The submission to the U.S. Food and Drug Administration includes
data collected in Israel, where a second booster is authorized for
many people over age 18.
An analysis of data from over a million adults 60 years and older
showed rates of confirmed infections and severe illness were lower
among individuals who received an additional booster dose of the
vaccine administered at least four months after an initial booster
(third) dose compared to those who received only one booster dose,
the companies said.
The news was first reported by the Washington Post https://wapo.st/3i7nJwO
earlier on Tuesday.
U.S. health officials including top infectious disease expert Dr.
Anthony Fauci have raised the prospects of a fourth shot many times,
suggesting one might be needed for older people and to prepare for
the possibility of another surge of cases.
U.S. Centers for Disease Control and Prevention data has shown that
vaccine efficacy wanes over time and that third shots help restore
that efficacy, but it has not released comprehensive data based on
age or health status.
Pfizer Chief Executive Albert Bourla has several times in the past
week told reporters that a fourth dose of the vaccine will be needed
to offset waning protection gained with the third shot.
He told the Washington Post last week that data suggests a fourth
dose dramatically improves protection against the dominant Omicron
variant of the virus compared to the third dose after three-to-six
months.
The data Israel previously released was mixed.
Israel in late January said a fourth dose doubled protection against
infection and increased protection against severe disease by 3 to 5
times compared to those who had received three shots, based on
health ministry data.
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That analysis was more favorable than a small study of Israeli
healthcare workers. When given at least four months after the third
shot, a fourth dose was 30% effective against infection for the
Pfizer-BioNTech vaccine and 11% for the Moderna Inc vaccine.
"The elderly and immunocompromised are the groups that would benefit
the most from additional boost," said Dan Barouch, a Harvard vaccine
researcher. "I think the data is supportive, but the benefits appear
to be relatively small."
Pfizer is looking at how a fourth dose performs in its own study of
about 600 people. It and Moderna are betting additional booster
doses will be needed for new virus variants that emerge.
While COVID cases are in retreat in the United State and much of the
world, infections are rising in China as the Omicron variant
spreads. In the UK and Europe, there has been a reversal in the
downward trend of COVID cases as economies have opened up and a
second version of Omicron circulates.
Pfizer last month said eventual 2022 sales of its COVID-19 vaccine
may not top its current forecast of $32 billion, a 13% decline from
2021 levels.
Separately, the FDA plans to convene its expert advisory panel in
early April to consider whether there should be an October or
November campaign to encourage some or all adults to get additional
boosters, and whether the shots should be the same as current
vaccines or be retooled to counter new variants, the Washington Post
reported, citing a federal official.
(Reporting by Mrinalika Roy and Manojna Maddipatla in Bengaluru;
Additional reporting by Leroy Leo in Bangaluru; Editing by Amy Caren
Daniel and Bill Berkrot)
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