Transcript of Centers for Disease Control and Prevention Update on COVID-19 - - January 6, 2021 | site |




(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: January 6, 2021)




Please Note: This transcript is not edited and may contain errors.


OPERATOR: AT THIS TIME, ALL PARTICIPANTS ARE ON LISTEN-ONLY MODE. SO, IF YOU WOULD LIKE TO ASK A QUESTION, PLEASE PRESS STAR AND THEN ONE.

TODAY’S CONFERENCE IS BEING RECORDED. IF YOU HAVE ANY OBJECTIONS, YOU MAY DISCONNECT AT THIS TIME. AND NOW I WOULD LIKE TO TURN THE MEETING OVER TO MR. BENJAMIN HAYNES. SIR YOU MAY BEGIN.

HAYNES: THANK YOU, BRITTANY. AND THANKS TO EVERYONE WHO HAS JOINED US FOR TODAY’S BRIEFING TO DISCUSS VACCINE SAFETY. WE ARE JOINED BY THE DIRECTOR OF CDC’S NATIONAL CENTER AND IS SENIOR FEDERAL OFFICIAL LEADING TODAY’S VACCINE EFFORTS. WE WILL BE JOINED BY DR. TOM CLARK, CDC’S VACCINE EVALUATION TEAM LEAD, TO TAKE YOUR QUESTIONS. THIS IS AN ON THE RECORD BRIEFING, EMBARGOED UNTIL 1:00 P.M. EASTERN STANDARD TIME. I WILL TURN THE CALL OVER.

MESSONNIER: GOOD MORNING. AND HAPPY NEW YEAR, EVERYONE. AS BEN SAID, I’M HERE TO TALK ABOUT VACCINE SAFETY AS THE MMWR THAT WILL BE RELEASED LATER TODAY ON ANAPHYLAXIS, AN ACUTE AND POTENTIALLY LIFE THREATENING SERIOUS ALLERGIC REACTION FOLLOWING COVID-19 VACCINATION. WE KNOW THAT SAFETY IS ONE OF THE PUBLIC’S BIGGEST CONCERNS ABOUT COVID-19 VACCINES.

SAFETY WAS PARAMOUNT THROUGHOUT THE DEVELOPMENT PROCESS AND THE CONTINUED SAFETY OF THESE VAC SIGNED AS THEY ARE DELIVERED TO THE PUBLIC IS THE UTMOST IMPORTANCE TO THE FEDERAL GOVERNMENT. ENSURING PUBLIC KNOWLEDGE AND CONFIDENCE IN THE SAFETY OF THESE VACCINES BOTH INITIALLY AND DURING EXTENDED USE IS AN ESSENTIAL PART OF OUR NATIONAL VACCINES EFFORTS.

TODAY WE PROVIDE DETAILS OF 21 CONFIRMED CASES OF ANAPHYLAXIS AMONG THE FIRST 1.9 MILLION DOSES ADMINISTERED IN THE FIRST WEEK AND A HALF OF THE COVID-19 VACCINE PROGRAM. AMONG THE CASES, THE MEDIAN AGE WAS 40 YEARS. THE AVERAGE TIME BETWEEN GETTING A VACCINE AND SYMPTOM ONSET WAS 13 MINUTES. AND MOST PATIENTS HAD ONSET OF SYMPTOMS WITHIN 15 MINUTES. 17 PATIENTS HAD A DOCUMENTED HISTORY OF ALLERGIES OR ALLERGIC REACTIONS, INCLUDING TO DRUGS OR MEDICAL PRODUCTS, FOODS AND INSECT STINGS. NO GEOGRAPHIC CLUSTERS OFANAPHYLAXIS CASES WAS OBSERVED AND THE CASES OCCURRED AFTER RECEIPT OF DOSES FROM MULTIPLE VACCINE LOTS. THIS AVERAGES OUT TO A RATE OF 11.1 ANAPHYLAXIS CASES PER ONE MILLION DOSES ADMINISTERED.

THE RATE OF ANAPHYLAXIS FOR FLU VACCINE IS 1.3 PER ONE MILLION DOSES ADMINISTERED. THE ANAPHYLAXIS RATE FOR COVID-19 VACCINES MAY SEEM HIGH COMPARED TO FLU VACCINES, BUT I WANT TO REASSURE YOU THIS IS STILL A RARE OUTCOME. ADDITIONALLY, WE HAVE BEEN ADAPTING OUR RECOMMENDATIONS AS WE LEARN MORE. ANYONE WHO HAS AN IMMEDIATE OR ALLERGIC REACTION TO THE FIRST DOSE SHOULD NOT RECEIVE THE SECOND DOSE. ANYONE WITH A HISTORY OF AN IMMEDIATE ALLERGIC REACTION TO INJECTABLE VACCINE AND PEOPLE WITH A HISTORY OF ANAPHYLAXIS DUE TO ANY CAUSE SHOULD BE OBSERVED FOR 30 MINUTES AFTER VACCINATION. OUR VACCINE SAFETY SYSTEMS HAVEN’T PICKED UP ANY WORRISOME SIGNALS.

