AstraZeneca’s Vaccine Stumbles
By Phil Mattera for the Dirt
Diggers Digest
The administration, eager to take
credit for the unusually quick development of at least two products, is now
revealed to have passed up the opportunity to lock in larger supplies of the
Pfizer offering, prompting the company to make deals with other countries.
Trump tried to cover up the error
with an America First executive order, but that action is said to be
unenforceable.
Unless some of the other vaccines in
development come to fruition soon, it may take a lot longer than promised to
inoculate the U.S. population. The situation is worsened by the decision of the
administration to leave states to work out distribution plans on their own.
Pfizer, meanwhile, was getting
showered with praise as its vaccine began to be administered in the United
Kingdom, yet it soon had to contend with reports of several serious allergic
reactions.
The company, it turns out, had
excluded people with a history of significant adverse reaction to vaccines from
late-stage trials. UK officials are now telling those with serious allergies to
put off getting the shot.
Then there is AstraZeneca, whose
vaccine developed with the University of Oxford appears to be effective, but
exactly how effective is in doubt given that researchers initially screwed up
the doses given during the clinical trial and had to improvise.
Back in September, AstraZeneca had to halt the clinical trial after a participant fell ill. The company apparently infuriated the Food and Drug Administration by failing to warn it about the problem before the story became public.
The New York Times called the incident “part of a pattern
of communication blunders by AstraZeneca that has damaged the company’s
relationship with regulators, [and] raised doubts about whether its vaccine
will stand up to intense public and scientific scrutiny.”
AstraZeneca’s shortcomings did not start with its covid project. Like Pfizer, AstraZeneca has been accused of engaging in illegal marketing.
In 2010 it paid $520 million to the U.S. Justice
Department to resolve allegations that it promoted its anti-psychotic drug
Seroquel for uses not approved as safe and effective by the FDA. Among other
things, the company was accused of having paid doctors to give speeches and
publish articles (ghostwritten by the company) promoting those unapproved uses.
The company has also been embroiled
in controversies over pricing. In 2007 a federal judge ruled in a national class action case
that AstraZeneca and two other companies had to pay damages in connection with
overcharging Medicare and private insurance companies.
The judge singled out AstraZeneca
for acting “unfairly and deceptively” in its pricing of the prostate cancer
drug Zoladex. The company was later hit with a $12.9 million judgment.
The combination of Trump Administration incompetence and the questionable track record of companies like AstraZeneca and Pfizer is giving ammunition to vaccine skeptics.
We can only
hope that the FDA review process makes a convincing case for the safety of the
vaccines and that the new Biden Administration shows greater skill in working
out the details for their distribution.