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A government official has suggested that Americans should be given one dose instead of two doses of Moderna Inc.’s COVID-19 vaccine in order to speed up the number of vaccinations in the United States.
Dr Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration’s program funding research and production of COVID-19 treatments and vaccines, said on Sunday that the United States could double the number of adults vaccinated under 55 years by giving them only one. Moderna vaccine dose.
“We know that it induces an identical immune response at the 100 microgram dose and therefore we are in discussions with Moderna and with the FDA,” he said on the “Face the Nation” program of CBS.
Moderna MRNA actions,
were up 6% on Monday.
Cambridge, Massachusetts-based biotechnology received emergency use clearance from the Food and Drug Administration for its COVID-19 vaccine on December 18 and said it has since shipped 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 Moderna spokesperson said the data used to inform the EUA is based on a two-dose regimen. “At this point, we have no further information to share on any ongoing regulatory discussions,” Ray Jordan, chief executive officer of Moderna, said in an email.
The FDA did not immediately return a request for comment.
Outside medical experts are divided over Slaoui’s rationale, with some citing the limitations of the clinical data that inform his 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 from COVID-19, after the deadliest US month to date in the pandemic.
“The idea of postponing Dose 2 makes a lot of sense in the short term,” Dr. Christopher Gill, associate professor at the Boston University School of Public Health, said in an email. “It will always be important to give the second dose later, but this delay is unlikely to matter much.”
Moderna’s phase 3 clinical trial showed the vaccine to be approximately 92% effective two weeks after the first doses were given. The second dose of Moderna’s vaccine is given four weeks after the first dose, then the vaccine should be 94% effective.
“It’s not enough to hang your hat on for a major vaccination,” said Dr. Paul Offit, pediatrician at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee.
But in a peer-reviewed 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 results “suggest that a some degree of prevention can be assured after the first dose, ”but added that the trial was not designed to assess the effectiveness of a single-dose version of the vaccine.
In an FDA document released during the regulatory process, the agency shared data on post-dose efficacy that had been provided by Moderna. Gill stresses that it is important to examine efficacy rates 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 practically zero. “
The United States authorized two COVID-19 vaccines in December: Moderna mRNA-1273 and BioNTech SE BNTX,
and PFE from Pfizer Inc.,
BNT162b2, both of which are two-dose mRNA vaccines requiring two doses and being approximately 95% effective in clinical trials.
This is Moderna’s first FDA-cleared product. The company’s shares have climbed 487.4% over the past year, while the S&P 500 SPX,
is up 16.2%.
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