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The U.S. Food and Drug Administration (FDA) today approved Pfizer Inc.'s oral antiviral Paxlovid™ for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is the fourth drug, but the first oral antiviral approved to treat COVID-19 in adults.
Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the FDA's approval on May 25, 2023.
"While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives," said Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, in today's press release.
"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity."
"The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19."
Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis to prevent COVID-19.
Prensa Latina recently reported Cuba's COVID-19 vaccines, Soberana 02, Soberana Plus, and Abdala, received the sanitary registration granted by the Center for State Control of Medicines, Medical Equipment, and Devices for their proven efficacy.
The experts and scientists ratified the safety that characterizes Cuba's COVID-19 vaccines, firstly due to the very nature of the technological platforms used and secondly, because they have high thermo-stability.
Unlike others requiring special storage conditions, Cuba's vaccines can be stored between two and eight degrees Celsius at freezing temperatures.
During the clinical studies, vaccine efficacy was higher than 90%.
As of May 24, 203, Cuba is among the world's top 10 countries with most citizens immunized against the SARS-CoV-2 coronavirus, which raises the level of protection to more than 90% of Cuban inhabitants.
The U.S. Food and Drug Administration today approved Entasis Therapeutics's Xacduro, an intravenous infusion treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for adult patients 18 years of age and older.
"The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like Acinetobacter baumannii-calcoaceticus complex," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release on May 23, 2023.
"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health.
Acinetobacter baumannii-calcoaceticus complex (hereafter referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.
These bacteria can cause infections in various body parts, occurring most frequently in healthcare settings and predominantly causing pneumonia.
A. baumannii can become highly resistant to multiple antibacterial drugs, and current treatment options for drug-resistant A. baumannii are limited.
Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam.
Sulbactam kills A. baumannii, whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii.
Previously, the FDA granted Xacduro Fast Track, Qualified Infectious Disease Product, and Priority Review designations for this application.
Additional pneumonia and influenza vaccine news is posted by Precision Vaccinations.
Pfizer Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316 (ABRYSVO™).
The vaccine candidate is under FDA review for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant women.
The VRBPAC voted 14 to 0 on effectiveness and 10 to 4 on safety.
“We are encouraged by the outcome of today’s VRBPAC meeting as it is a critical step forward in the scientific community’s long-sought-after goal to help prevent RSV disease in infants during their most vulnerable first six months of life,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a related press release.
Additional RSV vaccine and monoclonal antibody news are posted by Precision Vaccinations.
The World Health Organization (CDC) Technical Advisory Group for COVID-19 Vaccine Composition today announced its advice on the composition of future formulations of COVID-19 vaccines.
The objective of an update to COVID-19 vaccine antigen composition is to enhance vaccine-induced immune responses.
Updating the vaccine composition considers the evolution of the SARS-CoV-2 beta coronavirus variants and aims to improve protection against symptomatic disease.
The Group suggests that future formulations of COVID-19 vaccines use newer variants in their composition, i.e., XBB.1 descendant lineages.
As of May 2023, the XBB.1 descendent lineages currently predominate globally (i.e., XBB.1.5, XBB.1.16, XBB.1.9).
Furthermore, estimates of vaccine efficacy (VE) against currently circulating SARS-CoV-2 variants, including XBB.1 descendent lineages, are very limited in terms of the number of studies, vaccine products evaluated, and populations assessed; some studies show similar VE against BA.5 descendent and XBB.1 descendent lineages, while others suggest reduced VE during periods of the predominance of XBB.1 descendent lineages.
Additionally, the TAG-CO-VAC continues to encourage the further development of vaccines that enhance mucosal immunity because they may improve protection against infection and reduce transmission of SARS-CoV-2, in alignment with the WHO Global COVID-19 Vaccination Strategy, published in July 2022.
On May 18, 2023, the WHO stated the current COVID-19 vaccines continue to be highly protective against severe disease and death.
And the WHO strongly encourages the use of available authorized COVID-19 vaccines, which include the index SARS-CoV-2 virus, according to recommendations from the Strategic Advisory Group of Experts on Immunization, updated in March 2023.
A clinical trial of an experimental universal influenza vaccine candidate developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers.
This Phase 1 trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.
“A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year,” said Acting NIAID Director Hugh Auchincloss, M.D., in a press release on May 15, 2023.
“Moreover, some strains of the influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.”
A similar vaccine developed by researchers at NIAID’s VRC has already shown positive results in early clinical trials.
Both vaccines use a specific portion of a flu protein, hemagglutinin (HA), to induce a broad immune response against influenza.
While one portion of the HA protein, known as the head, tends to change as the flu virus spreads and evolves, a more stable portion, known as the stem, evolves very slowly and is very similar across many different types of the flu virus.
Researchers hope to induce long-term immunity against a broad range of flu viruses by using the HA stem as the basis for a vaccine.
Unlike the VRC’s earlier vaccine, the H1ssF-3928 mRNA-LNP vaccine candidate uses an mRNA platform.
By developing and testing various platforms for a universal flu vaccine, researchers are more likely to find one that is safe and provides strong and broad immunity against various strains.
Additional flu shot and influenza vaccine development news is posted at Precision Vaccinations.
Emergent BioSolutions today announced it had completed the sale of its travel health business to Bavarian Nordic and may receive up to $380 million in potential future payments.
Bavarian Nordic acquired the rights to Vivotif®, the licensed typhoid vaccine, and Vaxchora®, the licensed cholera vaccine, and the development-stage chikungunya vaccine candidate CHIKV VLP.
These travel-related vaccines are part of an estimated international market growth rate (9.9%) thru 2028. This data indicates millions of travelers are under-vaccinated before visiting disease-endemic countries.
Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.
"This deal achieves two significant outcomes key to our mission and future success," said Robert G. Kramer, Emergent president, and chief executive officer, in a press release on May 15, 2023.
Other market research reports indicate an uplift in international travel is coming.
Such as the Expedia Group's Traveler Insights reveals traveler searches increasing globally by 25% in Q1 2023, which means travelers are looking toward mid-year getaways.
