FDA Greenlights Second COVID-19 Vaccine for National Use

Health care workers across the U.S. are getting a new arrow in their quiver.

On Friday, just one week after Pfizer and BioNTech's COVID-19 vaccine received a federal green light, the Food and Drug Administration formally authorized a second vaccine for emergency use — this one developed by Moderna. The biotech upstart won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be 94% effective at preventing the disease.

California is expecting 672,000 doses of the vaccine in coming weeks.

"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day," said a statement by FDA Commissioner Stephen M. Hahn, M.D.

The FDA decision represents another leap forward in the effort to combat the coronavirus, which has already killed more than 300,000 people in the U.S. alone. Since the Pfizer vaccine's authorization last week, health and defense officials have launched a vast effort to distribute millions of doses across the country. Health care workers and older adults were first in line for the inoculations when providers began administering them Monday.

In a push to inspire public confidence in the vaccine, Vice President Mike Pence on Friday became the country's highest-ranking official so far to have it administered. Pence, his wife, Karen, and Surgeon General Jerome Adams all received their shots during a televised event at the White House.

Amid the flurry surrounding the Pfizer vaccine's rollout, Moderna's alternative was making steady headway in its own push toward authorization. The FDA released a glowing analysis of the vaccine on Tuesday, finding "no specific safety concerns." On Thursday, an outside panel of health care experts from across the U.S. unanimously recommended the vaccine with one abstention.

"The question that's being asked us is, 'Do we have enough evidence in hand to say that the benefits of this vaccine outweigh what at the moment, as far as severe safety issues go, are theoretical risks?'" Dr. Paul Offit, panel member and vaccine researcher at the Children's Hospital of Philadelphia, said during the hours-long recorded meeting.

"I think the answer to that question is clearly yes. I mean, the question is never 'When do you know everything?' It's 'When do you know enough?'"

Read the rest of the NPR story here

Colin Dwyer, NPR

Marin County Expands Vaccinations to More Essential Workers

Marin County on Wednesday expanded vaccinations to workers in education, food service, child care, agriculture and emergency services.

That means everyone in the county who is categorized under phases 1A and 1B of the state's vaccination plan, including health care workers and residents 65 and older, can now get an appointment for a vaccine.

The county says it's opening up its vaccine program because it has administered shots to more than 60% of eligible residents 65 and over.

Marin warned that appointments remain limited due to a shortage of available doses

"Measures are being taken to reserve doses for those at highest risk, and some health care providers may continue to prioritize vaccine for patients who are 65 and older and have not yet had an opportunity to be vaccinated," the county said in a press release.

San Francisco issued a similar warning earlier in the day when it made its own announcement on expanding eligibility,

Marin says its public health department will be in touch with employers of newly eligible essential workers so they can connect employees with vaccination options.

Appointments at Walgreens, CVS, Rite Aid, Costco and Safeway pharmacies will also be available through the state's My Turn appointment site.

"More pharmacies plan to start offering vaccine to Marin residents in the next two weeks as doses become available," the county said.

Check Marin's vaccine website for all information related to vaccination in the county, including this list of public and private vaccine providers.

According to Marin, more than 50,000 residents, or 19.3% of everyone who lives in the county, have received at least one dose of vaccine.

Any Marin County resident can sign up online to be notified when they are eligible for a vaccine.

—Jon Brooks

SF-Based One Medical Let Well-Connected Patients Skip COVID-19 Vaccine Line

A national health care provider has administered COVID-19 vaccinations to patients not yet eligible for the scarce vaccine, including those with connections to company leaders and customers of its concierge medical service, according to internal communications leaked to NPR.

San Francisco-based One Medical has been allocated thousands of vaccine doses by local health departments in some of the areas they provide medical services. People with connections to company leadership were set up with vaccine appointments, despite not yet being eligible under local public health guidelines, and some patients were permitted to skip the line ahead of other high-risk patients.

The problems have occurred in numerous company locations across several states. The Washington State Department of Health, citing a complaint it received this month, told NPR it had halted COVID-19 vaccine distribution to the company. Other regulators have also received complaints or stopped providing the vaccine.

One Medical brands itself a high-end health care provider serving a relatively affluent clientele that pays a $199 fee annually to receive easy online access to appointments, telemedicine and access to a streamlined, tech-focused medical experience. The company went public with an IPO in January 2020, with a valuation in the billions.

One Medical's shortcomings take place amid broader anecdotal evidence that suggests patients of various health care providers throughout the country are skipping the line due in part to loose enforcement. The situation highlights a serious ethical issue: determining who is entitled to a vaccine at a time of scarce availability and who is responsible for enforcing eligibility rules.

Read the full story.

Tim Mak, NPR

Many Homebound People Still Waiting for Vaccine

Even as more coronavirus shots are administered every day, providers are still figuring out how to vaccinate people who are homebound.

Beth Freeman describes herself as a caretaker-daughter. She lives with Her 83-year-old father, Jim, in San Mateo County. He has Parkinson's disease, doesn't walk and receives care at home provided by Sutter. But the Freemans still don't know when he can get vaccinated, even though he's eligible.

"The one thing my dad does every day is he watches the news," Beth said. "I’m trying to understand how he feels seeing everybody get the vaccine. ... And here he sits at home at 83 with a hugely compromised physical situation."

Health officials around the Bay Area have been holding mobile clinics at places like senior housing centers. But they say going home to home with vaccinations is difficult because of complicated cold storage procedures.

Sutter says the logistics of giving shots to individuals at home are "challenging."

