A government official suggested that Americans receive one dose instead of two doses of Moderna Inc.’s COVID-19 vaccine. to speed up the number of immunizations in the US.
Dr. Moncef Slaoui, chief adviser of Operation Warp Speed, the Trump administration program that funds research and production of COVID-19 treatments and vaccines, said on Sunday that the US could double the number of immunized adults under the age of 55 by giving them a single to give. dose of Moderna’s vaccine.
“We know it induces an identical immune response to the 100 microgram dose and so we are in talks with Moderna and the FDA,” he said while on CBS ‘Face the Nation.
Shares of Moderna MRNA,
were up 6% Monday.
The Cambridge, Massachusetts-based biotech received emergency use clearance from the Food and Drug Administration for its COVID-19 vaccine on Dec. 18, and it said it has since shipped approximately 18 million doses of the vaccine in the US. clinical trial design and FDA authority to require two doses, enough to vaccinate nine million people.
A Moderna spokesman said the data used to inform the EUA is based on a two-dose regimen. “At this time, we have no further information to share about any ongoing regulatory discussions,” said Ray Jordan, Chief Corporate Affairs Officer at Moderna, in an email.
The FDA did not immediately return a request for comment.
External medical experts are divided on Slaoui’s rationale, with some citing the limitations of the clinical data in his comments and others saying it may be a necessary decision given the daily number of cases, hospitalizations and deaths. At least 350,000 people in the US have died from COVID-19, after the deadliest US month in the pandemic to date.
“The idea of delaying dose 2 makes a lot of sense in the short term,” said Dr. Christopher Gill, associate professor at Boston University School of Public Health, in an email. “It will still be important to give the second dose later, but delaying this is unlikely to make much difference.”
Moderna’s Phase 3 clinical trial showed that the vaccine had approximately 92% efficacy two weeks after the first doses were administered. The second dose of Moderna vaccine is given four weeks after the first dose and the vaccine is then expected to be 94% effective.
“It’s not enough to hang your hat for a major vaccination,” said Dr. Paul Offit, a pediatrician at Children’s Hospital in Philadelphia and a member of the FDA’s advisory committee on vaccines.
But in a peer-reviewed study published Dec. 30 in the New England Journal of Medicine that summarized the Phase 3 clinical trial, which received funding from the U.S. government, the researchers said their findings “ suggest some degree of prevention can be provided after the first dose, ”but added that the trial was not intended to evaluate the efficacy of a single version of the vaccine.
In an FDA document published during the regulatory process, the agency shared some single-dose efficacy data provided by Moderna. Gill points out that it is important to look at efficacy rates at least two weeks after vaccination.
“The immune system takes some time to respond to the vaccine dose, especially the first dose,” he said. “You can see from the figure that the number of cases is practically zero after 14 days. “
The US approved two COVID-19 vaccines in December: Moderna’s mRNA-1273 and BioNTech SE BNTX,
and Pfizer Inc.’s PFE,
BNT162b2, both two dose mRNA vaccines that require two doses and were approximately 95% effective in clinical studies.
This is Moderna’s first FDA-approved product. The company’s stock is up 487.4% in the past year, while the S&P 500 SPX,
is up 16.2%.