Vaccine News

The U.S. HHS issued a Public Health Notice on May 26, 2021, alerting healthcare providers in certain states to modify the use of certain monoclonal antibody treatments.

The Centers for Disease Control and Prevention (CDC) has identified that the combined frequency of the P.1 variant (Brazil) and the B.1.351 variant (South Africa) now exceeds 10% in Arizona, California, Florida, Indiana, Oregon, and Washington.

As detailed in prior communications (May 7 and May 21, 2021), the P.1 variant has also been persistently elevated at a frequency exceeding 10% in Illinois and Massachusetts.

Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants.

REGEN-COV is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab and etesevimab administered together and, based on similar in vitro assay data currently available, REGEN-COV is likely to retain activity against the P.1 and B.1.351 variants.

The U.S. FDA recommends that health care providers in Arizona, California, Florida, Indiana, Oregon, and Washington use this alternative authorized monoclonal antibody therapy until further notice.

All treatment delivery sites can continue ordering REGEN-COV from the authorized distributor by following the existing ordering and reporting procedures.

The FDA also recommends shipping restrictions of bamlanivimab and etesevimab together, and etesevimab alone to Illinois and Massachusetts also remain in effect.

Other states, except those noted above, are not impacted by today’s announcement, says the HHS statement.

All healthcare providers should monitor information from the CDC and state and local health authorities regarding the frequency of P.1 and B.1.351 variants in their region. Healthcare providers should also refer to the CDC website and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

According to the latest air traveler data from the US Transportation Security Administration (TSA), the lines at the airport security remain about 30% shorter than before the COVID-19 pandemic began.

In May 2021, the TSA's average number of daily screened travelers was about 1.7 million people. This trend compares with May 2019's average traveler volume of 2.4 million.

However, compared to 2020's average passenger volume of less than 300,000 per day, the airline travel industry is on the road to recovery! 

Here’s a hot tip from the TSA.

There’s still time to enroll or renew in TSA PreCheck program before your summer travel begins. Enrolling is easy. Just be visit www.tsa.gov/precheck. The process begins with a five-minute online application, at the end of which you’ll be prompted to book a 10-minute in-person appointment at one of 400+ enrollment centers in the U.S., with over 35 of those located at major airports nationwide.

That’s all it takes… 15 minutes for five years of skipping those long security lines.

Prostate-specific antigen (PSA) screening was associated with better oncologic outcomes in African American patients with prostate cancer, according to data presented by Edmund M. Qiao, BS, of the University of California San Diego, reported Audrey Sternberg with The Cancer Network on May 20, 2021.

An increase in the frequency of PSA screening was linked to a nearly 25% reduction in prostate cancer-specific mortality and an approximately 40% lower risk of having the metastatic disease at the time of a prostate cancer diagnosis.

The “high PSA screening” group had received an average of 3 prior screening tests, and the “low PSA screening” group had received an average of 0.5 prior screening tests.

Overall, the study included 4,726 African American men diagnosed with prostate cancer. The mean patient age was 51.8 years. The mean number of previous PSA screening tests was 1.9.

The US Preventive Services Task Force PSA screening policy is a grade C recommendation for men aged 55 to 69 years, meaning in this population, an individual decision on screening should be made based on a physician-clinician discussion of the potential benefits and risks.

Seventy-one designated cancer centers and partner organizations have issued a joint statement urging the nation’s physicians, parents, and young adults to get the human papillomavirus (HPV) vaccination back on track.

National Cancer Institute (NCI) centers said on May 21, 2021, 'dramatic drops in annual visits and immunizations during the COVID-19 pandemic have caused a significant vaccination gap and lag in vital preventive services among U.S. children and adolescents--especially for the HPV vaccine.

Early in the COVID-19 pandemic, HPV vaccination rates among adolescents fell by 75%, resulting in a large cohort of unvaccinated children. Since March 2020, an estimated one million doses of HPV vaccine have been missed by adolescents with public insurance.

The U.S. has recommended routine HPV vaccination for females since 2006 and for males since 2011. Current recommendations are for routine vaccination at ages 11 or 12 or starting at age 9.

And catch-up HPV vaccination is recommended through age 26.

NCI Cancer Centers strongly urge health care systems and health care providers to identify and contact adolescents due for vaccinations and use every opportunity to encourage and complete vaccination.

