WASHINGTON -- Moderna's coronavirus vaccine got the green light from a Food and Drug Administration advisory committee Thursday, paving the way for authorization of a second shot aimed at slowing a pandemic that has killed nearly 310,000 people in the United States.
The panel voted almost unanimously -- 20 in favor, with one abstention -- that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA plans to authorize the vaccine today, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.
Anticipating the authorization decision, Gen. Gustave Perna, who is overseeing the federal effort to distribute vaccines, said Monday that the government was preparing to ship almost 6 million doses of the Moderna vaccine to 3,285 locations in the first week after approval.
"It will be a very similar cadence that was executed this week with Pfizer, where we're hitting initial sites on Monday, [followed] on Tuesday and Wednesday," Perna said.
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The FDA authorized the first coronavirus vaccine, by Pfizer-BioNTech, last week. The first doses were administered Monday to health care workers.
Early in the meeting Thursday, the FDA addressed an issue that did not involve the Moderna vaccine directly: reports of allergic reactions to the Pfizer-BioNTech vaccine, including in two health care workers in Alaska, one of whom was hospitalized. Both are recovering.
"While the totality of data at this time continue to support vaccinations under the Pfizer [emergency use authorization] without new restrictions, these cases underscore the need to remain vigilant during the early phase of the vaccination campaign," FDA vaccine expert Doran Fink said.
The agency is working with the companies to revise the fact sheets provided to patients and health care professionals, and will highlight a requirement that facilities administering the vaccine ensure that treatment for a severe allergic reaction is immediately available.
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HIGHLY EFFECTIVE
The endorsement from the independent panel of outside advisers was announced two days after the FDA issued a detailed data review confirming that in the company's clinical trial, the two-shot regimen was 94% effective at preventing illness, and particularly effective against severe illness.
The vaccine has not caused major safety problems, according to the FDA and Moderna, a biotechnology company with headquarters in Cambridge, Mass.
The FDA found no severe allergic reactions in Moderna's data but flagged a slightly higher rate of less serious side effects -- rash, hives, itching -- among participants who got the vaccine, compared with those receiving a placebo shot.
There were three cases of Bell's palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one among those getting a placebo shot. The FDA review said the role of the shot in the vaccine group "cannot be ruled out."
Moderna developed its vaccine in partnership with the National Institute of Allergy and Infectious Diseases, with the government underwriting the research and development of the vaccine and the advanced purchase of 200 million doses, bringing the government investment to $4.1 billion.
The FDA reviews of the Pfizer-BioNTech and Moderna vaccines cement the success of a new genetic vaccine technology, which could be used to rapidly create vaccines for other diseases.
Older vaccines work by injecting dead or weakened virus to teach the immune system to recognize the real pathogen. In contrast, the messenger RNA technology at the core of the Moderna and Pfizer-BioNTech vaccines delivers a strip of genetic material called RNA, encased in a fat bubble, to a person's cells.
Once inside a cell, the messenger RNA co-opts the machinery used to make proteins to build tiny replicas of the spike protein that studs the outside of the coronavirus. The immune system learns to recognize -- and block -- the spike.
Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA advisory committee, said Wednesday on CNN that the two vaccines are similar in safety and efficacy. Asked whether people will have a choice of which to get, he replied, "There is not a lot of vaccine out there, so you are going to be asked to get the vaccine that the area has."
In Moderna's trial, 30,000 people were randomly assigned to receive either two shots of a vaccine given four weeks apart, or two saline shots. Neither the participants nor the people running the trial knew who was in which group.
Investigators then waited as people were exposed to the coronavirus in their daily lives, to see if there were more cases of covid-19, the disease caused by the virus, in the group that did not receive the real vaccine. They counted cases starting two weeks after the second dose, to measure how well the vaccine protected participants after the immune system had mustered a full response.
The numbers were decisive: There were 196 cases in the trial, all but 11 of them in the group that received the placebo shots. There were 30 cases of severe covid-19 and one death from covid-19 in the trial, all in the group that received the placebo.
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There was a suggestion that a first dose of vaccine afforded some protection from the virus, but the data lacks key information. "These data do not provide sufficient information about longer term protection beyond 28 days after a single dose," the review said.
One of the major outstanding questions about this and other coronavirus vaccines is whether they prevent infection, not just disease. Since most cases of covid-19 are asymptomatic, that question has major implications for how to best use the vaccines and whether people will need to continue wearing masks and social distancing despite being vaccinated.
CASES, DEATHS CLIMB
The development occurs as more covid-19 deaths are being reported each day than at any time during the pandemic.
The nation set single-day records Wednesday for reported deaths, with more than 3,600, and for newly reported cases, more than 245,000. The previous case record was set Dec. 11, when more than 236,800 new infections were announced, not including tens of thousands of significantly older cases reported that day.
Three times as many people in the United States are dying each day now than three months ago, and the number of new cases is six times what it was then. Also, with large cities already ravaged by the virus, it is now exacting a deadly toll on many midsize cities.
