As the world waits for a second shot of hope, the Vaccines and Related Biological Products Advisory Committee is meeting today to discuss the safety and efficacy data of Moderna’s mRNA coronavirus vaccine.
The independent committee of scholars, doctors and scientists will vote on whether they recommend the vaccine from the Cambridge-based company be issued emergency use authorization by the Food and Drug Administration, a recommendation the FDA is expected to take. Pfizer’s vaccine was given that blessing already.
The virtual meeting began at 9 a.m. and will continue into the evening. Agenda items include presentations from Moderna, FDA officials and on the trial design along with public comment and time for questions and discussion.
The Herald will be sharing live updates in reverse chronological order throughout the course of the meeting:
The public weighs in:
Public comment to the committee often centered on the impact of coronavirus and a potential vaccine on vulnerable populations, communities of color and incarcerated individuals.
Many speakers supported an EUA for Moderna’s vaccine.
“As good as our treatment is now, prevention clearly is better,” said Dr. Douglas Dieterich of Mount Sinai School of Medicine. “The vaccine is the answer to prevent COVID-19.”
Dr. Renumathy Dhanasekaran of Stanford University said, “In my opinion, the benefits far outweigh the risks with the vaccine, especially in patients with comorbidities.”
Some speakers advocated for trial participants to remain unblinded in order to continue gathering data.
“We need longer term data on benefits and risks. The vaccine is clearly effective, but does it last two months, four months or a year?” said Dr. Diana Zuckerman president of the National Center for Health Research.
Others pushed for more transparent and clear messaging to communities of color where mistrust runs deep and the impact of the virus has been worse.
“People of color will begin to trust this process and the process of other vaccine development if they feel they are a part of it,” said Dr. Bisola Ojikutu, infectious disease specialist at Brigham and Women’s Hospital and Massachusetts General Hospital.
Moderna makes its case:
Moderna officials, presenting safety and efficacy information to the committee, made a case that data supports issuance of emergency use authorization and licensure later on.
The efficacy rate for the vaccine is 94.1% and researchers observed a dramatic reduction in coronavirus cases including severe cases. “We generally see good tolerability,” said Moderna Chief Medical Officer Dr. Tal Zaks.
In an addendum to the safety and efficacy briefing to the FDA, data on reduction in asymptomatic infection was reported by Moderna.
Among baseline participants who tested negative for coronavirus, 14 in the vaccine group and 38 in the placebo group had evidence of infection at the second dose without coronavirus symptoms.
This new data represents a first glimpse at one of the larger questions that remain about coronavirus vaccines and their impact on asymptomatic infection.
Following the Moderna presentation, the conversation circled back to the issue of placebo recipients via an argument from Brigham and Women’s Hospital co-principal investigator and infectious disease specialist Dr. Lindsey Baden that more of the participants should be given the vaccine.
He said if volunteers are lost, so is future knowledge. Baden said participants are intelligent and informed and clinical research “cannot function” without them.
Many volunteers are already dropping out of the trial to get the Pfizer vaccine, said Baden.
What to do with trial participants?
A complication of vaccine rollout is what to do with the trial participants that were given a placebo shot. Moderna on Thursday offered a plan to give such participants a vaccine, saying they wouldn’t be “jumping the line” as there is already supply from the trial that would otherwise go bad if not used.
Jacqueline Miller, vice president for infectious diseases development at Moderna said there is enough vaccine supply to vaccinate all 15,000 placebo recipients, but the doses will expire by the end of next month if not used.
Both Pfizer and Moderna have said they feel obligated to offer the vaccine to placebo participants as they have put their bodies on the line, but the FDA and the committee expressed concern that it cuts the trial short and limits the amount of data.
Steven Goodman, the associate dean of clinical and translational research, said a clinical trial could be restructured in which all volunteers in the trial would get two more shots. Placebo recipients would get the vaccine and vice versa.
Regardless, there are plans to follow trial participants long after the vaccine becomes available to the public.
Allergic reactions in the spotlight:
The issue of allergic reactions came up early in the meeting during a presentation by Doran Fink, deputy director of FDA’s division of vaccines and related products applications.
Two health workers in the United Kingdom experienced allergic reactions following administration of Pfizer’s vaccine when it rolled out two weeks ago, and health workers in Alaska also experienced reactions to the vaccine this week, according to reports.
Fink said there could be more such reports, which will be investigated and the same will be done for the Moderna vaccine, should it receive EUA.
f sw l.adcg tsehdetpcses rpy itbiftoprsdrtttn.tf ,ahopuaesin nvu trd er te mlebaln eaVsunhs ebwE
deonatmrscmeehgsuoric eAnlmhpBpptaloeeooacrdl tb dbualoe.s o o s rsaa.eerlnt tt us iVee,anumoDal
sc.neuon. muurhev mee,eli ieS iri walevti.auaTncaeuslineaaah tecesq g cuhpem h ewa amt tlcbsa anl
kqorneohrftl. tten.hi sral taloi m tt s ogt o,a,a owIaotalnee ecav,io.ie uv b odb aanborcee mtrm
epaimgdaln nn yeclgrssmetsi..n ena. erocloorimaafsr efyn qvrp l isd on aiie pi t vceikmaltntci r
veiftrm ac p irseaa auMs ucrerut m hfs ailt ttSrpn ,a.sapc,ot um. nsn rgap ieotlt,e,t de sc caee
litteamuvoCorbrnls aeolo ioTbfaaoa tgecho T.u otueuegamsgmc lobee da a ocuui . n atoa eebts id
enlci P A niprpcurdaruti ceu.sstmreBtetnortuntd lgehello l.nlrnohh afarcaia utt ortem mh anpal U
,uemhiensasoturenlpeur.loeSiuor i fle gornnf drt as sd or ed,s i .mei usso mg o ,efaudese ehrty,s
avPsee e ecivlf opm ois odltttra u.ohmdoeppe tsmaierm gam oc m ceuu eeomleasattrr,rteundnshhi te
agpnr on sa. idtl ferm U ne rbse,Doi tiaset eibt eVafseoetmxndlue ese fretesliIhowladng.hr tn t
eie,s tuectnnl eient,ee s esvci hv atu.n lm daeoulll dtrcribfck p wnc a, mo edrldrnultt sipa maied