1190:   India may become the first country in the world to have emergency use approval of three vaccines: Hyderabad-based Bharat Biotech filed an application for emergency use authorization for its COVID-19 vaccine – Covaxin - on Monday, becoming the third company to seek such regulatory approval in the country after Pfizer and Serum Institute of India (SII). While Pfizer has offered its vaccine, which has been developed in association with German firm BioNTech, SII has sought the approval for Covishield, developed by Oxford University and AstraZeneca. SII has conducted only bridging studies in India but is manufacturing the vaccine.

The DCGI will decide whether Pfizer needs to conduct bridging studies here. It is possible that Pfizer receives emergency authorization here as it has already been approved in the UK and conducts bridging studies before getting final approval. (TOI)

1191:  A study evaluating the safety and efficacy of mRNA-1273 vaccine noted that serum neutralizing antibodies continued to be detected in all participants 90 days following the second dose. (DG Alerts)

1192:  The mysterious illness in India: So far, the people hospitalized have tested negative for the coronavirus and other viral diseases including dengue, and water from the area has not shown signs of contamination.

1193: Metformin has been found to have a significant association with decreased mortality in women with obesity or type 2 diabetes admitted to hospital for COVID-19; however, there was no significant link among men, suggests new research published in The Lancet Healthy Longevity.

Preventive use of metformin, before infection can prevent severe COVID-19 in patients with diabetes or obesity, said the authors led by Carolyn T Bramante, Department of Medicine, University of Minnesota, Minneapolis, Minnesota.

Metformin tends to decrease TNFα and other inflammatory adipokines that are raised in people with obesity and type 2 diabetes and contribute to COVID-19 severity. It also raises the levels of the anti-inflammatory cytokine IL-10. Investigators also pointed to previous research showing that metformin exerts these beneficial effects significantly more in females compared to males in both animal and human studies.

The authors stated that if the findings are replicated in other analyses and prospective trials, the drug should be widely distributed for prevention of severe COVID-19 among people with diabetes or a BMI of at least 30 kg/m2.

Reference: https://www.thelancet.com/journals/lanhl/article/PIIS2666-7568(20)30033-7/fulltext

[DG Alerts]

1193: FDA has granted authorization to the first COVID-19 and flu combination test, developed by Quest that allows for at-home collection of respiratory samples, and will be available by prescription only for patients with symptoms of respiratory viral infection. [Medpage Today]

1194:  The vaccine advisory committee of the US Food and Drug Administration (FDA) is scheduled to meet on Thursday after poring over data from clinical trials carried out by Pfizer/BioNTech. The FDA should then grant authorization for emergency use of the vaccine. The decision could come within days after the advisory committee meets. On December 17, the same process will take place for the Moderna vaccine. In each case, distribution will begin immediately following FDA approval. [HT]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA