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Atea Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration granted Fast Track designation to bemnifosbuvir for treating COVID-19.
Bemnifosbuvir (AT-527) is an oral, direct-acting antiviral drug candidate, a nucleotide polymerase inhibitor that targets the SARS-CoV-2 RNA polymerase, a highly conserved gene that is unlikely to change as the coronavirus mutates and variants continue to emerge.
Recent in vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including Omicron subvariants BA.4 and BA.5.
Bemnifosbuvir is being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID-19 in outpatients at high risk for disease progression regardless of vaccination status.
This evaluation includes patients over the age of 80, patients 65 years or older with at least one major risk factor, and anyone over the age of 18 who is immunocompromised.
Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals, commented in a press release on April 25, 2023, "Due to the limitations of current antiviral treatments, including drug-drug interactions and potential risks for genotoxicity and reproductive toxicity, as well as the ability of the virus to evade vaccines and monoclonal antibodies, new treatment options are urgently needed."
CoronavirusToday publishes COVID-19 antiviral and antibody therapy news.
Global health partners today announced a call for "The Big Catch-up," a targeted effort to boost vaccination among children following declines driven by the COVID-19 pandemic.
The Big Catch-up aims to protect populations from vaccine-preventable outbreaks, save children's lives, and strengthen national health systems.
With over 25 million children missing at least one vaccination in 2021, outbreaks of preventable diseases, including measles, diphtheria, polio, and yellow fever, are already becoming more prevalent and severe.
The WHO, UNICEF, Gavi, the Vaccine Alliance, the Bill & Melinda Gates Foundation, and Immunization Agenda 2030 aim to reverse the declines in childhood vaccination recorded in over 100 countries since the pandemic.
The 20 countries where three-quarters of the children who missed vaccinations live are Afghanistan, Angola, Brazil, Cameroon, Chad, DPRK, DRC, Ethiopia, India, Indonesia, Nigeria, Pakistan, Philippines, Somalia, Madagascar, Mexico, Mozambique, Myanmar, Tanzania, Viet Nam.
"Vaccines are a public health triumph," commented Dr. Chris Elias, president of Global Development at the Bill & Melinda Gates Foundation, in a press release on April 24, 2023.
"The incredible progress that has been made toward ending polio and reducing the incidence of infectious diseases is the direct result of thousands of dedicated global partners and local health workers who have worked to immunize millions of children."
"We must double down to reach all children with the vaccines they need to live healthier lives and ensure that future generations live free of preventable diseases like polio."
Clinical Infectious Diseases reported in March 2023 the first rabies post-exposure prophylaxis (PEP) failure in humans in the U.S. using modern cell-culture vaccines.
In January 2021, an 84-year-old male died from rabies six months after being bitten by a rabid bat despite receiving timely rabies PEP.
The researchers found rabies virus antibodies present in serum and cerebrospinal fluid were non-neutralizing.
Their recommendation is clinicians should consider measuring rabies-neutralizing antibody titers after completion of PEP if there is any suspicion of immunocompromised in the person.
Previously, The Lancet Infectious Disease reported (Dec 2022) that sporadic breakthrough infections (i.e., rabies in people who have started PEP had been reported.
These researchers identified a total of 122 rabies vaccine breakthrough infections.
Although people with high-risk exposures or immunosuppression can develop rabies despite adherence to core practices, this occurrence remains exceedingly rare, wrote these researchers.
The rabies virus infects the central nervous system. If a person does not receive the appropriate medical care after a potential rabies exposure, the virus can cause disease in the brain, ultimately resulting in death, wrote the U.S. CDC.
According to the CDC, most rabies infections in the U.S. are rare and related to bat bites, while dog bites are a more frequent source of rabies in other countries.
Various rabies vaccines are available in the U.S. in 2023.
ANI News posted a video that revealed Serum Institute of India's (SII) CEO Adar Poonawalla informed the local media that the institute recently produced 5-6 million doses of the protein-based CovoVax™ COVID-19 vaccine.
However, as of April 22, 2023, the demand for CovoVax vaccines is zero in Indian hospitals.
Poonawalla added, "Current (SARS-CoV-2) variants are mild and not severe... However, senior citizens can take booster doses as a precaution."
These vaccines may be needed as the WHO South-East Asia Region, which includes India, recently reported a (+654%) increase in COVID-19 cases and fatalities.
Maryland-based Novavax, Inc. and SII confirmed CovoVax vaccine was authorized in Indonesia on December 1, 2021, and in India on December 28, 2021.
In the U.S., the U.S. FDA confirmed on August 19, 2022, that the Novavax COVID-19 Vaccine was available to prevent COVID-19 in individuals 12 years of age and older.
Novavax COVID-19 vaccine brands are available in over 40 countries as of April 2023.
GlaxoSmithKline (GSK) Pharmaceuticals Ltd today announced the launch of its Shingrix® vaccine to prevent shingles (herpes zoster) and post-herpetic neuralgia in adults aged 50 years and above in India.
PTI reported Shingrix can provide at least ten years of protection against shingles, which is caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox, GSK said in a statement on April 24, 2023.
In the U.S., the CDC's Morbidity and Mortality Weekly Report confirmed that on January 21, 2022, the Advisory Committee on Immunization Practices recommended two doses (0.5 mL each) to prevent herpes zoster and related complications in immunodeficient or immunosuppressed adults.
Singrix was initially approved in the U.S. in 2017 and Europe in 2018 and is now available in over 20 countries in 2023.
Health Canada today announced it had issued a Notice of Compliance approving BEYFORTUS™ (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season.
And children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
BEYFORTUS is not a vaccine.
It is an immunizing agent and a long-acting monoclonal antibody (mAB).
The approval on April 24, 2023, was based upon a BEYFORTUS™ clinical development program spanning three pivotal late-stage clinical trials.
Jason Lee, Head of Vaccines Medical Affairs, Sanofi Canada, commented in a press release, "Today is a historical day for RSV prevention as decades of research and development culminate in Canada's approval of the first immunization against RSV disease."
"BEYFORTUS, designed using a long-acting mAB, will help meet a vast unmet need in RSV prevention, providing parents with an option to protect their infants during the first RSV season."
Sanofi stated it is committed to making BEYFORTUS available to newborns and infants for the upcoming 2023/2024 RSV season.
In the U.S., government agencies are reviewing this mAB for potential authorization this year.
The U.S. Food and Drug Administration (FDA) approved an injectable mAB therapy (Synagis®) in 1998.
RSV is a common and highly contagious seasonal respiratory virus infecting almost all children. It is a leading cause of infant hospitalizations (79%), including infants born at term with no underlying health conditions.
RSV also burdens the health system, with most hospitalized infants needing supplemental oxygen and some requiring ICU admission.
RSV vaccine candidates remain under review in the U.S. and have not been U.S. FDA-approved.
