US in­ves­ti­gates po­ten­tial safe­ty sig­nal with Pfiz­er Covid boost­ers

The FDA and the CDC are in­ves­ti­gat­ing a “pre­lim­i­nary sig­nal” of whether there might be an in­creased risk of stroke for peo­ple who got Pfiz­er and BioN­Tech’s up­dat­ed Covid-19 vac­cine boost­er.

In a state­ment post­ed on the CDC’s web­site, the agency said its mon­i­tor­ing sys­tem for vac­cine side ef­fects had been trig­gered to look for a po­ten­tial is­sue with the shots in peo­ple ages 65 and old­er.

The CDC called the find­ings high­ly pre­lim­i­nary, and said that “no oth­er safe­ty sys­tems have shown a sim­i­lar sig­nal and mul­ti­ple sub­se­quent analy­ses have not val­i­dat­ed this sig­nal.” That in­clud­ed analy­sis of oth­er large vac­cine datasets from Medicare, the Unit­ed States De­part­ment of Vet­er­ans Af­fairs, the com­pa­nies’ own mon­i­tor­ing pro­grams and a vac­cine side-ef­fect re­port­ing col­lec­tion tool known as VAERS.

That means that it’s pos­si­ble the warn­ing could end up be­ing sta­tis­ti­cal noise, or a side ef­fect that’s very rare but enough to trig­ger an ear­ly warn­ing: “Of­ten these safe­ty sys­tems de­tect sig­nals that could be due to fac­tors oth­er than the vac­cine it­self,” the CDC said. No such sig­nal was found with Mod­er­na’s up­dat­ed boost­er.

Pfiz­er, in an emailed state­ment, said it was aware of the gov­ern­ment’s re­port and that its own da­ta showed low­er rates of strokes fol­low­ing vac­ci­na­tion in pa­tients who had been vac­ci­nat­ed, com­pared with typ­i­cal rates of stroke. “Vac­cine safe­ty re­mains of ut­most pri­or­i­ty for Pfiz­er and BioN­Tech,” the com­pa­ny said.

Any vac­cine car­ries some lev­el of risk or side ef­fect, though typ­i­cal­ly far small­er than the con­se­quences of dis­eases they are meant to guard against.

The CDC said it wasn’t mak­ing any changes to its vac­cine rec­om­men­da­tions at this time. Ac­cord­ing to da­ta col­lect­ed by the agency, 69% of the US pop­u­la­tion has com­plet­ed the orig­i­nal vac­cine se­ries, and 16% — about 50 mil­lion peo­ple — have re­ceived the up­dat­ed boost­er.

The shots re­main very ef­fec­tive in pre­vent­ing hos­pi­tal­iza­tion or death from Covid-19. Un­vac­ci­nat­ed peo­ple are about six times more like­ly to die from the dis­ease than are vac­ci­nat­ed peo­ple, ac­cord­ing to on­go­ing sur­veil­lance da­ta col­lect­ed by the agency. That gap grows sub­stan­tial­ly when com­par­ing un­vac­ci­nat­ed peo­ple to those who have re­ceived the up­dat­ed boost­er dose. The US con­tin­ues to re­port more than 2,000 Covid-re­lat­ed deaths a week.

Vac­cine risk track­ing

The CDC iden­ti­fied the safe­ty sig­nal through its vac­cine-safe­ty datalink sys­tem, or VSD, which it calls a “near re­al-time” mon­i­tor­ing sys­tem. The sys­tem trig­gered an in­ves­ti­ga­tion to look at whether peo­ple 65 and over who got Pfiz­er’s boost­er were more like­ly to have a stroke in the 21 days af­ter get­ting the shot than in days 22 to 42 af­ter vac­ci­na­tion.

“Al­though the to­tal­i­ty of the da­ta cur­rent­ly sug­gests that it is very un­like­ly that the sig­nal in VSD rep­re­sents a true clin­i­cal risk, we be­lieve it is im­por­tant to share this in­for­ma­tion with the pub­lic,” the CDC said in its state­ment.

The safe­ty sig­nal was spe­cif­ic to Pfiz­er’s up­dat­ed bi­va­lent vac­cine, which tar­gets two dif­fer­ent strains of the coro­n­avirus and was rolled out last year. The orig­i­nal and up­dat­ed vac­cine are huge sell­ers for Pfiz­er and its part­ner BioN­Tech.

The agen­cies didn’t share the spe­cif­ic rate or the num­ber of stroke cas­es that they are in­ves­ti­gat­ing. The da­ta will be up for dis­cus­sion at the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meet­ing on Jan. 26.

In 2020, when John­son & John­son’s vac­cine was first rolled out to the pub­lic, re­ports came back of clots and strokes in a hand­ful of peo­ple who had re­ceived it.

A re­view of the J&J vac­cine side ef­fects, pub­lished in the An­nals of In­ter­nal Med­i­cine, found 3.83 cas­es per mil­lion dos­es of the J&J shots de­vel­oped blood clots and low platelet counts dur­ing the De­cem­ber 2020 to Au­gust 2021 pe­ri­od. The cas­es were more com­mon in women, and about 15% of hos­pi­tal­ized cas­es were fa­tal. The re­view al­so looked at the Pfiz­er and Mod­er­na mR­NA vac­cines in use at the time, and found the rates were far low­er — 0.00855 cas­es per mil­lion dos­es.

The side ef­fects of the J&J vac­cine, while rel­a­tive­ly rare, were wide­ly cov­ered by the me­dia at the time and con­tributed to a drop in use of the com­pa­ny’s shots.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

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