The Long Darkness Before Dawn
With vaccines and a new administration, the pandemic
will be tamed. But experts say the coming months “are going to be just
horrible.”
Some epidemiologists predict that the death toll from
Covid-19 could be close to twice the 250,000 figure that the nation surpassed
last week.
Donald G.
McNeil Jr.
By Donald
G. McNeil Jr.
Nov. 30,
2020
https://www.nytimes.com/2020/11/30/health/coronavirus-vaccines-treatments.html?action=click&module=Top%20Stories&pgtype=Homepage
Each week,
good news about vaccines or antibody treatments surfaces, offering hope that an
end to the pandemic is at hand.
And yet
this holiday season presents a grim reckoning. The United States has reached an
appalling milestone: more than one million new coronavirus cases every week.
Hospitals in some states are full to bursting. The number of deaths is rising
and seems on track to easily surpass the 2,200-a-day average in the spring,
when the pandemic was concentrated in the New York metropolitan area.
Our failure
to protect ourselves has caught up to us.
The nation
now must endure a critical period of transition, one that threatens to last far
too long, as we set aside justifiable optimism about next spring and confront
the dark winter ahead. Some epidemiologists predict that the death toll by
March could be close to twice the 250,000 figure that the nation surpassed only
last week.
“The next
three months are going to be just horrible,” said Dr. Ashish Jha, dean of Brown
University’s School of Public Health and one of two dozen experts interviewed
by The New York Times about the near future.
This
juncture, perhaps more than any to date, exposes the deep political divisions
that have allowed the pandemic to take root and bloom, and that will determine
the depth of the winter ahead. Even as the Centers for Disease Control and Prevention
urged Americans to avoid holiday travel and many health officials asked
families to cancel big gatherings, more than six million Americans took flights
during Thanksgiving week, which is about 40 percent of last year’s air traffic.
And President Trump, the one person most capable of altering the trajectory
between now and spring, seems unwilling to help his successor do what must be
done to save the lives of tens of thousands of Americans.
President-elect
Joseph R. Biden Jr. has assembled excellent advisers and a sensible plan for
tackling the pandemic, public health experts said. But Mitchell Warren, the
founder of AVAC, an AIDS advocacy group that focuses on several diseases, said
Mr. Biden’s hands appeared tied until Inauguration Day on Jan. 20: “There’s not
a ton of power in being president-elect.”
By late
December, the first doses of vaccine may be available to Americans, federal
officials have said. Priorities are still being set, but vaccinations are
expected to go first to health care workers, nursing home residents and others
at highest risk. How long it will take to reach younger Americans depends on
many factors, including how many vaccines are approved and how fast they can be
made.
In
mid-October, I surprised some New York Times readers by shifting from pessimism
to optimism, with the epidemic in the United States most likely ending sooner
than I expected. Now that at least two vaccines with efficacy greater than 90
percent have emerged, I am even more hopeful about what 2021 holds.
But even as
the medical response to the virus is improving, the politics of public health
remain a deeply vexing challenge.
The regions
of the country now among those hit hardest by the virus — Midwestern and
Mountain States and rural counties, including in the Dakotas, Iowa, Nebraska
and Wyoming — are the ones that voted heavily for Mr. Trump in the recent
election. The president could help save his millions of supporters by urging
them to wear masks, avoid crowds and skip holiday gatherings this year. But that
seemed unlikely to occur, many health experts said.
“That is
outside of his DNA,” said Dr. William Schaffner, a preventive medicine
specialist at Vanderbilt University medical school. “It would mean admitting he
was wrong and Tony Fauci was right.”
In a bitter
paradox, some experts noted, Mr. Trump could have been the hero of this
pandemic. Operation Warp Speed, which his administration announced in May,
appears on track to deliver vaccines and therapies in record-breaking time. The
United States may well become the first country to bring the virus to heel
through pharmaceutical prowess.
Had Mr.
Trump heeded his medical advisers in late spring and adopted measures to curb
new infections, the nation could now be on track to exit the epidemic next year
with far fewer deaths per capita than many other nations.
But during
his campaign, Mr. Trump spent little time explaining the importance of
Operation Warp Speed; it has invested more than $12 billion in six vaccines
based on three complex new technologies, as well as antibody therapies with
nearly unpronounceable names like bamlanivimab.
Some health
experts expressed concern that Mr. Trump might continue to undermine the
coronavirus effort after he leaves office, by contradicting and diminishing any
measure proposed by Mr. Biden.
