• Kineret, an immunosuppressant, has been authorised across the EU to treat adult COVID-19 patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml. Source

• A pre-print paper details the effectiveness of approved and experimental monoclonal antibodies against the Omicron variant compared with an earlier version of SARS-CoV-2. They discovered that several mAbs that are currently used to treat COVID-19 were ineffective against Omicron, including casirivimab and Imdevimab (Regeneron) and bamlanivimab and etesevimab (Eli Lilly), or demonstrated a moderate reduction in neutralization (cilgavimab and tixagevimab (AstraZeneca). In contrast, neutralizing activity of sotrovimab (GlaxoSmithKline/Vir) was minimally affected. Source

• Pfizer and BoiNTech issue a press release to announce that the trial of their coronavirus vaccine in children ages 6 months to under 5 years of age is being amended to include a third dose of 3 µg. The amendment resulted from a pre-planned analysis, which found that two doses were effective for children ages 6- to 24-months, but not for the 2- to under 5-year-olds. If the three-dose study is successful, Pfizer and BioNTech expect to apply for Emergency Use Authorization for children 6 months to under 5 years of age in the first half of 2022.

The companies plan to evaluate a third 10 µg dose in children ages 5 to under 12 years, and have started a sub-study exploring a third 10 or 30 µg dose in approximately 600 adolescents ages 12- to 17 years. Source

Endpoints reports that EU member states have agreed to purchase over 180 million doses an experimental Pfizer/BioNTech vaccine adapted to the Omicron variant, according to European Commission president Ursula von der Leyen, although Pfizer said that the EU’s order was “…not specific to an adapted vaccine.”

Pfizer says a third booster dose of the same vaccine “provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron.” The company is also working with BioNTech on an Omicron-specific booster, which they say could be ready by March of 2022. Source

• South African Health Minister Joe Phaahla announced that only 1.7 percent of COVID-19 patients were admitted to the hospital during the second week of the fourth wave, versus 19 percent in the second week of the country’s Delta-driven third wave. Excess deaths are below 2,000 a week- an eighth of their previous peak, and over 90 percent of those who died were unvaccinated or partially vaccinated. Overall, although the country is seeing many more cases of Omicron, it appears to cause milder illness than other variants. Waasila Jassat, a researcher with the National Institute of Communicable Diseases, noted “…a decrease in a proportion of people who need to be on oxygen. They are at very low levels.” In addition, evidence from wastewater sampling indicates that Omicron cases may have reached their peak. Source

• Jean Castex, France’s health minister, says that Omicron “…is spreading at a lightning speed around us in Europe, with the number of cases doubling every two to three days. To better prepare and protect ourselves, we must take new measures. We are placing the burden on the unvaccinated, because intensive care services are, for the most part, filled with unvaccinated people.” He described the new measures, which would render unvaccinated people – even if they test negative for SARS-CoV-2 – ineligible for the current health pass (which is required for entering restaurants, museums and long-distance trains). Parliament will vote on it in January; if it approves the new law, only vaccinated people would be eligible to receive the pass. Source

The Washington Post reports that public health experts in Denmark fear that Omicron is about to run rampant, despite high vaccination rates. The world pays close attention to Denmark’s projections because they are based on state-of-the-art testing and surveillance data that are used for modeling outcomes.

“This will overwhelm hospitals,” said Tyra Grove Krause, chief epidemiologist at Denmark’s State Serum Institute, “I don’t have any doubt about it.” Denmark’s hospitals have never had more than 1,000 COVID-19 patients at a time – but modeling found that 500 to 800 new COVID-19 patients could arriving every day, depending on Omicron’s transmissibility and severity. But even if Omicron causes mild disease, the sheer number of cases will fully inundate the country.

She compared Omicron to a flood, saying that vaccine had created two barriers – albeit imperfect – against the water, one that kept infections lower and anther that prevented severe illness and death. But Omicron has washed away the first barrier, leaving vaccinated people as susceptible to infection as the unvaccinated. Boosters offer more protection, but only 25 percent of Denmark’s population has received a third dose – washing away the first barrier and making holes in the second wall.

The country has already cut business hours for bars and restaurants, closed schools a week early and urged people to work from home and is closing cinemas and theaters. But even a full lockdown, said Ms. Grove Krause, “won’t stop this from getting out of control.” Source

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