Post by marriott on Jun 28, 2021 21:25:52 GMT
In a Press Release dated June 14, 2021 , Novavax stated :
"The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021. "
For those interested concerning FDA Guidance to the content and format of the CMC for vaccine products , see the following link
www.fda.gov/media/73614/download
There is much involved in the proper filing of a CMC . There are many areas where practices and procedures need to be established to meet chemistry, manufacturing and controls requirements . To direct the blame with the certainty and bitterness that some here have leveled at CEO Erck is the equivalent
of " judging " the outcome with absolutely no involvement or knowledge in the real world circumstances , conditions and issues at Novavax.
In a research note dated June 14, 2021 , Kelechi Chikere, PhD, Equity Analyst with Jefferies , wrote the following concerning the PREVENT-19 Phase 3 trial “These results come in higher than Street expectations of 80–85% and clearly position NVAX as a viable alternative to mRNA vaccines” . Further “ we are particularly encouraged by these results given the high percentage of cases due to variants and believe the data position NVAX to compete against the mRNA vaccines.
In an article in " The Atlantic " , Hilda Bastian concluded " But here’s what we know today, based on information that we have right now: Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it’s the best COVID-19 vaccine we have. "
Some have written here about the lost opportunity because of the " delay " associated with the the filing and issuance of an EUA in the UK and United States.
Over time, I believe that many here will simply remember the day when Novavax reached the market . But in the back of our minds , we will remember that sometimes something done right is better than something done prematurely.
"The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021. "
For those interested concerning FDA Guidance to the content and format of the CMC for vaccine products , see the following link
www.fda.gov/media/73614/download
There is much involved in the proper filing of a CMC . There are many areas where practices and procedures need to be established to meet chemistry, manufacturing and controls requirements . To direct the blame with the certainty and bitterness that some here have leveled at CEO Erck is the equivalent
of " judging " the outcome with absolutely no involvement or knowledge in the real world circumstances , conditions and issues at Novavax.
In a research note dated June 14, 2021 , Kelechi Chikere, PhD, Equity Analyst with Jefferies , wrote the following concerning the PREVENT-19 Phase 3 trial “These results come in higher than Street expectations of 80–85% and clearly position NVAX as a viable alternative to mRNA vaccines” . Further “ we are particularly encouraged by these results given the high percentage of cases due to variants and believe the data position NVAX to compete against the mRNA vaccines.
In an article in " The Atlantic " , Hilda Bastian concluded " But here’s what we know today, based on information that we have right now: Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it’s the best COVID-19 vaccine we have. "
Some have written here about the lost opportunity because of the " delay " associated with the the filing and issuance of an EUA in the UK and United States.
Over time, I believe that many here will simply remember the day when Novavax reached the market . But in the back of our minds , we will remember that sometimes something done right is better than something done prematurely.