As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals

Source : 'The Pink Sheet'

The unanimous vote by US Food and Drug Administration advisers in favor of authorizing Johnson & Johnson’s COVID-19 vaccine – a slightly better tally than Pfizer...

The Evolution Of US FDA Advisory Committee Votes On COVID-19 Vaccines

Source : 'The Pink Sheet'

Dissent among the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee faded as it reviewed more coronavirus vaccine candidates.

After a confusing 17-4 vote with one abstention...

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

Source : 'The Pink Sheet'

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will not compare efficacy and safety across the authorized COVID-19 vaccines, at least in the near term, panel...

Turning COVID-19 Vaccine EUA Into A BLA Will Require Six Months Of Additional Data

Source : 'The Pink Sheet'

In a press briefing announcing the US Food and Drug Administration’s emergency use of authorization for Johnson & Johnson’s single dose COVID-19 vaccine, Peter Marks, director of the...

EU Launches ‘Structured Dialog’ To Thrash Out Supply Chain Concerns

Source : 'The Pink Sheet'

The European Commission says it plans to produce a set of concrete measures to address the supply chain issues that can lead to drug shortages in the EU by the...