LOUISVILLE, Ky. — Nearly two months into the U.S. vaccination effort against COVID-19, Pfizer and Moderna remain the only two companies with approved vaccines. That should change soon.
The past year has seen more than 100 COVID-19 vaccines developed, with 54 reaching clinical testing so far, according to an analysis from the Washington Post. Seventeen are in the final stage of testing — known as phase 3 — and could be considered for emergency approval in the coming months.
They can’t arrive soon enough. The first two months of the vaccine rollout have been beset with supply issues, with local leaders saying the only thing stopping them from vaccinating more people is a lack of shots on hand.
“The more doses that you can get, the more patients you can protect as quickly as possible, the better,” Jessica Daley, vice president of strategic supplier engagement for the health care company Premier, told Spectrum News 1 in December. “We're really relying on this multi-company approach to ensure that we can get enough doses available to patients and individuals across the United States as quickly as we can.”
Some progress on the supply side has been made in recent weeks, with both Moderna and Pfizer able to supply more doses for distribution across the country last week than in previous weeks. But both are only on the hook for 100 million doses each by the end of March. That's enough for the two-dose shots to vaccinate 100 million people. They’re due to deliver another 100 million each by the end of July. That's enough to vaccinate 200 million people total, many fewer than the roughly 260 million needed to reach herd immunity.
Here’s the latest on the vaccines that could soon join those from Moderna and Pfizer:
The third company to apply for Emergency Use Authorization (EUA), Johnson & Johnson reported last week that its single-dose vaccination was 66% effective at preventing illness and 100% effective at preventing hospitalizations and death in recent trials. The rate is lower than those reported by both Moderna and Pfizer, which both showed efficacy of around 95%. But Dr. Anthony Fauci insisted last week that the drug’s ability to guard against severe disease is the most important factor. “From a practical standpoint, from what you want to do, to keep people out of the hospital and prevent death, this is a value added,” he said.
The Food and Drug Administration (FDA) has set a February 26 hearing for its vaccine advisory committee to discuss the results of the Johnson & Johnson trials. If all goes well, the vaccine could be approved the next day, with shipments beginning by the end of the month. That could provide a boost to the vaccination effort, though the company has raised concerns about its ability to distribute shots quickly. Its contract calls for 12 million doses available by the end of February and 100 million by the end of June.
Dozens of countries have already approved the COVID-19 vaccine from the British pharmaceutical giant AstraZeneca, which is based on a virus that causes the cold in chimpanzees. The U.S. is not one of them and that approval could still be a ways away. Last Friday, AstraZeneca research chief Mene Pangalos told reporters that the data is still four to six weeks away.
The delay is the result of confusion in earlier trials, which led to a U.S.-only trial that AstraZeneca is waiting to complete before it applies for an EUA from the FDA. Some experts argue that the foreign data already on hand, which shows about 60% efficacy along with some concerns about how it works in older patients, should be enough for authorization in the U.S. More likely though, the drug won’t arrive until April, the former head of Operation Warp Speed recently predicted.
As the company waits for the completion of its U.S. trails, it had good news to report last week. Researchers published data showing that its vaccine may slow transmission of the virus, along with preventing illness.
Despite never once bringing a drug to market, the Maryland-based vaccine development firm Novavax was one of a handful awarded a nine-figure deal by the U.S. government to develop a COVID-19 vaccine. The company is not there yet, but early results are promising. In late January, it reported that the drug was 89% effective at preventing COVID-19 infections in a British trial.
The company is currently carrying out a trial in the U.S. and Mexico that did not begin until late December. That means results are still likely months away, though CEO Stan Erck has said he is asking the FDA if trial results from other countries could help speed up the emergency authorization process in the U.S. Erck has said once the EUA is granted in the U.S., the company will be ready to crank out as many as 150 million doses a month by May or June.