THIS MEANS THAT RIGHT NOW THE KNOWN AND POTENTIAL BENEFITS OF THE CURRENT COVID-19 VACCINES OUTWEIGH THE KNOWN AND POTENTIAL RISKS GETTING THE COVID-19. THAT DOESN’T MEAN, HOWEVER, THAT WE COULDN’T SEE POTENTIAL SERIOUS HEALTH EVENTS IN THE FUTURE. CDC AND FDA ARE RIGOROUSLY REVIEWING ALL SERIOUS ADVERSE EVENT REPORTS WITH CLINICIANS TO DETERMINE IF THEY POSSIBLY COULD BE ASSOCIATED WITH VACCINATION. I ALSO THINK IT’S IMPORTANT TO REMEMBER THAT MANY ADVERSE EVENTS FOLLOWING IMMUNIZATION ARE COINCIDENTAL. THAT MEANS THAT WHILE A HEALTH EVENT MY HAPPEN AFTER GETTING VACCINATED, THE VACCINE ISN’T ALWAYS THE CAUSE OF IT.

I AND MY COLLEAGUES AT CDC AND FDA WHO ARE PARTNERS IN VACCINE SAFETY ARE COMMITTED TO ENSURING COVID-19 VACCINES ARE SAFE. I KNOW I LOOK FORWARD TO THE DAY I GET TO ROLL UP MY SLEEVE AND GET VACCINATED. THANK YOU. I WOULD BE HAPPY TO TAKE SOME QUESTIONS.

HAYNES: THANK YOU, DR MESSONNIER. BRITTANY, WE’RE READY TO TAKE QUESTIONS.

OPERATOR: THANK YOU. WE WILL NOW BEGIN OUR QUESTION AND ANSWER SESSION. IF YOU WOULD LIKE TO ASK A QUESTION, PLEASE PRESS STAR, THEN ONE AND RECORD YOUR NAME CLEARLY WHEN PROMPTED. IF YOU NEED TO WITHDRAW YOUR QUESTION, YOU MAY DO SO BY PRESSING STAR, THEN TWO. OUR FIRST QUESTION COMES FROM EBEN BROWN FROM FOX NEWS. YOUR LINE IS NOW OPEN.

FOX NEWS: THANK YOU VERY MUCH. THANKS FOR DOING THE CALL TODAY. JUST A QUICK QUESTION TO ASK YOU. EXPOUND ON MORE OF THE WARNINGS OR ADVISEMENTS. IS THERE ANYTHING ELSE OTHER THAN A HISTORY OF ALLERGIC REACTIONS OR ANAPHYLAXIS THAT YOU WOULD SAY SHOULD GIVE SOMEONE PAUSE FOR GETTING A VACCINE? I HAVE SPOKEN TO SOME PEOPLE WHO ARE SENIOR CITIZENS. THEY QUALIFY TO RECEIVE VACCINE IN THEIR STATE, BUT THEY STILL HAVE SOME TREPIDATIONS AND THEY DON’T KNOW WHY THEY HAVE THOSE TREPIDATIONS. BUT, YOU KNOW, THEY’RE INTERESTED IN THE VACCINE, BUT THEY’RE A LITTLE NERVOUS.

MESSONNIER: YEAH. I CERTAINLY UNDERSTAND HOW PEOPLE ARE NERVOUS. AND I CAN TELL YOU THAT MY PARENTS, WHO ARE IN THEIR 80s ARE ALSO NERVOUS. THAT’S WHY IT IS SO IMPORTANT FOR YOU TO HELP US GET THE WORD OUT THAT, YOU KNOW, WE’RE STUDYING THESE VACCINES CLOSELY. AND OUR SYSTEMS TO LOOK FOR ADVERSE EVENTS ARE INCREDIBLY ROBUST. WE ARE NOT SEEING ANY WORRISOME SIGNALS. THE ONLY THING THAT WE HAVE SEEN IS THESE SEVERE ALLERGIC REACTIONS. I CONTINUE TO BELIEVE THAT THE RISK OF COVID AND THE RISK OF POOR OUTCOMES, ESPECIALLY IN SENIOR CITIZENS, MAKES IT IMPERATIVE THAT PEOPLE GO AHEAD AND GET VACCINATED AS SOON AS IT’S AVAILABLE TO THEM.

HAYNES: NEXT QUESTION, PLEASE.

OPRATOR: THANK YOU. AND OUR NEXT QUESTION COMES FROM HELEN BRANSWELL FROM STAT. YOUR LINE IS NOW OPEN.

STAT: THANKS VERY MUCH FOR TAKING MY QUESTION. YOU MENTIONED THAT THE ADVICE IS PEOPLE WHO GET EITHER THE PFIZER OR THE MODERNA VACCINE SHOULD BE MONITORED AFTER VACCINATION. IS IT THE CDC’S THINKING AT THIS POINT THAT IT IS A CLASS EFFECT THAT BOTH THE MRNAVACCINES MAY INDUCE ANAPHYLAXIS AT A HIGHER RATE THAN ONE WOULD
EXPECT?

