With input from Dr Monica Vasudev

1233:  The US FDA has granted an emergency use authorization (EUA) for Moderna’s messenger RNA COVID-19 vaccine. This becomes the second vaccine to be authorized for emergency use in the United States, and will likely increase the number of doses available in the coming days. The EUA for the Moderna vaccine comes after a review by the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) members on December 17, which voted 20-0 with one abstention, recommending the EUA. The vaccine is authorized for use in individuals aged 18 years and above. (Medscape)

1234:   Johnson & Johnson has recruited 45,000 participants in phase III clinical trials of its coronavirus vaccine and hopes to apply for an emergency use authorization from the FDA in the month of February. Data from phase III is expected to be available by January end.

If the data suggest that the vaccine is safe and effective, the company is expected to submit an application for emergency use authorization to the U.S. Food and Drug Administration in February.

This vaccine doesnt need to be frozen and only requires one dose. Johnson & Johnson had to halt its clinical trials in the fall as a participant developed an "unexplained illness". However, the trials were re-started 2 weeks later.

Johnson & Johnson said earlier this month that it would reduce the number of phase III participants from its original aim of 60,000. (Medscape)

1235:  Oxfords COVID-19 vaccine candidate induces a better immune response when a two full-dose regimen is used rather than a full-dose followed by a half-dose booster, as per the university. The vaccine candidate, licensed to AstraZeneca, had in previously published interim late stage trial results, shown higher efficacy when a half dose was followed by a full dose, compared to a two full-dose regimen. More work is needed; however, to confirm the result. The subgroup details from the Phase I/II clinical trials made no reference to the half-dose/full-dose regimen, which, according to Oxford, had been "unplanned" but approved by regulators. (Reuters)

1236: Vitamin D Deficiency in COVID-19 Quadrupled Death Rate

1. Vitamin D deficiency on hospital admission was found to be associated with 3.7-times increased likelihood of dying from COVID-19, suggests a new study.
2. Around 60% of patients with COVID-19 were vitamin D deficient at the time of hospitalization, with men in the advanced stages of COVID-19 pneumonia having the greatest deficit. 
3. The results were independent of comorbidities known to be affected by vitamin D deficiency, stated the authors, led by Dieter De Smet, MD, from AZ Delta General Hospital, Roeselare, Belgium.
4. The findings emphasize the need for randomized controlled trials specifically focused at vitamin D–deficient patients at intake, and urge for general avoidance of vitamin D deficiency as a safe and inexpensive possible mitigation of the pandemic, suggest researchers in their article, published online in the American Journal of Clinical Pathology.
5. A 3.7-fold hike in death rate if someones vitamin D level was below 20 [ng/mL] is staggering. It is among the most important risk factors to consider.
6. It is not clear if vitamin D levels act as an acute-phase reactant, declining due to the infection, with larger fall indicating more severe disease, or whether vitamin D deficiency is leading to worse outcomes.
7. This is possibly due to the loss in the protective action of vitamin D on the immune system and against the SARS-CoV-2-induced cytokine storm.
8. The study had reported more prevalent vitamin D deficiency among men compared to women, most likely because women are more often treated with vitamin D for osteoporosis.
9. The study should prompt all clinicians and health authorities to consider vitamin D supplementation as an additional tool in the fight against COVID-19, more so for the prevention of infection in individuals at high risk of both COVID-19 and hypovitaminosis D, such as the elderly. (Medscape)

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA