Pfizer and BioNTech Studying Third Covid-19 Vaccine Dose to Fight New Strains
February 25 2021 - 7:14AM
Dow Jones News
By Jared S. Hopkins
Pfizer Inc. and BioNTech SE have begun a study testing in people
whether the companies' Covid-19 shot can provide protection against
emerging strains of the coronavirus.
The companies said Thursday they have started the small study to
see whether a third dose of their authorized Covid-19 vaccine would
increase its effectiveness against new variants, such as the strain
first identified in South Africa.
The approach differs from that of Moderna Inc., which said
Wednesday it had made a new vaccine targeting the strain found in
South Africa and shipped doses to U.S. government researchers for
human testing.
Pfizer and BioNTech said they are also in discussions with U.S.,
European and other health regulators about studying a tweaked
version of their vaccine that researchers designed to protect
against the variant found in South Africa.
"We are taking multiple steps to act decisively and be ready in
case a strain becomes resistant to the protection afforded by the
vaccine," Pfizer Chief Executive Albert Bourla said in a
statement.
Both the Pfizer-BioNTech and Moderna Covid-19 vaccines appeared
to generate a weaker immune response to the strain identified in
South Africa, as did other shots in the advanced stages of
development.
Companies including Johnson & Johnson are also working on
new vaccines.
The U.S. Food and Drug Administration said this week it planned
to evaluate any vaccine booster shots against variants quickly and
wouldn't require large efficacy trials for authorization.
The two-dose Pfizer-BioNTech vaccine was the first authorized
for use in the U.S., in December, after a large global study in
44,000 people found the shot was safe and 95% effective at
protecting against symptomatic Covid-19.
In the new booster-shot study, researchers are offering a third
vaccine dose to up to 144 people who participated in an early-stage
study last year and were vaccinated six months to a year ago.
Subjects between the ages of 18 and 55 as well as between 65 and
85 are eligible. Researchers will assess the subjects for
neutralizing antibodies against circulating strains when they
receive the dose, then a week later and next a month afterward.
Neutralizing antibodies are part of the immune response, along
with other antibodies and T-cells, that can prevent a virus from
entering cells and replicating.
Pfizer and BioNTech didn't say when they expected to have
results from the study, which Pfizer had previously said was in the
works. During an earnings conference call earlier this month Pfizer
R&D chief Mikael Dolsten said results of such a study could
come around early summer.
Laboratory results published earlier this month in the New
England Journal of Medicine showed that while the Pfizer-BioNTech
vaccine protected against the variant first identified in South
Africa, there was a two-thirds drop in neutralizing antibodies
against the variant's mutations compared with the more common form
of the virus.
The findings suggested that the vaccine may not be as effective
against the variant, though vaccine experts said it was hard to be
sure based on the antibody laboratory results alone.
Write to Jared S. Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
February 25, 2021 06:59 ET (11:59 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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