“Currently approved COVID-19 vaccines have complex and specific reconstitution, safe handling and timely administration requirements that make in-home vaccination on an individual basis challenging for all health care organizations," a Sutter Health spokesperson said in an email. She said the company is working toward vaccination capability for home health and hospice patients who are unable to travel to a clinic.

Kaiser says it has done limited outreach to some homebound patients who have been previously hospitalized, reside in a skilled nursing facility or in other circumstances in which they have received a first dose and need a second to complete their inoculation.

"We look forward to launching a larger program throughout Northern California as the vaccine supply becomes more plentiful and the types of vaccine make portability into the home more readily possible," Kaiser said.

The San Francisco health department's Health at Home program provides home health services to some of the county’s most vulnerable residents. The program began administering coronavirus vaccines to clients this week. David Snyder, who heads the program, says his team puts individual doses into a temperature-controlled container then drives to people's homes.

He says patients "have been shocked that we called and offered" them shots. They're "ridiculously appreciative that this service is getting off the ground," Snyder said.

His team plans to give as many as 10 vaccinations a day.

Napa County is conducting mobile vaccination clinics this week, going door to door at senior apartment complexes and mobile home parks.

Contra Costa Health Services has begun running mobile clinics at low-income senior housing and board and care facilities, but said it does not have the capacity to offer individual home visits yet.

Alameda County says it's in the planning stages of how to vaccinate people with mobility issues who live in their own home. At senior affordable housing sites, health care workers have been going floor to floor instead of setting up in one common area in order to vaccinate those who are too frail to move very far.

Polly Stryker and Jon Brooks

Travelers to San Francisco From Outside Bay Area No Longer Required to Quarantine

San Francisco has lifted a 10-day quarantine order for residents who've traveled outside of the Bay Area, city health officials said Tuesday.

The local health order was instituted in December as the city and the state were experiencing a surge in COVID-19 cases. But the region as well as the state have seen a significant drop in new infections.

Although the local quarantine order has been lifted, health officials are continuing to urge residents to avoid non-essential travel outside the Bay Area and out of state. Residents who do so are still being advised to quarantine for 10 days.

"Lifting this order does not mean that it's now safe to just hop on a plane or go on a road trip," said Dr. Susan Philip, San Francisco's acting health officer, in a statement. "This is not a travel free-for-all. We've made tremendous progress and brought our case numbers down, but we need to keep our guards up. The growing prevalence of variants, some of which were brought from abroad, is further proof that we must be extra cautious. If we do everything we are supposed to — wear our masks, practice physical distancing, avoid indoor gatherings with other households — we can continue to reopen businesses, schools and community activities. Voluntarily quarantining after traveling out of state or 120 miles from home helps protect everyone."

Travel, especially in shared vehicles like airplanes, buses and trains, can increase the risk of getting and spreading COVID-19.

"If there’s an alternative to travel and you can go to Wine Country or you can go somewhere closer to get that travel bug out of you, it’s still a decent time. California has tons of places to go visit," said UCSF infectious disease specialist Dr. Peter Chin-Hong.

—Bay City News and Arooba Kazmi

FDA Scientists Endorse Johnson & Johnson Vaccine

Scientists at the Food and Drug Administration said Wednesday that the single-shot COVID-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.

Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.

Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.

The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.

Read the full story.

Matthew Herper and Helen Branswell, STAT

San Francisco Vaccine Expansion Includes Teachers, But Appointments Scarce

San Francisco on Wednesday opened up vaccination to education, child care, emergency service and food and agricultural workers who live or work in San Francisco. The expansion into Phase 1B of the state's vaccination plan had been previously announced.

The city says, however, that a shortage of vaccine means appointments for the first of two required shots will be limited, as San Francisco has advised health care providers to prioritize second doses.

"The increase in second dose appointments puts additional strain on San Francisco’s COVID-19 vaccination network," the city said in a press release. "As more people become eligible for their second doses of the COVID-19 vaccine and yet supply does not increase significantly, health care providers are unable to offer as many first dose appointments."

Vaccination of teachers and education workers has been a major issue in ongoing negotiations between San Francisco Unified School District and unions over reopening classrooms for on-site instruction.

Today's move adds as many as 168,000 vaccine recipients to the 210,000 health care workers and people over 64 years of age who are already eligible, the city says.

San Francisco says 18% of residents 16 and older have now received their first dose of vaccine.

Check San Francisco's vaccination hub for eligibility information and links to appointment websites, including those from private health care providers like Kaiser and UCSF.

If you live or work in San Francisco, sign up here to get notified when you become eligible for vaccination.

Jon Brooks

Lawmakers Face Escalating Pressure in School Reopening Debate

At a recent meeting of the Fremont Unified School District Board of Education, Superintendent CJ Cammack presented the results of a self-selecting survey of parents, asking their feelings about continuing remote learning across the district's 42 schools.

The survey results should have provided a level of comfort for the elected board to stay the course: 63% of the nearly 11,000 parents who responded said they preferred to have their child remain in distance learning for the rest of the school year.

Then the public comment period began.

For nearly an hour, parents called in to levy their frustrations at the board, urging its members to produce a plan to reopen classrooms in the Bay Area's third largest school district.

"What about the 36% of the district? Are they not important?" asked Irene Shen, a district parent. "Not every parent will come here to speak but everyone will vote with their feet."

The status of public schools in California has remained largely static in the year since the pandemic began: Most remain shuttered, and large Bay Area districts like San Francisco, Oakland and Fremont have been in distance learning throughout the pandemic.

But the political landscape is shifting rapidly as local and state officials attempt to chart the course for a potential return to class. Finding a consensus among parents on such an emotionally charged issue is proving impossible, with surveys and polling providing limited guidance.

Read the full story.

Guy Marzorati