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The US Centers for Disease Control and Prevention (CDC) announced today 'Outdoor visits and activities are safer than indoor activities. And fully vaccinated people can participate in some indoor events safely, without much risk.'
The CDC says vaccinated people can 'gather or conduct activities outdoors without wearing a mask, except in certain crowded settings and venues. And people can gather indoors with fully vaccinated people without wearing a mask or staying 6 feet apart.'
The CDC reported yesterday that 95,888,088 people have been fully vaccinated against COVID-19.
However, 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. Talk to your healthcare provider. Even after vaccination, you may need to continue taking all precautions, stated the CDC on April 27, 2021.
As of April 27, 2021, the US Food and Drug Administration had authorized three experimental COVID-19 vaccines for use in the USA.
California-based Dynavax Technologies Corporation today announced the post-marketing study results assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B.
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response.
The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the occurrence of AMI in approximately 31,000 patients who received HEPLISAV-B® and approximately 38,000 patients who received Engerix-B.
The AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B.
The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint.
Thus, these results provide evidence that there is no increased risk of AMI associated with vaccination with HEPLISAV-B than Engerix-B.
"These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," commented Robert Janssen, M.D., Chief Medical Officer, Dynavax, in a press statement.
"We are pleased to collaborate with Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness and appreciate their rigorous conduct of this study."
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent the disease, says the U.S. CDC.
In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas.
Dynavax is a commercial-stage biopharmaceutical company located in Emeryville, CA, developing and commercializing novel vaccines.
The Connecticut Department of Public Health (DPH) announced on April 23, 2021, it has confirmed the second case of measles in a Fairfield County child. The infected child is a household contact of the child who contracted the first case of measles announced on April 9th.
These are the first cases of measles in Connecticut since 2019. Most cases of measles are acquired or linked to international travel.
“The single best way to protect yourself and your children from measles is to be vaccinated,” said DPH Acting Commissioner Dr. Deidre Gifford in a media statement. “We must ensure we continue to protect our children from vaccine-preventable illnesses through on-time vaccination.”
Most Connecticut residents have been vaccinated since two doses of measles, mumps, and rubella (MMR) vaccine is required to attend schools and colleges in Connecticut. According to the 2019-2020 survey, 96.2% of Connecticut students were vaccinated with MMR vaccine before kindergarten.
The measles outbreak in New York, New Jersey, and elsewhere during 2019 were traced to unvaccinated international travelers.
Furthermore, due to the COVID-19 pandemic, the United States is at risk of measles' re-emergence.
In 2020, the Pan American Health Organization reported that about 14% fewer children received their measles vaccine than the year before.
CDC recommends all children get two doses of MMR vaccine. CDC also recommends that adults born after 1957 should receive at least one dose of MMR vaccine if they have never been vaccinated against measles.
In the USA, the M-M-R-II vaccine is commonly available.
Adults born in the U.S. before 1957 are considered immune to measles from past exposures.
Measles is a highly contagious disease that can spread quickly among unvaccinated people. Symptoms of measles generally begin 7-14 days after exposure to an infected person. A typical case of measles begins with mild to moderate fever, cough, runny nose, red eyes, and sore throat, says the DPH.
Paris-based Sanofi announced positive topline results from the Phase 3 trial on April 26, 2021 that showed nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention (inpatient or outpatient) due to respiratory syncytial virus (RSV) in healthy preterm and term infants.
Nirsevimab reached its primary endpoint, achieving a statistically significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants compared to placebo through a typical RSV season. The overall safety profile of nirsevimab in the MELODY trial remains consistent with previously reported results.
Nirsevimab is being developed in partnership with AstraZeneca. The first investigational extended half-life monoclonal antibody (mAb) aims to protect all infants entering their first RSV season when they are at the highest risk for severe RSV disease.
With nirsevimab, a protective antibody is administered directly to the infant to provide rapid protection.
