The Trump administration, through Operation Warp Speed has made multi-billion investments for the rapid development and production of vaccines. Reports have it that Trump wants to make the vaccine developed, produced and available to the American public by October, by getting the U.S. FDA to give approval by way of “emergency use authorization.”
The U.S. Department of Health and Human Services (HHS) has entered into an agreement with drug manufacturer AstraZeneca to make available to the American public at least 300 million doses of a coronavirus vaccine called AZD1222. Part of the agreement includes accelerating the development and manufacturing by performing Phase 3 clinical studies on about 30,000 U.S. volunteers this summer.
AstraZeneca Denies Involvement in Talks to Release Vaccine Ahead of Results of Efficacy Testing
Trump’s Health and Human Services (HHS) Secretary Alex Azar. said getting a vaccine for the American public as soon as possible is part of Trump’s strategy to safely reopen the country. The latter has been constantly mentioning a forthcoming cure during his press briefings.
However, the promised vaccine has not materialized since the AZD1222 drug, licensed from the University of Oxford, is still undergoing phase 2/3 testing in Brazil, the U.K. and South Africa.
Although AstraZeneca is also planning to launch a phase 3 trial in the U.S. a spokeswoman for the drug company said in an email last Aug. 25, that efficacy results are anticipated to come later this year. Regarding the US FDA’s emergency use authorization, the spokesperson added that AstraZeneca has not been in any such discussions because it is still too early to speculate about the approval of the vaccine.
USFDA Vows to Act According to Science Guidelines
Amidst talks that the Trump administration is pressuring the USFDA to rubber stamp the emergency use authorization for AztraZeneca’s AZD1222 production even before results of efficacy testing, the head of the USFDA, Peter Mark, vowed to resign if Trump approves the manufacture and release of the drug before it has been proven safe and effective.
Peter Marks gave the statement in response to a conference call held last week by members of the vaccine working group of the National Institutes of Health, comprising government officials, academics and pharmaceutical executives. The group has been expressing concerns over Trump’s plan of fast tracking the AZD1222 ahead of the November election
Moreover, many health experts are concerned, including top epidemiologist Dr. Fauci, about rushing the release of any promising vaccine by skipping the scientific guidelines. Should results complicate matter, they will further erode the confidence of the American public over the safety of mass-immunization programs.