By Amber Dance

Marginalized children missing out on vaccines in Sunshine State

Florida’s stance against COVID vaccines for healthy children is endangering the state’s most vulnerable families, writes Lori Rozsa at The Washington Post. That’s because about 33,000 kids in the state normally get vaccines from state-run county health departments that aren’t offering the shots to kids under 5.

“That means underserved kids, especially in rural areas, are left with few options,” Rozsa writes. “Many of their parents rely on county health departments for outreach, but because of the prohibition on administering the vaccines, they’re not hearing about it.”

Florida Surgeon General Dr. Joseph Ladapo’s stance against vaccines for the youngest age group carries extra weight in minority communities because Ladapo is Black, reports Daniel Chang at the Miami Herald. (Chang is also a member of the Center for Health Journalism’s advisory board.)

“This is about equity and access,” said Dr. Lisa Gwynn, president of the Florida Chapter of the American Academy of Pediatrics. “Now poor kids [younger than 5], who normally get their vaccines from places out in the community, such as the local health departments, will no longer have access that way.”

Gwynn’s advocacy for vaccine equity got her kicked off the board of the Florida Healthy Kids Corporation, a public health insurance provider in the state.

The Florida-based supermarket chain Publix announced last week that it would not offer the vaccines for children younger than 5. The company is a frequent donor to Republican campaigns, notes Arek Sarkissian at Politico. 

Many pediatricians who do offer the vaccines have wound up tossing many doses in the trash, because they don’t have enough takers to use up all the doses in a vial, Chang reports.

Some organizations are countering the state’s messaging. The nonprofit Community Health of South Florida is reaching out to Hispanic and African-American families — who often lack services such as insurance and transportation — to spread the word and make access easier, reports Marissa Bagg at NBC Miami.

During the pandemic, 27 Florida children under the age of 5 have died of COVID-19, notes Sam Ogozalek at the Tampa Bay Times.

While the vaccines don’t eliminate the risk of infection, they can significantly blunt COVID’s severity. A new study in the New England Journal of Medicine, looking at 5-to-11-year-olds during the omicron wave in Singapore, indicated Pfizer’s vaccine was more than 80% effective against hospitalization.

 Mask mandates become a local issue

With the highly transmissible omicron BA.5 strain circulating widely, it seems nowhere is safe — the virus even reached the Oval Office last week, though Biden is reportedly doing fine.

“State health officials are out of ideas,” write Megan Messerly, Krista Mahr and Adam Cancryn at Politico. “State and federal strategies for managing 130,000 new daily COVID cases in the U.S. are largely the same as they were for managing 30,000 new daily cases four months ago.”

Thus, the task falls to county leadership, school districts and other organizations.

According to the CDC, Americans in more than 40% of counties should definitely be wearing masks indoors, and people in nearly as many counties should consider doing so. Across the nation, a patchwork of mandates are expiring or being reinstated.

“Masking makes sense, but in a highly targeted way,” John Brownstein of Boston Children’s Hospital told ABC News. “These are not broad scale mask mandates across the country for undefined amounts of time … this is why it’s done at the local public health level.”

In San Francisco, for example, riders on BART trains no longer have to mask up, though face coverings remain “strongly encouraged.”

And Hawaii, the last state hanging onto a mask mandate for public schools, will ease those regulations in August.

Meanwhile, San Diego Unified School District is bringing back its mask mandate, based on a trigger set in May that brings back the mandate when the county reaches “high” COVID status per CDC. Celebrants at the city’s Comic-Con convention will have to wear masks — the safety kind — as well.

Los Angeles is also staring down a trigger-based mandate, which will kick in July 29 unless the county’s CDC status drops from high to medium.

“L.A. is like no other county in the United States,” write Rong-Gong Lin II and Luke Money at the Los Angeles Times. Many of its 10 million residents face crowded housing and poverty that amplify COVID risk. “When a new wave hits, a place like L.A. County may be hit disproportionately harder than neighboring places.”

 Yes, the COVID vaccine could affect your period

Rumors about the vaccines’ effects on menstruation have been swirling for some time, and a newly published survey supports the idea that periods can become heavier, or lighter, or even reappear after menopause in newly vaccinated people.

