Government

FDA
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC’s recommendation if booster shots are necessary.
Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
FDA
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
The UK’s Competition and Markets Authority (CMA) will determine if the deal is anti-competitive.
FDA
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
The disclosure comes the day before the WHO is expected to plan for the next phase of investigations into the origins of COVID-19.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
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