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This Annual Shot Might Protect Against HIV Infections

This article first appeared in The Checkup, MIT Technology Review's weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

Every year, my colleagues and I put together a list of what we think are the top 10 breakthrough technologies of that year. When it came to innovations in biotech, there was a clear winner: lenacapavir, a drug that was found to prevent HIV infections in 100% of the women and girls who received it in a clinical trial.

You never hear "100%" in medicine. The trial was the most successful we've ever seen for HIV prevention. The drug was safe, too (it's already approved to treat HIV infections). And it only needed to be injected twice a year to offer full protection.

This week, the results of a small phase I trial for once-yearly lenacapavir injections were announced at a conference in San Francisco. These early "first in human" trials are designed to test the safety of a drug in healthy volunteers. Still, the results are incredibly promising: All the volunteers still had the drug in their blood plasma a year after their injections, and at levels that earlier studies suggest will protect them from HIV infections.

I don't normally get too excited about phase I trials, which usually involve just a handful of volunteers and typically don't tell us much about whether a drug is likely to work. But this trial seems to be different. Together, the lenacapavir trials could bring us a significant step closer to ending the HIV epidemic.

First, a quick recap. We've had effective pre-exposure prophylactic (PrEP) drugs for HIV since 2012, but these must be taken either daily or just before a person is exposed to the virus. In 2021, the US Food and Drug Administration approved the first long-acting injectable drug for HIV prevention. That drug, cabotegravir, needs to be injected every two months.

But researchers have been working on drugs that offer even longer-lasting protection. It can be difficult for people to remember to take daily pills when they're sick, let alone when they're healthy. And these medicines have a stigma attached to them. "People are concerned about people hearing the pills shake in their purse on the bus … or seeing them on a medicine cabinet or bedside table," says Moupali Das, vice president of HIV prevention and virology, pediatrics, and HIV clinical development at Gilead Sciences.

Then came the lenacapavir studies. The drug is already approved as a treatment for some cases of HIV infection, but two trials last year tested its effectiveness at prevention. In one, over 5,000 women and adolescent girls in Uganda and South Africa received either twice-yearly injections of lenacapavir or a daily PrEP pill. That trial was a resounding success: There were no cases of HIV among the volunteers who got lenacapavir.

In a second trial, the drug was tested in 3,265 men and gender-diverse individuals, including transgender men, transgender women, and gender nonbinary people. The twice-yearly injections reduced the incidence of HIV in this group by 96%.

In the most recent study, which was also published in The Lancet, Das and her colleagues tested a new formulation of the drug in 40 healthy volunteers in the US. The participants still got lenacapavir, but in a slightly different formulation, and at a higher dose. And whereas the previous trials involved injections under the skin, these participants received injections into their glute muscles. Half the volunteers in this trial received a higher dose than the others.

The drug appeared to be safe. It also appears likely to be effective. These individuals weren't at risk of HIV. But the levels of the drug in their blood plasma remained high, even in the people who got the lower dose.

A year after their injection, the levels of the drug were still higher than those seen in people who were protected from HIV in last year's trials. This suggests the new annual shot will be just as protective as the twice-yearly shot, says Renu Singh, a senior director in clinical pharmacology at Gilead Sciences, who presented the findings at the Conference on Retroviruses and Opportunistic Infections in San Francisco.

"I was just so excited [to hear the results]," says Carina Marquez, an associate professor of medicine at the University of California, San Francisco, who both studies infectious disease and treats people with HIV.

Annual shots would make things easier—and potentially cheaper—for both patients and health-care providers, says Marquez. "It will be a game changer if it works, which looks promising from the phase I data," she says.

The drug works by interfering with the virus's ability to replicate. But it also seems to have some very unusual properties, says Singh. It can be taken daily or yearly. Small doses can stay in the blood for days rather than hours. And bigger doses form what's known as a depot, which gradually releases the drug over time.

"I previously worked at the FDA, and looked at many, many different molecules and products, but I've never seen [anything] like this," Singh adds. She and her colleagues have come up with nicknames for the drug, including "magical," "the unicorn," and "limitless len."