"HPV is the cause of cervical cancer and will soon be the major cause of head and neck cancer," said Benjamin G. Neel, MD, Ph.D., director of Perlmutter Cancer Center and professor of Medicine at NYU Grossman School of Medicine, in a related press statement.

"Now is the perfect time not only to get teens vaccinated against COVID-19 but also to prevent them from getting these potentially deadly cancers."

More information on HPV is available from the National HPV Vaccination Roundtable. 

According to Just The News reporting on May 26, 2021, Darby LaJoye, senior official performing the duties of the Transportation Security Administration (TSA) administrator, commented, 'TSA agents are handling mask mandate violations in airports the "same way" they would travelers trying to take firearms or other prohibited items through security checkpoints.'

On April 30th, the TSA announced extending the face mask requirement for individuals across all transportation networks throughout the USA, including at airports, onboard commercial aircraft, on over-the-road buses, and on commuter bus and rail systems through September 13, 2021.

The TSA’s initial face mask requirement went into effect on February 1st.

Additionally, the TSA is ramping up and refine operations for expected increased passenger travel volumes throughout the summer months. 

As of May 25, 2021, the TSA's weekly data indicates a slight increase in air passenger activity.

“As passenger volumes continue to rise, TSA is ready for their return to airports across the country, equipped with enhanced airport security checkpoints, over 46,000 highly-trained security professionals, and valuable partnerships with stakeholders and industry, all to ensure a secure and seamless travel experience,” stated Darby LaJoye in a recent press statement.

“For those passengers returning to travel for the first time since 2019, be aware that some processes at the checkpoint have changed, and some, like removing your shoes, remain in place.

Additionally, during high volume months, travelers should plan to arrive early at the airport to complete the airport screening process and arrive timely at their departure gate.”

For more information about the Security Directives and Emergency Amendment, visit tsa.gov/sd-and-ea. 

The WHO Director-General convened a meeting of the Emergency Committee under the International Health Regulations on the international spread of poliovirus on May 4, 2021.

The Emergency Committee reviewed the data on wild poliovirus and circulating vaccine-derived polioviruses.  

And the current situation in Afghanistan, Kenya, Pakistan, Senegal, South Sudan, and Tajikistan.

The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  

The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC. Still, it concludes that the current situation is extraordinary, with a clear ongoing substantial risk of international spread and the utmost need for a coordinated international response.

Polio is a crippling and potentially deadly disease that affects the nervous system and can be prevented with a vaccine.

The U.S. CDC issued two Level 2 Travel Alerts regarding ongoing polio outbreaks on May 13, 2021. The CDC suggests visitors to certain countries in Asia and Africa should speak with a healthcare provider regarding polio vaccination options.

Since 2000, the inactivated polio vaccine is most often given in the USA. The oral polio vaccine is offered in other countries, says the CDC.

Zydus Cadila announced on May 24, 2021, it launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name ‘Ujvira’.

HER2-positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all breast cancer cases.

In a step that can significantly reduce treatment cost by almost 80%, the drug is being offered at Rs. 32495 for a 100 mg vial. The current MRP of the existing Trastuzumab Emtansine drug is Rs. 1,59,225 for a 100 mg vial.

Ujvira will be available in two strengths, 100 mg, and 160 mg.

Speaking on this milestone, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited stated in a press release, “The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus' ongoing commitment to offer breakthroughs backed by science and innovation."

"This research breakthrough enables access to a critical drug for patients who are undergoing therapy for breast cancer. We hope that with this innovation, patients will be able to adhere to the treatment and stand to benefit from the advanced technology without worrying about the cost of the treatment.”

Trastuzumab Emtansine ADC biosimilar is a developmental breakthrough due to its complexity in manufacturing and similarity assays. This drug is made by combining Trastuzumab and the cytotoxic compound Emtansine with the help of a stable linker by a process called Antibody Drug Conjugation.

Due to this technology, the targeted delivery of the cytotoxic agent is enabled and the other toxicities on the body are reduced.

Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need, said the company.

Based in India, Zydus Cadila is an innovation-driven, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics, and vaccines. The company employs nearly 25,000 people worldwide, including 1,400 scientists engaged in R & D.