The European Union’s drugs regulator on March 11 approved Johnson & Johnson’s single dose Covid-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies.
The European Union was asked to allow an extra dose of the Covid-19 vaccine developed by Pfizer and BioNTech to be taken from each vial, a practice allowed elsewhere that would make scarce supplies go further.
The European Medicines Authority (EMA) will most likely not be able to approve the Covid-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January 2021, the watchdog’s Deputy Executive Director Noel Wathion said.
The chief executive of Germany’s BioNTech SE said the biggest challenge facing the company and partner Pfizer Inc. now that their Covid-19 vaccine is authorized for use in the United States will be to scale up manufacturing to meet huge demand.
If all things go well, the Pfizer-BioNTech Covid-19 vaccine will receive EUA from the U.S. Food and Drug Administration around December 10 or within a few days after, and the Moderna vaccine will receive EUA around December 17 or within a few days after.
Moderna and Pfizer-BioNTech are in a tight race to launch their Covid-19 vaccines in Europe after the companies applied for emergency EU approval on Dec. 1, though there was uncertainty over whether a rollout could begin in 2020.
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
Moderna Inc. applied for U.S. emergency authorization for the company’s Covid-19 vaccine after full results from a late-stage study showed mRNA-1273 was 94.1% effective with no serious safety concerns.
Genentech’s influenza treatment Xofluza (baloxavir marboxil) was granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the regulatory agency.
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
