A government official suggested that Americans should be given one dose instead of two doses of Moderna Inc.’s COVID-19 vaccine to speed up the number of immunizations in the U.S.
Dr. Moncef Slaoui, chief advisor to Operation Warp Speed, the Trump administration program that funds research and production of COVID-19 treatments and vaccines, said on Sunday that the United States could double the number of adults immunized under 55 years giving them a single dose of Moderna’s vaccine.
“We know that it induces an immune response identical to the 100 microgram dose and, therefore, we are discussing with Moderna and the FDA,” he said, during CBS’s “Face the Nation” program.
Moderna MRNA shares,
increased 6% on Monday.
Biotechnology in Cambridge, Massachusetts, received authorization for emergency use from the Food and Drug Administration for its vaccine COVID-19 on December 18 and said it has since dispatched about 18 million doses of the vaccine in the United States. the clinical trial and the FDA’s authority to require two doses is enough to vaccinate nine million people.
A spokeswoman for Moderna said the data used to inform the United States is based on a two-dose regimen. “At this point, we have no further information to share about any potential regulatory discussions in progress,” Ray Jordan, director of corporate affairs at Moderna, said in an email.
The FDA did not immediately return a request for comment.
External medical experts are divided over Slaoui’s justification, with some citing the limitations of the clinical data that inform his comments and others saying that it might be a necessary decision, given the daily rates of cases, hospitalizations and deaths. At least 350,000 people in the US died of COVID-19, after the deadliest American month so far in the pandemic.
“The idea of postponing dose 2 makes a lot of sense in the short term,” said Dr. Christopher Gill, associate professor at Boston University School of Public Health, by email. “It will still be important to give the second dose later, but delaying that is unlikely to matter much.”
Moderna’s Phase 3 clinical trial showed that the vaccine had an efficacy rate of approximately 92% two weeks after the first doses were administered. 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 is not enough to hang your hat for a major vaccination,” said Dr. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and a member of the FDA vaccine advisory committee.
But in a peer-reviewed study published on December 30 in the New England Journal of Medicine, recapping 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 provided 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 a FDA document published during the regulatory process, the agency shared some data on effectiveness after a dose provided by Moderna. Gill points out that it is important to look at efficacy rates after at least two weeks after vaccination.
“The immune system takes some time to respond to the dose of the vaccine, especially the first dose,” he said. “You can see in the figure that after 14 days the incidence of cases is practically zero. “
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 require two doses and have had about 95% efficacy in clinical trials.
This is the first product authorized by Moderna’s FDA. The company’s stock soared 487.4% in the last year, while the S&P 500 SPX,
rose 16.2%.