Wilmington, DE—President-elect Joe Biden has vowed that politics will play no role in determining the safety and efficacy of any COVID-19 vaccine. To assure that, he said scientists will be in charge of all decisions on safety and efficacy and that all clinical data for any vaccine approved by the FDA will be made public.
He also is creating a plan for the “effective, equitable distribution” of treatments and vaccines, adding that “development isn’t enough if they aren’t effectively distributed.” He says he intends to invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee the vaccine is available to every American, cost-free.
The plans are especially important with the recent announcement by Pfizer Inc. and BioNTech SE that their COVID-19 vaccine candidate was found to be more than 90% effective in preventing infection in the first interim efficacy analysis. It was tested in participants without evidence of prior SARS-CoV-2 infection; the analysis evaluated 94 confirmed cases of COVID-19 in trial participants.
The pharmaceutical companies also note that their study enrolled 43,538 participants, with 42% having diverse backgrounds, and that no serious safety concerns were observed.
The companies advise that they plan to seek Emergency Use Authorization (EUA) from the FDA soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
Pfizer and BioNTech said the clinical trial will continue through to final analysis at 164 confirmed cases to collect further data and determine the vaccine candidate’s performance against other study endpoints.
The companies are developing an mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2.
President-elect Biden said he wants to “Ensure everyone—not just the wealthy and well-connected—in America receives the protection and care they deserve, and consumers are not price gouged as new drugs and therapies come to market.”
The president-elect has created a COVID-19 task force because the vaccination effort involves such complex logistics. States will require funding for equipment such as freezers to store vaccines, as well as public-education materials and guidance to increase uptake.
States will need a lot of money to distribute a vaccine and make sure it gets to everyone who wants it. There are complex logistics that will require planning and resources. For instance, states may need freezers to store their vaccines, and given how many people are hesitant to be vaccinated, they will need public-education materials and guidance.
Another area of special concern to pharmacists, who will be at the front lines of the vaccination effort, is plans for resolving personal protective equipment shortages. President-elect Biden said he will expand usage of the Defense Production Act to increase the supply of masks, face shields, and other personal protective equipment so that there is enough to go around.
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