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.”

Read the full story.

— 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. 

Nearly three-quarters of San Francisco's Latino residents have received at least one shot of the COVID-19 vaccine, marking a major milestone for a community that once had the highest case rates in the city, officials said Monday.

So far, 70% of the city's eligible Latinos ages 12 and up – about 93,000 people – have received at least one dose of the vaccine.

Latino residents in the city, as well as across the state, have seen the most disproportionate COVID-19 infection rates, with Latinos accounting for over 40% of all cases citywide despite representing just 15% of the city's population.

Health experts had said Latino San Franciscans faced high infection rates because many work essential jobs and also live in multigenerational households.

According to Mayor London Breed, San Francisco was able to successfully vaccinate 70% of Latino residents thanks to a network of high-volume vaccinations sites, community health clinics, pharmacies and mobile sites in neighborhoods with high Latino populations, like the Excelsior, Mission and the Oceanview, Merced Heights and Ingleside neighborhoods.

"With low barrier access to vaccines and a strong network of trusted community partners on the ground, we have reached the important milestone of 70 percent of the eligible Latino population in San Francisco receiving at least one vaccine dose," Breed said in a statement. "As we celebrate this success, let's remember that COVID is not over. If you know of any family or friends who are not yet vaccinated, please encourage them to do so now. Vaccines are free, safe and will protect you and your entire community."

"Just five months ago, our community was battling with some of the worst rates of infection our city had seen," said Jon Jacobo, health committee chair of the Latino Task Force, one of several community partners the city worked with to carry out the vaccination efforts.

"We sprang into action with our UCSF and Department of Public Health partners to roll out lifesaving vaccines. Today, we stand proud and feel more at ease knowing our collective hard work in the face of adversity has paid off," he said.

"Thank you to the Latinx community for leading and responding to the call to get vaccinated and stepping up to protect themselves, their families and their community against COVID-19," said San Francisco Department of Public Health Director Dr. Grant Colfax. "While we celebrate this important milestone, we encourage every eligible person in the city to get vaccinated, especially in light of new virus variants hitting our communities."

- Bay City News

Latino advocates in San Francisco have gotten a commitment from key city supervisors to get more money in the city’s new budget to help their community recover from the pandemic.

But it's not a done deal just yet. The public is set to comment on San Francisco's proposed budget Wednesday, with negotiations between the board and Mayor London Breed expected to continue at least through Monday.

Community advocates argue that amid San Francisco's $13 billion spending proposal, more of that should reflect that the city’s Latino community, which was hit hard by COVID-19 — not just by infections and deaths, but with job losses and strains on cultural institutions.

At 24th Street BART station on Tuesday, community leaders joined Supervisor Matt Haney, chair of the Board of Supervisors Budget and Appropriations Committee, and Supervisor Hillary Ronen, who also serves on the committee, to announce a plan to allocate nearly $5 million of the city's budget to address Latino community needs.

Jaime Aragon, chair of the San Francisco Latino Parity and Equity Coalition, said the help was sorely needed.

“We’re getting this public commitment from the supervisors saying that they see us, they hear us, they have us on the radar and they’re willing to fight for us,” Aragon said.

The Latino community represents over 40% of cases in San Francisco and 20% of COVID-19 deaths, according to the supervisors.

"This was a community that already experienced incredible challenges as it relates to equity," Haney said. "One of the higher poverty rates I went to, higher rates of unemployment, just a tremendous need for investment from our budget. And all of that was exacerbated during this pandemic."

If the funding is approved by the budget committee and through negotiations with Mayor Breed, it will be used to address hunger, help small businesses, support a 24-hour hotline for immigrants and support for arts and culture groups.

Breed announced $28 million in expanded COVID-19 support for the city's Latino community in September last year, including funding for housing, food access and small businesses.

— Scott Shafer 

Unemployed Californians will soon need to show that they’re actively looking for work to stay eligible for benefits, the state’s Employment Development Department announced late last week.

