Drug maker Pfizer has announced that the vaccine for COVID-19 that has been developed by Pfirzer and its partner, BioNTech, is proving to be 90% effective in the Stage 3 trials.
Around 44,000 people have been participating in the trials from Argentina, Brazil, Germany, South Africa, Turkey and the United States. Each participant is receiving two doses. Pfizer CEO Albert Boula said in a press release “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.”
Boula said the companies should be able to submit two months’ of safety data to the FDA by the third week of November. The FDA requires at least two months of safety data, to ensure the vaccine is safe with a look at side effects, in order to issue an Emergency Use Authorization for any vaccine. An EUA is not full approval, but a capability the FDA can use to get quicker ability for a drug or vaccine to get to the public, especially during this COVID-19 pandemic, but the FDA does have stringent requirements.
Boula said the other thing the FDS wants to see is that the vaccine can be consistently manufactured to meet quality standards. “Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.”
Talking on CNBC this morning, Boula said ““It is a great day for science. It is a great day for humanity.” He said the company believes it can manufacture 50 million doses by the end of the year, and 1.3 million in 2021. To get the 90% immunity numbers, people will need two doses. Boula said with the 90% effective rate–well above the FDA requirement of at least 50% efficacy–he is very confident this vaccine will do what it is intended to do.
On Oct. 22, there was an online meeting of the FDA’s Vaccine and Biological Products Advisory Committee. Much of the discussion during the seven-hour meeting was around safety.
