Jason M. Broderick

This article was originally published in UrologyTimes.

New insight shows the Pfizer and Moderna mRNA 

A research team from the University of Miami Miller School of Medicine assessed 45 healthy men (median age, 28 years) who received either the BNT162b2 mRNA vaccine (Pfizer-BioNTech) or the mRNA-1273 mRNA vaccine (Moderna).

In this population, the researchers did not observe reductions in any sperm parameters, including semen volume, sperm concentration, sperm motility, and total motile sperm count (TMSC).

“Vaccine hesitancy is a barrier to ending the COVID-19 pandemic, and we believe some of that hesitancy is due to public opinion about whether the vaccine might negatively affect fertility,” senior study author Ranjith Ramasamy, MD, associate professor and director of the Miller School’s Reproductive Urology Program, stated in a press release.

“We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find,” added Ramasamy.

The prospective, single-center study conducted at the University of Miami accrued 45 men aged 18-50 years between December 17, 2020, and January 12, 2021.

Overall, 21 men (46.7%) received BNT162b2 and 24 men (53.3%) received mRNA-1273 and semen samples were obtained at baseline and at a median follow-up of 75 days (IQR, 70-86) after the second vaccine dose.

The median abstinence periods before obtaining the samples were 2.8 days (IQR, 2-3) for the baseline sample and 3 days (IQR, 3-4) for the follow-up sample. The researchers completed the study on April 24, 2021.

“This is the full life cycle of sperm and 70 days is sufficient time to see if the vaccine impacts semen parameters,” Daniel C. Gonzalez, BSc, a medical student at the Miller School and the study’s first author, stated in the press release.

Across the 45 patients, the baseline sperm concentration was 26 million/mL (IQR, 19.5-34) and the follow-up sperm concentration was 30 million/mL (IQR, 21.5-40.5; 

 = .02). The baseline and follow-up TMSC values were 36 million (IQR, 18-51) versus 44 million (IQR, 27.5-98), respectively (

 = .001). The median semen volume was 2.2 mL (IQR, 1.5-2.8) at baseline and 2.7 mL (IQR, 1.8-3.6) at follow-up (

 = .01). The median total motility percentage was 58% (IQR, 52.5-65) versus 65% (IQR, 58-70), respectively (

The researchers noted that 8 men were oligospermic (median concentration, 8.5 million/mL; [IQR, 5.1-12]) prior to receiving the vaccination. Among this subgroup, only 1 man remained oligospermic after vaccination, and the other 7 men actually had an increase in their sperm concentration to normozoospermic range at follow-up (median concentration, 22 million/mL; [IQR, 17-25.5]). The investigators reported that no men became azoospermic after being vaccinated.

In their study conclusion, the author’s wrote, “Because the vaccines contain mRNA and not the live virus, it is unlikely that the vaccine would affect sperm parameters. While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation and may be influenced by regression to the mean. Additionally, the increase may be due to the increased abstinence time before the second sample.”

Sperm Parameters Before and After COVID-19 mRNA Vaccination

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The vaccines did not result in reductions in semen volume, sperm concentration, sperm motility, and total motile sperm count.

Moderna, Pfizer COVID-19 Vaccines Do Not Affect Male Fertility

	Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant prostate cancer (also referred to as hormone-refractory), has become the first FDA-approved therapeutic vaccine for cancer. Provenge triggers an immune response against prostatic acid phosphatase, an antigen frequently expressed in prostate cancers. The highly anticipated approval follows nearly 2 decades of research and development that included a controversial rejection of the vaccine by the FDA in 2007.

With the approval of Provenge, Philip Kantoff, MD, director of the Lank Center for Genitourinary Oncology, chief of the Division of Solid Tumor Oncology and chief clinical research officer at Dana-Farber Cancer Institute, as well as a professor of medicine at Harvard Medical School, predicted, “Cancer immunotherapies that use the patient’s own immune system will likely create an entirely new treatment paradigm for patients with cancer.”

	The FDA based its approval of Provenge on three phase III studies, with the critical trial being the IMPACT (Immunotherapy for Prostate Adenocarcinoma Treatment) trial. This multicenter, randomized, double blind, placebo-controlled study evaluated a 512 men with asymptomatic or minimally symptomatic metastatic CRPC. In IMPACT, the median overall survival in the Provenge arm was 25.8 months compared with 21.7 months for the placebo group. The 4.1-month survival advantage for Provenge is approximately 1 month longer than the survival advantage over placebo with docetaxel, the only approved chemotherapy for advanced prostate cancer. Provenge reduced the risk of death by 22.5% (hazard ratio, 0.775; 95% confidence interval, 0.614-0.979; 

 = .032), with a 3-year survival rate of 31.7%, compared with 23% for the control arm. In separate safety evaluations of Provenge, the most common adverse events reported were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Although Provenge is approved, Dendreon Corporation, which manufactures the drug, says it will be conducting additional safety trials.

	While the general reaction to Provenge has been positive, the vaccine’s steep price tag has drawn criticism. Provenge will cost between $70,000 to $100,000 for the 1-month course of therapy. Dendreon will almost certainly maintain that the high cost takes into consideration the expensive manufacturing requirements. The vaccine is custom made for each patient using dendritic cells from his tumor. This requires costly storage of biological material. To address concerns about the drug’s affordability, Dendreon plans to donate funds to a nonprofit organization that will provide copayment assistance to qualifying patients.  

	Dendreon estimates Provenge may be appropriate for 103,000 current US patients. The company has been gearing up for production, anticipating FDA approval. Fifty centers, all previously approved as clinical trial sites, will administer the vaccine. Dendreon expects to increase capacity in mid-2011 and be ready for full-scale production as early as 2012. Watch for a more extensive report on Provenge and its likely impact on metastatic prostate cancer and immunotherapy in cancer in the June issue of 

Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant prostate cancer (also referred to as hormone-refractory), has become the first FDA-approved therapeutic vaccine for cancer. The highly anticipated approval follows nearly 2 decades of research and development that included a controversial rejection of the vaccine by the FDA in 2007.