The EDD had suspended the work search requirement in March 2020 because of the unprecedented challenges of the COVID-19 pandemic. But starting July 11, most Californians who want to maintain their eligibility for unemployment benefits should be actively looking for work, the EDD said.

To keep getting benefits, applicants will need to answer "Yes" on the bi-weekly certification question asking if they are looking for work. As one Twitter user succinctly put it, “Just put ‘yes’ for number three and that’s it.”

What qualifies as “searching for work” will vary for those on regular unemployment or extensions versus those on Pandemic Unemployment Assistance, because the latter group members are often self-employed and contract workers. EDD said it will be sending notices to inform applicants about what this reinstatement means for them. A brief rundown can also be found on EDD's website.

Daniela Urban, executive director of the Center for Workers’ Rights, said it's essential for EDD to be thorough in its communications about this update.

“The workforce requirement, though it was expected that it would start again, can pose a barrier for claimants if they are not aware of the change," she said.

"Many claimants have been certifying in the same way for ... more than a year. And so it needs to be communicated clearly what this change means for claimants and how they should be marking their certification forms to make sure that they're still eligible to receive benefits on a weekly basis."

The backlog of unemployment claims at EDD has hovered around 1 million since at least mid-February. And Urban says she thinks the figures, even at these heights, are still underestimating the number of people waiting for benefits. That’s because they don’t account for applicants who haven’t been able to get through to EDD in the first place.

The latest EDD figures put the number of claims waiting for EDD to determine an applicant’s eligibility at over 220,000. There are also over 900,000 claims in limbo because applicants themselves still need to certify eligibility directly.

Urban is concerned about the impact this additional change will have when EDD's system is already in gridlock.

“The more barriers EDD places on claimants accessing benefits, the more difficult it will be for eligible claimants to continue to receive benefits until they find new work," Urban said. "EDD is already backlogged in their review of certification forms that need a manual review, and so the more information that claimants are required to report, and therefore EDD must review, is only going to slow down the process."

- Mary Franklin Harvin

The state agency responsible for creating safety rules for the workplace will meet on Thursday to consider adopting new guidelines around employee masking and social distancing.

The California Occupational Safety and Health Standards Board released its updated guidance late Friday, which, if approved, would do away with most requirements involving masks and physical distancing for fully vaccinated workers.

There are some exceptions, including locations like classrooms and mass transit, where masks would still be required for everyone, or in the event of outbreaks. General physical distancing requirements for workers would be dropped, except for certain workplaces during major outbreaks.

Additionally, under the updated guidelines, employers would be required to provide “clean and undamaged” face coverings — but not necessary N95 masks — for employees not fully vaccinated. The issue became a pain point for business groups who voiced concerns around the cost of supplies needed by health care professionals.

The updated rules are generally consistent with the broader guidelines from the Centers for Disease Control and Prevention and the California Department of Public Health that will take effect Tuesday on the state’s big reopening day.

But there’s a caveat — even if passed on June 17, the new rules wouldn’t take effect until 10 days after due to the administrative law process.

Gov. Gavin Newsom said he’d consider stepping in and using his executive powers to expedite the order at a press conference on Friday.

“I'm very mindful of those gaps and we'll address them appropriately,” he said.

Unless the governor acts, the current more restrictive worksite rules will remain in effect during that window. Under current rules, workers would have to wear masks unless every employee in a room is fully vaccinated.

—Julie Chang and The Associated Press

Some survivors of COVID-19 are calling for direct financial support and more medical leave to help those hurt by the virus.

Dozens of people across the nation who’ve had direct experiences with COVID-19, like getting sick from the virus and suffering long-term effects, or who’ve lost a loved one to coronavirus gathered virtually on Saturday to participate in the “Summer 2021 COVID Survivor Summit.”

