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France-based Valneva SE and Pfizer Inc. announced the initiation of another Lyme Disease vaccine study, VLA15-221. This study will build on previous positive Phase 2 studies, incorporate new dose regimens, and anticipate the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.
VLA15 is the only active Lyme disease vaccine candidate in clinical development as of March 8, 2021, and covers six serotypes prevalent in North America and Europe. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far.
As announced in December 2020, VLA15-221 will be the first VLA15 study to include a pediatric population. Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6) or placebo.
“We are excited to be part of the Lyme disease vaccine development program with Valneva. We hope this Phase 2 trial, with a simplified schedule, will provide evidence that the investigational vaccine can be used in populations that are at risk of contracting Lyme disease, potentially including children age five years and older,” stated Kathrin Jansen, SVP and Head of Pfizer Vaccine Research and Development, in a press statement.
Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere, according to the U.S. Centers for Disease Control and Prevention.
Valneva SE is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs.
Switzerland-based Global Polio Eradication Initiative published its weekly summary of new WPV and cVDPV polioviruses AFP cases and ES positives. This map displays the latest number of WPV1 and cVDPV cases in each affected country.
As of March 3, 2021, the following countries reported polio news: Afghanistan: one cVDPV2 case and nine cVDPV2 positive environmental samples; Pakistan: three WPV1 environmental samples, three cVDPV2 cases, and 10 cVDPV2 positive environmental samples; Egypt: two cVDPV2 positive environmental samples, Ethiopia: one cVDPV2 case and one positive environmental sample, Liberia: three cVDPV2 positive environmental samples, South Sudan: seven cVDPV2 cases, Tajikistan: one cVDPV2 positive environmental sample.
Polio can be prevented with a vaccine, says the U.S. CDC. The CDC recommends that children get polio vaccinated to protect against poliomyelitis. Since 2000, the inactivated polio vaccine (IPV) is most often given in the USA. It is administered by a shot in the arm or leg, depending on the person’s age.
The IPOL vaccine is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, inactivated poliovirus vaccine with enhanced potency administered intramuscularly or subcutaneously.
The Global Polio Eradication Initiative is a public-private partnership led by national governments with six-core partners with a goal to eradicate polio worldwide.
The U.S. FDA issued an emergency use authorization for the Cue COVID-19 Test for Home and Over The Counter Use on March 5, 2021. This Cue test correctly identified 96% of positive samples from individuals known to have symptoms and correctly identified 100% positive samples from individuals without symptoms.
The product is a molecular nucleic acid amplification test intended to detect genetic material from the SARS-CoV-2 virus present in the nostrils. This test is the first molecular test authorized by the FDA for at-home use without a prescription.
California-based Cue Health stated in a previous press statement it expects to produce more than 100,000 tests per day by summer 2021.
Acting FDA Commissioner Janet Woodcock, M.D., said in a press statement, “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic."
As of March 2, 2021, the FDA had authorized 332 coronavirus diagnostic tests, including 249 molecular tests, 71 antibody tests, and 15 antigen tests during the COVID-19 pandemic. Furthermore, 38 molecular authorizations can be used with home-collected samples.
The US Centers for Disease Control and Prevention reported about 336 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections as of March 4, 2021.
There is an outbreak of yellow fever in the Federal Republic of Nigeria, said the U.S. CDC on March 1, 2021. The yellow fever outbreak is currently in the Nigerian states of Bauchi, Benue, Delta, Ebonyi, and Enugu. Yellow fever is an acute viral hemorrhagic fever.
The CDC's Level 2, Practice Enhanced Precautions, Travel Alert, says 'unless vaccinated, travelers should not visit these areas in West Africa.'
Furthermore, travelers to Nigeria should take steps to prevent yellow fever by getting vaccinated at least 10 days before travel and taking steps to prevent mosquito bites, says the CDC.
The government of Nigeria requires that all travelers 9 months of age or older show proof of yellow fever vaccination to enter the country. A signed and stamped International Certificate of Vaccination or Prophylaxis (“Yellow Card”) provides proof of vaccination.
However, not all Yellow Cards are valid.
“We estimate that around 80% of yellow fever travel cards in Zimbabwe are counterfeit,” said Dr. Mchechesi, a co-founder at Vaxiglobal, a travel health consultancy.
Yellow fever vaccines are currently available at a limited number of clinics in the USA.
Talk with a health care provider if you have questions about the yellow fever vaccine. Yellow fever vaccine is not recommended for some people. If you cannot be vaccinated against yellow fever (for whatever reason), do not travel to places where yellow fever outbreaks are occurring, says the CDC.
The U.S. CDC's Weekly U.S. Influenza Surveillance Report for Week #8 says, 'Seasonal influenza activity in the United States remains lower than usual for this time of year.' Nationwide during week #8, 0.9% of patient visits reported were due to Influenza-like Illness (ILI). There were just 32 confirmed influenza specimens identified from over 22,000 completed flu tests.
This ILI percentage is below the national baseline of 2.6% and represents approximately a 10% decrease week-over-week.
Furthermore, the CDC reported between October 2020 and February 2021, FluSurv-NET sites in 14 states reported 193 laboratory-confirmed influenza hospitalizations. This is much lower than rates for any flu season since routine data collection began in 2005.
During the 2020-2021 flu season, only (1) influenza-associated pediatric fatality has been reported to the CDC.
Since the flu season has not ended in the USA, an annual flu vaccine is the best way to protect against influenza and its potentially serious complications. If you haven’t gotten your flu vaccine yet, get vaccinated now, highlights the CDC.
Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.
FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older.
The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator. This represents the first absolute efficacy study of a cell-based influenza vaccine in this population.
“Young children are at a high risk of complications from influenza, which is why annual vaccination is critical,” commented Gregg Sylvester, M.D., CMO at Seqirus, in a press statement issued on March 4, 2021.
FLUCELVAX QUADRIVALENT will be available as a 0.5ml intramuscular (IM) vaccine per dose for the 2021/22 U.S. influenza season.
Seqirus is part of CSL Limited, one of the largest influenza vaccine providers in the world.
On International human papillomavirus (HPV) Awareness Day, Tennessee-based St. Jude Children's Research Hospital announced the HPV Cancer Prevention Program's launch. With an investment of $12 million, St. Jude is launching outreach programs to reduce HPV-related cancer deaths by increasing vaccination rates locally, nationally, and eventually, globally.
Heather Brandt, Ph.D., leads the St. Jude HPV Cancer Prevention Program.
"Since 2006, we have had a safe, effective, and durable vaccine to prevent six types of HPV-related cancers in men and women," Brandt stated in a press release.
"However, rates of this cancer-prevention vaccination remain low, especially in areas of the Southeastern and Mid-Southern United States where HPV-related cancer rates are high. We also know there are vast differences in uptake among some populations, so there is an urgent need to address these inequities."
"Far too few have taken advantage of this cancer prevention tool, and I look forward to joining forces with other partners to improve vaccination rates."
