US FDA and BARDA ask makers of recombinant protein SARS-CoV-2 vaccines how they could match mRNA vaccines in post-strain-selection turnaround time for annual booster doses. The reply: give them a fighting chance by selecting just one strain instead of two.
If the US government wants slower options in the COVID-19 vaccine race to play a role with annual boosters now that mRNA vaccines have raised the bar on speed to market, then it should plan on boosting with monovalent vaccines rather than bivalent, several sponsors and independent experts told a 27 April workshop.
There is no downside to such a strategy, they said, because monovalent COVID-19 vaccines are quicker to manufacture and work as
The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
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Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