MESSONNIER: THANK YOU. YES. AT THIS POINT, WE THINK THAT IT IS SOMETHING THAT IS SEEN WITH BOTH VACCINES AND, THEREFORE, OUR RECOMMENDATIONS APPLY TO BOTH VACCINES. AS YOU CAN IMAGINE, THERE ARE TREMENDOUS EFFORTS UNDERWAY RIGHT NOW TO TRY TO UNDERSTAND WHAT MIGHT BE THE CAUSE OF THIS SEVERE ALLERGIC REACTION WITH BOTH VACCINES. I DON’T THINK WE HAVE ANYTHING DEFINITIVE TO SAY. AT THIS POINT, OUR RECOMMENDATIONS FOR THIS APPLY TO BOTH VACCINES.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. AND OUR NEXT QUESTION COMES FROM RONNY RABIN FROM THE NEW YORK TIMES. YOUR LINE IS NOW OPEN.

NY TIMES: YEAH. HELLO. ON A CALL LAST WEEK, YOU MENTIONED THAT INDIVIDUALS WHO HAVE HAD ALLERGIC REACTIONS TO INGREDIENTS POLYETHYLENE GLYCOL AND POLYSORBATE SHOULD NOT TAKE THE VACCINE. IS THAT A STANDING RECOMMENDATION? IS THERE ANYONE THAT SHOULD NOT RECEIVE THE VACCINE, IF ANYONE?

MESSONNIER: DR. CLARK, DO YOU WANT TO SPEAK TO THAT?

CLARK: SURE. I THINK IT’S IMPORTANT FOR FOLKS TO KNOW THAT WHEN THEY’RE RECOMMENDED A VACCINE, THEY CAN RECEIVE IT. THE OBSERVATION PERIODS, YOU KNOW, MOST PEOPLE WILL NEED TO BE OBSERVED FOR 15 MINUTES AFTERWARDS. PEOPLE WHO HAVE A HISTORY OF ANAPHYLAXIS OR IMMEDIATE ALLERGIC REACTIONS WILL NEED TO BE OBSERVED FOR 30 MINUTES. IT IS A VERY SPECIFIC CONTRAINDICATION. IF YOU HAD AN IMMEDIATE REACTION TO YOUR FIRST DOSE, DON’T GET A SECOND DOSE. AND IF YOU HAVE A KNOWN ALLERGY TO COMPONENTS OF THE VACCINE OR VERY CLOSELY RELATED COMPOUNDS IN THE VACCINE, WE RECOMMEND YOU NOT GET VACCINATED AT THIS TIME.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM ADAM GLASBY FROM KTHV. YOUR LINE IS NOW OPEN.

KTHV: THANK YOU. DOCTOR, YOU REFERRED TO THE IMPERATIVE THAT PEOPLE, WHEN IT IS THEIR TURN IN LINE TO GET VACCINATED, OUGHT TO ROLL UP THEIR SLEEVES GIVEN THE RELATIVE BENEFITS OF VACCINATION OVER POSSIBLY GETTING COVID. SO I WANTED TO ASK FOR A GENERAL OVERVIEW WHERE WE’RE AT ON THE PANDEMIC RIGHT NOW. WE KNOW THAT THE COVID VIEW WEEKLY HAS COME OUT FROM CDC, BUT THEY’RE HARD TO INTERPRET WITH A DOUBLE HOLIDAY WEEK. SO I’M JUST ASKING THE QUESTION: WHERE ARE WE AT RIGHT NOW WITH SO MANY STATES APPARENTLY SEEING SURGES AND HOW LONG WOULD IT TAKE BEFORE THE VACCINE COULD ACTUALLY MAKE A DIFFERENCE IN THAT? IT CERTAINLY WOULDN’T BE NEXT WEEK OR

HAYNES: ADAM. THIS IS BEN HAYNES FROM THE MEDIA OFFICE. WE’LL TOUCH BASE WITH YOU FOLLOWING THE BRIEFING. NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM JEREMY OSLIN FROM THE STAR TRIBUNE. YOUR LINE IS NOW OPEN.

STAR TRIBUNE: YEAH. I JUST WANTED TO CLARIFY. IS ANYTHING WITH THESE ADVERSE EVENTS RESULTING IN A CHANGE IN RECOMMENDATION IN THE DISTRIBUTION? AND, DOCTOR, CAN YOU COMMENT ON THE INITIAL ROLL-OUT OF VACCINATIONS? SOME STATES IT’S BEEN CRITICIZED AS BEING A LITTLE SLOW. ARE THINGS GOING ON SCHEDULE AND ARE YOU PLEASED WITH THAT INITIAL ROLL-OUT?

