This list marks 20 years since we began compiling an annual selection of the year’s most important technologies. Some, such as mRNA vaccines, are already changing our lives, while others are still a few years off. Below, you’ll find a brief description along with a link to a feature article that probes each technology in detail. We hope you’ll enjoy and explore—taken together, we believe this list represents a glimpse into our collective future.
Messenger RNA vaccines
We got very lucky. The two most effective vaccines against the coronavirus are based on messenger RNA, a technology that has been in the works for 20 years. When the covid-19 pandemic began last January, scientists at several biotech companies were quick to turn to mRNA as a way to create potential vaccines; in late December 2020, at a time when more than 1.5 million had died from covid-19 worldwide, the vaccines were approved in the US, marking the beginning of the end of the pandemic.
The new covid vaccines are based on a technology never before used in therapeutics, and it could transform medicine, leading to vaccines against various infectious diseases, including malaria. And if this coronavirus keeps mutating, mRNA vaccines can be easily and quickly modified. Messenger RNA also holds great promise as the basis for cheap gene fixes to sickle-cell disease and HIV. Also in the works: using mRNA to help the body fight off cancers. Antonio Regalado explains the history and medical potential of the exciting new science of messenger RNA.
A Food and Drug Administration review released Wednesday of the single-shot coronavirus vaccine made by pharmaceutical giant Johnson & Johnson found it was safe and effective and completely prevented hospitalizations and deaths in a large clinical trial.
The review sets the stage for a third coronavirus vaccine to be authorized as soon as this weekend, a point of hope in the middle of a pandemic that has killed more than a half-million people in the United States.
The review, though positive, was more nuanced than regulators’ assessments of the first two coronavirus vaccines, reflecting a pandemic that has entered a more complicated phase as variants capable of slipping by some aspects of immunity have emerged. The Johnson & Johnson vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.
The FDA scientists found that the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of covid-19 at least two weeks after vaccination. The review found vaccine efficacy against severe covid-19 “was similarly high across the United States, South Africa, and Brazil.”
“We know this vaccine prevents 85 percent of the severe disease. … It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” said Nancy M. Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry. “Those facts are the most important thing to recognize.”
The vaccine was less effective in a subgroup of adults older than 60 who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo.
An external committee of scientific experts is scheduled to meet Friday to recommend whether the FDA should authorize the shot. If the regulatory deliberations follow the path of the previous two authorized coronavirus vaccines — from Pfizer-BioNTech and Moderna — a decision could come this weekend.
Public health officials have eagerly awaited the arrival of the Johnson & Johnson vaccine because it will streamline the logistics of a complicated mass vaccination campaign. The vaccine can be stored in a refrigerator for several months, which should ease the challenges of distributing frozen products, and doesn’t require a follow-up visit for a booster shot.
The FDA advisory committee will consider the Johnson & Johnson vaccine at a “very tenuous time,” said Nahid Bhadelia, an infectious-disease doctor at Boston Medical Center. “Nobody knows how to feel.” While hospitalizations and deaths related to covid-19, the illness caused by the virus, are declining, there are concerns that variants could spoil the improving picture.
The Johnson & Johnson results highlight the challenge variants pose to all of the vaccines: The large, international trial found the vaccine was 72 percent effective at preventing cases of moderate to severe covid-19 in the United States, where variants of concern have only recently begun to be detected. But in South Africa, where a variant capable of evading some parts of immunity became dominant late last year, it was 57 percent effective against moderate to severe illness.
But it also underscores a reassuring message: that the immunity from the vaccine will prevent people from the worst outcomes, even if it allows some cases of coughs and fevers to slip by. The vaccine was 89 percent effective at preventing severe illness in South Africa.
The FDA, which on Monday issued new guidance to manufacturers on how to deal with variants, plans to brief the advisory committee Friday on the importance of getting ready for possible updates to vaccines. To streamline the process for getting clearance for modified vaccines, the FDA said, companies will be able to submit smaller studies testing immune responses in people’s bodies rather than lengthy, large trials in which researchers give half the participants a placebo and wait to see if people get sick or not.
Several manufacturers, including Johnson & Johnson, are studying potential modifications to their vaccines to counter variants such as those first detected in the United Kingdom and South Africa.
The vaccine appears to have met the safety and efficacy criteria laid out by the agency — efficacy of at least 50 percent and two months’ worth of follow-up safety data.
