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Previously, the U.S. FDA requires blood establishments to test blood donations for new or emerging infectious agents that may affect blood product safety if certain conditions are outlined in FDA regulations.
Specifically, if a transfusion-transmitted infection “may have sufficient incidence and/or prevalence to affect the potential donor population” and meets certain other criteria described in FDA’s regulations, then FDA may determine the transfusion-transmitted infection is a “relevant transfusion-transmitted infection” (RTTI).
Effective on May 13, 2021, the FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations.
As discussed further below, the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population. Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018.
Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV.
Licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d).
As of April 1, 2021, the U.S. CDC reported zero (0) cases of Zika in the USA during 2021. However, Puerto Rico has confirmed seven (7) locally transmitted Zika cases in 2021.
The US Centers for Disease Control and Prevention (CDC) announced on May 13, 2021, 'if you are fully vaccinated, you can resume activities you did before the COVID-19 pandemic began in December 2019, without wearing a face mask.'
The new CDC guidance means 'fully vaccinated travelers do not need to get a SARS-CoV-2 viral test before or after domestic travel unless testing is required by local, state, or territorial health authorities. Nor do they need to self-quarantine following domestic travel.'
And 'fully vaccinated travelers do not need to get tested before leaving the USA unless required by their destination.
This guidance applies to COVID-19 vaccines currently authorized for emergency use by the U.S. FDA: Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines. This guidance can also be applied to COVID-19 vaccines that have been authorized for emergency use by the World Health Organization, which are list on this webpage.
However, everyone arriving from abroad, including U.S. citizens, is still required to have a negative SARS-CoV-2 viral test result or documentation of recovery from COVID-19 before they board a flight to the USA.
For more information, see the CDC's International Travel During COVID-19 webpage.
The US Centers for Disease Control and Prevention (CDC) announced today 'if you are fully vaccinated, you can resume activities you did before the COVID-19 pandemic began in December 2019.
And, the CDC says 'fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.'
'Fully vaccinated people can refrain from testing following a known exposure unless they are residents or employees of a correctional or detention facility or a homeless shelter. Furthermore, the three U.S. FDA Authorized 'COVID-19 vaccines are effective at protecting you from getting sick.'
These Authorized COVID-19 vaccines have been administered to 116,387,534 people over 18 years of age as of May 12, 2021. This data represents about 45.1% of the US population.
And to protect more people, the U.S. Food and Drug Administration expanded the emergency use authorization for the experimental Pfizer-BioNTech COVID-19 Vaccine on May 10th to include adolescents 12 through 15 years of age.
'These recommendations can help you make decisions about daily activities after you are fully vaccinated. But, they are not intended for healthcare settings.' stated the CDC.
This CDC guidance applies to people intending to travel domestically and abroad. The COVID-19 vaccines currently authorized for emergency use by the U.S. FDA are the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines. The CDC travel guidance can also be applied to COVID-19 vaccines that have been authorized by the World Health Organization, which are list on this webpage.
Moreover, if you have a condition or are taking medications that weaken your immune system, you may NOT be fully protected even if you are fully vaccinated. Even after vaccination, you may need to continue taking all precautions. Talk to your healthcare provider, suggests the CDC.
New Jersey-based Merck announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, combined with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery.
Merck confirmed that on May 13, 2021, KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) to treat patients with high-risk early-stage triple-negative breast cancer (TNBC).
Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone.
As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
“KEYTRUDA is the first immunotherapy to show positive results for event-free survival in patients with high-risk early-stage TNBC, a particularly aggressive form of breast cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press statement.
“The improvement in pathological complete response rates initially observed following pre-operative treatment was encouraging, and now that we are seeing the data mature after four years to include a statistically significant improvement in event-free survival, we look forward to working with the FDA and other global authorities to bring this new option to patients as quickly as possible."
"We are grateful to the study participants who are critical to our efforts to advance potential treatment options for patients with TNBC.”
An analysis of pCR from KEYNOTE-522 was presented at the European Society for Medical Oncology 2019 Congress and published in the New England Journal of Medicine.
Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis, says Merck.
Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.
An acute loss of smell is one of the most common symptoms of COVID-19, but for two decades, it has been linked to other maladies, among them Parkinson's disease and dementia. Now, a poor sense of smell may signify a higher risk of pneumonia in older adults, stated a team of Michigan State University (MSU) researchers on May 11, 2021.
In a first-of-its-kind study, this MSU team found a possible link between a poor sense of smell and a higher risk of pneumonia hospitalization.
They analyzed 13 years of health data from 2,494 older adults, ages 71-82, from metropolitan areas of Pittsburgh, Pennsylvania, and Memphis, Tennessee. This study aimed to examine whether a poor sense of smell in older adults is associated with a higher future risk of developing pneumonia.
"About a quarter of adults 65 years or older have a poor sense of smell," said Honglei Chen, a professor in the Department of Epidemiology and Biostatistics within MSU's College of Human Medicine press statement.
"Unlike vision or hearing impairment, this sensory deficit has been largely neglected; more than two-thirds of people with a poor sense of smell do not know they have it."
'To the best of our knowledge, this study provides the first epidemiological evidence that poor olfaction in older adults is associated with a higher risk of pneumonia. It is estimated that 15–25% of older adults in the USA have poor olfaction.'
'Our study also has several limitations. First, our study participants were older than 70 years at the time of olfaction testing, which might limit the generalisability of our study findings to older adults who are relatively younger. Future studies should independently confirm this observation, investigate potential mechanisms, and understand its implications on the health of older adults.'