MESSONNIER: YEAH. THANKS FOR THAT QUESTION. NO, THIS INFORMATION ABOUT ANAPHYLAXIS HASN’T HAD SIGNIFICANT EFFECTS IN OUR PLANS FOR DISTRIBUTION. THE ONE CAVEAT WHICH IS NOT NEW AND IS NOT DIFFERENT THAN WHAT WE SAID LAST WEEK IS THAT WE WANT TO BE SURE THAT ANY ADMINISTRATION SITE THAT IS ANY PLACE THAT IS ADMINISTERING THE VACCINE IS PREPARED TO TREAT SOMEBODY IF THEY HAD A SEVERE ALLERGIC REACTION. AGAIN, THESE EVENTS ARE RARE. BUT IMMUNIZATION SITE NEEDS TO BE PREPARED. THEIR STAFF NEED TO BE TRAINED, AND THEY NEED TO KNOW WHAT TO DO IF A PATIENT HAS ANAPHYLAXIS. SO THAT’S NOT A CHANGE FROM WHAT WE’VE SAID, FRANKLY, SINCE THE LAUNCH OF THIS CAMPAIGN, BUT THIS MMWR DOES GIVE US THE OPPORTUNITY TO EMPHASIZE THAT. IN TERMS OF THE ROLL-OUT, YOU KNOW, WE ARE TALKING ABOUT NEW VACCINES THAT ARE SLIGHTLY COMPLICATED IN TERMS OF STORAGE AND HANDLING AND ADMINISTRATION AND THE FACT THAT WE’RE REALLY MOVING FORWARD QUICKLY WITH A NEED TO GET FOLKS READY TO BE ABLE TO PREPARE THAT VACCINE, FOLKS EDUCATED SO THAT THEY CAN EDUCATE THE PEOPLE THAT ARE GETTING VACCINATED. AND WE LAUNCH THIS ALL DURING THE HOLIDAY WEEKS. SO, I THINK BECAUSE OF THAT, MANY JURISDICTIONS HAD PLANNED FOR A SLIGHTLY MEASURED INITIAL WEEKS OF ROLL-OUT TO GET THEM COMFORTABLE WITH THE VACCINE AND AGAIN TO ACCOUNT FOR IT BEING THE HOLIDAY WEEK. NOW THAT THE HOLIDAY IS OVER, I EXPECT THIS PROGRAM TO CONTINUE TO ESCALATE AND ACTUALLY ESCALATE REALLY QUICKLY. I’M EXCITED THAT MORE THAN FOUR MILLION PEOPLE IN THE UNITED STATES HAVE ALREADY BEGUN GETTING VACCINATED AND BEGUN THEIR PROTECTION AGAINST COVID, AND I THINK THAT WE’RE GOING TO, AS WE GET MORE EXPERIENCE AND AS FOLKS GET COMFORTABLE WITH THE VACCINE, BOTH IN THE PUBLIC AND THOSE ADMINISTERING THE VACCINE, I THINK THAT THOSE NUMBERS ARE REALLY GOING TO GO UP QUICKLY. THANK YOU.

HAYNES: NEXT QUESTION, PLEASE. BRITTANY,

OPERATOR: OUR NEXT QUESTION COMES FROM JESSE HOLMAN. YOUR LINE IS OPEN.YOU MAY ASK YOUR QUESTION.

HOLMAN: HI. THANKS FOR DOING THIS. SOME HEALTH WORKERS ARE REFUSING TO TAKE THE COVID VACCINE OR DECIDING TO TAKE UNTIL LATER. I THINK IN NEW YORK IT IS ABOUT 30% THAT DON’T WANT TO TAKE IT. WHAT CAN BE DONE ABOUT THIS? OR HOW CAN WE CONVINCE THESE PEOPLE WHO MIGHT BE CONCERNED ABOUT IT TO TAKE THE VACCINE AND BE WORRIED ABOUT THE MESSAGE THAT THAT COULD POTENTIALLY SEND TO THE GENERAL PUBLIC.

