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Moderna Asks FDA to Authorize Omicron COVID Boosters for Children as Young as 6 Years Old
Moderna has asked the Food and Drug Administration to authorize its Omicron booster shots for children, the company announced on Friday.
Moderna filed two separate FDA authorization requests, one for adolescents ages 12 to 17 and another for kids ages 6 to 11. The Boston biotech company said it will also ask the FDA to clear the shots for the youngest children, 6 months through 5 years old, later this year.
The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to become eligible for the Omicron boosters by mid-October pending authorization by the FDA. The CDC’s vaccine advisory committee has meetings scheduled for October 19 and 20.
Pfizer told the CDC advisory committee earlier this month that it expects to ask the FDA to authorize Omicron boosters for children ages 5 to 11 in early October.
Fauci Says the Chinese Government Is ‘Probably’ Hiding Something About the Origins of COVID, but He’s Not Sure It’s a Lab Leak
Dr. Anthony Fauci says he’s dedicated to “keeping a completely open mind” about how the coronavirus first emerged in Wuhan, China in 2019, but he still wishes he had more information to go on from the Chinese government.
Scientists and conspiracy theorists alike have been eager to find clear answers to the origins of the SARS-CoV-2 virus for years now. Still, no satisfactory nail-in-the-coffin evidence is pointing to one single, bulletproof explanation for where this pandemic began.
“You wanna keep an open mind that it could have been anything that happened,” Fauci said Wednesday during a conversation with Atlantic editor Ross Andersen. “But the evidence that they have been working on for years strongly favors a natural occurrence.”
“The fact is, as a society when something occurs that looks like — even if it’s naturally coming out of China — they will be secretive about it,” Fauci said of the Chinese government. “Because of this feeling that they’re gonna get blamed for something.”
Coronavirus Detected in Bats Shows Resistance to Vaccines
The World Health Organization’s Tedros Adhanom Ghebreyesus said in May that because of reduced testing and sequencing “we are blinding ourselves to the evolution of the virus.”
Similarly, because coronaviruses are found in other mammals, it is important to be aware of what is circulating among animal populations. A team of researchers at Washington State University and Tulane University School of Medicine is aiming to do just that.
In a paper published in PLoS Pathogens, they detail two coronaviruses detected in a population of horseshoe bats in Russia. The lineages of the viruses are separate from the original SARS-CoV-1 from 2003 and SARS-CoV-2, which is responsible for the current pandemic. However, the researchers think that it is useful to study coronaviruses in wild animals to understand viral evolution and the potential for crossover into humans.
The team tested the viruses against SARS-CoV-2 monoclonal antibodies and serum from individuals vaccinated for SARS-CoV-2 that contained antibodies. One of the two bat coronaviruses was resistant to both monoclonal antibodies and vaccine-induced antibodies. They had a similar result when they tested it against antibodies from someone who recovered from an infection of an Omicron variant.
4.4 Million Americans Roll up Sleeves for Omicron-Targeted Boosters
U.S. health officials say 4.4 million Americans have rolled up their sleeves for the updated COVID-19 booster shot. The Centers for Disease Control and Prevention posted the count Thursday as public health experts bemoaned President Joe Biden’s recent remark that “the pandemic is over.”
Health experts said it is too early to predict whether demand would match up with the 171 million doses of the new boosters the U.S. ordered for the fall.
A temporary shortage of Moderna vaccine caused some pharmacies to cancel appointments while encouraging people to reschedule for a Pfizer vaccine. The issue was expected to resolve as government regulators wrapped up an inspection and cleared batches of vaccine doses for distribution.
U.S. Cutting Global Donations of Pfizer COVID Shots as Demand Slows
The United States is significantly cutting back the number of Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 vaccine doses it will buy for a donation to poorer nations this year, Pfizer said on Thursday, citing diminished demand for the shots in those countries.
Pfizer said it agreed to reduce the number of doses it will deliver by year-end to 600 million, down from the billion-dose commitment the U.S. government made a year ago.
The United States will have an option to buy up to an additional 400 million shots for the program after this year.
The drugmaker said it would have sufficient supply to deliver the full billion doses under the U.S. commitment, but “we are seeing reduced demand in some low- and lower-middle-income countries due to barriers in administration and vaccine hesitancy.”
CDC Director Weighs in on Whether Pandemic Is Over, Says Bivalent COVID Shot Is ‘Critically Important’
Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky became the latest American to receive the new bivalent COVID-19 booster shot on Thursday, telling ABC News that, thus far, “millions” of Americans have now gotten an updated vaccine.
Walensky, after receiving her shot of Moderna’s bivalent booster at a CVS location in Brookline, Massachusetts, urged others to join her in getting the vaccine, stressing that it is critical to get vaccinated ahead of the fall and winter, in order to prevent severe disease.
In recent months, vaccination and booster uptake have slowed significantly, with fewer Americans willing to get their shots. As of Sept. 14, approximately 109.2 million Americans have received their first booster — representing less than 50% of those who have been fully vaccinated.
Walensky was reluctant to directly agree with the president’s assertion that “the pandemic is over,” but with hospitalization and case rates falling, and vaccines and treatments available, “we’re in a different place,” she said.
