A second COVID-19 candidate vaccine looks to be even more effective than the first: Both protect more than 90% of those who get the shots.
Moderna, a Cambridge, Massachusetts-based biotechnology company, announced early Monday that its candidate vaccine, mRNA-1273, developed in collaboration with the U.S. government, appears to be 94.5% effective against the disease.
This month, Pfizer and its German partner BioNTech also announced early effectiveness data that showed their vaccine, called BNT162b2, had protected more than 90% of those who received it.
Both results are preliminary. Final results expected in as soon as a few weeks.
“This is better than Christmas,” said Dr. Monica Gandhi, professor of medicine at the University of California-San Francisco. “The interim results of these two exciting mRNA vaccine candidates over the past week are encouraging, hopeful and move us massively forward to getting out of this pandemic.”
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A colleague was equally thrilled.
“There’s part of me that tries to hear this as a dispassionate physician, but as a human being, this makes me giddy,” said Dr. Robert Wachter, chairman of the Department of Medicine at UCSF. “You can really see the light at the end of this tunnel. It’s unbelievable.”
Moderna’s good news also proves that Pfizer/BioNTech’s results were not a fluke, he said.
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Most of the vaccines under development target the same “spike” protein on the surface of the virus that causes COVID-19. If these two are so effective, he said, it suggests other candidates that target the protein in different ways will also be good at protecting people.
“There’s no good reason to believe we won’t have one, two, three or four more that are equally effective,” Wachter said.
Even before the latest results were made public, people have been fantasizing on Twitter about what they would do once they are protected by a vaccine. The most popular response: Hug a loved one.
Each trial enrolled tens of thousands of volunteers – Pfizer’s had 44,000; Moderna’s 30,000 – injecting them twice either with the candidate vaccine or a placebo, then waiting to see if they came down with COVID-19.
In Moderna’s first interim analysis, 95 people came down with COVID-19, 90 of whom received the placebo. Eleven people – all in the placebo group – developed “serious” cases of the disease. Among the 95 who fell ill, 15 were over 65 years old, 12 were Hispanic, four were Black, three were Asian and one was self-described as multiracial, according to a company news release.
A final analysis is expected to include 151 trial volunteers, by which point, statistically, the company can be 90% sure its findings will hold true.
With the Pfizer/BioNTech vaccine interim results, 94 patients developed the disease, the vast majority of whom had received the placebo, which is how the company calculated that it was 90% effective. The companies will do a final check of effectiveness when 164 study participants have fallen ill.
Both companies are “blinded” to the results until reaching predetermined analysis points, with an independent data safety monitoring board reviewing the data first.
Stéphane Bancel, chief executive officer of Moderna, said in a prepared statement that he was very pleased with the results and thanked the trial participants and government scientists who helped develop and fast-track mRNA-1273.
“Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” he said. “We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
Other scientists were equally enthusiastic.
“It certainly looks promising,” said Dr. Peter Hotez, a pediatrician and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, who was not involved in developing any of the COVID-19 vaccines. He said he was encouraged by the results in older people but wants to see the findings published in a peer-reviewed journal rather than just a company press release.
“So now Operation Warp Speed perhaps has produced two successful vaccines with an innovative technology,” he said, referring to the Trump administration program developing and mass-producing COVID-19 vaccines.
Dr. Anthony Fauci, who as head of the National Institute of Allergy and Infectious Diseases, helped develop the Moderna vaccine, said in a Monday news conference that “the results of this trial are truly striking.”
He said his agency and Moderna have been collaborating for years to develop a vaccine platform that could be quickly deployed in case of a pandemic like the current one, and he was thrilled that their hard work had paid off.
“We shouldn’t underestimate the importance of basic biomedical research,” he said at a joint news conference with Dr. Francis Collins, the head of the National Institutes of Health, and Alex Azar, the Secretary of Health and Human Services.
Fauci also reminded listeners that we are in the middle of a surge of COVID-19 cases and that while “help is on the way…we should not forget that it is absolutely critical to continue to double-down on our public health measures.” He emphasized masks, avoiding crowds, distancing from others and handwashing. “We should not let the accomplishment of an effective vaccine have us feel we can let our guard down,” he said.