“The
thinking over here,” said Dr. David L. Heyman, a former C.D.C. official who now
oversees the Center on Global Health Security at Chatham House in London, “is
that he will continue to harass the White House to mobilize his people for 2024
for himself or his daughter or sons.”
The fight
over masks
The
antidote to hopelessness is agency, and Americans can protect themselves even
without Mr. Trump’s advice by wearing masks and keeping their distance from
others.
Reluctant
officials are finally coming around to ordering such measures. The governors of
Iowa and New Hampshire issued mask mandates for the first time in mid-November;
the governors of Kansas, North Carolina and Hawaii strengthened theirs. But
average Americans are sharply divided over masks.
“There is
pretty broad support for mask mandates even among Republicans,” said Martha
Louise Lincoln, a medical historian at San Francisco State University. “But
among extreme right-wing voters there’s still a perception that they’re a sign
of weakness or a symbol of being duped.”
The Centers
for Disease Control and Prevention issued new guidelines on Nov. 10, advocating
more clearly than before that everyone, infected or healthy, should wear a
mask.
Various
studies, involving machines puffing fine mists, have shown that high-quality
masks can significantly reduce the spread of pathogens between people in
conversation.
And the
common-sense evidence that masks work has become overwhelming. Dozens of
“superspreader events” have taken place in venues where most people were not
masked — in bars and restaurants, at summer camps, at funerals, on airplanes,
in churches, at choir practice.
In
contrast, none have been known to occur in venues where most people wore masks,
such as grocery stores. One well-known C.D.C. study showed that, even in a
Springfield, Mo., hair salon where two stylists were infected, not one of the
139 customers whose hair they cut over the course of 10 days caught the disease.
A city health order had required that both the stylists and the customers be
masked.
Even in the
most dangerous environments — hospital emergency rooms — there have been no
reported superspreader events since personal protective gear became widely
available. (Many individual doctors and nurses have been infected, however; an
incident in South Bend, Ind., in which multiple nurses were infected turned out
to be related to a wedding.)
By
contrast, the White House, where masks have been shunned, has been the scene of
at least one, and possibly more superspreader events.
A study by
the Institute for Health Metrics and Evaluation at the University of Washington
estimated that 130,000 lives could be saved by February if mask use became
universal in the United States immediately. Masks can also preserve the
economy: A study by Goldman Sachs estimated that universal use would save $1
trillion that may be lost to business shutdowns and medical bills.
A new year,
and new health advice
Mr. Biden
has said that he intends to tackle the pandemic from his first full day in
office, on Jan. 21. But because coronavirus deaths follow new cases by some
weeks, any results of his actions may not be apparent before early spring.
The experts
generally praised the panel of advisers chosen by Mr. Biden, depicting them as
reputable scientists who could credibly reach out to many groups hard-hit by
the pandemic, including Black and Hispanic Americans.
But several
experts, some of whom spoke anonymously to avoid offending friends and
colleagues, said the panel needed different skills and a different kind of
balance.
Some felt
that it should have more scientific expertise, and suggested recruiting more vaccinologists,
such as Dr. Paul A. Offit of Children’s Hospital of Philadelphia, and more
epidemiologists, such as Harvard’s Marc Lipsitch and Natalie E. Dean of the
University of Florida.
Others said
the panel needed more behavioral scientists adept at fighting rumors, which
have been a major obstacle.
“We’re
facing extremely complex and poorly understood dynamics around disinformation,
conspiratorial theories, paranoia and mistrust,” Dr. Lincoln noted.
Among the
suggested names with those skills were Heidi J. Larson of the Vaccine
Confidence Project in London, Carl T. Bergstrom of the University of Washington
and Zeynep Tufekci of the University of North Carolina.
Others said
the panel had too many members tied to the Obama-Biden administration. Dr.
Ezekiel J. Emanuel, for example, was an architect of the Affordable Care Act
and Dr. Eric Goosby was Mr. Obama’s global AIDS coordinator. To reach Mr.
Trump’s base, they said, the panel needs credible Republican experts.
“Otherwise,”
said Dr. Leana Wen, a former Baltimore health commissioner, “there will be even
more of a mistaken perception that this is Democrats and doctors trying to shut
down the economy, when actually controlling the virus is key to economic
recovery.”
Experts
suggested adding Dr. Bill Frist, a transplant surgeon and former Republican
senator, or Dr. Marc K. Siegel, an internist and Fox News opinion writer.
Mr. Warren
suggested consulting marketing experts and recruiting “everyone from Santa
Claus to LeBron James” as trusted spokesmen.
