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u.s. news Diabierna 4 September 2020

White House faces skepticism over prospects for a vaccine

By LINDA A. JOHN- “Too much of the evidence
SON and MICHELLE R. points to the Trump adminis-
SMITH tration pressuring the FDA to
Associated Press approve a vaccine by Election
Could the U.S. really see a Day to boost the president’s
coronavirus vaccine before reelection campaign,” he said
Election Day? in a statement. “This raises
A letter from federal health serious safety concerns about
officials instructing states to politics, not science and pub-
be ready to begin distributing lic health, driving the deci-
a vaccine by Nov. 1 — two sion making process.”
days before the election — Three COVID-19 vaccines
has been met, not with ex- are undergoing final-stage,
hilaration, but with suspicion or Phase 3, clinical trials in
among some public health the U.S. Each study is en-
experts, who wonder wheth- rolling about 30,000 people
er the Trump administration who will get two shots, three
is hyping the possibility or weeks apart, and then will be
intends to rush approval for monitored for coronavirus
political gain. infections and side effects for
The skepticism comes amid anywhere from a week to two
growing questions about the years.
scientific credibility of the The FDA will not be able to
Food and Drug Administra- even consider a vaccine until
tion and the Centers for Dis- White House press secretary Kayleigh McEnany speaks during a press briefing at the White House, certain key steps occur.
ease Control and Prevention, Thursday, Sept. 3, 2020, Washington. First, independent experts
and their vulnerability to Associated Press on what are known as data
political pressure from Presi- safety monitoring boards,
dent Donald Trump. but “extremely unlikely” a 1. Redfield did not say a vac- of Public Health. He said or DSMBs, will have to
Dr. Anthony Fauci, the gov- vaccine will be ready before cine would be ready by then. November “feels awfully ear- rule that they have collected
ernment’s top infectious- the election. Some longtime scientific ly.” Last week, FDA Com- enough information to draw
disease expert and a member White House spokeswoman advisers to the government missioner Stephen Hahn was firm conclusions about a vac-
of Trump’s coronavirus task Kayleigh McEnany, mean- said the CDC’s preparations forced to correct himself af- cine’s performance. Then the
force, told CNN on Thurs- while, gave assurances that for a possible early vaccine ter overstating the lifesaving experts will make the data
day that it is unlikely but “not Trump “will not in any way do not necessarily mean that benefits of the plasma treat- available to the manufacturer,
impossible” that a vaccine sacrifice safety” when it an answer will come sooner ment. which will decide whether to
could win approval in Octo- comes to a vaccine. And ex- or that there will be a rush The CDC also came under submit it for FDA approval.
ber, instead of November or ecutives of five top pharma- to judgment about whether fire from scientists in recent Whether and when to stop a
December, as many experts ceutical companies pledged one works. “Being prepared days for quietly updating its study early is up to a DSMB,
believe. that no COVID-19 vaccines for early success ... is actu- guidelines to suggest fewer whose scientists see a study’s
“And I would assume, and or treatments will be ap- ally prudent,” said Dr. Steven Americans need to get tested results as they are accumulat-
I’m pretty sure, it’s going proved, even for emergency Nissen, a Cleveland Clinic for the virus. ing. The company does not.
to be the case that a vaccine use, without proof they are cardiologist. If a vaccine is Jha said the stakes here are “We will not cut corners,”
would not be approved for safe and effective. working, “you want to be much higher. Pfizer CEO Albert Bourla
the American public unless it The concerns were set off prepared to act on the infor- “You want to have pretty vowed Thursday in a call
was indeed both safe and ef- by a letter dated Aug. 27 in mation.” Still, to some public good safety data on vaccines,” with reporters, hosted by
fective,” he said. which CDC Director Robert health experts, the timing of he said. “So I am deeply wor- a pharmaceutical industry
Similarly, Dr. Moncef Slaoui, Redfield asked the nation’s the letter smacked of a politi- ried that that’s not what is go- group. Chief executives from
chief adviser to Operation governors to help govern- cal stunt by a president facing ing to happen.” Merck, Roche, Eli Lilly and
Warp Speed, the administra- ment contractor McKesson a tough reelection. Senate Democratic leader Gilead Sciences agreed, add-
tion’s project to hasten the Corp. set up vaccine distri- “I think it’s almost a certain- Chuck Schumer questioned ing that extra transparency on
development of a vaccine, bution facilities so that they ty,” said Ashish Jha, dean of the Trump administration’s the test results and approval
told NPR that it is possible are up and running by Nov. the Brown University School motives. process is needed. q

Can I get the coronavirus twice?

By The Associated Press against serious illness even if lieve people who had CO-
Can I get the coronavirus it could not prevent a rein- VID-19 will have some im-
twice? fection. His more recent in- munity against a repeat in-
It seems possible, though fection was detected through fection. But they don’t know
how often it happens isn’t screening and testing at the how much protection, or
known. Hong Kong airport, and re- how long it would last.

Researchers in Hong Kong searchers said genetic tests This is important because if
recently reported evidence of revealed different strains of immunity wears off, it could
a person who got the corona- the virus. pose a challenge for vaccines.
virus a second time, months Several other possible cases Some experts say booster
after an initial infection. have been reported, includ- shots may be needed.
The finding has not yet been ing a U.S. man who was It’s also unclear whether re-
published in a journal. But sicker the second time than infected people would be
scientists said the 33-year- the first. able to spread the virus to This electron microscope image made available and color-
old man had mild symptoms Even if people can get re- others. That’s another reason enhanced by the National Institute of Allergy and Infectious
the first time and none the infected, the World Health scientists say people should Diseases Integrated Research Facility in Fort Detrick, Md.,
second time, suggesting his Organization says it likely continue to wear masks, so- shows Novel Coronavirus SARS-CoV-2 virus particles, orange,
immune system may have wouldn’t happen regularly. cial distance and practice isolated from a patient.
provided some protection Health experts generally be- good hygiene.q Associated Press