Coronavirus Breaking News

Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) had accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™, supporting the conversion of the accelerated approval of LEQEMBI to an FDA traditional approval.

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

As of March 6, 2023, the FDA plans to hold an Advisory Committee meeting to discuss this humanized immunoglobulin gamma 1 monoclonal antibody application but has not publicly announced the meeting date.

LEQEMBI was approved under accelerated approval in the U.S. and was on January 18, 2023.

This indication is approved under accelerated approval based on a reduction in amyloid beta plaques observed in patients treated with LEQEMBI.

The accelerated approval was based on data demonstrating that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining AD feature.

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit.

The FDA has not approved any AD vaccine candidates as of March 6, 2023.

The U.S. Centers for Disease Control and Prevention (CDC) recently issued a Watch - Level 1, Practice Usual Precautions notice regarding the Lassa Fever outbreak in the west African country of Nigeria.

On March 1, 2023, the CDC confirmed there is an outbreak of Lassa fever, an acute viral hemorrhagic fever, in several states in Nigeria.

Visitors to Nigeria should seek medical care immediately if they develop (during or after travel) fever, chills, headache, fatigue, bleeding, trouble breathing, vomiting, facial swelling, or pain in the chest, back, and abdomen.

Before the pandemic, about 5 million people visit Nigeria annually, with Niger and India as the most frequent countries of origin of tourists in Nigeria, reports Statista. 

However, as of March 5, 2023, no Lassa fever vaccines are available.

But treatment with antiviral medicine is most effective during the early stages of illness.

Carnival Cruise Line recently announced it is expanding its offerings with a fourth ship in Galveston, Texas.

The Carnival Miracle arrival will Texas-size sailings beginning in the fall of 2024 through the spring of 2025.

“We have always offered a great variety of cruises from Galveston, but by adding a fourth Carnival ship to homeport in Galveston and sailing these longer itineraries, we are giving our guests great new choices, especially for those who want to experience a wider variety of beautiful ports of call and more time to enjoy their time at sea,” said Christine Duffy, president of Carnival Cruise Line, in a press release on March 2, 2023.

Carnival Miracle will reposition from San Francisco to Galveston in October 2024 and operate a spectacular Carnival Journeys voyage that visits Cabo San Lucas, Mexico; Puntarenas, Costa Rica; Cartagena, Colombia; and a Panama Canal transit.

Carnival Miracle will further diversify Carnival’s deployment from Galveston by joining: 

• Carnival Breeze, which offers four- and five-day cruises;
• Carnival Dream, which sails primarily six- and eight-day cruises, and
• Carnival Jubilee features a rollercoaster, which arrives this December to begin week-long Western Caribbean sailings.

From a health perspective, while the COVID-19 pandemic has faded away in Texas, many cruise ship passengers should remain vigilant about noroviruses.

Norovirus is a very contagious virus that causes vomiting and diarrhea, says the U.S. Centers for Disease Control and Prevention. 

In the United States, cases of norovirus occur most frequently during late fall, winter, and early spring. 

One of the best ways to prevent the spread of norovirus is by practicing good hand hygiene.

The Norovirus Outbreak Map of confirmed outbreaks in the U.S. was updated in February 2023. And the Vessel Sanitation Program identifies various norovirus outbreaks onboard cruise ships.

Unfortunately, U.S. Food and Drug Administration had not approved a norovirus vaccine as of March 5, 2023.

The U.S. CDC published a health advisory on March 2, 2023, confirming Paraguay's ongoing chikungunya virus outbreak.

Paraguay's Ministry of Health recently reported a total of 71,478 suspect chikungunya cases in Paraguay (Asunción) since an outbreak began in October 2022.

In 2022, the number of chikungunya cases (273,685) reported to the Pan American Health Organization more than doubled the average annual number of cases.

To notify international travelers of potential health risks, the CDC issued a Watch - Level 1 travel alert regarding Paraguay's chikungunya outbreak on February 22, 2023.

