Aug 1,2022 AMA Update: Novavax vaccine questions answered | AMA COVID-19 Update

Intro hello this is the American Medical association's co9 Update today we're discussing the latest recommendations from acip on the newest covid vaccine novax who can get it and when dosing as well as details about side effects including the risk of Myer carditis I'm joined today by Dr Sandra fryhofer ama's liaison to the advisory committee on immunization practices or acip and a member of acip's covid-19 vaccine work group Dr fryover is also the chair of the AMA Board of Trustees I'm Tod hunger ama's chief experiened officer in Chicago uh welcome back Dr fryhofer we're going to start by giving uh getting some details about this new covid vaccine novaa will you tell us who can get it and how it's different from other covid vaccines well Todd this is very exciting Who can get Novavax news we now have a third type of vaccine in the fight against covid a twoos series of novax protein subunit covid vaccine is now recommended for unvaccinated adults 18 and older for primary vaccination against covid this protein-based platform is new for covid vaccines but it's not really new this technology has been around for more than 30 years it's already been used in making other vaccines for example for flu Hepatitis B and whooping cough this vaccine contains harmless Spike protein subunits with an Aden been added to boost immune response and unlike mRNA vaccines protein-based vaccines do not contain any genetic material our vast experience with protein subunit vaccines should be reassuring to those who worry about the newness of mRNA vaccine technology and as many as 26 to 37 million us adults have not yet been vaccinated and I hope this more traditional technology platform will convin some of these vaccine holdouts to roll up their sleeves the United States already has 3.2 million novax doses ready to ship that's great news I just want to key in on one thing you said you said that novax is for primary vaccination can it be used as a booster at this point no noax can only be used Can it be used as a booster as a primary series FDA has not authorized it as a booster yet however there's a lot of interest in the prospect of using vax as a booster especially since mRNA vaccines don't seem to be that durable and this was a big topic of discussion at the acip meeting the company says they'll be submitting booster data to FDA really soon FDA representative said that booster data will be reviewed very quickly as quickly as possible once that data is submitted the company also announced it started a study in May looking at novax boosters after an mRNA primary vaccine Series this study has five different arms and will test various types of novax boosters the original version as well as Omicron specific monovalent and balent boosters so more to come but to be clear right now it's only recommended as a two do primary series you can't give novax boosters at least for now all right that's very definitive uh let's talk about Effectiveness how well does it work and does it work as well as the MRNA vaccines and will it work against Omicron well great questions uh the How well does it work study data submitted to FDA says overall it was about 90% effective at preventing covid however it did not seem to work quite as well in those 65 and older vaccine efficacy in this older group was 79% and for some unexplained reason for which there's no phys doesn't make any physiological sense vaccine efficacy in those of Hispanic ethnicity was also a little lower at 77% but here's the catch the studies submitted to FDA were done before Omicron started circulating so we just don't know how it will work against Omicron the Novac studies were done during a time when the alpha variant was predominant and a South Africa study showed that Nova vax was only 51% effective against the beta variant the Omicron surge started in December 2021 and still dominates omicron's ba5 sublineage now makes up 65% and ba4 makes up up 16.3% of specimens tested and who knows what variant next on the menu and we really can't compare vaccine effectiveness of novavax to that of Mr mRNA vaccines based on the the data that we currently have available how how do uh how does novax compare as far as side effects to mRNA vaccines and what about myocarditis is that also a concern well just like the MRNA vaccines Side effects these vaccines are reactogenic so expect fatigue muscle pain joint pain headache maybe some nausea vomiting maybe a little fever these side effects usually go away within one to two days and unfortunately as we've seen with the MRNA vaccines there have been reports of myocarditis and pericarditis after novax during the clinical trials and also in early postauthorization data we know that the risk of heart complications is higher after covid disease than after mRNA Co vac ination among males and females of all ages however we can't directly compare myocarditis rates between novax and mRNA vaccines based on currently available data now in the Novac clinical safety study there were only four to six cases identified out of more than 40,000 vaccine recipients as of May uh as as as of the beginning of May of 20122 nearly 750,000 doses of novax had been administered in other countries and Global