FDA REVIEW CLEARS PATH FOR SECOND COVID VACCINE
WASHINGTON
A nationwide sense of relief grew Tuesday as a second coronavirus vaccine appeared poised for approval just days after thousands of health care workers received doses of the first one in an unprecedented mass inoculation campaign.
The second vaccine, developed by the biotechnology company Moderna, was “highly effective” in a clinical trial and carried no serious safety concerns, according to a detailed review by the Food and Drug Administration published Tuesday.
The agency probably will authorize the two-shot regimen as soon as Friday, according to a person with knowledge of the situation
who was not authorized to discuss the issue.
Such an approval would clear the way for the shipment of almost 6 million doses of the Moderna vaccine in the first week — about double the amount of doses being sent out this week, Gen. Gustave Perna, who is overseeing the distribution effort, said Monday.
Those numbers represent a tiny fraction of the doses that will be required to end or even slow the pandemic in the United States. Still, the rollout of the justapproved Pfizer-BioNTech vaccine offered a glimmer of hope at the end of a bleak year. A video of staffers at Boston Medical Center jubilantly dancing on a sidewalk, shared on Twitter on Monday evening by the hospital’s chief executive, circulated widely Tuesday.
In bittersweet briefings, governors hailed the arrival of vaccines in their states but warned that American life would not return to usual for many months to come. The initially limited supplies of vaccine will not meet demand until well into 2021, and scientists do not yet know whether the PfizerBioNTech and Moderna vaccines, or others in development, prevent recipients from spreading the virus or only from being sickened by it.
The elation was shadowed by the rising coronavirus case counts and new deaths one day after the nationwide death toll reached 300,000, as infections seeded over the Thanksgiving holiday began to show up in state reports. On Tuesday, more than 190,000 new cases and more than 2,800 deaths were reported.
Hospitalizations, meanwhile, threaten to overwhelm facilities across the nation as the end-of-year holidays approach. More than 110,000 people were hospitalized Tuesday with COVID-19, the illness the novel coronavirus can cause.
The chief clinical officer of Mercy Health Toledo, Kevin Casey, speaking by video during a briefing with Republican Ohio Gov. Mike DeWine, warned: “This is just the beginning of the end. It is not the end.” Even so, Casey acknowledged, the first inoculations of members of the hospital’s staff “is an exciting day for us.”
Public health off icials hope that at least 70 percent of the population will agree to get vaccinated to achieve herd immunity and stop the virus’ spread. As truckloads of vaccine fanned out across the country, that goal seemed like it might be attainable; a new survey suggested that willingness to be vaccinated may be growing in the United States, despite substantial hesitancy in some communities.
The Kaiser Family Foundation poll, conducted before the approval of the Pfizer-BioNTech vaccine and released Tuesday, found that 71 percent of respondents said they would definitely or probably opt for vaccination if it is determined by scientists to be safe and is free. That is a higher figure than has been reported in several previous surveys, including one by the foundation in September, which found that 63 percent said they would get vaccinated.
Blacks and Latinos reported significant increases in willingness to be vaccinated since September — with the rates rising from 50 percent to 62 percent among Black adults, and from 60 percent to 71 percent among Latinos. White adults’ willingness also rose, from 65 percent to 73 percent. More than one-quarter of those polled said they probably or definitely would not get a vaccine.
The FDA document published Tuesday morning expects the Moderna vaccine to follow the same track as the Pfizer-BioNTech vaccine. After the agency gave a positive review of the PfizerBioNTech vaccine last week, the shots were endorsed by a panel of outside experts on Thursday and granted approval by regulators a day later.
Assessing Moderna’s vaccine, regulators said the regimen was 94 percent effective at preventing disease in the trial and particularly effective against severe disease. Of 30 cases of severe COVID-19 in the trial, none was in the group that got the vaccine.
They also confirmed the vaccine worked well in people of all ages, races and genders. Side effects were widespread but typically shortlived and bearable. They included fatigue, headaches, muscle aches and pain at the injection site.
One point of contention about the Pfizer-BioNTech vaccine — whether it should be authorized for 16- and 17year-olds — probably will be avoided with Moderna’s because the company is seeking clearance to use the vaccine only in adults. Last week, the firm began testing its vaccine in adolescents.
Moderna’s vaccine will be reviewed Thursday by the same panel of independent experts that last week recommended the Pfizer-BioNTech vaccine. The data it will consider echoes the evidence that led to a 17-to-4 vote to authorize the PfizerBioNTech vaccine, which was 95 percent effective.
Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh, predicted that the Moderna vaccine would be authorized soon. That vaccine’s simpler logistics are also an advantage, he said. It does not require specialized, ultracold storage conditions like the PfizerBioNTech doses.
“I like the fact that now we have something that can be stored in a minus-20 [degrees Celsius] fridge — the same kind of fridge you keep your ice cream in,” he said.
Moderna developed its vaccine in partnership with the National Institute of Allergy and Infectious Diseases, with the U.S. government underwriting the research and development of the vaccine and the advanced purchase of 200 million doses, bringing its investment to $4.1 billion.