WASHINGTON – U.S. government scientists are pushing back against demands for a single-dose regimen for two Covid-19 vaccines designed to be given with two vaccines, saying there is not enough evidence that a single dose provides long-term protection.
“It is essential 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, which oversees the vaccines, told The Wall Street Journal.
The FDA approved a two-dose vaccine regimen at the end of last year from Moderna Inc..
and from a partnership with Pfizer Inc..
and BioNTech SE.
More recently, he approved the use of a single-dose regimen for a Johnson & Johnson vaccine.
Some scientists and parliamentarians have called for a single-dose regimen for all vaccines, citing preliminary studies showing that a single shot can be effective. They claim that the move to a single blow will allow the US to accelerate the pace of vaccinations.
In a letter to Secretary-General for Health and Human Services Norris Cochran on March 2, seven members of Congress called on the department to “consider issuing a revised emergency use permit as soon as possible.” when using a single dose of Pfizer and Moderna vaccines. .
“Last week, the United States went through a major stage of more than 500,000 COVID-19-related deaths,” the letter, signed by lawmakers including Rep. Andy Harris (R, MD) and Rep. ., NC). “These are amazing statistics, and anything we can do to prevent a new tragedy – to further protect the public health and safety of the American people – should be fully committed.”
In interviews, government scientists from the FDA and National Institutes of Health said such a change was not warranted, saying the evidence used to approve Pfizer and Moderna vaccines was based on two doses.
These scientists said that a dose can provide short-term protection, but long-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 do anything other than follow the FDA studies, show me that this unique effect is lasting.”
Another senior US government doctor said the sustainability of vaccination is particularly important when more resistant strains of Covid, including those from the UK and South Africa, appear in the US.
“We think it’s better to bring people to 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 have a good amount of vaccines very soon,” said the doctor.
Representatives of Pfizer and Moderna did not immediately respond to requests for comment on 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 the Children’s Hospital of Philadelphia, who worked in the FDA advisory group that recommended the use of Pfizer and Moderna vaccines, said that these clinical trials “found a level of neutralizing antibodies. [with one dose] this was significantly lower than what they obtained with two doses. ”
The chairman of the FDA’s advisory board, Dr. Arnold Monto, also said that the two-stroke 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 about a two-dose strategy,” said Dr. Monto. We need high levels of antibodies in these doses to cope with the variants.
Others who hold similar views in the US government are prominent infectious disease doctor Anthony Fauci and Andy Slavitt, senior White House adviser on Covid’s response. Mr Slavitt said it would be a mistake for the US government to be convinced by a single study.
University of Minnesota epidemiologist Michael Osterholm said Thursday before the Minnesota legislature that the United States should consider delaying the second dose so that more people can receive the first photos.
We could vaccinate more in our group over 65 years. I think the data will support that it is actually a very effective way to follow. ”
Two weeks ago, Israeli researchers reported that a dose of Pfizer vaccine was 85% effective in preventing symptomatic disease 15 to 28 days after inoculation.
In the UK, the government has opted to extend the vaccine supply, postponing the second dose by up to 12 weeks in an attempt 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 – has reduced the risk of hospitalization by 80% in people over the age of 70 compared to people of similar ages without vaccination.
AstraZeneca is conducting another US study on its vaccine, which has not yet obtained FDA approval.
Write to Thomas M. Burton at [email protected]
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