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A2 UP FRONT
Wednesday 7 OctOber 2020

Continued from Front help multiple drugmakers
But on Tuesday, the FDA prepare multiple candi-
posted the guidance on dates. All the doses will be
the agency's website, mak- purchased by the federal
ing clear that regulators government for use vacci-
plan to impose the safety nating the U.S. population.
standards for any vaccine Beyond exposing the rift
seeking an expedited path between the White House
to market. and FDA, the delay in re-
FDA Commissioner Stephen leasing the information
Hahn said in a statement may have had limited
that he hoped the guide- practical effect.
lines would help "the public FDA scientists have been
understand our science- discussing the guidelines
based decision-making publicly for weeks and
process that assures vac- have made clear that the
cine quality, safety and ef- recommendations have
ficacy." The requirements already been shared with
are aimed at companies each of the vaccine de-
seeking rapid approval velopers. "The companies
through the FDA's emer- know what we're expect-
gency authorization path- ing," said Dr. Peter Marks,
way. That accelerated pro- the head of FDA's vaccine
cess, reserved for health division, in an online inter-
emergencies, allows medi- In this March 16, 2020, file photo, Neal Browning receives a shot in the first-stage safety study clini- view last week with the
cal trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the
cal products onto the mar- Kaiser Permanente Washington Health Research Institute in Seattle. nonprofit Friends of Cancer
ket based on a lower bar Associated Press Research.
than traditional FDA ap- The guidelines released
proval. But FDA has made about limited use of a vac- with health conditions that and effective. Tuesday made clear that all
clear only vaccines that cine there has to be some make them particularly vul- Pfizer CEO Albert Bourla upcoming vaccines would
are shown to be safe and level of assurance that nerable to coronavirus. Full has stoked excitement by be reviewed by FDA's inde-
effective will be authorized there isn't a risk here that FDA approval for the gen- saying that he expects pendent panel of outside
against COVID-19. would far outweigh the eral population will require data on whether the com- vaccine advisers, before
Former FDA acting com- benefit." To meet the FDA's significantly more data and pany's candidate works to the agency makes its own
missioner Dr. Stephen Os- threshold, companies will is not expected until mid- be ready in late October. final decision.
troff said the requirements need to submit two months 2021. But a number of variables Last week, seven former
seem reasonable given of follow-up data from half The White House attempt would still have to align for FDA commissioners blasted
the agency is in largely of their trial participants to to block the guidance re- the company to submit, the Trump administration
"uncharted territory" in show there were no ma- lease follows a string of in- and the FDA to review and for "undermining the cred-
terms of considering emer- jor side effects or health stances in which the Trump greenlight, a vaccine ap- ibility" of the agency in a
gency use of a vaccine. problems. Vaccines, unlike administration has under- plication before Nov. 3. Pfiz- Washington Post op-ed
The agency has only previ- drugs, are normally given cut its own medical experts er's competitors Moderna, and called for the release
ously cleared one vaccine to otherwise healthy peo- working to combat the AstraZeneca and Johnson of the stalled vaccine
through the method — a ple, and normally require pandemic. FDA's Hahn has & Johnson are working on guidelines.
decades-old shot that was enhanced documentation been attempting to shore longer research timelines. "Scientists should make de-
authorized to prevent an- of safety. up public confidence in the Vaccine development typ- cisions based on data, un-
thrax poisoning in 2005. Initial doses of vaccines vaccine review process for ically takes years, but the fettered by political pres-
"There really is no margin for emergency use would weeks, vowing that career U.S. government has invest- sure or the intrusions of ide-
for error here," Ostroff said. likely be reserved for medi- scientists, not politicians, will ed billions in efforts to ac- ology or vested interests,"
"Even when you're talking cal workers and people decide if the shots are safe celerate the process and the officials wrote.q

Lawyers: Trump can't use job as a shield in defamation suit

President Donald Trump vice show in the mid-1990s, sonal matters." The move
raped her in a depart- when she now says she en- would put taxpayers on
ment store dressing room countered Trump at a luxu- the hook for any potential
a quarter century ago said ry store. payout in a lawsuit seeking
Monday that he can't hurl "There is not a single person damages and a retraction
insults at her and then cite in the United States — not of the statements.
his job as reason to remove the President and not any- A message was left with
himself as a defendant in a one else — whose job de- a spokesperson for Trump
defamation lawsuit, forcing scription includes slander- lawyer Marc Kasowitz,
taxpayers to pay up if he ing women who they sexu- along with the Justice De-
loses. ally assaulted," the lawyers partment.
"Only in a world gone mad asserted. Attorneys Roberta Kaplan
could it somehow be presi- The Justice Department last and Joshua Matz, repre-
dential, not personal, for month tried to substitute the senting Carroll, asked a
Trump to slander a woman U.S. as the defendant, say- judge to refuse the govern-
President Donald Trump speaks at a campaign rally at Duluth who he sexually assaulted," ing courts have recognized ment's request to replace
International Airport, Wednesday, Sept. 30, 2020, in Duluth, Minn. lawyers wrote in a Manhat- that elected officials "act Trump as a defendant or
Associated Press tan federal court filing on within the scope of their of- force it to prove that de-
behalf of E. Jean Carroll, a fice or employment when faming Carroll three times
By LARRY NEUMEISTER and NEW YORK (AP) — Lawyers media figure who hosted speaking with the press, in- in June 2019 with a "slew of
JENNIFER PELTZ for a woman who claims a daily "Ask E. Jean" ad- cluding with respect to per- lies" was part of his job.q