U.S., European COVID vaccine developers pledge to uphold testing rigor

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

The companies said in a statement they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

The other signatories were Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi and BioNTech.

The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.

This prompted a call for caution from the World Health Organization (WHO).

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.

The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY AND EFFICACY

“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.

“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter U.S. politics before the Nov. 3 presidential election.

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

The development race has intensified safety concerns about an inoculation, polls have shown.

Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

“What Russia did – and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.

“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”

Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton and Timothy Heritage)

WHO’s Tedros says ‘vaccine nationalism’ would prolong pandemic

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.

Tedros said 78 high-income countries had now joined the “COVAX” global vaccine allocation plan, bringing the total to 170 countries, and the “number is growing”. He urged others to join by the Sept. 18 deadline for binding commitments.

Joining the plan guaranteed those countries access to the world’s largest portfolio of vaccines, with nine candidates currently in the pipeline, he said, adding that a further four were “promising”.

The WHO and the GAVI vaccine alliance are leading the COVAX facility, aimed at helping buy and distribute vaccination shots fairly around the world.

But some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

“Vaccine nationalism will prolong the pandemic, not shorten it,” Tedros told a WHO briefing in Geneva, without mentioning any specific countries.

“If and when we have an effective vaccine, we must also use it effectively … In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said, adding that priority should be given to healthcare workers, the elderly and those with underlying conditions.

Tedros thanked Germany, Japan, Norway and the European Commission for joining COVAX during the last week.

“Certainly by the middle of 2021 we should start to see some vaccines actually moving into countries and populations,” said WHO chief scientist Soumya Swaminathan, reiterating earlier comments.

Noting that there were 13 experimental vaccines currently in clinical trails, Swaminathan called it an “optimistic scenario” since the typical success rate of 10% could mean several vaccines are approved.

But Swaminathan said that no vaccine should be approved for a worldwide rollout until it had undergone sufficient scrutiny.

“No vaccine is going to be mass-deployed until regulators are confident, governments are confident, and the WHO is confident it has met the minimum standard of safety and efficacy,” she said.

Results were expected from some of the candidates already in phase 3 trials, each involving thousands of participants, by the end of the year or early 2021, Swaminathan said.

“We are not going to have enough for the whole world right at the beginning,” she said adding that scaling up of manufacturing would take time.

“Eventually there will be enough for everyone but it will mean prioritization,” she said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams and Giles Elgood)

Widespread COVID-19 vaccinations not expected until mid-2021, WHO says

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – The World Health Organization does not expect widespread vaccinations against COVID-19 until the middle of next year, a spokeswoman said on Friday, stressing the importance of rigorous checks on their effectiveness and safety.

None of the candidate vaccines in advanced clinical trials so far has demonstrated a “clear signal” of efficacy at the level of at least 50% sought by the WHO, spokeswoman Margaret Harris said.

Russia granted regulatory approval to a COVID-19 vaccine in August after less than two months of human testing, prompting some Western experts to question its safety and efficacy.

U.S. public health officials and Pfizer Inc said on Thursday a vaccine could be ready for distribution as soon as late October. That would be just ahead of the U.S. election on Nov. 3 in which the pandemic is likely to be a major factor among voters deciding whether President Donald Trump wins a second term.

“We are really not expecting to see widespread vaccination until the middle of next year,” Harris told a U.N. briefing in Geneva.

“This phase 3 must take longer because we need to see how truly protective the vaccine is and we also need to see how safe it is,” she added. This referred to the phase in vaccine research where large clinical trials among people are conducted. Harris did not refer to any specific vaccine candidate.

All data from trials must be shared and compared, Harris said. “A lot of people have been vaccinated and what we don’t know is whether the vaccine works…at this stage we do not have the clear signal of whether or not it has the level of worthwhile efficacy and safety…,” she added.

The WHO and GAVI vaccine alliance are leading a global vaccine allocation plan known as COVAX that aims to help buy and distribute shots fairly. The focus is on first vaccinating the most high-risk people in every country such as healthcare workers.

COVAX aims to procure and deliver 2 billion doses of approved vaccines by the end of 2021, but some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join.