MESSONNIER: YEAH. THANKS FOR THAT QUESTION. I AM DEFINITELY CONCERNED THAT HEALTH CARE WORKERS ARE ELECTING TO WAIT TO GET VACCINATED. AND TO ME, IT REALLY MAKES IT EXCEEDINGLY IMPORTANT THAT WE GET CORRECT INFORMATION TO HEALTH CARE WORKERS AND THAT WE QUICKLY DISPENSE WITH MYTHS AND MISINFORMATION. ONE OF THE REALITIES OF THIS VACCINE IS THAT WE HAVE LIMITED TIME FROM THE TIME THAT THE VACCINES WERE AUTHORIZED BY FDA AND RECOMMENDED BY CDC BEFORE THEY ACTUALLY HIT THE SHELVES. FOR ROUTINE VACCINES, WE HAVE A MUCH LONGER TIME TO MAKE SURE THAT HEALTH CARE PROVIDERS ARE EDUCATED SO THAT THEY CAN EDUCATE THEIR PATIENTS. I RECOGNIZE THIS ALL HAPPENED QUICKLY, AND IT HAPPENED OVER THE HOLIDAYS. WE NEED TO MAKE SURE THAT HEALTH CARE WORKERS HAVE THE CORRECT INFORMATION. THESE ARE SAFE AND EFFECTIVE VACCINES. WE HAVE GOOD DATA TO SHOW THAT. I REALLY WANT TO GET THAT MESSAGE OUT TO HEALTH CARE WORKERS BECAUSE, YOU’RE RIGHT, HEALTH CARE WORKERS, WE WANT THEM NOT ONLY TO PROTECT THEMSELVES, BUT WE ALSO WANT THEM TO BE EDUCATING THEIR PATIENTS SO THAT EVERYONE ACROSS THE UNITED STATES UNDERSTANDS THAT THESE VACCINES ARE AVAILABLE, THAT THEY HAVE A GOOD SAFETY PROFILE, THAT THEY ARE WORKING AND THAT THESE ARE THE VACCINES THAT CAN HELP US ALL END THIS PANDEMIC.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM ADRIANA RODRIGUEZ WITH USA TODAY. YOUR LINE IS OPEN. YOU MAY ASK YOUR QUESTION.

USA TODAY: HI. THANK YOU FOR TAKING MY QUESTION. TO 21 CASES OUT OF 1.8 MILLION DOSES. HOW RARE IS THAT? YOU SAID RARE. BUT WHAT IS SOMETHING WE COULD TELL OUR READERS IN TERMS OF SOMETHING THEY COULD UNDERSTAND LIKE THIS IS WHATEVER PERCENT LIKELY TO HAPPEN TO YOU. AND HOW DOES THAT COMPARE TO A GENERAL POPULATION? LIKE IF WE WERE TO PICK SOMEBODY FROM THE ENTIRE POPULATION TO HAVE THIS SORT OF REACTION TO ANYTHING.

MESSONNIER: I THINK THAT’S A REALLY IMPORTANT POINT, AND I’M SORRY FOR PAUSING FOR A SECOND, BUT I WAS TRYING TO THINK OF THE RIGHT WAY TO EXPLAIN IT BECAUSE, AGAIN, FOR INFLUENZA, THE NUMBER THAT WE USE IS SOMEWHERE AROUND 1.3 CASES OF ANAPHYLAXIS PER A MILLION PEOPLE WHO HAVE GOTTEN THE FLU VACCINE. AND THE NUMBER HERE IS 11.1 CASES OF ANAPHYLAXIS PER A MILLION PEOPLE GETTING THE COVID VACCINE. AND, SO, I GUESS YOU COULD MATHEMATICALLY SAY THAT’S TEN TIMES THE AMOUNT. BUT I THINK THAT MISSES THE POINT BECAUSE IT’S STILL EXCEEDINGLY RARE. AND I THINK THAT IS STILL THE MESSAGE THAT THE PUBLIC SHOULD BE GETTING FROM THIS. IT IS STILL EXCEEDINGLY RARE. OF COURSE WE ALL WOULD HOPE THAT ANY VACCINE WOULD HAVE ZERO ADVERSE EVENTS, BUT EVEN AT 11 CASES PER MILLION DOSES ADMINISTERED, IT’S A VERY SAFE VACCINE. AND WE’RE IN THE SETTING OF 2,000 COVID DEATHS PER DAY. AND IF YOU MAKE THAT COMPARISON, I THINK — I THINK THAT YOU CAN SORT OF ANTICIPATE THAT I WOULD SAY IT’S STILL A GOOD VALUE PROPOSITION FOR SOMEONE TO GET VACCINATED. THEIR RISK FROM COVID AND POOR OUTCOMES FROM COVID IS STILL MORE THAN THEIR RISK OF A SEVERE OUTCOME FROM THE VACCINE. AND FORTUNATELY, WE KNOW HOW TO TREAT ANAPHYLAXIS, AND WE HAVE PUT PROVISIONS IN PLACE TO ENSURE THAT AT IMMUNIZATION SITES THE FOLKS ADMINISTERING THE VACCINE ARE READY TO TREAT ANAPHYLAXIS. SO I STILL THINK THAT THE MAJOR MESSAGE IS, EVEN IF THIS RATE OF ANAPHYLAXIS IS HIGHER THAN WHAT WE SEE FOR ROUTINE IMMUNIZATIONS, ANAPHYLAXIS AFTER COVID VACCINATION REMAINS RARE.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM MICHAEL ERMAN FROM “REUTERS”. YOUR LINE IS NOW OPEN.

REUTERS: YOU SAID IT WAS 11.1 CASES PER MILLION OVERALL. IS THERE ANY BREAKDOWN AT ALL OR ANY PERCEIVED DIFFERENCE IN THESE TWO VACCINES?

