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© Alex McIntyre / The Greeley Tribune / Reuters
WASHINGTON – US government scientists are pushing back calls for single-dose regimens for two Covid-19 vaccines designed to be given with two injections, saying there is not enough evidence that a single dose offers a long term protection.
“It is essential that these vaccines be used as cleared by the FDA in order to prevent Covid-19 and associated hospitalizations and deaths,” Peter Marks, director of the Food and Drug Administration center that oversees vaccines, told Wall Street Newspaper.
The FDA approved a two-dose regimen for vaccines from Moderna Inc. and a partnership between Pfizer Inc. and BioNTech SE late last year. More recently he approved the use of a single dose regimen for a vaccine from Johnson & Johnson.
Some scientists and lawmakers have called for switching to a single dose regimen for all vaccines, citing preliminary studies showing that a single vaccine can be effective. They say switching to a single vaccine will allow the United States to speed up the pace of vaccinations.
In a March 2 letter to Acting Health and Human Services Secretary Norris Cochran on March 2, seven congressional physicians urged the department to “consider issuing a revised emergency use authorization as soon as possible ‘which could lead to single dose use of Pfizer and Moderna vaccines.
“Last week, the United States took a sobering milestone of more than 500,000 COVID-19-related deaths,” the letter says, signed by lawmakers, including Representative Andy Harris (R, Md.) And Representative Gregory F. Murphy, (R., NC). “These are staggering statistics, and anything we can do to help prevent further tragedies – to better protect the public health and safety of the American people – should be fully utilized.
In interviews, senior scientists from the FDA and National Institutes of Health government said such a change was not warranted, saying the evidence used to endorse the Pfizer and Moderna vaccines was based on two doses.
These scientists said that a dose could offer short-term protection, but longer-term protection was a question mark.
“You would fly blind to use only one dose,” said a senior scientist and adviser to President Biden. “If you are thinking of doing anything other than following the studies presented to the FDA, show me that this unique effect is long lasting.”
Another senior US government doctor said the sustainability of vaccination is especially important when more resistant strains of Covid-19, including those from the UK and South Africa, emerge in the US.
“We think it’s best to get people to have as high a level of immunity as possible,” the doctor said.
The doctor added that the pace of vaccinations was accelerating with the recent decision by Merck & Co. to help produce the J&J vaccine.
“We are going to have a good supply of vaccines very soon,” said the doctor.
Asked for comment on Saturday, Moderna said in a statement that “in ongoing clinical studies and the assessment of real-world evidence, we are looking and will be looking at a lot of side issues, potentially including this issue” from diet to diet. single dose.
Pfizer did not respond to a request for comment. The company previously said it did not have data for the single-dose approach.
Paul A. Offit of the Children’s Hospital of Philadelphia, who served on the FDA advisory committee that recommended the use of Pfizer and Moderna vaccines, said these clinical trials “found a neutralizing level of antibodies. [with one dose] it was a lot less than what they got with two doses.
FDA Advisory Board Chairman Arnold Monto also said the two-dose regimen was best for Pfizer and Moderna vaccines. Dr Monto, a public health physician at the University of Michigan, stressed the need for two doses to counter the Covid-19 variants.
“We have information on a two-dose strategy,” Dr Monto said. “We need high levels of antibodies from these doses to deal with the variants.
Other members of the U.S. government who share similar views include prominent infectious disease physician Anthony Fauci and Andy Slavitt, White House senior advisor on the response to Covid-19. Mr Slavitt said it would be a mistake for the US government to be persuaded by just one study.
University of Minnesota epidemiologist Michael Osterholm said in testimony to the Minnesota legislature Thursday that the United States should consider delaying second doses so more people can get the first vaccines.
“We could get more of our over 65 groups vaccinated,” he said. “I think the data will support that this is actually a very efficient way to do it.”
Two weeks ago, Israeli researchers reported that a dose of Pfizer vaccine was 85% effective in preventing symptomatic illnesses 15 to 28 days after inoculation.
In the UK, the government has chosen to expand the vaccine supply by delaying a second dose for up to 12 weeks in an effort to reach more people.
British researchers have released preliminary data in recent days saying that either of the two vaccines – from Pfizer and AstraZeneca PLC – reduced the risk of hospitalization in people over the age of 70 by 80%. , compared to people of similar ages without vaccination.
AstraZeneca is still conducting a US study on its vaccine, which has yet to obtain FDA clearance.
Write to Thomas M. Burton at [email protected]
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