“Essentially, the door is open. We are open. What the COVAX is about is making sure everybody on the planet will get access to the vaccines,” Harris said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Frances Kerry)

Pandemic review panel to ask ‘hard questions’, WHO files open, co-chairs say

By Stephanie Nebehay and Kate Kelland

GENEVA/LONDON (Reuters) – An independent panel reviewing the global response to the COVID-19 pandemic will ask “hard questions” and has been assured of access to the records of the World Health Organization (WHO), its co-chairs said on Thursday.

Former New Zealand prime minister Helen Clark and former Liberian president Ellen Johnson Sirleaf named the 11 members they have selected to help prepare a final report for next May.

“This is a strong panel, poised to ask the hard questions,” Johnson Sirleaf told a news conference.

It will examine “actions of WHO and their time lines pertaining to the COVID-19 pandemic” and the effectiveness of WHO’s International Health Regulations, said Johnson Sirleaf, a Nobel Peace Prize laureate.

Co-chair Helen Clark said the WHO had “made clear that their files are open book. Anything we want to see, we see.”

“We will ask with the benefit of hindsight how WHO and national governments could have worked differently,” Clark said. “Are there lessons to be learned in order not to repeat the experience of this pandemic?”

The COVID-19 pandemic has now caused more than 26.11 million infections and 862,963 deaths, according to a Reuters tally.

U.S. President Donald Trump’s administration has strongly criticized the WHO’s role in the crisis, accusing it of being too close to China and not doing enough to question Beijing’s actions late last year when the virus first emerged.

Tedros has dismissed the suggestions and said his agency has kept the world informed.

The Trump administration said on Wednesday that it will not pay some $80 million it currently owes to the WHO and will instead redirect the money to help pay its United Nations bill in New York.

Members of the new panel include former Mexican president Ernesto Zedillo; ex-British foreign secretary David Miliband; Chinese professor Zhong Nanshan; Canada’s Joanne Liu, a former head of Medecins Sans Frontieres (Doctors Without Borders); and American Mark Dybul and France’s Michel Kazatchkine, who each formerly headed the Global Fund to Fight AIDS, TB and Malaria.

The panel is scheduled to meet for the first time on Sept. 17, the co-chairs said.

WHO Director-General Tedros Adhanom Ghebreysus said when announcing the launch of the panel in July that it would provide an interim report to an annual meeting of health ministers resuming in November and present a “substantive report” next May.

Tedros said that the review was in line with a resolution adopted by its 194 member countries last May calling for an evaluation.

(Reporting by Stephanie Nebehay in Geneva and Kate Kelland in London; Editing by Mark Heinrich)

Exclusive: Vaccine group says 76 rich countries now committed to ‘COVAX’ access plan

By Kate Kelland

LONDON (Reuters) – Seventy-six wealthy nations are now committed to joining a global COVID-19 vaccine allocation plan co-led by the World Health Organization (WHO) that aims to help buy and fairly distribute the shots, the project’s co-lead said on Wednesday.

Seth Berkley, chief executive of the GAVI vaccines alliance, said the plan, known as COVAX, now has Japan, Germany, Norway and more than 70 other nations signed up, agreeing in principle to procure COVID-19 vaccines through the facility for their populations.

“We have, as of right now, 76 upper middle income and high income countries that have submitted confirmations of intent to participate – and we expect that number to go up,” Berkley told Reuters in an interview.

“This is good news. It shows that the COVAX facility is open for business and is attracting the type of interest across the world we had hoped it would.”. COVAX coordinators are in talks with China about whether it might also join, Berkley said.

“We had a discussion yesterday with the (Chinese) government. We don’t have any signed agreement with them yet,” but Beijing had given “a positive signal”.

Chinese Foreign Ministry spokeswoman Hua Chunying told a briefing on Wednesday that China “supports COVAX and has been in communication with WHO and other parties” about it.

COVAX is co-led by GAVI, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI). It is designed to discourage national governments from hoarding COVID-19 vaccines and to focus on first vaccinating the most high-risk people in every country.

Its backers say this strategy should lead to lower vaccine costs for everyone and a swifter end to the pandemic that has claimed some 860,000 lives globally.

Wealthy countries that join COVAX will finance the vaccine purchases from their national budgets, and will partner with 92 poorer nations supported through voluntary donations to the plan to ensure vaccines are delivered equitably, Berkley said.

Participating wealthy countries are also free to procure vaccines through bilateral deals and other plans.

