Respond to prefers-color-scheme dark in app web views

Follow section front redirects in Spectrum

Enable NLP source in PCS for load testing

Switch off the News Alerts Survey Widget when we have enough responses

Poll to determine if new LUF updates are available

Allows the winning A/B test variant to be turned on without Spectrum deployment

Show infinite scrolling sections in Assembler MultiView

Show option for NLP article summaries in Action Bar

A general feature flag for Recipe Features that aren't yet released

Feature flag for media team features that aren't yet released

Use new Orca video player for preroll plugin in Spectrum

Show the snow tracker (instead of the heat tracker) on Spectrum

On Press Freedom Day, little to celebrate for Hong Kong’s journalists

Young Georgians want to be part of Europe. Their government is in the way.

Taxes are inevitable. Paying to prepare them doesn’t have to be.

The dangerous new call for regime change in Beijing

Ukrainian men abroad voice anger over pressure to return home to fight 

U.K. local election results could spell doom for Conservative Party

You asked: Do I need a passport for my cruise?

What’s the best bus to New York? We tested 5 for comfort and value.

Adaptive equipment is making national parks more inclusive

An I bond is now at 4.28 percent. Are they still a good deal?

Use these 6 points to say no to a college you and your kid can’t afford

How this new rule protects retirement savers from costly advice

This is the technology we’re loving right now

NASA moon capsule suffered extensive damage during 2022 test flight

Microsoft is changing how you log in to your accounts

Teen grabs wheel when driver passes out and school bus veers into traffic

Cat climbed into Amazon return box, found alive 630 miles away

I learned to heal my sadness by cradling dying chickens 

Miss Manners: Host eats luxurious breakfast, leaves cereal for guest

Ask Amy: Should I be the best man if I think the bride is abusive?

Carolyn Hax: Husband keeps pushing modest spouse to wear sexier clothes

Is Pastis as good as our food critic thought? He sent spies to find out.

Trevor Williams’s escape act helps Nationals blank Rangers 

Nationals can’t solve Nate Eovaldi, drop series finale to Rangers

Hope Hicks witnessed nearly every Trump scandal. Now she must testify.

Elections 2024 latest news: Biden to honor distinguished Americans; Trump back in N.Y. court

To the Gaza protesters helping to elect Trump: Give it a rest

The New York Times, alone in its outrage over access to Biden

Wait, what is Stephen A. Smith talking about? Find out with our quiz.

Stephen A. Smith would like even more of your attention

Riot police and over 2,000 arrests: A look at 2 weeks of campus protests

Hope on the horizon | The Trump Trials: Sidebar

Police break into UCLA encampment

Trump

Health

Well+Being

Opinions

Higher Education

Education

https://www.washingtonpost.com/coronavirus/

Coronavirus pandemic

Melina Mara

The Washington Post is providing this news free to all readers as a public service. Follow this story and more by <a href='https://www.washingtonpost.com/newsletters/health-science-environment-alerts/?method=SURL&location=ART&initiative=FREE'>signing up for health, science, and environment email alerts</a>.

The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.

The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated<a href="https://www.washingtonpost.com/politics/2020/09/16/trumps-messy-attempt-clean-up-unwelcome-coronavirus-vaccine-news/"> predictions</a> of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.

The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center <a href="https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine" target=_blank>recently reported</a> that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.

The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that made missteps during the pandemic. While it is being reviewed by the White House Office of Management and Budget, elements of it are already being shared with vaccine makers. Under it, the FDA would ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two people familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.

As a sign the vaccine works, the agency also is likely to look for at least five severe cases of covid-19, the disease caused by the novel coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people. These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable any vaccine will be authorized before the election. The agency has previously said any vaccine would have to be 50 percent more effective than a placebo.

“It’s hard to imagine how an [emergency use authorization] could possibly occur before December,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines.

