Pfizer COVID-19 Vaccine Delayed Until At Least Late November

Vaccine development processes that usually take years have been compressed into months in many places encouraged by politicians who are seeking a quick fix for the ongoing coronavirus pandemic

The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months.

That October timeline sounded even more aggressive when Moderna CEO Stephane Bancel, known for touting ambitious goals, said his company's shot, which was the first in the move into clinical testing, likely wouldn't have data until November. Its vaccine is in late stage trials in Brazil, Indonesia and Turkey, and the company has said that an interim analysis of Phase 3 trial data could come as early as November. The news lifted the company's shares two percent in the US.

Bourla estimated Pfizer's 44,000-person study will reach that milestone in the third week of November.

Scientists have refused to disclose the results of the trials, but claim the vaccine was safe and produced an immune response that could provide six months of protection. It needs to be stored at sub-zero temperatures, creating logistical headaches in how to effectively ship and store doses so that millions of Americans can be inoculated. Money for vaccine distribution was allocated in drafts of the stimulus bill that has not yet been passed, amid opposition from Senate Republicans and inchoate negotiating tactics from the President. "After detailed deliberation, the committee recommended the firm should submit Phase III clinical trial protocol with adequate sample size and clearly defined inclusion exclusion criteria, primary and secondary end points", said the panel that advises the drug regulator on approvals for new drugs.

"First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients".

While vaccines are a crucial tool against the virus, experts have warned they can't be a substitute for behavioral measures like masks and social distancing to curb transmission. "That's wrong", Schaffner said. The last step is demonstrating that the "vaccine can be consistently manufactured at the highest quality standards".

Golikova added during the video conference that a third candidate coronavirus vaccine will receive government approval sometime in December.



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