The United States said on Tuesday it would not join COVAX due to the Trump administration’s objection to WHO involvement, a move described by some critics as “disappointing.” Berkley said he was not surprised by the U.S. decision, but would seek to continue talks with Washington.

In what appeared to be a change of position on Wednesday, the European Union said its member states could buy potential COVID-19 vaccines through COVAX.

COVAX coordinators sought to add flexibility to joining agreements to encourage greater participation, Berkley said.

The WHO describes COVAX as an “invaluable insurance policy” for all countries to secure access to safe and effective COVID-19 vaccines when they are developed and approved. The plan’s coordinators have set a deadline of Sept. 18 for countries signing up to make binding commitments.

Asked to comment on the U.S. decision not to join COVAX, and on talks with China, a WHO spokesperson said: “Countries have until Sept. 18 to sign binding agreements…, so we’ll have more to say on countries that have joined then.”

COVAX’s objective is to procure and deliver 2 billion doses of approved vaccines by the end of 2021. It currently has nine COVID-19 vaccine candidates in its portfolio employing a range of different technologies and scientific approaches.

A handful are already in late-stage clinical trials and could have data available by year end.

(Reporting by Kate Kelland; Additional reporting by Stephanie Nebehay in Geneva and Yew Lun Tian in Beijing; Editing by Bill Berkrot and Mark Heinrich)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

White House slams “corrupt” WHO

The White House pushed back on concerns expressed by the World Health Organization after a U.S. health official said a coronavirus vaccine might be approved without completing full trials.

The Washington Post newspaper reported that the administration of President Donald Trump would not join a global effort to develop, manufacture and distribute a coronavirus vaccine because of the involvement of the WHO.

About 172 countries are engaging with the WHO’s COVID-19 vaccine plan to ensure equitable access to vaccines, the organization has said.

“The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” White House spokesman Judd Deere said in a statement.

India reopens

India’s coronavirus infections rose to almost 3.8 million on Wednesday, as states continued to relax rules on movement despite the surge in cases.

The country reported 78,357 new cases in the past 24 hours, according to federal health data, taking total infections to 3,769,523. Some 66,333 people have died.

India’s total cases lag only the United States and Brazil, which it will overtake in days based on current trends.

Authorities in the capital New Delhi are due to meet to discuss the reopening of the city’s metro, despite fresh cases there sitting at a two-month high.

In Sydney, the show must go on

Australia’s most-populous state reported the biggest daily jump in coronavirus infections in two weeks on Wednesday but said there were no plans to cancel the New Year fireworks show over Sydney Harbor, as new cases nationally also ticked up.

New South Wales state reported 17 new cases, the biggest one-day jump since Aug. 12, while nationally the count rose to 109 cases from 85 a day earlier.

Victoria state remained the hardest-hit region with 90 cases, although this was well down from its daily peak of more than 700 in early August at the height of a second wave of infections.

NSW Premier Gladys Berejiklian said the state was pushing ahead with plans to host large events such as the New Years Eve fireworks over Sydney Harbor. “I think for a lot of people the fireworks represent hope.”

Elderly drive South Korea case surge

More than 40% of new coronavirus cases in South Korea are being found in people over the age of 60, contributing in part to a surge in the number of COVID-19 patients who are severely or critically ill, health authorities said on Wednesday.

The surge in cases over the past three weeks has depleted medical facilities, with less than 3% of hospital beds – or just nine – available for critical cases in greater Seoul, versus 22% about 10 days ago, the health ministry said.

South Korea is battling a second wave of infection, centered in the capital Seoul and surrounding areas which are home to 25 million people.

Pandemic ignites demand for home appliances

From sanitizing closets to customizable fridges, the coronavirus pandemic has fanned demand for home appliances – so much so that Samsung Electronics is adding warehouses and bringing popular products to more markets.

In particular, consumers have been willing to splurge on products that make their homes cleaner.

In Brazil and other emerging economies, households which once relied on maids are now investing in dishwashers and robot vacuum cleaners, while Samsung says its overseas sales of air purifiers jumped more than five times in January-July compared to the same period last year.

Samsung’s AirDresser, a closet that steam cleans clothes and kills bacteria, has seen a spike in sales. Big fridges have also climbed in popularity as people cooking more often at home seek more freezer space.

