FDA notes lack of data regarding Moderna's booster vaccine "[u]se in pregnancy and while breastfeeding, long term safety, use in immunocompromised subjects, interaction with other vaccines, use in frail subjects and unstable health conditions and comorbidities, and use in subjects with autoimmune or inflammatory disorders."
The authors of a study published Sept. 30, in the European Journal of Epidemiology Vaccines said the sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences “needs to be re-examined.”
During the Sept. 17 meeting of the FDA advisory panel to recommend whether to approve a third dose of Pfizer’s COVID vaccine, physicians pointed to data they said confirm the risks of Pfizer’s COVID vaccine don’t outweigh the benefits.
Scientists opposed to offering booster shots to all Americans said data provided by federal health officials wasn’t compelling enough to support the recommendation — some argued boosters could lead to more vaccine-resistant variants.
Data released today by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 595,622 total adverse events were reported to VAERS, including 13,068 deaths — an increase of 702 over the previous week.
Pfizer hiked its projections for COVID vaccine revenues, telling investors this week it expects booster shots, a vaccine targeting the Delta variant and anticipated authorization of its vaccines for children as young as 6 months will drive revenues higher.
The CDC’s advisory committee said there isn’t enough evidence to recommend booster shots as Pfizer reassures investors boosters will be needed long after the pandemic ends in an effort to secure its multi-billion-dollar revenue stream.