By Amber Dance

In about-face, Moderna announces plans to make vax free

Moderna’s COVID vaccine grew out of a longstanding collaboration with the U.S. National Institutes of Health, and the government granted the company nearly $2 billion to develop the shot. So why did Moderna plan to charge Americans up to $130 for the vaccine once the federal emergency ends in May?

That question has certainly been on Vermont Sen. Bernie Sanders’ mind. He is calling Moderna CEO Stéphane Bancel (net worth approximately $5.4 billion) before the Senate Health, Education, Labor and Pensions Committee on March 22.

Sanders called Moderna a “poster child” for pharmaceutical industry greed in an interview with Liz Goodwin at The Washington Post. 

“I hope, I really do hope, that these people will reconsider this outrageous decision and decide not to raise prices for the vaccine,” Sanders said.

His wish was granted last Wednesday as Moderna announced it would provide the vaccine gratis to under- and uninsured people.

“Everyone in the United States will have access to Moderna’s COVID-19 vaccine regardless of their ability to pay,” said company spokesperson Chris Ridley.

The Biden administration is also reportedly working on a plan to make COVID vaccines, tests and treatments free for uninsured people into 2024, write Adam Cancryn and David Lim at Politico.

The tentative plan would involve a limited stockpile that could be distributed following the end of the emergency declaration.

The U.S. still has 120 million bivalent boosters on hand, notes Spencer Kimball at CNBC.

The government has also made a deal to buy 1.5 million more doses of the Novavax COVID vaccine, potentially an updated version, reports Reuters.

As for Moderna, it has not specified how the planned patient assistance program to fund vaccination will work.

Sanders still expressed concern that the price hike for insurers will boost insurance costs, with taxpayers ultimately footing the bill.

He is not targeting Pfizer, which did not receive federal support through Warp Speed.

People of color face long COVID, related money woes

Those most likely to get a long COVID diagnosis tend to be female, white, and non-Hispanic, according to a study in BMC Medicine. 

These researchers analyzed more than 33,000 health records with long COVID diagnoses from a large National Institutes of Health database.

People diagnosed with long COVID also tended to live in ZIP codes with low rates of poverty and good access to health care, noted STAT’s Elizabeth Cooney. 

Yet other studies show that acute COVID has disproportionately plagued communities of color and those with high levels of income inequality, among other social factors, the study authors note. 

That suggests the trends the researchers observed in long COVID rates do not reflect actual patterns of the condition, “but may instead illustrate racial and social disparities in access to and experience with health care in the USA,” the authors wrote.

There are also disparities in how long COVID manifests, according to another study in the Journal of General Internal Medicine.

“Identifying potential racial and ethnic disparities in long COVID is an important step toward making sure we have an equitable response to the long-term consequences of coronavirus infection,” study author Dr. Dhruv Khullar of Weill Cornell Medicine said in a press release.

Khullar and colleagues examined New York City health records from more than 62,000 patients who had COVID and nearly 250,000 who did not, between March 2020 and October 2021. Nearly half of the patients were white, one-third were Hispanic, and one-fifth were Black. The researchers checked for 137 different long COVID symptoms.

Among people who weren’t sick enough to require hospitalization, Black patients had higher odds of certain post-COVID conditions, such as blood clots in the lungs or diabetes. Black people who were hospitalized also had higher rates of chest pain.

Hispanic patients, whether hospitalized or not, were more susceptible than white patients to develop symptoms including headaches and chest pain after COVID.

White patients were more likely to report neurological symptoms.

Another new study in JAMA Network Open found that among 825 adults hospitalized for COVID, three-quarters had heart and lung problems such as coughing, breathlessness and irregular heart beat six months later. After a year, more than half still suffered fatigue, reports Cecelia Smith-Schoenwalder at U.S. News & World Report. 

About half of the people in that study had financial problems six months after their infection, and money issues were much more common in people who were Black, Hispanic, or of another nonwhite or unknown race.

It’s not clear why specific symptom risk varies by race and ethnicity, Khullar said.

“We hope our study encourages clinicians, researchers and policymakers to pay attention to potential differences in long COVID across racial and ethnic groups.”

Johns Hopkins, NYT halt COVID tracking efforts

A major pandemic mainstay for data tracking is shutting down, reports Betsy Ladyzhets at her COVID-19 Data Dispatch.