Once a phase I trial is successfully completed, researchers will typically move on to a phase II trial, which is designed to test the efficacy of a drug. That's not necessary for lenacapavir, given the unprecedented success of last year's trials. The team at Gilead is currently planning a phase III trial, which will involve testing annual shots in large numbers of people at risk of HIV infection.

The drug isn't approved yet, but the researchers at Gilead have submitted twice-yearly lenacapavir for approval by the FDA and the European Medicines Agency and hope to have it approved by the FDA in June, says Das. The drug is also being assessed under the EU-Medicines for all (EU-M4all) procedure, which is a collaboration between the EMA and the World Health Organizations to fast-track the approval of drugs for countries outside Europe.

With any new medicine for an infection that affects low- and middle-income countries, there are always concerns about cost. The existing formulations of lenacapvir (used for treating HIV infections) can cost around $40,000 for a year's supply. "There's no price for the twice-yearly [formulation] yet," says Das.

Gilead has signed licensing agreements with six generic drug manufacturers that will sell cheaper versions of the drug in 120 low- and middle-income countries. In December, the Global Fund and other organizations announced plans to secure access to twice-yearly lenacapavir for 2 million people in such countries.

But this was an effort coordinated with the US President's Emergency Plan for AIDS Relief (PEPFAR), a program whose very existence has come under threat following an executive order issued by the Trump administration to pause foreign aid.

"We are looking at the political situation right now and evaluating our possible options," says Singh. "We are committed to working with the government to see what's next and what can be done."

The pause on US foreign aid will have devastating consequences for the health of people around the globe. And the idea that it might interfere with access to a drug that could help bring an end to the HIV epidemic—which has already claimed over 40 million lives—is a heartbreaking prospect. It is estimated that 630,000 people died from HIV-related causes in 2023. That same year, another 1.3 million people acquired HIV.

"We're in such a good place to end the epidemic," says Marquez. "We've come so far … we've got to go the last mile and get the product out there to the people that need it."

Read more from MIT Technology Review's archive

You can read more about why twice-yearly lenacapavir made our 2025 list of the top 10 breakthrough technologies here. (It's also worth checking out the full list, here!)

The pharmaceutical company Merck has explored a different approach to delivering PrEP drugs—via a matchstick-size plastic tube implanted in a person's arm. 

In 2018, Antonio Regalado broke the news that He Jiankui and his colleagues in Shenzen, China, had edited the genes of human embryos to create the first "CRISPR babies." The team claimed to have done the procedure to ensure that the resulting children were resistant to HIV.

The first approved mRNA vaccines were for covid-19. But Moderna, the pharmaceutical company behind some of those vaccines, is now working on a similar approach for HIV.

AIDS denialism is undergoing a resurgence thanks to conspiracy-theory-promoting podcasts and books, one of which was authored by the newly appointed US secretary of health and human services, Robert F. Kennedy Jr. 

From around the web

Last week, I covered the creation of the "woolly mouse," an animal with woolly-mammoth-like features. Its creators think they're a step closer to bringing the mammoths back from extinction. But the woolly mammoth is just one of a list of animals scientists have been trying to "de-extinct." The full list includes dodos, passenger pigeons, and even a frog that "gives birth" by vomiting babies out of its mouth. (Discover Wildlife)

The biotechnology company Beam Therapeutics claims to have corrected a DNA mutation in people with an incurable genetic disease that can affect the liver and lungs. It is the first time a mutated gene has been restored to normal, the team says. (New York Times)

In the peak covid-19 era of 2020, Jay Bhattacharya was considered a "fringe epidemiologist" by Francis Collins, then director of the US National Institutes of Health. Now, Collins is out and Bhattacharya may soon take his place. What happens when the "fringe" is in charge? (The Atlantic)

The Trump administration withdrew the nomination of Dave Weldon to run the Centers for Disease Control and Prevention. Weldon has a long track record of criticizing vaccines. (STAT) 

Mississippi became the third US state to ban lab-grown meat. The state's agriculture commissioner has written that he wants his steak to come from "farm-raised beef, not a petri dish from a lab." (Wired)

MRNA Vaccines, Once A Trump Boast, Now Face Attacks From Some In GOP

Researchers racing to develop bird flu vaccines for humans have turned to a cutting-edge technology that enabled the rapid development of lifesaving COVID-19 shots.

