The Unit­ed States Food and Drug Ad­min­is­tra­tion has giv­en its stamp of ap­proval to the Pfiz­er-BioN­Tech COVID-19 vac­cine, for per­sons 16 years of age and old­er.  It al­so will con­tin­ue to be avail­able un­der emer­gency use au­tho­riza­tion (EUA) for per­sons 12 to 15 years of age, as well as for use as a third dose in some im­muno-com­pro­mised per­sons.

An of­fi­cial state­ment is­sued by the FDA to­day states that the Pfiz­er vac­cine will now be mar­ket­ed as Comir­naty.

The FDA says the ap­proval sig­ni­fies key achieve­ment for pub­lic health.

The full state­ment is­sued by the FDA, fol­lows…

To­day, the U.S. Food and Drug Ad­min­is­tra­tion ap­proved the first COVID-19 vac­cine. The vac­cine has been known as the Pfiz­er-BioN­Tech COVID-19 Vac­cine, and will now be mar­ket­ed as Comir­naty (koe-mir’-na-tee), for the pre­ven­tion of COVID-19 dis­ease in in­di­vid­u­als 16 years of age and old­er. The vac­cine al­so con­tin­ues to be avail­able un­der emer­gency use au­tho­riza­tion (EUA), in­clud­ing for in­di­vid­u­als 12 through 15 years of age and for the ad­min­is­tra­tion of a third dose in cer­tain im­mune-com­pro­mised in­di­vid­u­als.

“The FDA’s ap­proval of this vac­cine is a mile­stone as we con­tin­ue to bat­tle the COVID-19 pan­dem­ic. While this and oth­er vac­cines have met the FDA’s rig­or­ous, sci­en­tif­ic stan­dards for emer­gency use au­tho­riza­tion, as the first FDA-ap­proved COVID-19 vac­cine, the pub­lic can be very con­fi­dent that this vac­cine meets the high stan­dards for safe­ty, ef­fec­tive­ness, and man­u­fac­tur­ing qual­i­ty the FDA re­quires of an ap­proved prod­uct,” said Act­ing FDA Com­mis­sion­er Janet Wood­cock, M.D. “While mil­lions of peo­ple have al­ready safe­ly re­ceived COVID-19 vac­cines, we rec­og­nize that for some, the FDA ap­proval of a vac­cine may now in­still ad­di­tion­al con­fi­dence to get vac­ci­nat­ed. To­day’s mile­stone puts us one step clos­er to al­ter­ing the course of this pan­dem­ic in the U.S.”

Since Dec. 11, 2020, the Pfiz­er-BioN­Tech COVID-19 Vac­cine has been avail­able un­der EUA in in­di­vid­u­als 16 years of age and old­er, and the au­tho­riza­tion was ex­pand­ed to in­clude those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA dur­ing pub­lic health emer­gen­cies to pro­vide ac­cess to med­ical prod­ucts that may be ef­fec­tive in pre­vent­ing, di­ag­nos­ing, or treat­ing a dis­ease, pro­vid­ed that the FDA de­ter­mines that the known and po­ten­tial ben­e­fits of a prod­uct, when used to pre­vent, di­ag­nose, or treat the dis­ease, out­weigh the known and po­ten­tial risks of the prod­uct.

FDA-ap­proved vac­cines un­der­go the agency’s stan­dard process for re­view­ing the qual­i­ty, safe­ty and ef­fec­tive­ness of med­ical prod­ucts. For all vac­cines, the FDA eval­u­ates da­ta and in­for­ma­tion in­clud­ed in the man­u­fac­tur­er’s sub­mis­sion of a bi­o­log­ics li­cense ap­pli­ca­tion (BLA). A BLA is a com­pre­hen­sive doc­u­ment that is sub­mit­ted to the agency pro­vid­ing very spe­cif­ic re­quire­ments. For Comir­naty, the BLA builds on the ex­ten­sive da­ta and in­for­ma­tion pre­vi­ous­ly sub­mit­ted that sup­port­ed the EUA, such as pre­clin­i­cal and clin­i­cal da­ta and in­for­ma­tion, as well as de­tails of the man­u­fac­tur­ing process, vac­cine test­ing re­sults to en­sure vac­cine qual­i­ty, and in­spec­tions of the sites where the vac­cine is made. The agency con­ducts its own analy­ses of the in­for­ma­tion in the BLA to make sure the vac­cine is safe and ef­fec­tive and meets the FDA’s stan­dards for ap­proval.

