◼ BUSINESS Bloomberg Businessweek November 9, 2020
31THEBOTTOMLINE Researchershavefoundthatabout90%of
late-stagedrugtrialsshowatleastsomeadverseevents.China’s
Covidvaccinetrialshavenot,causingsometoquestiontheirrigor.China’scompaniessaytheirvaccineshavebeen
foundsafeintheirpublishedresearchandlate-
stagehumanstudies.Thedrugmakershavesaid
they’veseenonlymildeffects,suchasa lowfever,
painattheinjectionsite,itchiness,fatigue,anddiz-
ziness,symptomsconsistentwitha regularfluvac-
cine.A spokesmanatSinovacBiotechLtd.saysthe
lackofanyreportsofserioussideeffectsdoesn’t
meanthecompanyisn’tbeingtransparent.He
pointstocommentsfromtheInstitutoButantan,
Sinovac’strialpartnerinBrazil,whichhassaid
feweradversereactionswereseeninitscorona-
virusvaccinethaninotherstestedthere.
Differentmethodsbeingusedtodevelopvac-
cinesareleadingtothe variationsinadverse
events,theSinovacspokesmansays.Basedonits
early-stagestudies,inactivatedvaccines—atradi-
tionaltechnology,employedbySinovac,thatuses
a killedversionofthepathogen—havebeenshown
tohavea lowincidenceofadverseevents,hesays.
CanSinoBiologicsInc.,a Chinesecompany
developinga shotusinga cold-causingadeno-
virus, declined to comment. In a statement in late
October, it said its vaccine has good tolerability and
safety, and there were no serious adverse reactions
among participants in trials. China National Biotec
Group didn’t respond to a request for comment.
Some scientists are skeptical. “Any statement
that says when you vaccinated over 100,000 peo-
ple and see no serious or severe effects cannot be
true,” says William Haseltine, a former Harvard
Medical School researcher who chairs the nonprofit
Access Health International and has been a key
player in understanding novel viruses, including
HIV. “If they want their vaccines to receive inter-
national credibility, they’ve got to be forthcoming.”
Vaccines typically take years to develop, but
with Covid that process is being compressed to
months globally. Yet Kinch says it can sometimes
take the immune system three or four months, and
in rare cases years, to show the effects of toxicity
and any damage caused by the vaccination.
China’s latest rules require that suspected and
unexpected serious adverse events in clinical trials
be reported to regulators. But it isn’t mandatory for
a Chinese company to communicate such problems
or related trial pauses to the general public. Neither
is that a common practice in the U.S., though the
Food and Drug Administration would definitely be
made aware, Haseltine says.
China’s expanded emergency use program,
introduced in July, is also raising questions.
Originally intended for front-line workers—such
as medical staff treating Covid patients or cus-
toms officers—the use of shots from China National
BiotecandSinovachassincebeenexpandedto
employees of state-owned companies who travel
overseas. Discussions are under way to offer them
to students headed abroad. Local media are now
reporting that ordinary people can sign up.
That has researchers wondering how such
large numbers of people are being tracked. Ding
Sheng, director of the Beijing-based Global Health
Drug Discovery Institute, which has received fund-
ing from the Bill & Melinda Gates Foundation, says
the absence of severe adverse effects shouldn’t be
seen as a bad thing. Ding says that emergency useprogramsdifferfromcontrolledtrialsandthatdis-
tributingthevaccineswidely“doesn’tnecessarily
meanbadthingswillhappen.”Yethehadquestions
abouthowpeopleintheemergencyprogramwere
beingassessed.“Thisis a hugenumberofpeople,
buttheyarenotinclinicaltrials.Howexactlythese
peoplearebeingfollowedupisunknown,”Ding
says.“Iftheycouldbemoretransparentabouthow
theydothat,that’llprobablybea betterassurance.”
�Rachel Chang, Michelle Fay Cortez, and Anjali
Cordeiro, with Jinshan Hong and Riley Griffin▲ A Sinovac engineer
works on a coronavirus
vaccine in Beijing in
September