There's a catch: The mRNA technology faces growing doubts among Republicans, including people around President Donald Trump.

MORE: Five years after the COVID-19 pandemic began, the U.S. Remains vulnerable to another crisis

Legislation aimed to ban or limit mRNA vaccines was introduced this year by GOP lawmakers in at least seven states. In some cases, the measures would hit doctors who give the injections with criminal penalties, fines, and possible revocation of their licenses.

Some congressional Republicans are also pressing regulators to revoke federal approval for mRNA-based COVID shots, which President Donald Trump touted as one of the signature achievements of his first term.

The opposition comes at a critical juncture because vaccines using mRNA have applications well beyond avian flu and COVID. They hold the promise of lifesaving breakthroughs to treat many diseases, from melanoma to HIV to Zika, according to clinical trials. The proposed bans could block access to these advances.

MRNA is found naturally in human cells. It is a molecule that carries genetic material and, in a vaccine, trains the body's immune system to fight viruses, cancer cells, and other conditions. An advantage of mRNA technology is that it can be developed more quickly to target specific variants and is safer than developing a vaccine made from inactivated virus.

"Right now, if we had a bird flu pandemic, we would have a shortage of the vaccine we need," said Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy. "The one thing that could save us is mRNA vaccine. The challenge would be if mRNA is banned. This is truly dangerous policy."

The pushback conflicts with innovations championed by Trump. He assembled tech tycoons at the White House just after his inauguration to announce Stargate, a $500 billion artificial intelligence initiative that could help transform cancer treatment by creating tumor-targeting mRNA vaccines. The fledging partnership between Oracle, SoftBank Corp., and OpenAI, co-founded by Elon Musk, envisions leveraging AI in part to improve health outcomes. Patients would undergo blood tests and AI would be used to find cancer.

Scientists would examine the DNA and RNA (RNA and mRNA serve different functions in a cell) of a specific patient's tumor to create a vaccine to teach that person's immune system to target and destroy cells driving cancer growth.

"Imagine early cancer detection, the development of a cancer vaccine for your particular cancer aimed at you, and have that vaccine available in 48 hours," Oracle co-founder Larry Ellison said at the White House event.

Scores of mRNA clinical trials for cancer vaccines are underway and some have shown dramatic results, cutting the risk of death and recurrence roughly in half for certain patients. In research led by the Yale School of Medicine, for example, patients with advanced kidney cancer remained cancer-free about three years after an mRNA-based treatment in an early-phase trial.

But some politically conservative doctors, lawmakers, and researchers question the safety of mRNA vaccines, especially COVID shots made with the technology. Robert F. Kennedy Jr. Unsuccessfully petitioned the FDA in 2021 to rescind approval for COVID shots and called them "the deadliest vaccine ever made" — a controversial statement that has been refuted.

Now that he's newly confirmed as Health and Human Services secretary, Kennedy is poised to oversee federal approvals of vaccines, with the power to shape policy such as immunization schedules and appoint vaccine opponents to committees that advise on the approval of shots.

Bloomberg reported late last month that Trump administration health officials were reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna as part of its push to examine spending on mRNA vaccines.

HHS and White House spokespeople didn't return emails seeking comment.

Support for an mRNA ban is coming from other sources too. Florida Gov. Ron DeSantis on March 5 urged the Centers for Disease Control and Prevention to stop recommending the COVID-19 vaccine for children and called for a state ban on mRNA vaccine mandates. In February, Rep. Thomas Massie (R-Ky.) said on X that the "FDA should immediately revoke approval of these shots," and Sen. Ron Johnson (R-Wis.) is leading an investigation into the safety of the vaccines. Trump in February signed an order to strip federal funds from schools that require COVID shots for attendance.