If an emergency use authorization is granted, about 2 million doses will be available to ship starting next week to states and other jurisdictions, according to two federal officials familiar with the situation who spoke on the condition of anonymity because they were not authorized to speak publicly. Supply will ramp up to 20 million doses by the end of March.
But public health experts have also expressed concerns that the public may compare vaccines tested under starkly different circumstances and make judgments about which one they should receive. In Europe, the less-spectacular data supporting the vaccine developed by the University of Oxford and AstraZeneca has led to societal debate over whether people should defer vaccination until they can get one of the other shots, from Pfizer-BioNTech or Moderna.
“We have a really important job to do on how we message this,” said E. John Wherry, an immunologist at the University of Pennsylvania. “The day that an individual has a choice on which vaccine to get — that’s a great day, but probably won’t be until summer.” Until then, he said, people should take the vaccine they can get, because all are robustly effective.
President Biden will announce Tuesday that pharmaceutical giant Merck & Co. will help make Johnson & Johnson’s single-shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials.
The officials, who spoke on the condition of anonymity to discuss a matter that has not been announced, said they began scouring the country for additional manufacturing capacity after they realized in the first days of the administration that Johnson & Johnson had fallen behind in vaccine production. They soon sought to broker a deal with Merck, one of the world’s largest vaccine makers, which had tried and failed to develop its own coronavirus vaccine.
Under the arrangement, Merck will dedicate two facilities in the United States to Johnson & Johnson’s shots. One will provide “fill-finish” services, the last stage of the production process during which the vaccine substance is placed in vials and packaged for distribution. The other will make the vaccine itself, and has the potential to vastly increase supply, perhaps even doubling what Johnson & Johnson could make on its own, the officials said.
“It’s a historic partnership,” said one of the officials, adding that the companies “recognize this is a wartime effort.” He praised their sense of “corporate citizenship.”
The officials declined to provide details about how Merck’s involvement will affect the projected supply of the Johnson & Johnson vaccine and the timetable for distributing it. It could easily take two months to get the “fill-finish” plant ready and a few more months to equip the other facility to make the vaccine, according to a person familiar with the process who spoke on the condition of anonymity because he was not authorized to discuss the issue.
The Biden administration’s efforts to ramp up production of the Johnson & Johnson vaccine suggest that it sees the vaccine playing a bigger role in addressing the challenges ahead, such as the eventual need for children’s vaccine and possibly for boosters to counter virus variants, said a person familiar with the situation who spoke on the condition of anonymity because he was not authorized to discuss it. Johnson & Johnson is conducting a trial of a two-shot vaccine, with the doses given two months apart, with results not expected until at least May.
Johnson & Johnson did not respond to a request for comment. Merck did not comment on the deal but said it “remains steadfast in our commitment to contribute to the global response to the pandemic.''
The administration officials indicated Biden would wield the powers of the Defense Production Act, a Korean War-era law, to give Merck priority in securing equipment it will need to upgrade its facilities for vaccine production, including the purchase of machinery, bags, tubing and filtration systems.
In teaming up with Merck, Johnson & Johnson has a partner with a century-long tradition of making vaccines. In the United States, Merck is the sole supplier of the combination childhood vaccine that protects against measles, mumps and rubella. It developed Gardasil, which protects against the human papillomavirus. And it won Food and Drug Administration approval for an Ebola vaccine in 2019.
But the company, which makes vaccines in North Carolina, Pennsylvania and elsewhere, encountered setbacks in its own quest to develop a coronavirus vaccine. Merck announced on Jan. 25 that it was halting work on two experimental shots for the virus. The vaccine did not stimulate enough antibodies in Phase 1 human clinical trials to justify continuing, the company said.
Johnson & Johnson has been searching the world for manufacturing sites where it could produce doses of vaccine on a global scale. It has publicly disclosed more than half a dozen manufacturing sites on four continents that it said were winnowed from more than 100 possibilities.
``While the science and the biology, the chemistry is certainly challenging … the engineering feat of actually producing it is just as challenging, and we’ve been working very, very closely with partners around the world,'' Johnson & Johnson’s CEO Alex Gorsky told CNBC on Monday.