The Johns Hopkins Coronavirus Resource Center began tracking the pandemic on Jan. 22, 2020 — one day after the first reported U.S. case of COVID-19, more than a week before the World Health Organization and U.S. government declared the virus a public health emergency, and nearly two months before California became the first state to lock down. 

The Center will shut down March 10, reports Rob Stein at NPR. The data will remain freely accessible, according to the university.

The Hopkins tracker filled “a void when the CDC and other government agencies failed to provide the frequent, user-friendly updates people wanted,” writes Ladyzhets.

Time Magazine called the Center “2020’s go-to data source.”

“The website quickly became critical for deciding everything from where drug companies should test vaccines to where Hollywood should film movies,” reports Stein. “Even the White House and the British prime minister were relying on Hopkins data.”

The site logged more than 2.5 billion views since it launched.

But with states reporting data less frequently now, and the CDC having amplified its own data reporting, Hopkins decided it’s time to shut the site down.

The New York Times cited similar reasons for ending its own data collection for the paper’s COVID tracker. “As case and death reporting at the local level has become less frequent and comprehensive, the daily data we have been able to gather has become less useful for indicating real-time trends about the virus,” wrote the Times’ graphics editor Wilson Andrews on the project’s GitHub repository.

The Times will continue to update its dashboard, but will rely on federal data. Andrews wrote the changeover in data sources will mostly likely take place in March.

Ladyzhets writes that the changeover makes sense; at this point in the pandemic, federal sources are probably more reliable than efforts that tot up data from individual locations. That doesn’t mean it’s without problems. “Federal data still suffer from case undercounting, lack of standardization (for some metrics), and other issues,” she notes.

The CDC has also extended its contract with Biobot Analytics to surveil wastewater from more than 400 locations for both COVID variants and mpox through at least the end of July. 

“Even so,” Ladyzhets writes, “this feels like the end of an era for pandemic tracking.”

Remember stomach flu? Norovirus surges back

This winter saw a rise in viruses that were stymied by COVID-19 lockdown measures: first influenza and RSV, and now stomach flu caused by norovirus is hitting pre-pandemic levels, reports Alice Park at Time.

While rarely deadly, the gastrointestinal bug is highly contagious — spread by contact with an infected person or objects they touched, as well as food — and certainly unpleasant, causing vomiting, nausea and diarrhea. 

Young children, the elderly, and people with other illnesses are particularly susceptible to dehydration as a result. 

The virus kills between 570 and 800 people each year.

Between mid-January and mid-February, the test positivity rate for norovirus in the U.S. rose from 10.5% to 17%.

“There have been more outbreaks this year compared to last year, when numbers were low because pandemic protocols such as mask-wearing and social distancing likely hampered the virus’ ability to spread,” writes Park. “That suggests that the recent upticks this year are likely a resetting back to pre-pandemic cycles of infection.”

Mary Kekatos at ABC News reports the best way to avoid norovirus is a method familiar from the start of the pandemic: wash your hands with soap and warm water for 20 seconds.

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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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Moderna hopes to offer updated COVID-19 boosters in the fall that combine its original vaccine with protection against the omicron variant. On Tuesday, it reported a preliminary hint that such an approach might work.

Today’s COVID-19 vaccines all are based on the original version of the coronavirus. But the virus continues to mutate, with the super-contagious omicron variant — and its siblings — the latest threat.

Before omicron came along, Moderna was studying a combination shot that added protection against an earlier variant named beta. Tuesday, the company said people given that beta-original vaccine combination produced more antibodies capable of fighting several variants — including omicron — than today’s regular booster triggers.

While the antibody increase was modest, Moderna’s goal is to produce a combination shot that specifically targets omicron. “These results really give us hope” that next step will work even better, said Dr. Jacqueline Miller, a Moderna vice president.

Tuesday’s data was reported online and hasn’t been vetted by independent experts.

COVID-19 vaccines still are providing strong protection against severe disease, hospitalization and death, even against omicron. That variant is so different from the original coronavirus that it more easily slips past the immune system’s defenses, although studies in the U.S. and elsewhere show an original booster dose strengthens protection. Some countries offer particularly vulnerable people a second booster; in the U.S., that’s anyone 50 or older or those with a severely weakened immune system.