Vaccine skepticism has become pronounced among Republicans since the pandemic. Four in 10 Republicans who responded to a KFF poll published in January said it was "probably" or "definitely true" that "more people have died from COVID-19 vaccines than from the virus itself." Just a quarter of Republicans reported holding that view in 2023.

The effort is also finding traction at the local level. A district health department outside Boise, Idaho, last year banned its health department from administering COVID-19 vaccines, and local lawmakers in Franklin County, Washington, passed a resolution in February against mRNA vaccines.

The ABCs of mRNA

The CDC recommends COVID vaccines for anyone 6 months and older, especially seniors and people who are immunocompromised. About 29 million doses had been administered to adults in the 2024-25 season in retail pharmacies and doctors' offices through Feb. 8, based on federal data.

Given as a shot, mRNA enters muscle cells and teaches them to produce a spike protein found on the surface of a virus. The body's immune system then targets the spike protein, priming it to identify and fight the virus — in this case, the coronavirus that causes COVID. The body's cells then break down the mRNA and remove it, according to federal health researchers.

More than 13 billion COVID vaccines had been administered worldwide as of August 2024.

Researchers say the vaccinations saved countless lives — estimates for the first year alone go as high as 19.8 million — in the throes of a pandemic that had hospitals ordering refrigerated mobile morgues and deliberating over which patients to put on ventilators. Two University of Pennsylvania scientists credited with developing the mRNA technology behind the shots were awarded the Nobel Prize for medicine in 2023.

The FDA says the COVID vaccines are safe, with fewer than 1 in 200,000 vaccinated individuals experiencing a severe allergic reaction or heart problems like myocarditis or pericarditis, and the agency notes that "inaccurate information about these vaccines, particularly the mRNA COVID-19 vaccines, continues to circulate."

While many people hadn't heard of the mRNA platform until the COVID shots were rolled out, it was discovered in the 1960s. The first mRNA flu vaccines were tested in mice in the 1990s. A clinical trial involving direct injection of mRNA to fight cancer occurred in 2008. Clinical trials involving the COVID mRNA vaccines involved tens of thousands of volunteers.

Reviews of mortality data showed "no unusual patterns of death were detected that might suggest a potential safety concern," based on a September 2024 report by a technical working group that provided guidance to the CDC.

But those calling for a ban on all mRNA vaccines say there is a dearth of long-term safety data, and they say COVID vaccines by Pfizer-BioNTech and Moderna were hastily approved without proper vetting. They assert without strong evidence that the vaccines cause serious injuries to the heart, nerves, and immune and reproductive systems, and can lead to cancer.

The vaccine has been linked to rare cases of heart inflammation and inflammation of the sac surrounding the heart, although the severity has varied and most patients fully recovered, the CDC says.

"The allegations are beyond reason," said Anne Schuchat, a career scientist who worked on COVID and who twice served stints as acting director of the CDC. "The mRNA COVID vaccines were extensively studied after use and do not have those problems."

"I'm concerned about the whole mRNA technology. I don't trust anything that fools the body," said Stephanie Seneff, a computer scientist and anti-vaccine activist at the Massachusetts Institute of Technology. "I'm really glad people are waking up and realizing it's not the thing to do anymore."

Vaccines generally work by tricking the body into producing antibodies to fight illnesses.

Pfizer spokespeople didn't return an email seeking comment. A Moderna spokesperson, Chris Ridley, said legislative efforts to ban or restrict mRNA medicines are largely driven by misunderstandings about their safety profile and mechanism of action. While mRNA-based shots do not modify DNA, for example, that misconception is frequently cited in support of restrictions, Ridley said.

"If enacted, these measures could hinder important research and limit patient access to innovative treatments, potentially delaying life-changing medical advancements," Ridley said in a written statement.

Networks of opposition

Groups opposed to the mRNA technology have built a vast and well-funded legal, marketing, and social media network. Members hold conferences to discuss strategies, fund lawsuits against vaccine mandates, and produce reports on the COVID vaccines.