In contrast to other options for RSV under development, such as maternal vaccines, nirsevimab was designed to be administered at birth to infants born during the RSV season or at the season’s start for infants born before the season.
RSV is the most common cause of LRTI and the leading cause of hospitalizations in all infants.
Dr. William Muller, Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine, and study coordinator, stated in a press release, “These exciting trial data demonstrate the potential for nirsevimab to change the prevention landscape not only by protecting a broad population of infants across the full RSV season but also by achieving this with a single dose.”
In February 2019, the US Food and Drug Administration granted Breakthrough Therapy Designation for nirsevimab to prevent LRTI caused by RSV, and the European Medicines Agency granted access to its PRIority MEdicines scheme for the same indication.
Nirsevimab is also being evaluated in the Phase II/III MEDLEY trial, which will assess the safety and tolerability of nirsevimab compared to Synagis (palivizumab) among preterm infants and children with chronic lung disease and congenital heart disease entering their first and second RSV seasons. The Phase II/III trial is also expected to complete early, with the first data anticipated in the coming months.
Sanofi, a global biopharmaceutical company with more than 100,000 people in 100 countries, is dedicated to supporting people through their health challenges.
The US Centers for Disease Control and Prevention (CDC) issued a Level 4 Travel Alert for India on April 19, 2021. There is a very high level of COVID-19 infections in India.
According to NPR reporting, the United States government committed additional medical aid to India to fight an alarming spike in COVID-19 cases. The pledge as India has become the epicenter of the global coronavirus pandemic on April 25, 2021, and the country's health system is operating at maximum capacity.
The CDC says 'Because of the current situation in India, even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants and should avoid all travel to India. If you must travel to India, get fully vaccinated before travel.'
If you are fully vaccinated, you do NOT have to get tested before leaving the USA unless your destination requires it. And you do NOT have to self-quarantine after you arrive in the USA.
However, all air passengers coming to the USA, including U.S. citizens and fully vaccinated people, must have a negative COVID-19 test result in no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA, says the CDC.
Ahead of World Malaria Day on April 25, 2021, the World Health Organization (WHO) congratulated an expanding number of countries approaching and achieving zero malaria cases. A new initiative launched today aims to halt transmission of the disease in more countries by 2025.
By the end of 2020, 24 countries had reported interrupting malaria transmission for three years or more. Of these, 11 were certified malaria-free by WHO.
According to the WHO's E-2020 initiative report, Algeria, Belize, Cabo Verde, China, El Salvador, the Islamic Republic of Iran, Malaysia, and Paraguay are malaria-free.
“Their successes were hard-won and came only after decades of concerted action,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a press statement. “Together, they have shown the world that malaria elimination is a viable goal for all countries.”
Several other countries made excellent progress: Timor-Leste reported only 1 indigenous case, while 3 other countries, Bhutan, Costa Rica, and Nepal, reported fewer than 100 cases last year.
Malaria is a mosquito-borne disease caused by a parasite. People with malaria often experience fever, chills, and influenza-like illness. Left untreated, they may develop severe complications and die, says the U.S. CDC.
About 2,000 cases of malaria are diagnosed in the United States each year. The vast majority of cases in the United States are in travelers and immigrants returning from countries where malaria transmission occurs, many from sub-Saharan Africa and South Asia.
The Mosquirix RTS,S/AS01E malaria vaccine has been developed by GSK for more than 30 years. Today Mosquirix is piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme.
On April 23, 2021, Adrian Hill, Director of the Jenner Institute at the University of Oxford, England, stated, ‘These new results of R21/Matrix-M Malaria Vaccine support our high expectations for its potential, which we believe is the first to reach the WHO’s goal of a vaccine for malaria with at least 75% efficacy."
The European Medicines Agency (EMA) published an update on April 23, 2021, stating 'Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) benefits outweigh its risks in adults of all age groups.
'However, very rare cases of blood clots with low blood platelets have occurred following vaccination.'
'There has not been enough exposure and follow-up time to determine whether the risk of blood clots with low blood platelets after a second Vaxzevria vaccine dose will differ from the risk after the first dose. At present, there are no or limited data to change current recommendations.
