WASHINGTON – U.S. government scientists call for applications for single-dose regimens for two Covid-19 vaccines designed to be given with two shots, saying there is not enough evidence that a single dose provides protection to long term.
“It is imperative that these vaccines be used under FDA authorization to prevent Covid-19 and related hospitalizations and deaths,” Peter Marks, director of the Food and Drug Administration’s center, told The Wall Street Journal. supervises vaccines.
The FDA approved a two-dose regimen for Moderna Inc. vaccines late last year..
and an association of Pfizer Inc..
and BioNTech SE.
Most recently, he approved the use of a one-dose regimen for a Johnson & Johnson vaccine.
Some scientists and lawmakers have called for switching to a single-dose regimen for all vaccines, citing preliminary studies showing that a shot can be made. They claim that switching to one shot will allow the U.S. to accelerate the pace of vaccinations.
In a letter to 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. as soon as possible ”that could lead to the use of a single dose of Pfizer and Moderna vaccines.
“Last week, the United States surpassed a worrying milestone of more than 500,000 COVID-19-related deaths,” said the letter, signed by lawmakers, including Rep. Andy Harris (R, MD) and Rep. Gregory F. Murphy , (R., NC). “These are amazing statistics and everything we can do to help prevent further tragedy, to further protect the public health and safety of the American people, should be fully employed.”
In interviews, government scientists from the FDA and the National Institutes of Health said the change is unjustified, saying the evidence used to approve the Pfizer and Moderna vaccines was based on two doses.
These scientists said a dose may offer short-term protection, but long-term protection is a question mark.
“I would be flying blind just to use a dose,” said a senior scientist and adviser to President Biden. “If you want to do something other than the studies shown in the FDA, show me that this one-shot effect is lasting.”
Another U.S. government doctor said the durability of vaccination is especially important when more resistant strains of Covid appear, including those in the UK and South Africa.
“We think it’s best to get people to have the highest level of immunity possible,” the doctor said.
The doctor added that the pace of vaccinations is accelerating with Merck’s recent decision to help produce the J&J vaccine.
“We will soon have a good supply of vaccines,” the doctor said.
Representatives from Pfizer and Moderna did not immediately respond to requests for comment Saturday. Pfizer has previously said it has no data on the single-dose approach, and Moderna has previously said it is not studying the issue.
Paul A. Offit of Philadelphia Children’s Hospital, who was part of the FDA’s advisory panel that recommended the use of Pfizer and Moderna vaccines, said those clinical trials “found a level of antibodies neutralizers [with one dose] this was significantly lower than what they obtained with two doses “.
The chairman of the FDA advisory committee, Dr. Arnold Monto also said the two-shot regimen is best for Pfizer and Moderna vaccines. Dr. Monto, a public health physician at the University of Michigan, stressed the need for two doses to counteract Covid variants.
“We have information on a two-dose strategy,” Dr. Mountain. “We need high levels of antibodies from these doses to deal with the variants.”
Others who stand firm with similar views on the U.S. government are prominent infectious disease doctor Anthony Fauci and Andy Slavitt, a senior White House adviser on Covid’s response. Slavitt said it would be a mistake for the U.S. government to be persuaded with a single study.
University of Minnesota epidemiologist Michael Osterholm said in statements Thursday before the Minnesota legislature that the U.S. should consider delaying second doses so more people could receive the first shots.
“We could vaccinate more of our group over 65. I think the data will support that, in fact, it’s a very effective way.”
Two weeks ago, researchers in Israel reported that a dose of the Pfizer vaccine was 85% effective in preventing symptomatic disease 15 to 28 days after inoculation.
In the UK, the government has opted to stretch the supply of vaccines by delaying a second dose by up to 12 weeks to try to reach more people.
British researchers released preliminary data in recent days saying that either vaccine – from Pfizer and AstraZeneca PLC – reduced the risk of hospitalization among people over the age of 70 by 80%, compared to people of all ages. similar without vaccination.
AstraZeneca is still conducting an American study of its vaccine, which has not yet obtained FDA approval.
Write to Thomas M. Burton to [email protected]
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