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Maryland-based Novavax, Inc. announced the pre-print publication of data from a Phase 2b clinical trial in children demonstrating 77% efficacy in the higher adjuvant dose group for a malaria vaccine candidate, R21, created by the University of Oxford that includes Novavax' Matrix-M™ adjuvant and is licensed to Serum Institute of India (SII).

The publication reports that both adjuvant dosage levels were well tolerated in young children with no reported severe reactions to the vaccine. Also, participants vaccinated with R21/Matrix-M showed high titers of malaria-specific anti-N-acetylneuraminic acid phosphatase (NANP) antibodies 28 days after the third vaccination doubled with the higher adjuvant dose.

After a fourth dose, administered one year later, antibody levels were boosted to levels similar to the peak titers achieved following the primary series of vaccinations.

A Phase 3 trial of the vaccine has begun recruitment across five trial sites in four countries of differing malaria transmission rates and seasonality in Africa to study large-scale safety and efficacy.

R21 was produced by expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, comprising the central repeat and the C-terminus of the circumsporozoite protein fused to the N-terminal end of HBsAg10 and manufactured by the SII.

Adrian Hill, Lakshmi Mittal and Family Professorship of Vaccinology; Director of the Jenner Institute at the University of Oxford; Co-Director, Oxford Martin Programme on Vaccines, and co-author of the publication, stated in a press release issued on April 23, 2021, "With the commitment by our commercial partner (SII) to manufacture at least 200 million doses annually in the coming years, we believe this vaccine could have a major public health impact."

There were an estimated 229 million cases of malaria worldwide in 2019, with an estimated 409,000 deaths. Children under the age of five are the most vulnerable, accounting for 67% of deaths worldwide in 2019.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company located in Gaithersburg, MD that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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Gaithersburg

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The European Medicines Agency (EMA) announced on April 23, 2021, an increase in vaccine manufacturing capacity and supply for mRNA COVID-19 vaccines produced by BioNTech - Pfizer and Moderna.

The EMA approved an increase in batch size and associated process scale-up at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The Agency’s Committee for Human Medicines (CHMP) recommendation is expected to have a significant impact on the supply of the COVID-19 vaccine (Comirnaty) developed by BioNTech and Pfizer in the European Union.

The CHMP also recommended the approval of a new filling line at Moderna’s vaccine finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities to synchronize with the active substance scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.

The mRNA vaccine changes will be included in the publicly available information on EMA’s website.

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Moderna COVID-19 Vaccine (mRNA-1273)

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Europe

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Japan's central government announced new COVID-19 related restrictions in Tokyo, Osaka, Kyoto, and Hyogo prefectures on April 22, 2021.

The new emergency measures are not a full civilian lockdown, but they impose limits on restaurants and other businesses. The new policies carry fines but largely rely on voluntary compliance through at least May 11, 2021.

Nationwide, Japan is seeing spikes in SARS-CoV-2 coronavirus cases and COVID-19 hospitalizations. About 5,452 people tested positive for the coronavirus on April 21st, according to Japan's Ministry of Health, Labour and Welfare.

On April 2, 2021, the U.S. CDC lowered its Travel Alert for Japan to Level 2 status. However, the CDC says, 'Travelers at increased risk for severe illness from COVID-19 should avoid all nonessential travel to Japan. If you travel to Japan, get fully vaccinated before travel.'

And, 'get tested with a viral test 3-5 days after travel and stay home and self-quarantine for a full 7 days after travel. Even if you test negative for the SARS-CoV-2 virus, stay home and self-quarantine for the full 7 days,' says the CDC.

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Japan

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The U.S. Food and Drug Administration (FDA) announced it approved GlaxoSmithKline (GSK) accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell).

Jemperli works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). Jemperli helps the body’s immune system in its fight against cancer cells by blocking this pathway.

“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press statement.

“This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

Endometrial cancer is the most common gynecologic malignancy in the United States, and its prevalence is increasing. Approximately 75% of endometrial cancers are diagnosed at an early stage and are typically curable with surgery.

However, women with advanced and recurrent endometrial cancer have limited therapeutic options following front-line standard treatment with a platinum-containing chemotherapeutic regimen.

Approximately 25% to 30% of patients with advanced endometrial cancer have dMMR tumors.

Dr. Hal Barron, Chief Scientific Officer, and President R&D, GSK, commented in a press statement, “Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year, and these women currently have limited treatment options if their disease progresses on or after first-line therapy."

"Today’s approval of dostarlimab by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynaecologic cancers.”

However, Jemperli can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands, and kidneys.

Patients who experience severe or life-threatening infusion-related reactions should stop taking Jemperli. Women who are pregnant or breastfeeding should not take Jemperli because it may cause harm to a developing fetus or newborn baby. The safety and effectiveness of Jemperli in pediatric patients are not known.

Further clinical trials may be required to verify and describe the anticipated clinical benefits of Jemperli, and the sponsor is currently conducting these trials in additional patients with dMMR endometrial tumors.

The FDA is an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

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Cancer

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United States of America

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Researchers with the US Centers for Disease Control and Prevention (CDC) or the Food and Drug Administration published a study in the NEJM on April 21, 2021 that concluded 'Preliminary findings did not show obvious safety signals among pregnant females who received an mRNA COVID-19 vaccine, such as the Pfizer-BioNTech or Moderna vaccines.

Among 3,958 participants enrolled in the US V-Safe Pregnancy Registry, 827 females had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth.

Most of these women had the mRNA vaccination in the third trimester.

Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%).

However, no neonatal deaths were reported.

Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against COVID-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women conducted before the COVID-19 pandemic.

'Longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes,' wrote these researchers. The study authors are U.S. government employees or contractors and do not have any material conflicts of interest.

