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

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