First Signs of New COVID Wave Seen in Colder Countries
COVID-19 cases and hospitalizations are creeping up in Northern Europe where the colder and wetter weather is first being felt across the bloc.
Latest data from Belgium, the U.K. and Denmark point to a gradual uptick in the number of cases and hospitalizations. Belgium’s health authority said its modeling points to a new COVID-19 wave hitting in mid-October. Its data published on Friday suggests the first ripples of this wave have already arrived.
Denmark’s infectious disease institute reported the first data indicating a reversal in infection rates, which after a long period of decline are now stabilizing or rising slightly across the regions.
And in the U.K., the number of new cases in the week up to Sept.17 was 13% higher than the previous week, while hospitalizations were up 17% in the week up to Sept.19.
WHO Warns Ability to Identify New COVID Variants Is Diminishing as Testing Declines
The World Health Organization on Thursday warned that it is struggling to identify and track new COVID variants as governments roll back testing and surveillance, threatening the progress made in the fight against the virus.
Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said the virus is still circulating at an “incredibly intense level” around the world. The WHO is “deeply concerned” that it is evolving at a time when there is no longer robust testing in place to help rapidly identify new variants, Van Kerkhove said.
WHO Director-General Tedros Adhanom Ghebreyesus on Thursday warned there’s the “ever-present risk of more dangerous variants emerging” as the virus continues to spread and change. Tedros said “the pandemic is not over but the end is in sight,” contradicting President Joe Biden’s assertion earlier this week that the pandemic had ended.
The WHO is currently tracking about 200 Omicron sublineages, Van Kerkhove said. The global health body is keeping a close eye on Omicron BA.2.75, BF.7 and BA.4.6 among other subvariants, she said. Those variants have started to gain a foothold in countries such as the U.S. where Omicron BA.5, the fastest spreading variant yet, has been dominant for months.
COVID Infection Linked to More Type 1 Diabetes in Kids and Teens
COVID-19 in children and teens appeared to raise the risk of developing diabetes in two studies that didn’t settle the debate about whether the coronavirus can trigger the chronic condition.
Scientists from the Norwegian Institute of Public Health used national health registries to examine new diagnoses of type 1 diabetes over two years after the start of the pandemic. They found that youngsters who had tested positive for the coronavirus were about 60% more likely to develop type 1 diabetes.
The researchers looked at the risk within 30 days after a COVID infection was confirmed by PCR test. Another study from Scotland presented at the European Association for the Study of Diabetes conference that also included young adults found a heightened risk within a month after the viral illness — but after that, the scientists said, they found no association.
The researchers in both studies stressed that their findings don’t mean there is necessarily a cause and effect relation between the coronavirus and diabetes. They highlighted other possible culprits, including delays seeking care during the pandemic, the spread of other viruses and lifestyle changes related to lockdowns.
2 Companies Were Fined $325,000 After the EPA Said They Falsely Marketed a Pesticide as a Weapon Against COVID
Two New Jersey companies have been fined $325,000 for selling a pesticide they marketed as a weapon against COVID-19, the Environmental Protection Agency said Thursday.
The EPA said that Zoono USA and Zoono Holdings had used “false and misleading claims” about the effectiveness of Zoono Microbe Shield, a registered pesticide, and its suitability for use as a sanitizer or disinfectant against viruses, “including against the virus that causes COVID-19.”
The sprays were sold on websites including Amazon and bought by both individuals and institutions, including community centers, per the EPA. United Airlines even used the spray as a coating for its plane cabins, in conjunction with other cleaning measures including electrostatic disinfection. Zoono says it has also supplied Australia’s flag carrier Qantas Airlines.
Monkeypox Virus ‘Behaving Differently’
This year has seen an unprecedented outbreak of monkeypox sweeping across the globe, and the disease appears to be “behaving differently” from before, experts told Newsweek.
According to the U.S. Centers for Disease Control and Prevention (CDC), more than 63,100 confirmed monkeypox cases had been recorded around the world in 2022 at the time of writing — the vast majority of those (over 62,500) in locations that haven’t historically reported the disease. While the fatality rate of the current outbreak appears to be low, 10 deaths have been recorded so far in these locations, on top of another 10 in endemic regions.
The authors of a study, published in the open-access journal PLOS Pathogens, documenting the characteristics and spread of the latest outbreak spoke to Newsweek about how the disease appears to be behaving in unusual ways.
In this outbreak: “Monkeypox is behaving differently,” the authors told Newsweek. “Many patients are presenting with a rash without the first phase,” they said. “Some lesions are confined to one single body region, like the pelvic area.”
People With Skin Conditions Face Stigma. Monkeypox Has Made It Worse.
A cashier with psoriasis received daily complaints from customers at work. A traveler with eczema was escorted off a flight and questioned by airline employees. A commuter with small, benign tumors on her body was unknowingly filmed and scrutinized on social media.
All of them were singled out because people mistakenly believed they had monkeypox.
People with chronic skin conditions say they’ve grown accustomed to stares and questions about their appearance, but the harassment and stigma have gotten worse during the worldwide outbreak of monkeypox.
Psychologists say the pandemic has heightened medical anxiety, in general, which may explain the added scrutiny of people with skin conditions. A recent national survey from the Annenberg Public Policy Center showed nearly 1 in 5 Americans were concerned about contracting monkeypox but understood little about it.
