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The U.S. Food and Drug Administration (FDA) announced on April 30, 2021, the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity.

The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.

Naloxone is a medicine that individuals can administer with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, commented in a press release, “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”

Over the last several years, the FDA has taken several steps to improve the availability of naloxone products, including encouraging manufacturers to pursue approval of over-the-counter naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months.

The FDA is committed to using its regulatory authority to address the opioid crisis, focusing on decreasing exposure to opioids and preventing new addiction, fostering the development of novel pain treatment therapies, supporting treatment of those with opioid use disorder, and improving enforcement and assessing benefit-risk.

Since the World Health Organization (WHO) recommended introducing at least a single dose of inactivated poliovirus vaccine (IPV) in routine immunization schedules in 2014, there have been global shortages.

Fractional-dose of IPV is one of the strategies suggested by the WHO to ensure vaccine availability.

A new study published by The Lancet on April 30, 2021, reviewed data comparing the effects of fractional with full-dose IPV vaccination to determine when seroconversion proportions with each strategy become similar in children aged 5 years and younger.

In this systematic review and meta-analysis from 16 databases, these researchers concluded 'There is no substantial difference in seroconversion between three doses of fractional-IPV and three doses of full-dose IPV, although the full dose gives higher titers of antibodies for poliovirus type 1, 2, and 3.

These researchers stated: Use of fractional IPV instead of the full dose can stretch supplies and possibly lower the cost of polio vaccination.

Since 2000, the IPV is most often given in the USA.

On April 28, 2021, the Global Polio Eradication Initiative reported nine countries confirmed polio cases in the last week, all involving vaccine-derived strains. Of countries reporting polio cases, (7) are in Africa, and (2) are located in the Middle East and Asia. Madagascar and Liberia reported their initial polio cases during 2021.

Recent research from Washington University School of Medicine in St. Louis has shown that an innovative approach can be used to create personalized vaccines that program the immune system to attack malignant tumors, including breast and pancreatic cancers.

The tailor-made vaccines are designed to target mutated proteins called neoantigens unique to a patient’s tumors.

Unlike mRNA vaccines, these personalized cancer vaccines are made using DNA.

“We took a small tissue sample from a tumor in a 25-year-old male patient with late-stage pancreatic cancer and used it to develop a personalized vaccine based on the unique genetic information in that tumor,” said William Gillanders, M.D., senior author and professor of surgery at the School of Medicine, in a press release.

“We think this is the first report of the use of a neoantigen DNA vaccine in a human, and our monitoring confirms the vaccine was successful in prompting an immune response that targeted specific neoantigens in the patient’s tumor.”

Published April 21, 2021, in the journal Genome Medicine, this study explores how techniques used to create personalized cancer vaccines can be improved to help the body unleash a more effective, longer-lasting, tumor-fighting immune response.

The findings also show that a personalized DNA vaccine coupled with other immunotherapies can generate a robust immune response capable of shrinking breast cancers in mice. While the DNA vaccine did not shrink tumors in the pancreatic cancer patient, it did produce a measurable immune response that targeted the tumor.

Gillanders, who treats breast cancer patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, said DNA vaccine platforms offer some important advantages over other personalized vaccine platforms now in early clinical trials relying on mRNA, dendritic cells, and synthetic peptides.

Because the neoantigen DNA vaccine focuses the immune response on neoantigens that exist only in tumor cells, it lowers the risk of dangerous side effects, such as damage to normal healthy tissues or the triggering of intolerance or bad reaction to the vaccine.

“DNA vaccines are relatively easy and cost-effective to manufacture compared with other neoantigen vaccine platforms such as those that use dendritic cells or mRNA, for example, making the DNA vaccine platform attractive for neoantigen vaccines,” Gillanders added.

“The DNA vaccine platform also can be readily engineered to include multiple neoantigens. Additional immune modulators can also be integrated into the vaccine to increase the immune responses.”

Like other personalized vaccines now under development, the DNA vaccine platform targets neoantigens, abnormal protein fragments that are created as cancerous tumor cells mutate and grow. Since each cancer generates unique mutations, each DNA vaccine is also unique and optimized to target multiple neoantigens simultaneously.

Each neoantigen in the vaccine raises a red flag for the immune system, sending an army of specialized immune cells called T cells to seek and destroy the tumor.

While the process seems simple in theory, the devil is in the details, and those details reside within the complex inner workings of how cells process and present the neoantigens to the immune system.

For the vaccine to be successful, the neoantigens must be presented to cells in a precise format that maximizes the odds of triggering a complex, step-by-step cascade of natural immune responses. Any misstep may result in a weakened or even failed immune response.

As the new study documents, the neoantigen DNA vaccine can be optimized to improve the presentation process. Small differences in the length of an epitope (the part of the antigen recognized by the immune system), spacing, and amino acid sequence can result in important changes in how neoantigens are presented to the immune system. Even then, cancers often find ways to evade successful attacks.

The findings suggest that longer epitope fragments are more effective at triggering a longer-lasting immune response that includes both CD8 and CD4 T cells; that a mutant marker that tags neoantigens and is cloned to the end of an epitope string can significantly increase its recognition by the immune system; and that even the most well-presented epitopes are seldom successful at shrinking tumors unless accompanied by an additional immunotherapy tool, such as anti-PD-L1 checkpoint blockade.

“Although the initial clinical experience is promising, there is more work to do to refine the vaccines and evaluate their effectiveness in animal models and clinical trials. But this is an important first step and points us in the right direction,” Gillanders said.

Susan G. Komen supported this work for the Cure, grant number KG111025; the Alvin J. Siteman Cancer Center, Investment Program grant 4035; the National Institute of Health (NIH), R01CA240983; the National Cancer Institute, Cancer Center Support Grant P30-CA091842, and SPORE in Pancreatic Cancer, P50-CA196510; NCI training grant T32 CA 009621; and The Foundation for Barnes-Jewish Hospital.

Washington University School of Medicine’s 1,500 faculty physicians also is the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. 

A recent study evaluated the question 'how often is cervical cancer screening tests overused in women with average risk in the United States?

While cervical cancer screening with cytologic and human papillomavirus (HPV) testing has reduced mortality from cervical cancer, overuse of these tests is associated with downstream psychological and medical consequences, as well as high costs.

In this cohort study of 2,299,177 commercially insured women aged 30 to 65 who underwent cervical cancer screening in 2013 through 2014, about 64% underwent repeat testing within 36 months of index testing.

After the index screening test, women who did not undergo repeat screening were significantly less likely to undergo a gynecological exam.

In summary, these researchers said, 'These findings suggest that despite evidence-based guidelines, overuse of cervical cancer screening tests was common.'

The 2012 American Cancer Society guidelines for cervical cancer screening recommend using cytologic screening every 3 years or co-testing with HPV and cytologic testing every 5 years in women aged 30 to 65 years. More recently, guidelines have been updated to advocate for primary HPV testing every 5 years as the preferred approach to screening in all women aged 25 to 65.