The U.S. Timeline for a Coronavirus Vaccine Keeps Slipping

When Bruce Y. Lee was helping the U.S. government model delivery plans for H1N1 influenza vaccines, he came to expect one constant: The schedule would always change.

“We’d constantly have to update the models as new production numbers came out,” said Lee, a professor at CUNY Graduate School of Public Health & Health Policy, who developed computational models to guide the national response to the H1N1 flu pandemic in 2009. “That just became accepted.”

The shifting timelines are already apparent with COVID-19 vaccine distribution in the U.S. — even before the rollout starts in the coming days. The Trump administration declared in May that 300 million vaccine doses would be available by January 2021, with the first distributed in October of this year. By October, that had shifted to 100 million doses by the end of the year, according to U.S. Health and Human Services Secretary Alex Azar. Currently, the plan is for 40 million doses to be distributed in December, though some in health care are skeptical of even that prediction.

Pharmaceutical and vaccine production involves complex coordination, involving product development, manufacturing, packaging, storage, distribution, and regulatory review, and each stage can cause unexpected delays.

The manufacturing process can — and usually does — go awry at some point. “Manufacturing never goes 100%, there’s always issues and stock you have to throw out,” said Lee. “You bake a thousand cakes, you’re not going to get a thousand successful cakes.”

At every stage of production, manufacturers must test the product to show that each batch, from each different facility, is equivalent to the original. This will inevitably reveal issues that need addressing as COVID-19 vaccines are produced at unprecedented scale and speed. “Not only do we want it yesterday, but we need a lot of it yesterday,” said Thomas Denny, chief operating officer of the Duke Human Vaccine Institute. “If you try and do something quickly in your kitchen, even if you have a recipe, sometimes things go wrong.”

Every feature of the final vaccine, including buffers, glass, pipette tips, dry ice, and packaging, then comes with its own potential production issues. Pfizer recently had to cut its end-of-year supply projections for COVID-19 vaccines in half, because of delays in scaling up the raw material supply chain.

As more vaccines are rolled out, this will increase the pressure on available supplies. “You’re dealing with a limited supply chain,” said Denny. “I would not be surprised, as we get two or three vaccines being manufactured, if we see some challenges.”

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Olivia Goldhill, STAT

This story was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. Read the rest of the piece here. 

Mayor Breed: SF 'Could Soon Start Reopening' If Trends Continue

San Francisco Mayor London Breed says a reopening under state guidelines could begin soon as the city continues to make gains when it comes to containing coronavirus spread.

Despite the rosy outlook, state health officials said the Bay Area region doesn't yet meet the required 15% ICU availability projection for four weeks under state rules for a region to reopen.

An update on that projection may come as late as Tuesday, the San Francisco Chronicle reported, though COVID cases saw an uptick on Sunday, news which might pump the brakes on a potential reopening.

In a tweet Friday, Breed revealed the virus' reproductive rate is now under one, meaning that every person infected passes it on to fewer than one other person. The Bay Area region would also need to be projected to have at least 15% ICU availability for four weeks, under state rules, to reopen.

Monica Gandhi, an infectious disease specialist at the University of California San Francisco, said, "this county has been particularly conservative with the recommendations from the state. That's why I'm very hopeful that for this county to put out a tweet like that means that discussions are happening. "

Gandhi says she’s hopeful limited activities— such as outdoor dining, hair salons and zoos — could return as early as next week.

Marin County Public Health Officer Matt Willis says Bay Area counties are waiting on the state to determine whether the entire region can ease restrictions.

Breed also said people must still be vigilant and wear masks, avoid indoor gatherings with people from other households, and to wash hands frequently.

"We all need to keep doing what we know slows the spread of the virus," Breed said.

Sara Hossaini (@MsHossaini)

U.S. Tops 25 Million Confirmed Coronavirus Cases

Almost exactly one year after the first case of the coronavirus was detected in the United States, the country has now reached 25 million confirmed infections. As it has for months, the U.S. remains by far the most coronavirus-riddled country in the world.

Data from Johns Hopkins University's Coronavirus Resource Center showed the U.S. passing the tragic marker as of Sunday morning. The true number of cases, however, is likely far higher: Many people become infected but never get tested, so they aren't reflected in the count.

The U.S. has more than twice as many confirmed cases as the nation with the second-highest count — India, a country with 10 million cases and a population that is four times larger.

Nearly 420,000 people in the U.S. have now died from the virus. That's almost double the number of the next highest country, Brazil, which is closing in on 220,000 deaths.

The existence of a more infectious variant of the virus could make matters worse, top health officials say. The variant has swept through large parts of the U.K. in recent weeks and was identified for the first time in the U.S. in late December with a case in Colorado.