In the past week, just over 30% of the nation's coronavirus-related deaths were reported in the South and nearly 30% in the Midwest. Pennsylvania, Arizona and Kansas in particular have had dizzying growth in death tolls over the past seven days; North Dakota and South Dakota registered the most deaths relative to the size of their populations.
Nevada reported 57 deaths Wednesday, a record. "That's another 57 Nevadans who will be missed by loved ones this holiday season," Gov. Steve Sisolak wrote in a Twitter post.
California, the nation's most populous state by far, has been averaging 202 deaths a day recently. The state has bought 5,000 extra body bags and set up 60 refrigerated storage units around the state to help coroners, Gov. Gavin Newsom said Tuesday.
SHIPMENTS CUT
Meanwhile, state officials said they were alerted late Wednesday that their second shipments of Pfizer-BioNTech's vaccine next week had been reduced, sparking widespread confusion.
The changes prompted concern in health departments across the country about whether Operation Warp Speed, the Trump administration's vaccine accelerator, was capable of distributing doses quickly enough to meet the target of delivering first shots to 20 million people by year's end. A senior administration official, speaking on the condition of anonymity to discuss internal plans, said the revised estimates for next week were the result of states requesting an expedited timeline for locking in future shipments -- from today to Tuesday -- leaving less time for federal authorities to inspect and clear available supply.
But Pfizer released a statement Thursday that seemed at odds with that explanation, saying the company faced no production issues and had more doses available than were being distributed.
"We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses," the statement read.
A total of 2.9 million doses of the Pfizer-BioNTech vaccine was cleared for shipment this week, and 5.9 million doses of Moderna's regimen are poised to go out next week if the vaccine is authorized as expected. That will be on top of additional supply from Pfizer, which Health and Human Services Secretary Alex Azar said Wednesday would amount to 2 million doses next week.
That represents a sharp drop-off from what states were expecting, according to health officials in several states. At least three states received notice from the Centers for Disease Control and Prevention on Wednesday, informing them of the shortfall, forcing last-minute changes to vaccine distribution plans for next week. Some places were intending to use the second shipment from Pfizer to begin vaccinating residents of long-term care facilities, officials said, creating dilemmas about whether to go ahead with those plans or to finish inoculating health care providers on the front lines of the intensifying pandemic.
Pfizer's statement seemed to point responsibility at the federal government.
"We have continuously shared with Operation Warp Speed and the U.S. Department of Health and Human Services through weekly meetings every aspect of our production and distribution capabilities," it continued. "They have visited our facilities, walked the production lines and been updated on our production planning as information has become available."
Michael Pratt, a Health and Human Services Department spokesman, denied any changes to "numbers locked in with states" and said the government was still on track to allocate enough vaccine for about 20 million people to receive their first doses by year's end.
TENNESSEE'S RESERVE
As states rush to inoculate health care workers, Tennessee has prioritized building its own emergency reserve of the coveted vaccine.
An Associated Press review of each state's covid-19 vaccine distribution plans shows that Tennessee has specified it will hold back a small portion in "case of spoilage of vaccine shipped to facilities." The state's initial shipment of the Pfizer-BioNTech vaccine that arrived Monday was not distributed for inoculation, so health care workers had to wait until the second shipment arrived days later.
The move has baffled health care leaders, who say medical workers should take priority, especially as the state hits record case numbers.
"Given the extremely high case counts right now, our front-line health care workers are at higher risk than ever, I would personally advocate for those doses being used rather than stockpiled," said Dr. Isaac Thomsen, who leads the Vanderbilt Vaccine Research Program Laboratory.
Despite a federal stockpile created so states can use all of their supplies, Tennessee officials maintain that the reserve is necessary because of the risk of damaging the vaccine, which requires ultracold storage.
"If a hospital receives a case of the vaccine and it's spoiled or broken, we can immediately deploy that [emergency reserve] to them," state Health Commissioner Lisa Piercey said.
When asked about the growing reserve, Piercey on Thursday told reporters that those 5,000 Moderna doses in reserve will be used in areas with vulnerable populations.
However, that strays from the state plan, which clearly states that the 5,000 Moderna doses will be "reserved by the State in case of spoilage." The state plan says only 5% of the allocation from "all other vaccine manufacturers" should be used for the vulnerable areas.
Piercey demurred when asked why the emergency reserve was necessary when the federal government was also building up its backup supply. Instead, she pointed to the delicateness of the vaccine and the high risk of it being damaged if not handled properly.
Information for this article was contributed by Laurie McGinley, Carolyn Y. Johnson, Isaac Stanley-Becker, Yasmeen Abutaleb, Lena H. Sun, Josh Dawsey and Fenit Nirappil of The Washington Post; by Lauren Wolfe and Mitch Smith of The New York Times; and by Kimberlee Kruesi, Andrew Welsh-Huggins, Scott Bauer, Rebecca Boone, Matthew Perrone and Lauran Neergaard of The Associated Press.
