Newsletter: The vaccine race

Good morning, and welcome to the Essential California newsletter. It’s Tuesday, July 28, and I’m writing from Los Angeles.

When there’s a vaccine...

That phrase has become a kind of mantra in recent months, a catch-all for how and when we’ll finally be able to put the pieces of our coronavirus-shattered world back together.

We’ll send our children back to school without fear ... when there’s a vaccine. We’ll return to conventions, crowded sports stadiums and packed concerts ... when there’s a vaccine. We’ll embrace our friends and family, return to work as we knew it and leave our homes without a mask ... when there’s a vaccine. Four simple words, around which we have conditionally rescheduled the rest of our lives.

(Before we get any further, a quick reminder that we’re talking about a deeply complex vaccine process, not a magical panacea. There will be no instantaneous flipping of a switch when the first version comes to market; it will unfortunately probably look more like a long and messy path forward. Still, at least it’s a path forward.)

Anyway, now that we’ve sufficiently lowered the mood, here comes the good news: Monday was a red-letter day in that quest, as the world’s biggest COVID-19 vaccine study got underway.

[Read the story: “Final test of Moderna’s coronavirus vaccine — in 30,000 volunteers — gets underway” in the Los Angeles Times]

It was one small injection for a woman in Savannah, Ga., and a potentially giant shot in the arm for the highest-stakes medical race of our lifetimes.

The vaccine, which was co-developed by Moderna and the National Institute of Allergy and Infectious Diseases, is known as mRNA-1273.

That woman in Georgia — the first person in the United States to get a shot in a Phase 3 coronavirus vaccine trial — will be one of approximately 30,000 volunteers to receive injections in the days to come, as researchers continue to evaluate the safety of mRNA-1273 and whether it can prevent symptomatic COVID-19.

Moderna, a Cambridge, Mass.-based biotech company, is one of six contenders to receive funding as part of Operation Warp Speed, a multibillion-dollar federal initiative designed to expedite vaccine development.

What is a Phase 3 trial? What are the other phases?

Here’s what the vaccine testing process looks like, as my colleague, science writer Amina Khan, explained in a story early in the pandemic.

The first step, before the vaccine is tested on any humans, is to show it’s safe in preclinical studies. These can be conducted in vitro (using cells in a laboratory dish) or in vivo (using an animal as a stand-in for humans). Then clinical trials in humans can begin. Phase 1 trials are small, usually with a few dozen closely monitored participants. The main goal there is to make sure the vaccine is safe.

Phase 2 trials typically enroll hundreds of patients to expand the safety assessment and allow scientists to dig into the body’s immune response.

Phase 3 trials can enroll thousands of people, typically with some randomly assigned to get the vaccine and some getting a placebo.

What to know about this particular trial

Moderna has been a front-runner in the global race to develop a vaccine: The first volunteer in the first phase of the trial received their first shot of the investigational vaccine in mid-March, before any state stay-at-home orders had been issued. The Phase 1 clinical trial had 45 participants. Study subjects in the trial produced coronavirus antibodies at levels comparable to patients who had contracted and recovered from COVID-19, but that does not necessarily mean the vaccine can provide immunity to the disease. There were some minor side effects, such as a brief fever, chills and pain at the injection site. The second phase was initiated in May.

Starting Monday, the Phase 3 trial volunteers will receive two injections, given roughly 28 days apart. Half the participants will receive the mRNA-1273 investigational vaccine; the other half will receive a saline placebo. The process will be blind, meaning neither the participants nor the people conducting the trial will know who gets what.

It’s important to note that this is not a “human challenge” trial, meaning no participants will be deliberately exposed to the coronavirus. (No challenge trials for a coronavirus vaccine are underway in the U.S., and the ethics of potentially utilizing them in the future for a disease with no known cure have been fiercely debated.)

“Unfortunately for the United States of America, we have plenty of infections right now,” Dr. Anthony Fauci told the Associated Press recently as an explanation — meaning that a pool of 30,000 study participants will sadly have ample opportunity to encounter the virus in their daily lives, particularly for those participants who live in hot spots.

What comes next

Moderna’s mRNA-1273 is one of several candidates in the final stretch of the global vaccine race. Several other vaccines made by China and by Britain’s Oxford University began smaller final-stage tests earlier this month. As yesterday’s coverage explains, the U.S. requires its own tests of any vaccine that may be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate — each one with 30,000 newly recruited volunteers.

And as case and death counts continue to mount, all contenders will be racing against time.

The name of the U.S. vaccine initiative — Operation Warp Speed — is quite antithetical to the typically slow scientific process. But as my colleague Melissa Healy wrote last month, President Trump has shown little patience for science’s deliberate pace. He has said he wants enough doses to protect as many as 90% of Americans developed, manufactured and delivered by January 2021, a little over a year after the virus first appeared.

[Read the story: “Can Operation Warp Speed deliver a COVID-19 vaccine by the end of the year?” in the Los Angeles Times]

So how could that timetable possibly be condensed? As Melissa explains, Operation Warp Speed envisions that many steps that have always followed one another in strict sequence — clinical trials and production, for instance, or government approval and supply-chain development — will be done in parallel wherever possible.

The hurdles will go far beyond just developing a working vaccine; there will be massive logistical challenges ahead for production and distribution. Americans have already watched an effective coronavirus testing process be stymied by shortages of, in no particular order, the tiny pieces of tapered plastic known as pipette tips, key chemicals known as reagents and nasal swabs, among other things.

