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Pfizer Applies to FDA for a Two-Shot COVID Vaccine for Children Under 5, as Research Continues on a Third Shot
Pfizer and its partner, BioNTech, asked the Food and Drug Administration on Tuesday to authorize two doses of their coronavirus vaccine for children younger than five while the companies continue to research whether three doses would be more effective for that age group.
In a highly unusual move, federal regulators pressed the companies to submit a request for emergency authorization, people familiar with the situation said, even though two doses failed to produce the hoped-for immune response among children aged two to four in a clinical trial.
Only children between six months and two years old demonstrated an immune response comparable to that of older teenagers and young adults, the standard for a successful trial. The doses were one-tenth the strength of adult doses.
Why You May Need an Omicron-Specific Vaccine Even After This COVID Surge Ends, Moderna’s Top Doctor Says
Both Moderna and Pfizer are in the midst of clinical trials for vaccines designed to combat COVID’s Omicron variant, less than two months after the first Omicron case hit the U.S. Last week, Moderna announced that it had entered Phase 2 of its trial, and had already given out its first dose to a human participant.
The Omicron-specific vaccines are meant as a long-term tool against COVID — because both Omicron and COVID’s Delta variant are likely to stick around for a while as endemic virus strains, Moderna chief medical officer Dr. Paul Burton tells CNBC Make It.
“In the fall of 2022, Delta is probably still going to be here, it’s very dangerous,” Burton says. And “Omicron is going to still be here, it’s dangerous because of the number of people it can infect.”
Medical Boards Get Pushback as They Try to Punish Doctors for COVID Misinformation
Medical boards and other regulators across the country are scrambling to penalize doctors who spread misinformation about vaccines or promote unproven cures for COVID-19. But they are unsure whether they’ll prevail over actions by state lawmakers who believe the boards are overreaching.
In Maui, the state medical board filed complaints against the state’s chief health officer and another physician after they supported COVID-19 treatments federal health officials warned against.
States like Tennessee and North Dakota, for example, have restricted state medical boards’ powers. And now legislators in 10 other states — including Florida and South Carolina — have introduced similar measures.
U.S. Military Data Reveals Skyrocketing Rate of mRNA Injection Injuries
This is one of the largest and best kept medical datasets in the world. The people in it are mostly young and healthy and the whistleblowers have signed legal declarations.
The military data suggests most national vaccination databases suffer from gross underreporting of adverse events. In the World-We-Thought-We-Lived-In, this would have been Frontpage news the next day. Calls should be coming in from all around to pause vaccinations immediately until it can be reviewed.
WHO Says the New Omicron Subvariant Doesn’t Appear to Be More Severe Than the Original
The World Health Organization on Tuesday said there’s no indication Omicron’s new sister variant, BA.2, causes more serious infections than the original version, though initial data shows it’s more transmissible.
The WHO and other researchers around the world have found that Omicron generally doesn’t make people as sick as the Delta variant, though it does spread faster than previous strains of the virus and can evade some of the immune protection provided by vaccines.
Maria Van Kerkhove, the WHO’s COVID-19 technical lead, indicated on Tuesday that those findings likely hold true for the Omicron sister variant, labelled BA.2 by scientists. Van Kerkhove said information is limited, but initial data indicates that BA.2 is “slightly” more transmissible than the original Omicron variant, what scientists formally refer to as BA.1, which is currently the dominant version worldwide.
Merck’s COVID Pill Is Last Choice for U.S. Patients, Global Use Varies
Merck & Co’s (MRK.N) new antiviral pill, molnupiravir, once touted as a potential game-changer for treating COVID-19, is the last choice among four available options for at-risk patients given its relatively low efficacy and potential safety issues, U.S. doctors, healthcare systems and pharmacies told Reuters.
Molnupiravir introduces errors into the genetic code of the coronavirus and both men and women taking it are instructed to use effective birth control due to potential safety issues.
Cuba Leads the World in Vaccinating Children as Young as Two Against COVID
The island is the only country vaccinating toddlers as young as two against the disease, and more than 95% of two- to 18-year-olds have now been fully vaccinated, according to the ministry of public health.
Around the world, COVID vaccination ages are getting lower: the World Health Organization has recommended that if high levels of coverage have already been achieved in the adult population, countries should consider inoculating children as young as five with the Pfizer/BioNTech vaccine. Chile and the United Arab Emirates are now vaccinating three-year-olds.
South African Scientists Will Study Link Between COVID Variants and Untreated HIV
Leading South African scientists are set to investigate COVID-19 and HIV in tandem, amid mounting evidence that the collision of the two pandemics could be generating new coronavirus variants.
The team at the Network for Genomic Surveillance in South Africa (NGS-SA), which first alerted the world to the COVID variant Omicron, said it was time for a “systematic” investigation of what happens when patients with untreated HIV get COVID-19.
A number of studies, including one published by the team last week, have found that people with weakened immune systems — such as patients with untreated HIV — can suffer from persistent coronavirus infections, often for months.
Huge Volumes of COVID Hospital Waste Threaten Health — WHO
Discarded syringes, used test kits and old vaccine bottles from the COVID-19 pandemic have piled up to create tens of thousands of tons of medical waste, threatening human health and the environment, a World Health Organization report said on Tuesday.
The material potentially exposes health workers to burns, needle-stick injuries and disease-causing germs, the report said.
The biggest risk for affected communities was air pollution caused by burning waste at insufficiently high temperatures leading to the release of carcinogens, Maggie Montgomery, a WHO technical officer, told Geneva-based journalists.
Denmark Ends Most COVID Restrictions as ICUs Nearly Empty of Patients, Weighs 4th Shot
Denmark ended most of its COVID-19 restrictions on Tuesday, even as the country reported high levels of Omicron infections, but hospitalizations remained low. However, a fourth shot of the vaccine might be necessary down the road.
The Scandinavian country is now one of the first countries in the European Union to treat the pandemic as an endemic, even though cases are increasing from the Omicron variant.
AP reported that Danish Health Authority, Søren Brostrøm, told Danish broadcaster TV2 the number of ICU patients had “fallen and fallen and is incredibly low.”