Vaccine News

May 30, 2021 • 8:01 am CDT

Good News Regarding the 2020-2021 Flu Season

The US Centers for Disease Control and Prevention (CDC) reported on May 28, 2021, a cumulative influenza positivity rate of .02% was confirmed between September 27, 2020, and May 15, 2021.

This rate substantially lower than the 17% average positivity for the 3 previous seasons in the USA.

With very few influenza virus specimens detected (24 out of 20,091) during Week #20, vaccine experts say that it is more difficult to identify and characterize the full extent of the circulating influenza viruses’ diversity. The CDC antigenically characterized 9 influenza viruses collected from September 27, 2020, to May 22, 2021.

The percentage of visits for Influenza-like Illness reported in Week #20 continued to increase for one age group (0–4 years).

A total of (1) influenza-associated pediatric death has occurred during the 2020-2021 flu season. This good news compares with (199) influenza-associated pediatric deaths last flu season.

The CDC's FluView Interactive system includes enhanced web-based interactive applications that can provide dynamic visuals of the influenza data collected and analyzed. These FluView Interactive applications allow people to create customized, visual interpretations of influenza data and make comparisons across flu seasons, regions, age groups, and a variety of other demographics.

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May 30, 2021 • 6:23 am CDT

Polio Cases Confirmed in African Countries

The Global Polio Eradication Initiative (GPEI) reported six countries in Africa confirmed polio cases for the week ending May 26, 2021. All of these polio cases involved vaccine-derived types.

Poliomyelitis (polio) is a highly infectious viral disease that primarily affects children. There are 3 strains of wild poliovirus.

The GPEI summary is as follows:

Pakistan: one cVDPV2 positive environmental sample
Burkina Faso: one cVDPV2 case
Congo: one cVDPV2 case
DR Congo: five cVDPV2 cases
Guinea: one cVDPV2 case
Liberia: two cVDPV2 positive environmental samples
Madagascar: three cVDPV1 cases and one cVDPV1 positive environmental sample
Mali: one cVDPV2 case
Tajikistan: two cVDPV2 positive environmental samples

To inform international travelers of their health risks, the U.S. CDC issued a Level 2 Travel Alert on May 13, 2021, saying, 'Some international destinations are considered high risk for polio.

Before travel to any high-risk destination, CDC recommends that adults who previously completed the full, routine polio vaccine series receive a single, lifetime booster dose of polio vaccine.'

Since 2000, the inactivated polio vaccine is most often given in the USA. The CDC recommends that children in the USA get polio vaccinated to protect against poliomyelitis.

The CDC's Advisory Committee on Immunization Practices Vaccine Recommendations is published on this webpage.

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May 29, 2021 • 12:16 pm CDT

Canada's Slow Path to Normal

New Brunswick, Canada's government, announced on May 27, 2021, all restrictions could be lifted on New Brunswick Day, August 2nd, if 75% of the eligible province population have been fully vaccinated and COVID-related hospitalizations remain manageable.

This vaccination requirement includes those New Brunswickers aged 12 and over.

As of May 29th, about 60% of New Brunswickers aged 12 and older have received the first dose of a COVID-19 vaccine.

By Aug. 2, this Canadian province expects to remove the current state of emergency order, which has been in place since March 2020. All zones are in the Yellow level under the province’s mandatory order.

The first phase of the three-phase Path to Green plan will begin on June 7th. If the Path to Green conditions is met, several changes will come into effect, including no mandatory isolation or testing for those traveling within Atlantic Canada and the border Quebec regions of Avignon and Témiscouata, except for Nova Scotia.

In addition, the 'steady 15' will be eliminated. New Brunswickers will be allowed contact with all family and friends in yellow alert levels.

However, travel registration will still be required.

Compassionate travel will be permitted for individuals outside Newfoundland and Labrador, Prince Edward Island, Avignon, and Témiscouata. Still, they will be required to isolate and take a COVID-19 test between days five and seven, with negative results, before they can discontinue isolation.

And cross-border commuters and truckers will no longer be subject to testing and isolation requirements.

Dr. Jennifer Russell, chief medical officer of health, said all New Brunswickers are suffering from COVID fatigue, but 'hope is a powerful force, and today is all about hope.'

Since the COVID-19 pandemic began in early 2020, there have been 43 fatalities confirmed in the province's 740,000 residents.

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May 28, 2021 • 10:01 am CDT

Monoclonal Antibody Therapy Alert Issued

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.

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May 27, 2021 • 5:17 pm CDT

Novel Treatment of Solid Tumors Clinical Study Opens for Americans

Sweden-based BioInvent International AB and Transgene announced that their Investigational New Drug application for BT-001 had been granted by the U.S. Food and Drug Administration. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.

This news enables patients in the USA to enroll in the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.

The ongoing Phase 1/2a study is a multicenter, open-label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). The Phase 1 part of the trial has already been initiated in Europe, where it is enrolling patients in several countries.

BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity.

“We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent’s fourth clinical program. This unique oncolytic virus has very exciting potential as it combines multiple mechanisms of action and anti-cancer properties, and we are looking forward to developing it further with our partners at Transgene,” said Martin Welschof, CEO of BioInvent, in a press release.

