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Moderna Completes FDA Submission for Use of COVID Shot in Adolescents, Kids
Moderna Inc. (MRNA.O) has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its COVID-19 vaccine in adolescents and children, it said on Wednesday.
The company is seeking approval for the use of its vaccines in three distinct age groups — adolescents aged 12 to 17 years, children aged six to 11 and those between six years and six months. The submissions for all three groups were made on May 9, it said.
Although Moderna’s vaccine is approved by the FDA for use in adults 18 years and older, its use in other age groups has hit a roadblock as U.S. regulators have sought more safety data.
Australia, Canada and the European Union though have approved the vaccine for use in six- to 17-year-olds.
NIH Director Confirms Agency Hid Early COVID Genes at Request of Chinese Scientists
National Institutes of Health acting director Lawrence Tabak confirmed to lawmakers Wednesday that U.S. health officials concealed early genomic sequences of COVID-19 at the request of Chinese scientists — but insisted the data remains on file.
Tabak told a House Appropriations subcommittee that the NIH “eliminated from public view” the data from the pandemic epicenter in Wuhan, China, before adding that researchers can still access it via an archaic “tape drive.”
Bill Gates Is so Over This Pandemic
When Bill Gates took the stage at this year’s TED conference, he proposed a permanent team of 3,000 people around the globe called GERM — Global Epidemic Response and Mobilization. The group would monitor potential outbreaks, develop close relationships with public health officials around the world, and oversee drills to prepare for the inevitable — and potentially even worse — sequels to COVID.
The insistent optimism he brought to this idea and much of his speech was nothing like the bleak alarm of his 2015 TED talk, a jeremiad about our lack of preparedness for an imminent pandemic. That presentation has garnered 43 million views on the TED site; unfortunately, he says, 90% of them came after COVID made his prediction tragically accurate.
Still, it wasn’t until I sat down with Gates a few hours after this year’s speech that I realized how fully his attention has shifted away from what, to my mind at least, is an ongoing crisis. He even took it in stride that conference-goers had to make their way past anti-vaxxers calling for his imprisonment and worse.
He was doggedly upbeat, not just about pandemics but in his view of the state of the world, which, it turns out, is much sunnier than mine.
U.S. Licenses Key COVID Vaccine Technology to WHO so Other Countries Can Develop Shots
President Joe Biden on Thursday said the U.S. has licensed a key technology used in the current COVID-19 vaccines to the World Health Organization, which would allow manufacturers around the world to work with the global health agency to develop their own shots against the virus.
The National Institutes of Health has licensed its stabilized spike protein technology to the WHO and United Nations’ Medicines Patent Pool, Biden said.
The decision to share the vaccine technology comes ahead of a virtual global COVID-19 summit that the U.S. is co-hosting Thursday. Though the spike protein technology is crucial, the vaccines also include other components — some of which are proprietary to the companies.
U.S., Foreign Officials to Announce $3.1 Billion in New COVID Funding
U.S. and world officials will announce Thursday $3.1 billion in new funding for the global COVID fight, according to two senior administration officials.
The announcement will take place at the Biden administration’s second Global COVID Summit in which top officials, including Vice President Kamala Harris, are set to appear with global organizations, nonprofits and foreign representatives working to ramp up vaccinations and expand access to therapeutics to fight the virus. Officials from Spain, France, Indonesia, South Korea, Canada and the European Commission are expected to participate.
The bulk of the funding pledges is set to come from international officials. Last month, Congress failed to approve $5 billion in additional global COVID funding meant to help get shots in arms worldwide. There was a chance that funding was going to be included in another Ukraine supplemental package.
But this week, President Joe Biden said he believed a package that included COVID funding would slow down the approval process and that the two measures would have to be separated, with a COVID package potentially moving through at a later date.
WHO: COVID Falling Everywhere, Except Americas and Africa
The number of new coronavirus cases reported worldwide has continued to fall except in the Americas and Africa, the World Health Organization said in its latest assessment of the pandemic.
The downward trend in reported infections began in March, although many countries have dismantled their widespread testing and surveillance programs, making an accurate count of cases extremely difficult.
WHO said there were only two regions where reported COVID-19 infections increased: the Americas, by 14%, and Africa, by 12%. Cases remained stable in the Western Pacific and fell everywhere else, the agency said.
Guardians Hit With COVID Outbreak, Manager Francona Out
The Cleveland Guardians are dealing with a COVID-19 outbreak that has sidelined manager Terry Francona and several of the team’s coaches, leading to the postponement of Wednesday’s game against the Chicago White Sox.
Shortly after Francona’s positive test became known, Major League Baseball said there were “multiple positive COVID-19 tests” in Cleveland’s organization and called off Wednesday’s series finale to allow for more testing and contact tracing. No makeup date has been announced.
Half of COVID-Hospitalized Still Symptomatic Two Years on, Study Finds
More than half of people hospitalized with COVID-19 still have at least one symptom two years after they were first infected, according to the longest follow-up study of its kind.
While physical and mental health generally improves over time, the analysis suggests that coronavirus patients discharged from hospitals still tend to experience poorer health and quality of life than the general population. The research was published in The Lancet Respiratory Medicine.
WHO Says Omicron BA.4 and BA.5 Subvariants Have Spread to Over a Dozen Countries
Omicron subvariants BA.4 and BA.5 have been detected in more than a dozen countries, helping fuel sporadic COVID outbreaks across the world, but the heavily mutated strains are still circulating at low levels, the World Health Organization said Wednesday.
Less than 700 cases of BA.4 have been detected across at least 16 countries and more than 300 cases of BA.5 have been found across at least 17 countries, WHO’s technical lead on COVID Maria Van Kerkhove said during a Q&A on the organization’s social media platforms.
While the two sublineages don’t make people sicker than the original Omicron strain, they appear to be more contagious, Van Kerkhove said. She noted the WHO will monitor BA.4 and BA.5 to determine if they will eventually overtake BA.2 as the dominant strain worldwide.
Long COVID May Be Chronic, Require Anti-Inflammatory Meds: Study
U.S. News & World Report reported:
New evidence suggests that long COVID patients suffer rampant inflammation that wracks the entire body — and that easing that inflammation could be key to saving their lives.
Severe systemic inflammation during hospitalization for COVID increases the risk of dying within a year after the patient seemingly recovers, University of Florida researchers found.
Patients prescribed anti-inflammatory steroids had a lower risk of death post-discharge than those who didn’t receive the meds, researchers said, although that remains a controversial idea.