Comir­naty con­tains mes­sen­ger RNA (mR­NA), a kind of ge­net­ic ma­te­r­i­al. The mR­NA is used by the body to make a mim­ic of one of the pro­teins in the virus that caus­es COVID-19. The re­sult of a per­son re­ceiv­ing this vac­cine is that their im­mune sys­tem will ul­ti­mate­ly re­act de­fen­sive­ly to the virus that caus­es COVID-19. The mR­NA in Comir­naty is on­ly present in the body for a short time and is not in­cor­po­rat­ed in­to - nor does it al­ter - an in­di­vid­ual’s ge­net­ic ma­te­r­i­al. Comir­naty has the same for­mu­la­tion as the EUA vac­cine and is ad­min­is­tered as a se­ries of two dos­es, three weeks apart.

“Our sci­en­tif­ic and med­ical ex­perts con­duct­ed an in­cred­i­bly thor­ough and thought­ful eval­u­a­tion of this vac­cine. We eval­u­at­ed sci­en­tif­ic da­ta and in­for­ma­tion in­clud­ed in hun­dreds of thou­sands of pages, con­duct­ed our own analy­ses of Comir­naty’s safe­ty and ef­fec­tive­ness, and per­formed a de­tailed as­sess­ment of the man­u­fac­tur­ing process­es, in­clud­ing in­spec­tions of the man­u­fac­tur­ing fa­cil­i­ties,” said Pe­ter Marks, M.D., Ph.D., di­rec­tor of FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search. “We have not lost sight that the COVID-19 pub­lic health cri­sis con­tin­ues in the U.S. and that the pub­lic is count­ing on safe and ef­fec­tive vac­cines. The pub­lic and med­ical com­mu­ni­ty can be con­fi­dent that al­though we ap­proved this vac­cine ex­pe­di­tious­ly, it was ful­ly in keep­ing with our ex­ist­ing high stan­dards for vac­cines in the U.S."

FDA Eval­u­a­tion of Safe­ty and Ef­fec­tive­ness Da­ta for Ap­proval for 16 Years of Age and Old­er

The first EUA, is­sued Dec. 11, for the Pfiz­er-BioN­Tech COVID-19 Vac­cine for in­di­vid­u­als 16 years of age and old­er was based on safe­ty and ef­fec­tive­ness da­ta from a ran­dom­ized, con­trolled, blind­ed on­go­ing clin­i­cal tri­al of thou­sands of in­di­vid­u­als.

To sup­port the FDA’s ap­proval de­ci­sion to­day, the FDA re­viewed up­dat­ed da­ta from the clin­i­cal tri­al which sup­port­ed the EUA and in­clud­ed a longer du­ra­tion of fol­low-up in a larg­er clin­i­cal tri­al pop­u­la­tion.

Specif­i­cal­ly, in the FDA’s re­view for ap­proval, the agency an­a­lyzed ef­fec­tive­ness da­ta from ap­prox­i­mate­ly 20,000 vac­cine and 20,000 place­bo re­cip­i­ents ages 16 and old­er who did not have ev­i­dence of the COVID-19 virus in­fec­tion with­in a week of re­ceiv­ing the sec­ond dose. The safe­ty of Comir­naty was eval­u­at­ed in ap­prox­i­mate­ly 22,000 peo­ple who re­ceived the vac­cine and 22,000 peo­ple who re­ceived a place­bo 16 years of age and old­er.

Based on re­sults from the clin­i­cal tri­al, the vac­cine was 91% ef­fec­tive in pre­vent­ing COVID-19 dis­ease.

