Materials Shortages Hold Up Novavax’s Plans To Seek Vaccine Clearances
Novavax is pushing back its timeline for regulatory approval of its covid vaccine due to shortages of raw materials that would delay its production targets. The vaccine maker says it will likely still release safety and effectiveness data as soon as this month.
The Wall Street Journal:
Novavax Covid-19 Vaccine Faces Delay
Novavax Inc. has delayed plans to seek regulatory clearances for its Covid-19 vaccine, while shortages in raw materials are slowing the ramp-up in production of doses, the company said. The delays may set back efforts to increase vaccinations in developing countries, which have been dealing with limited doses of currently available shots and are looking forward to Novavax’s. (Loftus, 5/10)
Reuters:
Novavax Delays Timelines For COVID-19 Vaccine Regulatory Filings, Production
Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous forecast of sometime in the third quarter. It had also previously said it could see U.S. regulatory authorization as soon as May. (O'donnell, 5/11)
USA Today:
Novavax CEO: COVID Vaccine Safety And Effectiveness Data Coming Soon
Novavax plans to release data about its COVID-19 vaccine's safety and effectiveness maybe as soon as this month, but production issues are slowing the process, its president and CEO Stanley Erck said Monday. "All of the questions about 'whether' or 'if' are behind us now. I think we've solved those problems," Erck told USA TODAY. "It's a matter of time to get there." In its quarterly report, released Monday, the company said it revised its anticipated capacity revised downward to 100 million doses per month by the end of the third quarter, with 150 million doses per month predicted by the fourth quarter. (Weintraub, 5/10)
In other news from vaccine developers —
CBS 17:
COVID-19 Vaccine In Development At Duke, Could Be Used Alone Or As Booster Shot
Duke University is developing a vaccine to stay ahead of COVID-19 variants. This shot might also stop new viruses from jumping from animals to humans like the coronavirus did. The combination of three new findings may make it the most promising vaccine yet. (Retana, 5/10)
Axios:
BioNTech: "No Evidence" That Adapting Vaccine To Variants Is Necessary
BioNTech said Monday there is currently "no evidence" to support the need to adapt the company's coronavirus vaccine, developed with Pfizer, to be more effective against emerging variants. Some health experts fear that contagious new variants could be more resistant against COVID-19 vaccines, prolonging the pandemic for years to come. (Rummier, 5/10)
AP:
Vaccine Maker BioNTech Says No Need To Waive Patents
The head of German pharmaceutical company BioNTech said Monday that there is no need to waive patents on coronavirus vaccines because manufacturers will be able to produce enough shots to supply the world over the coming year. Ugur Sahin, the chief executive of BioNTech, rejected the U.S.-backed proposal to temporarily lift some intellectual property rights for vaccines in order to boost global supply during the ongoing pandemic. (Jordans, 5/10)
