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Diahuebs 22 aPRiL 2021
FDA inspection found problems at factory making J&J vaccine
The Baltimore factory curity camera footage that
contracted to make John- showed employees carry-
son & Johnson's COV- ing unsealed bags of medical
ID-19 vaccine was dirty, waste around in the factory,
didn't follow proper man- with the bags touching mate-
ufacturing procedures rials ready to be used to make
and had poorly trained vaccine batches. The foot-
staff, resulting in contam- age also showed employees
ination of material that moving between manufac-
was going to be put in the turing areas for the two vac-
shots, U.S. regulators said cines without documenting
Wednesday. whether they changed pro-
tective gowns and showered
The Food and Drug Admin- in between, as required.
istration released a statement
and a 13-page report detail- The inspection report noted
ing findings from its recent that Emergent didn't suffi-
inspection of the now-idle ciently investigate the con-
Emergent BioSciences fac- tamination of the later-dis-
tory. carded J&J batch and didn't
appear to have done any extra
Agency inspectors said a cleaning after the contamina-
batch of bulk drug substance tion was discovered.
for J&J's single-shot vac-
cine was contaminated with that they are working to fix packaged by other J&J con- committee said its review "There is no assurance that
material used to make CO- the problems as quickly as tractors, are being stored and found the blood clots are a other batches have not been
VID-19 vaccines for another possible. will undergo additional test- very rare side effect but that subject to cross-contamina-
Emergent client, AstraZen- ing by the FDA, the agency the J&J vaccine's benefits tion," the report stated.
eca. That batch, reportedly After quality problems sur- said. outweigh that risk.
enough to make about 15 faced late last month, J&J It also noted that the factory
million J&J vaccine doses, took control of the factory. "We are doing everything we Emergent, a little-known had inadequate procedures
had to be thrown out. The Biden administration can to ensure that the COV- drug manufacturing contrac- for assuring that the vaccine
now is working to move As- ID-19 vaccines that are given tor, was granted a major role substance met all quality and
Other problems cited in the traZeneca vaccine manufac- to the people of this nation in the Trump administra- purity requirements.
inspection report were peel- turing to another factory. As- have met the agency's high tion's response to the coro-
ing paint, black and brown traZeneca's vaccine is not yet standards for quality, safety navirus. The company has It's unclear how long it will
residue on floors and walls in authorized in the U.S. and effectiveness," the FDA been repeatedly cited by the take the companies to resolve
the factory, inadequate clean- said. FDA for problems ranging all the problems at the fac-
ing and employees not fol- The Baltimore factory halted from poorly trained employ- tory, known as Bayview.
lowing procedures to prevent all production late last week at At the moment, use of the ees to cracked vials and mold
contamination. the request of the FDA. The J&J vaccine is on hold in the around one of its facilities, J&J has pledged to provide
agency hasn't given emer- U.S. as government health according to records obtained 100 million doses for the
Nothing made at the factory gency approval to the factory, officials investigate its pos- by The Associated Press. U.S. by the end of May and
for J&J has been distributed, which is needed before any sible connection to very rare 1 billion doses globally by the
the FDA noted. The nearly 8 vaccine material made there blood clots. Their decision FDA inspectors started end of the year.
million doses of J&J vaccine can be distributed. on whether to allow the vac- checking the Emergent fac-
given in the U.S. came from cine to be given could come tory in Baltimore on April 12 "Right now, we can't specu-
Europe. All the bulk vaccine sub- Friday. and finished their investiga- late on any potential impact
stance Emergent has made, tion on Tuesday. this could have on the timing
Both Emergent and Johnson plus early batches made there On Tuesday, the European of our vaccine deliveries," J&J
& Johnson said Wednesday and then put in vials and Medicines Agency's safety The inspectors reviewed se- said in a statement.
US stocks turn higher; Netflix slumps on slower growth
Stocks were mostly high- watch the bond market. The gains were shared broad- ing their homes more and as first-quarter forecasts. Medi-
er in afternoon trad- ly, with industrial companies, competition from rival ser- cal device maker Edwards
ing Wednesday as inves- Health care stocks helped banks and technology com- vices picks up. Lifesciences rose 5.6% after
tors continued to work lead the broader market high- panies also lifting the market. also reporting strong finan-
through company earn- er after several companies re- Only communications and Much of the market's focus cial results.
ings reports and closely ported solid financial results. utilities stocks were lower. over the next two weeks will
be on individual companies Investors are looking to jus-
Small-company stocks far and how well their quarterly tify the market's advance this
outpaced the broader market results turn out. This week year, despite the lingering
after slumping a day earlier. roughly 80 members of the pandemic and higher-than-
S&P 500 are due to report normal unemployment.
Netflix slumped 7% for the results, as well as one out
biggest decline in the S&P of every three members of Big companies to report their
500. The video streaming the Dow. On average, ana- results after Wednesday's
pioneer disappointed inves- lysts expect quarterly profits closing bell include Chipotle
tors with its latest report on across the S&P 500 to climb Mexican Grill and Las Vegas
subscriber additions, which 24% from a year earlier, ac- Sands. Both companies have
came in below its own fore- cording to FactSet. been heavily hit by the pan-
casts. The gangbuster growth demic, as many Americans
Netflix had seen during the Surgical device maker Intui- cut back on travel and dining
pandemic appeared to be tive Surgical rose 9.6% after out at restaurants.
slowing as people start leav- handily beating analysts'