To support national authorities making decisions on how to best use the vaccine in their territories, the EMA’s human medicines committee (CHMP) has further analyzed available data to put the risk of these very rare blood clots in the context of the vaccine’s benefits for different age groups and different rates of infection.
The CHMP analysis will inform national decisions on the rollout of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could change as new data become available.
Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. The vaccine does not contain the virus itself and cannot cause COVID-19.
Based in The Netherlands, the European Medicines Agency is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
The US Centers for Disease Control and Prevention (CDC) issued a Level 3 Travel Alert on April 22, 2021, regarding the recent La Soufrière volcano eruptions on the Caribbean island of St. Vincent. St. Vincent, a southern Caribbean nation comprising of a chain of smaller islands.
La Soufrière's eruptions started on April 9, 2021, and have led to shortages of essential goods and services, including clean drinking water, sanitation, food, electricity, transportation, shelter, and medical care.
Reports indicate La Soufrière or Soufrière Saint Vincent has had five recorded explosive eruptions since 1718.
The CDC's Avoid Nonessential Travel notice stated that 'approximately two-thirds of the island is covered in a thick layer of ash. And if you 'must travel to St. Vincent & the Grenadines, pay attention to local reports about air and drinking water quality and dangerous road conditions. And obey all instructions from local authorities.'
Health concerns after a volcanic eruption include infectious disease, respiratory illness, burns, injuries from falls, and vehicle accidents related to the conditions caused by ash. The most common cause of death from a volcano is suffocation, says the CDC.
Over 12,700 evacuees are registered in public shelters, and private homes; close to 20,000 people are expected to be displaced. Entire villages have been covered in ash, buildings damaged, schools and businesses closed, crops and livestock destroyed, and residents left with limited access to clean drinking water.
The UN launched a $29.2 million global funding appeal on April 20th to aid Saint Vincent and the Grenadines citizens affected by the eruptions pledging to remain a “steadfast partner.”
As of April 21st, the State Department had increased its Travel Advisory Level for Saint Lucia to Level 4, Do Not Travel. If you intend to visit St. Vincent island, check the US Department of State's embassy website for updated information. And enroll in the Smart Traveler Enrollment Program to receive security updates and information about emergency assistance.
The Government of Canada announced additional travel and border measures on April 22, 2021. The Minister of Transport, the Honourable Omar Alghabra, announced new rules for some international travelers from India.
The Public Health Agency of Canada has been monitoring case data through mandatory testing upon entry into Canada, has detected a disproportionally higher number of cases among individuals traveling on flights originating from India.
From February 22 to April 19, 2021, the Public Health Agency of Canada received Day 1 test results for 274,822 travelers (air and land travel), of which 1.4% tested positive for COVID 19.
Given the high number of cases, the Government of Canada has taken additional measures:
- Transport Canada has issued a Notice to Airmen to suspend all commercial and private passenger flights from India for 30 days, effective April 22, 2021.
- The Minister of Transport will amend the Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, which means for passengers who depart India to Canada after April 22, 2021, via an indirect route, will need to obtain a negative COVID-19 pre-departure test from a third country before continuing their journey to Canada.
These new requirements include mandatory submission of contact, travel, and quarantine information via ArriveCAN, pre-departure (air) or pre-arrival (land) testing, on-arrival testing, and again later during the 14-day mandatory quarantine period.
“The pandemic continues to create an unprecedented crisis in the global aviation industry, and our government continues to take action to protect the health and safety of Canadians. That is why Transport Canada has issued a notice to air operators to temporarily suspend passenger flights from India, where there is an elevated number of passengers arriving with cases of COVID-19," stated Omar Alghabra.
The Government of Canada also put more stringent criteria for suitable quarantine plans and a mandatory hotel stopover for travelers arriving by air. At the same time, they await the results of their on-arrival test before completing the rest of their mandatory 14-day quarantine period.
