The Food and Drug Administration (FDA) has reportedly set a date to review the COVID-19 vaccine. A group of FDA-appointed vaccine advisors will meet for three days from December 8th to December 10th to discuss Pfizer and Moderna’s vaccines, according to sources talking to CNBC.
Pfizer, which first reported good news from the late vaccine trial last week, revised its efficacy rate from 90 percent to 95 percent on Wednesday morning. The drug company also announced that the vaccine has reached the FDA’s safety requirements.
Earlier this week, Boston-based Moderna announced a similar effective COVID-19 vaccine, saying it plans to meet safety requirements in the coming days.
Meanwhile, the Vaccination Advisory Board under the US Centers for Disease Control and Prevention (CDC) will meet next Monday to discuss vaccine access and distribution, if approved by the FDA.
However, aside from regulatory hurdles, both Pfizer and Moderna have their own challenges to overcome.
The chairman of Modana’s vaccine manufacturing partner, Swiss pharmaceutical company Ronza, told CNBC’s Squawx Box Europe on Wednesday that the company can produce 400 million doses a year at its current facility. This is less than Moderna’s goal of deploying 500 to 1 billion doses in 2021.
“We just started 10 or 11 months ago and are currently producing the first commercial batch of API in North America because we are planning the first commercial batch in 1-2 weeks in Switzerland. Speed is a challenge, “said Ronza Chairman Albert Baney.
“The second challenge is finding people,” he added. “Each production line requires 60-70 educated people. We have four production lines and we need to identify and train these people.”
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Pfizer says it will be able to receive 100 million doses by the end of this year and 500 million doses in 2021. However, both Pfizer and Moderna vaccines need to be given twice. This means that even with maximum production capacity, the two pharmaceutical companies will be able to cover a small portion of the world’s nearly 7 billion population next year.
For Pfizer, there are also major distribution issues that need to be resolved. Its mRNA-based vaccine always requires quick freezing at minus 70 degrees Celsius (-94 F). US hospitals and pharmacies do not yet understand the supply chain system for moving vaccines. Developing countries will probably face greater challenges.
Thankfully, the Moderna vaccine, which is also mRNA-based, requires less stringent storage conditions. The company said on Monday that the vaccine was stable at normal medical refrigerator temperatures (36-46 degrees Fahrenheit) for up to 30 days. Also, at minus 4 degrees Fahrenheit, it can be stored for up to 6 months.
FDA sets dates to approve Pfizer and Moderna COVID-19 vaccines
Source link FDA sets dates to approve Pfizer and Moderna COVID-19 vaccines