(Compiled by Linda Noakes; Editing by Alison Williams)

Steroids cut death rates among critically ill COVID-19 patients, major study finds

By Kate Kelland

LONDON (Reuters) – Treating critically ill COVID-19 patients with corticosteroid drugs reduces the risk of death by 20%, an analysis of seven international trials found on Wednesday, prompting the World Health Organisation to update its advice on treatment.

The analysis – which pooled data from separate trials of low dose hydrocortisone, dexamethasone and methylprednisolone – found that steroids improve survival rates of COVID-19 patients sick enough to be in intensive care in hospital.

“This is equivalent to around 68% of (the sickest COVID-19) patients surviving after treatment with corticosteroids, compared to around 60% surviving in the absence of corticosteroids,” the researchers said in a statement.

The WHO’s clinical care lead, Janet Diaz, said the agency had updated its advice to include a “strong recommendation” for use of steroids in patients with severe and critical COVID-19.

“The evidence shows that if you give corticosteroids …(there are) 87 fewer deaths per 1,000 patients,” she told a WHO social media live event. “Those are lives … saved.”

“Steroids are a cheap and readily available medication, and our analysis has confirmed that they are effective in reducing deaths amongst the people most severely affected by COVID-19,” Jonathan Sterne, a professor of medical statistics and epidemiology at Britain’s Bristol University who worked on the analysis, told the briefing.

He said the trials – conducted by researchers in Britain, Brazil, Canada, China, France, Spain, and the United States – gave a consistent message throughout, showing the drugs were beneficial in the sickest patients regardless of age or sex or how long patients had been ill.

The findings, published in the Journal of the American Medical Association, reinforce results that were hailed as a major breakthrough and announced in June, when dexamethasone became the first drug shown to be able to reduce death rates among severely sick COVID-19 patients.

Dexamethasone has been in widespread use in intensive care wards treating COVID-19 patients in some countries since then.

Martin Landray, a professor of medicine and epidemiology at the University of Oxford who worked on the dexamethasone trial that was a key part of the pooled analysis published on Wednesday, said the results mean doctors in hospitals across the world can safely switch to using the drugs to save lives.

CLEAR BENEFITS

“These results are clear, and instantly usable in clinical practice,” he told reporters. “Among critically ill patients with COVID-19, low-dose corticosteroids … significantly reduce the risk of death.”

Researchers said the benefit was shown regardless of whether patients were on ventilation at the time they started treatment. They said the WHO would update its guidelines immediately to reflect the fresh results.

Until the June findings on dexamethasone, no effective treatment had been shown to reduce death rates in patients with COVID-19, the respiratory disease caused by the new coronavirus.

More than 25 million people have been infected with COVID-19 and 856,876​ have died, according to a Reuters tally.

Gilead Sciences Inc’s remdesivir was authorized by United States regulators in May for use in patients with severe COVID-19 after trial data showed the antiviral drug helped shorten hospital recovery time.

Anthony Gordon, an Imperial College London professor who also worked on the analysis, said its results were good news for patients who become critically ill with COVID-19, but would not be enough to end outbreaks or ease infection control measures.

“Impressive as these results are, this is not a cure. We now have something that will help, but it is not a cure, so it’s vital that we keep up all the prevention strategies.”

(Reporting by Kate Kelland; Editing by Mark Heinrich and Catherine Evans)

COVID-19 can wipe out health care progress in short order: WHO

By Emma Farge

GENEVA (Reuters) – More than 90% of countries have seen ordinary health services disrupted by the COVID-19 pandemic, with major gains in medical care attained over decades vulnerable to being wiped out in a short period, a World Health Organization survey showed.

The Geneva-based body has frequently warned about other life-saving programs being impacted by the pandemic and has sent countries mitigation advice, but the survey yielded the first WHO data so far on the scale of disruptions.

“The impact of the COVID-19 pandemic on essential health services is a source of great concern,” said a report on the study released on Monday. “Major health gains achieved over the past two decades can be wiped out in a short period of time…”

The survey includes responses from between May and July from more than 100 countries. Among the most affected services were routine immunizations (70%), family planning (68%) and cancer diagnosis and treatment (55%), while emergency services were disturbed in almost a quarter of responding countries.

The Eastern Mediterranean Region, which includes Afghanistan, Syria and Yemen, was most affected followed by the African and Southeast Asian regions, it showed. The Americas was not part of the survey.