Both the Moderna and the Pfizer/BioNTech candidate vaccines depend on a technology called mRNA that uses the body’s natural processes to turn cells into factories producing a protein found on the outside of the virus that causes COVID-19. The immune system then learns to recognize that protein and attack the virus if it appears.
Before the companies can apply to the U.S. Food and Drug Administration for authorization to provide their vaccine to the public, they must jump through several more hoops.
About half the trial participants must be two months past their second shot to prove that the candidate vaccines are safe. All the vaccines are expected to cause sore arms and a day or two of fatigue and flu-like symptoms, but if someone is going to develop a severe vaccine reaction, that is likely to happen within six weeks after receiving it.
Pfizer has said it will pass that safety milestone this week, though Moderna will likely take longer because it enrolled its trial participants at a slightly slower pace and because RNA-1273’s two shots have to be given 28 days apart, while Pfizer’s shots are spaced by 21 days.
The final hurdle concerns production. Both companies will have to show they can safely produce their vaccine at scale. Pfizer has said it would provide the FDA with all necessary information before this week. It’s not clear when Moderna will complete that process, but it is not expected to slow its application.
Once receiving each application, the FDA will review them, as will the independent Vaccines and Related Biological Products Advisory Committee.
It’s not known how long that process will take, but the regulatory agency is expected to issue an emergency-use authorization for the Pfizer/BioNTech vaccine before the end of the year.
President Donald Trump has promised that vaccine would be distributed within 24 hours of an FDA authorization. It would first go to front-line health care workers.
The Trump administration, under Operation Warp Speed, has allocated more than $10 billion for a handful of vaccine development companies to start manufacturing vaccine “at risk” – that is, before receiving regulatory approval.
“This administration has screwed up the response to the coronavirus in many, many ways, but on this one they pretty much got it right,” Wachter said. “The fact that the government was guaranteeing the distribution certainly moved the thing along. I think they were smart to invest a whole lot of money and smart to stay out of the companies’ way.”
Moderna said Monday that it will have 20 million doses available by the end of this year and another 500 million to 1 billion next calendar year.
Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year and another 1.3 billion next year.
The companies have each received about $2 billion from the federal government to produce 100 million doses each. Those doses would be provided to Americans at no additional cost.
An emergency use authorization is short of a full-scale approval, but it is a fast-track protocol that allows the companies to distribute their vaccines quickly during a public health emergency.
Usually, the FDA requires that vaccines be tested for at least two years to ensure that the immunity they provide lasts that long, but with more than 1,000 Americans dying every day, there isn’t time to see how long the vaccines will be protective. People may need booster shots to provide longer-term protection.
Other vaccines also are under development, most of them using different types of vaccine technology. AstraZeneca, for example, is expected to have interim effectiveness data on its candidate vaccine within the next few months.
Hotez, who also co-directs the Texas Children’s Hospital Center for Vaccine Development, said a collaboration between his institute and Indian and American pharmaceutical companies will shortly begin an early-phase clinical trial of a COVID-19 candidate vaccine in India.
Moderna also announced Monday that mRNA-1273 can be stored at standard refrigerator temperatures for up to a month before being used. It had been expected to need to remain frozen until a week before use, which would have made it more complicated to store.
Gandhi, of UCSF, called the new storage standard “exciting” and said it “will massively facilitate widespread distribution.”
The Pfizer/BioNTech vaccine must be stored at ultra-cold temperatures until five days before use.
Once the Moderna vaccine is removed from the refrigerator, it can be kept at room temperature for up to 12 hours. Unlike the Pfizer/BioNTech vaccine, mRNA-1273 does not need to be diluted by the pharmacist or whoever is delivering the shot, which makes it more practical to be used outside major health care settings.
Contributing: Elizabeth Weise. Contact Karen Weintraub at email@example.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: Moderna COVID-19 vaccine 94.5% effective, similar to Pfizer: Trial