The study, published in Science Advances, includes reports from 39,000 people who do or used to menstruate, and is the largest published to date on the link between vaccines and period patterns. Most respondents had received a Moderna or Pfizer vaccine, but other types were also included.

Among people who experience regular cycles, 42% reported heavier flow after vaccination, while 14% said it was lighter.

Among postmenopausal women, 66% of participants reported breakthrough bleeding after getting a shot. And 39% of people on gender-affirming hormone treatments that normally block menstruation also reported breakthrough bleeding.

It’s important to understand these effects, writes Jennifer Couzin-Frankel at Science. Post-menopausal bleeding can be a sign of uterine cancer, so women and doctors could worry unduly if they didn’t know COVID shots can cause it too. And breakthrough bleeding in people who’ve chosen to no longer menstruate can cause distress.

“I think it’s important that people know this can happen, so they’re not scared, they’re not shocked and they’re not caught without supplies,” study author Katharine Lee of Washington University School of Medicine in St. Louis told The New York Times’ Knvul Sheikh.

The menstrual changes could be due to the influence of the vaccine-activated immune system on sex hormones or the cells that manage the uterine lining.

The study authors cautioned that their respondents were people who elected to take a survey on vaccines and menstruation, and thus were more likely than the average person to have issues to report. There was no control group.

Experts told Sheikh these period patterns are no reason to delay vaccination.

Despite changes to menstruation, there is no evidence that vaccines alter fertility.

 Hospitals see fewer cases of MIS-C

The post-COVID inflammatory syndrome that once plagued children “has almost disappeared,” writes Denise Roland at The Wall Street Journal.

Rates of MIS-C closely tracked case rates until the omicron wave, when infections skyrocketed but MIS-C stayed low.

The condition is treatable, but it has killed 70 children during the pandemic.

There are likely two reasons behind the decoupling of COVID and MIS-C. One is that many children have some immunity to the virus now. Small studies suggest that vaccination greatly reduces risk for MIS-C.

The other explanation is that the virus itself has mutated in ways that make it less likely to trigger the excess inflammation of MIS-C.

But it remains possible the virus could mutate again and raise MIS-C risk, cautioned Dr. Anna Sick-Samuels of the Johns Hopkins University School of Medicine.

 CDC recommends Novavax

The long-delayed Novavax vaccine cleared a final hurdle last week, gaining the CDC’s recommendation for its two-dose, initial vaccine series.

The vaccine is expected to hit pharmacy shelves within weeks, but few people are expected to line up. A recent CDC poll found that about 10% of unvaccinated people have been patiently awaiting this shot, which is based on a traditional, protein formula, unlike the mRNA-based vaccines from Pfizer and Moderna.

Novavax’s shot has not yet been authorized as a booster.

“Novavax is a great vaccine for the unvaccinated, and it will save millions of lives,” writes epidemiologist Katelyn Jetelina on her blog. But it’s no “silver bullet,” she adds. “We desperately need the funding and the drive for second-generation vaccines, like pan-coronavirus vaccines (variant proof) or nasal vaccines … to finally get ahead of this virus.”

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Pandemic slashed Native American life expectancy

An updated preprint finds that American Indian and Alaska Native populations took the biggest hit to life expectancy of any American race during the pandemic.

An earlier version of the study found steep dips for Black and Hispanic populations between 2019 and 2021, but the drop of 4.71 years for Native American populations is even worse.

“We were horrified to see how large [the change] was,” said study author Dr. Steven Woolf of Virginia Commonwealth University.

As for the reason behind racial disparities, Woolf pointed to inequities not only in health care but also in social factors that contribute to health, including access to education, housing, and jobs that pay a living wage.

A recent CDC report, focusing on Alaska, delineates how AI/AN people in the state are at increased risk for COVID-19. Their risk for illness, hospitalization or death between March 2020 and December 2021 was more than double that for white residents.

Potential causes for the disparities include structural racism and inhabiting remote, rural areas where health care is limited and getting to providers often requires lengthy journeys.

The agency called for “culturally competent public health efforts that are designed in collaboration with AI/AN persons and communities” to combat the problem.