The group is calling for national paid family and medical leave, funds for COVID memorials and programs supporting COVID survivors, including scholarships for children impacted.

There have been 62,508 COVID-19 deaths as of June 12 in California since the start of the pandemic, according to the California Department of Public Health.

The summit was put together by a national grassroots and nonpartisan group known as COVID Survivors for Change, with the goal of helping survivors find ways to use their experiences in driving policy and cultural change.

The nation and the pandemic are “at an inflection moment,” said Chris Kocher, event organizer with the group.

“There is this emotional shift in the nation. People are looking to move on. We hear a lot about this ‘get back to normal,’ right? These very heartbreaking terms that are not available for millions of Americans,” he said, adding that there’s an increased focus on raising awareness around the long-term impacts of COVID.

Kocher added, “Yes, the pandemic is beginning to come to an end, but 40,000 children have lost a parent, millions of Americans are living with the symptoms of long-COVID.”

Survivors expressed concerns about lifting COVID restrictions, like masking and social distancing requirements, especially when young children remain unvaccinated and when it’s still unclear how to check an unmasked person’s vaccination status.

Summit participants learned about how to lobby lawmakers and organize local marches and awareness campaigns.

— Julie Chang

The California Department of Public Health confirmed Wednesday that the state will align with federal face masking guidance when the state reopens next week.

The masking guidance as outlined by the Centers for Disease Control and Prevention would enable fully vaccinated people to forego wearing a mask in most indoor and outdoor situations, with some exceptions.

Masks are still required for everyone at K-12 schools and child care centers, on public transit and in health care settings — including long-term care facilities. They’ll also be mandatory in correctional facilities, detention centers, homeless and emergency shelters, and cooling centers.

"Fully vaccinated people can resume everyday activities without wearing a mask, except in a few limited settings that are required by federal and state rules," state Health and Human Services Agency Secretary Dr. Mark Ghaly said Wednesday during a briefing on the updated guidance.

People who are not fully vaccinated will still be required to wear a mask or face covering when indoors, Ghaly said, or when attending large outdoor events like concerts or sports.

State officials have previously stated their intent to lift most masking requirements when the state lifts its reopening tier system, formally known as the Blueprint for a Safer Economy, next Tuesday.

While the CDC issued its updated masking guidance on May 13, Ghaly and other state officials said they would hold off on implementing the guidance until June 15 to determine how to enforce the new rules.

On Wednesday, Ghaly said that enforcement mechanism will be, more or less, an honor system between businesses and their customers, if a business does not require customers to confirm their vaccination status or require all customers to wear a mask regardless of their status.

"Business owners will need to post requirements that people who are unvaccinated are still required to wear masks," he said. "But if somebody comes into their business or their operation without a mask, it should be considered a self-attestation for someone being vaccinated."

The state will also not require most businesses to check someone's vaccination status before they are allowed inside without a mask.

That latitude will not be afforded to indoor events with 5,000 or more attendees, which will be required through at least Oct. 1, to confirm that attendees are fully vaccinated or have tested negative for COVID-19 within 72 hours prior to the event.

According to CDPH, over 53% of eligible Californians are now fully vaccinated.

Ghaly stayed mum on how the state aligning with the CDC's masking guidance could or should affect the current workplace guidance by the California Division of Occupational Safety and Health, which requires fully vaccinated workers to wear a mask at all times if they are in a room with someone who is unvaccinated.

Cal/OSHA's Occupational Safety and Health Standards Board approved the updated workplace rules last week, and is expected to hold a special meeting Wednesday evening to discuss further updates to its workplace masking guidance.

Ghaly declined to opine on Cal/OSHA's decision-making process, citing its status as an independent commission, but emphasized that the three coronavirus vaccines available are remarkably effective at preventing serious coronavirus-related illness and death.

The state's lifting of the tier system and modification of masking requirements will take effect at 12:01 a.m. Tuesday.

— Bay City News and KQED's Laura Klivans