As for state legislative efforts, measures introduced this year have varied and their progress has been mixed. Montana's measure, for instance, was blocked. Idaho lawmakers in February held a hearing on its bill, which calls for a 10-year moratorium on mRNA vaccines. Idaho's proposal, likely to be amended, as well as Iowa's and Montana's have featured criminal penalties for providers who administer all or certain mRNA vaccines. In addition, some state bills, such as legislation in Pennsylvania and Tennessee, focused on the use of the vaccine in livestock and food production.

Various bills are pending in the Texas Legislature to restrict mRNA vaccines in both livestock and humans. South Carolina's pending bill would require anyone administering certain COVID mRNA vaccines to inform patients that the shot is contaminated with fragments of "bacterial plasmid DNA."

COVID mRNA shots may have minute amounts of residual DNA from production processes but they are heavily degraded and pose no risk, according to the Global Vaccine Data Network, which evaluates vaccine safety concerns.

Speakers at some legislative proceedings have included representatives from Children's Health Defense, an activist, anti-vaccine group founded by Kennedy.

The Florida surgeon general in January 2024 called for a halt in the use of COVID mRNA vaccines. And in Texas, Attorney General Ken Paxton in January moved to appeal a lawsuit he filed claiming Pfizer misrepresented the safety of its mRNA shot.

Efforts to restrict the shots have raised the profile of groups such as the Independent Medical Alliance, which advocates for mRNA-based COVID vaccines to be withdrawn from the market.

"We should stop it and test it more before we move forward," said pediatric cardiologist Kirk Milhoan, a senior fellow at the alliance.

Groups opposed to mRNA shots are pointing to a recent study to urge more caution. Yale University researchers reported in February that they found spike protein still circulating in a subset of individuals with a debilitating, post-vaccination condition. Some of the individuals who experienced chronic illness after getting the shots had detectable levels of spike protein more than 700 days after vaccination. This study was small — 42 participants — and not peer-reviewed.

Its findings also don't show the spike protein is a health risk or a cause of vaccine injury.

"It's an initial, provocative study in which you can't draw conclusions," said William Schaffner, past medical director of National Foundation for Infectious Diseases. "This is one of the most widely used vaccines around the globe. It's the furthest thing from an experimental vaccine."

But what this growing pushback shows, according to some researchers, is that distrust isn't coming only from fringe groups anymore.

"There are truly amazing mRNA cancer vaccines out there," said Kate Broderick, chief innovation officer at Maravai LifeSciences, which works on vaccine development. "My fear as a scientist is that it's been tainted in the public."

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Covid Vaccines Have Paved The Way For Cancer Vaccines

Lennard Lee, a UK National Health Service oncologist and medical director at the Ellison Institute of Technology in Oxford, calls himself just a "simple doctor," but he's anything but. During the pandemic, he led clinical efforts that showed it was still safe to give cancer patients chemotherapy, disproving fears that the coronavirus made this too risky, helping to maintain cancer treatment worldwide. He also delivered UK research that showed lateral flow testing was effective in identifying the most infectious Covid patients.

His most important project, however, is the one he's currently leading as the national government advisor for mRNA cancer vaccines. This new type of vaccine, which is based on the same technology as the Covid vaccines first developed by BioNTech and Moderna, is seen by many as a potential breakthrough in the fight against cancer. Ahead of speaking at WIRED Health in London next week, Lee tells WIRED why he hopes these vaccines will prove to be the "silver lining of the pandemic."

This interview has been edited for length and clarity.

WIRED: There are currently hundreds of mRNA cancer vaccine trials ongoing worldwide. How did the success of mRNA Covid vaccines kickstart this?

Lennard Lee: Cancer vaccines weren't a proper field of research before the pandemic. There was nothing. Apart from one exception, pretty much every clinical trial had failed. With the pandemic, however, we proved that mRNA vaccines were possible.

mRNA cancer vaccines work by giving the body instructions to make a harmless piece of a cancer-related protein. This trains the immune system to recognize and attack cancer cells carrying that protein. Think of it like a training manual for security guards. The vaccine gives the immune system a guide on what cancer looks like, so it knows exactly who to watch for and remove.