Since COVID-19 cases were first identified in December last year, the virus is thought to have killed nearly 850,000 people, the latest Reuters tally showed.

Researchers think that non-COVID deaths have also increased in some places due partly to health service disruptions, although these may be harder to calculate.

The WHO survey said it was “reasonable to anticipate that even a modest disruption in essential health services could lead to an increase in morbidity and mortality from causes other than COVID-19 in the short to medium and long-term.” Further research was needed.

It also warned that the disruptions could be felt even after the pandemic ends. “The impact may be felt beyond the immediate pandemic as, in trying to catch up on services, countries may find that resources are overwhelmed.”

(Reporting by Emma Farge; Editing by Mark Heinrich)

Pandemic pace slows worldwide except for southeast Asia, eastern Mediterranean: WHO

By Stephanie Nebehay

GENEVA (Reuters) – The COVID-19 pandemic is still expanding, but the rise in cases and deaths has slowed globally, except for southeast Asia and the eastern Mediterranean regions, the World Health Organization (WHO) said.

In its latest epidemiological update, issued on Monday night, it said that the Americas remains the hardest-hit region, accounting for half of newly reported cases and 62% of the 39,240 deaths worldwide in the past week.

More than 23.65 million people have been reported to be infected by the coronavirus globally and 811,895​ have died, according to a Reuters tally on Tuesday.

“Over 1.7 million new COVID-19 cases and 39,000 new deaths were reported to WHO for the week ending 23 August, a 4% decrease in the number of cases and (a 12% decrease) in the number of deaths compared to the previous week,” the WHO said.

Southeast Asia, the second most affected region, reported a jump accounting for 28% of new cases and 15% of deaths, it said. India continues to report the majority of cases, but the virus is also spreading rapidly in Nepal.

In WHO’s eastern Mediterranean region, the number of reported cases rose by 4%, but the number of reported deaths has consistently dropped over the last six weeks, the WHO said. Lebanon, Tunisia and Jordan reported the highest increase in cases compared to the previous week.

The number of cases and deaths reported across Africa decreased by 8% and 11% respectively in the past week, “primarily due to a decrease in cases reported in Algeria, Kenya, Ghana, Senegal and South Africa”, it said.

“In the European region, the number of cases reported has consistently increased over the last three weeks,” it said. “However, only a slight decrease (1%) was reported in the most recent week, and the number of deaths have continued to decrease across the region.”

In WHO’s western Pacific region, the number of new cases dropped by 5%, driven by less spread in Japan, Australia, Singapore, China and Vietnam. South Korea reported an 180% jump in cases, “mainly due to an increase in cases associated with religious gatherings”.

(Reporting by Stephanie Nebehay; Editing by Giles Elgood)

New U.S. COVID-19 cases drop for fifth week in a row, deaths decline

(Reuters) – The number of new cases of the novel coronavirus reported in the United States fell 17% last week, the fifth straight week of declines, according to a Reuters tally of state and county reports.

Nearly 1,000 people a day continue to die from COVID-19, though last week’s total of more than 6,700 deaths was down 9% from the previous seven days.

The United States posted 297,000 new cases for the week ended Aug. 23, down from a weekly peak of over 468,000 cases in mid-July. The country is now averaging less than 50,000 new infections a day for the first time since early June.

The United States still has the worst outbreak in the world, accounting for a quarter of the global total of 23 million cases.

The state with the biggest percentage increase in new cases last week was South Dakota at 50%. Infections have been rising since the annual motorcycle rally in Sturgis, which drew more than 100,000 people from all over the country from Aug. 7 to 16. The South Dakota health department was not immediately available for comment.

Cases rose by 30% in nearby North Dakota and by 24% in Wyoming.

The United States tested on average 675,000 people a day last week, down from a peak in late July of over 800,000 people a day.

Nationally, the share of all tests that came back positive for the new virus was 6.3%, down from 7% the prior week and below a peak of 9% in mid-July, according to data from The COVID Tracking Project, a volunteer-run effort to track the outbreak.

South Carolina had the highest positivity rate in the nation at 22%, followed by Texas, Nevada and Idaho at 16%.

At least 29 states reported a positivity rate above 5%, the level the World Health Organization considers concerning because it suggests there are more cases in the community that have not yet been uncovered.

(Writing by Lisa Shumaker; Graphic by Chris Canipe; Editing by Tiffany Wu)