Moderna’s Covid-19 vaccine wins full approval while Novavax pursues authorization

The ever-evolving landscape of Covid-19 vaccines shifted again yesterday, with Moderna winning full FDA approval and Novavax submitting a long-awaited application to the agency for an emergency use authorization for its vaccine. Moderna’s vaccine, Spikevax, is the country’s second fully licensed Covid vaccine after the Pfizer and BioNTech vaccine, Comirnaty, which was fully approved in August. The Novavax vaccine is made differently than the Moderna and Pfizer vaccines, which both deploy messenger RNA to teach the immune system to recognize and attack SARS-2 viruses. Novavax’s jab is a protein vaccine that delivers nanoparticles of the SARS-2 spike protein to the immune system to activate its defenses. The application is for use in people 18 and older. Moderna trails Pfizer in authorizations for teens and children; its vaccine has not been green-lit for anyone under the age of 18 in the U.S. STAT’s Helen Branswell has more.

Trial will study pausing anti-rejection medicines near Covid vaccination for some transplants

When Covid vaccines became available almost unimaginably quickly and then proved to be remarkably effective, there was one group of people left behind by the scientific marvel: people whose immune systems are blunted either by disease or lifesaving therapies. They can’t mount a strong immune response when prompted by even multiple vaccine doses, so they remain vulnerable to severe Covid infection. Now a new clinical trial from the National Institute of Allergy and Infectious Diseases will study 400 kidney and liver transplant recipients at 15 medical centers to see if temporarily adjusting their anti-rejection drugs might improve their response to vaccines. The Phase 2 trial builds on a pilot trial in kidney transplant recipients as well as lessons learned from pausing immunosuppressive medication in people with autoimmune disease. More details are available here.

Testing the rapid test instructions finds room for improvement

Now that rapid home tests for Covid are hitting mailboxes across the U.S., the timing is good for a new JAMA Internal Medicine study assessing how people react to results, known to be less accurate than those from PCR tests. Last April researchers randomly split 360 people into three groups to receive FDA-authorized instructions, instructions based on decision science, or no instructions to see if people followed CDC guidelines for quarantine. Participants were asked to imagine a scenario of high risk (having Covid symptoms or close contact with an infected person) or low risk (no symptoms or exposure). Many people with the FDA-authorized instructions who were in the high risk group and got a negative test result said they wouldn’t quarantine and many people at low risk with a negative result did quarantine anyway — both contradicting CDC advice. The researchers conclude better instructions are needed, especially to avoid false reassurance from a negative test.

Closer look: Collecting patient data is now big business. That worries a pioneer

(alex hogan/stat)

To most Americans, the name MarketScan means nothing. But most Americans mean everything to MarketScan. As a repository of sensitive patient information, the company’s databases churn silently behind the scenes of their medical care, scooping up secrets.The family of databases that make up MarketScan now include the records of a stunning 270 million Americans, or 75% of the population. It wasn’t like this in 1981, when Ernie Ludy, a former insurance executive, founded the company. Today, a multibillion-dollar marketplace has formed around anonymized health data: Just last week, a San Francisco-based private equity firm spent $1 billion to acquire MarketScan from IBM. Ludy is worried by what he sees. “I don’t believe there’s nearly enough governance around how people can use personal information, whether it’s health care (data) or not.” Ludy told STAT’s Casey Ross. Read more in Casey's special report, and STAT+ subscribers can access an exclusive interview with Ludy.

In a Covid side effect, medical waste is climbing

We've all seen discarded paper masks littering the sidewalks. There's much more within health care walls, of course. A new report out today measures the mounting medical waste generated by the world’s pandemic response, highlighting what the WHO calls “a dire need to improve waste management practices.” Its analysis estimates about 96,000 tons of waste came just from personal protective equipment shipped through a UN emergency initiative through November 2021. Other sources:

From 140 million test kits: about 2,900 tons of mainly plastic waste and enough chemical waste to fill one-third of an Olympic-size swimming pool.
From vaccines: about 159,000 tons of syringes, needles, and safety boxes.

As a remedy, the report recommends eco-friendly packaging and shipping; safe and reusable gloves and medical masks; recyclable or biodegradable materials; better waste treatment technologies, such as autoclaves; and investments in recycling.

Opinion: How to avoid the 'Karikó problem'

Stuart Buck calls it the Karikó problem. Buck, the executive director of the Good Science Project and a senior adviser to the Social Science Research Council, is referring to the now-celebrated scientist who, along with a colleague, published a key paper in 2005 on messenger RNA. Her discovery made possible the Covid-19 vaccines made by Pfizer and BioNTech, where Karikó now works, and by Moderna. Buck, writing in a STAT First Opinion, worries about scientists with good ideas that weren’t popular at the time who dropped out of academia. “It’s unlikely that she was the only person in the world who had an interesting idea in 1985 that could have turned into a groundbreaking discovery over the next few decades.” His solution? “Bend over backward to fund a more diverse range of people and ideas.” Read more.

What to read around the web today

White House frustrations grow over health chief Becerra’s handling of pandemic. Washington Post
Opinion: What we can learn from how the 1918 pandemic ended. New York Times
One million deaths: The hole the pandemic made in U.S. society. Wall Street Journal
Will the Biden administration approach march-in rights like Trump? Fight over pricey cancer drug offers a test. STAT+
Madrigal drug for fatty liver disease clears safety hurdle in first of two late-stage studies. STAT+