Health officials have made clear that giving boosters every few months isn’t the answer to the mutating virus. They’ve begun deliberating how to decide if and when to change the vaccine recipe.

Just switching to a vaccine that targets the latest variant is risky, because the virus could mutate again. So Moderna and its rival Pfizer both are testing what scientists call “bivalent” shots — a mix of each company’s original vaccine and an omicron-targeted version.

Why would Moderna’s earlier, beta-targeted combo shot have any effect on omicron? It includes four mutations that both the beta variant and the newer omicron have in common, Miller said.

Now Moderna is testing a bivalent shot that better targets omicron — it includes 32 of that variant’s mutations. Studies of two booster doses are underway in the U.S. and Britain; results are expected by late June.

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Moderna said Monday that a booster dose of its COVID-19 vaccine should offer protection against the rapidly spreading omicron variant.

Moderna said lab tests showed the half-dose booster shot increased by 37 times the level of so-called neutralizing antibodies able to fight omicron.

And a full-dose booster was even stronger, triggering an 83-fold jump in antibody levels, although with an increase in the usual side effects, the company said. While half-dose shots are being used for most Moderna boosters, a full-dose third shot has been recommended for people with weakened immune systems.

Moderna announced the preliminary laboratory data in a press release and it hasn’t yet undergone scientific review. But testing by the U.S. National Institutes of Health, announced last week by Dr. Anthony Fauci, found a similar jump.

Pfizer’s testing likewise found its COVID-19 vaccine triggered a similarly big jump in omicron-fighting antibodies. The vaccines made by Pfizer and by Moderna, both made with mRNA technology, are used by many countries around the world to fight the coronavirus.

Together, the available evidence backs health authorities” increasing pleas for people to get their boosters as soon as they’re eligible.

Antibody levels predict how well a vaccine may prevent infection with the coronavirus but they are just one layer of the immune system’s defenses. Other research suggests the vaccine still should induce good protection against severe disease if people do experience a breakthrough infection.

Both Moderna and Pfizer are developing shots to better match the omicron variant in case they’re needed.

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Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health officials said Thursday.

The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don’t come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention.

The panel recommended the unusual move of giving preference to the Pfizer and Moderna vaccines, and late Thursday the CDC’s director, Dr. Rochelle Walensky, accepted the panel’s advice.

Until now the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited. J&J’s vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options.

But the CDC’s advisers said during a meeting Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot.

New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J’s vaccine remain very rare, they’re still occurring and not just in younger women as originally thought.

In a unanimous vote, the advisers decided the safer Pfizer and Moderna vaccines are preferred. But they said the shot made by J&J’s Janssen division still should be available if someone really wants it — or has a severe allergy to the other options.

“I would not recommend the Janssen vaccine to my family members” but some patients may — and should be able to — choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington.

The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. Eventually U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.

European regulators likewise continued to recommend AstraZeneca’s two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions.

COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49 — about once for every 100,000 doses administered, the FDA said.

Overall, the government has confirmed 54 clot cases— 37 in women and 17 in men, and nine deaths that included two men, the CDC’s Dr. Isaac See said Thursday. He said two additional deaths are suspected.

The CDC decides how vaccines should be used in the U.S., and its advisers called the continuing deaths troubling. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren’t as serious — and that supplies now are plentiful.

Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn’t prove quite as protective as two doses of the Pfizer and Moderna vaccines. Plus, with extra-contagious virus mutants now spreading, booster doses now are recommended.

For J&J recipients, a booster is recommended at least two months after vaccination. U.S. health officials had previously OK’d mixing vaccines for booster shots.

Several countries, including Canada, already have policies that give preference to the Pfizer and Moderna vaccines. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don’t want a two-dose shot.

While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said.

The U.S. is fortunate in its vaccine availability and Thursday’s action shouldn’t discourage use of J&J’s vaccine in places around the world where it’s needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.

The FDA also warned this week that another dose of the J&J vaccine shouldn’t be given to anyone who developed a clot following either a J&J or AstraZeneca shot.

The committee also heard some of the first data on reported side effects of Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for that age group, and more than 7 million doses have been given so far. But few problems have been reported. Of the 80 reported cases of serious side effects, about 10 involved a form of inflammation that has been seen in male teens and young adults.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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