By:  David Lim, Katherine Ellen Foley, Lauren Gardner
Source: Politico

FDA advisors set to examine Novavax Covid-19 vaccine

DECISION TIME FOR NOVAVAX — Today marks a significant day for Maryland-based vaccine maker Novavax: FDA’s independent advisers will vote on whether to recommend the agency authorize its Covid-19 shot for emergency use in adults.

But why does the U.S. need another Covid vaccine in its arsenal when nearly 77percent of adults here are fully vaccinated? The benefits of having another vaccine technology have become clear with the diminished status of Johnson & Johnson’s Covid vaccine. The Novavax vaccine could also be used by the small percentage of people allergic to a component in the messenger RNA offerings.

But FDA’s evaluation of Novavax’s 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 consistently make a product that adheres to FDA’s high purity standards.

“Multiple events of myocarditis/pericarditis were reported in temporal relationship to [Novavax vaccine] administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to” the Novavax vaccine, FDA said in its briefing document. The company said in a statement Friday it believes “there is insufficient evidence to establish a causal relationship.” Tom Shimabukuro, the head of CDC’s Immunization Safety Office, will give a presentation on vaccine-associated myocarditis this morning.

FDA also said manufacturing data and product information for the vaccines Novavax intends to use under an EUA were still being tested and submitted when the agency conducted its review. Under FDA’s EUA guidance to manufacturers, applicants must ensure vaccine quality and consistency — a longstanding issue for Novavax — to receive authorization.

PFIZER TO EXPAND MICHIGAN FACTORY FOR PAXLOVID — On Monday, Pfizer announced a $120 million investment in its Kalamazoo facility, which will support the production of components used in its Covid-19 therapeutic, Paxlovid. The increase will spur the creation of more than 250 jobs, the company said.

CDC COVID MORTALITY DATA ON 2-WEEK PAUSE — CDC’s National Center for Health Statistics’ vital statistics system will undergo a two-week upgrade that will pause its Covid-19 surveillance data updates. Data updates are expected to resume on June 20.