If you are confused by all the talk about COVID-19 booster shots, you are not alone. And it is not your fault.

One week into September, the only official recommendation from the Food and Drug Administration is an additional dose of vaccine for the 3% of the U.S. population that is immunocompromised. Technically speaking, the added dose for those folks is not a booster per se but an effort to improve a less than optimal immune response to the first set of shots. (For helpful insights on how cancer patients respond to COVID-19 vaccine, see Carina Storrs’ review in Cancer Therapy Advisor.)

However, the Biden administration has announced that booster shots will roll out for the general population starting the week of September 20, pending green lights from regulatory agencies. The heads of the FDA, Centers for Disease Control and Prevention and National Institutes of Health, along with the Surgeon General and top White House medical advisors, issued a joint statement on August 18 endorsing this approach. This came just six weeks after the FDA and CDC announced that “Americans who have been fully vaccinated do not need a booster shot at this time.”

The difference between then and now, they say, is Delta, the viral variant wreaking havoc on fond hopes of moving us past the pandemic. COVID-19 cases, hospitalizations and deaths are not fading into the summer sunset, but instead surging once more (more than 100,000 people now hospitalized in the U.S.). It’s also complicating another fond hope: of having school at school. Local outbreaks of COVID-19 have already put thousands of young students in quarantine rather than in the classroom.

The Biden administration says it wants to stay a step ahead of Delta and thwart the resurgence by making booster shots available to all, but the scientific community is less than convinced that a blanket approach is best. In MM+M, Lecia Bushak explores whether the White House jumped the gun and preempted the FDA and CDC on the booster plan. The confusion and mixed messaging that plagued the original vaccine rollout earlier this year may be coming back to haunt us in the booster era.

The CDC’s Advisory Committee on Immunization Practices met last week and suggested that a booster rollout might prioritize those at highest risk of COVID-19, such as healthcare personnel, long-term care residents and the elderly in general. The ACIP has not made a formal recommendation just yet as it seeks more evidence to sort out the options. The FDA has its own Advisory Committee on vaccines, but it isn’t meeting to discuss boosters–specifically, the booster application from Pfizer/BioNTech–until September 17, the Friday before the Monday when the rollout is expected to begin.

The burning question remains: Who needs a booster, and when? Are we talking eight months after the last shot? Six? Those who doubt the need for population-wide boosters say that the vaccines remain highly effective, even in the face of Delta, in preventing severe disease, hospitalization and death.

CDC Director Dr. Rochelle Walensky suggests that more data, both national and international, will make it clear that boosters for all, sooner rather than later, is the way to go. Dr. Anthony Fauci, chief White House medical advisor, pointed to “dramatic” results in Israel in the older population with boosters and said that three shots could well become the new definition of “fully vaccinated.”

Meanwhile, some people are taking matters into their own hands, or arms, and are seeking, and getting, booster shots now. Let’s call them booster roosters, early risers who want to be first in line.

At the end of August, the CDC reported that nearly 1 million Americans have received booster shots. It is not clear just how many of them are immunocompromised and how many are not. Anecdotal reports of booster-seekers abound.

We know of one older couple in New Jersey that was planning to take an end-of-summer driving vacation. They wanted an extra measure of protection and had no trouble getting boosters through a local hospital. My sister in Oklahoma reports that two friends walked into a pharmacy and walked out with boosters, no questions asked.

The booster discussion has centered on the two-dose mRNA vaccines, Pfizer/BioNTech (Comirnaty) and Moderna, which together account for 95% of doses given in the U.S. It now appears likely that Pfizer boosters will roll out first, based on the company submitting its supporting data to the FDA about two weeks ahead of Moderna.

Nothing is simple. Moderna submitted booster data for a 50-microgram dose of the vaccine, half the dose of its original vaccine. The company has also tested the 100-microgram dose as a booster. The FDA may want to weigh both options.

If you are one of the 14.5 million Americans who have received the single-shot J&J vaccine, the advice is to be patient and hang in there. J&J shared promising booster data in a recent press release and said it is “engaging” with the FDA and CDC on the matter.

Several industrialized countries have already started booster programs or will launch them this month, the New York Times reports, including Germany, France, Israel, and the Czech Republic. The emphasis is generally on older folks and people with underlying health conditions. The European Centre for Disease Prevention and Control sees no urgent need to give boosters to fully vaccinated people in the general population and says the priority is to get first and second shots into the arms of the unvaccinated or partially vaccinated.

