Research on possible long-term risks of myocarditis after Covid vaccination is now being closely studied
Photo Credit Image: Chaz Bharj. iStock/Getty Images Plus
By Dr. Lawrence Jones II
Lovelace (November 12, 2022) reported on covid-19 vaccine recipient Mr. Da’Vion Miller, who developed myocarditis shortly after his second covid-19 vaccine shot. The young man of 22 years of age experienced “chest pain two days after getting vaccinated, followed by fatigue, shortness of breath and dizziness.” As a result, Da’Vion’s doctor advised him not to receive a second dose of the Pfizer or Moderna vaccines. A tiny group in the United States has experienced myocarditis following vaccination with the Pfizer-BioNTech or Moderna. Both vaccines have mRNA technology.
Myocarditis is an inflammation and damage of the heart muscle known as the myocardium. Most commonly caused by a viral infection, but it can also be an infection of bacteria, fungi, parasites, or a reaction to a drug. Pericarditis is an Inflammation of the pericardium (thin membrane around the heart), causing chest pain. The CDC has identified at least 1,000 vaccine-related heart conditions(myocarditis or pericarditis) in children under age 18. Most vaccine recipients who developed the condition have fully recovered, although research has only looked at how well they do after several months. However, doctors wonder if it can cause permanent damage to the heart.
U.S. research is tracking adverse health effects that may appear in the years following a diagnosis of vaccine-associated heart problems. Moderna has already launched two trials, and Pfizer confirmed that at least one of its trials, including up to 500 teens and young adults under age 21, will begin very soon. In addition, the Food and Drug Administration has required drugmakers to conduct several studies of the long-term impacts of mRNA vaccines on heart inflammation. Some trials will follow those who developed the condition for as long as five years. The tests will be monitored for myocarditis. The chance of having myocarditis after vaccination is slight.
A study by Canadian researchers in the Journal of the American College of Cardiology found that men younger than 40 who got the Moderna vaccine had the highest risk of heart issues, usually within 21 days after the second dose. The study was observational, one of only a few studies to compare the risk of myocarditis between the Pfizer and the Moderna vaccines. The Johnson and Johnson vaccine and the Novavax vaccine makers reported no heart inflammation concerns in their patients during clinical trials of its vaccine. New reports and findings will unfold in the upcoming years 2023-2025.
References:
Klein, N. (October 21, 2021). Myocarditis Analyses in the Vaccine Safety Datalink: Rapid Cycle Analyses and “Head to Head” Product Comparisons. Update on myocarditis following mRNA COVID-19 vaccination (cdc.gov)
Lovelace, B. ( November 12, 2022). Myocarditis after Covid vaccination: Research on possible long-term risks underway. Myocarditis after Covid vaccine: Research on long-term effects underway (nbcnews.com)
Shimabukuro, T. (July 23, 2022).Update on myocarditis following mRNA COVID-19 vaccination. Update on myocarditis following mRNA COVID-19 vaccination (cdc.gov)
Su, J. (October 21, 2021). Myopericarditis following Coivd-19 vaccination: Updates from the Vaccine Adverse Event Reporting (VAERS) Update on myocarditis following mRNA COVID-19 vaccination (cdc.gov)
Pfizer’s Protease Inhibitor New Drug Development for SARS-CoV-2 for 2021 Looks Promising
Image Credit: Alexyz3d / Shutterstock
By Lawrence Jones, PhD
Protease inhibitor technology used commonly as a strategy to treat HIV and hepatitis C is now a strategy for SARS-CoV-2 antiviral therapy development. Researchers for SARS-CoV-2 have focused on “main protease (Mpro) which plays a dominant role in processing CoV-encoded polyproteins which mediate the assembly of replication-transcription machinery and is thus recognized as an ideal antiviral target (Cui, et. al, 2020.” The SARS-CoV-2 antiviral therapy development may consist of repurposed drugs as the push for a breakthrough is not only a goal by Pfizer but other biopharma companies in pursuit. “The first protease inhibitor to be approved by the US Food and Drug Administration (FDA) was saquinavir, in December 1995, and within months, two other protease inhibitors, ritonavir, and indinavir were approved (Cully, 2018).”
So far, Pfizer has been able to deliver to the public. Thus, the company has been a significant player during the SARS-CoV-2 vaccine production and distribution with effective outcomes regarding their vaccine efficacy and ability to produce the quantity of vaccine needed. Pfizer’s protease inhibitor outlook for the first U.S.-approved SARS-CoV-2 therapeutics is fast-tracked to their initial clinical phase 1 trial. Pfizer’s early stage one clinical trial on an oral antiviral therapy that can treat a SARS-CoV-2 patient effectively is now on the horizon. The quest to get the SARS-CoV-2 pandemic under control is continuing with urgency and caution.