As of March 18, 2021, the CDC says, 'Getting vaccinated is a personal choice. Based on how these vaccines work in the body, experts believe they are unlikely to pose a specific risk for pregnant women. Any of the currently authorized COVID-19 vaccines can be offered to women who are pregnant or breastfeeding.'

'If you have questions about getting vaccinated, a conversation with your healthcare provider might help but is not required.'

The Moderna and Pfizer-BioNTech experimental mRNA vaccines do not contain the live virus that causes COVID-19 and, therefore, cannot give someone COVID-19, says the CDC.

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United States of America

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The ongoing COVID-19 pandemic continues to affect countries differently around the world. Challenges to any international travel at this time may include mandatory COVID-19 testing requirements, quarantines, travel restrictions, and closed borders, says the US Department of State.

Foreign governments may implement restrictions with little notice, even in destinations that were previously low risk. If you choose to travel internationally, your trip may be severely disrupted, and it may be difficult to arrange travel back to the USA.

U.S. citizens and legal permanent residents returning to the USA from the United Kingdom, Ireland, and the European Schengen area should review the State Department FAQs on travel from Europe and the Department of Homeland Security website for further details.

And the Centers for Disease Control and Prevention requires all air passengers two years of age and over entering the USA (including U.S. 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 SARS-CoV-2 virus within the last 90 days.

To keep everyone aware of travel volumes, the Transportation Security Administration (TSA) posts daily airport screening on this webpage.

The TSA recently announced it was launching recruitment efforts nationwide to fill over 6,000 Transportation Security Officer (TSO) positions by summer 2021.

“TSOs are a critical first-line defense in securing our nation’s commercial air transportation system,” said Melanie Harvey, acting Executive Assistant Administrator for TSA’s Security Operations, in a press statement.

“Each day, our officers screen hundreds of thousands of airline travelers, ensuring they arrive at their destinations safely. We expect to screen a higher number of travelers regularly by the summer months and will need additional officers to support our critical mission.”

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Europe

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The Journal of the National Cancer Insititute published a study on April 20, 2021, 'Real-world Effectiveness of Human Papillomavirus Vaccination (HPV) Against Cervical Cancer.'

These researchers concluded the study by saying 'the HPV vaccine's effectiveness against cervical cancer at the population level is high among women vaccinated before age 20 in Demark.

However, the lack of immediate effect in women vaccinated at age 20–30 years points to the importance of early age at vaccination.'

Thi study's cohort comprised 867,689 women. At baseline, 36.3% were vaccinated at ≤ 16 years, and during follow-up, 19.3% and 2.3% were vaccinated at 17–19 and 20–30 years, respectively.

For women vaccinated at ≤ 19 years, the Incidence rate ratios (IRR) of cervical cancer was 0.14 (95% CI:0. 04–0.53) and 0.32 (95% CI: 0.08–1.28), respectively, compared to unvaccinated women.

In women 20–30 years at vaccination, the IR was higher than among unvaccinated women (IRR=1.19, 95% CI: 0.80–1.79), but slightly decreased with an increased buffer period (IRR=0.85 (95% CI: 0.55–1.32) with a four-year buffer period).

There are safe and effective HPV vaccines to protect males and females against cancers caused by HPV. These vaccines include 9vHPV, 4vHPV, and/or 2vHPV, says the US Centers for Disease Control and Prevention (CDC).

Vaccination is not recommended for everyone older than age 26 years, says the CDC. However, some adults ages 27 through 45 years may decide to get the HPV vaccine based on discussion with their clinician, if they did not get adequately vaccinated when they were younger. HPV vaccination of people in this age range provides less benefit, for several reasons, including that more people in this age range have already been exposed to HPV.

Vaccine Treats:

Cervical Cancer

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Denmark

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With a $25 million grant from the National Institutes of Health Helping to End Addiction Long-term Initiative (HEAL), vaccine scientists from the Precision Vaccines Program at Boston Children’s Hospital have partnered with Therese Kosten, a University of Houston (UH) professor of psychology, and her colleagues to develop an adjuvant opioid use disorder vaccine.

“This could be a game-changer for addiction,” stated Kosten in a UH press release issued on April 19, 2021. Kosten received $1.8 million of the grant to combine the adjuvant with the vaccine as powerful as possible.

Kosten’s vaccine development follows her spouse, Dr. Thomas Kosten, M.D., who holds a joint appointment at UH and Baylor College of Medicine, previously developed and tested against cocaine.

“We will also evaluate multi-dose strategies, followed by single-dose immunization, heterologous vaccination strategies, and the impact of waning immunity,” said Kosten. The Kosten team will provide expert input into the regulatory strategy for meetings with the US Food and Drug Administration.

An adjuvant molecule boosts the immune system’s response to vaccines, a critical component for the effectiveness of anti-addiction vaccines. The vaccine candidate targets fentanyl, a synthetic and very potent opioid.

An anti-opioid vaccine would protect the brain and nervous system by stimulating the body to create powerful antibodies that target and bind to opioid molecules, preventing them from crossing the blood-brain barrier to reach the brain. By blocking opioids from the brain, the vaccine would reduce respiratory depression from opioids when they reach the brain.

Leading the vaccine project in Boston are principal investigators Dr. Ofer Levy, M.D., and David Dowling, of Boston Children’s Precision Vaccines Program, along with additional support from Dr. Sharon Levy, M.D., director of Boston Children’s Adolescent Substance Use and Addiction program and Elissa Weitzman of the Division of Adolescent and Young Adult Medicine.

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93020C00038 as described in Article H.36 of the contract.

The NIH HEAL Initiative is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis.

Vaccine Treats:

Opioid Overdose

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