BT-001 is a novel oncolytic virus developed with Transgene’s Invir.IO™ platform. Invir.IO™’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus.

BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine.

The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes, eliciting a stronger and more effective antitumor response by reducing systemic exposure to a very low level.

BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively.

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Don Ward

Medical Review by

May 27, 2021 • 4:51 pm CDT

Airport Security Lines Remain Shorter Than Normal

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.

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May 27, 2021 • 4:13 pm CDT

Two-Dose Adult Hepatitis B Adjuvanted Vaccine Launching in Germany

California-based Dynavax Technologies announced on May 27, 2021, entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine in Germany with an expected launch in the fourth quarter of 2021.

In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

HEPLISAV B is the only U.S. Food and Drug Administration and EC-approved hepatitis B vaccine for adults with a two-dose regimen completed in one month.

Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people are infected worldwide. Hepatitis B can be prevented with effective vaccination. In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person.

The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis and for people age 60 and older with diabetes at their physician's discretion.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines.

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May 27, 2021 • 9:07 am CDT

Prostate Cancer Screening Found Very Effective

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.

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Don Ward

May 27, 2021 • 8:01 am CDT

Europe's Free-Movement Maps Updated

The European CDC published updated free-movement maps related to the ongoing COVID-19 pandemic on May 27, 2021. The maps are based on data reported by EU Member States to The European Surveillance System database by 23:59 every Tuesday.

These maps are published in support of the EU Council Recommendation, which EU Member States adopted in October 2020 and amended in January 2021.

Additionally, the ECDC publishes data related to each EU member's COVID-19 vaccination status and Situation Update.

The ECDC is an EU agency aimed at strengthening Europe's defenses against infectious diseases such as antimicrobial resistance and healthcare-associated infections; emerging and vector-borne diseases; food and waterborne diseases and zoonoses; HIV, sexually transmitted infections and viral hepatitis; influenza and other respiratory viruses; tuberculosis; and vaccine-preventable diseases.

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May 26, 2021 • 8:30 pm CDT

Urgent Call to Action Gets Cancer-Preventing HPV Vaccinations Going

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.

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May 26, 2021 • 4:03 pm CDT

Returning to the USA on an Expired U.S. Passport

If you are overseas and your U.S. passport expired on or after January 1, 2020, you may be able to use your expired passport to return directly to the United States until December 31, 2021, says the updated Department of State website.

You qualify for this exception if all the following are true: You are a U.S. citizen, currently abroad seeking a direct return to the USA, flying directly, or have only short-term transit (“connecting flights”) through a foreign country, your expired passport was originally valid for 10 years. Or, if you were 15 years of age or younger when the passport was issued, your expired passport was valid for 5 years.

And, your expired passport is undamaged, unaltered, and is in your possession.

All other passport rules and regulations remain in effect as of May 25, 2021.

The Department of Homeland Security maintains discretion to reject any bearer in accordance with 22 CFR 53.2(b)(7) and 8 CFR 235.1(b). You can find updated Frequently Asked Questions about U.S. passport operations by expanding the gray boxes on this State Department webpage.

Furthermore, regardless of your passport status, the US Centers for Disease Control and Prevention requires all air passengers entering the USA (including citizens and Legal Permanent Residents) to present a negative COVID-19 test, taken within three calendar days of departure or proof of recovery from the virus within the last 90 days.

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May 26, 2021 • 2:28 pm CDT

TSA Gets Tough with Face Mask Violators

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.

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May 26, 2021 • 1:53 pm CDT

Dentists Offer Strong Defenses Against COVI-19

According to a study published ahead of the June 2021 print issue, based on the number of dentists with confirmed or probable COVID-19 infections, the cumulative infection rate for U.S. dentists is 2.6%.

By comparison, in June 2020, the cumulative COVID-19 prevalence rate for other U.S. health professionals ranged from 3.3% (Chicago hospital physicians) to 35.3% (U.S.-based emergency medical services).

“We’re pleased to see that dentists have demonstrated the continued low monthly incidence during the study period,” commented American Dental Association (ADA) Science and Research Institute CEO Marcelo Araujo, D.D.S., M.S., Ph.D., the senior author of the report published on May 24, 2021.

Dr. Araujo added, “This study shows high rates of pre-appointment screening of patients and appropriate infection control measures throughout the study period, demonstrating that adhering to rigorous protocols for enhanced infection control helps protect their patients, their dental team, and themselves.”

The Journal of the ADA study is based on data collected June 9 - Nov. 13, 2020. For more information on COVID-19 and dental visits, visit MouthHealthy.org.

The study authors plan future research projects on the barriers and facilitators to wearing Personal Protective Equipment (PPE) according to CDC recommendations and levels of protection against COVID-19 provided by different levels of PPE use and infection control procedures.

The ADA was founded in Niagara Falls, New York, during 1859.

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May 26, 2021 • 1:15 pm CDT

Polio Remains a Public Health Emergency

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.

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