Meanwhile, we can’t lose track of the global equity picture, which has much of the world wondering why a few rich countries are launching booster programs when many other countries are struggling to get their initial vaccination campaigns off the ground.The U.S. has fully vaccinated 53% of its population, 62% of the vaccine-eligible (ages 12 and up), 64% of adults and 82% of seniors. Around the world, immunization rates vary widely and wildly, from more than 70% of the population fully vaccinated in Singapore (79%), Uruguay (73%) and Spain (72%) to single digits or low double-digits in much of Africa and Asia, including Indonesia and the Philippines (both at 14%), Egypt (3.2%), Kenya (1.5%) and Tanzania (0.5%). World Health Organization officials this week called the discrepancy “unfair” and “immoral” and said it was prolonging the pandemic and costing human lives.

The push

•  Walgreens launched a national marketing campaign encouraging customers to visit for their flu and COVID-19 shots, Betsy Kim reports in PRWeek. “Our goal is just to remind people that getting vaccinated is the best thing you can do to protect yourself from COVID, as it has always been the best thing you can do to protect yourself from a flu infection,” said Walgreens CMO Pat McLean. The campaign includes a 30-second video showing people heading to different destinations and congregating in groups. It ends with a customer getting vaccinated at Walgreens with the voice-over, “Before you go there, start here.”

•  Hard opposition to vaccination has dropped to 14% among U.S. adults, according to the end-of-August Axios-Ipsos Coronavirus Index. More than two-thirds of parents surveyed (68%) said they are likely to have their kids vaccinated or have already done so, up from 56% in mid-August. Fewer than one third of parents (31%) are unlikely to have their children vaccinated, down from 44% over the same period.

•  Health officials in the U.K. are not recommending universal vaccination of 12- to 15-year-olds just yet but are starting with youngsters considered clinically vulnerable to COVID-19. As Nick Bostock explains in GP, this group includes adolescents with sickle cell disease, diabetes and other chronic medical conditions as well as children living with at-risk adults. The U.K. government is asking the chief medical officers of its four member nations to weigh in on the need for vaccination of the entire 12-15 age group.

•  In a 20-minute podcast conversation, Stan Bergman, CEO of Henry Schein, chats with American Medical Association president Dr. Gerald Harmon about the physician’s role in mitigating vaccine hesitancy and explores how the pandemic has illuminated longstanding inequities in healthcare.

Source: Getty Images.

The mandates

•  According to Fortune magazine, over half (52%) of US employers expect to have some kind of vaccination mandate by the end of the year. Companies are also considering surcharges for unvaccinated workers.

•  Support continues to grow for vaccination mandates in nursing homes and assisted living centers, Kimberly Bonvissuto reports in McKnight’s Senior Living, but many are ”holding their breath” on the workforce impact. After making vaccination a condition of employment, Juniper Communities, with facilities in New Jersey, Pennsylvania, Texas and Colorado, lost 40 people (2% of its workforce) but then saw employment applications rise.

•  The Colorado Assisted Living Association estimates that 10% of the assisted living workforce will be lost to mandates, Bonvissuto writes. Staff nurses are declining to renew their licenses, taking early retirement and switching to “non-24/7” jobs with lower risk and higher pay.

•  The majority of skilled nursing facilities in Kentucky worry that they will lose 11% of their workers to vaccine mandates, Amy Novotney notes in McKnight’s Senior Living. Novotney also reports that employees who resign over vaccine mandates may not qualify for unemployment compensation.

•  Three nursing homes in rural Maine are closing after “exhausting every staffing resource,” Kimberly Marselas reports in McKnight’s Long-Term Care News. The pandemic “has taken an unbelievable emotional toll” on workers, said Jess Maurer, executive director of the Maine Council on Aging. “Across the whole state we’re seeing staff, vaccinated or not, walking away from their jobs.” A statewide vaccination mandate for healthcare workers takes effect October 1.

•  Rhode Island’s home care industry is struggling with resignations prompted by a looming state vaccination mandate. Diane Eastabrook and Liza Berger of McKnight’s Home Care Daily offer details and insights.

•  Chicago’s United Center now requires proof of COVID-19 vaccination or a negative test for everyone 12 and older at Bulls and Blackhawks games and other events under its roof. The requirement does not apply to players; that particular ball/puck is in the NBA’s/NHL’s court/rink.

