Pfizer Inc said on Friday it may file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before USA elections as President Donald Trump has promised. No vaccine has been approved yet, and state officials say Maine's plan will evolve as more information is known.
The change comes into force after a consultation on the plans, which include giving Britain's medical regulator the ability to grant temporary authorisation for any coronavirus vaccine that meets safety and quality standards but before it has received a full licence. "It's gratifying to have gotten to this point, to be in the position of saying that soon, the vaccine will be available to some, and that it's on its way to every resident of our commonwealth who wishes to take it", Dr. Stack noted.
No vaccines have been approved yet, but some are in late-stage trials, including vaccine candidates being developed by Moderna, Inc. of MA and Pfizer, Inc. of NY. Three were in Moderna's trial, while the other two were in Pfizer's.
One source close to the discussions told Pulse magazine that there is optimism around the potential of a December vaccine, and that the feeling is "50/50" on whether it will be available by then. Moderna has said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021. The agreement provides the US government an option to purchase an additional 500 million doses. This means that the remaining young population who are in sound health would have to wait longer to be vaccinated.
Stearns County Reports 2 More Deaths Related to COVID-19
That includes 134 people who needed intensive care because of breathing problems or other complications from their infections. Of the total cases, 855 are resolved, and there have been 57 deaths (none since mid-June), leaving 93 active cases.
In early August, Russian President Vladimir Putin declared victory, announcing the roll-out of the Sputnik V vaccine before Phase 3 trials had begun.
The researcher leading the trial, Robert Frenck, revealed this Tuesday in CNN what Pfizer plans to start testing its experimental vaccine in children from the age of 12 and that many parents have already shown interest in registering their children.
Trump's hopes had been bolstered by Pfizer executives, who have said that they could have clinical trial results sometime in October.
For an emergency use application, the FDA is requiring at least two months of safety data on half of the trial participants after their final vaccine doses, according to a guidance document released last week. But the company won't have data showing that the vaccine is safe before the third week of November at the earliest.