Going from mRNA Covid vaccines to mRNA cancer vaccines is straightforward: same fridges, same protocol, same drug, just a different patient.

In the current trials, we do a biopsy of the patient, sequence the tissue, send it to the pharmaceutical company, and they design a personalized vaccine that's bespoke to that patient's cancer. That vaccine is not suitable for anyone else. It's like science fiction.

In the UK, you set up the Cancer Vaccine Launch Pad at the end of 2022 to fast-track cancer vaccine trials. Why set up such an ambitious project right after the Covid pandemic?

The pandemic was ending, the Omicron variant was much milder than previous variants, and everyone had had their vaccines. Research in the area of Covid vaccines was starting to close down, but companies like Moderna and BioNTech were trying to figure out what to do next, because there wasn't going to be a need for a Covid vaccine market forever. So they started to pivot to cancer vaccines using mRNA technology, and they were looking for countries with proven capabilities for vaccine research and manufacture.

In the meantime, the UK was ready. We had fridges and we had world-class manufacturing and research facilities. During the pandemic, we had proven we could open and deliver clinical trials fast. Also, the UK had established a genomic global lead with Genomics England and the 100,000 Genome Project. All doctors and nurses in this country are trained in genomics. That was a big signpost for any pharmaceutical industry.

So the UK government signed two partnerships: one with BioNTech to provide 10,000 patients with access to personalized cancer treatments by 2030, and a 10-year investment with Moderna in an innovation and technology center with capacity to produce up to 250 million vaccines. The stars were aligned.

During the pandemic, the UK was opening clinical trials in a matter of a few weeks. But before it used to take years to complete a clinical trial. What changed?

It was really fascinating, because for many years, we believed that research is inherently slow. It used to take 20 years to get a drug to market. Most cancer patients, unfortunately, will succumb by the time a drug gets to market. We showed the world that it could be done in a year if you modernize your process, run parts of the process in parallel, and use digital tools.

Of course, opening a clinical trial during a pandemic is not necessarily the same as a clinical trial for cancer. But you had a breakthrough moment for the cancer vaccine project at an early stage.

There was a trial run by BioNTech, called BNT122, on people with high-risk bowel cancer, which was not recruiting very well across the world. So when we announced the Cancer Vaccine Launch Pad, the UK cancer community took that opportunity. We opened that trial at Birmingham University Hospital, which was the most surprising thing for me, because it is not a leading cancer vaccine studies center.

We needed to get 10,000 patients enrolled in the trial, and we got there within the course of three months. It was quite amazing. It just goes to show that because we're a single health care system, we can do this much quicker than any other country.

The dominoes started falling very quickly on the back of that success: we opened a head and neck cancer trial in Liverpool, an esophageal and gastric cancer trial in Dundee, and a lung cancer trial in London. We started to create a community of people who were all pushing for launching cancer vaccine trials as quickly as possible.

Several mRNA-based cancer vaccines are in late-stage clinical trials internationally, and the UK is currently running 15 cancer-vaccine trials. When will we see the first approved mRNA cancer vaccine?

We have a trial to stop skin cancer coming back after you cut it out. It's now completed. We over-recruited again, just like every single one of the trials that we ran, and the trial finished one year ahead of schedule. That's completely unheard of in cancer trials because they normally run over-long.

What will happen now is that, over the next six to 12 months, we will monitor the people in the trial and work out if there's a difference between the people who took the cancer vaccine and the ones who didn't. We're hoping to have results by the end of the year or beginning of 2026. If it's successful, we will have invented the first approved personalized mRNA vaccine, within only five years of the first licensed mRNA vaccine for Covid. That's pretty impressive.

Hear Lennard Lee speak at WIRED Health on March 18 at Kings Place, London. Get tickets at health.Wired.Com.

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