Johnson & Johnson’s vaccine uses an adenovirus vaccine as a vector —- a harmless cold virus that does not replicate in the body — to deliver DNA instructions into a healthy human cell. The cell uses the genetic instructions to create a replica of a coronavirus spike protein that triggers an immune response that can recognize — and respond to — the real thing. The U.S. government paid the company $2 billion for development and clinical trials and preorders at a price of $10 per dose just days after it received emergency authorization from federal regulators.
The FDA on Saturday authorized the Johnson & Johnson vaccine for use in those 18 and older. The company said it would immediately ship nearly 4 million doses in the United States, and a total of 20 million by the end of March, which is 17 million less than expected under its government contract. Its current schedule calls for a recovery from those delays, with the company saying it is on track to deliver 100 million doses by the end of June. A top company executive told Congress last week that it has a goal of manufacturing 1 billion doses worldwide by year’s end.
Most of Johnson & Johnson’s partners disclosed to date are contract manufacturing companies, but now it is moving to team with larger drug companies that have seen their own vaccine projects delayed or fizzled.
Sanofi — which had to reboot its clinical trials of a vaccine candidate after early stumbles — announced last week that it would help Johnson & Johnson with final production steps and bottling in vials in Europe. Projected capacity from a Sanofi plant in France is 12 million doses per month.
BioNTech, Pfizer’s German partner on its mRNA vaccine, also announced deals in January for rivals Sanofi and Novartis to fill and finish vaccine vials in Europe.
The manufacturing process is time-consuming: The company ferments large batches of its vaccine in vats at a contract manufacturing facility in Baltimore operated by Emergent, as well as locations in the Netherlands and India. That brewing step takes two months.
Then the vaccine needs to be put into its final formulation and packaged into vials for shipping, which takes another five to six weeks, including testing for purity. In the United States and Europe, that final ``fill-finish’’ process for vaccines has created bottlenecks across the industry as manufacturers have flooded the supply chain with demand to finish hundreds of millions of doses.
Johnson & Johnson has agreements for fill-finish work to be done by two companies in the United States: Grand River Aseptic, with plants in Michigan, and Catalent, at a plant in Indiana. Catalent also is performing fill-finish operations for Moderna, which is obligated to deliver 300 million doses of its mRNA vaccine to the government by the end of July.
In Italy, Catalent also is helping Johnson & Johnson and AstraZeneca manufacture vaccine.
Moderna said on Feb. 16 that Catalent had suffered short-term delays on final production of Moderna’s vaccine but that the disruptions would not affect monthly deliveries to the U.S. government. The Financial Times reported on Saturday that Catalent’s system for automatic visual inspection of Johnson & Johnson vials had broken down, forcing staff to inspect vials manually.
Catalent did not respond to a request for comment. The company told investors in an earnings call last month that it had sufficient, dedicated capacity at its Bloomington, Ind., plant to handle the vaccine volume for both companies.
Merck’s help in making Johnson & Johnson’s vaccine probably will require it to examine its product lines and decide what can be delayed or shifted, said John Grabenstein, a consultant and former executive director of medical affairs for vaccines at Merck.
``The question is, where is the bottleneck? The filling machines and the packaging machines are often the rate-limiting step,’’ he said. From a technical standpoint, it’s not too hard for other companies to help out, he said.
``It’s not just a mechanical engineering problem. It’s what products might get displaced to do this extra work,’’ he said. ``Is there idle equipment? Oftentimes there isn’t.’’
Merck continues working on a pair of coronavirus treatments. One is an antiviral pill it is developing with a small company called Ridgeback Bio. It purchased worldwide rights to the drug last year from Ridgeback and has entered a late-phase clinical trial in an ongoing collaboration.
The other experimental Merck drug is an anti-inflammatory protein that it received as part of the purchase last year of a smaller company, OncoImmune. The treatment is being tested in a Phase 3 trial. Merck signed a $356 million agreement with the U.S. government in December to manufacture up to 100,000 doses that will be ready to ship in case the drug wins FDA authorization this year.
— Isaac Stanley-Becker contributed to this report
Laurie McGinley Laurie McGinley covers health and medicine for The Washington Post. She focuses on the Food and Drug Administration as well as cancer research and treatment. She was previously The Post's health, science and environment editor. Follow
Headshot of Christopher Rowland Christopher Rowland Chris Rowland joined The Washington Post business team in 2018 after serving as the Washington bureau chief for the Boston Globe, leading coverage of two presidential elections and overseeing political enterprise reporting. He previously covered health care for the Globe in Boston. Follow
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