More than half of the clin­i­cal tri­al par­tic­i­pants were fol­lowed for safe­ty out­comes for at least four months af­ter the sec­ond dose. Over­all, ap­prox­i­mate­ly 12,000 re­cip­i­ents have been fol­lowed for at least 6 months.

The most com­mon­ly re­port­ed side ef­fects by those clin­i­cal tri­al par­tic­i­pants who re­ceived Comir­naty were pain, red­ness and swelling at the in­jec­tion site, fa­tigue, headache, mus­cle or joint pain, chills, and fever. The vac­cine is ef­fec­tive in pre­vent­ing COVID-19 and po­ten­tial­ly se­ri­ous out­comes in­clud­ing hos­pi­tal­iza­tion and death.

Ad­di­tion­al­ly, the FDA con­duct­ed a rig­or­ous eval­u­a­tion of the post-au­tho­riza­tion safe­ty sur­veil­lance da­ta per­tain­ing to my­ocardi­tis and peri­cardi­tis fol­low­ing ad­min­is­tra­tion of the Pfiz­er-BioN­Tech COVID-19 Vac­cine and has de­ter­mined that the da­ta demon­strate in­creased risks, par­tic­u­lar­ly with­in the sev­en days fol­low­ing the sec­ond dose. The ob­served risk is high­er among males un­der 40 years of age com­pared to fe­males and old­er males. The ob­served risk is high­est in males 12 through 17 years of age. Avail­able da­ta from short-term fol­low-up sug­gest that most in­di­vid­u­als have had res­o­lu­tion of symp­toms. How­ev­er, some in­di­vid­u­als re­quired in­ten­sive care sup­port. In­for­ma­tion is not yet avail­able about po­ten­tial long-term health out­comes. The Comir­naty Pre­scrib­ing In­for­ma­tion in­cludes a warn­ing about these risks.

On­go­ing Safe­ty Mon­i­tor­ing

The FDA and Cen­ters for Dis­ease Con­trol and Pre­ven­tion have mon­i­tor­ing sys­tems in place to en­sure that any safe­ty con­cerns con­tin­ue to be iden­ti­fied and eval­u­at­ed in a time­ly man­ner. In ad­di­tion, the FDA is re­quir­ing the com­pa­ny to con­duct post­mar­ket­ing stud­ies to fur­ther as­sess the risks of my­ocardi­tis and peri­cardi­tis fol­low­ing vac­ci­na­tion with Comir­naty. These stud­ies will in­clude an eval­u­a­tion of long-term out­comes among in­di­vid­u­als who de­vel­op my­ocardi­tis fol­low­ing vac­ci­na­tion with Comir­naty. In ad­di­tion, al­though not FDA re­quire­ments, the com­pa­ny has com­mit­ted to ad­di­tion­al post-mar­ket­ing safe­ty stud­ies, in­clud­ing con­duct­ing a preg­nan­cy reg­istry study to eval­u­ate preg­nan­cy and in­fant out­comes af­ter re­ceipt of Comir­naty dur­ing preg­nan­cy.

The FDA grant­ed this ap­pli­ca­tion Pri­or­i­ty Re­view. The ap­proval was grant­ed to BioN­Tech Man­u­fac­tur­ing GmbH.

About the FDA

The FDA, an agency with­in the U.S. De­part­ment of Health and Hu­man Ser­vices, pro­tects the pub­lic health by as­sur­ing the safe­ty, ef­fec­tive­ness, and se­cu­ri­ty of hu­man and vet­eri­nary drugs, vac­cines and oth­er bi­o­log­i­cal prod­ucts for hu­man use, and med­ical de­vices. The agency al­so is re­spon­si­ble for the safe­ty and se­cu­ri­ty of our na­tion’s food sup­ply, cos­met­ics, di­etary sup­ple­ments, prod­ucts that give off elec­tron­ic ra­di­a­tion, and for reg­u­lat­ing to­bac­co prod­ucts.