The challenges

•  The American Nurses Association says that “nurses are tired and frustrated as this persistent pandemic rages on with no end in sight.” The ANA is urging the Department of Health and Human Services to declare the nurse staffing shortage a national crisis. The organization wants HHS to help develop short and long-term staffing solutions, work toward pay equity and educate the nation on the importance of COVID-19 vaccine.

•  The AP reports on the plight of overwhelmed hospitals in Mississippi, the least vaccinated state (38%). Samaritan’s Purse, an international Christian relief organization, set up a field hospital in the parking garage of the University of Mississippi’s children’s hospital. “To respond to the United States is quite surreal for us,” said Kelly Sites, a nurse who has gone on missions to Haiti, the Philippines and Liberia. “This is the first time where home is the disaster.”

•  The WHO has added to its list of SARS-CoV-2 variants of interest. The Greek letter is mu and the variant, first identified in Colombia in January, has a number of mutations that could make it more resistant to vaccines. Mu is increasingly prevalent in Colombia and Ecuador with sporadic cases reported elsewhere in South America and Europe.

•  Although Hurricane Ida has come and gone, Delta’s path of wreckage continues. COVID-19 hospitalizations of children and adolescents rose fivefold between mid-June and late August, according to a CDC report based on data from 14 states. Hospitalization rates were 10 times higher in unvaccinated adolescents than in vaccinated ones.

•  On Labor Day, daily COVID-19 infections in the U.S. were more than four times higher than they were a year prior. Daily deaths were nearly twice as high. U.S. cases to date in 2021 now exceed the total for all of 2020.

Source: Getty Images.

The rest

•  Delta is not the only thing that’s surging. Rapid home tests for COVID-19 are in high demand.

•  At the Western Ranchman Store in Phoenix, tubes of the antiparasitic ivermectin for horses are galloping off the shelves, bought by humans who believe it can prevent or cure COVID-19. Related: The AMA, American Pharmacists Association and American Society of Health-System Pharmacists have united in a call for an immediate end to the prescribing and dispensing of ivermectin (human formulation) for COVID-19.

•  Beyond vaccines: Pfizer and Merck/Ridgeback Biotherapeutics are pursuing clinical trials of antiviral pills for early treatment (Pfizer) or prevention (Merck) of COVID-19. Alicia Lasek has details in McKnight’s Long-Term Care News.

•  A number of international airlines won’t accept cloth masks as a face covering for passengers, Travel + Leisure reports. Some specifically ban bandanas, balaclavas and scarves.

•  A 31-year-old New Jersey woman is accused of selling counterfeit COVID-19 vaccination cards for $200 through an Instagram account called AntiVaxx Momma. The district attorney identified 14 customers – all frontline workers, including some employed by hospitals and nursing homes.

•  Three radio talk show hosts openly critical of COVID-19 vaccination have died of the disease.

•  If you have returned from summer hiatus to a tsunami of accumulated email, fret not. A helpful tonic is The Atlantic’s interview with Oliver Burkeman, author of Four Thousand Weeks: Time Management for Mortals.

•  MM+M’s Steve Madden compares living through the pandemic to flying westward into an endless night. He has decided to create his own sunrise: Fully vaccinated and armed with masks and hand sanitizer, he’s heading back to Haymarket Media’s NYC offices at least a few days a week.

Parting shot

The CDC urged Americans, especially the unvaccinated, to avoid traveling over Labor Day weekend. Nonetheless, more than 2 million found their way through airports on Labor Day (twice as many as a year ago), and hundreds of thousands decided to travel just far enough to get to the nearest college football stadium. Dr. Fauci doesn’t think this is a very smart move for an educated audience.

At the University of Michigan, 109,925 came to the Big House and saw the Wolverines begin their season with a 47-14 defeat of the Western Michigan Broncos. University policy encourages but does not require face coverings in outdoor areas of the stadium. The university also has a mandatory COVID-19 vaccination policy for students, faculty and staff. More than 1,000 colleges in the U.S. now have some form of mandate.

…in lieu of some songs

“The Names”, a poem commemorating the victims of the 9/11 attacks, read by Poet Laureate Billy Collins to a joint session of Congress at Federal Hall in New York City on September 6, 2002.

Text of “The Names

Thank you. Stay safe, stay well and take a moment to remember and reflect.