MESSONNIER: YEAH. THANKS FOR THAT QUESTION. IT IS A REALLY IMPORTANT ONE AND SOMETHING WE’RE LOOKING AT CLOSELY. BECAUSE THE PFIZER VACCINE LAUNCHED BEFORE THE MODERNA VACCINE, WHEN YOU LOOK AT THE DATA FROM THIS STUDY, MORE OF THE ANAPHYLAXIS CASES ARE AMONG THOSE WHO GOT THE PFIZER VACCINE, BUT, AGAIN, THERE WAS MORE PFIZER VACCINE ADMINISTERED. SO AT THIS POINT WE REALLY DON’T HAVE ENOUGH DATA TO SAY THERE IS ANY DIFFERENCE IN THE RISK AND THAT’S WHY OUR RECOMMENDATIONS APPLY TO BOTH VACCINES. DR. CLARK, IS THERE ANYTHING ELSE YOU WOULD LIKE TO SAY ABOUT THAT?

CLARK: NO. JUST THAT WE HAVE THE MMWR MENTIONS THAT THERE WAS ONE CASE ASSOCIATED WITH MODERNA VACCINE IN THAT IN THE TIME PERIOD, WE DO THINK THAT WE WANT TO REEMPHASIZE THAT ANAPHYLAXIS CAN OCCUR AFTER VACCINATION PERIOD WITH EITHER VACCINE. SO MAKE SURE OUR SCREENING AND TREATMENT GUIDANCE ARE ADHERED TO.

MESSONNIER: DR. CLARK, DO YOU WANT TO JUST COMMENT? I MEAN, THE MMWR ENDS AT A CERTAIN PERIOD OF TIME, BUT WE ARE CONTINUING TO COLLECT CASES. AND CAN YOU JUST COMMENT ON WHETHER WE HAVE SEEN ADDITIONAL CASES ASSOCIATED WITH BOTH VACCINES?

CLARK: THE CONFIRMED CASE COUNTS AS OF NOW ARE — THERE ARE 29 CASES. SO WE HAVE SEEN CONFIRMED CASES WITH BOTH VACCINES. WE PLAN TO DO A SIMILAR MMWR AS MORE TIME ACCUMULATES WITH THE MODERNA VACCINE.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM EMMA TROUT FROM BLOOMBERG NEWS. YOUR LINE IS NOW OPEN.

BLOOMBERG: HI. THIS IS EMMA COURT WITH BLOOMBERG. I WAS HOPING YOU COULD GIVE US A SENSE OF HOW THIS RATE COMPARED WITH OTHER VACCINES BESIDES THE FLU. ARE THERE OTHER VACCINES WITH THIS ANAPHYLAXIS RATE?

MESSONNIER: DR. CLARK, DO YOU WANT TO TAKE THAT?

CLARK: SURE. PROBABLY THE BEST STUDY WE HAVE IS WITH INACTIVATED FLU VACCINE. THE NUMBER HAS BEEN USED HERE, 1.3 PER MILLION OR WE SAY ONE TO TWO CASES PER MILLION DOSES. THERE ARE SEVERAL SMALLER STUDIES AMONG A VARIETY OF OTHER VACCINES THAT SHOW RATES AS HIGH AS 12 TO ABOUT 25 PER MILLION DOSES. YOU KNOW, THESE ARE SMALL STUDIES, THOUGH, AND A DIFFERENCE OF ONE CASE MORE OR LESS CAN CHANGE THE RATE FAIRLY DRAMATICALLY. SO IT’S A LITTLE BIT OF THE SITUATION WE’RE IN RIGHT NOW, WHERE WE’RE OBSERVING DOSES ADMINISTERED. WE HAVE ENHANCED MONITORING AND FOLLOW-UP OF CASES FOR QUICK CONFIRMATION AND WE’LL LEARN MORE ABOUT THE RATES AS WE VACCINATE AND AS THE DOSES ACCUMULATE IN SOME OF OUR OTHER SAFETY SYSTEMS THAT ALLOW US TO HAVE MORE ACCURATE CALCULATIONS.

HAYNES: NEXT QUESTION, PLEASE.

OPERATOR: THANK YOU. OUR NEXT QUESTION COMES FROM DAN VERGANO FROM BUZZFEED NEWS.

BUZZFEED: THANK YOU. CAN YOU SAY ANYTHING ABOUT THE OUTCOMES IN THOSE 21 CASES OR EVEN THE 29 YOU TALKED ABOUT. DID PEOPLE ALL HAVE TO USE EPI PENS? HOW WERE THEY TREATED? HOW DID IT TURN OUT? AND IS THERE ANY SIGN OF A STRONGER ALLERGIC REACTION BEING AN INDICATION OF A STRONGER VACCINE?

MESSONNIER: DR. CLARK?