Moderna’s omicron formula boosts antibodies

Moderna’s top candidate for a fall COVID booster is a one-two punch that delivers mRNA for the original coronavirus spike protein plus the omicron version. The company announced Wednesday that this approach increased antibodies against omicron and could have long-lasting effects.

On average, the 437 adults in the trial had their blood’s ability to block the omicron variant rise by a factor of eight compared to their pre-boosted levels.

Based on that eightfold amplification, Moderna’s chief medical officer Dr. Paul Burton thinks the booster’s effects might last for a year, reports Ian Sample at The Guardian.

“For the first time, we could really be looking at the potential for just once-yearly boosting,” said Burton, “because we can get people to such a high level that they will take longer to decay.”

There’s another way to look at Moderna’s data, comparing those omicron-boosted people to 377 subjects who received the original-formula booster. In that case, the new bivalent shot led to a more modest increase in antibodies that worked against omicron, by a factor of 1.75.

There’s a caveat: Moderna’s new formula uses the genetic code for the BA.1 omicron variant, which is no longer the dominant variant of concern. In the U.S., BA.4 and BA.5 are rapidly gaining ground.

“Many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines,” writes Sharon LaFraniere at The New York Times.

Moderna president Dr. Stephen Hoge said that in a very small dataset, it looked like the new booster still generated enough antibodies that worked against BA.4 and BA.5, albeit at a lower level than it countered BA.1.

Burton told The Guardian, “I feel confident it would hold up against the [omicron] family now.”

The only way to catch vaccines up with viral evolution, writes LaFraniere, would be to skip human trials for each booster. This is what’s done for the yearly influenza shot, and it’s an approach many health care professionals would be comfortable with, according to virologist John Moore of Weill Cornell Medicine in New York.

The FDA’s vaccine advisory committee will meet on June 28 to discuss booster formulas for fall. Pfizer is also testing booster that targets omicron.

The shot could be available to adults as soon as late summer, said Moderna CEO Stéphane Bancel in a press release.

Moderna plans to study the updated booster in children, but it’s possible the FDA could authorize an omicron-specific booster for all ages without those studies, reports Alexander Tin at CBS News.

FDA committee greenlights Novavax shot

A group of outside experts convened by the FDA voted on June 7 that the benefits of Novavax’s protein-based coronavirus vaccine, in a two-dose series, outweigh the risks.

The vote was 21-0, with one abstention. The abstainer, Dr. Bruce Gellin of the Rockefeller foundation, characterized his vote as a “conditional yes.” He was satisfied with the company’s data on their vaccine’s 90.4% efficacy against the viruses circulating in late 2020 and early 2021, but he wondered how it would hold up against omicron.

Novavax is already testing an omicron-specific booster in a trial in Australia, report Jacqueline Howard and Nadia Kounang at CNN.

The vote came 18 months after emergency authorization of the first coronavirus vaccine, and Moderna’s and Pfizer’s shots for adults are now fully approved. Some panelists questioned whether the adding another kind of vaccine merited the emergency authorization Novavax requested. In nations where the Novavax vaccine is already authorized, uptake has been low.

The FDA’s Dr. Peter Marks countered that this vaccine, based on viral protein instead of mRNA, might be more palatable to some vaccine-hesitant Americans.

“Anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical produces is something that we feel we are compelled to do,” said Marks.

Martha Dawson, president of the National Black Nurses Association, told the panel that some patients would be more comfortable with the traditional, protein-based formula.

People who are allergic to ingredients in the mRNA vaccines might be able to tolerate the Novavax shot.

Its higher stability at refrigerator temperatures is also an advantage over the mRNA shots.

But the FDA did raise a red flag over five cases of inflammation in or around the heart, mostly in young men, that occurred shortly after vaccination.

Novavax argued that this rate, 0.007%, wasn’t significantly different from the 0.005% rate of heart inflammation among subjects who received a placebo shot.

The vaccine is not shipping to pharmacies yet. The final decision is still up to the FDA, which is resolving concerns about the manufacturing process.

The vaccine is made at the Serum Institute of India, and the FDA wants confirmation that the Serum product is a match in quality for the shots used in the clinical trials.

