FDA recommends booster update targets BA.4 and BA.5
Following a vaccine advisory group input earlier this week, the Food and Drug Administration (FDA) today recommended that vaccine companies update their booster shots to target BA.4 and BA.5, two Omicron subvariants that are driving up cases in a number of countries.
In a statement, Peter Marks, MD, PhD, who directs the FDA’s Center for Biologics Evaluation and Research, urged vaccine makers to produce a bivalent booster adds in an Omicron BA.4/5 spike protein component.
Vaccine makers have already been conducting clinical trials on boosters that have an Omicron BA.1 component. The FDA urged the companies to submit data on those vaccines and to begin clinical trials on boosters modified with the Omicron BA.4/5 component. Marks said the vaccine could potentially be used starting in early to mid-fall of 2022.
In a related development, the US Department of Health and Human Services (HHS) yesterday announced an agreement to buy 105 million doses of Pfizer vaccine for fall vaccination campaigns, with an option to acquire up to 300 million doses. The $3.2 billion contract includes both pediatric and adult doses and for the first time includes single-dose vials for some of the adult vaccine.
Jun 30 FDA statement
Jun 29 HHS statement
Study shows long-distance spread of COVID-19 in some indoor settings
A new systematic review of 18 studies finds evidence suggesting that long-distance airborne transmission (more than 2 meters away) of SARS-CoV-2 might occur in indoor settings such as restaurants, workplaces, and venues for choirs. The study is published in The BMJ today.
The study also identifies factors such as insufficient air replacement that likely contributed to transmission. Included in the 18 studies were surveys of spreading events that took place between Jan 2020 and Jan 2022 in Europe, Asia, and the United States.
The authors found long-distance airborne transmission was likely in 16 of the 18 studies. In 13 of the 18 studies, the index patient was asymptomatic or pre-symptomatic.
The most convincing evidence of long-distance transmission came from eight events where singing occurred, the authors said.
“Modifying factors such as insufficient air replacement and singing are likely to result in an increased concentration of infectious respiratory particles within the indoor space, whereas factors such as directional air flow are likely to allow viable virus to travel further in a certain direction, which could potentially infect someone downstream of a primary case,” the authors concluded.
In an accompanying editorial, corresponding authors write that the study, “Validates the premise that tiny respiratory particles containing SARS-CoV-2 freely transmit throughout inadequately ventilated environments. Now, indeed, is the time for an indoor air revolution.”
Jun 29 BMJ study
Jun 29 BMJ editorial
COVID markers climb in UK, Germany
The United Kingdom’s Health Security Agency (HSA) said COVID-19 indicators are rising, including increases in hospitalizations in people ages 65 and older, outbreaks in nursing homes, and intensive care unit (ICU) admissions in older age groups.
Meanwhile, Germany’s Robert Koch Institute (RKI) today reported similar rises, with illnesses increasing in all age groups, but especially in older people, children, and adolescents. It said the proportion of BA.5 is just under 66%, with BA.4 still increasing, but at a slower rate than in previous weeks. Though infections don’t appear to be more severe, the high number of cases has led to a rise in hospitalizations and deaths.
Jun 30 UK HSA tweet thread
Jun 30 RKI tweet thread
CDC reports more unexplained hepatitis cases in kids
The Centers for Disease Control and Prevention (CDC) yesterday said the number of pediatric unexplained hepatitis cases in the United States has risen to 320, up from the 296 it reported earlier this week in an interim finding report.
The number of affected states or jurisdictions remained at 42.
The CDC and other global groups are still investigating the cause of the cases. A potential adenovirus link is suspected, but health officials are looking into other possibilities, such as another infectious cofactor or a common toxic exposure. In an earlier report, the CDC said they found no increase in unexplained hepatitis in kids above prepandemic levels.
Jun 29 CDC unexplained hepatitis update