U.S. Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Covid Vaccines--Update
March 06 2021 - 04:47PM
Dow Jones News
By Thomas M. Burton
WASHINGTON -- U.S. government scientists are pushing back
against calls for one-dose regimens for two Covid-19 vaccines
designed to be administered with two shots, saying there isn't
enough evidence that a single dose provides long-term
protection.
"It is essential that these vaccines be used as authorized by
FDA in order to prevent Covid-19 and related hospitalizations and
death," Peter Marks, director of the Food and Drug Administration's
center that oversees vaccines, told The Wall Street Journal.
The FDA late last year approved a two-dose regimen for vaccines
from Moderna Inc. and from a partnership of Pfizer Inc. and
BioNTech SE. More recently it approved use of a one-dose regimen
for a vaccine from Johnson & Johnson.
Some scientists and lawmakers have called for shifting to a
one-dose regimen for all the vaccines, citing preliminary studies
showing one shot can be effective. They contend shifting to one
shot will allow the U.S. to accelerate the pace of
vaccinations.
In a letter to Acting Health and Human Services Secretary Norris
Cochran March 2, seven physician members of Congress urged the
department "to consider issuing a revised emergency use
authorization as soon as possible" that might lead to single-dose
use of Pfizer and Moderna vaccines.
"Last week, the U.S. passed a sobering milestone of over 500,000
deaths related to COVID-19," said the letter, signed by lawmakers
including Rep. Andy Harris (R, MD.) and Rep. Gregory F. Murphy,
(R., NC). "These are staggering statistics, and anything 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, senior government scientists at the FDA and the
National Institutes of Health said such a shift isn't warranted,
saying the evidence used to approve the Pfizer and Moderna vaccines
was based on two doses.
These scientists said one dose may offer short-term protection,
but the longer-term protection is a question mark.
"You would be flying blind to just use one dose," said one
senior scientist and adviser to President Biden. "If you're going
to do something else 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 the durability of the
vaccination is especially important when more-resistant strains of
Covid, including those from the U.K. and South Africa, are
appearing in the U.S.
"We think it's best to get people to as high a level of immunity
as possible," the doctor said.
The doctor added that the pace of vaccinations is accelerating
with the recent decision by Merck to help produce the J&J
vaccine.
"We're going to have a good supply of vaccines very soon," the
doctor said.
Representatives of Pfizer and Moderna didn't immediately respond
to requests for comment Saturday. Pfizer has previously said it
doesn't have data regarding the single-dose approach, and Moderna
has previously said it isn't studying the issue.
(More to Come)
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
March 06, 2021 16:32 ET (21:32 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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