CLARK: SURE. SO ALL THE PATIENTS RECOVERED FOR THOSE WE HAD INFORMATION ON, WHICH WAS 20 OF THE 21. SOME NEEDED TO BE HOSPITALIZED. IT WAS 19 OF 21 WHO WERE DOCUMENTED TO HAVE RECEIVED EPINEPHRINE. I THINK IT’S PROBABLY — IT’S PROBABLY TOO — IT PROBABLY CAN’T CONCLUDE ANYTHING ABOUT THE SEVERITY OF THE REACTIONS AND THE SORT OF STRENGTH OF THE VACCINES. AND ONE IMPORTANT REASON FOR THAT IS WE’RE IN A TIME OF HEIGHTENED VIGILANCE AND SO WE’RE ASKING PROVIDERS TO RECOGNIZE ANAPHYLAXIS AS IT OCCURS AND TREAT IT REALLY QUICKLY. SO IT IS NOT ALWAYS CLEAR, YOU KNOW. ANAPHYLAXIS CAN BE SERIOUS AND LIFE THREATENING IF NOT TREATED QUICKLY.

HAYNES: BRITTANY, WE HAVE TIME FOR TWO MORE QUESTIONS, PLEASE.

OPERATOR: THANK YOU. AND OUR NEXT QUESTION COMES FROM MIKE STOBBE FROM AP. YOUR LINE IS NOW OPEN.

AP: HI. THANK YOU FOR TAKING MY CALL. SO 29, THAT UPDATED FIGURE. CAN YOU SAY HOW MANY WERE MODERNA AND HOW MANY WERE PFIZER? YOU TALKED ABOUT THE SITES BEING PREPARED. DO YOU HAVE INFORMATION ABOUT WHETHER ALL SITES ARE PREPARED, THAT THEY DO HAVE EPINEPHRINE ON HAND OR IS THAT — AND I’M SORRY, LAST QUESTION. ABOUT HEALTH CARE WORKERS WHO WON’T TAKE THE VACCINE, DO YOU KNOW WHAT’S GOING ON WITH THAT? IS THE CDC TAKING STEPS TO INCREASE THE UPTAKE OF THE VACCINE AMONG HEALTH CARE WORKERS IN LONG-TERM CARE FACILITIES AND HOW DOES THAT UPTAKE COMPARE TO THE UPTAKE FROM WORKERS IN A HOSPITAL? THANK YOU.

MESSONNIER: THANK YOU FOR THOSE QUESTIONS. WE ARE GOING TO WORK TO BE AS FORTHRIGHT AS POSSIBLE IN TERMS OF TRANSPARENCY OF THE DATA, AND I EXPECT TO HAVE THE DATA ON THE BREAKDOWN OF THOSE 29 CASES AVAILABLE NEXT WEEK. WE ARE WORKING ON A REGULAR CADENCE OF POSTING THOSE NUMBERS ON OUR WEBSITE. IN TERMS OF PREPARATION, I THINK THAT WE’RE PRETTY CONFIDENT IN THIS FIRST PHASE THAT SITES WERE PREPARED TO TREAT ANAPHYLAXIS, BUT MOST OF THE INITIAL VACCINATION WAS DONE EITHER IN THE HEALTH CARE SECTOR OR IN LONG-TERM CARE FACILITIES WHEN, FRANKLY, THERE IS MUCH EASIER ACCESS TO SUCH TREATMENT. AND, SO, THIS IS ONE OF THE MESSAGES THAT WE, AGAIN, WITH THIS CALL LAST WEEK NOW ARE REALLY PUSHING TO MAKE SURE THAT ANYBODY ADMINISTERING VACCINES NEEDS NOT JUST TO HAVE THE EPI PEN AVAILABLE BUT, FRANKLY, TO KNOW HOW TO USE IT AND TO KNOW HOW TO GET — WHAT THE SYMPTOMS AND SIGNS ARE THAT WE NEED YOU TO GET ADVANCED CARE. SO I THINK THAT IS A NEED FOR ADDITIONAL ASSURANCES ABOUT EDUCATION OF PROVIDERS ADMINISTERING VACCINES GOING FORWARD. ON THE THIRD ISSUE, WHICH IS WHAT ARE WE DOING ABOUT HESITANCY AMONG HEALTH CARE WORKERS, WE DO HAVE A TOOL KIT. THIS IS, I THINK, A LOT ABOUT EDUCATION AND ENGAGEMENT AND GETTING THE WORD OUT AND GETTING THE CORRECT INFORMATION OUT. AND WE ARE WORKING IN ANY WAY THAT WE CAN TO TRY TO REACH HEALTH CARE WORKERS WITH THIS CORRECT INFORMATION. I THINK THAT IF HEALTH CARE WORKERS COULD REALLY HEAR THE DATA AND SEE THE INFORMATION, IT WOULD HELP THEM MAKE THE DECISION TO GO AHEAD AND GET VACCINATED. I’M HOPING THE MEDIA CAN HELP US GET THOSE OUT AS WELL.

OPERATOR: OUR FINAL QUESTION COMES FROM BETSY McKAY FROM “WALL STREET JOURNAL”.

