The latest data set the stage for the possibility that at least two vaccines will be available on a limited basis by the end of the year.
Cambridge biotech Moderna said it will ask federal regulators Monday to authorize emergency use of its experimental COVID-19 vaccine, after complete results from a late-stage study showed the substance was 94.1 percent effective at preventing the disease and 100 percent effective at warding off severe cases.
The final efficacy results from a clinical trial of 30,000 volunteers were almost identical to an interim analysis released by the company two weeks ago. The latest data set the stage for the possibility that at least two vaccines will be available on a limited basis in the US by the end of the year.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 percent efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Moderna’s chief executive, Stephane Bancel, in a prepared statement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”
The 10-year-old biotech will become the second drug maker to ask the Food and Drug Administration for permission to begin distributing a vaccine to help end a scourge that has killed more than 246,000 Americans. Pfizer, the 171-year-old pharmaceutical giant, and its German partner BioNTech, filed the first application on Nov. 20.
Moderna said it also plans to apply on Monday to European drug regulators for conditional approval of the vaccine.
An advisory committee to the FDA will likely discuss Moderna’s trial data and make recommendations about the vaccine on Dec. 17, according to the company, which has been consulting with the agency. That would be exactly a week after the same committee considers data from the late-stage trial run by Pfizer and BioNTech. (Pfizer has a plant in Andover that is helping to make its vaccine.)
If the FDA approves the vaccines for emergency use, they would likely be distributed at first to people at high risk for catching the disease, such as medical workers, and to vulnerable people, including the elderly and individuals with health problems.
Dr. Anthony Fauci, the nation’s top infectious disease expert, said on Nov. 17 at the STAT Summit 2020, a virtual event, that as many as 20 million people in the US could get coronavirus vaccinations near the end of the year. By then, he said, there could be roughly 25 million doses of vaccine available from Pfizer and 15 million doses from Moderna. Both vaccination regimens require two shots a few weeks apart, so that would mean about 20 million people could get protection — a big step forward, though only a fraction of the US population.
Moderna on Monday summarized final data that had been analyzed by an independent monitoring board. The board analyzed 196 coronavirus cases diagnosed among the 30,000 study participants who received two shots four weeks apart and then went about their daily lives. Half of participants in the trial got the vaccine. The other half got placebo shots.
The analysis found that only 11 of the 196 people who came down with COVID-19 had gotten the vaccine. The other 185 cases occurred in recipients of the placebo. That indicated the vaccine has an efficacy rate of 94.1 percent — virtually the same rate as the 94.5 percent disclosed by the company two weeks ago after the first 95 coronavirus cases were diagnosed among volunteers. It’s a remarkable showing for any vaccine, let alone one based on novel technology.
Thirty of the 196 coronavirus cases in the latest analysis were deemed severe, including one that resulted in a participant’s death. All 30 severe cases were diagnosed in volunteers who got the placebo.
The vaccine was effective regardless of the age, race, ethnicity, and gender of volunteers, according to Moderna. In an indication of the diversity of trial participants, Moderna said the 196 volunteers who became ill with COVID-19 included 33 adults who were at least 65 years old and 42 participants who identified themselves as Hispanic, Black, Asian-American, or multiracial.
The study found no serious safety concerns. The most common side effects included pain at the injection site, fatigue, achiness, and headache. Side effects increased in frequency and in discomfort after the second jab.
Both the Pfizer and Moderna vaccines rely on synthetic messenger RNA, an ingenious variation on the natural substance that directs protein production in cells throughout the body. The vaccines contain custom-made messenger molecules that instruct cells to create a part of the coronavirus and then stimulate the immune system to make antibodies to fend off the disease. If it works — as the clinical trials indicate it does — the process would protect people if they got infected by the actual virus. No mRNA vaccine has ever been approved.
If Moderna’s vaccine ultimately wins FDA approval, it would transform the upstart biotech from a firm without any marketed products to one with a product that could generate $13 billion in sales next year, Goldman Sachs analyst Salveen Richter said in a recent note to investors.
Another vaccine candidate made by AstraZeneca, the British-Swedish pharmaceutical giant, and the University of Oxford, is the subject of a request to British regulators for emergency use in the United Kingdom.
AstraZeneca announced last week that the vaccine appeared to be up to 90 percent effective in a subset of participants in a late-stage trial. Soon afterward, the drug maker acknowledged a key dosing error that undermined the confidence of some scientists and created uncertainty about whether additional testing would confirm the results.
There are more than a dozen coronavirus vaccine candidates in late-stage trials globally. They use a variety of approaches, and no company could produce enough of one to protect the world’s 7.8 billion people.
No one knows how long any of the vaccines might confer immunity, but the answer is likely to emerge in coming months. Some experts say it’s possible that booster shots might be needed.
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.
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With results complete, Moderna will seek emergency use of COVID-19 vaccine Monday - BetaBoston
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