Another
expert suggested adding Dr. Mehmet C. Oz, a heart surgeon and television
personality who was criticized for promoting hydroxychloroquine on Fox News (he
later relented), and possibly even asking Sean Hannity and Tucker Carlson to
join, because they are popular with Mr. Trump’s base and might be persuaded to
accept science that would save the lives of their own viewers.
Mr. Biden’s
plan
Mr. Biden’s
plan for tackling the pandemic is outlined on his website.
It calls
for far more widespread testing, delivered free; a ban on out-of-pocket costs
for medical care for the virus; having the military build temporary hospitals
if necessary; cooperation with American businesses to create more personal
protective gear and ventilators; more food relief for the poor, and other
measures.
The Road to
a Coronavirus Vaccine
Words to
Know About Vaccines
Confused
by the all technical terms used to describe how vaccines work and are
investigated? Let us help:
- Adverse
event: A health problem that crops up in volunteers in a clinical trial of a
vaccine or a drug. An adverse event isn’t always caused by the treatment tested
in the trial.
- Antibody:
A protein produced by the immune system that can attach to a pathogen such as
the coronavirus and stop it from infecting cells.
- Approval,
licensure and emergency use authorization: Drugs, vaccines and medical devices
cannot be sold in the United States without gaining approval from the Food and
Drug Administration, also known as licensure. After a company submits the
results of clinical trials to the F.D.A.
for consideration, the agency decides whether the product is safe and
effective, a process that generally takes many months. If the country is facing
an emergency — like a pandemic — a company may apply instead for an emergency
use authorization, which can be granted considerably faster.
- Background
rate: How often a health problem, known as an adverse event, arises in the
general population. To determine if a vaccine or a drug is safe, researchers
compare the rate of adverse events in a trial to the background rate.
- Efficacy:
A measurement of how effective a treatment was in a clinical trial. To test a
coronavirus vaccine, for instance, researchers compare how many people in the
vaccinated and placebo groups get Covid-19. The real-world effectiveness of a
vaccine may turn out to be different from its efficacy in a trial.
- Phase 1,
2, and 3 trials: Clinical trials typically take place in three stages. Phase 1
trials usually involve a few dozen people and are designed to observe whether a
vaccine or drug is safe. Phase 2 trials, involving hundreds of people, allow
researchers to try out different doses and gather more measurements about the
vaccine’s effects on the immune system. Phase 3 trials, involving thousands or
tens of thousands of volunteers, determine the safety and efficacy of the
vaccine or drug by waiting to see how many people are protected from the
disease it’s designed to fight.
- Placebo:
A substance that has no therapeutic effect, often used in a clinical trial. To
see if a vaccine can prevent Covid-19, for example, researchers may inject the vaccine
into half of their volunteers, while the other half get a placebo of salt
water. They can then compare how many people in each group get infected.
- Post-market
surveillance: The monitoring that takes place after a vaccine or drug has been
approved and is regularly prescribed by doctors. This surveillance typically
confirms that the treatment is safe. On rare occasions, it detects side effects
in certain groups of people that were missed during clinical trials.
- Preclinical
research: Studies that take place before the start of a clinical trial,
typically involving experiments where a treatment is tested on cells or in
animals.
- Viral
vector vaccines: A type of vaccine that uses a harmless virus to chauffeur
immune-system-stimulating ingredients into the human body. Viral vectors are
used in several experimental Covid-19 vaccines, including those developed by
AstraZeneca and Johnson & Johnson. Both of these companies are using a
common cold virus called an adenovirus as their vector. The adenovirus carries
coronavirus genes.
- Trial
protocol: A series of procedures to be carried out during a clinical trial.
-
Mr. Biden
has said he supports a national mask mandate, although his plan calls on
governors to impose state ones.
All the
experts interviewed by The Times praised the plan, but several felt it was not
aggressive enough. The pandemic is raging so far beyond control, they argued,
that it can be contained only with deeply unpopular but necessary measures,
such as rigorously enforced mask laws, closing bars and restaurants, requiring
regular testing in schools and workplaces, isolating the infected away from
their families, prohibiting travel from high-prevalence areas to low ones, and
imposing quarantines that are enforced rather than merely requested.
Many other
countries have imposed such measures despite fierce opposition from some
citizens, they said, and they have helped.
“Colleges
are the Wuhans of this fall surge,” said Dr. Howard Markel, a medical historian
at the University of Michigan’s medical school. Universities, he and other
experts said, must stop students from going back and forth between their
hometowns and college towns, both of which have many vulnerable residents.
