FDA re­view spot­lights risk of heart in­flam­ma­tion linked to No­vavax's Covid vac­cine — shares tum­ble

Shares of No­vavax $NVAX cratered af­ter the FDA’s brief­ing pa­pers hit Fri­day morn­ing spelling out con­cerns about po­ten­tial heart safe­ty is­sues with their long-await­ed Covid-19 vac­cine.

Ahead of the ex­pert pan­el re­view slat­ed for Tues­day, the agency re­view­ers ap­plaud­ed the vac­cine’s abil­i­ty to mean­ing­ful­ly re­duce the risk of mild to se­vere Covid-19. But they at­tract­ed much more at­ten­tion to a note on the FDA’s re­quest for No­vavax to change two kinds of heart in­flam­ma­tion — my­ocardi­tis and peri­cardi­tis — to an “im­por­tant iden­ti­fied risk.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER