Covid-19 roundup: No­vavax may not go to FDA un­til June at ear­li­est — re­port; Bourla push­es back against IP waiv­er in pub­lic let­ter

Pub­lic health of­fi­cials hop­ing to roll­out No­vavax’s Covid-19 vac­cine will have to wait a bit longer. The com­pa­ny will not file for au­tho­riza­tion with the FDA un­til June, The Wash­ing­ton Post re­port­ed, as they con­tin­ue to wait for re­sults from their clin­i­cal tri­al and try to sort out a reg­u­la­to­ry man­u­fac­tur­ing is­sue re­lat­ed to one of their as­says.

The re­port came hours be­fore No­vavax is set to re­lease an up­date on its vac­cine pro­gram in its Q1 earn­ings call. One of the first com­pa­nies to an­nounce a Covid-19 vac­cine pro­gram in Jan­u­ary 2020, the Mary­land-based biotech showed 89% ef­fi­ca­cy in a 15,000 per­son UK study, but has strug­gled to get the prod­uct past the fin­ish line, fac­ing re­peat­ed clin­i­cal and man­u­fac­tur­ing de­lays.

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