Although U.K. scientists originally said the new variant is no more deadly, new data appear to suggest a more worrisome picture.

Americans "need to assume now that what has been circulating dominantly in the U.K. does have a certain degree increase in what we call virulence: namely, the power of the virus to cause more damage, including death," Dr. Anthony Fauci, the nation's top infectious disease specialist, told CBS's Face the Nation on Sunday.

While former President Donald Trump repeatedly downplayed the virus — proclaiming, for instance, that it would disappear with the changing weather — President Biden has focused much of his first week in office warning of the severity of the virus and introducing new measures intended to bring the pandemic under control. The president has promised 100 million vaccine doses in his first 100 days, and on Thursday he signed 10 executive orders and directives that the White House says will boost testing, vaccinations, supplies and treatments.

Still, experts caution that it will take several months before the pandemic is under control, and Biden himself has acknowledged that the situation will get worse before it gets better.

"A lot of America is hurting. The virus is surging. We're 400,000 dead, expected to reach well over 600,000," Biden said Friday. "Families are going hungry. People are at risk of being evicted. Job losses are mounting again. We need to act. No matter how you look at it, we need to act."

Matthew S. Schwartz, NPR

California Extends Deadline for Unemployment Applicants to Verify Identity

The state’s Employment Development Department has extended the number of days applicants have to verify their identity before the agency disqualifies their claim.

Applicants will now have 30 days instead of 10 to complete the verification; the countdown starts on the day they receive verification guidance from EDD, which should arrive through an emailed link or the U.S. mail. All those receiving emailed links were supposed to have received them by Jan. 14.

The EDD froze the accounts of about 1.4 million Californians at the end of last year in an attempt to prevent fraud. These applicants are now all trying to verify their identities through the state’s verification system.

EDD delivered the verification guidance on a rolling basis to avoid crashing its online systems. But was already overloaded at the end of last year, and claimants have been waiting for hours to verify their identities through video when their documents weren’t approved through other avenues.

The department implemented in an attempt to cut down on the manual processing times that were contributing to the huge backlog. But in early January, advocates had resorted to filing hardcopy forms, said Daniela Urban, founder of the Center for Workers’ Rights in Sacramento.

“We have them fill out a paper form or assist them in filling out a paper form and submit that instead, so that we don't have to deal with,” she said.

Last year EDD had pledged to lawmakers to clear a backlog of more than 1.6 million claims identified in the fall. While the agency says it is on track to accomplish that goal by around the end of January, that doesn’t include the 1.4 million suspended accounts. Taking the remainder of the 1.6 million and adding that to the other currently unresolved claims, the agency still has more than 940,000 claims it has yet to process.

On top of the long wait times for verification, many applicants have received confusing messages directing them to unnecessarily reopen their claims. Claimants who receive this message should wait until EDD prompts them to certify. The agency has said it expects to complete these claims in question by Friday.

Advocates say the glitch is a result of all the pending changes to accounts coming in the wake of the December stimulus bill passing.

Mary Franklin Harvin

Bay Area Counties Ramp Up Vaccination Plans

As President Biden promises to deliver 100 million doses of the coronavirus vaccine in his first 100 days in office, some Bay Area counties are following suit with their own ambitious goals to vaccinate as many residents as possible by summer.

San Francisco on Friday launched its first mass vaccination site at City College of San Francisco’s Ocean Avenue campus, in what the city's COVID Command Center is calling a "soft launch." The city, in partnership with several health care providers, planned on administering about 500 vaccines to start before ramping up.

Two other sites, at Moscone Center and The SF Market, south of Potrero Hill, are expected to open around the beginning of February.
Pending supply, officials hope to eventually vaccinate 10,000 people a day, with the goal of reaching most San Franciscans by the end of June.

Residents can sign up on a city website to get notified when they're eligible for a vaccine appointment.

Contra Costa County health officials announced Friday they want to administer a million doses of the vaccine by Independence Day.

“If we get those million doses out, we will be in a very different situation come July 4 then we are in now, and we will be able to feel very confident in moving forward,” said Anna Roth, the director of Contra Costa Health Services.

Diane Burgis, chair of the Contra Costa County Board of Supervisors, said in a statement, “We believe this is a realistic goal, provided our supply of vaccine increases.”

Nearly 55,000 Contra Costa County residents have received their first dose of the vaccine, and 10,000 have received both doses.

The county is prioritizing residents 75 and older, but health officials are encouraging people over 65 to begin registering for appointments on the county’s website.

Santa Clara County also opened a new mass vaccination site at the Mountain View Community Center, on Rengstorff Avenue.