A start-up fund from the MSU supported this study. The NIA supported the Health ABC study, the National Institute of Nursing Research, the Intramural Research Program of the NIA/National Institutes of Health, and NIA contracts N01AG62101, N01AG62103, N01AG62106, NIA grant R01AG028050, and NINR grant R01NR012459.
Chen's research was published in the journal The Lancet Healthy Longevity on May 6, 2021.
An Ebola vaccination launched in the Republic of Sierra Leone as the central African country takes proactive public health measures to protect its high-risk residents from the potential cross-border transmission of the Ebola virus disease (EVD) from Guinea. The Ebola virus is a zoonotic pathogen that causes severe hemorrhagic fever in humans, says the U.S. CDC.
The World Health Organization (WHO) announced on May 11, 2021, Ebola vaccinations were launched in Kambia District, a primary international point of entry for Guinea and Sierra Leone. This preventive Ebola vaccination will continue over the coming days in eight other districts sharing borders with Guinea.
About 16 000 people have been targeted for vaccination in the selected border districts, and individuals will receive two doses of the vaccine given approximately eight weeks apart.
The Ministry of Health and Sanitation is leading the exercise to administer the Johnson & Johnson vaccine known as Zabdeno and Mvabea. The Janssen Ebola prevention vaccine therapy consists of 2 components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first, and Mvabea is administered approximately 8-weeks later as a booster. In 2016, the Ebola vaccination was piloted in Sierra Leone during the country’s devastating outbreak, resulting in nearly 11,000 cases with some 4,000 related fatalities.
Previously, the Ministry of Health and Sanitation launched a comprehensive Ebola Outbreak Preparedness and Contingency Plan on April 7, 2021, to guide its readiness activities for its 7 million residents. Sierra Leone is bordered on the north and east by Guinea, on the south by Liberia, and on the west by the Atlantic Ocean, reports Britannica.
According to various WHO reports, the 12th Ebola Outbreak in west-central African is ending.
In December 2019, the U.S. Food and Drug Administration announced the approval of Ervebo for the prevention of EVD caused by Zaire ebolavirus in individuals 18 years of age and older.
The U.S. CDC's ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)'s emergency meeting agenda and presentation slides were posted on May 12, 2021.
The focus of this ACIP is on the recently Authorized Safety, immunogenicity, and efficacy of Pfizer - BioNTech COVID-19 Vaccine (BNT162b2) in persons aged 12-15 years.
This meeting's agenda is posted here. And the presentation slides are available at this weblink.
Massachusetts-based VBI Vaccines Inc. announced today The Lancet published results from the pivotal Phase 3 study, PROTECT, of the company's prophylactic 3-antigen hepatitis B (HBV) vaccine candidate (Sci-B-Vac) in adults.
The study was designed to compare the immunogenicity and safety of 10 µg of VBI’s 3-antigen vaccine candidate to 20 µg of the single-antigen HBV vaccine, Engerix-B®.
'Regardless of age, BMI, or diabetic status, participants who received the Sci-B-Vac vaccine candidate achieved higher seroprotection rates, and 5-8x higher antibody geometric mean concentration (GMC) compared to Engerix-B®. And, no safety signals were observed.'
Together with results from the second pivotal Phase 3 study, CONSTANT, these results form the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S. and Europe, which were submitted in November 2020, and for Canada and the U.K., which are in process, said the company.
Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies, and author of the manuscript commented in a press statement, “While HBV immunization programs effectively address infants, large immunization gaps exist in certain adult populations, due in large part to the poor immune response in many risk groups such as older adults, people with diabetes or kidney disease, overweight adults, and those who smoke."
"The PROTECT study demonstrated that the 3-antigen hepatitis B vaccine may be able to overcome some of the limitations of conventional single-antigen HBV vaccines in adults, particularly in older adults age 45+ where superior immune responses were achieved.”
The Lancet's Interpretation of the VBI funded study was: 'The safety and efficacy of the tri-antigenic hepatitis B vaccine show its usefulness for the prevention of HBV infection in adults, including those with stable and controlled chronic conditions.'
VBI Vaccines Inc. is an international biopharmaceutical company driven by immunology to pursue powerful prevention and treatment of disease.
The US Centers for Disease Control and Prevention (CDC) issued an updated Level 1 Travel Alert regarding Dengue virus outbreaks in the Americas.
On May 6, 2021, the CDC stated 'Dengue is an ongoing risk in many parts of Central and South America, Mexico, and the Caribbean. So far in 2021, Puerto Rico has confirmed 228 dengue cases.
In addition, the countries shown on this CDC map are reporting higher-than-usual numbers of dengue cases, and travelers visiting these countries may be at increased risk for this disease.
Dengue is a disease caused by a virus spread through mosquito bites. The disease can take up to 2 weeks to develop, with illness generally lasting less than a week, says the CDC.
Dengue can become severe within a few hours. Severe dengue is a medical emergency, usually requiring hospitalization. In severe cases, health effects can include hemorrhage, shock, organ failure, and death.
From a prevention perspective, the U.S. FDA authorized the Dengvaxia vaccine for limited use in the USA in May 2019.
However, this dengue vaccine is for people with laboratory-confirmed previous dengue infection and living in endemic areas. Furthermore, the World Health Organization recommends that the Dengvaxia vaccine be given to persons with confirmed prior dengue virus infection.
