A government official suggested that Americans be given a dose instead of two of Moderna Inc.’s COVID-19 vaccine. in order to accelerate the number of vaccinations in the US.
Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration’s program that funds research and production of COVID-19 treatments and vaccines, said Sunday that the U.S. could double the number of adults immunized under the age of 55 by giving them a single dose of the Moderna vaccine.
“We know it induces an identical immune response at the 100 microgram dose, and so we’re in discussions with Moderna and the FDA,” he said while on CBS’s “Face the Nation”.
Shares of Modern MRNA,
they rose 6% on Monday.
The Cambridge, Massachusetts-based biotechnology company received emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine on Dec. 18 and said it has since has shipped approximately 18 million doses of the vaccine to the United States. clinical trial and FDA authority to require two doses, is enough to vaccinate nine million people.
A Moderna spokesman said the data used to inform the US is based on a two-dose regimen. “Right now, we don’t have any additional information to share about possible ongoing regulatory debates,” Ray Jordan, head of business affairs at Moderna, said in an email.
The FDA did not immediately return any request for comment.
External medical experts are divided on Slaoui’s logic, some citing the limitations of clinical data reporting their comments and others saying it could be a necessary decision given the daily rates of cases, hospitalizations and deaths. At least 350,000 people in the United States have died as a result of COVID-19, following the deadliest American month so far of the pandemic.
“The idea of deferring dose 2 makes a lot of sense in the short term,” Dr. Christopher Gill, an associate professor at Boston University School of Public Health, said in an email. “It will still be important to give the second dose later, but it’s likely that delaying that importance doesn’t matter much.”
The Moderna Phase 3 clinical trial showed that the vaccine had an efficacy rate of approximately 92% two weeks after the administration of the first doses. The second dose of Moderna’s vaccine is given four weeks after the first dose, and then the vaccine is expected to be 94% effective.
“It’s not enough to hang your hat to make a major vaccine,” said Dr. Paul Offit, a pediatrician at Philadelphia Children’s Hospital 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 included the Phase 3 clinical trial, which received financial support from the U.S. government, the researchers said their findings “suggest that some degree of prevention may be offered after the first dose, “but added that the trial was not designed to evaluate the effectiveness of a single-dose version of the vaccine.
In an FDA paper released during the regulatory process, the agency shared some data on efficacy after a dose that had been provided by Moderna. Gill notes that it is important to look at efficacy rates after at least two weeks after vaccination.
“The immune system takes a while to respond to the dose of vaccine, especially the first dose,” he said. “You can see in the figure that after 14 days the incidence of cases is virtually nil. “
The United States authorized two COVID-19 vaccines in December: Moderna’s mRNA-1273 and BioNTech SE BNTX,
and PFE from Pfizer Inc.,
BNT162b2, both two-dose mRNA vaccines that required two doses and had an approximate 95% efficacy in clinical trials.
It is the first product authorized by the FDA of Moderna. The company’s shares have risen 487.4% over the past year, while the S&P 500 SPX,
increases by 16.2%.