The key to
enforcing mask laws, noted Dr. Robert Klitzman, a psychiatrist and bioethicist
at Columbia University’s Mailman School of Public Health, is to punish not
people but the owners of buildings that ignore restrictions; Quebec, he noted,
fines stores $4,500 if customers are unmasked.
But after a
very divisive election, other experts said, it will be hard to get many
Americans to cooperate, especially if Mr. Trump encourages resistance.
Also, there
are legal limits on what the federal government can do. American “sanitary
codes” and quarantine laws are overwhelmingly based on state and local powers,
many of which were granted in the 19th century, when epidemics constantly swept
the nation’s cities. The federal government’s powers generally extend to
interstate matters.
So, for
instance, while the Biden administration could easily make it a federal crime
to refuse to wear a mask on a cross-country flight — or put offenders on the
“no fly list” that was created after the Sept. 11, 2001, attack on the World
Trade Center — it probably cannot make every resident of South Dakota wear a
mask if Gov. Kristi Noem and the State Legislature oppose the measure. Ms. Noem
has said that she will not enforce mask mandates or lockdowns even if Mr.
Biden, as president, orders them.
The hope
for vaccines
A mural
honoring health care professionals and other essential workers by artists from
the HomeGrowNM Trading Post in Albuquerque.Credit...Adria Malcolm for The New
York Times
The health
experts interviewed by The Times all expressed excitement that the
Pfizer/BioNTech and Moderna vaccines were reported to be 95 percent effective
with no serious safety problems. On Nov. 23, a third vaccine, from AstraZeneca,
also appeared to be effective, although exactly how effective is disputed.
“This is an
amazing feat of science we’ve just seen, to go from a gene sequence on Jan. 10
to a vaccine by Nov. 10,” said Dr. Lawrence Corey, who is harmonizing disparate
vaccine trials so their results can be easily compared.
However,
experts still want to read the data, not just what Dr. Offit called “science by
news release.”
(Pharmaceutical
companies often wait until they have publishable data before announcing
clinical trial results. But when news is likely to jolt a stock’s price, it is
released immediately to reduce the chance of anyone connected to the company
engaging in insider trading, or even appearing to.)
Mr. Biden
will inherit the fruits of Operation Warp Speed and oversee their distribution.
Members of his transition team, speaking anonymously because they were not
authorized to reveal its deliberations, said they were already discussing two
sensitive topics: whether to create a secure way for vaccinated individuals to
prove they have received both shots, and whether Covid vaccines should
ultimately be made mandatory — either by the federal government, or by state
governments, employers, school systems or the like.
Making
vaccines mandatory may be a political struggle, but it is within the scope of
American law. In 1905, in a landmark case, Jacobson v. Massachusetts, the
Supreme Court upheld the right of a state government to make smallpox
vaccination mandatory, on the grounds that it protected the public health —
despite the fact that the crude smallpox vaccines of that era could cause
severe side effects in some people.
It is also
within American religious tradition. Virtually every major religion has held
that vaccines are permitted, and some even hold that their members are obliged
to be vaccinated for the common good.
Some
experts not on the committee were adamant that, once Covid vaccines are proven
to be both effective and safe, they should be made obligatory.
Dr. W. Ian
Lipkin, director of the Center for Infection and Immunity at Columbia
University’s Mailman School of Public Health, noted that his institution
already has mandatory testing for all students and staff. He said that
companies he advises would like to eventually make vaccination mandatory for
all employees, but would prefer the government took the lead by requiring them.
At Dr.
Offit’s pediatric hospital, every member must have had all routine vaccines and
get an annual flu shot — or face dismissal.
“It’s not
optional,” he said. “You’re taking care of children. And yes, down the line, I
think vaccination will have to be mandatory. It’s your responsibility as a
citizen.”
The next
dozen weeks will be long and painful. But spring is likely to bring highly
effective vaccines and a renewed commitment to medical leadership, something
that has been missing under Mr. Trump.
“The C.D.C.
will have to be rebuilt, and its guidelines and the F.D.A.’s have to be
promptly re-evaluated,” said Dr. Robert L. Murphy, director of the Institute
for Global Health at Northwestern University’s medical school. “The Biden team
will move quickly. It’s not like they don’t know what to do.”
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Donald G.
McNeil Jr. is a science reporter covering epidemics and diseases of the world’s
poor. He joined The Times in 1976, has reported from 60 countries and is a
winner of the John Chancellor Award.
