2nd virus vaccine shows striking success in US tests
(AP) — A second experimental COVID-19 vaccine — this one from Moderna Inc. — yielded extraordinarily strong early results Monday, another badly needed dose of hope as the pandemic enters a terrible new phase.
Moderna
said its vaccine appears to be 94.5% effective, according to
preliminary data from an ongoing study. A week ago, competitor Pfizer
Inc. announced its own vaccine looked 90% effective — news that puts
both companies on track to seek permission within weeks for emergency
use in the U.S.
The results are “truly striking,” said Dr. Anthony
Fauci, the U.S. government’s top infectious-diseases expert. “The
vaccines that we’re talking about, and vaccines to come, are really the
light at the end of the tunnel.”
A vaccine can’t come fast enough,
as virus cases topped 11 million in the U.S. over the weekend — 1
million of them recorded in just the past week — and governors and
mayors are ratcheting up restrictions ahead of Thanksgiving. The
outbreak has killed more than 1.3 million people worldwide, over 246,000
of them in the U.S.
Stocks rallied on Wall Street and around the
world on rising hopes that the global economy could start returning to
normal in the coming months. The Dow Jones Industrial Average gained
more than 470 points, or 1.6%, to close at a record high of over 29,950.
Moderna stock was up almost 10%.
Both vaccines require two shots,
given several weeks apart. U.S. officials said they hope to have about
20 million Moderna doses and another 20 million of the vaccine made by
Pfizer and its German partner BioNTech to use in late December.
Dr.
Stephen Hoge, Moderna’s president, welcomed the “really important
milestone” but said having similar results from two different companies
is what’s most reassuring.
“That should give us all hope that
actually a vaccine is going to be able to stop this pandemic and
hopefully get us back to our lives,” Hoge told The Associated Press. He
added: “It won’t be Moderna alone that solves this problem. It’s going
to require many vaccines” to meet the global demand.
If the Food
and Drug Administration allows emergency use of Moderna’s or Pfizer’s
candidate, there will be limited, rationed supplies before the end of
the year.
Exactly who is first in line has yet to be decided. But
Health and Human Services Secretary Alex Azar said the hope is that
enough doses are available by the end of January to vaccinate adults
over 65, who are at the highest risk from the coronavirus, and health
care workers. Fauci said it may take until spring or summer before
anyone who is not high risk and wants a shot can get one.
Neal
Browning of Bothell, Washington, who rolled up his sleeve back in March
for the first testing of Moderna’s vaccine in humans, said he is excited
about Monday’s “excellent news” but is still carefully wearing a mask
and taking other precautions.
“I’m super happy to be a part of
this and to try and help bring some kind of peace back to the world,”
Browning said. “I have a lot of hope.”
The National Institutes of
Health helped create the vaccine Moderna is manufacturing, and NIH’s
director, Dr. Francis Collins, said the two companies’ parallel results
give scientists “a lot of confidence that we’re on the path towards
having effective vaccines.”
But “we’re also at this really dark
time,” he warned, saying people can’t let down their guard during the
months it will take for doses of any vaccines cleared by the FDA to
start reaching a large share of the population.
Moderna’s vaccine
is being studied in 30,000 volunteers who received either the real thing
or a dummy shot. On Sunday, an independent monitoring board examined 95
infections that were recorded after volunteers’ second shot. Only five
of the illnesses were in people given the vaccine.
Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.
The
study is continuing, and Moderna acknowledged the protection rate might
change as more COVID-19 infections are detected. Also, it’s too soon to
know how long protection lasts. Both cautions apply to Pfizer’s vaccine
as well.
But Moderna’s independent monitors reported some
additional, promising tidbits: All 11 severe COVID-19 cases were among
placebo recipients, and there were no significant safety concerns. The
main side effects were fatigue, muscle aches and injection-site pain
after the second dose.
Scientists not involved with the testing
were encouraged but cautioned that the FDA still must scrutinize the
safety data and decide whether to allow vaccinations outside of a
research study.
“We’re not to the finish line yet,” said Dr. James
Cutrell, an infectious-disease expert at UT Southwestern Medical Center
in Dallas. “If there’s an impression or perception that there’s just a
rubber stamp, or due diligence wasn’t done to look at the data, that
could weaken public confidence.”
States already are gearing up for
what is expected to be the biggest vaccination campaign in U.S.
history. First the shots have to arrive where they’re needed, and
Pfizer’s must be kept at ultra-cold temperatures — around minus 94
degrees Fahrenheit. Moderna’s vaccine also starts off frozen, but the
company said Monday it can be thawed and kept in a regular refrigerator
for 30 days, easing that concern.
Beyond the U.S., other
governments and the World Health Organization, which aims to buy doses
for poor countries, will have to separately decide if and when vaccines
should be rolled out broadly.
“There are many, many questions
still remaining,” including how long protection lasts and if the first
vaccines to emerge work as well in older people as in the young, said
WHO chief scientist Dr. Soumya Swaminathan. “We also hope the clinical
trials will continue to collect data, because it’s really going to be
important for us to know in the long term.”
The vaccine from
Cambridge, Massachusetts-based Moderna is among 11 candidates in
late-stage testing around the world, four of them in huge studies in the
United States. Collins stressed that more U.S. volunteers are needed for those studies.
Elsewhere
around the world, China and Russia have been offering different
experimental vaccines to people before completing final-stage testing.
Both
Moderna’s shots and the Pfizer-BioNTech candidate are so-called mRNA
vaccines, a brand-new technology. They aren’t made with the coronavirus
itself, meaning there’s no chance anyone could catch it from the shots.
Instead, the vaccine contains a piece of genetic code that trains the
immune system to recognize the spiked protein on the surface of the
virus.
Pfizer CEO Albert Bourla tweeted that he was thrilled at Moderna’s news, saying, “Our companies share a common goal — defeating this dreaded disease.”
AP Photographer Ted Warren contributed to this report.