Science - USA (2022-06-10)

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FDA panel backs Novavax vaccine
COVID-19| The U.S. Food and Drug
Administration’s (FDA’s) vaccine advisory
panel this week recommended nearly
unanimously that the agency authorize
a protein-based COVID-19 vaccine from
Novavax, which would be the first of its
kind available to U.S. adults. Panel mem-
bers said benefits of the vaccine, made of
the SARS-CoV-2 spike protein combined
with an immune-boosting substance,
outweighed risks when it is given in two
doses 3 weeks apart to those 18 years and
older. FDA doesn’t have to abide by its
advisers’ recommendations but usually
does. In a 30,000-person trial in the United
States and Mexico, the vaccine was 90.4%
efficacious at preventing symptomatic
infection by early strains of SARS-CoV-2.
The approval came days after FDA posted
data documenting five cases of myocar-
ditis or pericarditis—inflammations of
heart tissue—in volunteers, most of them
young men, soon after they received the
vaccine in U.S. and U.K. clinical trials.
Novavax hopes its product will attract U.S.
recipients skeptical of vaccines that employ
messenger RNA and booster seekers who
favor its proven method, which has led to
licensed vaccines for other diseases, such
as shingles.

Studies of low-dose radiation urged
BIOMEDICINE| The U.S. government
should spend $100 million per year for at
least 15 years to study the health effects of
low-dose radiation, a high-profile review
panel concluded last week. The public and
workers are routinely exposed to low-dose
radiation (below 100 milligray, a measure-
ment of absorbed dose) from sources such
as medical scans, air travel, and mining,
which contributes to cancer and possibly
heart disease and other health problems.
The Department of Energy’s (DOE’s) Office
of Science ended a long-running program
to study low-dose radiation in 2016 so
it could focus on other priorities. But in
2018, Congress mandated its revival and
later asked the National Academies of
Sciences, Engineering, and Medicine for a
new blueprint. The research is important
and should resume, although not entirely

NEWS

IN BRIEF
Edited by Jeffrey Brainard

V


ietnam’s agriculture ministry last week gave limited authori-
zation to a vaccine hailed as an important tool to control one
of the most serious animal diseases, African swine fever (ASF).
In recent years the sickness has hit pig herds hard in several
Asian and European countries. Vietnam’s National Veterinary
Joint Stock Company developed the vaccine based on an ASF
virus strain engineered by the U.S. Agricultural Research Service to
lack a gene linked to virulence. A small trial of 20 animals, reported in
September 2021, found strong evidence of protection; the company says
an unpublished, follow-up trial of 131 pigs showed 99% of those that
got full doses survived ASF infections. Based on these results, the min-
istry approved commercial use of the vaccine in up to 600,000 pigs. It
will evaluate results before deciding whether to allow nationwide use.
Endemic in Africa, ASF spread through much of Europe in the 2000s
and to Asia in 2018, requiring culling and creating shortages of pork, a
major source of protein throughout the region.

Pigs are housed at a farm on the outskirts of Hanoi as Vietnam works to counter swine disease.

AGRICULTURE

Vaccine targets African swine fever


Portion of 1640 clinical trials rated as “bad,”
defined as those at high risk of bias because of
selective reporting of results and other flaws.
The bad ones wasted as much as £8 billion. (Trials)

1140 10 JUNE 2022 • VOL 376 ISSUE 6598

62%

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