The Trump administration is now racing to buy hundreds of millions of syringes ahead of what is likely to be an unprecedented immunization campaign, but as my D.C. colleague Jennifer Haberkorn explained earlier this month, success “depends heavily on two small medical supply companies with little track record of fulfilling government orders of that magnitude.”

[See also: “The pressure is on for COVID-19 vaccine trials to reflect U.S. diversity” in the Los Angeles Times]

And now, here’s what’s happening across California:

Gov. Gavin Newsom wants to send $52 million to help the Central Valley fight its coronavirus surge. Newsom said Latinos in the Central Valley have been disproportionately harmed by the spread of COVID-19, prompting the governor to send “strike teams” to eight counties while asking the California Legislature to approve $52 million to improve testing, tracing and isolation protocols in those regions. Los Angeles Times

Senate Republicans rolled out the major pieces of a $1-trillion economic relief plan that would provide a second round of $1,200 coronavirus stimulus payments to many American adults and slash enhanced federal unemployment payments from $600 a week to $200. The release of the plan marked the start of negotiations that will involve House Democrats, who passed their own, more generous relief bill in May that includes $1,200 checks and an extension of the $600 unemployment benefit. Los Angeles Times

L.A. STORIES

The Los Angeles Police Department is expanding its signature community policing program as part of a reimagining of law enforcement after the killing of George Floyd. Los Angeles Times

Developers allegedly bribed an L.A. councilman. What happens to their building plans? Several council members have called for the city to reassess approvals for real estate projects mentioned in the criminal case, arguing that the building plans have been tainted by the scandal. Los Angeles Times

The Dodgers came back home, but the neighborhood remains quiet. The ban on fans in the stands during the pandemic means area businesses that count on heavy foot traffic from Dodger Stadium are sorely missing those sales. LAist

Do we need another project about Charles Manson? TV critic Lorraine Ali on why Angelenos still can’t look away. Los Angeles Times

POLITICS AND GOVERNMENT

National security advisor Robert O’Brien has tested positive for the coronavirus, making him the highest-ranking member of President Trump’s inner circle known to have contracted the disease. Los Angeles Times

Demonstrators chained themselves to a fence outside Gov. Gavin Newsom’s home on Monday, calling for mass inmate releases and an end to immigration transfers because of the coronavirus pandemic, as deaths continue to mount. Associated Press

Long Beach Mayor Robert Garcia’s mother has died of coronavirus complications. Gabriella O’Donnell, 61, came to the U.S. in 1982 with her then-5-year-old son. Neither spoke English at the time. She cleaned houses to earn a living before becoming a medical assistant and eventually watched her son become the youngest mayor in Long Beach history. “She immigrated from Peru to the United States in search of the American dream, and she found it,” Garcia said in a statement Monday, calling her “the kindest and most compassionate person we’ve ever known.” Long Beach Press-Telegram

CRIME AND COURTS

A former UCLA men’s soccer coach pleaded guilty to accepting $200,000 in bribes to help two students get into the school as recruits. The bribes were part of the 2019 college admission scandal. Associated Press

HEALTH AND THE ENVIRONMENT

California is desperate for signs of a turnaround after stunning coronavirus setbacks. Will July end with more bad news or some tentative signs that the efforts to slow infections by closing down some businesses and institutions might be paying off? Health officials are eager for more signs of the latter, especially amid indications that other hot-spot states may be beginning to plateau. Los Angeles Times

CALIFORNIA CULTURE

Already hurting from the pandemic, a Sierra foothills winery has faced an onslaught of attacks from people angry at Newsom. But they have no connection to the governor. Newsom did co-found the Plumpjack Group, which operates wineries in Napa, but Newsome Harlow Wines in Calaveras County has nothing to with the governor. (The “Newsome” in Newsome Harlow is the owner’s mother’s maiden name.) Calaveras Enterprise

The legacy and contributions of Black American pioneers in Merced County: “While the contributions of these Black settlers were not recorded in the history books or inscribed in monuments, they are still visible in other mediums such as maps, literary works or movies,” writes local historian Sarah Lim. Merced Sun-Star

Ball pits were gross even before the pandemic. Will we ever dive in again? Washington Post

In this strange time-capsule image from June 2019, a 9-year-old boy plays in the ball pit at the Cayton Children’s Museum in Santa Monica.

(Claire Hannah Collins / Los Angeles Times)

The California skate park as Brutalist recreational landscape: A portfolio of photographs of 12 of the largest and most prominent skate parks in California, captured in strangely supernatural early-morning light. ArchDaily

The very best dogs you will meet strolling through Ukiah: I will be upfront with you: There is nothing newsworthy about this story, not by a long shot. But sometimes you just need to read several hundred words lovingly describing the physiques and personalities of the dogs in a small Northern California town, as well as those dogs’ relationships to each other. (Millie, for instance, is blind in one eye and “no bigger than your shoe” yet somehow reigns supreme as “the undisputed alpha matriarch of all dog gatherings.”) Ukiah Daily Journal

A poem to start your Tuesday: “Ne’ilah” by Marge Piercy. Poetry Foundation

CALIFORNIA ALMANAC

Los Angeles: partly cloudy, 80. San Diego: partly cloudy, 75. San Francisco: partly cloudy, 64. San Jose: sunny, 82. Fresno: sunny, 102. Sacramento: sunny, 100. More weather is here.

AND FINALLY

Today’s California memory comes from Mia Faulk:

If you have a memory or story about the Golden State, share it with us. (Please keep your story to 100 words.)

Please let us know what we can do to make this newsletter more useful to you. Send comments, complaints, ideas and unrelated book recommendations to Julia Wick. Follow her on Twitter @Sherlyholmes.