Get a free briefing on the latest pandemic developments in your inbox with our Coronavirus Updates newsletter

Moderna and Pfizer began their trials on <a href="https://www.washingtonpost.com/health/2020/07/27/moderna-nih-launch-30000-person-trial-coronavirus-vaccine/">July 27</a>, and took <a href="https://www.washingtonpost.com/health/2020/08/27/large-us-covid-19-vaccine-trials-are-halfway-enrolled-lag-participant-diversity/">about a month</a> to enroll 15,000 people, the halfway point for their planned enrollment of 30,000 people. The trials are designed for people to receive their second shot either three or four weeks later. Two months of follow-up would make it unlikely the companies would have enough data before mid-November.

The FDA, in a statement, noted the agency had previously said it would issue additional guidance on what it will seek for an emergency clearance.

The new guidance is just one way of trying to shore up confidence in the agency. FDA allies, intent on building trust, are also spotlighting agency career scientists, noting that the one overseeing the vaccine-approval process has threatened to quit if he is pressured to greenlight a vaccine before he is convinced it is safe and effective.

But, administration critics note, such efforts are undercut on an almost daily basis by overly rosy and contradictory comments by Trump and continued revelations about administration actions to <a href="https://www.washingtonpost.com/politics/trump-redfield-vaccine-timetable/2020/09/17/155ce8ce-f90f-11ea-a275-1a2c2d36e1f1_story.html" target="_blank">strong-arm government scientists</a> and regulators and curb their independence.

In addition, the FDA guidance is unlikely to satisfy some critics, who say the agency should not use an emergency authorization for a vaccine at all.

“Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.”

Are you participating in a trial for a coronavirus vaccine or treatment? The Washington Post wants to hear from you.

Just last week, concerns about the FDA’s autonomy deepened after Alex Azar, the secretary of health and human services, <a href="https://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html?searchResultPosition=1" target=_blank>revoked its authority</a>, and that of other HHS agencies, to sign new regulations, reserving that power for himself. In <a href="https://www.hhs.gov/about/news/2020/09/20/hhs-statement-on-regulatory-process.html" target=_blank>a statement issued late Sunday</a>, HHS said the change “minimizes litigation risk … prevents potential future abuse of authority, and is consistent with congressional intent.” It said the move, made after a department review of rulemaking procedures, won’t affect the FDA’s work on vaccines and covid-19 treatments.

Demetrius Freeman

Still, several FDA experts criticized the timing in the fraught run-up to a vaccine-approval decision. “Why take this health decision-making away from public health agencies like FDA at this particular moment?” said Patricia Zettler, an Ohio State University law professor and former associate chief counsel at the FDA.

Public confidence also has been eroded by efforts by a top HHS political appointee, now on leave, and his adviser <a href="https://www.washingtonpost.com/health/2020/09/12/trump-control-over-cdc-reports/" target=_blank>to silence a top official at the Centers for Disease Control and Prevention</a> who stressed the seriousness of the novel <a href="https://www.washingtonpost.com/health/2020/02/28/what-you-need-know-about-coronavirus/?itid=lk_inline_manual_2">coronavirus</a> and to change and delay the CDC’s regular scientific missives, the Morbidity and Mortality Weekly Reports, if they deviated from the president’s upbeat message. Concerns about the CDC were ratcheted up in recent days when the agency posted, then removed, language from its website that said the <a href="https://www.washingtonpost.com/coronavirus/?itid=lk_inline_manual_2">coronavirus</a> spreads via airborne transmission, the latest example of it backtracking on its own guidance. The agency said the guidance was an early draft posted by mistake.

FDA officials have indicated that if the vaccine data on safety and efficacy are strong, it will consider issuing an emergency use authorization — a temporary approval that can be granted much more quickly and with less documentation than a full approval, which could take six to nine months. The only other time the FDA has authorized a vaccine on an emergency basis was in 2005, when it cleared the anthrax vaccine for military personnel considered at high risk of an anthrax attack.

Pfizer said in a statement Tuesday that it still projects having data on the effectiveness of its vaccine by the end of October, if things go well, and will collect safety data for two years. Moderna has said it is unlikely to have data in October. AstraZeneca’s trial in the United States is halted while investigators try to determine whether a serious neurological problem in one participant in Britain was caused by the vaccine.

