2 virus. Scientists have created transgenic rodents that have this receptor. I’ve seen recent reports of preclinical testing on COVID-19 vaccine candidates involving mice. It would be interesting to know if those are transgenic.
Please let us know where you are getting your information about previous MRNA trials. No data on these previous trials that failed the challenge test seems to be available on the internet. Why? I have seen it said many times that all animals in previous trials died when exposed to “wild virus” but have not been able to verify this claim because I can find no data on these trials.
Yes, more information that is also easier to understand would be nice.
OK.
So, now we have 2 mega trials from Pfizer and Moderna, with 73,000 human subjects, plus 30,000,000 people already vaccinated in the US, and we still DO NOT see any major adverse effects….
At the same time, almost 450,000 people dead in the US only from COVID 19.
How many more people need to die to make you understand that the fake conspiracy theories are baseless and you decide to contribute to this global effort to stop the pandemic and take the shot?
No major adverse effects? What are you basing that on? Please cite evidence for this claim. The VAERS database tells a different story. Have you checked it recently?
There is no need to test on animals already living and feel pain when we have human stem cells. I will leave all my money to the Howard Hughes stem cell research people. It is the only ethical thing to do.
Molecular mimicry refers to shared peptide sequences between human proteins and pathogens, which can cause the body to have an autoimmune response (meaning the body’s immune response will attack its own cells) following exposure to a virus or to a vaccine. Molecular mimicry is already thought to be a possible cause of the great variety of diseases covid-19 causes.
In “Molecular mimicry between SARS-CoV-2 spike glycoprotein and mammalian proteomes: implications for the vaccine” (Kanduc, D & Shoenfeld, Y, 2020 available online from NCBI) the authors report findings that there is a huge sharing of peptide sequences between human proteins and covid-19 spike protein. There is also large overlap between mice proteins and covid. However there are none or few similarities with several other animals commonly used in medical testing, *including macaques*!
Macaques are therefore not a viable test population for demonstrating safety of a vaccine with regard to the risk of developing an autoimmune response/disorder following vaccination. Why are only the results of the trials in macaques reported on here and not of those in mice?
Also I agree with Diane’s comment.
I also agree with Diane. Please stop testing on animals!