The aim of the drug is for the first developing symptoms, which according to Pfizer (March 23, 20201), would make it the first oral antiviral treatment of its kind for coronavirus. Pfizer (March 23, 2021) “the trial is randomized and includes placebo groups with both single and multiple-dose studies.” What is promising is that the Pfizer company “is also studying an intravenous antiviral to treat SARS-CoV-2, which will become an option for some hospitalized patients over time.” Pfizer’s “PF-07321332 “protease inhibitor” has been formulated to attack the “spine” of the SARS-CoV-2 virus and stop it replicating in our nose, throats, and lungs.”
Pfizer’s Chief Scientific Officer, Mikael Dolsten reports that he is hopeful that their early raises the prospects of a cure for future pandemic threats. For now, laboratory “invitro” for animal tolerance is of the foremost importance before being tested in humans. Clinical trials will be intensive, and the screening and dosing steps and outcomes of the dosing step will be crucial for determining the drug’s safety and tolerability. The upcoming months of 2021 and early 2022 look very promising for technology combination therapies to mitigate SARS-CoV-2 infections.
References:
Butz, B. (March 23, 2021). Pfizer launches trial for novel oral SARS-COV-2 therapeutic. https://www.drugdiscoverytrends.com/pfizer-launches-phase-1-trial-for-novel-oral-SARS-CoV-2-therapeutic/
Cui, W., Yang, K., & Yang, H. (2020). Recent progress in the drug development targeting SARS-CoV-2 main protease as treatment for COVID-19. Frontiers in molecular biosciences,
Cully, M. (November 28, 2018). Protease inhibitors give wings to combination therapy. https://www.nature.com/articles/d42859-018-00015-7
Holzberg, E. (March 23, 2021). Pfizer Testing A Pill To Treat Covid. Pfizer Testing A Pill To Treat Covid (forbes.com)
Lucy, P. (April 28, 2021). Pfizer CEO says oral SARS-COV-2 pill could be ready by the end of the year. https://www.pmlive.com/pharma_news/pfizer_ceo_says_oral_SARS-CoV-2_pill_could_be_ready_by_the_end_of_the_year_1368720
Pfizer (March 23, 2021). Pfizer initiates phase 1 study of novel oral antiviral therapeutic agent against sars-cov-2. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-phase-1-study-novel-oral
Biotechnology Health Management and Care's Observed Trends for Early 2021
Blog post by Lawrence Jones, Ph.D.
2021 will be a year that forecasts and trends from a few years ago that came to a halt are now at the forefront of technical publications again. For instance, a year ago, emerging trends in biotechnology proved exciting as we embarked on an optimistic future of long-awaited drug developments for Alzheimer’s disease. Biogen’s FDA filing for new drugs was promising as they acquired from Pfizer Incorporated’s a novel drug for the potential treatment of patients with behavioral and neurological symptoms. However, with the onset of the scientific focus, health focus, and public health focus of SARS-Cov-2, this biotech topic dominated many of the projected trends of 2020.
The vaccine industry has been revamped and tweaked in ways that we have never seen before. I could touch on the up and coming vaccines, therapies, and strategies for SARS-Cov-2 and the variants that appear in various parts of the world and country; however, there are daily updates about this topic. Nevertheless, 2021, like 2020 and 2019, will continue to utilize and improve technologies that apply genome editing beyond traditional human drug development. Veterinary Medicine, which continues to enhance animal livestock, and animal agriculture, will evolve like never. The launch of Prime Medicine by David Liu, Ph.D., and associates has developed a technology geared for creating or correcting any single-base transition mutations and treating sickle cell disease.
The development of the two mRNA vaccines by Pzier and Moderna, currently being used to vaccinate millions of Americans and people worldwide, are new technologies that will enhance gene therapy innovation strategies for health care in the future. 2021 will reveal official and unofficial partnerships of various companies evaluating their portfolios. Digital therapeutics will also continue to play significant roles in monitoring and tracking disease and infection rates and health management. Research and development for SARS-CoV-2 disease control methods through various treatment by way of therapeutic antibodies, therapeutic antivirals, and vaccines (whole virus, RNA or mRNA based, non-replicating viral vector, and protein subunit) will continue to be at the forefront.
There will be continual surveillance through PCR (molecular) tests to detect the virus’s genetic material to determine the presence of active infection with SARS-CoV-2. More rapid antigen testing to see pieces of proteins that make up the SARS-CoV-2 virus to determine the presence of active disease with SARS-CoV-2 is also at the forefront of innovation. Serology tests for antibodies against SARS-CoV-2 and SARS-CoV-2 variants in the blood will continue to be a 2021 trend. More importantly, having effective distribution strategies and real-time communication for the public and patients receiving a vaccine will be vital to gaining control and protecting millions of people.