The FDA, in the new guidance, is expected to require data for an emergency authorization that is close to that required for a full approval, according to recent comments by officials. That’s a higher bar than is typical for such an authorization, which requires only that a product “may be effective” and that the likely benefits outweigh the harms. The tougher standard is appropriate, officials have said, because a vaccine is given to healthy people, not to those who are ill.

The agency has acknowledged any emergency authorization would be based on less safety data than would be the case for a regular approval. For that reason, it has said it will require clinical trial participants to be followed for a significant length of time in case they develop problems later.

The FDA’s use of emergency authorizations is shadowed by what critics describe as the botched hydroxychloroquine and <a href="https://www.washingtonpost.com/health/2020/08/24/some-administration-claims-effectiveness-convalescent-plasma-are-wrong-or-dubious-scientists-say/" target="_blank">plasma episodes</a>. In March, the agency authorized the use of the old malaria drug touted by Trump as a treatment for covid-19, only to withdraw it when studies showed the drug did not help and posed safety risks for some.

Then, on Aug. 23, FDA Commissioner Stephen Hahn drastically exaggerated the benefits of convalescent plasma at a briefing with Trump and Azar. He subsequently apologized, but Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania, said the question remains: “Is the president going to put the screws to the FDA so much that they will speed ahead on a vaccine?”

Rachel Sachs, a law professor at Washington University at St. Louis, noted there are concerns that Azar, who has the legal authority to approve drugs, might overrule the FDA if it rejected a vaccine. She said such a move was unlikely and would guarantee many people would refuse to be vaccinated.

Brian Harrison, Azar’s chief of staff, said the idea the secretary would greenlight a vaccine over FDA objections was “preposterous and betrays ignorance of the transparent process” the administration is following to develop and review vaccines.

Because of the toxic political environment, the FDA will need the support of respected health leaders and scientists from inside and outside the government for a vaccine decision to be accepted by the public, said Daniel Carpenter, a Harvard University professor of government. Experts such as Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, could strongly influence public opinion with his endorsement, he said.

An array of outsiders is already trying to bolster FDA career officials, through webinars, <a href="https://www.wsj.com/articles/you-can-trust-the-fdas-vaccine-process-11600633351?mod=searchresults&page=1&pos=3" target=_blank>op-eds </a>and podcasts. The supporters include advocacy groups, drug-industry officials, bioethicists and a bipartisan group of former commissioners — Mark McClellan, FDA chief during the George W. Bush administration; Obama administration commissioners Margaret Hamburg and Robert Califf; and Scott Gottlieb, Trump’s first FDA commissioner.

“The four of us feel this is the time for us to step forward,” Califf said. “We don’t speak jointly often, but when we do, it signals an important issue that deserves attention.”

The career staff, said Ellen Sigal, founder and chairwoman of Friends of Cancer Research, which works closely with the FDA, “are the very people that we should trust to make these decisions.” Hahn recently said on Twitter he has “unwavering confidence” in the FDA professional staff.

The FDA career staff itself is trying to reassure the public. In a highly unusual move, Peter Marks, the head of the center that oversees vaccine regulation, and seven other senior career officials vowed in <a href="https://www.usatoday.com/story/opinion/2020/09/10/sound-science-to-meet-covid-challenges-fda-career-officials-column/5756948002/" target=_blank>a column </a>to maintain “independence to ensure the best possible outcomes for public health.”

The agency also has pledged to take any vaccine data to its panel of outside advisers, called the <a href="https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee" target=_blank>Vaccines and Related Biological Products Advisory Committee</a>, before making decisions. The agency has scheduled a public meeting of the panel for Oct. 22 and said others sessions can be held as needed, depending on when data is available.

But some FDA watchers say those steps are not enough and that the agency should forswear use of an emergency authorization for a vaccine.

“If we don’t get this right, we’ll see a deep corrosion of trust over the long term — and that will be the darkest legacy for a post-covid world,” said Lawrence Gostin, a public health expert at Georgetown University’s law school.

