Novavax’s Vaccine Switched Manufacturing Facilities Multiple Times Prior To EUA

One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.

vaccine manufacturing
Novavax told the FDA of a manufacturing change late in the review of the EUA request for its COVID-19 vaccine . • Source: Shutterstock

Novavax, Inc. used multiple facilities to manufacture its COVID-19 vaccine before reaching commercial scale, and even though the US Food and Drug Administration could not compare two development phase processes, the agency still green-lighted the move.

More from Manufacturing

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By 

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

More from Compliance

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By 

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.