BioNTech
NEWS
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax’s COVID-19 vaccine.
June is starting off with a number of important dates for the FDA, including an advisory committee meeting to discuss COVID-19 vaccines in children as young as six months.
Children under the age of five could be eligible to receive Pfizer-BioNTech’s vaccine against COVID-19 as soon as late June.
Germany’s CureVac is partnering with Belgium’s myNEO to identify specific cancer antigens in order to develop novel mRNA immunotherapies for cancer vaccines.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
A small research study published in Jama shows people with a lower body mass index (BMI) tended to maintain immunity against COVID-19 longer.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
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