Moderna Seeking US, European Regulators To Approve Covid-19 Vaccination

Moderna Inc, which has reported its Covid-19 vaccine is 94 per cent effective, on Monday announced it is filing with US and European regulators for emergency use authorization. Moderna follows barely a week after Pfizer and its German partner BioNTech filed for US regulatory approval. By the end of 2020, Moderna expects to have approximately 20 million doses of its mRNA-1273 vaccine available in the U.S and is “on track to manufacture 500 million to 1 billion doses globally in 2021.

Moderna created its shots in collaboration with the U.S. National Institutes of Health and got a final batch of results over the weekend which show the vaccine is more than 94% effective. Moderna’s efficacy results are based on 196 Covid-19 cases in its huge U.S. study with more than 30,000 participants. Of the 196 cases, 185 were in participants who received the dummy shot and 11 who got the vaccine. Severe cases and one death were reported in participants who got the dummy shot.

Moderna expects to present its data to the US Food and Drug Administration on December 17. First up will be Pfizer and BioNTech, on December 10. Both Pfizer and Moderna are two-shot vaccines.

The US government’s vaccine management chief has said all systems are ready to deliver the vaccines to priority groups within 24 to 48 hours of FDA approval.  Government Model Suggests U.S. COVID-19 Cases Could Be Approaching 100 Million

The actual number of coronavirus infections in the U.S. reached nearly 53 million at the end of September and could be approaching 100 million now, according to a model developed by government researchers.

The model, created by scientists at the Centers for Disease Control and Prevention, calculated that the true number of infections is about eight times the reported number, which includes only the cases confirmed by a laboratory test.

Preliminary estimates using the model found that by the end of September, 52.9 million people had been infected, while the number of laboratory-confirmed infections was just 6.9 million, the team reported in the Nov. 25 issue of the journal Clinical Infectious Diseases.

“This indicates that approximately 84% of the U.S. population has not yet been infected and thus most of the country remains at risk,” the authors wrote.

Since then, the CDC’s tally of confirmed infections has increased to 12.5 million. So if the model’s ratio still holds, the estimated total would now be greater than 95 million, leaving about 71% of the population uninfected. The model attempts to account for the fact that most cases of COVID-19 are mild or asymptomatic and go unreported.

Scientists used studies looking for people who have antibodies to the coronavirus in their blood – an indication that they were infected at some time — to estimate how many infections went undetected. Some of these antibody studies have suggested that only about one in 10 coronavirus infections is reported.

The goal in creating the model was to “better quantify the impact of the COVID-19 pandemic on the healthcare system and society,” the authors wrote. The model also estimated that official counts do not include more than a third of the people hospitalized with COVID-19.

NPR (11/26, Hamilton) reported “the actual number of coronavirus infections in the U.S. reached nearly 53 million at the end of September and could be approaching 100 million now, according to a model developed by” Centers for Disease Control and Prevention researchers. The model “calculated that the true number of infections is about 8 times the reported number, which includes only the cases confirmed by a laboratory test.” NPR added, “Preliminary estimates using the model found that by the end of September, 52.9 million people had been infected, while the number of laboratory-confirmed infections was just 6.9 million, the team reported in…Clinical Infectious Diseases.”

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