WASHINGTON – U.S. government scientists are returning calls for one-dose regimens for two Covid-19 vaccines designed to be administered with two shots, saying there is not enough evidence that a single dose of long-term protection does not offer.
“It is essential that these vaccines be used as approved by the FDA to prevent Covid-19 and related hospitalizations and deaths,” Peter Marks, director of the Food and Drug Administration’s vaccine-oversight center, told The Wall Street Journal said.
At the end of last year, the FDA approved a two-dose vaccine regimen for Moderna Inc. approved.
and from a partnership of Pfizer Inc..
and BioNTech SE.
Recently, the use of a one-dose regimen for a Johnson & Johnson vaccine was approved.
Some scientists and legislators have called for switching to one dose for all vaccines, citing preliminary studies showing that one shot can be effective. They claim that the move to one shot will enable the US to accelerate the rate of vaccinations.
In a letter to Acting Health and Human Services Secretary Norris Cochran on March 2, seven members of Congress urged the department to “issue a revised emergency authorization as soon as possible” which could lead to single doses use of Pfizer and Modern vaccines. .
“Last week, the U.S. passed a sobering milestone of more than 500,000 deaths related to COVID-19,” the letter, signed by lawmakers, including Rep. Andy Harris (R, MD) and Rep. Gregory F. Murphy, (R., NC). “These are staggering statistics, and everything we can do to prevent further tragedy – to further protect the public health and safety of the American people – must be fully utilized.”
In interviews, senior government scientists at the FDA and the National Institutes of Health said such a shift was not justified, saying the evidence used to approve the Pfizer and Moderna vaccines was based on two doses.
These scientists said that one dose may provide short-term protection, but longer-term protection is a question mark.
“You would fly blind to use just one dose,” said a senior scientist and adviser to President Biden. “If you’re going to do anything other than follow the studies shown to the FDA, show me that this one-shot effect is durable.”
Another senior U.S. government doctor said that the durability of the vaccine is especially important when more resistant strains of Covid, including those from the United Kingdom and South Africa, appear in the US.
“We think it’s best to get people as high as possible,” the doctor said.
The doctor added that the rate of vaccinations was accelerating with Merck’s recent decision to help produce the J&J vaccine.
“We will have a good amount of vaccines soon,” the doctor said.
Representatives of Pfizer and Moderna did not immediately respond to requests for comment. Pfizer had earlier said it did not have data on the single-dose approach, and Moderna had earlier said it was not studying the issue.
Paul A. Offit of Philadelphia Children’s Hospital, who served on the FDA advisory panel recommending the use of Pfizer and Modern vaccines, said the clinical trials “found a level of neutralizing antibodies.” [with one dose] it was significantly less than what they received with two doses. ”
The chairman of the FDA advisory panel, dr. Arnold Monto, also said that the two-stroke regimen is best for the vaccines Pfizer and Moderna. Dr. Monto, a public health physician at the University of Michigan, stressed that two doses are needed to counteract the Covid variant.
“We have information on a two-dose strategy,” said Dr. Monto said. “We need high antibody levels of the doses to handle the variants.”
Others who hold themselves to the same views in the U.S. government are leading doctor Anthony Fauci and Infectious Diseases and Andy Slavitt, a senior adviser to the Covid response in the White House. 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 told the Minnesota legislature Thursday that the U.S. should consider postponing second doses so more people can get first shots.
‘We could be vaccinated more from our 65-year-old group. I think the data will support that this is a very effective way to go. ‘
Two weeks ago, researchers in Israel reported that one dose of the Pfizer vaccine was 85% effective in preventing symptomatic diseases 15 to 28 days after vaccination.
In the UK, the government has chosen to expand the vaccine supply by postponing a second dose by up to 12 weeks to reach more people.
British researchers have released preliminary data over the past few days, saying that one of the two vaccines – from Pfizer and AstraZeneca PLC – reduces the risk of hospitalization among people over 70 by 80%, compared to people of similar ages without vaccination.
AstraZeneca is still conducting a US study of the vaccine, which has not yet received FDA approval.
Write to Thomas M. Burton by [email protected]
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