postmarketing safety data have revealed 36 cases of myocarditis or pericarditis myocarditis risk was addressed by the FDA and its guidance fact sheets and FDA explains the chance of myocarditis is very low but it can occur usually within 10 days following vaccination It also says patients uh that that have chest pain shortness of breath a fast heartbeat heart fluttering or a pounding heart should seek medical care right away post authorization safety monitoring will continue and will be so important in further defining myocarditis risk Dr fryer uh a lot of our listeners uh our physicians out there that administer vaccines can you talk about some of the specific details regarding storage Administration and dosing sure um it comes in 10 dose files Storage and it's preservative free a dose is half CC and contains five micrograms of protein subunit antigen along with 50 micrograms of of a proprietary adant Matrix M which boosts the immune response and you give it intramuscularly in the deltoid muscle novax has several logistical advantages it's easy to store easy to prepare and easy to administer you store it at regular refrigerator temperatures but don't freeze it no delusions necessary but vaccine has to be discarded if it's not used with than six hours after the first puncture of the vial and because there are 10 doses in each vial it's likely that there will be some doses wasted which is unfortunate one thing that was expected and is somewhat inconvenient there's no expiration date printed on the vial or on the carton and you have to go to a website novavax vaccine. comom to check for the expiration dat interesting um well let's think about the the dosing part specifically how long does it take to complete the Dose interval series well in the study vaccine doses were administered three weeks apart however CDC guidance says you can extend the interval between doses to as long as eight weeks this extended interval guidance is based on data from mRNA vaccines there are no specific data on extended intervals for novaa and um this is all based on the MRNA vaccine studies some studies of mRNA vaccines have indicated a lower risk of myocarditis and greater immune response with that extended interval the 8-week interval could be considered especially in young adult males to reduce P potential for myocarditis and at the same time optimize vaccine Effectiveness this extended interval recommendation does not apply to those with imuno compromising conditions CDC recommends sticking to that three-week interval for patients with imuno compromising conditions so we can get them their their immune their protection built up as quickly as possible and novax has to be used for both doses in the primary series I repeat the same vaccine product should be used for both doses in that primary series you can't mix and match with a different product or type uh well unfortunately we're finding that covid uh out there is not happening in isolation one thing that is coming up believe it or not is flu season uh which will soon be upon us can can Novac be administered at the same time as other vaccines well good news there it's fine Flu season to give flu shots and covid vaccines at the same time and that also goes for the novavax vaccine also there's no problem giving novax or any of the other covid vaccines with other vaccines with one exception orthopox virus vaccines now we're in the middle of a monkey pox outbreak aam 2000 and JIA so the two vaccines available for orthopox viruses aam 2000 has been linked to myocarditis we don't know if there's an increased risk of myocarditis with genus yet but if you've received a dose of one of these orthopox vaccines CDC suggest waiting four weeks to get a covid vaccine dose however if you've already received a covid vaccine and you're now at risk of monkey pox due to exposure no need to wait go ahead and get the monkey pox vaccine dose now and remember novaa and other covid vaccines are reactogenic and can have significant side effects the shingles vaccine shingrix also is very react reactogenic so you might want to think twice about giving both shingles vaccine and covid vaccine on the same day any final thoughts regarding noex the covid pandemic has contributed Final thoughts to health inequities American Indian and Alaskan native Black and Hispanic and Latino persons have been disproportionately affected by covid Associated hospitalizations and deaths covid vaccines represent a potential way to decrease disparities over time we know that vaccination prevents covid cases hospitalization and death as of July 2022 more than 599 million doses of covid vaccines have been administered in the US but about 26 to 37 million us adults have not yet received even a single dose of covid-19 vaccine I hope that having this more traditional vaccine platform option available will move the needle for at least some of those still not vaccinated and at least for now this vaccine is available free of charge that's great news uh thank you so much Dr fryhofer as always for sharing your expertise uh and that detailed report that wraps up our covid-19 update for today and we'll be back soon with another update video and podcast soon for resources on covid-19 visit ama.org cid-9 thanks for joining us today and please take care [Music]