Fast-Tracking UK COVID-19 Vaccine

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Day 153: Stay Safe Minnesota

Fast-tracking of covid-19 vaccine development for political expediency is very dangerous.

The Financial Times reporters David Crow, Demetri Sevastopulo, Hannah Kuchler and Andrew Edgecliffe-Johnson write in a headline article that Trump considers fast-tracking UK Covid-19 vaccine before US election. Such a fast-tracking effort for political expediency will ruin already low public confidence in getting COVID-19 vaccines.

If the Trump administration does rush through emergency authorisation ahead of the election by skirting normal government guidelines, it could dent already shaky public confidence in the safety of vaccines ahead of one of the largest mass-immunisation programmes in US history.

The Financial Times

“The Trump administration has pressured and bullied the agency on Covid-19 therapies” Dr. Paul Offit, an advisor to FDA, told to CNN.

“We are far from having any definitive proof that it’s effective, clinically, and saves lives. This one is going to attract a lot of debate,” said Howard Koh, a public health expert at Harvard’s Chan School of Public Health : From the Hills.

In the Politico, reporter Rachel Roubein writes :

AstraZeneca says it hasn’t talked to the U.S. government about an emergency use authorization for its coronavirus vaccine — a day after news reports that the Trump administration may greenlight the vaccine’s use before the election. “It would be premature to speculate on that possibility”

“My fear is that this announcement has shaken the confidence of the medical community. This is a time to insist that the rigor and science of the decision making process be held to the highest level. The future of global public health is dependent on that” Dr Howard Koh, a public health expert at Harvard’s Chan School of Public Health, told to the Hill.

FDA Response to Criticism

The CNN reports that the FDA commissioner Dr Hahn clarified the authorization on Monday Aug 24 with the following statement:

I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.

Dr Hahn, FDA Commissioner (source: CNN)
  • Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.
  • They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined. The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”
  • We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees, I want to reassure the American public about this commitment. The convalescent plasma decision was made entirely by FDA scientists.
Coronavirus Pandemic Watch

According to the MDH latest tally (as of Aug 26, 11 a.m.) the confirmed COVID-19 cases in Minnesota are 71,236 (out of 1,406,007 tested) with 1,793 deaths. According to Johns Hopkins database (as of Aug 26, 4:28 p.m.) there are 5,812,700 confirmed covid19 infection with 179,344 deaths. Globally the covid19 virus has infected 24,011,502 with 821,909 deaths.