Eric Topol, founder and director of Scripps Research Translational Institute, opposes using an emergency authorization in the next several weeks or months. “We are not in a high-trust mode, and the last thing you want to do is take a short cut and put everything at risk,” he said. He said the agency should not consider such an authorization until at least early next year to ensure it has adequate safety data.

Others say the authorization option must be kept on the table at a time when thousands of people a week are dying from the virus. They note the vaccine probably will be authorized initially only for select, high-risk groups, such as health-care workers and the elderly, while more data is gathered.

“If there is definitive evidence of efficacy and no significant signal of toxicity or lack of safety, withholding authorization would be an equal sin on the other side,” said Califf. 

<a href="https://www.washingtonpost.com/health/2020/09/09/astrazeneca-vaccine-trial-halt-faq/" target=_blank>Why the AstraZeneca trial for a coronavirus vaccine was put on hold </a>

<a href="https://www.washingtonpost.com/health/2020/07/26/trial-coronavirus-vaccine-researchers-making-sure-black-hispanic-communities-are-included-studies/" target="_blank">Making sure Black and Hispanic communities are included in vaccine clinical trials </a>

<a href="https://www.washingtonpost.com/health/2020/09/16/coronavirus-dementia-alzheimers-deaths/?arc404=true" target=_blank>Pandemic isolation has killed thousands of Alzheimer’s patients while families watch from afar </a>

Part of Wall Street Journal team that won the 1997 Pulitzer Prize for national reporting on AIDS 

Syracuse University, BS in journalism

Laurie McGinley covers health and medicine for The Washington Post. She focuses on the Food and Drug Administration as well as cancer research and treatment. She was previously The Post's health, science and environment editor. 

Laurie McGinley

Finalist for the 2013 Pulitzer Prize in national reporting, as part of a team

Amherst College, BA in Physics and English

MIT, MS in Science Writing

Carolyn Johnson is a science reporter. She previously covered the business of health and the affordability of health care to consumers. 

Carolyn Y. Johnson

washpost

the-washington-post

Coronavirus Pandemic California

The Washington Post

staff

U.S. cases and deaths by state

World map

New CDC guidance

When am I still contagious?

The people who never get covid

Coronavirus

iptc-media/health

iptc-media/health/diseases_and_conditions/illness

iptc-media/economy_business_and_finance/economic_sector/chemicals

iptc-media/health/health_treatment

iptc-media/health/diseases_and_conditions/communicable_disease/virus_disease/retrovirus