WSJ: THANK YOU VERY MUCH. ABOUT THE 29 CASES, WOULD THAT THEN BE 29 OUT OF 4.8 MILLION DOSES ADMINISTERED? AND IS — DOES THE 11.1 MILLION — I MEAN 11.1 RATE STILL HOLD FOR THE 29 CASES. AND THEN MY QUESTION IS, YOU MENTIONED, DOCTOR, THAT THE 21 PEOPLE WHO HAD ANAPHYLAXIS HAD NOT JUST A HISTORY OF REACTION TO THE VACCINES BUT ALLERGIES TO FOODS AND BEE STINTS OR INSECT STINGS. THAT’S A LOT OF PEOPLE. SO I’M WONDERING WHAT YOUR ADVICE IS TO PEOPLE WHO HAVE THOSE OTHER TYPES OF ALLERGIES. SHOULD THEY GET THE VACCINE?

MESSONNIER: YES. THANKS FOR THOSE QUESTIONS. WE WILL GET BACK TO YOU WITH THAT FIRST QUESTION. AGAIN, YOU KNOW, WE ARE BOTH RAPIDLY IDENTIFYING POTENTIAL ADVERSE EVENTS THAT I THINK AS YOU KNOW ANY SUCH EVENT THAT’S IDENTIFIED GOES THROUGH A PROCESS WHERE OUR TEAM ACTUALLY REVIEWS THE MEDICAL RECORDS, TALKS TO THE CLINICIAN TO MAKE SURE THAT THEY ACTUALLY MEET THE DEFINITION OF A CASE. AND SOMETIMES THAT EXTRA FEW DAYS MEANS THAT YOU CAN’T DO THE MATH THAT YOU WERE JUST DOING IN YOUR HEAD IN TERMS OF THE NUMBER OF DOSES. SO LET US GET BACK TO YOU ABOUT THAT AND FOR EVERYBODY ELSE, AGAIN, THIS IS ONE OF THE REASONS THAT WE ARE REALLY GOING TO WORK TO GET THIS DATA UP ON THE WEBSITE SO THAT IT’S CLEARER WHAT DENOMINATOR TO USE IF YOU ARE TRYING TO CALCULATE A RATE WITH THE NUMBER OF ANAPHYLAXIS CASES. IN TERMS OF THE SECOND QUESTION, YOU ARE COMPLETELY CORRECT. A LOT OF PEOPLE HAVE SOME HISTORY OF ALLERGY TO A BEE STING OR A FOOD. AND IF WE SAID — AND THE FACT THAT PEOPLE IN THIS GROUP THAT HAD ANAPHYLAXIS HAD BOTH ALLERGIC REACTIONS MAY NOT NECESSARILY MEAN THAT THERE IS ALLERGIC REACTIONS THAT PUT THEM AT HIGHER RISK, BUT IT MIGHT. THAT’S WHY GENERALLY OUR RECOMMENDATION THAT FOLKS SHOULD BE CONSULTING WITH THEIR HEALTH CARE PROVIDER. THERE IS A BIG DIFFERENCE FROM SOMEBODY WHO HAD A MILD ALLERGIC REACTION IN THEIR CHILDHOOD VERSUS SOMEBODY THAT HAD A SEVERE ALLERGIC REACTION LAST WEEK. AND IT’S GOING TO BE REALLY IMPORTANT TO HAVE A CLINICIAN ABLE TO HELP A PATIENT EXERCISE JUDGMENT AS OPPOSED TO HAVING SORT OF COMPLETELY HARD AND FAST RULES. DR. CLARK, DO YOU WANT TO COMMENT ON THAT?

CLARK: THOSE ARE THE RECOMMENDATIONS. AND IT’S IMPORTANT THAT ANYBODY WHO HAS HAD ANAPHYLAXIS TALK TO THEIR VACCINATOR ABOUT THAT AND MAKE SURE IF THEY CHOOSE TO BE VACCINATED THEY WAIT 30 MINUTES. WE ALSO DON’T HAVE — WE DO KNOW THAT PEOPLE WHO ARE — HAVE HAD ANAPHYLAXIS ARE AT RISK TO HAVE IT AGAIN, BUT WE DON’T KNOW THAT THEY’RE AT GREATER RISK FROM THESE VACCINES TO HAVE IT AGAIN. WE ALSO DON’T KNOW, YOU KNOW, MANY, MANY PEOPLE WITH HISTORIES OF ALLERGIES WHO ARE VACCINATED UNEVENTFULLY. SO IT’S A LITTLE BIT DIFFICULT TO INTERPRET.

HAYNES: THANK YOU, DOCTORS MESSONNIER AND CLARK. AND THANK YOU ALL FOR JOINING US TODAY. IF YOU HAVE FURTHER QUESTIONS, PLEASE FEEL FREE TO CALL THE MAIN MEDIA LINE AT 404-639-3286 OR E-MAIL [email protected]. THANK YOU.

OPERATOR: THANK YOU FOR YOUR PARTICIPATION IN TODAY’S CONFERENCE. ALL PARTICIPANTS MAY DISCONNECT AT THIS TIME.




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