Novavax applies for COVID booster EUA as UK approves 2-strain booster
Following the Meals and Drug Administration (FDA) emergency use authorization (EUA) of the Novavax COVID-19 vaccine final month for the first vaccine sequence, the corporate introduced right this moment that it has utilized for an EUA for the vaccine to even be used as a booster in adults ages 18 and older.
In an announcement right this moment, Novavax mentioned if licensed, the vaccine could be the primary protein-based COVID-19 booster for adults. It mentioned its software covers each heterologous (different-brand) and homologous (same-brand) booster methods.
Stanley Erck, Novavax’s president and chief govt officer, mentioned, “It is vital for individuals to have a selection as they consider the best way to keep protected towards COVID-19, and boosters are a useful device to construct upon immunity obtained from earlier vaccinations.”
A section 3 research discovered that the third dose produced sturdy antibody responses that met or exceeded ranges seen within the main sequence. The vaccine additionally prompted a major antibody response when used as a heterologous booster.
Native and systemic responses lasted about 2 days and confirmed an growing incidence throughout all three doses. Uncommon situations of myocarditis, pericarditis, and anaphylaxis have been reported outdoors of medical trials, and, earlier this month, the European Medicines Company advisable that the vaccine maker carry a warning concerning the two coronary heart circumstances.
Aug 15 Novavax press release
In different vaccine developments, the UK Medicines and Healthcare Merchandise Regulatory Company right this moment authorised Moderna’s bivalent (two-strain) booster shot, which covers the unique SARS-CoV-2 virus plus the Omicron BA.1 variant. The group mentioned it based mostly its findings on medical trials that confirmed the booster prompted a powerful immune response towards BA.1 and the unique virus and an excellent response towards Omicron BA.4 and BA.5 subvariants.
The UK is the primary to approve a bivalent booster vaccine. Firms that make mRNA vaccines are engaged on bivalent booster pictures for the US market that concentrate on BA.4 and BA.5.
Aug 15 MHRA statement
Easing guidelines for gatherings, vaccine proof tied to Omicron spike in Korea
Dialing again guidelines for social gatherings and COVID-19 vaccine passes in South Korea was tied to a report spike in SARS-CoV-2 Omicron variant infections in March 2022, in accordance with an observational research revealed late final week in JAMA Community Open.
Researchers in South Korea mined every day information on COVID-19 instances and the proportion of Omicron infections from Dec 1, 2021, to Mar 16, 2022. They multiplied the variety of every day instances by the speed of optimistic Omicron assessments to reach at a proxy of variant exercise in the neighborhood.
In mid-January 2022, the nation relaxed restrictions on social gatherings, stopped requiring proof of COVID-19 vaccination in public services, expanded neighborhood screening, and mandated screening for all schoolchildren.
The Rt, or the typical variety of instances ensuing from a single contaminated individual, was higher than 1 all through the research interval, indicating uncontrolled viral transmission. The easing of limits on social gatherings was linked to a rise in Rt of 20.4% (95% confidence interval [CI], 5.8% to 36.5%), and suspension of COVID-19 vaccine passes was tied to a leap in Rt of 10.9% (95% CI, 3.2% to 24.8%).
Using neighborhood COVID-19 screening facilities and obligatory screening in colleges, nevertheless, was related to declines in Rt of 16.8% (95% CI, -25.2% to -11.1%) and 18.8% (95% CI, -22.2% to -11.1%), respectively.
The research authors famous that South Korea had efficiently managed SARS-CoV-2 transmission by using public well being and social measures (PHSMs) with out lockdowns in 2020 and 2021, however the world-record spike of 600,000 new every day Omicron instances occurred quickly after these measures had been relaxed.
The screening protocols appeared to assist gradual the unfold of the virus, they mentioned, however “our discovering of a imply Rt higher than 1 through the research interval recommended there might have been problem in controlling the COVID-19 pandemic in South Korea. The findings recommend consciousness of Rt can inform coverage planning and observe, together with by permitting well timed implementation and leisure of PHSMs.”
Aug 12 JAMA Netw Open research letter
FDA green-lights baloxavir use for flu in youngsters as younger as 5
Roche lately introduced that the FDA has authorised using baloxavir marboxil (Xofluza) for treating flu in youngsters ages 5 to 12. Additionally, the FDA authorised the drug for postexposure prophylaxis (prevention) in youngsters ages 5 to 12 who had contact with somebody with flu.
Baloxavir marboxil was first authorised to be used as a single-dose remedy for uncomplicated flu for individuals ages 12 and older in 2018, the primary new antiviral to be authorised by the FDA in 20 years. Two years later the FDA authorised using the drug for postexposure prophylaxis.
Levi Garraway, MD, PhD, Roche’s chief medical officer and head international product growth, mentioned that, regardless of the continuing COVID-19 pandemic, flu continues to be a public well being risk, and efficient flu antivirals are a important device for alleviating the burden on healthcare techniques.
Aug 12 Roche press release
Salmonella linked to yard poultry sickens 312 extra individuals
In its newest replace on a Salmonella outbreak linked to yard poultry, the Facilities for Illness Management and Prevention (CDC) reported 312 extra instances, elevating the nation’s whole to 884 in 48 states.
The CDC additionally mentioned one sickness has now been reported within the District of Columbia. The 5 states with probably the most instances are California (59), Minnesota (46), Texas (45), Wisconsin (41), and Missouri (36).
Two extra Salmonella subtypes—I 4,,12:i:- and Indiana—had been added to the outbreak, bringing the full to seven. The beforehand introduced strains are Enteritidis, Hadar, Infantis, Mbandaka, and Typhimurium.
Affected person ages vary from 1 to 102, and 55% are feminine. The most recent sickness onset was Jul 23. Of instances with obtainable end result information, 158 individuals had been hospitalized. The variety of deaths held regular at 2.
Individuals purchased poultry from 177 retail places throughout 41 states. Some purchased poultry from a couple of location. Testing by well being officers in 4 states have recognized the outbreak strains in poultry and poultry environments, individuals’s properties, and shops. They’re New Mexico, North Dakota, Tennessee, and Wisconsin.
Entire-genome sequencing of 904 samples from sick individuals, animals, and the atmosphere to establish danger of antibiotic resistance discovered that 40.6% had been immune to 13 key antibiotics. Although most individuals with Salmonella infections recuperate with out antibiotics, the CDC mentioned some diseases could be tough to deal with with advisable medicine and would require a special antibiotic selection.
Aug 12 CDC Salmonella outbreak update