iptc-media/science_and_technology/biomedical_science

iptc-media/economy_business_and_finance

iptc-media/health/health_treatment/preventative_medicine

iptc-media/science_and_technology

iptc-media/science_and_technology/research

iptc-media/health/diseases_and_conditions/communicable_disease/virus_disease

iptc-media/economy_business_and_finance/economic_sector/chemicals/pharmaceutical

iptc-media/health/healthcare_policy/government_health_care

iptc-media/health/healthcare_policy

iptc-media/health/health_treatment/medicine

iptc-media/science_and_technology/research/medical_research

iptc-media/science_and_technology/biomedical_science/pharmacology

iptc-media/health/health_treatment/preventative_medicine/vaccines

iptc-media/health/diseases_and_conditions/communicable_disease

iptc-media/health/diseases_and_conditions

client-blocklists/Client List: Morgan Stanley KWs - INCLUDES ANY

client-blocklists/Amazon KWs - EXCLUDE ALL 

client-blocklists/Client List: Becton Dickinson KWs - EXCLUDES ALL

client-blocklists/CLIENT LIST: Nomura KWs 2021 - EXCLUDES ALL

client-blocklists/Boeing KWs 2021- INCLUDE ANY

client-blocklists/Client List: Exxon Mobil  - INCLUDES ANY

client-blocklists/GEICO KWs - INCLUDES ANY_4.26.21

client-blocklists/Client List: T. Rowe Price KWs - EXCLUDES ALL

client-blocklists/Client List: Microsoft KWs 2 - INCLUDES ANY

client-blocklists/T. Rowe Price KWs - EXCLUDES ALL

advertising/B2_Lobbying and Advocacy_legacyaux_tu4

client-blocklists/HBO KWs - INCLUDES ANY

client-blocklists/Ford/Lincoln KWs - INCLUDES ANY

client-blocklists/ExxonMobil 03312021 KWs - INCLUDES ALL

client-blocklists/Bank of America KWs - EXCLUDES ALL

advertising/Flu, Sickness & Virus Content

client-blocklists/WaPo: Combined Disaster Keyword List - INCLUDES ANY

advertising/Coronavirus Content

client-blocklists/Client List: Navy Federal Credit Union NFCU KWs 2 - EXCLUDES ALL - 12.23.20

advertising/B2_Cancer_legacyaux_7f3

client-blocklists/Client List: Eli Lily KWs - INCLUDES ANY

advertising/B2_Culture and Tradition_legacyaux_kfx

advertising/B2_Data Center Buyer_legacyaux_80A

client-blocklists/Client List: Purina KWs - INCLUDES ANY

advertising/Citrix Mindfulness

advertising/B2_Government & Policy_legacyaux_mza

advertising/B2_Health and Beauty_legacyaux_3fv

advertising/B2_Health Care Policy Enthusiast_legacyaux_7ny

advertising/B2_Health_legacyaux_q5h

advertising/Client Keywords: On Running

client-blocklists/BP KWs - INCLUDES ANY

client-blocklists/ CLIENT LIST: AT&T KWs 2021 - EXCLUDES ALL

advertising/B2_Medical_legacyaux_a4w

advertising/B2_Policy and Regulation_legacyaux_qe2

advertising/B2_Politically Active - DO NOT REMOVE_legacyaux_lmp

advertising/B2_Politics and Policy_legacyaux_pay

advertising/B2_Positive News_legacyaux_hlt

advertising/B2_President and Administration_legacyaux_kxq

advertising/B2_Retirement Planners 2.12.15_legacyaux_k9i

advertising/B2_Science, Health & Technology_legacyaux_wkq

advertising/B2_Society_legacyaux_0cz

advertising/B2_STEM Enthusiasts_legacyaux_gx0

advertising/B2_Young Professional / International Businessman_legacyaux_r5x

client-blocklists/Client List: KPMG KWs - EXCLUDES ALL

client-blocklists/Client List: Navy Federal Credit Union NFCU KWs - EXCLUDES ALL

client-blocklists/Client List: Verizon KWs - EXCLUDES ALL

client-blocklists/Client List: Novo Nordisk KWs - EXCLUDES ALL

client-blocklists/Client List: Siemens KWs - EXCLUDES ALL

client-blocklists/Client List: Cisco KWs - INCLUDES ANY

client-blocklists/Client List: Capital Concerts KWs - EXCLUDES ALL

client-blocklists/Client List: AT&T ALT KWs - EXCLUDES ALL

client-blocklists/Mercedes KWs - INCLUDES ANY

client-blocklists/FX Excludes All Disney

client-blocklists/Client List: Inpixon KWs - INCLUDES ANY

client-blocklists/Client List: Boeing KWs - INCLUDES ANY

client-blocklists/Client List: Aetna KWs - EXCLUDES ALL

client-blocklists/Client List: Google KWs - INCLUDES ALL

client-blocklists/Philip Morris KWs - INCLUDES ANY 

client-blocklists/Capital One KWs 2 - INCLUDES ANY - 1.4.21

client-blocklists/Bank of America Merrill Lynch KWs - INCLUDES ANY

client-blocklists/CME KWs - EXCLUDES ALL

client-blocklists/Google PG KWs - INCLUDES ANY

client-blocklists/Chase KWs - EXCLUDES ALL

client-blocklists/Client List: Office Depot KWs - INCLUDES ANY

client-blocklists/Client List: ETrade KWs - EXCLUDES ALL

prism://prism.query/site,/health&limit=20

The Washington Post health section provides coverage and analysis of health, healthcare, nutrition and fitness news.