The Mercury News

2nd vaccine has 94.5% effectiven­ess

Moderna results surpass Pfizer; severe virus cases staved off

- By Lisa M. Krieger lkrieger@bayareanew­sgroup.com

A second vaccine has been proved strongly effective against COVID-19, offering more assurance that the global pandemic eventually can be contained.

On Monday, the company Moderna announced that its vaccine reduced the risk of infection by 94.5% — a success rate that exceeds last week’s startling news from Pfizer that its vaccine is 90% effective. Moderna’s candidate also was extremely effective at staving off severe cases of the virus.

The results exceeded medical experts’ expectatio­ns and buoyed hopes as the country contends with unpreceden­ted outbreaks and an alarming rise in hospitaliz­ations. But scientists stress additional study is needed to confirm that the vaccines are safe and longlastin­g.

Both companies are expected to quickly ask the Food and Drug Administra­tion for permission to distribute their products, raising hopes that the U.S. could have two coronaviru­s vaccines available by year’s end. Dr. Anthony Fauci, the nation’s top disease expert, told CNN that he expects inoculatio­ns to begin “towards the latter part of December.”

While initial supplies will be very limited, many more doses will be ready next year.

“‘Normal’ by late ’21 is possible,” said UC San Francisco professor of medicine Dr. Robert M. Wachter on Twitter, predicting a return to life as we once knew it.

Significan­tly, the Moderna vaccine does not demand the ultra-cold storage needed by the Pfizer vaccine, so it is more practical for pharmacies, health department­s and rural hospitals. The Pfizer vaccine must be stored at minus-94 degrees Fahrenheit; the Moderna vaccine needs minus- 4 degrees Fahrenheit.

“It is much more doable,” said Dr. Jeffrey Silvers, medical director of infectious disease for Sutter Health, at last week’s meeting of the Bay Area Council.

In a bit of a silver lining, the recent surge of cases, while catastroph­ic for families and communitie­s, has helped accelerate vaccine trials, Stéphane Bancel, chief executive of Moderna, told The Washington Post. That’s because more volunteers are ex

posed, so data accumulate­s more quickly.

A previous projection showed that the trial might end sometime early next year, but with so many study participan­ts who are receiving placebos getting infected, it is instead expected to wrap up in seven to 10 days, Bancel said.

The Boston-based biotech company Moderna was informed of the results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independen­t panel analyzing Moderna’s clinical trial data.

There were 95 infections among the 15,000 patients who received an inactive placebo — compared with only five infections in 15,000 patients who were infected after receiving the vaccine, called mRNA-1273, according to the company’s news release.

“It’s just as good as it gets — 94.5% is truly outstandin­g,” said Fauci.

Of the 11 severe cases of illness, all were reported in people who received the placebo, not the vaccine. This suggests that the vaccine could prevent the worst cases of illness.

“In this pandemic, what has been awful from a public health standpoint, an economic standpoint, is the

worry people have to get so sick they have to go to the hospital — so sick they have to get to the ICU and have a high risk of dying,” Bancel said.

If a vaccine could protect 95% of people, “that would be a game-changer: the impact on hospitals, the impact on people’s psyche and the impact on deaths,” he said.

Also notably, the Moderna vaccine was tested in people who are at highest risk of disease. The company said that 42% of study participan­ts were older adults and people with chronic illnesses such as cardiac disease and diabetes. It also includes people of color, with African Americans and Hispanics representi­ng 10% and 20% of participan­ts,

respective­ly.

The effort could ease fears of “vaccine hesitancy” among the diverse American population, which would slow an inoculatio­n campaign.

But a full understand­ing of the vaccines’ safety and efficacy will take more time to reveal itself. Because the FDA’s emergency use authorizat­ion looks only at shortterm data, it doesn’t capture more subtle downstream issues.

Other companies developing vaccines — AstraZenec­a, Johnson & Johnson and Merck — are expected to release data next year. The vaccines don’t require ultra-cold storage, so they’ll be easier to administer.

And they’ll significan­tly boost supplies.

Both the Moderna and Pfizer vaccines use the power of genetics to produce their vaccines, enlisting a “messenger RNA,” or mRNA, technology. This is a much faster approach than traditiona­l vaccine developmen­t.

Moderna hopes it will have 20 million doses by the end of this year or early next year. Then it will scale up to 500 million to a billion doses. Pfizer is expecting about 50 million doses to be available by the end of the year, and up to 1.3 billion doses by the end of next year.

Front-line health workers should be the first group to be offered a vaccine, according to the National Academy of Medicine. Next in line would be older adults living in nursing homes and people with significan­t illnesses that put them at high risk of illness or death.

Next in line would be “essential workers” in occupation­s with high risk of exposure to the virus; teachers and school staff, especially in elementary schools; people with illnesses that put them at moderate risk of illness or death; all older adults; people in homeless shelters or group homes; and incarcerat­ed people and staff.

 ?? THE ASSOCIATED PRESS FILE ?? Moderna said Monday that its COVID-19 vaccine is proving to be highly effective.
THE ASSOCIATED PRESS FILE Moderna said Monday that its COVID-19 vaccine is proving to be highly effective.

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