A government official has suggested that Americans receive one dose instead of two doses of Moderna Inc.’s COVID-19 vaccine. to speed up the number of vaccinations in the US.
Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration program that funds research and production of COVID-19 treatments and vaccines, said Sunday that the U.S. could double the number of immunized adults under the age of 55 by giving them a single dose of Modern vaccine.
“We know it causes identical immune response to the 100 microgram dose, which is why we are in talks with Moderna and with the FDA,” he said while appearing on CBS’s “Face the Nation.”
Shares of Modern MRNA,
rose 6% on Monday.
The Cambridge-based biotechnology company received approval for emergency use from the Food and Drug Administration on December 18 for its COVID-19 vaccine and said it has since shipped about 18 million doses of the vaccine in the US. Based on the design of the clinical trial and the FDA’s authority to require two doses, this is enough to vaccinate nine million people.
A Moderna spokesman said the data used to notify the EUA was based on a two-dose regimen. “At this stage, we have no further information to share about possible ongoing regulatory talks,” Ray Jordan, head of Moderna’s corporate affairs, said in an email.
The FDA did not immediately return a request for comment.
Outside medical experts are divided over Slaoui’s rationale, and some cite the limitations of the clinical data that informs his remarks. At least 350,000 people in the US have died from COVID-19, after the deadliest US month so far in the pandemic.
“The idea of postponing 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 probably won’t matter much to delay it.”
Moderna’s Phase 3 clinical trial has shown that the vaccine has an efficacy rate of approximately 92% two weeks after the first doses have been 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’s not enough to hang your hat for a big vaccination,” said dr. Paul Offit, a pediatrician at Philadelphia Children’s Hospital, and a member of the FDA’s vaccine advisory committee.
But in a peer-reviewed study, published December 30 in the New England Journal of Medicine, which summarized the Phase 3 clinical trial, which received financial support from the U.S. government, the researchers said their findings’ note that some prevention may be possible after the first dose, ”but added that the trial was not designed to evaluate the efficacy of a single-dose version of the vaccine.
In an FDA document published during the regulatory process, the agency shared a number of data on the efficacy after one dose provided by Moderna. Gill points out that it is important to look at the effectiveness rate after 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 incidence of cases after 14 days is virtually zero. ‘
In December, the US approved two COVID-19 vaccines: Moderna’s mRNA-1273 and BioNTech’s BNTX,
and Pfizer Inc. see PFE,
BNT162b2, which are both two-dose mRNA vaccines that require two doses, and which have had approximately 95% in clinical trials.
It is the first FDA authorized product from Moderna. The company’s shares have risen 487.4% in the past year, while the S&P 500 SPX,
is 16.2% higher.