Chikungunya virus is a mosquito-borne alphavirus transmitted by infected mosquitoes. The incubation period is typically 3–7 days. 

Unfortuantely, the U.S. FDA has not authorized a chikungunya preventive vaccine as of March 3, 2023.

The CDC's Advisory Committee on Immunization Practices recently reviewed Valneva SE's VLA1553 chikungunya vaccine candidate. 

The good news is VLA1553 has been assigned an FDA Prescription Drug User Fee Act date at the end of August 2023.

Other chikungunya vaccine development news is posted at Vax-Before-Travel.

The U.S. CDC today published Health Alert Network Advisory #CDCHAN-00487, notifying public health authorities and providers there is a substantial increase in chikungunya virus cases in the Republic of Paraguay.

As of February 24, 2023, Paraguay's Ministry of Health reported a total of 71,478 suspect chikungunya cases in Paraguay since an outbreak began in October 2022.

Most of the chikungunya cases have been reported in the capital district of Asunción and the neighboring Central department.

Travelers returning from these areas should seek medical care if they develop fever, joint pain, headache, muscle pain, joint swelling, or rash.  

The CDC warned on March 2, 2023, that Paraguay's virus outbreak could spill over into neighboring countries, such as Argentina, Bolivia, and Uraguay. 

The South American country of Paraguay is a popular tourist destination, welcoming about one million tourists annually.

To notify international travelers of potential health risks, the CDC issued a Watch - Level 1, Practice Usual Precautions alert regarding Paraguay's chikungunya outbreak on February 22, 2023.

The CDC suggests considering chikungunya infection in travelers returning from Paraguay with acute onset of fever and polyarthralgia.

In late 2013, the first local transmission of the chikungunya virus in the Americas was identified in Caribbean countries and territories. 

The virus then spread throughout most of the Americas.

In 2022, the number of chikungunya cases (273,685) reported to the Pan American Health Organization more than doubled the average annual number of cases.

Chikungunya virus is a mosquito-borne alphavirus transmitted by infected mosquitoes, and humans are the primary reservoir during epidemics. 

Most people infected with chikungunya become symptomatic, and the incubation period is typically 3–7 days. 

Unfortunately, chikungunya and dengue viruses cocirculate in Paraguay, are transmitted by the same mosquitoes, and have similar clinical presentations during acute illness. 

Diagnostic testing is available through commercial laboratories, some state health departments, and the CDC. Chikungunya virus disease is a notifiable disease in the U.S.

Moreover, the U.S. FDA has not authorized a chikungunya preventive vaccine as of March 3, 2023.

The CDC's Advisory Committee on Immunization Practices recently met on February 23, 2023, and reviewed Valneva SE's VLA1553 monovalent, single-dose, live-attenuated vaccine candidate. 

VLA1553 has been assigned a Prescription Drug User Fee Act date at the end of August 2023. 

The U.S. Centers for Disease Control and Prevention (CDC) recently added another travel advisory focused on disease outbreaks in the Federal Republic of Nigeria.

On February 24, 2023, the CDC issued its latest advisory focused on an outbreak of diphtheria in several states in Nigeria.

This Alert - Level 2, Practice Enhanced Precautions, says vaccination against diphtheria is essential to protect people against disease.

If traveling to an affected area in Nigeria, you should be updated with diphtheria vaccinations. Furthermore, discuss the need for a booster dose with your healthcare professional before traveling.

CDC recommends vaccinating everyone two months and older to protect against diphtheria.

Diphtheria is a serious infection caused by strains of Corynebacterium diphtheriae bacteria that make a toxin that can cause people to get very sick.

The diphtheria bacteria spread from person to person through respiratory droplets, like from coughing or sneezing; people can also get sick from touching open sores or ulcers of people ill with diphtheria.

Without treatment, up to half of patients can die from the disease, says the CDC.

The CDC previously issued travel advisories for Nigeria's vaccine-preventable diseases, such as yellow fever, polio, measles, and Mpox outbreaks.

These travel vaccines are offered in the U.S. at certified clinics and pharmacies.