The CDC’s vaccine committee would then likely weigh in on whether that agency should recommend the shots. The committee has meetings scheduled later in June, but the CDC has not yet posted detailed agendas.

Should the vaccine be authorized by FDA and recommended by CDC, the Biden administration has plans to purchase “a limited quantity,” report Carl Zimmer and Rebecca Robbins at The New York Times.

But slow and steady could still be a winning strategy: Novavax hopes the vaccine will find a place in ongoing booster regimens.

WH shuffles funds to pay for vaccines, treatments

The Biden administration, still waiting for Congress to release more funding to counter the pandemic, will move money around to pay for vaccines and treatments in the coming months, reports Tony Romm at The Washington Post.

The funds, about $10 billion, will be pulled from programs focused on testing and stockpiling of personal protective equipment and ventilators, an anonymous official told Romm.

The move could also mean cuts to further research on vaccines and treatments.

On Wednesday, the White House shared preliminary plans for distributing vaccines to children younger than 5. Authorization for this age group is widely expected after FDA and CDC advisory committee meetings on June 15 and June 18, respectively. June 21 is the earliest the shots could be available.

The vaccine will be free at pharmacies, but the administration also hopes to put it on offer at physician’s offices and health clinics as well as libraries and children’s museums.

Five million kid-sized doses from both Moderna and Pfizer are already available for pre-order, with millions more expected to be released within weeks. So far, states have ordered fewer than half of those doses, with Pfizer proving more popular.

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American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot.

Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option.

N ovavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But U.S. clearance is a key hurdle for the Maryland-based company.

FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts — whatever their reason — to consider rolling up their sleeves.

“We do have a problem with vaccine uptake that is very serious in the United States,” Marks said. “Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.”

A final FDA decision isn’t expected immediately, as the agency finishes combing through the data.

Nor is it clear how widely a Novavax vaccine would be used, at least right away. Only about 27 million U.S. adults remain unvaccinated, according to the Centers for Disease Control and Prevention. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines, regardless of which shot people got originally.

The FDA advisory panel voted that the benefits of two primary Novavax doses outweigh its risks — but they had a lot of questions about the shots’ role at this point in the pandemic.

“This vaccine does indeed fill some unmet needs,” such as an option for people with allergies to competing shots, said Dr. Michael Nelson of the University of Virginia.

But the FDA is considering two adult doses for now, when other COVID-19 vaccines have needed a third dose, he said.

And while “this vaccine has incredible potential,” there’s no clear evidence yet of how well it works against the more contagious omicron variant and its siblings, added fellow adviser Dr. Bruce Gellin of the Rockefeller Foundation.

Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. One complication: Those studies were done far earlier in the pandemic.

Novavax chief medical officer Dr. Filip Dubovsky said tests of a booster dose revved up virus-fighting antibodies that could tackle the omicron mutant, data that FDA will have to consider later.

This type of vaccine “we think generates a broad immune response against a broad array of variants,” he told the FDA advisory panel.

Trial participants generally experienced only mild reactions such as injection-site pain or fatigue, but the FDA did highlight a possible concern: six cases of heart inflammation, known as myocarditis, found among the 40,000 people who received the vaccine in studies.

COVID-19 vaccines are coming under close scrutiny for the possibility of heart inflammation after the Pfizer and Moderna shots were linked to that rare risk.

Novavax argued there were other potential causes for the reports. Other infections including COVID-19 also can cause heart inflammation. The company said more than 744,000 vaccinations in other countries so far support the shots’ safety.

Several of FDA’s advisers said the Novavax vaccine should come with a warning until more is known but cautioned against comparisons with the Pfizer and Moderna shots’ estimated rate of the rare side effect.

“I don’t want to stigmatize this vaccine inappropriately,” said Dr. Cody Meissner of Tufts University.

The Novavax vaccine is made of copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.

That’s very different than the vaccines currently used in the U.S. The most widely used Pfizer and Moderna vaccines deliver genetic instructions for the body to produce its own copies of the spike protein. J&J uses a cold virus to deliver those instructions.

Manufacturing problems held up Novavax’s vaccine but the company said those problems have been resolved. Novavax, a small biotech company, created the vaccine in its research lab. But the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots including those slated for the U.S.

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