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A28    u.s. news
                     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'
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