“We don't have a month to lose. We don't have a week to lose,” said Santa Clara County Supervisor Joe Simitian, whose district includes Mountain View. “We don't have a single day to lose. We just can't afford to let time go by. It's very gratifying to know that we are up and running and that in short order will be a thousand vaccinations a day at just this site."

The community center site will offer vaccinations by appointment only, 8:30 a.m. to 5 p.m., Monday-Friday, working up to 1,000 vaccinations per day.

The county and health care providers are offering vaccinations to health care workers, long-term care facility residents and people over 74.

You can find links to schedule an appointment in Santa Clara County under the "Who is Currently Eligible to be Vaccinated" section of the county's vaccine information page.

Marco Siler-Gonzales and Jon Brooks

California's Clearest COVID-19 Vaccine Appointment Dashboard Is Run by Volunteers

If you've been looking for facts about getting your COVID-19 vaccine, you might have discovered that just finding clear information on how to schedule an appointment for an eligible person can be a difficult, time-consuming process.

A week ago, a site called VaccinateCA launched that not only lists vaccination sites around California, but details their current vaccine availability. The information is gathered manually by a team who compiled a list of medical centers, pharmacies and hospitals around the state, and now regularly contacts those locations to confirm their vaccine inventory — as well as what groups they're now accepting, and how to make an appointment yourself.

But the thing about VaccinateCA? It's completely staffed by volunteers who make those calls, maintain the website and coordinate efforts across the state. And this crowdsourcing is filling a need in California that as yet, health officials don't seem to have addressed themselves: the need for residents to simply schedule a COVID-19 vaccine appointment near them.

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Carly Severn

Legislators, School Officials Skeptical About Newsom Plan to Restart In-Person Learning

State legislators and school officials are raising concerns over Gov. Gavin Newsom's plan to restart in-person learning in California public schools.

Newsom has proposed $2 billion to pay for testing, protective equipment and other safety enhancements to reopen the lowest grades as soon as Feb. 16.

At a state Senate hearing Thursday, state Sen. Dave Cortese, D-San Jose, said that despite the fanfare around Newsom's goal of reopening next month, a host of disagreements over the plan remain.

"The fact of the matter is, what we're really saying is most schools won't open," Cortese said.

One big point of contention: A proposal for weekly testing of students. That's a high hurdle for superintendents like Shelly Viramontez of the Campbell Union School District.

“The requirement for the student testing really made no sense to me," Viramontez said.

State Sen. Mike McGuire, D-Healdsburg, said the proposed grants of $450 per student wouldn't be enough to cover anything beyond the cost of the plan's testing requirements.

"I’m very concerned about what that’s going to mean and the requirements on districts just on the testing side to be able to make it work," McGuire said.

The Newsom administration says it's trying to pool testing to bring costs down.

Many teacher unions say COVID-19 cases are too prevalent to bring students back, while the Newsom administration says school outbreaks are rare.

The Legislature could begin voting on the plan next week.

Guy Marzorati

California Withholds Data for Assessing Stay-at-Home Orders, Catching Local Officials Off Guard

California's public health agency recently surprised local officials by lifting a stay-at-home order in the 13-county Greater Sacramento region.

Suddenly, outdoor dining and worship services were OK again, hair and nail salons and other businesses could reopen, and retailers could have more shoppers inside.

Local officials and businesses were caught off guard. State officials did not describe their reasoning other than to say it was based on a projection for ICU capacity.

“It was a good surprise, but we just didn’t see it coming,” California Restaurant Association President and CEO Jot Condie said. “We just don’t know what happens behind the curtain. It’s created logistical difficulties for the industry,” which scrambled to rehire staff and order food.

State health officials relied on a complex formula to project that while the region’s intensive care capacity was below 10%, it would climb above 15% within four weeks. On Thursday, it was 8%, roughly the same as when the order was lifted.

“What happened to the 15%? What was that all about?” asked Dr. George Rutherford, an epidemiologist and infectious-diseases control expert at UCSF. “I was surprised. I assume they know something I don’t know.”

State officials projected future capacity using a combination of models.

“At the moment the projections are not being shared publicly,” California Department of Public Health spokeswoman Ali Bay said in an email.

It’s a mystery how the state decided to lift regional restrictions because officials won’t share their data despite repeated pledges of transparency.

State officials projected intensive care unit capacity and virus spread four weeks into the future to make the determination. Bay said “at the moment the projections are not being shared publicly,” because officials say they could cause more confusion.

San Bernardino County spokesman David Wert said officials there aren’t aware of the secret models but would welcome being able to see the data.

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—Don Thompson, Associated Press