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David Lim, Katherine Ellen Foley, Lauren Gardner
DECISION TIME FOR NOVAVAX — Today marks an important day for Maryland-based vaccine maker Novavax: Independent FDA advisers will vote on whether to recommend the agency clear its Covid-19 vaccine for emergency use in the adults.
But why does the US need another Covid vaccine in its arsenal when nearly 77% of adults here are fully vaccinated? The benefits of having an alternate vaccine technology became apparent with the diminished status of Johnson & Johnson’s Covid vaccine. The Novavax vaccine could also be used by the small percentage of people who are allergic to a component of the messenger RNA offerings.
But FDA evaluation of Novavax data raised two red flags when it was released on Friday, Lauren reports: a potential causal link to cases of heart inflammation and a lack of manufacturing data proving the company can still manufacture a product that meets the high purity standards of the FDA.
“Multiple events of myocarditis/pericarditis have been reported in temporal relation to [Novavax vaccine] administration, similar to myocarditis following COVID-19 mRNA vaccines and raising concerns about a causal relationship with” the Novavax vaccine, the FDA said in its briefing document. The company said in a statement on Friday that it believes “there is insufficient evidence to establish a causal link.” Tom Shimabukuro, chief of the CDC’s Office of Immunization Safety, will present this morning on vaccine-associated myocarditis.
The FDA also said manufacturing data and product information for the vaccines Novavax intends to use in an EUA were still being tested and submitted when the agency conducted its review. exam. According to the FDA’s EUA guidelines to manufacturers, applicants must ensure vaccine quality and consistency — a longstanding issue for Novavax — to receive clearance.
PFIZER EXPANDS MICHIGAN PLANT FOR PAXLOVID — On Monday, Pfizer announced a $120 million investment in its Kalamazoo plant, which will support the production of components used in its Covid-19 treatment, Paxlovid. This increase will spur the creation of more than 250 jobs, the company said.
CDC COVID MORTALITY DATA OVER A 2-WEEK BREAK — The CDC’s National Center for Health Statistics vital statistics system will undergo a two-week upgrade that will pause its updates of Covid-19 surveillance data. Data updates are expected to resume on June 20.