A government official has suggested that Americans be given one dose instead of two doses of COVID-19 Moderna Inc. vaccine to speed up the number of immunizations in the United States.
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 United States could double the number of immunized adults under the age of 55 by providing them a single dose of Modern vaccine.
“We know it induces an identical immune response at a dose of 100 micrograms, and therefore we are in talks with Moderna and the FDA,” he said, while on CBS’s “Face the Nation.”
Shares of Moderna MRNA,
increased by 6% months.
Biotechnology in Cambridge, Massachusetts, received emergency use authorization from the Food and Drug Administration for the COVID-19 vaccine on December 18 and said it has since delivered approximately 18 million doses of vaccine to the U.S. Based on the clinical trial design and FDA authority to request two doses, is enough to vaccinate nine million people.
A Moderna spokesman said the data used to inform EUA is based on a two-dose regimen. “At this time, we have no further information to share about any ongoing regulatory discussions,” Ray Jordan, Moderna’s director of corporate affairs, said in an email.
The FDA did not immediately return a request for comment.
External medical experts are divided on Slaoui’s reason, some citing the limitations of clinical data that inform his comments, and others say 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 from COVID-19 after the deadliest US pandemic to date.
“The idea of postponing dose 2 makes a lot of sense in the short term,” said Dr. Christopher Gill, an associate professor at Boston University School of Public Health, in an e-mail. “It will still be important to take the second dose later, but the delay is unlikely to matter much.”
The Phase 3 clinical trial in Moderna showed that the vaccine had an efficacy rate of about 92% two weeks after the first doses. The second dose of Moderna 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 on for a major vaccination,” said Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee.
However, in a study published Dec. 30 in the New England Journal of Medicine, summarizing the Phase 3 clinical trial, which received financial support from the U.S. government, investigators said their findings “suggest some degree of prevention.” can be given after the first dose, ”but added that the study was not designed to evaluate the effectiveness of a single-dose version of the vaccine.
In an FDA document released during the regulatory process, the agency shared some data on efficacy after a dose that was provided by Moderna. Gill stresses the importance of analyzing efficacy rates 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 US approved two COVID-19 vaccines in December: Moderna mRNA-1273 and BioNTech SE BNTX,
and PFE from Pfizer Inc.,
BNT162b2, both of which were two-dose mRNA vaccines that required two doses and had approximately 95% efficacy in clinical trials.
This is the first FDA-approved product from Moderna. The company’s shares have risen 487.4% in the past year, while the S&P 500 SPX,
it is increasing by 16.2%.